ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00528645
Conditions: Extensive Stage Small Cell Lung Cancer Lung Metastases Malignant Pleural Effusion Recurrent Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-11-01; Completion date: 2013-05-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II study is studying how well giving AZD0530 works in treating patients with extensive-stage small cell lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the 12-week progression-free survival rate of patients with extensive stage small cell lung cancer treated with AZD0530.

SECONDARY OBJECTIVES:

I. To determine the response rate in patients treated with this drug. II. To determine the overall survival and time-to-progression in patients treated with this drug.

III. To determine the adverse events of AZD0530 in these patients IV. To determine the effect of AZD0530 treatment on levels of circulating tumor cells in these patients.

V. To determine potential predictive markers of response in circulating tumor cells after treatment with this drug.

VI. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in patients treated with this drug.

TERTIARY OBJECTIVES:

I. To determine the effect of AZD0530 treatment on levels of circulating tumor cells.

II. To determine potential predictive markers of response in circulating tumor cells after treatment with this drug.

III. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in patients treated with this drug.

OUTLINE: Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.

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

Arms: arm 1: Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.
Interventions: intervention 1: saracatinib
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00668642
Conditions: Prostate Cancer
Sponsor: Endeavor Health
Start date: 2007-03-01; Completion date: 2013-05-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).

Detailed description:
We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. Prostate-specific antigen (PSA) levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics.

Arms: arm 1: Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle arm 2: Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle
Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: 0.5 mg capsule given orally on daily basis intervention 2: Identical placebo

Protocol documents:
Clinical trial NCT00672139
Conditions: Opioid-Induced Constipation
Keywords: Opioid-Induced Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2008-07-01; Completion date: 2013-05-01
Enrollment: 156 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

Detailed description:

Arms: arm 1: Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.

Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and \<62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.
Interventions: intervention 1: Methylnaltrexone bromide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00693719
Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer
Sponsor: University of Arizona
Start date: 2007-08-01; Completion date: 2013-05-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide works in treating patients with recurrent, locally advanced, or metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the response rate, as assessed by RECIST criteria, in patients with recurrent locally advanced or metastatic breast cancer treated with irinotecan hydrochloride and etoposide after prior exposure to anthracycline, taxane, and capecitabine therapy.

Secondary

* To determine the median time to progression in these patients.
* To determine the response duration and survival in these patients.
* To measure the type and rate of grade 3 or greater toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

After completion of study therapy, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Arms: arm 1: Irinotecan 100 mg/m2 IV days 1 and 15. Etoposide 50 mg PO x14 days followed by 2 weeks off.
Interventions: intervention 1: Etoposide intervention 2: Irinotecan hydrochloride
Intervention descriptions: intervention 1: 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle intervention 2: Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle

Protocol documents:
Clinical trial NCT00700102
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-02-01; Completion date: 2013-05-01
Enrollment: 820 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

Detailed description:

Arms: arm 1: Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal arm 2: Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
Interventions: intervention 1: Chemotherapy intervention 2: Bevacizumab
Intervention descriptions: intervention 1: As prescribed intervention 2: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.

Protocol documents:
Clinical trial NCT00701363
Conditions: Acromegaly
Sponsor: Ipsen
Start date: 2008-10-01; Completion date: 2013-05-01
Enrollment: 124 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lanreotide Autogel 120 mg
Intervention descriptions: intervention 1: 120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24

Protocol documents:
Clinical trial NCT00712348
Conditions: Gaucher Disease
Keywords: Gaucher disease imiglucerase glucocerebrosidase enzyme replacement therapy lysosomal storage disorder
Sponsor: Pfizer
Start date: 2008-12-01; Completion date: 2013-05-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy.

Detailed description:
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) ERT. Eligible patients will enter a 12-week Stability Evaluation Period to establish the stability of their disease. Patients with stable disease will then be switched from their imiglucerase treatment to receive intravenous (IV) infusions of taliglucerase alfa every two weeks for a total of 20 IV infusions. The dose of taliglucerase alfa will be equal to each patient's previous imiglucerase dose. The infusions will be administered at the selected investigational site (clinic/hospital), infusion center, or at home. At the end of the 9-month treatment period (20 visits, 38 weeks) eligible patients will be offered enrollment in an open-label extension study.

Arms: arm 1: Open label taliglucerase alfa treatment
Interventions: intervention 1: Taliglucerase alfa
Intervention descriptions: intervention 1: Intravenous infusion every 2 weeks

Protocol documents:
Clinical trial NCT00717197
Conditions: Malignant Glioma
Keywords: HGG anaplastic astrocytoma anaplastic oligodendroglioma anaplastic mixed glioma glioblastoma multiforme GBM Xeloda capecitabine
Sponsor: University of Florida
Start date: 2008-07-01; Completion date: 2013-05-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if capecitabine is effective in the treatment of high grade gliomas that have returned after completing treatment.

Detailed description:
High grade gliomas (HGGs) represent a heterogenous group of primary brain tumors that share WHO grade III or IV classification (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma multiforme). Despite the upfront use of surgery, radiation, and chemotherapy, high grade gliomas uniformly result in recurrence and death. Palliative chemotherapy offers an improvement in time to progression, symptom control, quality of life, and potential survival; however, no established chemotherapy regimen for recurrence exists and new treatments are needed. Oral capecitabine is a rationale strategy for therapeutic palliation of recurrent high grade gliomas given its oral administration, its well-known kinetics and toxicities, its non-competitive toxicities to other high grade glioma treatments, its well established management algorithms, its established evidence of entry into the central nervous system, and its evidence of safety and efficacy in malignancies in the central nervous system.

Arms: arm 1: Capecitabine (1,000-1,250 mg/m2) taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.
Interventions: intervention 1: Capecitabine
Intervention descriptions: intervention 1: 1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00743119
Conditions: Pain Threshold Mood
Keywords: oral thc cannabis pain analgesic effects dronabinol
Sponsor: New York State Psychiatric Institute
Start date: 2008-06-01; Completion date: 2013-05-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Oral THC (dronabinol) is known to have a slower onset and longer duration of action compared with smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and last longer than effects produced by smoked marijuana.

Detailed description:
Laboratory animal studies have demonstrated the analgesic effects of drugs which act on the cannabinoid system, however, these effects have et to be clearly elucidated in humans. To better understand the potential clinical application of cannabinoids for pain management, the following study is designed to determine the analgesic efficacy of smoked marijuana (3.56% THC) and oral THC (20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Non-treatment seeking marijuana smokers will be recruited for a five-session study during which the analgesic, subjective, and physiologic effects of cannabinoids will be evaluated. Determining the efficacy of cannabinoids in an experimental model of pain will provide important endpoints (i.e., dose, route of administration, time course) or this effect to further investigate the potential role for clinical use of smoked marijuana and/or oral THC as analgesics.

Arms: arm 1: Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. arm 2: Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. arm 3: Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. arm 4: Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order. arm 5: Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order.
Interventions: intervention 1: Placebo capsules intervention 2: Inactive marijuana (0% THC) intervention 3: Low dose Dronabinol intervention 4: High dose Dronabinol intervention 5: Low THC marijuana intervention 6: High THC marijuana
Intervention descriptions: intervention 1: Placebo capsules intervention 2: Inactive marijuana cigarettes (0% THC) provided by NIDA intervention 3: Dronabinol 10mg intervention 4: Dronabinol 20mg intervention 5: marijuana cigarettes (1.98% THC) provided by NIDA intervention 6: Marijuana cigarettes (3.56% THC) provided by NIDA

Protocol documents:
Clinical trial NCT00802737
Conditions: Leukaemia, Lymphocytic, Chronic
Keywords: Maintenance Retreatment Chronic lymphocytic leukemia B-Cell Chronic Lymphocytic Leukemia Ofatumumab
Sponsor: GlaxoSmithKline
Start date: 2009-01-01; Completion date: 2013-05-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).

Detailed description:

Arms: arm 1: Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years
Interventions: intervention 1: Ofatumumab
Intervention descriptions: intervention 1: Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years

Protocol documents:
Clinical trial NCT00834652
Conditions: Depression
Keywords: Metabolic Diseases Depressive Disorder, Major Depressive Disorder Glucose Metabolism Disorders Depression Recurrence
Sponsor: Washington University School of Medicine
Start date: 2007-09-01; Completion date: 2013-05-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight.

Detailed description:
Current depression treatments are not effective for approximately one-half of overweight people, and depression eventually returns in approximately one-third of those overweight people whose initial treatment is effective. One possible reason for these treatment failures is that overweight people often experience a condition called insulin resistance (IR), which can lead to type 2 diabetes, an associated disease that might also affect depression treatment. IR results in elevated blood sugar levels that may interfere with medications used to treat depression. Metformin, a medication commonly used to treat diabetes, reduces blood sugar levels. This study will examine whether taking metformin with the antidepressant medication sertraline will enhance the effectiveness of sertraline in people who are overweight and depressed.

Participation in this study will last a total of 16 weeks and will include baseline testing and ten scheduled study visits. Participants will be randomly assigned to receive either sertraline and metformin or sertraline and placebo on a daily basis. The baseline visit will include the following tests and measures: an electrocardiogram (EKG), which will measure the electrical activity in the heart; an oral glucose tolerance test (OGTT), which will measure how a person's body breaks down glucose; a blood test, which will measure lipids, glycosylated hemoglobin (A1C), and other cardiometabolic risk factors; a dual energy x-ray absorptimetry (DEXA) scan, which will measure body fat; a pregnancy test for women; measurements of vital signs, height, weight, waist-to-hip ratio, and waist circumference; and questionnaires concerning health, medication use, physical activity, diet, and mood. Some of the questionnaires will be administered through interviews with a researcher. During the study visits, which will occur every 2 weeks, participants will complete questionnaires, unused medication will be collected, and new medication will be handed out. At Week 8, participants will provide an additional blood sample by finger stick.

Arms: arm 1: Participants will receive sertraline and metformin. arm 2: Participants will receive sertraline and placebo.
Interventions: intervention 1: Sertraline intervention 2: Metformin
Intervention descriptions: intervention 1: 50 mg once a day, which may be increased to 200 mg once a day intervention 2: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily

Protocol documents:
Clinical trial NCT00838916
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
Sponsor: GlaxoSmithKline
Start date: 2009-02-01; Completion date: 2013-05-01
Enrollment: 779 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: albiglutide weekly subcutaneous injection arm 2: insulin glargine daily injection
Interventions: intervention 1: albiglutide intervention 2: insulin glargine
Intervention descriptions: intervention 1: albiglutide weekly injection intervention 2: insulin glargine

Protocol documents:
Clinical trial NCT00850343
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Certolizumab Pegol Cimzia
Sponsor: Astellas Pharma Inc
Start date: 2009-03-01; Completion date: 2013-05-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.

Detailed description:
This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

Arms: arm 1: Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. arm 2: Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Interventions: intervention 1: Certolizumab pegol
Intervention descriptions: intervention 1: Subcutaneous (SC) injection

Protocol documents: