ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00085540
Conditions: Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2005-01-01; Completion date: 2009-03-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of FR901228 and to see how well it works in treating patients with recurrent high-grade gliomas. FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of FR901228 (depsipeptide) in patients with recurrent malignant gliomas who are taking enzyme-inducing antiepileptic drugs (EIAEDs). (Phase I) II. Determine the safety profile of this drug in these patients. (Phase I) III. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. (Phase I) IV. Determine the clinical efficacy of this drug, as measured by 6-month progression-free survival and objective tumor response, in these patients. (Phase II) V. Determine the safety profile of this drug when administered at the phase I MTD concurrently with or without EIAEDs in these patients. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study. Patients are stratified according to study phase (I vs II), concurrent use of enzyme-inducing anti-epileptic drugs (EIAEDs) (yes vs no), histology (recurrent glioblastoma multiforme/gliosarcoma vs recurrent anaplastic glioma), pre-operative candidacy (yes vs no), and measurable/evaluable disease (yes vs no). Patients are assigned to 1 of 2 treatment groups (group A: no EIAEDs or group B: concurrent use of EIAEDs).

Phase I (group B only): Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity.

Phase II (groups A and B):

Group A (phase II): Patients receive FR901228 as in phase I at dose level 1. Group B (phase II): Patients receive FR901228 as in phase I at the MTD.

Arms: arm 1: Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose escalation two dose levels:

Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2

Pharmacokinetics arm 2: Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Romidepsin (depsipeptide): 13.3mg/m2
Interventions: intervention 1: depsipeptide
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00086385
Conditions: Tobacco Use Disorder
Keywords: Smoking cessation Tobacco
Sponsor: University of California, San Francisco
Start date: 2001-09-01; Completion date: 2009-03-01
Enrollment: 403 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.

Detailed description:
The overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study were to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression. Participants were 50 years or older and smoker 10 or more cigarettes per day. Baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use.

Arms: arm 1: Pharmacological Treatment - Subjects received 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment (NRT)

Brief Counseling - The counseling intervention consisted of five 90-minute group meetings.

There was no further treatment during Weeks 12-52. arm 2: Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition would continue receiving NRT for up to 52 weeks. Subjects in this condition would be encouraged to continue NRT through Week 24. If a subject terminated NRT and resumed smoking, before Week 50, would be instructed to set a quit date and resume NRT.

Counseling Treatment - This is identical to the Brief Counseling described above. arm 3: This condition was identical to the Tailored/NRT condition except that no NRT was available after completion of the Brief Treatment. arm 4: Tailored Counseling Treatment- The primary goal of the extended treatment was to prevent relapse. Secondary goal was to encourage initiation of abstinence for those who have not attained it by Week 12, and re-initiation of abstinence after slips. Subjects would participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session would occur at Week 10. Additional sessions would be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session would be 20-30 minutes long. Between sessions subjects would be contacted by phone for brief check-ins (5-10 minutes).
Interventions: intervention 1: Nicotine polacrilex, Bupropion
Intervention descriptions: intervention 1: Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Protocol documents:
Clinical trial NCT00091793
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis Postmenopausal
Sponsor: Amgen
Start date: 2004-08-01; Completion date: 2009-03-01
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.

Detailed description:

Arms: arm 1: 60 mg/mL denosumab given day 1, month 6, month 12 and month 18 arm 2: Placebo given day 1, month 6, month 12 and month 18
Interventions: intervention 1: AMG 162 intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg/mL denosumab given day 1, month 6, month 12 and month 18 intervention 2: Placebo given at day 1, month 6, month 12 and month 18

Protocol documents:
Clinical trial NCT00104728
Conditions: Lung Cancer
Keywords: stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IA non-small cell lung cancer stage IB non-small cell lung cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2004-10-01; Completion date: 2009-03-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery for stage I, stage II, or stage III non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the effects of neoadjuvant gefitinib on downstream signaling pathways, including Src-Stat3, PI3K/Akt, ERK activity, and Bcl-2 family members in patients with resectable stage I-IIIA non-small cell lung cancer.
* Determine the effects of this drug on cell cycle and apoptosis within the primary tumor, by measuring changes in pre- and post-treatment Ki-67, Mcm2, cleaved caspase-3, and ApoTag, in these patients.

Secondary

* Determine the clinical response rate in patients treated with this drug.
* Determine the pathological response rate, defined as \> 95% necrosis or fibrosis in the pathological specimen, in patients treated with this drug.
* Determine the metabolic activity of this drug in these patients.
* Determine the safety, tolerability, and feasibility of this drug, in terms of toxicity and post-treatment resectability, in these patients.
* Correlate plasma and tumor concentrations of this drug with changes in post-treatment molecular markers in these patients.
* Identify a gene profile that predicts response to this drug in these patients.

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

Patients receive oral gefitinib once daily for 4 weeks in the absence of disease progression or unacceptable toxicity.

Within 3 days after completion of gefitinib, patients undergo restaging evaluation. Patients whose disease is still considered resectable proceed to surgery. Patients undergo thoracotomy with lobectomy or pneumonectomy OR sleeve resection. Patients also undergo mediastinal lymph node dissection. After surgical resection, treatment with gefitinib may continue off study at the discretion of the principal investigator.

After completion of study therapy, patients are followed at 30 days, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12.5 months.

Arms: arm 1: The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.

At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.
Interventions: intervention 1: ZD1839
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00104884
Conditions: Malignant Melanoma Melanoma
Keywords: stage III melanoma stage IV melanoma Depsipeptide
Sponsor: ECOG-ACRIN Cancer Research Group
Start date: 2005-10-04; Completion date: 2009-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as FR901228, 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 FR901228 works in treating patients with unresectable stage III or stage IV malignant melanoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 (depsipeptide).

Secondary

* Determine the progression-free and overall survival of patients treated with this drug.
* Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive FR901228 (depsipeptide) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 18 months.

Arms: arm 1: Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
Interventions: intervention 1: Depsipeptide
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00112866
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2005-01-01; Completion date: 2009-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Giving cilengitide before and after surgery may be an effective treatment for glioblastoma multiforme. This phase II trial is studying how well cilengitide works in treating patients who are undergoing surgery for recurrent or progressive glioblastoma multiforme.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the 6-month progression-free survival rate in operative patients with recurrent or progressive glioblastoma multiforme treated with cilengitide.

SECONDARY OBJECTIVES:

I. Determine the safety and toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment groups for the preoperative treatment component.

Preoperative Treatment Group I: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1.

Preoperative Treatment Group II: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1.

Resection: All patients undergo tumor resection on day 0.

Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 44 patients (22 per preoperative treatment group) will be accrued for this study.

Arms: arm 1: Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)

Resection: All patients undergo tumor resection on day 0.

Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. arm 2: Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (500mg)

Resection: All patients undergo tumor resection on day 0.

Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity
Interventions: intervention 1: cilengitide intervention 2: therapeutic conventional surgery intervention 3: pharmacological study intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Undergo tumor resection intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT00113516
Conditions: Non-small Cell Lung Cancer
Keywords: Lung Neoplasms
Sponsor: Pfizer
Start date: 2005-09-01; Completion date: 2009-03-01
Enrollment: 84 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: carboplatin intervention 2: paclitaxel intervention 3: sunitinib
Intervention descriptions: intervention 1: AUC of 6 mg\*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices. intervention 2: 175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices. intervention 3: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).

Protocol documents:
Clinical trial NCT00117637
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Cancer RCC Cancer
Sponsor: Bayer
Start date: 2005-06-01; Completion date: 2009-03-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to:

* Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a
* Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression
* Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a
* Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage
* Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer
* Find out the level of BAY43-9006 in the blood once per month and any changes in this level
* Find out whether BAY43-9006 effects are associated with specific biomarkers

Detailed description:
Analyses on Biomarkers were exploratory and assessed as tertiary objective of the trial.

Arms: arm 1: Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis. arm 2: Interferon (IFN) α-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period.After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Interferon
Intervention descriptions: intervention 1: Multi kinase inhibitor intervention 2: Interferon

Protocol documents:
Clinical trial NCT00134043
Conditions: Insular Thyroid Cancer Recurrent Thyroid Cancer Stage II Follicular Thyroid Cancer Stage II Papillary Thyroid Cancer Stage IV Follicular Thyroid Cancer Stage IV Papillary Thyroid Cancer Thyroid Gland Medullary Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-12-01; Completion date: 2009-03-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with metastatic and/or locally advanced or locally recurrent thyroid cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with metastatic and/or locally advanced or locally recurrent thyroid cancer treated with suberoylanilide hydroxamic acid.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this drug in these patients.

OUTLINE:

Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA. After completion of study treatment, patients are followed within 4 weeks.

Arms: arm 1: Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
Interventions: intervention 1: vorinostat
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00136760
Conditions: Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder
Keywords: tobacco
Sponsor: Brown University
Start date: 2003-09-01; Completion date: 2009-03-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.

Detailed description:
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.

Arms: arm 1: Contingent reinforcement plus bupropion arm 2: Contingent reinforcement plus placebo arm 3: Non-contingent reinforcement plus bupropion arm 4: Non-contingent reinforcement plus placebo
Interventions: intervention 1: Bupropion intervention 2: Contingent reinforcement plus placebo intervention 3: non-contingent reinforcement plus bupropion intervention 4: Non-contingent reinforcement plus placebo
Intervention descriptions: intervention 1: Contingent reinforcement plus bupropion (300 mg/day for 3 weeks) intervention 2: contingent reinforcement plus placebo (3 weeks) intervention 3: non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks) intervention 4: Non-contingent reinforcement plus placebo

Protocol documents: