ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00243243
Conditions: Burns
Keywords: Burns
Sponsor: United States Army Institute of Surgical Research
Start date: 2006-01-01; Completion date: 2011-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.

Detailed description:
To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.

Arms: arm 1: intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery) arm 2: intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)
Interventions: intervention 1: Recombinant Factor VIIa intervention 2: Placebo
Intervention descriptions: intervention 1: intravenous infusion of Factor VIIa intervention 2: intravenous infusion of placebo (sterile water)

Protocol documents:
Clinical trial NCT00265785
Conditions: Lung Cancer
Keywords: bronchoalveolar cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer
Sponsor: SWOG Cancer Research Network
Start date: 2006-07-01; Completion date: 2011-07-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar carcinoma treated with pemetrexed disodium.

Secondary

* Evaluate the progression-free survival of patients treated with this drug.
* Evaluate the response rate (confirmed and unconfirmed, partial and complete) in the subset of patients with measurable disease treated with this drug using standard RECIST criteria and computer assisted image analysis.
* Evaluate frequency and severity of toxicities in patients treated with this drug.
* Perform molecular correlative studies on patient tissue to investigate potential predictors of efficacy. (This will not be completed as this study was closed due to poor accrual.)

OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib (yes vs no).

Patients receive pemetrexed disodium intravenous (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

Arms: arm 1: pemetrexed
Interventions: intervention 1: pemetrexed
Intervention descriptions: intervention 1: Pemetrexed 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.

Protocol documents:
Clinical trial NCT00268242
Conditions: Leukemia
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7)
Sponsor: The Cleveland Clinic
Start date: 2006-01-01; Completion date: 2011-07-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

PURPOSE: This phase II trial is studying how well giving gemcitabine together with mitoxantrone works in treating patients with relapsed acute myeloid leukemia.

Detailed description:
OBJECTIVES:

Primary

* Determine the complete response (CR) rate (CR and incomplete blood count recovery (CRi)) of patients with acute myeloid leukemia in first relapse treated with gemcitabine hydrochloride and mitoxantrone hydrochloride.

Secondary

* Evaluate disease free and overall survival of patients with acute myeloid leukemia in first relapse treated with this particular chemotherapy regimen.
* Assess hematologic and non-hematologic toxicity associated with this regimen.
* Assess laboratory correlates of drug resistance in patients with relapsed acute myeloid leukemia.
* Assess the percentage of patients receiving subsequent bone marrow transplantation.

OUTLINE: This is an open-label, multicenter study.

Patients receive gemcitabine hydrochloride IV over 12 hours on day 1 and mitoxantrone hydrochloride IV over 30-60 minutes on days 1, 2, and 3. After completion of a single course of therapy, patients who achieve a complete response may receive 1 additional course of therapy at the discretion of the treating physician.

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

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Arms: arm 1: Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m\^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m\^2/day I.V. on days 1, 2, and 3.
Interventions: intervention 1: Gemcitabine Hydrochloride intervention 2: Mitoxantrone Hydrochloride
Intervention descriptions: intervention 1: 10 mg/m2/ min IV for 12 hours intervention 2: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3

Protocol documents:
Clinical trial NCT00272844
Conditions: Smith-Lemli-Opitz Syndrome
Keywords: cholesterol Smith-Lemli-Opitz syndrome mental retardation sterols congenital anomalies
Sponsor: Boston Children's Hospital
Start date: 1998-01-01; Completion date: 2011-07-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether supplementation with an oil-based cholesterol suspension will correct the biochemical abnormalities in cholesterol and its precursors in individuals with the Smith-Lemli-Opitz syndrome.

Detailed description:
This study involves treating individuals with the Smith-Lemli-Opitz syndrome, a rare inborn error of cholesterol metabolism, with supplemental cholesterol to determine it effects on biochemical sterol metabolites, growth, neuropsychological development, ophthalmologic and auditory function, ERG (electroretinogram) parameters, and CNS metabolites as determined by brain MRS-imaging. Safety of the supplemental cholesterol suspension is monitored by tests of hematologic, renal, and liver function at periodic intervals. There is also a substudy that is investigating potential genotype-phenotype correlations, as well as another that studies biochemical parameters of light sensitivity in cultured skin fibroblasts from affected patients.

Arms: arm 1: None
Interventions: intervention 1: crystalline cholesterol oil-based suspension
Intervention descriptions: intervention 1: 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.

Protocol documents:
Clinical trial NCT00274456
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer, nab paclitaxel, docetaxel,
Sponsor: Celgene
Start date: 2005-11-01; Completion date: 2011-07-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).

Detailed description:
This was an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity:

* the maximum tolerated dose (MTD) of ABI-007 300 mg/m\^2 every 3 weeks;
* ABI-007 100 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* ABI-007 150 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* the standard dose and schedule of Taxotere (100 mg/m\^2 every 3 weeks).

Arms: arm 1: ABI-007 300 mg/m\^2 administered once every third week (q3w). arm 2: ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest arm 3: ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest arm 4: Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Interventions: intervention 1: ABI-007 intervention 2: Docetaxel
Intervention descriptions: intervention 1: ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m\^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment. intervention 2: Docetaxel dosed q3w at 100 mg/m\^2

Protocol documents:
Clinical trial NCT00280735
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2004-05-01; Completion date: 2011-07-01
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin 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 carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the survival patterns of patients treated with this regimen.
* Assess the patterns of recurrence in patients treated with this regimen.

OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
Interventions: intervention 1: carboplatin intervention 2: docetaxel
Intervention descriptions: intervention 1: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25) intervention 2: 75 mg/m² intravenously, once, every 3 weeks

Protocol documents:
Clinical trial NCT00300274
Conditions: Graft Rejection
Keywords: Everolimus heart transplant heart disease transplantation heart IVUS assessment at 12 months rate of graft loss acute rejection episodes survival
Sponsor: Novartis Pharmaceuticals
Start date: 2006-01-01; Completion date: 2011-07-01
Enrollment: 721 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.

Detailed description:

Arms: arm 1: Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL. arm 2: Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.

Randomization of new patients in this arm was prematurely stopped as of 27 March 2008 due to high mortality rate, as per Data Monitoring Committee. arm 3: Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
Interventions: intervention 1: everolimus intervention 2: mycophenolate mofetil intervention 3: cyclosporine intervention 4: corticosteroids
Intervention descriptions: intervention 1: Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments. intervention 2: Mycophenolate mofetil supplied as 500 mg tablets. intervention 3: Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm. intervention 4: Corticosteroids standard dose.

Protocol documents:
Clinical trial NCT00307736
Conditions: Rectal Cancer Adenocarcinoma of the Rectum
Keywords: Fluorouracil bevacizumab erlotinib external beam radiation therapy EBRT
Sponsor: Massachusetts General Hospital
Start date: 2006-05-01; Completion date: 2011-07-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II portion) patients with locally advanced rectal cancer.

Detailed description:
* All participants will receive the following drugs: 5-fluorouracil (5-FU) given as a continuous 24-hour infusion; Bevacizumab given intravenously; erlotinib given orally at home. In the Phase I portion, we are looking for the highest dose of erlotinib that can be given safely in combination with the 5-FU, bevacizumab and radiation therapy. Therefore the dose of erlotinib may not be the same for each participant. The dose will increase until we find the highest dose without causing serious or unmanageable side effects.
* Study treatment is given as an outpatient and consists of 14 day cycles with a total of 3 cycles. Patients will be given all three study drugs and radiation therapy on a monday (unless a monday falls on on a holiday). This will be day 1 of the first treatment cycle. 5-FU is given continuously days 1-14. Bevacizumab is given on day 1. Erlotinib will be given on days 1-14. Radiation therapy will be performed on Days 1-5 and 8-12.
* The following tests and procedures will be performed weekly while participants are receiving study treatment: physical examination, measurement of vital signs, height and weight; performance status; blood work, urine sample.
* At the end of treatment the following tests will be performed: physical examination and measurement of vital signs; performance status; blood work; CT scans of chest, abdomen and pelvis. Patients will also be evaluated for surgery at this time. Patients will be followed every three months for the first three years after surgery, then every 6 months for the next two years.

Arms: arm 1: Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
Interventions: intervention 1: 5-fluorouracil intervention 2: bevacizumab intervention 3: erlotinib intervention 4: External beam radiation therapy (EBRT)
Intervention descriptions: intervention 1: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles. intervention 2: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles. intervention 3: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles. intervention 4: Given on days 1-5 and 8-12

Protocol documents:
Clinical trial NCT00337129
Conditions: Head and Neck Cancer
Keywords: metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity untreated metastatic squamous neck cancer with occult primary salivary gland squamous cell carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-05-01; Completion date: 2011-07-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer.

Detailed description:
OBJECTIVES:

* Evaluate the response probability (confirmed, complete, and partial responses) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389.
* Estimate progression-free and overall survival probability in these patients.
* Evaluate the qualitative and quantitative toxicities of this treatment regimen.

OUTLINE: This is a multicenter study.

Patients receive E7389 IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

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

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Arms: arm 1: eribulin mesylate
Interventions: intervention 1: eribulin mesylate
Intervention descriptions: intervention 1: 1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.

Protocol documents:
Clinical trial NCT00340834
Conditions: Multiple Sclerosis
Keywords: FTY720 Interferon RRMS Multiple Sclerosis Efficacy
Sponsor: Novartis
Start date: 2006-05-01; Completion date: 2011-07-01
Enrollment: 1292 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Fingolimod 1.25 mg intervention 2: Fingolimod 0.5 mg intervention 3: Interferon β-1a 30 µg
Intervention descriptions: intervention 1: Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.

Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment. intervention 2: Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.

Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily. intervention 3: Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.

Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.

Protocol documents:
Clinical trial NCT00353275
Conditions: Necrotizing Fasciitis
Keywords: Strict glycemic control
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2009-08-01; Completion date: 2011-07-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate two glycemic control regimens on clinical outcome in patients with necrotizing soft tissue infections. Secondary aim is to evaluate the inflammatory and immune responses to the glycemic control regimens.

Detailed description:
This is a multi-center explanatory trial of strict glycemic control for surgical patients with necrotizing soft tissue infection (NSTI). The primary objective of this study is to verify feasibility of the intervention, provide unbiased and evidence-based estimates of treatment effects, and obtain data needed to design and direct a larger multi-center trial if necessary. The multi-center trial (n \>100) will have adequate power to identify a 30% difference in favorable outcome defined as discharge alive from the hospital without an amputation in less than the median number of hospital days. Secondary objectives include evaluation of specific hypotheses relating the intervention to cytokine and neutrophil responses. These preliminary data will provide the basis for future research and grant applications, lend insight into the mechanisms by which hyperglycemia results in adverse effects, and improve outcome through the development of evidence-based therapeutic strategies for patient care.

Arms: arm 1: Strict glycemic control with a blood glucose target range of 80-110 mg/dL arm 2: Conventional glycemic control with blood glucose target range of 110-140 mg/dL
Interventions: intervention 1: Strict Glycemic control intervention 2: Conventional Glycemic Control
Intervention descriptions: intervention 1: Blood glucose target range is 80-110 mg/dL. intervention 2: Blood glucose target range is 110-140 mg/dL.

Protocol documents: