ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00472186
Conditions: Post-tonsillectomy Pain Post-tonsillectomy Activity Post-tonsillectomy Hydration
Keywords: Tonsillectomy Pain
Sponsor: Boston Children's Hospital
Start date: 2008-06-01; Completion date: 2011-02-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to determine whether post-operative pain following a tonsillectomy can be reduced by adding an antacid-like medication to the medications taken after surgery. It is hypothesized that even a small amount of stomach acid backing up and entering the mouth can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should help to decrease pain and reduce the amount of narcotic medication required for pain control.

Detailed description:
This study has been limited to children and adolescents ages 5-18 who are undergoing tonsillectomy for an indication of obstructive sleep disturbance (snoring, choking/gasping or pauses in breathing during sleep.)

Study participants will be randomized to two groups: study medication (Lansoprazole) or an inactive substance(placebo).

Participants will be asked to do all of the following:

1. Take the study medication twice a day for 14 days.
2. Keep a log book which will include:

   * Record the medications and amount of each medication taken each day for 14 days. This includes pain medication and the study drug.
   * Record your child's activity level daily for 14 days.
   * Collect your child's urine one time daily and test it using special medicated strips to monitor their daily liquid intake for 14 days.
3. Meet with a Research Assistant or Study Physician 14-21 days after the study to collect the log book and perform a post-operative examination.

Arms: arm 1: Post-operative administration of Lansoprazole arm 2: Placebo
Interventions: intervention 1: Lansoprazole intervention 2: Placebo
Intervention descriptions: intervention 1: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered. intervention 2: Placebo will also be administered based on weight.

Protocol documents:
Clinical trial NCT00514020
Conditions: Gastric Cancer
Keywords: adenocarcinoma of the stomach stage IV gastric cancer recurrent gastric cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2007-08-01; Completion date: 2011-02-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, 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 giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.

Detailed description:
OBJECTIVES:

Primary

* Compare the response rate in patients with "good risk" genotype (TSER\*2/\*2 or TSER\*2/\*3 genotype \[low TS expression\]) to historical control response rates in non-genotype selected patients.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.

Available tumor tissue samples are assessed for expression of TS at the mRNA and protein levels. The results are correlated with germline and tumor TSER genotypes as well as response to the study treatment regimen. Polymorphisms in other genes associated with treatment outcome or toxicity are also assessed.

After completion of study treatment, patients are followed periodically for 4 years.

Arms: arm 1: None
Interventions: intervention 1: fluorouracil intervention 2: leucovorin calcium intervention 3: oxaliplatin intervention 4: gene expression analysis intervention 5: polymorphism analysis intervention 6: protein expression analysis intervention 7: pharmacological study
Intervention descriptions: intervention 1: Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15. intervention 2: through a vein over 2 hours on days 1 and 15. intervention 3: 500 ml D5W through a vein over 2 hours on days 1 and 15. intervention 4: Blood collection intervention 5: Blood collection intervention 6: Blood collection intervention 7: Blood collection

Protocol documents:
Clinical trial NCT00537030
Conditions: Adult Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia
Sponsor: Children's Oncology Group
Start date: 2008-02-11; Completion date: 2011-02-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, 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 OBJECTIVES:

I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase.

II. To determine the frequency of asparaginase-related toxicity in these patients.

III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients.

SECONDARY OBJECTIVES:

I. To compare serum asparaginase activity and serum asparagine concentration between patients treated with Erwinia asparaginase on this trial and historical controls treated with PEG-asparaginase on CCG-1961 and CCG-1962.

II. To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the starting date of Erwinia asparaginase therapy.

III. To determine the presence of anti-Erwinia asparaginase antibodies in patients treated with a course(s) of Erwinia asparaginase following clinical allergy to PEG-asparaginase (PEG, pegaspargase).

IV. To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of these patients.

OUTLINE: This is a multicenter study.

Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.

Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Patients receive 6 doses of Erwinia asparaginase IM on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
Interventions: intervention 1: Asparaginase intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given IM intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00543569
Conditions: Kidney Transplantation
Keywords: kidney transplant alefacept
Sponsor: Astellas Pharma Inc
Start date: 2008-02-01; Completion date: 2011-02-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.

Detailed description:
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.

Arms: arm 1: Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. arm 2: Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. arm 3: Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. arm 4: Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
Interventions: intervention 1: Alefacept intervention 2: tacrolimus intervention 3: basiliximab intervention 4: mycophenolate mofetil intervention 5: Corticosteroids
Intervention descriptions: intervention 1: Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks. intervention 2: The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations. intervention 3: Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3. intervention 4: Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms. intervention 5: Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.

Protocol documents:
Clinical trial NCT00557505
Conditions: Neoplasms
Sponsor: Pfizer
Start date: 2007-12-01; Completion date: 2011-02-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits P-cadherin. This study will test how well the drug is tolerated, and what effects there might be. Blood will also be taken to measure the amount of drug in blood.

Detailed description:

Arms: arm 1: Single Arm study
Interventions: intervention 1: PF-03732010
Intervention descriptions: intervention 1: IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops.

Protocol documents:
Clinical trial NCT00558259
Conditions: Venous Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2007-11-01; Completion date: 2011-02-01
Enrollment: 1353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

Detailed description:

Arms: arm 1: Patient to receive dabigatran etexilatate capsules 150 mg twice daily arm 2: Patient to receive dabigatran extexilate matching placebo capsules twice daily
Interventions: intervention 1: dabigatran etexilate 150 mg twice daily (BID) intervention 2: matching placebo twice daily (BID)
Intervention descriptions: intervention 1: dabigatran etexilate capsules 150 mg BID intervention 2: Matching placebo BID

Protocol documents:
Clinical trial NCT00559507
Conditions: Estrogen Receptor-negative Breast Cancer Male Breast Cancer Progesterone Receptor-negative Breast Cancer Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-10-01; Completion date: 2011-02-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying saracatinib to see how well it works in treating patients with metastatic or locally advanced breast cancer that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the disease control rate of AZD0530 (saracatinib) in patients with metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To estimate the efficacy of AZD0530 in terms of overall response rate (complete and partial response) and progression free survival.

II. To describe the toxicity profile of AZD0530 in this patient population. III. To prospectively explore changes in circulating tumor cells from pre-treatment levels in patients receiving AZD0530.

OUTLINE:

Patients receive saracatinib orally (PO) on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Arms: arm 1: Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: saracatinib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00560352
Conditions: Multiple Myeloma
Sponsor: Bristol-Myers Squibb
Start date: 2008-02-01; Completion date: 2011-02-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.

Detailed description:

Arms: arm 1: Phase I dose escalation study
Interventions: intervention 1: Dasatinib intervention 2: Bortezomib intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD intervention 2: Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m\^2 QD, 1.3 mg/m\^2 QD intervention 3: Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD

Protocol documents:
Clinical trial NCT00607919
Conditions: Attention Deficit Hyperactivity Disorder Dyslexia
Sponsor: Eli Lilly and Company
Start date: 2008-03-01; Completion date: 2011-02-01
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)

Detailed description:

Arms: arm 1: Atomoxetine will be administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine arm 2: Placebo will be packaged in the same way as experimental drug to enforce double-blind study design. Placebo will be administered orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine.
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks intervention 2: oral, daily, for 16 weeks

Protocol documents:
Clinical trial NCT00611897
Conditions: Cognitive Dysfunction
Keywords: NMDA glutamate N-acetylcysteine P3
Sponsor: Yale University
Start date: 2006-01-01; Completion date: 2011-02-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study tests the hypothesis that extrasynaptic mechanisms are critically linked with cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in healthy humans.

Detailed description:

Arms: arm 1: The NAC capsules were administered orally in divided doses: 2000 mg followed by 1000 mg 2 hours later. Each morning, 165 min after NAC administration, subjects received a 1-min bolus of normal saline, followed by a 70-minlong saline infusion during which behavioral, cognitive, and ERP data were collected. Ketamine was administered intravenously as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min (SPM and RVP), and then .29 mg/kg for 40 min (P300 and MMN). arm 2: The placebo capsules were administered orally in divided doses: 2000 mg followed by 1000 mg 2 hours later. Each morning, 165 min after placebo administration, subjects received a 1-min bolus of normal saline, followed by a 70-minlong saline infusion during which behavioral, cognitive, and ERP data were collected. Ketamine was administered intravenously as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min (SPM and RVP), and then .29 mg/kg for 40 min (P300 and MMN).
Interventions: intervention 1: N-acetylcysteine and ketamine intervention 2: placebo and ketamine
Intervention descriptions: intervention 1: Active drug (N-acetylcysteine) intervention 2: placebo N-acetylcysteine

Protocol documents:
Clinical trial NCT00646763
Conditions: Cytokines
Sponsor: Emory University
Start date: 2008-04-01; Completion date: 2011-02-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.

Detailed description:
The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.

Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.

Arms: arm 1: These subjects will have their cytokine injections administered only to their abdomen. arm 2: The extremity arm will have their injections administered to their upper and/or lower extremities.
Interventions: intervention 1: G-CSF, GM-CSF administered at extremities intervention 2: G-CSF and GMCSF administered at abdomen
Intervention descriptions: intervention 1: Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete. intervention 2: Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.

Protocol documents:
Clinical trial NCT00672932
Conditions: HIV Infections
Keywords: raltegravir central nervous system (CNS) HIV-1 AIDS cerebrospinal fluid (CSF) immunoactivation antiretroviral therapy suppression
Sponsor: University of California, San Francisco
Start date: 2008-04-01; Completion date: 2011-02-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot study focuses on the persistence of central nervous system (CNS) immune activation that has been observed in the presence of 'effective' combination antiretroviral therapy (cART). Attention to this issue is based on the fear that chronic CNS immunoactivation can cause indolent brain injury that will eventually compromise brain function as patients survive for years on treatment. A leading hypothesis explaining this continued immunoactivation is that viral replication continues within the brain at a level too low for detection in cerebrospinal fluid (CSF), yet sufficient to stimulate local immunoactivation. Based on this hypothesis, we propose to use augmented treatment with raltegravir to test whether additional suppression of this hypothesized CNS HIV-1 replication will reduce continued CNS immunoactivation.

Detailed description:

Arms: arm 1: The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol. arm 2: Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
Interventions: intervention 1: raltegravir
Intervention descriptions: intervention 1: 400 mg two times daily for three months

Protocol documents: