ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00448682
Conditions: Gastric Cancer
Keywords: recurrent gastric cancer stage IV gastric cancer adenocarcinoma of the stomach
Sponsor: University of Miami
Start date: 2005-06-01; Completion date: 2010-03-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as floxuridine, leucovorin, oxaliplatin, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works as first-line therapy in treating patients with stage IV gastric cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Determine the overall response rate in patients with unresectable stage IV gastric adenocarcinoma treated with floxuridine, leucovorin calcium, oxaliplatin, and docetaxel as first-line treatment.

Secondary

* Determine the feasibility of this regimen in managing patients with unresectable stage IV gastric adenocarcinoma who have not received prior chemotherapy for metastatic disease.
* Determine disease-free survival of patients treated with this regimen.
* Evaluate overall survival of patients treated with this regimen.
* Assess the safety and toxicity of this regimen in these patients.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over 30 minutes, floxuridine IV over 24 hours, and leucovorin calcium IV over 24 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Arms: arm 1: Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:

Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.

Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).

There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles.
Interventions: intervention 1: Docetaxel intervention 2: Floxuridine intervention 3: Leucovorin intervention 4: Oxaliplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00449163
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum
Sponsor: University of Miami
Start date: 2006-03-01; Completion date: 2010-03-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer.

Detailed description:
For the purpose of this study treatment cycle consist of six weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29 according to the schedule. There will be no treatment delivered on weeks 3 \& 6 (Days 15 and 36).

Disease will be evaluated by CT scan at the completion of every two cycles. Patients with complete response (CR), or partial response (PR), will be evaluated for possible surgical resection. Patients who become operable will continue to be evaluated for survival and disease relapse. Patients with stable disease (SD), and those with less than pCR after surgery should continue chemotherapy until radiographic evidence of tumor progression is identified or unacceptable side effects.

Arms: arm 1: Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:

* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
Interventions: intervention 1: Bevacizumab intervention 2: Floxuridine intervention 3: Irinotecan intervention 4: Leucovorin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00464542
Conditions: Bacterial Vaginosis
Keywords: herpes simplex virus
Sponsor: University of Pittsburgh
Start date: 2007-12-01; Completion date: 2010-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.

Detailed description:
An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is its high frequency of asymptomatic shedding in the genital tract, as transmission usually occurs during these periods of subclinical reactivation of the virus. Therefore, an improved understanding of the risk factors associated with HSV-2 shedding is needed.

Preliminary data suggests that bacterial vaginosis (BV) may be associated with increased genital tract shedding of HSV-2. As BV is the most common cause of vaginal symptoms in reproductive age women, even modest associations with genital tract shedding of HSV-2 would result in substantial attributable risks for transmission of the virus.

This study assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV. Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. These women were instructed to self-collect daily swab specimens for HSV-2 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) analysis from the lower genital tract for one month. At the end of the one month follow-up visit, each participant completed a one week course of oral metronidazole for treatment of BV. This was followed by daily home collection of genital tract swab specimens for an additional one month.

Arms: arm 1: Observational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days
Interventions: intervention 1: Metronidazole
Intervention descriptions: intervention 1: 500 mg, taken by mouth, two times a day, 7 days

Protocol documents:
Clinical trial NCT00479856
Conditions: Relapsed Breast Cancer Neoplasms, Breast
Keywords: ErbB1 ErbB2 GW572016 lapatinib Relapsed breast cancer dual tyrosine kinase inhibitor MBC EGFR Her-2/neu FISH amplification
Sponsor: GlaxoSmithKline
Start date: 2007-11-01; Completion date: 2010-03-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of lapatinib in combination with chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing breast cancer whose disease has progressed during or within 12 months after completion of trastuzumab-containing therapy in the neoadjuvant or adjuvant setting.

Detailed description:

Arms: arm 1: Lapatinib is administered in combination with one of the following chemotherapies based on the discretion of the investigator : capecitabine, docetaxel or nab-paclitaxel.
Interventions: intervention 1: Lapatinib intervention 2: Capecitabine intervention 3: Docetaxel intervention 4: nab-Paclitaxel
Intervention descriptions: intervention 1: Small molecule tyrosine kinase inhibitor intervention 2: Chemotherapy intervention 3: Chemotherapy intervention 4: Chemotherapy

Protocol documents:
Clinical trial NCT00498628
Conditions: Alcoholism Alcohol Abuse
Keywords: Alcoholism Alcohol dependence Quetiapine
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date: 2007-12-01; Completion date: 2010-03-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.

Detailed description:
This study will investigate quetiapine fumarate XR (SEROQUEL XR®), a dibenzothiazepine derivative, as a potential medication for treating alcohol dependence. The immediate release form of quetiapine fumarate, SEROQUEL XR®, is approved by the FDA for treatment of schizophrenia and acute manic episodes associated with bipolar disorder. The extended release formulation (SEROQUEL XR®) is also approved by the FDA and is undergoing clinical investigation for the treatment of major depressive disorders, schizophrenia, generalized anxiety disorder, and alcohol dependence.

Treatment with other atypical antipsychotics such as clozapine and olanzapine has resulted in decreases in alcohol use in alcohol dependent patients with and without comorbid psychiatric diagnoses. Quetiapine, like clozapine, appears to have efficacy in reducing drug and alcohol use among alcoholics and drug dependent patients with co-morbid psychiatric illness.

Arms: arm 1: Quetiapine fumarate plus medical management arm 2: Medical management plus placebo comparator
Interventions: intervention 1: Quetiapine fumarate intervention 2: Placebo
Intervention descriptions: intervention 1: Quetiapine fumarate- taken daily, for 12 weeks intervention 2: Placebo

Protocol documents:
Clinical trial NCT00504777
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2007-07-01; Completion date: 2010-03-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate
Intervention descriptions: intervention 1: 1000mg iv on days 1 and 15 intervention 2: 10-25mg/week po or parenteral

Protocol documents:
Clinical trial NCT00520234
Conditions: Invasive Candidiasis
Keywords: Candida Prophylaxis High risk adults Intensive care unit (ICU)
Sponsor: Mycoses Study Group
Start date: 2007-08-01; Completion date: 2010-03-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.

Detailed description:

Arms: arm 1: Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy arm 2: Normal Saline 100 cc IV daily
Interventions: intervention 1: Caspofungin intervention 2: Normal Saline
Intervention descriptions: intervention 1: 50 mg IV daily intervention 2: 100 cc IV daily

Protocol documents:
Clinical trial NCT00520286
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine Dependence
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2007-12-01; Completion date: 2010-03-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Detailed description:
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.

Arms: arm 1: Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks arm 2: Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: 200 mg or 400 mg /daily intervention 2: Placebo / daily

Protocol documents:
Clinical trial NCT00520299
Conditions: Metastatic Melanoma Skin Cancer Neoplasm
Keywords: metastatic melanoma ADI ADI-PEG 20 ADI SS PEG 20,000mw arginine enzyme therapy
Sponsor: Ludwig Institute for Cancer Research
Start date: 2007-07-01; Completion date: 2010-03-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This was a phase 1/2, open-label, dose-escalation study of arginine deiminase linked via succinimidyl succinate to polyethylene glycol of 20,000 molecular weight (ADI-PEG 20) in subjects with advanced melanoma. ADI-PEG 20 was administered intramuscularly (IM) at escalating doses weekly for 9 weeks (cycle 1) or 8 weeks (subsequent cycles). The primary objectives were to the establish the safety, tolerability, and clinical efficacy of ADI-PEG 20. Secondary objectives included evaluation of the metabolic activity by \[18F\]-fluorodeoxyglucose positron emission tomography (FDG PET), pharmacodynamics, correlation of immunogenicity with clinical response, and correlation of argininosuccinate synthetase (ASS) tumor expression with clinical response.

Detailed description:
A 3+3 design was implemented during phase 1, in which 3 to 6 subjects were enrolled sequentially into the following escalating dose cohorts:

* Cohort 1 (40 IU/m\^2)
* Cohort 2 (80 IU/m\^2)
* Cohort 3 (160 IU/m\^2)

Subjects were monitored for dose-limiting toxicity (DLT) during the first 2 weeks of cycle 1, with DLT defined as any grade 3 or higher toxicity. The maximum tolerated dose (MTD) was defined as the cohort in which \< 33% of subjects (ie, 0/3 or 1/6 subjects in a cohort) experienced DLT. In phase 2, the MTD cohort was expanded in up to 25 patients.

Subjects who completed treatment in cycle 1 without DLT were eligible to initiate cycle 2 at week 10 provided that a computed tomography (CT) scan showed either enlargement of existing disease without accompanying symptoms OR stable disease or improvement with no unacceptable toxicity. The same radiologic criteria applied for initiation of subsequent cycles. Subjects could continue to receive study treatment until disease progression.

Arms: arm 1: Subjects received ADI-PEG 20 at a dose of 40 IU/m\^2 arm 2: Subjects received ADI-PEG 20 at a dose of 80 IU/m\^2 arm 3: Subjects received ADI-PEG 20 at a dose of 160 IU/m\^2
Interventions: intervention 1: ADI PEG 20
Intervention descriptions: intervention 1: Intramuscular injections were administered into the deltoid, gluteal, or quadricep muscles once weekly (± 2 days) for 9 weeks during cycle 1 and 8 weeks during subsequent cycles

Protocol documents:
Clinical trial NCT00520403
Conditions: Renal Cell Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-09-01; Completion date: 2010-03-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Interferon alfa-2a intervention 3: Vinblastine
Intervention descriptions: intervention 1: 15mg/kg iv every 3 weeks intervention 2: 3 MioIU sc escalating to 18 MioIU sc, 3 times weekly intervention 3: 0.1mg/kg iv every 3 weeks

Protocol documents:
Clinical trial NCT00534976
Conditions: Exercise-induced Bronchoconstriction (EIB)
Sponsor: Organon and Co
Start date: 2008-02-01; Completion date: 2010-03-01
Enrollment: 364 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.

Detailed description:

Arms: arm 1: Participants 4-5 years: A single dose of 4 mg Montelukast chewable tablet daily, crossing over to matching placebo (Pbo) after a 3- to 7-day washout period (no participants 4-5 years were enrolled)

Participants 6-14 years: A single dose of 5 mg Montelukast chewable tablet daily, crossing over to matching Pbo after a 3- to 7-day washout period arm 2: Participants 4-5 years: A single dose of 4 mg Pbo chewable tablet daily, crossing over to Montelukast 4 mg chewable tablet after a 3- to 7-day washout period (no participants 4-5 years of age were enrolled)

Participants 6-14 years: A single dose of 5 mg Pbo chewable tablet daily, crossing over to Montelukast 5 mg chewable tablet after a 3- to 7-day washout period
Interventions: intervention 1: Comparator: montelukast sodium intervention 2: Comparator: Comparator: placebo (unspecified)
Intervention descriptions: intervention 1: Patients 4-5 years: 4 mg Montelukast chewable tablet daily

Patients 6-14 years: 5 mg chewable tablet daily intervention 2: Patients 4-5 years: 4 mg Pbo chewable tablet daily

Patients 6-14 years: 5 mg Pbo chewable tablet daily

Protocol documents:
Clinical trial NCT00546364
Conditions: Breast Neoplasms
Sponsor: R-Pharm
Start date: 2008-02-01; Completion date: 2010-03-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 intervention 2: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 intervention 3: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Intervention descriptions: intervention 1: Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle. intervention 2: Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle. intervention 3: Docetaxel 75 mg/m\^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.

Protocol documents:
Clinical trial NCT00560573
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Pfizer
Start date: 2007-11-01; Completion date: 2010-03-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1 Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: CP-751,871 intervention 2: Cisplatin intervention 3: Gemcitabine intervention 4: Pemetrexed
Intervention descriptions: intervention 1: CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year). intervention 2: Cisplatin 75\* mg/m2 or 80\* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles.

\* 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine intervention 3: Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles intervention 4: Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle

Protocol documents: