ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00161213
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer stage IV pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage II pancreatic cancer
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2005-09-01; Completion date: 2010-10-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works as first-line therapy in treating patients with locally advanced or metastatic pancreatic cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the time to progression in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as first-line therapy.

Secondary

* Assess the response rate in patients treated with this regimen.
* Assess the percentage of patients treated with this regimen who survive 1 year or more.
* Assess the toxicity of this regimen in these patients.
* Assess the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, nonrandomized, open-label, uncontrolled study.

Patients receive gemcitabine hydrochloride IV over 120 minutes on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: gemcitabine hydrochloride intervention 2: imatinib mesylate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00248625
Conditions: Acute Liver Failure Hepatic Encephalopathy
Keywords: acute liver failure hepatic encephalopathy acetaminophen toxicity N-acetylcysteine
Sponsor: University of Pittsburgh
Start date: 2000-01-01; Completion date: 2010-10-01
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antidote or other specific treatment is available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver Failure (PALF) Study Registry.

Detailed description:
The Pediatric Acute Liver Failure (PALF) Study Group to identify, characterize, and develop management strategies for infants, children and adolescents who present with acute liver failure. The PALF study group includes 20 sites (17 in the United States, 2 in the United Kingdom, and 1 in Canada). The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.

Patients enrolled in the PALF study registry were able to enroll in the NAC study providing they met the additional required inclusion/exclusion criteria.

Arms: arm 1: Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and hepatic encephalopathy (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days arm 2: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and hepatic encephalopathy (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Interventions: intervention 1: N-acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge. intervention 2: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and hepatic encephalopathy (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.

Protocol documents:
Clinical trial NCT00262873
Conditions: Myelodysplastic Syndromes
Keywords: previously treated myelodysplastic syndromes refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia secondary myelodysplastic syndromes de novo myelodysplastic syndromes
Sponsor: University of Rochester
Start date: 2005-05-01; Completion date: 2010-10-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with myelodysplastic syndromes.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of bortezomib, in terms of reduced cytopenia, in patients with myelodysplastic syndromes.
* Determine the safety and toxic effects of this drug in these patients.

Secondary

* Determine changes in marrow blast percentage or karyotypic profile in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 1 year.

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

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

Protocol documents:
Clinical trial NCT00272038
Conditions: Prostate Cancer
Sponsor: Oncology Specialists, S.C.
Start date: 2005-12-01; Completion date: 2010-10-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives to evaluate the activity of Erlotinib in prostate cancer patients who are hormone refractory and androgen independent and have not been exposed to chemotherapy.

Detailed description:
This is a phase II open label single center study that evaluates the activity, efficacy, and toxicity of single agent Tarceva in chemotherapy-naive AIPC patients. Patients will receive single agent Tarceva at 150 mg daily without interruption until disease progression, unacceptable toxicity, or investigator's discretion. Eligible patients are those with documented prostate cancer (regardless of Gleason Score) who are considered hormone refractory as defined below. All patients must fail an anti-androgen withdrawal trial if they were already on such therapy. If patients were on LHRH analogues alone, they must fail the addition of an anti-androgen before being classified as hormone refractory. All patients must have adequate organ functions as specified below and have an ECOG performance status of 2 or less. It is hypothesized that 25 patients will be needed to adequately assess the activity of Tarceva in AIPC.

The activity of Tarceva in other malignancies has been demonstrated with dosed ranging from 100 to 150 mg daily. It is acceptable not to interrupt therapy unless toxicity occurs of disease progression is documented. Starting patients at 150 mg daily seems to be the most logical step, but dose reductions will be implemented based on side effects and adverse events.

Arms: arm 1: Tarceva 150 mg QD
Interventions: intervention 1: Tarceva
Intervention descriptions: intervention 1: 150mg QD

Protocol documents:
Clinical trial NCT00276406
Conditions: Constipation Diabetes Mellitus Colonic Transit Gastric Emptying
Sponsor: Mayo Clinic
Start date: 2006-05-01; Completion date: 2010-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Doctors at Mayo Clinic are doing this study to learn if pyridostigmine, a drug, affects the speed at which food travels through the stomach, intestines and colon, and if pyridostigmine improves constipation symptoms in patients with diabetes. Pyridostigmine has been approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed in this study is considered investigational.

Detailed description:
Chronic constipation in diabetes mellitus is associated with colonic motor dysfunction and is managed with laxatives. Cholinesterase inhibitors increase colonic motility. The study evaluated the effects of a cholinesterase inhibitor (pyridostigmine vs. placebo) on gastrointestinal and colonic transit and bowel function in diabetic patients with constipation.

After a 9-day baseline period, patients with diabetes mellitus and chronic constipation without defecatory disorder will be randomized to oral placebo or pyridostigmine, starting with 60 mg three times a day, increasing by 60 mg every third day up to the maximum tolerated dose of 120 mg three times a day; this dose will be maintained for 7 days. Gastrointestinal and colonic transit (assessed by scintigraphy) and bowel function will be evaluated at baseline and the final 3 and 7 days of treatment, respectively.

Arms: arm 1: Oral pyridostigmine, starting with 60 mg capsules three times per day (TID), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg TID (a total of 360 mg per day). This dose was maintained for 7 days. arm 2: Placebo (sham) capsules, matching the appearance of the active drug comparator and taken TID.
Interventions: intervention 1: Pyridostigmine intervention 2: Placebo
Intervention descriptions: intervention 1: Pyridostigmine will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days. intervention 2: If subject is randomized to placebo, placebo pills will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.

Protocol documents:
Clinical trial NCT00281632
Conditions: Peritoneal Cancer Ovarian Cancer Neoplasms, Ovarian Fallopian Tube Cancer
Keywords: Pazopanib Fallopian tube cancer Ovarian epithelial cancer Peritoneal cancer
Sponsor: GlaxoSmithKline
Start date: 2006-03-01; Completion date: 2010-10-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.

Detailed description:

Arms: arm 1: 800 mg GW786034 administered orally on a daily basis.
Interventions: intervention 1: GW786034
Intervention descriptions: intervention 1: 800 mg GW786034 administered orally on a daily basis.

Protocol documents:
Clinical trial NCT00297596
Conditions: Breast Cancer
Keywords: Metastatic HER2/neu+
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-02-01; Completion date: 2010-10-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer

Detailed description:
Eligible patients will receive a minimum of six cycles of combination therapy. If a patient is still responding to the oxaliplatin at 6 cycles, the oxaliplatin may be continued with the trastuzumab up to 10 cycles at the investigator's discretion. After discontinuing the oxaliplatin/trastuzumab combination, patients should continue with single agent trastuzumab until disease progression.

Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes. Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles.

For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab

Arms: arm 1: Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days.
Interventions: intervention 1: Trastuzumab intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes. intervention 2: Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles.

For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab

Protocol documents:
Clinical trial NCT00320385
Conditions: Neoplasms, Breast
Keywords: lapatinib GW572016 ErbB2 EGFR ErbB1 MBC FISH amplification Metastatic Breast Cancer dual tyrosine kinase inhibitor Her-2/neu
Sponsor: GlaxoSmithKline
Start date: 2005-11-01; Completion date: 2010-10-01
Enrollment: 296 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

Detailed description:

Arms: arm 1: Lapatinib 1000mg once daily in combination with trastuzumab 4mg/kg loading dose followed by 2mg/kg weekly arm 2: Lapatinib 1500mg once daily
Interventions: intervention 1: Lapatinib intervention 2: Trastuzumab
Intervention descriptions: intervention 1: oral lapatinib once daily intervention 2: IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose

Protocol documents:
Clinical trial NCT00364182
Conditions: Hemophilia B
Keywords: Hemophilia B BeneFIX
Sponsor: Pfizer
Start date: 2007-05-01; Completion date: 2010-10-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to evaluate BeneFIX infused as prophylaxis regimens, compared with BeneFIX administered as an on-demand regimen only. In the trial, subjects will participate in 4 study periods. The first period is a 16-week on-demand treatment, during which subjects will utilize BeneFIX to treat bleeding events episodically only as they occur (i.e., on-demand treatment). At the end of this period, subjects will be randomly assigned to 1 of 2 BeneFIX prophylaxis regimens: either 100 IU/kg once weekly or 50 IU/kg twice weekly, and followed for 16 weeks. At the end of this period, subjects will use on-demand treatment for 8 weeks. The purpose of this 8-week period is to mitigate the potential carry-over effect of the prior prophylaxis regimen on bleeding frequency. Following this 8-week on-demand treatment, subjects will cross-over and receive the alternate study prophylactic regimen for 16 weeks.

The primary endpoint is annualized number of bleeding episodes, compared between the first on-demand period and each of the prophylaxis regimens. A comparison of annualized bleeding episodes between the two prophylaxis regimens will also be performed. Subject-reported outcomes will also be collected using a patient diary. At 24 and 48 hours following the onset of each joint bleeding episode, information on pain, sleep, and work will be collected. Additional data on physical functioning will be recorded on the diary at the end of the 16-week on-demand period, and at the end of each prophylaxis period. Information on safety will also be collected.

Each subject will participate in this study for approximately 59 weeks (15 months), including a screening period of up to 3 weeks, an initial 16-week on-demand period, two prophylaxis treatment periods of 16 weeks each, separated by an 8-week on-demand treatment period.

A modified FIX recovery study will be performed once during each prophylaxis period.

The study diary will also be used by subjects to collect secondary endpoints. These endpoints, which are subject-reported outcomes, will be recorded in the diary at 24 and 48 hours following the onset of each joint bleeding episode. Additional data on physical functioning will be recorded on the diary at the end of the 16-week on-demand period, and at the end of each prophylaxis period.

Patients will be recruited in the United States, Canada, Europe and Russia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Recombinant Coagulation Factor IX (BeneFIX) intervention 2: Recombinant Coagulation Factor IX (BeneFIX)
Intervention descriptions: intervention 1: 100 IU/kg once weekly then crossover to 50 IU/kg twice weekly intervention 2: 50 IU/kg twice weekly then crossover to 100 IU/kg once weekly

Protocol documents:
Clinical trial NCT00381095
Conditions: Bone Neoplasms Pain, Intractable Cancer
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-12-01; Completion date: 2010-10-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.

Detailed description:
Pfizer decided to discontinue additional enrollment into the study effective Sept 5 2010 after assessing the feasibility of completing this study in a realistic timeframe.The study was not stopped for any safety concerns.

Arms: arm 1: flexible dosing arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days). intervention 2: Placebo

Protocol documents:
Clinical trial NCT00385580
Conditions: Prostate Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2007-01-01; Completion date: 2010-10-01
Enrollment: 94 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: dasatinib intervention 2: dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression intervention 2: Tablets, Oral, 100 mg, once daily (QD) treatment may continue until disease progression

Protocol documents:
Clinical trial NCT00410072
Conditions: Hepatitis B, Chronic
Sponsor: Bristol-Myers Squibb
Start date: 2007-04-01; Completion date: 2010-10-01
Enrollment: 669 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

Detailed description:

Arms: arm 1: TDF=tenofovir arm 2: ETV=entecavir; TDF=tenofovir
Interventions: intervention 1: Entecavir intervention 2: Entecavir + Tenofovir
Intervention descriptions: intervention 1: Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks intervention 2: Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks

Protocol documents:
Clinical trial NCT00411450
Conditions: Colon Cancer Colorectal Cancer Rectal Cancer Cancer Metastatic Cancer Metastatic Colorectal Cancer Oncology
Keywords: k-ras biomarker colorectal colon rectal FOLFOX FOLFIRI
Sponsor: Amgen
Start date: 2006-11-01; Completion date: 2010-10-01
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.

Detailed description:

Arms: arm 1: Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
Interventions: intervention 1: Panitumumab intervention 2: FOLFIRI
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.

Protocol documents:
Clinical trial NCT00418665
Conditions: Myelodysplastic Syndromes Thrombocytopenia
Keywords: Revlimid Lenalidomide Low Platelet Count Low Risk Myelodysplastic Syndrome Intermediate 1 Myelodysplastic Syndrome MDS Myelodysplastic Syndrome
Sponsor: Amgen
Start date: 2006-12-01; Completion date: 2010-10-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.

All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.

Detailed description:

Arms: arm 1: 750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) arm 2: Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) arm 3: Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) arm 4: 500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) arm 5: 750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)
Interventions: intervention 1: AMG 531 intervention 2: Placebo
Intervention descriptions: intervention 1: AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg. intervention 2: Subjects in the control group will receive placebo via subcutaneous injection.

Protocol documents: