ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00483327
Conditions: Atypical Endometrial Hyperplasia Endometrial Carcinoma
Keywords: Well Moderately Differentiated
Sponsor: NYU Langone Health
Start date: 2007-06-01; Completion date: 2013-10-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to study the efficacy, toxicity, and tolerability of a standard hormonal regimen of Megestrol Acetate (Megace) in the treatment of Atypical Endometrial Hyperplasia or well to moderately differentiated endometrial carcinoma.

Detailed description:
The trial's objectives are to study the efficacy, defined as complete pathologic resolution of disease, of a standard hormonal regimen with the progestin Megace for the treatment of atypical endometrial hyperplasia or well or moderately differentiated endometrial carcinoma in women desiring conservative medical management of these conditions in the Women's Cancer Program at the NYU School of Medicine and at the Bellevue Gynecologic Oncology clinics.

The major endpoint is pathologic complete response (pCR). For the purposes of this study, patients will be reevaluated for response every 12 weeks until complete response. Response will be assessed within 4 weeks of completion of 12 weeks of Megace, by endometrial biopsy or dilation and curettage (D\&C)/hysteroscopy. An endometrial biopsy is sufficient to document progressive, stable disease or partial response. A D\&C is necessary to confirm complete response.

Patients whose disease has completely responded will discontinue treatment and be encouraged to pursue fertility. Those not desiring immediate fertility will be placed on low dose oral contraceptive pills for at least 6 months. Patients who have had either a partial response or stable disease will be recounseled and offered continued medical management or surgical therapy. Patients whose disease has progressed will be offered definitive surgical management. Those patients declining surgery will still be followed on study.

Arms: arm 1: 80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
Interventions: intervention 1: Megestrol Acetate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00545792
Conditions: Cervical Cancer Endometrial Cancer Ovarian Cancer Vaginal Cancer Carcinoma of the Vulva
Keywords: Recurrent Endometrial cancer Recurrent Cervical cancer Recurrent Ovarian cancer Recurrent Vaginal cancer Recurrent Vulvar cancer Vaginal recurrence Brachytherapy Radiation Treatment External Beam Radiation Avastin Bevacizumab
Sponsor: Dana-Farber Cancer Institute
Start date: 2007-05-01; Completion date: 2013-10-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is evaluating a drug called avastin in combination with standard radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).

Detailed description:
The purpose of this research study is to learn the effects (good and bad) of an antiangiogenic therapy drug (drugs that stop new blood vessel growth and starve a tumor by cutting off its blood supply) called avastin. Avastin is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a potent, specific growth factor with a well-defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In laboratory studies, avastin has been shown to inhibit the growth of several different types of human cancer cells.

This drug has been studied in at least 3500 people with breast, colorectal, renal, ovarian and lung cancer. It has not been studied in combination radiation therapy in people with recurrent gynecological cancer.

Previous clinical trials involving the use of avastin in combination with standard radiation in colorectal and pancreatic cancer show no significant increase in toxicity as compared to standard radiation therapy toxicity.

The primary objective of this study is to assess the toxicity of administering avastin with radiation for recurrent gynecological cancer. The secondary endpoint will be to assess the time to progression of the disease. This means we hope this treatment program will delay any regrowth of your cancer as compared to standard therapy with radiotherapy alone. In addition, how well you respond to the treatment, patterns of remission or recurrence will be measured.

Arms: arm 1: Avastin
Interventions: intervention 1: Avastin
Intervention descriptions: intervention 1: Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.

Protocol documents:
Clinical trial NCT00585312
Conditions: Adenomatous Polyposis Coli
Keywords: FAP
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-09-01; Completion date: 2013-10-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).

Detailed description:
Per DMC recommendation, the study was terminated early (31Oct2013) due to low enrollment and low endpoint accumulation rate. No safety concerns were involved in the decision to terminate the study.

Arms: arm 1: celecoxib, 16 mg/kg/day, for 5 years arm 2: Masked, placebo comparator
Interventions: intervention 1: Celecoxib intervention 2: Placebo
Intervention descriptions: intervention 1: celecoxib, 16 mg/kg/day, for 5 years intervention 2: Masked, placebo comparator

Protocol documents:
Clinical trial NCT00621751
Conditions: Traumatic Brain Injury
Keywords: Brain Injury Irritability Aggression
Sponsor: Wake Forest University Health Sciences
Start date: 2008-02-01; Completion date: 2013-10-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if carbamazepine reduces irritability and aggression among individuals with traumatic brain injury

Detailed description:
To achieve the enrollment of 66 needed, over enrollment of 70 subjects with 70 corresponding subject informants will be recruited at Carolinas Rehabilitation. Subjects will be recruited from the clinic at Carolinas Rehabilitation. Subjects will also be referred by psychiatrists at North Carolina Neuropsychiatry.

Subjects who consent and qualify will be randomized in a 1:1 ratio to Tegretol® or placebo. Stratification to randomization group will occur based on the presence of depression defined by a Beck Depression Inventory-II score ≥ 13. Subjects randomized to active drug will be titrated up in dose, as tolerated, over a period of 3 weeks. Starting dose is 200mg twice daily to 200mg three times daily to 200mg, 2 tabs, twice daily. There will be 3 clinic visits. Visits will occur at baseline for consenting and screening, day 28, and day 42. Follow up phone calls will occur each week that the subject is not seen in the clinic until the end of the study. Follow up phone calls will assess for study medication compliance, adverse events and concomitant medication changes. Day 42 ends the period of the Randomized Clinical Trial phase of the study and the subjects will begin the 1 week of taper of Tegretol® at 400mg daily and then stop drug. A safety phone call will be made at day 49.

The following questionnaires will be used as measures of irritability for the subject and the informant: Neuropsychiatric Inventory (NPI), and Global Impression of Change. The Beck Depression Inventory will be administered to the participant only at baseline for purposes of stratification of the randomization on depression. The Clinician Investigator will complete the Clinician Global Impressions scale at Visits 2 and 3.

History and Physical Exam, hematology, chemistry, including renal and liver function studies will be obtained for safety and tolerability. Serum pregnancy tests will be drawn at screening for females of childbearing potential. Carbamazepine levels will be drawn at visits 2 and 3.

Arms: arm 1: Carbamazepine 800 mg daily arm 2: Placebo
Interventions: intervention 1: Carbamazepine intervention 2: Placebo
Intervention descriptions: intervention 1: 800 mg daily intervention 2: Placebo

Protocol documents:
Clinical trial NCT00656136
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2008-04-01; Completion date: 2013-10-01
Enrollment: 585 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed.

The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.

Patients enrolled into the trial will be treated and followed until death or lost to follow-up.

Detailed description:

Arms: arm 1: Patients receive placebo once daily arm 2: Patients receive BIBW 2992 tablets once daily
Interventions: intervention 1: placebo intervention 2: BIBW 2992
Intervention descriptions: intervention 1: Patients receive placebo once daily intervention 2: Patients receive afatinib tablets once daily, and can reduce dose for adverse event management. Afatinib is given once daily, continuously until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00657267
Conditions: Glioblastoma Gliosarcoma
Keywords: recurrent glioblastoma temodar temozolomide
Sponsor: Patrick Y. Wen, MD
Start date: 2008-05-01; Completion date: 2013-10-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. The purpose of this study is to determine if patients that have failed standard temozolomide treatment will respond to temozolomide when given at a different dose and schedule (21 days every 28 days).

Detailed description:
* Participants will be given a medication-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks (28 days) during which time they will be taking temozolomide orally once a day for the first three weeks.
* At the end of each cycle (day 28, +/- 2 days), the following procedures will be performed: Complete physical examination including a neurological exam; vital signs; a review of current medications and symptoms; blood samples; a pregnancy test for women of child-bearing potential; self-administered quality of life questionnaire; brain MRI or CT scan.
* Participants may continue taking temozolomide until their tumor grows or if they experience unacceptable side effects.

Arms: arm 1: None
Interventions: intervention 1: Temozolomide
Intervention descriptions: intervention 1: Taken orally daily for the first three weeks of a four-week cycle.

Protocol documents:
Clinical trial NCT00684411
Conditions: T Cell Non-Hodgkin Lymphoma
Keywords: T NHL Gleevec imatinib mesylate
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-06-01; Completion date: 2013-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to evaluate the overall response rate to imatinib mesylate in participants with relapsed or refractory T cell non-Hodgkin's lymphoma. This drug has been used in chronic myeloid leukemia and information from those other research studies suggests that it may help to treat T cell non-Hodgkin's lymphoma.

Detailed description:
OBJECTIVES:

Primary Objective To evaluate the overall response rate

Secondary Objectives To assess the safety and tolerability To assess the duration of response To assess the progression free survival and overall survival

STATISTICAL DESIGN:

This trial will use a single stage design to differentiate a \>/= 25% response rate from a \</= 5% rate. If observed data is consistent with the alternative response rate of 25%, imatinib would be deemed clinically interesting and worthy of a larger phase II study.

Arms: arm 1: The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Interventions: intervention 1: Imatinib mesylate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00718809
Conditions: Invasive Thymoma and Thymic Carcinoma Recurrent Thymoma and Thymic Carcinoma Stage III Thymoma Stage IVA Thymoma Stage IVB Thymoma
Sponsor: National Cancer Institute (NCI)
Start date: 2008-06-01; Completion date: 2013-10-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well saracatinib works in treating patients with relapsed or refractory thymoma or thymic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (complete response and partial response) in patients with relapsed or refractory thymoma or thymic carcinoma treated with AZD0530.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of AZD0530 in these patients. II. To evaluate the progression-free survival of these patients. III. To evaluate the overall survival of these patients. IV. To evaluate the disease control rate, defined as complete response, partial response, and stable disease, in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Arms: arm 1: Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: saracatinib
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00742963
Conditions: Soft Tissue Sarcoma
Keywords: TH-302 Advanced Soft Tissue Sarcoma Doxorubicin Phase 1/2
Sponsor: ImmunoGenesis
Start date: 2008-08-01; Completion date: 2013-10-01
Enrollment: 107 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Advanced Soft Tissue Sarcoma.

Detailed description:
A broad range of tumors have been shown to contain significant numbers of hypoxic cells and hypoxia has been shown to be associated with a poor prognosis and an increase in resistance to chemotherapy and radiotherapy (Brizel 1997, Vaupel 2007, Shannon 2003).

It is likely that an agent that could effectively target hypoxic regions in tumors would improve efficacy when combined with standard chemotherapy or radiotherapy. TH-302 is activated at lower oxygen concentrations than other bioreductive prodrugs (Duan 2008) and tirapazamine, a hypoxic cytotoxin that has been extensively studied in both preclinical and clinical studies. This should result in an improved therapeutic ratio (tumor vs normal tissue toxicity) as compared with other bioreductive agents. Because TH-302 is expected to be minimally toxic to aerobic cancer cells, optimal efficacy would be expected when TH-302 is combined with treatments that are most effective under aerobic conditions such as radiotherapy and cytotoxic chemotherapy. Preclinical data have shown at least additive efficacy when TH-302 is combined with chemotherapy. In order to minimize the risk of additive toxicity, TH-302 is not being evaluated in combination with alkylating agents. The study will enroll subjects with advanced soft tissue sarcoma. These tumors have evidence supporting the presence of hypoxia based on pO2 histography, F-MISO and gene expression profiling (Vaupel 2007, Francis 2007, Rajendran 2003).

Arms: arm 1: 75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.
Interventions: intervention 1: TH-302
Intervention descriptions: intervention 1: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.

Dose escalation dose levels:

Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2

Protocol documents:
Clinical trial NCT00770770
Conditions: Macular Edema Retinal Vein Occlusion
Keywords: Macular edema secondary to RVO
Sponsor: Alimera Sciences
Start date: 2009-05-01; Completion date: 2013-10-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.

Detailed description:

Arms: arm 1: 0.2 µg/day arm 2: 0.5 µg/day
Interventions: intervention 1: Fluocinolone Acetonide intervention 2: Fluocinolone Acetonide
Intervention descriptions: intervention 1: 0.2 µg/day intervention 2: 0.5 µg/day

Protocol documents:
Clinical trial NCT00778102
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-10-01; Completion date: 2013-10-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 5-FU intervention 2: 5-FU intervention 3: 5-FU intervention 4: Irinotecan intervention 5: Leucovorin intervention 6: Leucovorin intervention 7: Oxaliplatin intervention 8: bevacizumab [Avastin]
Intervention descriptions: intervention 1: Bolus 400mg/m2, day 1 every 2 weeks intervention 2: 3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks intervention 3: 2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks intervention 4: 165mg/m2 1-hour iv infusion, day 1 every 2 weeks intervention 5: 400mg/m2 2-hour iv infusion, day 1 every 2 weeks intervention 6: 200mg/m2 2-hour iv infusion, day 1 every 2 weeks intervention 7: 85mg/m2 2-hour iv infusion, day 1 every 2 weeks intervention 8: 5mg/kg iv day 1 every 2 weeks

Protocol documents:
Clinical trial NCT00827606
Conditions: Familial Hypercholesterolemia
Keywords: pediatric heterozygous familial hypercholesterolemia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-03-01; Completion date: 2013-10-01
Enrollment: 272 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin treatment.

Detailed description:

Arms: arm 1: All subjects will be treated with atorvastatin
Interventions: intervention 1: atorvastatin
Intervention descriptions: intervention 1: Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)

Protocol documents:
Clinical trial NCT00837200
Conditions: Non-hodgkins Lymphoma Hodgkins Lymphoma Multiple Myeloma
Keywords: lymphoma myeloma
Sponsor: Milton S. Hershey Medical Center
Start date: 2009-03-01; Completion date: 2013-10-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an exploratory study to study the efficacy of combination regimen of Oncaspar/Doxil/Decadron (ODD) in patients with refractory lymphoid malignancies. Patients with any form of lymphoid malignancy will be eligible: acute lymphoblastic leukemia, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma and plasma cell leukemia. Patients must have failed standard regimens for their cancers and could have had unlimited number of prior regimens. Patients will be staged appropriately for their disease with clinical examination, laboratory tests, and imaging studies. Both Oncaspar and Doxil will be given on day 1 and 15. Patients will be clinically evaluated prior to each cycle and will have disease assessments every 2 cycles. Responding patients will continue therapy until disease progression or excessive toxicity. Responders who are candidates for allogenic stem cell transplantation could go to conditioning chemotherapy and stem cell transplant after 4 cycles of ODD.

Detailed description:
This phase II trial will study the effectiveness of a combination regimen which includes Oncaspar (PEG-asparaginase), Doxil (PEG-liposomal doxorubicin), and Decadron (ODD) in terms of disease response against refractory lymphoid malignancies. Asparaginase is an enzyme that depletes asparagines, a key amino acid for survival and growth of malignant lymphocytes. Its depletion results in death of the neoplastic cell. Asparagine depletion has induced a significant improvement of clinical outcomes in acute lymphoblastic leukemia (ALL) and L-asparaginase has been a mainstay for more than 30 years in the treatment of ALL. Although this drug has been used primarily in ALL, promising results have been reported even in other non-ALL lymphoid malignancies, such as chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, refractory non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). One of the main goals of this trial is to measure the asparaginase level as a surrogate marker of asparagine depletion with Oncaspar, a PEG-enhanced version of E. coli L-asparaginase. The therapeutic value of the simple, non-pegylated form of L-asparaginase is limited by its short half-life and propensity to cause allergic reactions.

Arms: arm 1: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Interventions: intervention 1: Oncaspar, Doxil, Decadron
Intervention descriptions: intervention 1: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.

Protocol documents: