ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01064401
Conditions: Relapsing-Remitting Multiple Sclerosis
Sponsor: Biogen
Start date: 2010-05-01; Completion date: 2014-07-01
Enrollment: 1841 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

Detailed description:

Arms: arm 1: Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks arm 2: Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
Interventions: intervention 1: BIIB019 (Daclizumab High Yield Process) intervention 2: Interferon beta-1a Placebo intervention 3: Interferon beta-1a intervention 4: Daclizumab High Yield Process Placebo
Intervention descriptions: intervention 1: Daclizumab High Yield Process for subcutaneous injection intervention 2: Placebo to interferon beta-1a intramuscular injection intervention 3: Interferon beta-1a for intramuscular injection intervention 4: Placebo to Daclizumab High Yield Process subcutaneous injection

Protocol documents:
Clinical trial NCT01076010
Conditions: Advanced Renal Cell Carcinoma
Sponsor: AVEO Pharmaceuticals, Inc.
Start date: 2010-03-01; Completion date: 2014-07-01
Enrollment: 277 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Open-label, multi-center extension treatment protocol to allow access to tivozanib and sorafenib for subjects who have participated on the AV-951-09-301 protocol. Eligible subjects who were randomized to receive sorafenib on AV-951-09-301 and had documented progression of disease will receive a tivozanib dose of 1.5 mg/day. Eligible subjects who were randomized to tivozanib or sorafenib in AV-951-09-301, and displayed clinical benefit and acceptable tolerability to treatment, will continue to receive tivozanib or sorafenib at the same dose and schedule as in AV-951-09-301.

Detailed description:
This is an extension treatment protocol to allow access to tivozanib or sorafenib for subjects enrolled on AV-951-09-301(parent protocol). Subjects who failed sorafenib on the parent protocol will be offered tivozanib. Subjects who were randomized to tivozanib, and demonstrated clinical benefit and acceptable tolerability will be offered long-term access to tivozanib. Subjects who were randomized to sorafenib, and demonstrated clinical benefit and acceptable tolerability will be offered long-term access to sorafenib. Subjects who continue receiving sorafenib on this protocol and progress will be allowed to cross-over to tivozanib.

Arms: arm 1: The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902. arm 2: The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301. arm 3: The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
Interventions: intervention 1: Tivozanib intervention 2: Sorafenib
Intervention descriptions: intervention 1: Tivozanib capsules, administered orally, on a dosing schedule of 3 weeks of treatment (beginning on Day 1) followed by 1 week off treatment. One cycle was defined as 4 weeks of treatment. intervention 2: Sorafenib tablets, 400 mg twice daily, administered orally for 4 weeks (1 cycle = 4 weeks). One cycle was defined as 4 weeks of treatment. Cycles were repeated every 4 weeks.

Protocol documents:
Clinical trial NCT01097304
Conditions: Barrett Esophagus Esophageal Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-04-01; Completion date: 2014-07-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot phase II trial studies how well ursodiol works in treating patients with Barrett esophagus or cells that look abnormal under a microscope but are not cancer (low-grade dysplasia). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ursodiol may keep cancer for forming in patients with Barrett esophagus or low-grade dysplasia.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the ability of UDCA (ursodiol) treatment to reverse oxidative deoxyribonucleic acid (DNA) damage in the esophageal epithelium of subjects with Barrett's esophagus.

SECONDARY OBJECTIVES:

I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell proliferation in Barrett's epithelium.

OUTLINE:

Patients receive ursodiol orally (PO) twice daily (BID) for 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up for 2 weeks.

Arms: arm 1: Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Ursodiol intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01128296
Conditions: Pancreatic Cancer
Keywords: high risk stage IIb or III adenocarcinoma of the pancreas
Sponsor: Amer Zureikat
Start date: 2010-10-01; Completion date: 2014-07-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary goal of the research study is to determine whether treating pancreatic cancer patients with hydroxychloroquine in combination with gemcitabine before surgery is safe. The secondary goal is to determine if this new treatment regimen can effectively treat pancreatic cancer. This study will test the safety and efficacy of this combination in two parts, or phases.

Detailed description:
This is a phase I/II trial designed to assess the safety, tolerability and efficacy of neoadjuvant oral hydroxychloroquine (Plaquenil®) in combination with FDR gemcitabine in subjects with high risk IIb or III adenocarcinoma of the pancreas. Eligible subjects will be administered hydroxychloroquine orally once or twice daily (depending on dose) in combination with FDR gemcitabine (on days 1 and 15) for 31 days prior to surgical resection. Dose escalations of hydroxychloroquine will proceed using Storer's Up-and-Down algorithm D. Subjects will be monitored for side effects and tolerability of the drug. Pre- and post-treatment PET scans will be the primary means to assess response to therapy. Resected tumors will also be assessed for evidence of inhibition of autophagy as well as histopathologic response and margin negative resection and number of positive lymph nodes.

Arms: arm 1: Hydroxychloroquine orally twice daily in combination with gemcitabine for 31 days prior to surgical resection
Interventions: intervention 1: Hydroxychloroquine intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Oral dosing daily starting at 48 hours before first dose of gemcitabine (starting on Day -2) and for a total of 31 days (ending on Day 29), prior to surgical resection. Capsules are available in 200 mg strengths. Daily doses are 200, 400, 600, 800, 1000, or 1200 mg, and will be administered BID for doses above 200 mg. intervention 2: Intravenous administration on Days 1 and 15, with the infusion given at the fixed dose rate of 10mg/m2/min (e.g. 150 min for a 1500 mg/m2 dose).

Protocol documents:
Clinical trial NCT01149057
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-10-01; Completion date: 2014-07-01
Enrollment: 145 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg intravenously, every 4 weeks for 96 weeks

Protocol documents:
Clinical trial NCT01152021
Conditions: Safety and Efficacy of Sedation Medications
Keywords: dexmedetomidine propofol sedation MRI scanning pediatric children Magnetic Resonance Imaging
Sponsor: Boston Children's Hospital
Start date: 2011-08-01; Completion date: 2014-07-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, open label randomized study. The purpose of this study is to compare propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically identifying important patient demographics and looking at important outcomes including adverse events.

Detailed description:
Patients will be randomized to either arm of the study. Throughout the sedation and recovery period, all study patients will have careful, routine documentation of hemodynamics (blood pressure, heart rate, plus oximeter, respiratory rate) as well as sedation depth. Patients will remain in recovery room until they have maintained discharge criteria for 30 minutes.

Arms: arm 1: Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol. arm 2: Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to two additional 1 mg/kg boluses may be administered (total 3 mg/kg) - each over a one (1) minute interval, waiting 30 seconds after completion of each bolus to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg.
Interventions: intervention 1: Dexmedetomidine intervention 2: Propofol
Intervention descriptions: intervention 1: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete. intervention 2: An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete.

Protocol documents:
Clinical trial NCT01192295
Conditions: Pain
Keywords: Malignant pain Nonmalignant pain Pediatric Opioid Moderate to severe malignant or nonmalignant pain
Sponsor: Purdue Pharma LP
Start date: 2010-11-01; Completion date: 2014-07-01
Enrollment: 155 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.

Detailed description:

Arms: arm 1: Oxycodone hydrochloride (HCl) controlled-release (CR)
Interventions: intervention 1: Oxycodone HCl controlled-release tablets
Intervention descriptions: intervention 1: Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.

Protocol documents:
Clinical trial NCT01204697
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2010-11-01; Completion date: 2014-07-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized parallel group study will assess the efficacy and safety of erlotinib \[Tarceva\], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: docetaxel intervention 2: erlotinib [Tarceva] intervention 3: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 75 mg/m2 intravenously every 3 weeks for 4 cycles intervention 2: 150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter intervention 3: 150 mg/day orally as monotherapy

Protocol documents:
Clinical trial NCT01226914
Conditions: Thyroid Neoplasm Goiter
Keywords: EVICEL, Fibrin Sealant, Thyroidectomy
Sponsor: Medical University of South Carolina
Start date: 2010-06-01; Completion date: 2014-07-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objectives

* To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B).
* To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives
* To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups.
* To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS).
* To compare the length of hospital stay between the two groups of patients.

Detailed description:

Arms: arm 1: For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure. arm 2: For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.
Interventions: intervention 1: EVICEL
Intervention descriptions: intervention 1: EVICEL

Protocol documents:
Clinical trial NCT01242111
Conditions: MPS IV A Mucopolysaccharidosis IVA Morquio A Syndrome
Keywords: Mucopolysaccharidosis IV type A MPS IV Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase N-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT
Sponsor: BioMarin Pharmaceutical
Start date: 2010-11-01; Completion date: 2014-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, open-label extension study is designed to assess long-term efficacy and safety of 2.0 milligrams (mg)/kilogram(kg)/week of BMN 110 in patients diagnosed with Mucopolysaccharidosis IVA (MPS IVA). Patients with MPS IVA, who enrolled in a prior BioMarin sponsored clinical study of BMN 110 (NCT00884949; Study Identification Number MOR-002), were eligible to enroll in this study (except patients who enrolled in NCT01275066; Study Identification Number MOR-004).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: BMN 110
Intervention descriptions: intervention 1: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.

Protocol documents:
Clinical trial NCT01244451
Conditions: Patients With CLL Relapsing After an Initial Response (CR, PR ≥ 6 Months) Following no More Than Two Prior Treatment Lines; or Patients With CLL Refractory (SD, PD or CR/PR < 6 Months) Following no More Than Two Prior Treatment Lines
Keywords: CLL relapsed refractory Bendamustine Ofatumumab
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Start date: 2010-12-01; Completion date: 2014-07-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In the last ten years there have been significant developments in CLL treatment. The advent of fludarabine, rituximab and the association of chemo-immunotherapy have substantially increased overall response rate, CR rate, time to progression and may also have an impact on overall survival.

Even though, CLL remains incurable and all patients eventually relapse and progressively become resistant to treatment. The development of an effective therapy that is not cross-resistant with the ones currently available as front-line treatment, is one of the clinical unmet needs within CLL.

BendOfa is a non comparative phase II trial designed to determine the therapeutic benefit of bendamustine given together to ofatumumab in relapsed or resistant patients with CLL.

Bendamustine is approved by FDA for CLL treatment, it is an hybrid drug with alkylating agents and purine analogue properties that may lack of cross resistance with fludarabine. It was utilized in CLL as a single agent and its association with rituximab is currently under clinical investigation.

Ofatumumab is a new fully human anti-CD20 monoclonal antibody with high in vitro efficacy on CD20 low-expressing CLL cells. An early report showed that ofatumumab in single therapy is effective in highly pre-treated refractory CLL patients.

Both drugs were generally well tolerated without unexpected untoward toxicity. On the basis of these data, bendamustine and ofatumumab could be a new effective and well tolerated combination for patients with relapsed and refractory CLL.

Detailed description:

Arms: arm 1: Bendamustine + Ofatumumab
Interventions: intervention 1: Ofatumumab intervention 2: Bendamustine
Intervention descriptions: intervention 1: Ofatumumab will be administered at the dose of 300 mg IV D1 and 1000 mg IV D8 1st course; 1000 mg IV D1, 2nd -6th courses. intervention 2: Bendamustine will be infused at the doses of 70 mg/m2 IV on days D1 and D2 of each course.

Protocol documents:
Clinical trial NCT01270880
Conditions: Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2011-01-01; Completion date: 2014-07-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090 works in treating patients with metastatic hormone-resistant prostate cancer previously treated with docetaxel-based chemotherapy

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate progression-free survival (PFS) achieved with STA-9090 (Hsp90 inhibitor STA-9090) in men with castration-resistant prostate cancer (CRPC) who have received prior docetaxel based therapy.

SECONDARY OBJECTIVES:

I. To assess the percentage change in prostate-specific antigen (PSA) from baseline to 12 weeks.

II. To assess overall safety and tolerability of STA-9090. III. To evaluate overall survival (OS) outcome in metastatic CRPC who have received prior docetaxel therapy.

IV. To investigate the association of progression-free survival (PFS) and PSA response rate with primary and secondary target markers.

TERTIARY OBJECTIVES:

I. To evaluate potential markers for predicting drug response or efficacy, blood samples will be used to collect the serum and extract messenger ribonucleic acid (mRNA) from mononuclear cells and analyzed by quantitative real-time polymerase chain reaction (PCR) and/or enzyme-linked immunosorbent assay (ELISA).

OUTLINE:

Patients receive Hsp90 inhibitor STA-9090 intravenously (IV) over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 weeks.

Arms: arm 1: Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Hsp90 inhibitor STA-9090 intervention 2: laboratory biomarker analysis intervention 3: polymerase chain reaction intervention 4: enzyme-linked immunosorbent assay intervention 5: RNA analysis intervention 6: spectrophotometry intervention 7: reverse transcriptase-polymerase chain reaction intervention 8: gene expression analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies

Protocol documents:
Clinical trial NCT01289028
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST Imatinib Sunitinib Gastrointestinal Stromal Tumors
Sponsor: Novartis Pharmaceuticals
Start date: 2008-11-01; Completion date: 2014-07-01
Enrollment: 125 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.

Detailed description:

Arms: arm 1: nilotinib 400 mg twice daily (bid).
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01290094
Conditions: Post Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2011-04-01; Completion date: 2014-07-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: 3 mg intravenously every 3 months

Protocol documents: