ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00085410
Conditions: Adenocarcinoma of the Extrahepatic Bile Duct Adenocarcinoma of the Gallbladder Advanced Adult Primary Liver Cancer Gastrointestinal Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-01-01; Completion date: 2010-04-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well bortezomib works as first-line systemic therapy in treating patients with unresectable locally advanced or metastatic adenocarcinoma (cancer) of the bile duct or gallbladder. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the bile duct or gallbladder treated with bortezomib.

SECONDARY OBJECTIVES:

I. Determine the time to disease progression in patients treated with this drug.

II. Determine the overall survival of patients treated with this drug. III. Correlate the degree of proteasome inhibition in peripheral blood with degree of proteasome inhibition in tumor specimens of patients treated with this drug.

IV. Correlate phenotypic expression of NF-kB, p53, and other molecular markers in biliary washings and tumor biopsies with clinical outcomes in patients treated with this drug.

V. Correlate treatment with this drug with changes in phenotypic expression of molecular markers in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

Arms: arm 1: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
Interventions: intervention 1: bortezomib
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00090519
Conditions: Diabetic Retinopathy
Sponsor: Chromaderm, Inc.
Start date: 2004-02-01; Completion date: 2010-04-01
Enrollment: 731 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.

Detailed description:

Arms: arm 1: 32 milligrams (mg) once daily (QD) oral for up to 36 months arm 2: QD oral for up to 36 months
Interventions: intervention 1: ruboxistaurin intervention 2: placebo
Intervention descriptions: intervention 1: 32 mg once daily (QD) oral for up to 36 months intervention 2: QD oral for up to 36 months

Protocol documents:
Clinical trial NCT00117988
Conditions: Anaplastic Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Mantle Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-02-01; Completion date: 2010-04-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well 17-AAG works in treating patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVE:

I. Determine the complete and partial response rates and time to treatment failure in patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or classical Hodgkin's lymphoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).

SECONDARY OBJECTIVES:

I. Determine the safety of this drug in these patients. II. Determine the biologic effect of this drug on selected molecular targets in primary lymphoma cells from these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type (anaplastic large cell lymphoma vs mantle cell lymphoma vs Hodgkin's lymphoma).

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response.

After completion of study treatment, patients are followed every 3 months until disease progression.

Arms: arm 1: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response. After completion of study treatment, patients are followed every 3 months until disease progression.
Interventions: intervention 1: tanespimycin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00156013
Conditions: Lymphoma, B-Cell Lymphoma, Non-Hodgkin
Keywords: B-Cell NHL
Sponsor: Oncology Specialists, S.C.
Start date: 2005-09-01; Completion date: 2010-04-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research is being done to develop new treatment for non-hodgkin's lymphoma in subjects whose cancer has returned or resisted treatment with chemotherapy. The investigational drug clofarabine is being used in this study. An investigational drug is one that has not been approved by the United States Food and Drug Administration (FDA).

Detailed description:
The safety profile of clofarabine appears acceptable within the target populations studied to date in the clinical studies, with numerous responses observed in heavily pre-treated patients with relapsed/refractory ALL or AML. Dose escalation of clofarabine in patients with solid tumors and lymphoproliferative disorders has been limited because grade 3 and 4 myelosuppression was considered acceptable in patients with acute leukemia, provided that hematologic recovery occurred within 6 weeks of therapy , and dose escalation has proceeded as high as 40 mg/m2 in this patient population. Furthermore, no responses were observed in a recent trial in which patients with relapsed CLL were treated with clofarabine 2 mg/m2, an indolent B-cell lymphoproliferative disorder indicating that low doses are likely to be ineffective in patients with aggressive NHL. (Personal Communication with ILEX Products, INC.)

This Phase I/II study will evaluate escalating doses of clofarabine in patients with relapsed and refractory diffuse large cell B-cell NHL starting at a dose of 4 mg/m2/day for 5 consecutive days and repeated every 28 days for a maximum of 6 cycles. This dosing regimen should be evaluated in this patient population because there is no standard therapy at relapse and grade 3 and 4 myelosuppression is frequently observed with traditional NHL salvage. Additionally, patients will receive granulocyte colony stimulating factors at the discretion of the investigator. Antifungal and antibacterial prophylaxis will be administered to minimize the risk of infection.

Arms: arm 1: Clofarabine 4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles.
Interventions: intervention 1: CLOFARABINE
Intervention descriptions: intervention 1: 4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles

Protocol documents:
Clinical trial NCT00157573
Conditions: Ovarian Cancer Fallopian Tube Cancer
Keywords: Asymptomatic Clinical trial Phase II GM-CSF Immunotherapy
Sponsor: Massachusetts General Hospital
Start date: 2004-12-01; Completion date: 2010-04-01
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. This study looks at ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian cancer.

Detailed description:
This is an open labeled, single arm phase II study of GM-CSF, sargramostim delivered daily without a break in a population of healthy and fit women with evidence of recurrent but asymptomatic mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). The main goal is to determine the time to treatment termination due to disease progression or toxicity.

Arms: arm 1: GM-CSF, Sargramostim 250 μg/m\^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. arm 2: GM-CSF, sargramostim 150 μg/m\^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity fora median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m\^2 per day if applicable based on toxicity and white blood cell count.
Interventions: intervention 1: GM-CSF, sargramostim
Intervention descriptions: intervention 1: GM-CSF subcutaneous injection

Protocol documents:
Clinical trial NCT00163293
Conditions: Asthma
Keywords: Asthma Ciclesonide Exacerbation
Sponsor: AstraZeneca
Start date: 2005-01-01; Completion date: 2010-04-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.

Detailed description:
The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat children who have mild asthma.

The study enrolled 240 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Ciclesonide 100 µg
* Ciclesonide 200 µg
* Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the study drug but has no active ingredient.

All participants were asked to take two puffs from a metered-dose inhaler once daily, in the evening, for up to 12 months.

This multi-center trial was conducted in Canada, Hungary and South Africa. The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks. Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment.

Arms: arm 1: None arm 2: Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. arm 3: Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Interventions: intervention 1: Ciclesonide intervention 2: Placebo
Intervention descriptions: intervention 1: Ciclesonide metered-dose inhaler intervention 2: Ciclesonide placebo-matching metered-dose inhaler

Protocol documents:
Clinical trial NCT00220961
Conditions: Impaired Glucose Tolerance Type 2 Diabetes
Keywords: Impaired Glucose Tolerance Type 2 Diabetes Prevention Pioglitazone
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2004-01-01; Completion date: 2010-04-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine whether pioglitazone versus placebo can reduce the conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus

Detailed description:
IGT is a prediabetic state. If IGT can be prevented from progressing to overt diabetes, the hyperglycemia-related complications of this devastating disease can be prevented. Subjects with IGT will be identified with an oral glucose tolerance test (OGTT). Eligible subjects also will have a measurement of first phase insulin secretion and insulin sensitivity using the frequently sampled intravenous glucose tolerance test (FSIVGTT) and carotid intimal media thickness using carotid ultrasound. Following these measurements subjects will be randomized to receive pioglitazone or placebo and they will return every 3 months for determination of fasting plasma glucose (FPG) concentration and interim medical history. Recruitment will take place over 15 months. From the time that the recruitment period ends, subjects will be followed for a total of 24 months on pioglitazone or placebo. The OGTT will be repeated at 15,27, and 39 months, or if the FPG is ≥ 126 mg/dl on the 3-month follow up visits. If the diagnosis of diabetes is established before month 39 or at month 39, the FSIVGTT and carotid ultrasound will be repeated. At 39 months, subjects will be washed out of pioglitazone or placebo and the OGTT, FSIVGTT, and carotid ultrasound will be repeated at month 45.

Arms: arm 1: Placebo tablet similar to pioglitazone tablet arm 2: Pioglitazone tablet similar to placebo tablet
Interventions: intervention 1: Pioglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: Pioglitazone tablets - 45 mg/day intervention 2: Placebo tablets similar to pioglitazone tablets - 1 tablet/day

Protocol documents:
Clinical trial NCT00239642
Conditions: Anemia Chronic Kidney Disease
Keywords: Iron Anemia CKD
Sponsor: American Regent, Inc.
Start date: 2005-07-01; Completion date: 2010-04-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

Detailed description:
Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)

Arms: arm 1: 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously arm 2: 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously arm 3: 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Interventions: intervention 1: Venofer (iron sucrose injection) intervention 2: Venofer (iron sucrose injection) intervention 3: Venofer (iron sucrose injection)
Intervention descriptions: intervention 1: 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously intervention 2: 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously intervention 3: 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Protocol documents:
Clinical trial NCT00262730
Conditions: Glioblastoma Multiforme
Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2006-01-01; Completion date: 2010-04-01
Enrollment: 97 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as poly ICLC, may stimulate the immune system in different ways and stop tumor cells from growing. Giving poly ICLC after radiation therapy and temozolomide may stop any remaining tumor cells from growing.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide followed by temozolomide and poly ICLC works in treating patients with newly diagnosed glioblastoma multiforme.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly diagnosed glioblastoma multiforme.

Secondary

* Estimate the frequency of toxicity associated with this treatment regimen.

OUTLINE: This is an open-label, multicenter study.

* Induction chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. During the same 6 weeks, patients also receive oral temozolomide once daily. Four weeks later, patients are evaluated for disease progression. Patients with progressive disease are removed from the study. Patients with no progressive disease proceed to maintenance therapy.
* Maintenance therapy: Patients receive oral temozolomide once daily on days 1-5 (week 1). Patients also receive poly ICLC intramuscularly three times a week in weeks 2-8. Courses repeat every 9 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for survival.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Arms: arm 1: RT + TMZ 6wks, followed by

poly ICLC, temozolomide, radiation: radiation therapy
Interventions: intervention 1: poly ICLC intervention 2: temozolomide intervention 3: radiation therapy
Intervention descriptions: intervention 1: 20 mcg/kg 3x each week (Maintenance cycles) intervention 2: daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) intervention 3: RT: 60 Gy (6 weeks) concomitant therapy

Protocol documents:
Clinical trial NCT00275561
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis Fluticasone Dysphagia
Sponsor: Mayo Clinic
Start date: 2005-11-01; Completion date: 2010-04-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the esophagus becomes filled with large numbers of eosinophils, a type of white blood cell. Patients who have this condition have difficulty in swallowing (dysphagia) solid food.

Prior to treatment the patients had biopsies of their esophagus and took questionnaires regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken from the esophagus to measure any changes in the tissue from before treatment. The primary endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue) response to treatment.

Detailed description:
This was a double-blind randomized placebo controlled trial to evaluate the effect of aerosolized fluticasone therapy on symptomatic dysphagia and histologic eosinophilia in adults newly diagnosed with eosinophilic esophagitis (EoE). Participants were randomized to receive aerosolized swallowed fluticasone 880 mcg bid or placebo inhaler swallowed bid for 6 weeks.

Four mid esophageal biopsies were obtained from 10 cm above the squamo-columnar junction; then formalin-fixed and stained with hematoxylin and eosin. All esophageal biopsies were read and scored by a single expert gastrointestinal pathologist. The formalin-fixed paraffin-embedded esophageal biopsies were retrieved and underwent standard major basic protein (MBP) immunofluorescence staining. All special stain slides were then read and scored by another pathologist. 24-hour urine was collected for free cortisol by the standard technique. The original endoscopy was performed before the patient was enrolled in the trial by standard clinical technique. The endoscopy post treatment was done in the clinical research unit by the principal investigator.

Patients kept compliance logs that were reviewed at phone interviews at 2 and 4 weeks time and at the end of study evaluation. Ninety percent compliance was required for study inclusion.

At the end of 6 weeks, a 24-hour urine cortisol was done, and patients underwent a repeat endoscopy while still on treatment. Mid-esophageal biopsies were obtained and evaluated for eosinophil density and mast cell degranulation. At this visit the patients returned dysphagia and side effects questionnaires.

Arms: arm 1: Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks arm 2: Placebo inhaler swallowed bid for 6 weeks
Interventions: intervention 1: Fluticasone intervention 2: Placebo
Intervention descriptions: intervention 1: Aerosolized swallowed fluticasone 880 mg twice a day intervention 2: Placebo inhaler swallowed twice a day for 6 weeks

Protocol documents:
Clinical trial NCT00280059
Conditions: Epilepsy, Partial
Keywords: Epilepsy partial seizures pregabalin monotherapy lamotrigine comparator double-blind and randomized trial
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-08-01; Completion date: 2010-04-01
Enrollment: 660 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Lamotrigine
Intervention descriptions: intervention 1: dose 150-600 mg/day given BID intervention 2: dose 100-500 mg/day given BID

Protocol documents: