ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00365053
Conditions: Advanced Malignant Mesothelioma Epithelial Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-06-01; Completion date: 2009-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 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 OBJECTIVES:

I. Determine the objective response rate in patients with unresectable malignant pleural mesothelioma (MPM) treated with PXD101.

SECONDARY OBJECTIVES:

I. Determine the overall survival and time to progression in these patients. II. Assess the toxicities associated with this drug in these patients. III. Perform molecular correlative studies on tumor tissue (optional) and peripheral blood (required) and identify potential predictive markers for response.

OUTLINE:

Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection during course 1 of treatment for biomarker correlative studies. Fetal hemoglobin (hemoglobin F) levels are measured via reverse transcriptase-polymerase chain reaction as a potential predictive marker for response.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: belinostat intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00387894
Conditions: Adult Brain Tumors
Keywords: adult glioblastoma adult gliosarcoma recurrent adult brain tumor
Sponsor: Michael Prados
Start date: 2007-01-01; Completion date: 2009-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Erlotinib 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 erlotinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the objective response rate in patients with recurrent epidermal growth factor receptor (EGFR)-positive and PTEN wild-type glioblastoma multiforme or gliosarcoma treated with erlotinib hydrochloride.

Secondary

* Assess the response rate in patients who also EGFRVIII mutant and PTEN wild type glioblastoma multiforme or gliosarcoma.
* Determine the progression-free survival of patients treated with this drug.

OUTLINE: This is an open-label study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no).

Patients receive oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may receive additional erlotinib hydrochloride after 1 year at their physician's discretion.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Arms: arm 1: During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
Interventions: intervention 1: erlotinib hydrochloride
Intervention descriptions: intervention 1: Tarceva will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.

Protocol documents:
Clinical trial NCT00389974
Conditions: Cervical Adenocarcinoma Cervical Adenosquamous Cell Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Cancer Stage IVB Cervical Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-01-01; Completion date: 2009-03-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well sunitinib malate works in treating patients with cervical cancer which cannot be cured by standard therapy. Sunitinib malate may stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the efficacy (objective response rate) of sunitinib (sunitinib malate) given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or metastatic carcinoma of the cervix.

II. To assess the toxicity of sunitinib in patients with unresectable, locally advanced or metastatic carcinoma of the cervix.

III. To document time to progression, early objective progression rate, and, if objective responses are observed, response duration.

OUTLINE:

Patients receive sunitinib malate orally (PO) daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) may receive 2 courses after CR or PR is reached.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.

Arms: arm 1: Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00392041
Conditions: Fibromyalgia Insomnia
Keywords: Fibromyalgia Insomnia Sleep Eszopiclone Lunesta
Sponsor: Lesley A. Allen, Ph.D.
Start date: 2006-08-01; Completion date: 2009-03-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.

Detailed description:
Fibromyalgia (FM) is a prevalent, debilitating, and costly syndrome. Although the pathophysiology of FM is not yet well-understood, sleep disturbance is a prominent feature of most theories. Eszopiclone has been approved by the FDA for the treatment of insomnia, but has not been studied in the treatment of FMS. The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia (FMS) in FMS patients. Participants will be randomly selected to receive eszopiclone or placebo. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eszopiclone intervention 2: placebo
Intervention descriptions: intervention 1: 3mg qpm for 12 weeks intervention 2: 1 pill qpm for 12 weeks

Protocol documents:
Clinical trial NCT00392379
Conditions: Smokeless Tobacco Use
Keywords: Tobacco use disorder Tobacco cessation
Sponsor: Mayo Clinic
Start date: 2007-01-01; Completion date: 2009-03-01
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Detailed description:
Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment

Arms: arm 1: 4 mg nicotine lozenges for 3 months arm 2: Placebo nicotine lozenges for 3 months
Interventions: intervention 1: Nicotine Lozenges intervention 2: Placebo lozenge
Intervention descriptions: intervention 1: Nicotine lozenges, 4 mg intervention 2: Placebo lozenge

Protocol documents:
Clinical trial NCT00393705
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes type 2
Sponsor: Eli Lilly and Company
Start date: 2006-10-01; Completion date: 2009-03-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.

Detailed description:

Arms: arm 1: Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved. arm 2: Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).
Interventions: intervention 1: Insulin Biphasic Aspart 30/70 intervention 2: insulin lispro LM intervention 3: insulin lispro MM intervention 4: insulin lispro LM
Intervention descriptions: intervention 1: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks intervention 2: Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels. intervention 3: Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks intervention 4: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks

Protocol documents:
Clinical trial NCT00395629
Conditions: Iron Overload Hereditary Hemochromatosis
Keywords: Deferasirox ICL670A Iron chelators Deferiprone Transfusional Hemochromatosis
Sponsor: Novartis Pharmaceuticals
Start date: 2006-08-01; Completion date: 2009-03-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.

Detailed description:

Arms: arm 1: Three dose cohorts: 5 mg/kg/day, 10 mg/kg/day, 15 mg/kg/day
Interventions: intervention 1: Deferasirox (ICL670)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00397046
Conditions: Tumors
Keywords: Advanced Malignant Solid Tumors HKI-272 Neratinib Nerlynx
Sponsor: Puma Biotechnology, Inc.
Start date: 2006-11-01; Completion date: 2009-03-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to assess the tolerability and safety of HKI-272, and to determine the maximum dose that can safety be given. The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors.

Detailed description:
This is a phase 1 open-label sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will participate in only 1 dose group and will receive a single dose of test article, followed by a 1-week observation period, and then will receive the test article administered once-daily by mouth in cycles consisting of 28 days. Subjects will be enrolled in groups of 3 to 6. Adverse events and dose-limiting toxicities will be assessed from the first single dose.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: neratinib
Intervention descriptions: intervention 1: HKI-272

Protocol documents:
Clinical trial NCT00398918
Conditions: Alcoholism
Sponsor: Boston University
Start date: 2006-11-01; Completion date: 2009-03-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a pilot study in which our intent is to establish an alcohol administration laboratory in which we will be able to test the effect of the anticonvulsant medication zonisamide as compared to placebo on alcohol self administration and on cognitive functioning in non treatment seeking heavy users of alcohol. Our first goal is to establish the safety of zonisamide when used together with alcohol. Our second goal is to test the effect of an acute dose of zonisamide on alcohol consumption and show that it may reduce the consumption of alcohol. To achieve this goal we seek subjects with a history of heavy drinking to be tested on the self-administration procedures described below in two sessions with either zonisamide or placebo. These procedures will involve first, the administration of a challenge dose of ethanol to evaluate the effect of alcohol on performance on neuropsychological tests. This initial challenge will be followed by a period of alcohol self-administration in which the research subject can choose to select either ethanol or another reinforcer, money.

Detailed description:
In preclinical studies three novel anticonvulsants have been studied. The administration of tiagabine did not decrease ethanol consumption in rodents (Schmitt et al., 2002; Rimondini et al., 2002). In a study with alcohol preferring mice topiramate reduced alcohol consumption in a two bottle choice prolonged access model of drinking (Gabriel and Cunningham, 2005). In a study done at our laboratory both topiramate and zonisamide were found to have similar effects on reducing the consumption of ethanol in Wistar rat (Knapp et al., 2004). More recently we found that zonisamide administration decreased alcohol consumption in a limited access model in the C57BL/B6 mouse. These results suggest that zonisamide might be useful as a medication for the treatment of alcohol dependence.

Topiramate and zonisamide have some structural similarities with a sulfamate or methane-sulfonamide containing chain respectively attached to cyclic structure. These structural similarities may explain some of their pharmacological similarities including blockade of voltage sensitive sodium channels and low potency inhibition of carbonic anhydrase (Taverna et al., 1999; Dodgson et al., 2000; Schaf et al., 1987; Masudaet al., 1993). Both topiramate and zonisamide promote weight loss (McElroy et al., 2003; McElroy et al., 2004; Gadde et al., 2003). This effect may be a result of neuromodulation of the regulation of alcohol and food shared by these drugs.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: zonisamide intervention 2: Placebo
Intervention descriptions: intervention 1: zonisamide (100 mg)one time intervention 2: Placebo Comparator

Protocol documents:
Clinical trial NCT00406315
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-11-01; Completion date: 2009-03-01
Enrollment: 255 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.

Detailed description:

Arms: arm 1: atypical antipsychotic for the treatment of schizophrenia
Interventions: intervention 1: ziprasidone
Intervention descriptions: intervention 1: Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase

Protocol documents:
Clinical trial NCT00419159
Conditions: Colorectal Cancer
Keywords: Colorectal cancer metastatic colorectal adenocarcinoma anti-EGFR antibody
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2009-03-01
Enrollment: 199 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Everolimus (RAD001)
Intervention descriptions: intervention 1: Everolimus was supplied in 5 mg tablets in blister packs.

Protocol documents:
Clinical trial NCT00422227
Conditions: Rheumatoid Arthritis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-06-01; Completion date: 2009-03-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.

Detailed description:

Arms: arm 1: Etanercept + Methotrexate arm 2: DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide
Interventions: intervention 1: Etanercept , Methotrexate intervention 2: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
Intervention descriptions: intervention 1: * Etanercept: 25 mg twice weekly over 16 weeks, SC
* Methotrexate: \> 7.5 mg/week and no more than 25 mg/week, PO intervention 2: * Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
* Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO
* Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day
* Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily

Protocol documents:
Clinical trial NCT00423592
Conditions: Pulmonary Hypertension
Sponsor: Gilead Sciences
Start date: 2005-05-01; Completion date: 2009-03-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This Phase 2 study was to determine the incidence of increased serum aminotransferase concentrations (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]), as well as the overall safety and tolerability of ambrisentan, in participants with pulmonary arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST concentrations.

Detailed description:

Interventions: intervention 1: ambrisentan
Intervention descriptions: intervention 1: All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).

Protocol documents:
Clinical trial NCT00437294
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-03-01; Completion date: 2009-03-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: enzastaurin intervention 2: placebo intervention 3: capecitabine
Intervention descriptions: intervention 1: 1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease intervention 2: oral, daily, 21-day cycles until progressive disease intervention 3: 1250 mg/m\^2, BID, days 1-14 of each 21-day cycle until progressive disease

Protocol documents:
Clinical trial NCT00442104
Conditions: Infantile Spasms
Keywords: infantile spasms anticonvulsant pediatric epilepsy West Syndrome epileptic spasms
Sponsor: Marinus Pharmaceuticals
Start date: 2007-01-01; Completion date: 2009-03-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To allow open-label extension to patients who have completed Protocol 1042-0500

Detailed description:
Patient should have completed all scheduled clinical study visits in the double blind, controlled trial (Protocol 1042-0500) and have been deemed eligible (had a response to treatment) by the Investigator. Male or female, with a diagnosis of IS with a video EEG (vEEG) recording confirming the diagnosis.

There will be a total of 14 visits over 99(+or-1)week. A 24-hr vEEG is only required if the subject has been spasm-free for more than 24-hrs.

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

Protocol documents: