ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01997229
Conditions: Refractory Generalized Myasthenia Gravis
Keywords: Myasthenia Gravis Eculizumab safety efficacy
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2013-12-01; Completion date: 2016-06-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

Detailed description:

Arms: arm 1: Biological/Vaccine: Eculizumab; Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4); Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26). arm 2: Placebo contains the same buffer components without the active ingredient; Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4); Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26).
Interventions: intervention 1: Eculizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26 intervention 2: Placebo

Protocol documents:
Clinical trial NCT02668692
Conditions: Psoriasis Vulgaris
Keywords: LEO 80185 gel, calcipotriol, betamethasone
Sponsor: LEO Pharma
Start date: 2016-02-01; Completion date: 2016-06-01
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Detailed description:
A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 80185 gel versus Dovobet® ointment in Japanese subjects with psoriasis vulgaris.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LEO 80185 gel intervention 2: Dovobet ® ointment
Intervention descriptions: intervention 1: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions intervention 2: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions

Protocol documents:
Clinical trial NCT00438204
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer recurrent non-small cell lung cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2006-05-01; Completion date: 2016-06-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium and gemcitabine together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of pemetrexed disodium, gemcitabine hydrochloride, and bevacizumab in chemotherapy-naïve patients with stage IIIB or IV nonsquamous cell non-small cell lung cancer.

Secondary

* Determine the response rate in patients treated with this regimen.
* Determine the time to treatment failure in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes, gemcitabine hydrochloride IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive bevacizumab alone in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Arms: arm 1: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days

Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed disodium every 14 days

Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
Interventions: intervention 1: bevacizumab intervention 2: gemcitabine hydrochloride intervention 3: pemetrexed disodium
Intervention descriptions: intervention 1: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days intervention 2: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days intervention 3: Pemetrexed disodium 400 mg/m2 intravenously over 10 minutes every 14 days.

Protocol documents:
Clinical trial NCT00490061
Conditions: Head and Neck Cancer Carcinoma, Squamous Cell Head and Neck Cancers
Sponsor: Quynh-Thu Le
Start date: 2007-07-01; Completion date: 2016-06-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Detailed description:
There is substantial data to suggest that EGFR and Her-2/neu expressions are important predictors for prognosis in HNSCC. EGFR blockade with a monoclonal antibody in conjunction with radiotherapy has been shown to improve survival over radiotherapy alone in patients with locally advanced HNSCC. Dual inhibition of EGFR and ErbB2 tyrosine kinases results in greater inhibitory effect of the downstream signaling pathways in cancer cells than inhibition of either receptor alone. Phase I studies in HNSCC suggested that the drug is well tolerated when delivered either alone or concurrently with cisplatin based chemoradiotherapy in HNSCC.

We propose to combine lapatinib with RT alone in patients with locally advanced HNSCC who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced HNSCC.

Arms: arm 1: DCE-MRI will precede radiotherpy before and after Lapatinib loading. 1500mg/d once daily oral Lapatinib will be administration for seven days prior to and throughout radiotherapy. Radiotherapy will be delivered as Intensity Modulated Radio Therapy (IMRT) using a G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Interventions: intervention 1: Lapatinib intervention 2: Radiotherapy (radiation) intervention 3: G.E. Healthcare 1.5T MR, systems revision 12.0 M5 intervention 4: DCE-MRI
Intervention descriptions: intervention 1: 1500 mg po daily orally intervention 2: Standard of Care intervention 3: Standard of Care, used to deliver IMRT intervention 4: A subset of patients received imaging before and after Lapatinib loading, prior to starting radiotherapy.

Protocol documents:
Clinical trial NCT00680823
Conditions: Headache Migraine
Keywords: Headache Migraine Ropivacaine
Sponsor: Robert Hickey
Start date: 2009-01-01; Completion date: 2016-06-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.

Detailed description:
Methods: The study will be a double-blind randomized control trial. Patients will be randomly assigned to receive either intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side, placebo injections with 1 mL normal saline on each side, or no intervention at all. If randomized to an injection, the investigator and the patient will both be blinded as to the nature of the injection.

The location of the child's pain as well as severity will be assessed immediately prior to intervention and every 10 minutes for 30 minutes. If after 30 minutes relief is insufficient for discharge to home, intravenous treatment will be instituted according to current protocol. Pain will be reassessed at the time of ultimate disposition. The scale used to assess severity will vary based on the child's age.

Arms: arm 1: Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. arm 2: Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. arm 3: Observation for 30 minutes.
Interventions: intervention 1: Ropivacaine intervention 2: Normal saline
Intervention descriptions: intervention 1: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1. intervention 2: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Protocol documents:
Clinical trial NCT00729300
Conditions: Cocaine Addiction
Keywords: cocaine disulfiram antabuse addiction stimulant
Sponsor: Baylor College of Medicine
Start date: 2006-04-01; Completion date: 2016-06-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The problem of cocaine dependence remains a major medical, social, and legal concern. Several studies have suggested that disulfiram may be beneficial for the treatment of cocaine dependence. A common assumption has been that disulfiram treatment, by increasing DA availability, enhances the aversive aspects of stimulants. This study aims to measure plasma activity in those with the C/C DBH genotype, which is associated with higher DBH activity subsequently making the disulfiram treatment more effective, as well as determine the effects of treatment with disulfiram on cocaine self-administration using a human laboratory model of cocaine self-administration.

Detailed description:

Arms: arm 1: Placebo arm 2: disulfiram
Interventions: intervention 1: placebo intervention 2: disulfiram
Intervention descriptions: intervention 1: 0mg daily intervention 2: 250mg daily

Protocol documents:
Clinical trial NCT00866047
Conditions: Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin
Keywords: Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic monomethyl auristatin E Drug Therapy Immunotherapy Hematologic Diseases Lymphoma
Sponsor: Seagen Inc.
Start date: 2009-03-01; Completion date: 2016-06-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.

Detailed description:

Arms: arm 1: Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Interventions: intervention 1: brentuximab vedotin
Intervention descriptions: intervention 1: 1.8 mg/kg every 3 weeks by IV infusion

Protocol documents:
Clinical trial NCT00924118
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction Reperfusion injury Nitric oxide
Sponsor: Johns Hopkins University
Start date: 2009-07-01; Completion date: 2016-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the intravenous infusion of sodium nitrite safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction resulting in improved left ventricular function.

Detailed description:
Despite reperfusion therapies, significant myocardial injury continues to occur from ischemic-reperfusion injury. Studies in animal models of acute myocardial infarction suggest that an infusion of sodium nitrite, which is nonenzymatically converted to nitric oxide in the setting of ischemia, significantly reduces ischemia-reperfusion injury resulting in smaller infarcts and improved left ventricular function. The objectives of this phase 2 trial are to determine the tolerability and safety of a 48-hour infusion of sodium nitrite in patients with an acute ST-segment elevation myocardial infarction receiving percutaneous coronary intervention. The efficacy of a 48-hour infusion of sodium nitrite will be determined by noninvasive imaging to determine infarct size and left ventricular function.

Arms: arm 1: Dose escalation of sodium nitrite. arm 2: Standard therapy
Interventions: intervention 1: Sodium Nitrite
Intervention descriptions: intervention 1: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.

Protocol documents:
Clinical trial NCT00928252
Conditions: Hormone Refractory Prostate Cancer
Keywords: Hormone Refractory Prostate Cancer Castrate Resistant Prostate Cancer
Sponsor: Queen's Medical Center
Start date: 2009-06-01; Completion date: 2016-06-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide information that may help guide subsequent investigational or clinical treatments for patients with advanced (hormone-refractory) metastatic prostate cancer.

Detailed description:
Patients who meet eligibility criteria and are enrolled will undergo whole-body imaging with 18F-choline PET/CT at 3 time points during the course of treatment that is indicated for castrate resistant prostate cancer. The 1st PET/CT scan is performed at baseline before treatment initiation. The 2nd and 3rd scans are performed at two other treatment-releated timepoints or at approximately 1 month and 3 months after treatment initiation. Change in lesion 18F-choline uptake from baseline measured at each time point will be determined. Cancer 18F-choline uptake will be evaluated as a marker of therapeutic response in comparison to PSA response and symptom scores. Treatment-related changes in tumor 18F-choline uptake occur will be studied after the second and third PET scans to determine the acuity by which changes in tumor 18F-choline uptake can be expected following specific treatments for castrate-resistant prostate cancer. The study evaluates a diagnostic intervention and the treatments themselves are not considered part of the investigation. All treatment decisions will be made independent of the study and must be deemed clinically-warranted by a treating physician.

Arms: arm 1: IV fluorine-18 labeled methylcholine before PET/CT
Interventions: intervention 1: IV fluorine-18 labeled methylcholine before PET/CT
Intervention descriptions: intervention 1: Intervention at pre-treatment, and at two timepoints post treatment intiation.

Protocol documents:
Clinical trial NCT01063283
Conditions: Advanced Non-squamous Non-Small Cell Lung Cancer
Keywords: Non-squamous Non-Small Cell Lung Cancer Bevacizumab Ambulatory Blood Pressure Monitoring
Sponsor: University of Chicago
Start date: 2010-03-01; Completion date: 2016-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if higher dose of bevacizumab can be taken safely by some patients and if changes in the dose of bevacizumab have any effect on blood pressure.

Detailed description:
Carboplatin and pemetrexed are FDA approved chemotherapy agents for patients with advanced non squamous non small cell lung cancer. Bevacizumab is also FDA approved in lung cancer , and the combination of all three drugs is promising. The doctors directing this research want to learn how to better personalize drug dosing of bevacizumab by identifying people who could safely take a higher dose of the drug.

Arms: arm 1: Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses arm 2: Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses
Interventions: intervention 1: Pemetrexed intervention 2: Carboplatin intervention 3: Bevacizumab 7.5 mg/kg intervention 4: Bevacizumab 15 mg/kg
Intervention descriptions: intervention 1: Pemetrexed 500 mg/m\^2 intravenously over 10 minutes intervention 2: Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes intervention 3: Bevacizumab at 7.5 mg/kg intravenously over 90 minutes intervention 4: Bevacizumab at 15 mg/kg intravenously over 90 minutes

Protocol documents:
Clinical trial NCT01109979
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular, vascular
Sponsor: Brigham and Women's Hospital
Start date: 2009-12-01; Completion date: 2016-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compares the effects of two common hormone medications on the heart and blood vessels of healthy post-menopausal women over the age of 45.

The study will take place over the course of about 5 months. Each subject will take two different medications over two six-week periods. They will be randomized at the beginning of the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the first period, and will receive the other medication the second six-weeks of the study. At the very beginning of the study and at the end of each six-week treatment period, subjects will come to the hospital various tests including non-invasive blood vessel imaging tests, blood draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment periods, there will be a four-week medication-free washout period.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Estradiol+MPA intervention 2: Estradiol+Drospirenone
Intervention descriptions: intervention 1: 1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg intervention 2: 1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg

Protocol documents:
Clinical trial NCT01111526
Conditions: Graft-Versus-Host Disease
Keywords: Graft versus host disease GVHD allogeneic transplant acute GVHD chronic GVHD
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2010-04-01; Completion date: 2016-06-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To test a new agent, LBH589, in combination with glucocorticoids as initial therapy of acute graft versus host disease (GVHD).

Detailed description:
Dose escalation study to test the safety (Phase I), pharmacology and preliminary clinical activity (Phase II) of a Novel histone deacetylase (HDAC) inhibitor, LBH589, in the treatment of the following GVHD presentations: Classic, Late-onset acute GVHD, Recurrent acute GVHD, Overlap syndrome.

Arms: arm 1: Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
Interventions: intervention 1: Panobinostat (LBH589)
Intervention descriptions: intervention 1: Phase I Initial Treatment Plan - Intravenous (IV) Formulation: Up to 4 dose levels (DL) of LBH589 IV formulation to establish LBH589 Maximum Tolerated Dose (MTD) in acute GVHD treatment. The first 4 participants began this treatment plan, before the IV Formulation became unavailable.

DL -1: 1.25 mg/m\^2 IV; DL 1: 2.5 mg/m\^2 IV; DL 2: 5 mg/m\^2 IV; DL 3: 7.5 mg/m\^2 IV; DL 4: 10 mg/m\^2 IV.

Phase I Revised Treatment Plan - Oral Formulation (to replace IV Formulation): Dose escalation levels for LBH589; participants treated with LBH589 by mouth (PO) 3 times a week (48 hours apart) every week for 4 weeks.

DL -1: 5 mg PO; DL 1: 10 mg PO (starting dose level); DL 2: 15 mg PO; DL 3: 20 mg PO; DL 4: 25 mg PO.

Phase II Treatment Plan: LBH589 PO at MTD, 3 times a week (48 hours apart) every week for 4 weeks.

Protocol documents:
Clinical trial NCT01153763
Conditions: Melanoma
Keywords: Metastatic melanoma BRAF mutant Melanoma BRAF mutant metastatic melanoma
Sponsor: GlaxoSmithKline
Start date: 2010-08-09; Completion date: 2016-06-01
Enrollment: 92 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

Detailed description:

Arms: arm 1: Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
Interventions: intervention 1: GSK2118436
Intervention descriptions: intervention 1: Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

Protocol documents: