ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00274768
Conditions: Breast Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2004-04-01; Completion date: 2012-11-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, 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 capecitabine works in treating patients with metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.

Secondary

* Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity profile of this regimen in these patients.
* Determine the pharmacokinetics (PK) and pharmacogenetics in these patients.
* Correlate pharmacodynamic effects of this drug with toxicity and response in these patients.
* Determine compliance and adherence to this regimen and correlate with PK parameters in these patients.

OUTLINE: This is an open-label study.

Patients receive a fixed-dose of oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

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

Arms: arm 1: 26 patients received the pre-defined starting dose of capecitabine of 3,000 mg orally daily given in two divided doses. Two thirds of the patients received either the same dose or a 500 mg lower dose compared to what would have been administered with a commonly used body surface area (BSA)-dosing schedule (2,000 mg/m2 with rounding down to nearest 500 mg multiple).
Interventions: intervention 1: capecitabine
Intervention descriptions: intervention 1: A total of 115 cycles of therapy were administered and five patients did not complete cycle 1. The median number of cycles initiated was four (range 1-16).

Protocol documents:
Clinical trial NCT00311766
Conditions: Epidermolysis Bullosa
Keywords: Epidermolysis Bullosa cutaneous wound-healing chronic wound-healing Thymosin Beta 4 laminin-5
Sponsor: RegeneRx Biopharmaceuticals, Inc.
Start date: 2006-02-01; Completion date: 2012-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source - FDA Office of Orphan Product Development (OOPD).

Detailed description:
EB is a group of genetic diseases characterized by skin-blistering and lesion-formation after minor trauma to the skin. This family of disorders, most of which are inherited, range in severity from mild to the severely disabling and life-threatening. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Arms: arm 1: Placebo comparator gel does not contain any active drug. Topical administration of 0.0% Thymosin Beta 4 gel, once a day (qd) up to 56 days arm 2: Topical Administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel once a day (qd) up to 56 days
Interventions: intervention 1: Thymosin Beta 4 intervention 2: Placebo
Intervention descriptions: intervention 1: Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days intervention 2: Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days

Protocol documents:
Clinical trial NCT00314262
Conditions: Precancerous Conditions
Keywords: Skin Lesions Premalignant Lesion
Sponsor: Emory University
Start date: 2006-10-01; Completion date: 2012-11-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.

Detailed description:
The purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may tell how the drug works, before, and after receiving the study medications.

Approximately 61 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.

Arms: arm 1: None
Interventions: intervention 1: Erlotinib & Celecoxib
Intervention descriptions: intervention 1: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.

Celecoxib given 400 mg orally BID continuously for 6 months.

Protocol documents:
Clinical trial NCT00351819
Conditions: Pain Hypogonadism
Keywords: Testosterone Pain Opioid Hypogonadism
Sponsor: Boston University
Start date: 2006-04-01; Completion date: 2012-11-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for pain control have decreased serum testosterone levels. Indeed, these men complain of decreased libido, erectile dysfunction and impaired quality of life. Animal studies have shown that gonadectomy results in a decrease in pain threshold in rats and repletion of testosterone elevates that threshold. These observations suggest that testosterone may possess analgesic properties. Hence, the investigators hypothesize that hypogonadism developing in men on opioids results in an increased sensitivity to pain and requirement of higher doses of opioids. In this study, the investigators plan to administer testosterone to men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in response to noxious stimuli and changes in the requirement of opioids in response to testosterone administration.

Hypothesis:

Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance, pain perception and quality of life.

Specific aims:

1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance, and pain modulation in men with opioid-induced hypogonadism.
2. To determine the effects of testosterone replacement on health-related quality of life.
3. To determine whether testosterone replacement in hypogonadal men induces changes in the dosage requirements of opioid medications for pain control.

To accomplish our specific aims, the investigators propose a randomized, double blind, placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back pain syndrome on chronic opioids and low testosterone levels (\<300 ng/dl) will be randomized to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in pain tolerance using various external painful stimuli. Secondary outcomes are change in pain sensitivity and modulation, quality of life and opioid requirements.

Detailed description:

Arms: arm 1: Testosterone replacement therapy arm 2: Placebo gel
Interventions: intervention 1: AndroGel intervention 2: Placebo
Intervention descriptions: intervention 1: 5g gel, applied once daily to the upper arms, upper back or shoulders. intervention 2: 5g gel, applied once daily to the upper arms, upper back or shoulders.

Protocol documents:
Clinical trial NCT00364286
Conditions: Leukemia Lymphoma
Keywords: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Prolymphocytic Leukemia Leukemia Lymphoma Dasatinib BMS-354825
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-08-01; Completion date: 2012-11-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if dasatinib can help to control Chronic Lymphocytic Leukemia (CLL). The safety of the drug will also be studied.

Optional Procedures: You will be asked to have additional blood samples drawn. These samples will be used to see how the disease is responding to the drug.

Detailed description:
Dasatinib is designed to interfere with a type of protein that appears to be important for the survival of CLL cells.

If you are found to be eligible to take part in this study, you will take dasatinib by mouth twice a day. You will be instructed to take dasatinib in the morning and in the evening.

You will have an electrocardiogram (ECG-a test of the electrical activity of your heart) and a physical exam once every 3 months while on study. Blood (about 2-3 teaspoons) will be drawn for routine tests once a week for 1 month and then once a month for the rest of your treatment on this study. A bone marrow biopsy and aspiration will be performed, as needed, to check the status of the disease. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

Dasatinib will be given for as long as you are responding. You will be taken off study if the disease gets worse or intolerable side effects occur.

This is an investigational study. Dasatinib is not FDA-approved for CLL, and it has been authorized for use in research only. Up to 25 patients will take part in this multicenter study. Up to 25 will be enrolled at M. D. Anderson.

Optional Procedures: If you agree, blood samples (about 2 tablespoons each time) will be collected before therapy starts, at 3-4 hours after the first dose, and at 3 months on therapy. These blood draws will be done when other routine tests are done. No additional needle sticks will be needed. The blood will be used to see how the disease is responding to the drug.

You do not have to agree to take part in the optional procedures in order to receive treatment on this study.

Arms: arm 1: Dasatinib 50mg Orally twice daily.
Interventions: intervention 1: Dasatinib (BMS-354825)
Intervention descriptions: intervention 1: 50mg Orally twice daily

Protocol documents:
Clinical trial NCT00422656
Conditions: Waldenstrom's Macroglobulinemia
Keywords: relapsed Waldenstrom's Macroglobulinemia refractory Waldenstrom's Macroglobulinemia WM perifosine
Sponsor: Dana-Farber Cancer Institute
Start date: 2006-09-01; Completion date: 2012-11-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Waldenström's Macroglobulinemia (lymphoplasmacytic lymphoma, WM) remains incurable with limited therapeutic options and notably absent FDA approved therapy with any WM indication. Therefore, there is a need to identify new therapeutic agents for WM patients both in the upfront and relapsed/refractory setting. The purpose of this research study is to assess the efficacy of perifosine in patients with relapsed or refractory WM.

Detailed description:
Perifosine is a drug that in particular inhibits Akt thought to be important for initiation and progression of malignancies, specifically in lymphomas. In laboratory experiments of WM and lymphoma cell lines, perifosine has shown to have cytotoxic and anti-proliferative activity as a single agent. This drug has been used in clinical research studies of other types of cancers including soft tissue sarcomas, head and neck cancers and prostate cancer. This study uses a two-stage design to evaluate efficacy of perifosine based on overall response (OR). The null and alternative OR rates are 20% and 40%. If 4 or more patients enrolled in the stage one cohort (n=17 patients) achieve OR than accrual will proceed to stage two (n=20 patients). If fewer than 10 ORs are observed then the regimen will be considered ineffective.

Arms: arm 1: Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Interventions: intervention 1: Perifosine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00436644
Conditions: Ovarian Cancer Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer peritoneal cavity cancer
Sponsor: Mayo Clinic
Start date: 2007-03-01; Completion date: 2012-11-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

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

PURPOSE: This phase II trial is studying how well giving lapatinib together with topotecan works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that did not respond to cisplatin or carboplatin.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of lapatinib ditosylate and topotecan hydrochloride, in terms of response, in patients with platinum-resistant or refractory ovarian epithelial or primary peritoneal cavity carcinoma.

Secondary

* Determine the overall survival time in patients treated with this regimen.
* Determine the time to progression in patients treated with this regimen.
* Assess the toxicity profile of this regimen in these patients.

Translational

* Determine the expression patterns of epidermal growth factor receptor, HER2/neu, hypoxia-induced factor 1 alpha, CD31, breast cancer resistance protein, and topoisomerase I by immunohistochemistry using tumor tissue from primary debulking surgery.
* Determine the feasibility of monitoring circulating tumor cells with specific biological markers to determine or follow response in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral lapatinib ditosylate once daily on days 1-28 and topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and on day 8 of course 1 (immediately after the topotecan infusion) and are evaluated for pharmacological studies. Tumor tissue samples obtained at debulking surgery are examined by immunohistochemistry for epidermal growth factor receptor, HER1, ErbB1, HER2/neu, ErbB2, hypoxia-induced factor 1 alpha, CD31, platelet endothelial cell adhesion molecule 1, topoisomerase I, and breast cancer resistance protein.

After the completion of study treatment, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Arms: arm 1: Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
Interventions: intervention 1: Lapatinib intervention 2: Topotecan
Intervention descriptions: intervention 1: 1250 mg orally days 1 -28. intervention 2: 3.2 mg/m2 IV over 30 min in 100mL D5W (5% dextrose in water) or 0.9% NS at days 1, 8 \& 15.

Protocol documents:
Clinical trial NCT00437281
Conditions: Epilepsies, Partial
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-04-01; Completion date: 2012-11-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Pregabalin
Intervention descriptions: intervention 1: Placebo intervention 2: Orally-administered pregabalin

Protocol documents:
Clinical trial NCT00442689
Conditions: Polycystic Ovary Syndrome Metabolic Syndrome
Keywords: Polycystic Ovary Syndrome Metabolic Syndrome PCOS overweight infertility Insulin Resistance menstrual cycle
Sponsor: Northwestern University
Start date: 2006-07-01; Completion date: 2012-11-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.

Detailed description:
Polycystic ovary syndrome (PCOS) is one of the most common conditions of young women, and it is frequently associated with insulin resistance or metabolic syndrome (MBS). In addition, affected women have significantly elevated mean low-density lipoprotein (LDL) levels and an increased prevalence of at risk LDL levels, independent of obesity. We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone (LH) with oral contraceptive pills (OCPs), compared with placebo, on visceral adiposity, circulating LDL levels, insulin secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests (FSIGT) and oral glucose tolerance tests (OGTT), resting energy expenditure, and maximal aerobic capacity measurement.

Note: Originally there were 2 additional study arm, Metformin only and Metformin + Flutamide. These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints.

Arms: arm 1: oral contraceptive (35 mg ethinyl estradiol) arm 2: Flutamide 250 mg twice daily arm 3: Placebo
Interventions: intervention 1: flutamide intervention 2: ethinyl estradiol 35 mcg and drospirenone 3 mg intervention 3: placebo
Intervention descriptions: intervention 1: 250 mg twice daily intervention 2: one active pill per day for three weeks and then 1 sugar pill per day for one week intervention 3: None

Protocol documents:
Clinical trial NCT00443352
Conditions: Migraine
Sponsor: Thomas Jefferson University
Start date: 2007-08-01; Completion date: 2012-11-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.

Detailed description:
Pharmacologic therapy of migraine headaches can be divided into two types: acute treatment and prophylactic treatment. Acute headache medication is intended to relieve the pain and disability of an acute attack and stop its progression. Prophylactic (preventive) headache therapy is generally given daily, even in the absence of headache, to reduce the frequency and perhaps the severity of anticipated attacks. Subjects who experience recurring migraine attacks which significantly interfere with the subject's daily routine despite acute treatment, may warrant chronic prophylactic treatment.

Duloxetine may be an important treatment option for millions of unsuccessfully treated migraine patients and therefore warrants further study. Considering this, we propose a single-center, open-label pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects with episodic migraine headaches. The results of this pilot trial will provide preliminary insight into the clinical role duloxetine may play in the treatment of headache, as well as provide a basis for future well-controlled trials of this medication.

This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.

Arms: arm 1: Duloxetine 120mg daily for 12 weeks.
Interventions: intervention 1: duloxetine
Intervention descriptions: intervention 1: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)

Protocol documents:
Clinical trial NCT00460603
Conditions: Colorectal Neoplasms
Keywords: GI neoplasms (phase 1)
Sponsor: Pfizer
Start date: 2006-01-01; Completion date: 2012-11-01
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.

Detailed description:

Arms: arm 1: bevacizumab 5 mg/kg every 2 weeks + FOLFOX arm 2: AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX arm 3: AG-013736 5 mg bid starting dose + FOLFOX
Interventions: intervention 1: bevacizumab intervention 2: AG-013726 intervention 3: AG-013736 (axitinib)
Intervention descriptions: intervention 1: bevacizumab 5 mg/kg every 2 weeks intervention 2: AG-013726 5 mg bid every 2 weeks intervention 3: AG-013736 5 mg bid starting dose

Protocol documents: