ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00979017
Conditions: Glioblastoma Multiforme Gliosarcoma
Keywords: malignant glioma glioblastoma multiforme gliosarcoma Avastin bevacizumab Temodar temozolomide Irinotecan CPT-11 Pro00019065 Vredenburgh Duke
Sponsor: Katy Peters
Start date: 2009-11-01; Completion date: 2013-01-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin, temozolomide and irinotecan in unresectable glioblastoma patients.

This is a phase II study with the combination of Avastin, temozolomide and irinotecan for unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan. Approximately 41 subjects will take part in this study at Duke.

Detailed description:

Arms: arm 1: Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Interventions: intervention 1: Avastin intervention 2: Temozolomide intervention 3: Irinotecan
Intervention descriptions: intervention 1: Avastin, by intravenous infusion, 10 mg/kg every 14 days intervention 2: Oral temozolomide at 200 mg/m2 daily for 5 days intervention 3: Irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)

Protocol documents:
Clinical trial NCT00985738
Conditions: Prostate Cancer
Keywords: Prostate Cancer Early Stage Prostate Cancer
Sponsor: University of Colorado, Denver
Start date: 2009-09-01; Completion date: 2013-01-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.

Detailed description:
This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer by having a Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.

Arms: arm 1: The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months. arm 2: The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.
Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy. intervention 2: The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.

Protocol documents:
Clinical trial NCT00998738
Conditions: Neuropathy Pain Recurrent Breast Carcinoma Stage IV Breast Cancer
Sponsor: Mayo Clinic
Start date: 2009-11-01; Completion date: 2013-01-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase III trial studies calcium and magnesium to see how well they work in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are effective in preventing peripheral neuropathy caused by ixabepilone.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare ixabepilone-induced peripheral neuropathy (sensory) as measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN)20 sensory subscale between calcium (Ca) Magnesium (Mg) and placebo arms.

SECONDARY OBJECTIVES:

I. To compare the incidence of CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms.

II. To compare the times to onset of CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms.

III. To compare the proportion of patients requiring ixabepilone dose reductions and/or stopping ixabepilone secondary to peripheral neuropathy (sensory) between CaMg and placebo arms.

IV. To assess the toxicity of CaMg in this situation. V. To document the incidence and severity of the acute pain syndrome (APS, commonly known as arthralgias/myalgias) induced by ixabepilone.

VI. To evaluate whether CaMg will decrease the acute pain syndrome (APS). VII. To evaluate the incidence and characteristics of, and change in, ixabepilone-APS over several cycles.

VIII. To evaluate the association between the ixabepilone-APS and eventual chemotherapy-induced neuropathy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.

ARM II: Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.

After completion of study treatment, patients are followed up monthly for 12 months.

Arms: arm 1: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration. arm 2: Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.
Interventions: intervention 1: Calcium Gluconate intervention 2: Magnesium Sulfate intervention 3: Placebo intervention 4: Quality-of-Life Assessment intervention 5: Questionnaire Administration intervention 6: Ixabepilone
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Ancillary studies intervention 5: Ancillary studies intervention 6: Given IV

Protocol documents:
Clinical trial NCT01025232
Conditions: Age Related Macular Degeneration Choroidal Neovascular Membrane Subfoveal Neovascular Age-Related Macular Degeneration Macular Degeneration Wet Age-Related Macular Degeneration
Keywords: Antibodies, Monoclonal Immunologic Factors Eye Diseases Retinal Degeneration Macular Degeneration Pharmacologic Actions Retinal Diseases
Sponsor: David M. Brown, M.D.
Start date: 2009-12-01; Completion date: 2013-01-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.

Detailed description:
This is an open-label, Phase I/II study of intravitreally administered 2.0 mg ranibizumab in subjects with persistent fluid or recurrent fluid on OCT after having received at least nine ranibizumab injections in the past twelve months. Consented, enrolled subjects will receive have monthly ETDRS BCVA, ophthalmic examination and OCTs evaluation using Stratus, Cirrus and Spectralis machines. Fluorescein angiography and autofluorescence will be done at BSL, and Months 6 and 12. DNA samples for genetic analysis will be collected at baseline.

Subjects will receive open-label intravitreal injections of 2.0 mg ranibizumab administered every 28 days for 3 months: Following the three loading doses, all patients will receive a minimum "capped" PRN treatment (all patients will receive 2.0 mg intravitreal ranibizumab quarterly). Dosing should not occur earlier than 22 days after the previous treatment. Study visits should be scheduled to occur every 30 (±7) days relative to the date of the first injection (Day 0).

Subjects will be randomized into two re-treatment cohorts for additional re-treatment, if needed:

* Cohort A - Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal ,or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation.
* Cohort B - Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal ,or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab.

Arms: arm 1: Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment. arm 2: Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Intravitreal Injection of 2.0mg formulation

Protocol documents:
Clinical trial NCT01037127
Conditions: Cancer
Keywords: GSK1120212 BRAF Inhibitor melanoma MEK Inhibitor
Sponsor: GlaxoSmithKline
Start date: 2009-11-01; Completion date: 2013-01-01
Enrollment: 97 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity.

Detailed description:

Arms: arm 1: Subjects who have had previous treatment with a BRAF inhibitor. arm 2: Subjects who have had previous chemotherapy or immunotherapy without a BRAF inhibitor.
Interventions: intervention 1: GSK1120212
Intervention descriptions: intervention 1: Daily oral dosing

Protocol documents:
Clinical trial NCT01042795
Conditions: Urothelial Carcinoma Bladder Cancer
Keywords: sunitinib bladder neoplasm adjuvant treatment disease free survival cystectomy
Sponsor: University of Michigan
Start date: 2009-09-01; Completion date: 2013-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether sutent (sunitinib)is effective in preventing tumor recurrence in patients with high risk bladder cancer who have previously had chemotherapy and cystectomy (bladder removal).

A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal. The patients are followed up to 2 years.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: Sunitinib 37.5 mg daily X 16 weeks

Protocol documents:
Clinical trial NCT01053663
Conditions: Influenza
Sponsor: Hoffmann-La Roche
Start date: 2011-01-01; Completion date: 2013-01-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will assess the pharmacokinetics and safety of oseltamivir \[Tamiflu\] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-\<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir \[Tamiflu\] therapy over 5 or 6 days. Optional oral therapy with oseltamivir \[Tamiflu\] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is \<50 patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tamiflu
Intervention descriptions: intervention 1: 10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6

Protocol documents:
Clinical trial NCT01058369
Conditions: Myelodysplastic Syndromes
Sponsor: University of Erlangen-Nürnberg Medical School
Start date: 2010-04-01; Completion date: 2013-01-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Study outline: Deferasirox (Exjade®) is regularly used in severe iron overload in order to avoid organ damage of liver, heart and other organs. It has been proposed, that iron overload may not only impose damage to other organs but also to the bone marrow and thus worsen hematopoietic insufficiency in patients with MDS. Patients presenting with low or INT-1 risk MDS with only mild iron overload will be treated with deferasirox in this study. It will be analyzed if hematological improvement can be observed during this treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Deferasirox (Novartis Pharma)
Intervention descriptions: intervention 1: Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol

Protocol documents:
Clinical trial NCT01084174
Conditions: Peanut Hypersensitivity Food Hypersensitivity Immediate Hypersensitivity
Keywords: Peanut Allergy
Sponsor: Johns Hopkins University
Start date: 2010-03-01; Completion date: 2013-01-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.

Detailed description:
To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21 years with: (1) a convincing clinical history of peanut allergy (PA), (2) a serum immunoglobulin E (IgE) specific to peanut of \>0.35 kilo units per liter (kU/L) and a skin prick test (SPT) wheal \>3 mm, will be enrolled. Subjects will be recruited from the Johns Hopkins Pediatric Allergy Clinic.

Participants will undergo an initial screening visit that will include a medical history, physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At the next two visits, 20 participants will complete a double-blind placebo-controlled food challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One group will receive active SLIT with placebo OIT and the other group will begin active OIT with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12 months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge will be administered at the end of this period.

Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as longitudinal controls for the mechanistic studies. These subjects will follow a modified schedule compared to those subjects receiving study treatment and will be evaluated by phlebotomy, end point titration prick skin testing, and saliva collection. These patients will continue strict avoidance of peanut unless otherwise advised by their personal physician.

Arms: arm 1: These subjects will receive peanut powder given orally and placebo extract given sublingually. arm 2: These subjects will receive peanut extract given sublingually and placebo powder given orally.
Interventions: intervention 1: Peanut powder intervention 2: Peanut extract intervention 3: Placebo extract intervention 4: Placebo powder
Intervention descriptions: intervention 1: Delivered orally intervention 2: Delivered sublingually intervention 3: Delivered sublingually intervention 4: Delivered orally

Protocol documents:
Clinical trial NCT01104870
Conditions: Pulmonary Hypertension
Sponsor: United Therapeutics
Start date: 2010-04-01; Completion date: 2013-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized, parallel group study to assess the hemodynamic effect of three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with exercise-induced pulmonary hypertension (PH), as measured by the change in peak total pulmonary resistance index (TPRI) during exercise from Baseline to Week 12.

Detailed description:
Prospective, randomized, parallel group study with two periods: a 10 week, dose titration period, followed by a 2 week, dose maintenance period in patients with exercise-induced PH.

The study population will be randomized into Dose Group 1, Dose Group 2, or an Individual Maximum Tolerated Dose (iMTD) of UT-15C SR by Week 10 and maintained through Week 12. Patients may be either currently receiving an approved oral background therapy for their PH (phosphodiesterase-5 \[PDE-5\] inhibitor, OR endothelin receptor antagonist \[ERA\]) (no dual background therapy), or not currently receiving therapy for PH.

Arms: arm 1: UT-15C 0.25 mg twice daily arm 2: UT-15C 1.25 mg twice daily arm 3: UT-15C individual Maximum Tolerated Dose
Interventions: intervention 1: UT-15C
Intervention descriptions: intervention 1: oral

Protocol documents:
Clinical trial NCT01125930
Conditions: Rosacea
Keywords: rosacea tretinoin atralin
Sponsor: Lisa E. Maier
Start date: 2010-05-01; Completion date: 2013-01-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).

Detailed description:

Arms: arm 1: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. arm 2: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Interventions: intervention 1: vehicle gel intervention 2: Atralin gel
Intervention descriptions: intervention 1: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. intervention 2: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.

Protocol documents:
Clinical trial NCT01128959
Conditions: Epilepsy
Keywords: Epilepsy Intravenous Carbamazepine Oral Carbamazepine
Sponsor: Lundbeck LLC
Start date: 2010-06-01; Completion date: 2013-01-01
Enrollment: 108 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of intravenous (IV) carbamazepine (CBZ) administered as multiple 15 minute infusions and a single 5 minute infusion to adult patients with epilepsy on stable higher doses of oral CBZ.

Detailed description:
This was a phase III, multicenter, open-label study designed to assess the safety and tolerability of intravenously administered CBZ in adult patients with epilepsy. This study included a 28 day Lead-in Period, a Confinement Period (up to 7 days and 6 nights) and a 28 day Follow-up Period.

Patients began confinement on Day -1 of the trial, continuing to take their oral CBZ as prescribed by the investigator. On the morning of Day 0, Day 4, and Day 17, patients began the 24hr urine collection for evaluation of urinary biomarkers. All patients temporarily discontinued their prescribed oral CBZ and begin IV CBZ administration on the morning of Day 1, continuing administrations every 6 hours (Q6h) through the morning of Day 4.

Arms: arm 1: None
Interventions: intervention 1: Intravenous Carbamazepine (IV CBZ)
Intervention descriptions: intervention 1: 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.

Protocol documents:
Clinical trial NCT01142193
Conditions: Epilepsy
Keywords: Epilepsy partial onset seizure adjunctive therapy
Sponsor: Upsher-Smith Laboratories
Start date: 2010-05-01; Completion date: 2013-01-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: USL255 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01151215
Conditions: Neoplasms Breast Neoplasms Breast Cancer
Keywords: Cancer tumour breast cancer metastatic secondary locally advanced
Sponsor: AstraZeneca
Start date: 2010-06-01; Completion date: 2013-01-01
Enrollment: 482 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.

Detailed description:

Arms: arm 1: AZD8931 40mg (bd) plus anastrozole 1mg (od) arm 2: AZD8931 20mg (bd) plus anastrozole 1mg (od) arm 3: Placebo (bd) plus anastrozole 1mg (od)
Interventions: intervention 1: AZD8931 intervention 2: anastrozole intervention 3: Placebo
Intervention descriptions: intervention 1: Tablet, oral, bd intervention 2: Tablet, oral, od intervention 3: Tablet, oral

Protocol documents: