ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00591123
Conditions: Unresectable Adenocarcinoma of the Esophagus Metastatic Adenocarcinoma of the Esophagus Unresectable Adenocarcinoma of Gastric Cardia Metastatic Adenocarcinoma of Gastric Cardia
Keywords: Unresectable Metastatic Esophagus Gastric Cardia
Sponsor: Translational Oncology Research International
Start date: 2007-12-01; Completion date: 2015-09-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer.

Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.

Detailed description:

Arms: arm 1: single arm
Interventions: intervention 1: FOLFOX intervention 2: 5-FU intervention 3: Erlotinib
Intervention descriptions: intervention 1: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions intervention 2: 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. intervention 3: All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.

Protocol documents:
Clinical trial NCT00619684
Conditions: Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: Fred Hutchinson Cancer Center
Start date: 2008-02-01; Completion date: 2015-09-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well lenalidomide works in treating patients with progressive or recurrent multiple myeloma after a donor stem cell transplant. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate response of relapsed or progressive multiple myeloma to lenalidomide after allogeneic stem cell transplant.

II. Proportion of patients achieving a complete, partial or minor response.

SECONDARY OBJECTIVES:

I. Evaluate toxicity and tolerability of lenalidomide in this setting.

II. For patients with chronic graft-versus-host disease (GVHD), evaluate the response to lenalidomide.

III. Evaluate time to progression (TTP).

IV. Evaluate overall survival (OS).

OUTLINE:

Patients receive lenalidomide orally (PO) on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

Arms: arm 1: Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: lenalidomide
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00654836
Conditions: Breast Cancer
Keywords: recurrent breast cancer stage III breast cancer stage IV breast cancer
Sponsor: Loyola University
Start date: 2007-10-01; Completion date: 2015-09-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with locally recurrent or metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the progression-free survival of patients with locally recurrent or metastatic breast cancer treated with carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, and bevacizumab as first-line therapy.

Secondary

* To determine the response rate in these patients.
* To determine the overall survival of these patients.
* To evaluate the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive carboplatin IV over 1 hour and bevacizumab IV on days 1, 22 and 43. Patients also receive paclitaxel albumin-bound nanoparticle formulation IV over 30 minutes on days 1, 8 ,15, 22, 29, 36, 43, and 50. Treatment continues in the absence of disease progression or unacceptable toxicity.

Formalin-fixed paraffin-embedded archived tumor tissue samples are assessed by immunohistochemistry (IHC) for various biomarkers. Levels of Notch-1, Notch-4, cyclin A, cyclin B, Jagged-1, and DLL4 in tumor-associated endothelial cells are correlated with response in both estrogen- and progesterone-positive and negative tumors, and independently of p53 status.

After completion of study treatment, patients are followed for up to 2 years.

Arms: arm 1: Participants will receive combination carboplatin, nanoparticle albumin-bound paclitaxel (ABI-007-Abraxane), and bevacizumab (Avastin)
Interventions: intervention 1: bevacizumab intervention 2: Carboplatin intervention 3: ABI-007
Intervention descriptions: intervention 1: Participants will receive bevacizumab 15 mg/kg on days 1,22, and 43. intervention 2: Participants will receive a standard carboplatin dose according to their area under the plasma drug concentration-time curve (AUC-6) on days 1, 22, and 43. intervention 3: Participants will receive ABI-007 (Abraxane) 100mg/m2 on days 1,8, 15, 22, 29, 36,43,and 50.

Protocol documents:
Clinical trial NCT00829166
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-02-01; Completion date: 2015-09-01
Enrollment: 991 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

Detailed description:

Arms: arm 1: Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination. arm 2: Participants will receive lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Eligible participants will cross over to receive trastuzumab emtansine if second interim analysis demonstrates statistically significant overall survival benefit in favor of trastuzumab emtansine.
Interventions: intervention 1: Trastuzumab emtansine intervention 2: Lapatinib intervention 3: Capecitabine
Intervention descriptions: intervention 1: Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle. intervention 2: Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle. intervention 3: Capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.

Protocol documents:
Clinical trial NCT00876993
Conditions: Central Nervous System Tumors
Sponsor: Johns Hopkins All Children's Hospital
Start date: 2008-09-01; Completion date: 2015-09-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.

Detailed description:
Bevacizumab dosing is 10 mg/kg on day 1 and day 15 of a 28 days course given IV.

Irinotecan dosing is 125 mg/m2 on day 1 and day 15 of a 28 day course given IV for the first 3 dose levels. If the MTD of temozolomide is not reached at dose level 3, then dose level 4 will be an escalation of irinotecan to 150 mg/m2.

For dose level 0 Temozolomide, dosing is 75 mg/m2/day day 1-5 of a 28 day course given PO. Doses will be escalated according to standard phase I dose escalation criteria.

Arms: arm 1: Bevacizmuab 10 mg/kg IV Irinotecan 125 mg/m\^2 IV Temozolomide 75 mg/m\^2 PO arm 2: Bevacizmuab 10 mg/kg IV Irinotecan 125 mg/m\^2 IV Temozolomide 125 mg/m\^2 PO arm 3: Bevacizmuab 10 mg/kg IV Irinotecan 125 mg/m\^2 IV Temozolomide 175 mg/m\^2 PO arm 4: Bevacizmuab 10 mg/kg IV Irinotecan 125 mg/m\^2 IV Temozolomide 200 mg/m\^2 PO arm 5: Bevacizmuab 10 mg/kg IV Irinotecan 150 mg/m\^2 IV Temozolomide 200 mg/m\^2 PO
Interventions: intervention 1: Bevacizumab intervention 2: Irinotecan intervention 3: Temozolomide
Intervention descriptions: intervention 1: Bevacizumab 10 mg/kg IV on day 1 and day 15 of a 28 day cycle intervention 2: Irinotecan 125 mg/m2 on day 1 and day 15 of a 28 day course given IV for the first 3 dose levels. If the Maximum Tolerated Dose of temozolomide is not reached at dose level 3, then dose level 4 will be an escalation of irinotecan to 150mg/m2. intervention 3: For the first cohort (dose level 0) of patients, dosing is 75 mg/m2/day day 1-5 of a 28 day course given PO for the first course. Doses will be escalated according to standard phase I dose escalation criteria. Dose levels are as follows (Dose level 1 = 125mg/m2, Dose level 2 = 175mg/m2, Dose levels 3 and 4 = 200 mg/m2)

Protocol documents:
Clinical trial NCT00906282
Conditions: Non Small Cell Lung Cancer
Keywords: neoadjuvant NSCLC NSCLC pemetrexed
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-06-01; Completion date: 2015-09-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this multi-center Phase II trial is to examine the impact of pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown to have better survival rates than patients with squamous tumors when given pemetrexed with a platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and undifferentiated), not including squamous histology, will be allowed to participate in this study. If this novel regimen proves to be safe and active in this setting, it will provide rationale for further investigation in a larger, prospective, randomized trial.

Detailed description:

Arms: arm 1: 4 cycles of preoperative treatment (1 Cycle = 21 days):

Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle; Carboplatin: AUC 6.0 by IV on Day 1 each cycle.
Interventions: intervention 1: Pemetrexed intervention 2: Carboplatin
Intervention descriptions: intervention 1: 500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks). intervention 2: AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).

Protocol documents:
Clinical trial NCT00981435
Conditions: Glaucoma
Keywords: Glaucoma Trabeculoplasty Selective laser trabeculoplasty Intraocular pressure
Sponsor: Stanford University
Start date: 2009-09-01; Completion date: 2015-09-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).

Detailed description:
SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.

Arms: arm 1: Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. arm 2: Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. arm 3: Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Interventions: intervention 1: Prednisolone 1% intervention 2: Ketorolac intervention 3: Artificial Tears
Intervention descriptions: intervention 1: Prednisolone 1% to lasered eye 4 times/day for 4.5 days intervention 2: Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days intervention 3: Artificial saline tears to lasered eye 4 times/day for 4.5 days

Protocol documents:
Clinical trial NCT01054911
Conditions: Tumor
Keywords: GIST gastrointestinal stromal tumor gastrointestinal stomach tumor Sunitinib
Sponsor: University of Alabama at Birmingham
Start date: 2009-10-01; Completion date: 2015-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.

Detailed description:
Gastrointestinal stromal tumor (GIST) is a rare cancer affecting primarily the digestive tract and sometimes abdominal cavity in adults. The most common site is the stomach followed by the duodenum and small intestine.

Surgery is the mainstay of therapy for GIST patients whose primary tumor is felt to be resectable. Prior to the introduction of Gleevec, patients with inoperable GIST had essentially no therapeutic options. However, sunitinib trials offer options to patients who are Gleevec resistant or have intolerant GIST. Clinical benefit has been demonstrated with positive results in several sunitinib studies of varying phases.

Arms: arm 1: Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Interventions: intervention 1: Sunitinib intervention 2: Surgery
Intervention descriptions: intervention 1: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally. intervention 2: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.

Protocol documents:
Clinical trial NCT01059929
Conditions: Mechanical Ventilation Critical Illness
Keywords: Hypnotics and Sedatives Respiration, Artificial Ventilators, Mechanical Critical care Intensive care Physical therapy Occupational therapy Sedative medications
Sponsor: University of Chicago
Start date: 2009-09-01; Completion date: 2015-09-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (\> 24 hours) in critically ill patients who require mechanical ventilation.

Detailed description:
Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.

Arms: arm 1: Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. arm 2: Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Interventions: intervention 1: Dexmedetomidine intervention 2: Propofol intervention 3: Fentanyl intervention 4: Midazolam intervention 5: Physical and Occupational Therapy
Intervention descriptions: intervention 1: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS intervention 2: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS intervention 3: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale intervention 4: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS\>+2) intervention 5: Daily therapy sessions targeting range of motion, strength, and mobility

Protocol documents:
Clinical trial NCT01060345
Conditions: Ductal Carcinoma in Situ
Keywords: DCIS
Sponsor: University of Chicago
Start date: 2010-05-01; Completion date: 2015-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).

Detailed description:
Many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. Some studies have found that Asian women who drink many cups of green tea have lower rates of breast cancer. Green tea may have an effect on proliferative and inflammatory pathways. Women with ductal carcinoma in situ (DCIS) have been found to have inflammation in the breast tissue surrounding DCIS lesions. Inflammatory pathways are being studied for a possible link to cancer. This study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.

Arms: arm 1: Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E
Interventions: intervention 1: Polyphenon E
Intervention descriptions: intervention 1: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery

Protocol documents:
Clinical trial NCT01101100
Conditions: Psoriasis
Keywords: Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2010-04-01; Completion date: 2015-09-01
Enrollment: 181 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

Detailed description:
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.

Arms: arm 1: AMG 827
Interventions: intervention 1: AMG 827
Intervention descriptions: intervention 1: 210 mg SC or 140 mg SC

Protocol documents:
Clinical trial NCT01113398
Conditions: Glioblastoma Multiforme Gliosarcoma
Keywords: glioblastoma multiforme gliosarcoma malignant glioma glioma Avastin bevacizumab AMG 102 rilotumumab recurrent Duke Pro00022491
Sponsor: Katy Peters
Start date: 2010-08-01; Completion date: 2015-09-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the study is to assess the response rate of AMG 102 and Avastin treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate overall survival and 6-month progression-free survival rates in this population and to assess the safety of this combination in this population.

Patients must have recurrent histologically confirmed diagnosis of World Health Organization (WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at Duke.

In initial Phase I and II clinical trials, four potential Avastin-associated safety issues were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most common side effect for AMG 102 have been nausea and fatigue.

Detailed description:

Arms: arm 1: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
Interventions: intervention 1: AMG 102 intervention 2: Avastin
Intervention descriptions: intervention 1: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes. intervention 2: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.

Protocol documents: