ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00732901
Conditions: Cocaine Dependence
Keywords: substance abuse cocaine impulsivity serotonin Remeron Mirtzapine Lexapro Escatilopram
Sponsor: Virginia Commonwealth University
Start date: 2008-06-01; Completion date: 2013-02-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity and cue reactivity in cocaine dependent subjects and healthy controls and examine specific effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine users.

Detailed description:
Specific Aim 1: We will test the hypothesis that cocaine-dependent subjects will exhibit greater impulsivity than controls as determined by a battery of impulsivity measures and that impulsivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or mirtazapine will reduce impulsivity and cocaine-positive urines, in concert with a normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression.

Specific Aim 2: We will test the hypothesis that cocaine-dependent subjects will exhibit greater cue reactivity than controls as determined by a modified Stroop task, and that cue reactivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or mirtazapine will reduce cue reactivity and cocaine-positive urines, in concert with a normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression.

Specific Aim 3: We will test the hypothesis that specific polymorphisms in the 5-HT2AR and/or 5-HT2CR will predict baseline impulsivity and/or cue reactivity as well as treatment response to serotonergic medications in cocaine-dependent subjects.

Arms: arm 1: Escitalopram arm 2: Placebo
Interventions: intervention 1: Escitalopram intervention 2: Placebo
Intervention descriptions: intervention 1: Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28 intervention 2: Once daily days 1-28

Protocol documents:
Clinical trial NCT00740636
Conditions: Lung Cancer
Keywords: TEMOZOLOMIDE Lung
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-08-01; Completion date: 2013-02-01
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with temozolomide will shrink small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently used to treat brain cancer and melanoma.

As part of this study, we will be doing additional tests that may help us understand how temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will be analyzed for an abnormal gene that may be present in lung cancer. Before starting temozolomide, a research blood test will be done to look for the same abnormal gene we are looking for in your tumor sample. Also, before starting temozolomide and every time you have a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in your bloodstream.

Detailed description:

Arms: arm 1: 75 mg/m2/day Temozolomide for 21 days (7 days off treatment). 28 day cycles. arm 2: 200 mg/m2/day Temozolomide for 5 days (23 days off treatment). 28 day cycles.
Interventions: intervention 1: Temozolomide intervention 2: Temozolomide
Intervention descriptions: intervention 1: Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 75 mg/m2/day. intervention 2: Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 200mg/m2/day.

Protocol documents:
Clinical trial NCT00743574
Conditions: Polycystic Ovarian Syndrome Vitamin D Deficiency
Sponsor: Yale University
Start date: 2008-08-01; Completion date: 2013-02-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation in overweight (BMI \> 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels \< 20 ng/mL).

Detailed description:
We had hypothesized that in women with PCOS, administering optimal daily doses of vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of calcium, both per oral (PO), over a three month period will improve their metabolic picture, and possibly hormone profile.

Over the course of the trial, after the first 5 subjects had completed 3 month intervention,we observed that daily 2000IU D3 dosing regime was inadequate in normalizing vitamin D status in the study population; the dosing regimen was therefore modified to include weekly supplementation with 50,000IU D2 in addition to daily dosing with 2000IU D3.

Arms: arm 1: None
Interventions: intervention 1: Vitamin D2 (Ergocalciferol) intervention 2: Medroxyprogesterone (Provera) intervention 3: Vitamin D3 (Cholecalciferol) intervention 4: Elemental Calcium
Intervention descriptions: intervention 1: 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months) intervention 2: 10mg, PO, daily for ten days intervention 3: 2,000IU (or 2 tablets), PO, daily (supplements taken for three months) intervention 4: 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)

Protocol documents:
Clinical trial NCT00768144
Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords: Sutent sunitinib
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-09-01; Completion date: 2013-02-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.

Detailed description:
This study used a two-stage design to evaluate efficacy of sunitinib based on overall response (OR) defined as complete response (CR) or partial response (PR). The null and alternative OR rate were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=17 patients) achieved PR or better than accrual would proceed to stage two (n=18 patients). There was 42% probability of stopping the trial at stage one if the true OR rate was 5%. With 35 patients, this design had 85% power to detect the 15% difference in OR rates assuming 2-sided type I error rate of 0.05.

Arms: arm 1: Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00769600
Conditions: Recurrent Non Small Cell Lung Cancer
Keywords: Recurrent Non-Small Cell Lung Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2008-11-01; Completion date: 2013-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective

To evaluate the 3-month event-free survival of the combination of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.

Secondary Objectives

To determine the objective response rate of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.

Detailed description:
Primary Objective

To evaluate the 3-month event-free survival of the combination of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer. 3-month event-free survival (EFS) is defined as the proportion of patients who are alive and without event after 3 months (evaluated in a window of +/- 1 week) of treatment. Events are defined as disease progression or death from any cause. All patients treated on protocol will be included in the determination of EFS, regardless of treatment modification or discontinuation.

Secondary Objectives

To determine the objective response rate of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

Arms: arm 1: Pemetrexed IV every 21 days with oral Itraconazole 200mg daily. arm 2: Pemetrexed IV on day 1 of 21-day cycle.
Interventions: intervention 1: Itraconazole intervention 2: Pemetrexed
Intervention descriptions: intervention 1: Itraconazole 200 mg once daily intervention 2: Pemetrexed every 21 days.

Protocol documents:
Clinical trial NCT00850460
Conditions: Statin Adverse Reaction
Sponsor: Rockefeller University
Start date: 2009-02-01; Completion date: 2013-02-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed study will focus on possible effects of statins on muscle strength and why they become tired more easily, quality of life, and measurements to understand why muscles are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life.

This study hypothesize that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:

1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36) scores (primary end point)
2. alleviation of muscle symptoms,
3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results
4. decreased intramyocellular lipid (IMCL)
5. improved insulin sensitivity.

Detailed description:
The proposed study will focus on possible effects of statins on muscle strength and quality of life, and measurements to understand why muscles of statin users are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life.

This study hypothesizes that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:

1. improved INQoL and SF-36 scores (primary end point)
2. alleviation of muscle symptoms,
3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results
4. decreased IMCL
5. improved insulin sensitivity.

Arms: arm 1: Lactose placebo pill arm 2: Statin medications
Interventions: intervention 1: Statins intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth. intervention 2: Placebo pills will consist of lactose and will be given one capsule once daily

Protocol documents:
Clinical trial NCT00855218
Conditions: Carcinoma, Hepatocellular
Keywords: Sorafenib TACE DC bead Combination
Sponsor: Bayer
Start date: 2009-03-01; Completion date: 2013-02-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

Detailed description:
Safety issues will be reported in Adverse Event section. In addition to the secondary outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other variables.

Arms: arm 1: Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) arm 2: Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: 800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. \[twice daily\], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead intervention 2: 4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead

Protocol documents:
Clinical trial NCT00859456
Conditions: Sarcoma, Soft Tissue
Sponsor: Columbia University
Start date: 2007-04-01; Completion date: 2013-02-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib.

Detailed description:
Soft tissue sarcomas are rare tumors that arise from mesenchymal tissue from anywhere in the body. While surgical intervention can offer a cure for localized soft tissue sarcoma, treatment of unresectable and metastatic disease is particularly challenging. New treatment options are needed for patients with unresectable or metastatic disease if they progress or cannot tolerate conventional chemotherapy. This study will investigate sunitinib - a novel orally-administered multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities.

Arms: arm 1: Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens.
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.

A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).

Protocol documents:
Clinical trial NCT00868959
Conditions: Bipolar Depression
Keywords: Bipolar Depression Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2009-04-01; Completion date: 2013-02-01
Enrollment: 817 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: lurasidone
Intervention descriptions: intervention 1: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Protocol documents:
Clinical trial NCT00920023
Conditions: Pancreatic Cancer
Keywords: SPIO MRI Feridex
Sponsor: Massachusetts General Hospital
Start date: 2008-07-01; Completion date: 2013-02-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for surgical resection.

Detailed description:
* On the first day, study participants will undergo 2 MRI examinations. A scan will be done prior to administration of the contrast agent (Feraheme) and then a second scan immediately after administration. On the second day, study participants will be asked to return for a third MRI.
* All MRI scans will be done at Massachusetts General Hospital.

Arms: arm 1: None
Interventions: intervention 1: Superparamagnetic Iron Oxide Magnetic Resonance Imaging
Intervention descriptions: intervention 1: Two MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol

Protocol documents:
Clinical trial NCT00927589
Conditions: Solid Cancers
Keywords: HER2+ Metastatic Cancer HER2+ Locally Advanced Inoperable Cancer HER2+ Solid Malignancy
Sponsor: Genentech, Inc.
Start date: 2009-07-01; Completion date: 2013-02-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with HER2-positive metastatic or locally advanced inoperable cancer.

The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia's correction; the QTcB interval is the QT interval as calculated using Bazett's correction.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: carboplatin intervention 2: docetaxel intervention 3: trastuzumab
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00973479
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, Rheumatoid Active rheumatoid arthritis Golimumab CNTO148 Anti-TNFalpha monoclonal antibody Methotrexate Intravenous
Sponsor: Centocor, Inc.
Start date: 2009-09-01; Completion date: 2013-02-01
Enrollment: 592 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.

Detailed description:
This is a randomized (study medication is assigned by chance), double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), multicenter, 2-arm (2 groups) study of golimumab in participants with active RA despite concurrent MTX therapy. Approximately 564 participants will be randomly allocated to 1 of 2 treatment groups in a 2:1 ratio ie, Group 1(approximately 376 participants will receive golimumab + MTX) and Group 2 (approximately 188 participants will receive MTX + placebo). Total duration of study for each participant is 112 weeks. Safety will be evaluated by assessment of adverse events, tuberculosis testing and blood testing.

Arms: arm 1: Participants will receive placebo at Weeks 0, 4, 12, and 16. Participants will cross over to golimumab at Week 24, and receive administrations at Weeks 24, 28, and every 8 weeks thereafter. They will be maintained on their stable dose of commercial methotrexate throughout the study. Participants will be eligible for early escape (receive golimumab) at Week 16 if they demonstrate a less than 10 percent improvement in both tender and swollen joint count. These participants will receive golimumab at Weeks 16, 20, and every 8 weeks thereafter. arm 2: Participants will receive golimumab at Weeks 0, 4, and every 8 weeks thereafter. They will be maintained on their stable dose of commercial methotrexate throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
Interventions: intervention 1: Golimumab intervention 2: Placebo intervention 3: methotrexate (MTX)
Intervention descriptions: intervention 1: Participants will receive 2 mg/kg of golimumab intravenously over 30 ± 10 minutes. Group 1: at Weeks 0, 4, and every 8 weeks thereafter (up to Week 100). Group II: Weeks 24, 28, and every 8 weeks thereafter (up to Week 100); Early escape: at Week 16, 20 and every 8 weeks thereafter (up to Week 100). intervention 2: Participants will receive placebo intravenous infusion over 30 ± 10 minutes as: Group I: at Week 16 and 24; Group II: at Weeks 0, 4, 12, 16, and 20; and for early escape: at Week 24. intervention 3: Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.

Protocol documents:
Clinical trial NCT00996216
Conditions: Hepatitis C
Keywords: Peginterferon Platelets Ribavirin Hepatitis C-related thrombocytopenia Thrombocytopenia Hepatitis C Thrombopoietin
Sponsor: GlaxoSmithKline
Start date: 2009-09-01; Completion date: 2013-02-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.

Detailed description:

Arms: arm 1: Open-label eltrombopag with dose titrations to support adequate platelet counts.
Interventions: intervention 1: Eltrombopag intervention 2: Antiviral therapy
Intervention descriptions: intervention 1: Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose. intervention 2: Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.

Protocol documents: