ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00267748
Conditions: Carcinoma, Renal Cell
Sponsor: Pfizer
Start date: 2005-12-01; Completion date: 2010-06-01
Enrollment: 317 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.

The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sunitinib Malate Continuous Daily Dosing intervention 2: Sunitinib Malate Schedule 4/2
Intervention descriptions: intervention 1: Sunitinib malate starting dose 37.5 mg daily continuous daily regimen. intervention 2: Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.

Protocol documents:
Clinical trial NCT00275509
Conditions: Kidney Failure, Chronic
Keywords: kidney transplantation positive crossmatch antibody mediated rejection rejection induction therapy trial
Sponsor: Johns Hopkins University
Start date: 2007-01-01; Completion date: 2010-06-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.

Detailed description:
Kidney transplantation is widely recognized as the optimal therapy for the management of end-stage renal disease. Presently, the deceased donor kidney waiting list has expanded disproportionately with the number of transplant procedures that are performed in the United States. To further compound this problem, as many as 1/3 of the patients on this list are highly sensitized against a broad range of potential donors.

In order to address this problem, we developed an antibody depletion protocol that permits transplantation in patients who have a positive crossmatch with their live donor. The protocol consists of standard immunosuppressant therapy, plasmapheresis, and intravenous immunoglobulin infusion. We have successfully performed transplantation in over 100 such patients with low complication rates.

Because these patients have been exposed to their donor's human leukocyte antigen (HLA) they are at high risk for both acute cellular and acute antibody-mediated rejection. This intent of this prospective, randomized, open-label trial is to determine whether induction therapy (i.e. therapy given at the time of transplantation for prophylaxis) with Thymoglobulin is associated with a lower 6-month incidence of acute cellular and antibody-mediated rejection than with our standard therapy, daclizumab.

Arms: arm 1: Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6. arm 2: Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
Interventions: intervention 1: Thymoglobulin intervention 2: Daclizumab intervention 3: Plasmapheresis intervention 4: Mycophenolate mofetil intervention 5: Tacrolimus intervention 6: Dexamethasone intervention 7: Prednisone intervention 8: Cytogam
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered intervention 4: 2 gm/day. Standard of care intervention 5: To achieve serum level of 8-10 ng/ml. intervention 6: 100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses intervention 7: Taper over three months to 5 mg daily intervention 8: Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered

Protocol documents:
Clinical trial NCT00290693
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer
Sponsor: University of Miami
Start date: 2004-07-01; Completion date: 2010-06-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine 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 giving capecitabine together with docetaxel works in treating patients with recurrent or progressive metastatic pancreatic cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the overall (complete and partial) response rate in patients with recurrent or progressive metastatic pancreatic cancer treated with capecitabine and docetaxel.

Secondary

* Determine the overall and progression-free survival of patients treated with the chemotherapy combination.
* Determine the duration of response (complete or partial) among patients who attain a response.
* Determine the frequency of patients having \> 50% fall of CA19-9 from an initial level of \> 100 U/mL in association with treatment with this regimen.
* Evaluate the toxicity associated with the administration of the combination in these patients.

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

Patients receive oral capecitabine twice daily on days 1-14 and docetaxel IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 1 year.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Arms: arm 1: Capecitabine + Docetaxel (Taxotere)
Interventions: intervention 1: Capecitabine intervention 2: Docetaxel
Intervention descriptions: intervention 1: Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle intervention 2: 30 mg/m2, IV, days 1 and 8 every 3 weeks

Protocol documents:
Clinical trial NCT00293202
Conditions: End Stage Renal Disease
Keywords: etanercept malnutrition inflammation hemodialysis
Sponsor: Kaysen, George A., M.D., Ph.D.
Start date: 2005-01-01; Completion date: 2010-06-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid arthritis. We are examining whether Etanercept is effective in improving the nutritional status of hemodialysis patients as a consequence of its ability to decrease inflammation.

Detailed description:
Hemodialysis patients with end stage renal disease have a high mortality rate. In individual patients, mortality is associated with a low serum albumin concentration, a marker of poor nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since efforts to improve nutrition through dietary intake have not been successful, inflammation is thought to play a key role in determining nutritional status. Recently, it has been shown that malnutrition, inflammation, and atherosclerosis are closely related in patients with chronic renal failure. It is our hypothesis that suppression of the cycle of inflammation, malnutrition, and vascular injury caused by atherosclerosis will improve survival in dialysis patients. This study is designed to examine whether suppression of the inflammatory response can be accomplished safely with Etanercept and to determine if this suppression will improve nutritional status and clinical outcome in hemodialysis patients with poor nutritional status and evidence of inflammation.

Arms: arm 1: Etanercept 25 mg injection twice a week arm 2: Saline injection twice a week
Interventions: intervention 1: Etanercept intervention 2: Placebo
Intervention descriptions: intervention 1: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week intervention 2: Hemodialysis patients will receive Saline by subcutaneous injection twice a week

Protocol documents:
Clinical trial NCT00305162
Conditions: Myocardial Infarction (MI) Acute Coronary Syndromes (ACS)
Keywords: Acute Coronary Syndrome (ACS) Percutaneous Coronary Intervention (PCI) non-ST-segment elevation myocardial infarction (NSTEMI) ST-segment elevation myocardial infarction (STEMI)
Sponsor: The Medicines Company
Start date: 2006-04-01; Completion date: 2010-06-01
Enrollment: 8882 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.

Detailed description:

Arms: arm 1: placebo capsules (to match) + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion arm 2: clopidogrel capsules (600 mg) + placebo bolus \& infusion (to match) + placebo capsules (to match) post infusion
Interventions: intervention 1: Cangrelor (P2Y12 inhibitor) intervention 2: clopidogrel (oral P2Y12 inhibitor) intervention 3: Placebo bolus & placebo infusion intervention 4: Placebo capsules - end of infusion intervention 5: Placebo capsules - as soon as possible after randomization
Intervention descriptions: intervention 1: IV bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion). intervention 2: 600 mg active clopidogrel administered as soon as possible following randomization (after need for PCI confirmed), but not more than 30 minutes prior to the placement of the arterial access. intervention 3: placebo bolus (30 mcg/kg) \& placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) intervention 4: Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing intervention 5: Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing

Protocol documents:
Clinical trial NCT00314353
Conditions: Colorectal Neoplasms
Keywords: NSABP bevacizumab capecitabine oxaliplatin irinotecan rectal cancer colon cancer colorectal cancer
Sponsor: NSABP Foundation Inc
Start date: 2006-03-01; Completion date: 2010-06-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.

Detailed description:
Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bevacizumab intervention 2: Oxaliplatin intervention 3: Capecitabine intervention 4: Irinotecan
Intervention descriptions: intervention 1: 7.5 mg/kg IV Day 1 every 21 days for eight cycles\*

\*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression. intervention 2: 130 mg/m2 IV Day 1 every 21 days for eight cycles intervention 3: 850 mg/m2 po BID Days 1-14 every 21 days for eight cycles\*#

\*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression.

#For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID intervention 4: 200 mg/m2 IV Day 1 every 21 days for eight cycles

Protocol documents:
Clinical trial NCT00318370
Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms
Keywords: Ovarian Cancer Primary Fallopian Tube Cancer Peritoneal Cancer
Sponsor: Morphotek
Start date: 2006-05-01; Completion date: 2010-06-01
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.

Detailed description:
MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) either alone or in combination with other drugs. MORAb-003 works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if MORAb-003 can work either as a single agent

1. to treat a CA125-only relapse, or
2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic relapse, and
3. to prolong a second response to chemotherapy.

Arms: arm 1: Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2). arm 2: Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Interventions: intervention 1: Farletuzumab intervention 2: Chemo Plus Far
Intervention descriptions: intervention 1: Weekly Farletuzumab infusions Dose dependent on dosing group intervention 2: Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Protocol documents:
Clinical trial NCT00324272
Conditions: Malignant Melanoma Carcinoma, Squamous Cell
Keywords: Groin dissection Axilla (or axillary) dissection Lymph node dissection Lymphadenectomy Seroma Wound drainage Fibrin sealant Malignant melanoma Squamous cell carcinoma
Sponsor: Oxford University Hospitals NHS Trust
Start date: 2003-01-01; Completion date: 2010-06-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the use of fibrin sealant reduces post-operative drainage following groin and axillary lymph node dissection.

Detailed description:
Background: Fibrin sealant has been used for many years in clinical practice and has a wide range of applications including the control of lymphatic leaks and haemostasis. The physiological mechanism of action of fibrin was first described by Morawitz in 1905; fibrin sealant was first marketed in 1983.

Lymph node dissection is undertaken for the control of malignant disease - frequently malignant melanoma or squamous cell carcinoma. Following groin or axillary dissection, excessive post operative drainage may necessitate the presence of wound drains for 10 days or more. This may prolong hospital stay in some patients, and may be associated with an increased complication rate (such as wound infection).

Hypothesis: the use of fibrin sealant prior to wound closure following either groin or axillary dissection may reduce post-operative wound drainage.

Comparison: patients who require an elective groin or axillary dissection who either undergo standard wound closure or those who have fibrin sealant instilled into the surgical wound prior to wound closure.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Fibrin Sealant (Tisseel) used in the Experimental Arm.
Intervention descriptions: intervention 1: For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duploject™ spray delivery system prior to wound closure. Tisseel™ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK.

For patients in the Active Comparator (Control) Arm, no fibrin sealant was used during wound closure (with the surgical procedure being identical in all other respects).

Protocol documents:
Clinical trial NCT00353704
Conditions: Intervertebral Disk Displacement Disk Prolapse
Keywords: Intervertebral disk displacement disk prolapse pregabalin
Sponsor: Asker & Baerum Hospital
Start date: 2005-11-01; Completion date: 2010-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain.

Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.

Detailed description:
The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that gabapentin can be effective to reduce sensitization and postoperative pain. Pregabalin (S-aminomethyl-5-methylhexaninacid) is a further development of gabapentin. Pregabalin has a fewer side-effects compared with gabapentin.

The purpose of this study is to compare the analgetic and anxiolytic effect of pregabalin and placebo used as premedication.

The hypothesis is that a single-dose pregabalin (150 mg postoperatively (p.o.)) gives significant better anxiolysis and analgesia than placebo.

The study is including patients undergoing surgery of the vertebral columna.

Arms: arm 1: 150 mg Pregabalin per orally about one hour before surgery arm 2: One capsule of saccharose (placebo) was administered orally about one hour before surgery.
Interventions: intervention 1: pregabalin intervention 2: Placebo intervention 3: morphine
Intervention descriptions: intervention 1: capsule 150 mg x 1 per orally one hour before surgery intervention 2: One capsule of saccharose (placebo) was administered about one hour before surgery intervention 3: All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).

Protocol documents:
Clinical trial NCT00356889
Conditions: Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma of the Gallbladder Gastrointestinal Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-05-01; Completion date: 2010-06-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving bevacizumab together with erlotinib hydrochloride works in treating patients with metastatic or unresectable biliary tumors. 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. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and erlotinib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with erlotinib hydrochloride may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate the objective response rate in patients with metastatic or unresectable cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride.

SECONDARY OBJECTIVES:

I. Evaluate time to progression in these patients.

II. Evaluate overall and progression-free survival of these patients.

III. Evaluate the adverse events associated with this regimen. OUTLINE: This is an open-label, multicenter study.

Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically for up to 3 years.

Arms: arm 1: Patients receive 5 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15 and 150 mg oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
Interventions: intervention 1: erlotinib hydrochloride intervention 2: bevacizumab
Intervention descriptions: intervention 1: Given orally, 150 mg, once daily. intervention 2: Given IV, 5mg/kg on days 1 and 15 every cycle

Protocol documents: