ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00003470
Conditions: Anaplastic Astrocytoma
Keywords: persistent anaplastic astrocytoma recurrent anaplastic astrocytoma adult anaplastic astrocytoma
Sponsor: Burzynski Research Institute
Start date: 1996-03-01; Completion date: 2009-12-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytomas that have not responded to standard therapy.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytomas that have not responded to standard therapy.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with anaplastic astrocytomas that have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with a anaplastic astrocytoma

OVERVIEW: This is a single arm, open-label study in which adults withanaplastic astrocytomas that have not responded to standard therapy receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Protocol documents:
Clinical trial NCT00007020
Conditions: Infantile Refsum's Disease Zellweger Syndrome Adrenoleukodystrophy Peroxisomal Disorders Cholestasis
Sponsor: Mirum Pharmaceuticals, Inc.
Start date: 1992-01-01; Completion date: 2009-12-01
Enrollment: 85 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
OBJECTIVES:

I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism

II. To assess the safety and tolerability of cholic acid

Detailed description:
Investigational Plan:

A Phase III, open label, single arm, nonrandomized, non-comparative, compassionate treatment study of cholic acid in the treatment of defects of bile acid metabolism.

The study was begun with a single study site at Cincinnati Children's Hospital Medical Center (CCHMC), but in 2005 was expanded so that compassionate treatment could be provided to additional patients who had been identified with inborn errors of bile metabolism through the center's screening/diagnostic program.

Patients who were screened were contacted and evaluated with respect to the inclusion/exclusion criteria. Signed informed consent by the patient and/or parents/legal guardian was obtained as soon as it is confirmed that the patient met inclusion/exclusion criteria and the parents/guardian would agree for the child to participate in the study.

The primary interventions for the study were:

1. Administration of study drug.
2. Collection of baseline physical exam, vital signs, blood and urine samples for laboratory tests.
3. Collection of periodic physical exam, vital signs, blood and urine samples for laboratory tests during the period of administration of the study drug.
4. Collection of any adverse event information.

Time and Events Schedule:

Baseline:

1. Confirm eligibility
2. Obtain written informed consent from patient and/or parents/legal guardian
3. Collect demographic data and disease and medication history, including family history

   Baseline and Ongoing:
4. Obtain body weight
5. Record adverse events
6. Obtain blood and urine samples for laboratory tests
7. Initiate study drug therapy \& monitor study drug therapy and adjust dose as needed

Arms: arm 1: None
Interventions: intervention 1: Cholic Acids
Intervention descriptions: intervention 1: 10-15 mg/kg body weight/day taken orally.

Protocol documents:
Clinical trial NCT00045162
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
Sponsor: SWOG Cancer Research Network
Start date: 2002-11-01; Completion date: 2009-12-01
Enrollment: 671 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.

Detailed description:
OBJECTIVES:

* Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide.
* Compare the objective response rate and progression-free survival of patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic effects in these patients.
* Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs more than 5%). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 4 weeks.
* Arm II: Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 3 weeks.

Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 620 patients (310 per treatment arm) will be accrued for this study within 4 years.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: cisplatin intervention 2: etoposide intervention 3: irinotecan hydrochloride
Intervention descriptions: intervention 1: Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles

Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles intervention 2: 100 mg/m2 IV (over 30-60 min) on Days 1 , 2 \& 3. Q 3 weeks x 4 Cycles intervention 3: 60 mg/m2 IV (over 90 min)on Days 1, 8 \& 15. Q 4 weeks x 4 Cycles

Protocol documents:
Clinical trial NCT00045734
Conditions: Adult Grade I Meningioma Adult Grade II Meningioma Adult Grade III Meningioma Adult Meningeal Hemangiopericytoma Adult Meningioma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2003-02-01; Completion date: 2009-12-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Detailed description:
PRIMARY OBJECTIVE:

I. Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.

SECONDARY OBJECTIVES I. Determine the response rate and overall survival of patients treated with this drug.

II. Evaluate the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Develop exploratory data concerning surrogate markers of of angiogenic activity in vivo using functional neuro-imaging studies and in vitro assays of serum angiogenic peptides of this drug in these patients.

V. Develop exploratory data concerning evidence of platelet-derived growth factor (PDGF) inhibition in tumor specimens taken from patients undergoing surgery VI. Develop exploratory data correlating molecular abnormalities in the tumor with response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (yes vs no), histology (benign vs atypical or malignant), neurofibromatosis positivity (yes vs no), and preoperative candidacy (yes vs no).

Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 8-12 months.

Arms: arm 1: Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study/ laboratory biomarker analysis
Interventions: intervention 1: imatinib mesylate intervention 2: laboratory biomarker analysis intervention 3: pharmacological study
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00076336
Conditions: Hepatitis Hepatitis B, Chronic Cirrhosis
Sponsor: Novartis Pharmaceuticals
Start date: 2003-12-01; Completion date: 2009-12-01
Enrollment: 232 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.

Detailed description:
Multicenter, multinational, randomized, double-blind study designed to compare the safety and efficacy of telbivudine (600 mg/day) versus lamivudine (100 mg/day) for 104 weeks in adults with decompensated chronic hepatitis B and evidence of cirrhosis. Patients were pre-stratified by screening Child-Turcotte-Pugh score (CTP score \< 9 or ≥ 9) and ALT level (within normal limits (WNL) or \> 1.0 x ULN) to help assure similar degrees of hepatic insufficiency and liver inflammation on both treatment arms. After 104 weeks of treatment, participants were followed-up with for an additional 16 weeks.

Arms: arm 1: Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment. arm 2: Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
Interventions: intervention 1: Telbivudine intervention 2: Lamivudine intervention 3: Placebo
Intervention descriptions: intervention 1: 600mg/day oral tablet for 104 weeks intervention 2: 100mg/day oral tablet for 104 weeks intervention 3: Telbivudine matching placebo or lamivudine matching placebo tablet.

Protocol documents:
Clinical trial NCT00086619
Conditions: Postmenopausal Osteoporosis Osteoporosis
Keywords: Osteoporosis Parathyroid hormone Teriparatide Bone formation Bone resorption
Sponsor: Massachusetts General Hospital
Start date: 2004-05-01; Completion date: 2009-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time. This study will test whether increasing the daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies will test several potential reasons why PTH's effects on bone formation decline over time.

Detailed description:
In women with postmenopausal osteoporosis, PTH increases bone mineral density more than anti-resorptive agents, and its use markedly reduces the incidence of new spine and non-spine fractures. Still, PTH is not a cure for osteoporosis in many patients because PTH-stimulated bone formation declines as PTH therapy continues. Biochemical analyses suggest that bone formation and resorption peak after 6 to 9 months of daily PTH therapy and then decline progressively.

The study will last 18 months. Blood, urine, and bone density tests will occur at screening. At the start of the study, participants will be randomly assigned to one of two PTH dose regimens. Patients will go to Massachusetts General Hospital at Months 0, 3, 6, 9, 12, 15, and 18 for blood and urine collection. In addition, bone density tests by DXA will be performed at Months 0, 6, 12, and 18, and by quantitative CT scans at Months 0 and 18. Approximately 6 weeks after any change in PTH dose, each participant's blood calcium will be checked 4 to 6 hours after that day's PTH injection, and her 24-hour urine calcium excretion will also be checked.

Participants may enroll in optional substudies that will test whether reduced skeletal responses to long-term treatment with PTH are accompanied by changes in its absorption and/or destruction and whether reduced skeletal responses to long-term treatment with PTH are accompanied by parallel reductions in kidney responses to PTH.

Arms: arm 1: Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a constant dose of 30 mcg/day. arm 2: Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a dose that ascends at 6 month intervals (20-30-40 mcg/day).
Interventions: intervention 1: synthetic hPTH 1-34
Intervention descriptions: intervention 1: Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34

Protocol documents:
Clinical trial NCT00097500
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide exendin-4 Amylin Lilly
Sponsor: AstraZeneca
Start date: 2004-09-01; Completion date: 2009-12-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Detailed description:

Arms: arm 1: Exenatide and Metformin arm 2: Insulin Glargine and Metformin
Interventions: intervention 1: exenatide intervention 2: Insulin glargine intervention 3: Metformin
Intervention descriptions: intervention 1: subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets intervention 2: subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets intervention 3: Patients usual dosage

Protocol documents:
Clinical trial NCT00108342
Conditions: Smoking
Keywords: nicotine drug therapy Smoking Cessation
Sponsor: US Department of Veterans Affairs
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke.

Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.

Detailed description:
The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.

Arms: arm 1: Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)

2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device). arm 2: Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
Interventions: intervention 1: Nicotine gum - 2 mg and 4 mg intervention 2: Nicotine lozenges - 2 mg and 4 mg intervention 3: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing intervention 4: Computer learning
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: can yield 4 mg from 10 mg device - infrequent and frequent puffing intervention 4: None

Protocol documents:
Clinical trial NCT00116207
Conditions: Diabetic Autonomic Neuropathy
Keywords: Type 1 Diabetes Oxidative Stress Diabetic Complications Neuropathy
Sponsor: University of Michigan
Start date: 2000-01-01; Completion date: 2009-12-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be tested for their effectiveness in DAN.

Detailed description:

Arms: arm 1: Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally These drugs were given together as a combination and not as individual treatment. arm 2: Placebo administered twice daily.
Interventions: intervention 1: ORAL ANTIOXIDANT
Intervention descriptions: intervention 1: Comparison of triple antioxidant combination therapy vs placebo.

Protocol documents:
Clinical trial NCT00138125
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer
Sponsor: Translational Oncology Research International
Start date: 2005-04-01; Completion date: 2009-12-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer.

PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Compare the overall objective response rate in postmenopausal women with estrogen receptor (ER)- and/or progesterone receptor (PR)-positive, HER2/neu-overexpressing stage IV breast cancer treated with first-line therapy comprising fulvestrant and/or trastuzumab (Herceptin®).

Secondary

* Compare the duration of response in patients treated with these regimens.
* Compare overall survival of patients treated with these regimens.
* Compare the antitumor activity of these regimens, in terms of time to disease progression, in these patients.
* Compare the clinical benefit of these regimens in these patients.
* Determine the safety and toxicity of these regimens in these patients.
* Correlate HER2/neu expression and ER and/or PR expression with response in patients treated with these regimens.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to prior adjuvant endocrine therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 only in all subsequent courses.
* Arm II: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, 15, and 22.
* Arm III: Patients receive fulvestrant as in arm I in combination with trastuzumab as in arm II.

In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 120 patients (40 per treatment arm) will be accrued for this study.

Arms: arm 1: see intervention description for details
Interventions: intervention 1: Faslodex intervention 2: Herceptin
Intervention descriptions: intervention 1: Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter. intervention 2: Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly

Protocol documents: