ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00807495
Conditions: Diffuse Large B-cell Lymphoma Mantle Cell Lymphoma Burkitt's Lymphoma T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component
Keywords: MLN8237 Alisertib Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2009-02-10; Completion date: 2013-02-13
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.

Detailed description:
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have relapsed or refractory non-Hodgkin's lymphoma (NHL). The study looked at anti-tumor activity in participants who received alisertib.

The study enrolled 48 patients. Participants were categorized as per disease subtypes into five subtypes: Large B-Cell lymphoma, mantle cell lymphoma, transformed follicular lymphoma, Burkitts lymphoma and aggressive T-Cell lymphoma (Note: There were no participants enrolled with Precursor B-lymphoblastic Leukemia/Lymphoma). Participants received:

• Alisertib 50 mg BID on Days 1 to 7

All participants took alisertib capsules approximately every 12 hours each day for 7 days followed by a 14-day rest period in a 21-days cycle. MLN8237 was supplied in capsules of 5 or 25 mg strength.

This multi-center trial was conducted in United States. The overall time to participate in this study was until there is evidence of disease progression or unacceptable treatment-related toxicity. If the participant would derive benefit from continued alisertib treatment beyond 24 months, the Sponsor was consulted for approval of further treatment. Participants made multiple visits to the clinic, with imaging assessments every 12 weeks. Participants discontinuing treatment prior to disease progression continue with clinic visits, chemistry and hematology lab testing, and tumor assessments every 12 weeks up to 12 months after last dose of study drug for follow-up assessments.

Arms: arm 1: Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months or longer with Sponsor approval).
Interventions: intervention 1: Alisertib
Intervention descriptions: intervention 1: Alisertib capsules

Protocol documents:
Clinical trial NCT01513759
Conditions: Pulmonary Embolism Acute Pulmonary Embolism Sub-massive Pulmonary Embolism Massive Pulmonary Embolism Pulmonary Thromboembolism
Keywords: Fibrinolysis catheter directed fibrinolysis ultrasound accelerated fibrinolysis recombinant t-PA Activase
Sponsor: Boston Scientific Corporation
Start date: 2012-06-07; Completion date: 2013-02-17
Enrollment: 150 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.

Detailed description:

Arms: arm 1: Participants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Interventions: intervention 1: recombinant tissue plasminogen activator intervention 2: EKOS EkoSonic Endovascular System
Intervention descriptions: intervention 1: Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device. intervention 2: 24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.

Protocol documents:
Clinical trial NCT00885755
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-08-13; Completion date: 2013-02-18
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Standard taxane therapy intervention 2: capecitabine [Xeloda] intervention 3: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: As prescribed intervention 2: 1000mg/m2 po bid on days 1-14 of each 3-week cycle (only in patients who have progressed) intervention 3: 8mg/kg iv loading dose on day 1 of first 3-week cycle, and 6mg/kg iv on day 1 of each subsequent cycle

Protocol documents:
Clinical trial NCT01428453
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Sponsor: GlaxoSmithKline
Start date: 2011-10-01; Completion date: 2013-02-18
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to investigate the effects of rilapladib on biomarkers related to the Alzheimer's disease, and cognitive function.

Detailed description:
The study is in subjects with Alzheimer's disease and evidence of cerebrovascular disease (CVD) who are currently treated with an acetylcholinesterase inhibitor (AChEI) and/or memantine. The study is a randomized, double-blind, placebo controlled, parallel group, repeat dose design, in which subjects (up to 60 randomized subjects per arm) will receive oral placebo or rilapladib (250 mg), once daily for 24 weeks in addition to their stable background AD therapy consisting of an acetylcholinesterase inhibitor (AChEI) and/or memantine. Subjects will take 250mg of rilapladib or placebo once daily for a period of 24 weeks. The total duration of participation for each subject will be approximately 30 weeks comprising approximately 4 weeks screening, 24 weeks treatment and 2 weeks follow-up. From the time of randomization and throughout the treatment period subjects will attend visits after 1 week, 4 weeks and thereafter every 4 weeks until Week 24. A follow-up visit will occur approximately 2 weeks after the final dose of study medication. Cognitive assessments will be performed at the screening visit, at the randomization (baseline) visit and at weeks 12 and 24 of the treatment period. Cerebrospinal fluid (CSF) samples will be taken via lumbar puncture at baseline and Week 24 for biomarker analyses related to Alzheimer's disease. Blood samples will be collected throughout the study for pharmacokinetics and a range of biomarker analyses. A range of safety and tolerability assessments will also be performed (including vital signs, laboratory tests, eye examinations and ECGs).

Arms: arm 1: Experimental drug arm 2: Placebo comparator
Interventions: intervention 1: 250mg rilapladib intervention 2: placebo
Intervention descriptions: intervention 1: Experimental Drug intervention 2: Placebo comparator

Protocol documents:
Clinical trial NCT01302119
Conditions: Onychomycosis of Toenails
Keywords: Onychomycosis nail fungus toenail fungus fungal nail hyperkeratosis nail infection nail treatment toenail infection toenail treatment foot dermatoses fungal culture onycholysis podiatrist podiatry subungual tinea unguium antifungal anti-fungal dermatologist dermatology dermatophyte distal subungual onychomycosis yellow nail thick nail brittle nail crumbling nail discolored nail weak nail
Sponsor: Pfizer
Start date: 2011-02-01; Completion date: 2013-02-20
Enrollment: 604 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

Detailed description:

Arms: arm 1: AN2690 Topical Solution, 5% arm 2: Solution Vehicle
Interventions: intervention 1: AN2690 Topical Solution, 5% intervention 2: Solution Vehicle
Intervention descriptions: intervention 1: AN2690 Topical Solution, 5%, applied once daily for 48 weeks intervention 2: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

Protocol documents:
Clinical trial NCT01432730
Conditions: Chronic Cough
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2011-09-22; Completion date: 2013-02-21
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomised, double-blind, placebo-controlled, crossover, single centre study of gefapixant (AF-219/MK-7264) in participants with idiopathic or treatment resistant chronic cough designed to evaluate the effectiveness of gefapixant in reducing daytime objective cough frequency.

Detailed description:

Arms: arm 1: Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks. arm 2: Placebo to gefapixant BID, taken orally for 2 weeks followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks.
Interventions: intervention 1: Gefapixant intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablets, BID intervention 2: Oral tablets, BID

Protocol documents:
Clinical trial NCT01262898
Conditions: Gastroparesis
Keywords: tolerability pharmacokinetics 13 C oral breath test Type I and II Diabetes mellitus gastroparesis gut motility phase II pharmacodynamics repeat dose gastric emptying symptoms GSK962040
Sponsor: GlaxoSmithKline
Start date: 2011-05-03; Completion date: 2013-02-26
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory findings. Pharmacokinetic parameters were linear and approximately dose proportional over the range of doses administered. Single doses of 50 mg - 150 mg GSK962040 significantly increased the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable isotope breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed throughout repeated dosing to healthy volunteers for 14-days.

The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040 after 28 days of once-daily dosing in Type I and Type II diabetic subjects with gastroparesis. An additional aim is to characterize the dose/exposure - pharmacodynamic effect relationship.

Detailed description:

Arms: arm 1: GSK962040 10 mg arm 2: GSK962040 50 mg arm 3: GSK962040 125 mg arm 4: Placebo
Interventions: intervention 1: GSK962040 (5 mg tablet) intervention 2: GSK962040 (25 mg tablet) intervention 3: GSK962040 (125 mg tablet) intervention 4: Placebo
Intervention descriptions: intervention 1: 5 mg tablet intervention 2: 25 mg tablet intervention 3: 125 mg tablet intervention 4: matching placebo tablet

Protocol documents:
Clinical trial NCT01274559
Conditions: Primary Hypercholesterolemia Mixed Dyslipidemia
Keywords: MK-0524A/ER Hypercholesterolemia Dyslipidemia Niacin Laropiprant
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-03-01; Completion date: 2013-02-26
Enrollment: 1173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER) niacin/laropiprant \[ERN/LRPT (MK-0524A)\] when added to the following ongoing lipid-modifying therapy (LMT): simvastatin,

atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC), or any statin co-administered with ezetimibe. The study is based on the hypothesis that ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.

Detailed description:

Arms: arm 1: ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant. arm 2: Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Interventions: intervention 1: Extended-release niacin/laropiprant (ERN/LRPT) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 oral 1 g tablet of ERN/LRPT to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of ERN/LRPT to be taken together in the evening or at bedtime with food for the next 8 weeks. Each 1g tablet contains 1g ERN and 20 mg LRPT intervention 2: 1 oral 1 g tablet of placebo to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of placebo to be taken together in the evening or at bedtime with food for the next 8 weeks.

Protocol documents:
Clinical trial NCT00953758
Conditions: Hematologic Malignancies
Keywords: Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor
Sponsor: Pfizer
Start date: 2010-03-03; Completion date: 2013-02-27
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-04449913
Intervention descriptions: intervention 1: Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles

Protocol documents:
Clinical trial NCT00941720
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
Sponsor: Case Comprehensive Cancer Center
Start date: 2009-06-11; Completion date: 2013-02-28
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.

Detailed description:
OBJECTIVES:

Primary

* To compare relapse-free survival and overall survival of patients with multiple myeloma treated with IV busulfan vs historical control patients treated with oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation.

Secondary

* To compare pulmonary toxicity rates of IV busulfan vs oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation.

OUTLINE: Patients receive high-dose busulfan IV every 6 hours on days -8 to -4 and high-dose cyclophosphamide IV over 4 hours on days -3 and -2. Patients undergo autologous hematopoietic stem cell transplantation on day 0.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: None
Interventions: intervention 1: busulfan intervention 2: cyclophosphamide intervention 3: autologous hematopoietic stem cell transplantation
Intervention descriptions: intervention 1: IV busulfan 0.8 mg/kg every 6 hours x 16 doses intervention 2: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days intervention 3: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0

Protocol documents:
Clinical trial NCT00059332
Conditions: Cerebrovascular Accident
Keywords: stroke brain attack magnesium sulfate neuroprotection prehospital care emergency medical services
Sponsor: Jeffrey L. Saver
Start date: 2005-01-01; Completion date: 2013-03-01
Enrollment: 1700 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.

Detailed description:
Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.

Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.

The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.

Arms: arm 1: Magnesium sulfate (Mg) was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. The bolus-loading dose consisted of 4 grams Mg in 54 ml normal saline. The maintenance infusion contained 16 grams Mg diluted in 240 ml 0.9% normal saline, infused at 10 ml/hr for 24 hours. Paramedics in the field initiated the bolus-loading dose, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose. arm 2: Normal saline was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. Paramedics in the field initiated the bolus-loading dose of 54 ml normal saline, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose at 10 ml/hr for 24 hours.
Interventions: intervention 1: Magnesium Sulfate intervention 2: Normal Saline
Intervention descriptions: intervention 1: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours. intervention 2: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.

Protocol documents:
Clinical trial NCT00555906
Conditions: Multiple Myeloma
Sponsor: Pfizer
Start date: 2008-01-01; Completion date: 2013-03-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade® \[bortezomib\] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bortezomib intervention 2: Dexamethasone intervention 3: PD 0332991
Intervention descriptions: intervention 1: Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone. intervention 2: 20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib. intervention 3: Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.

Protocol documents:
Clinical trial NCT00643201
Conditions: Venous Thrombosis
Sponsor: Bristol-Myers Squibb
Start date: 2008-07-01; Completion date: 2013-03-01
Enrollment: 5614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Detailed description:

Arms: arm 1: apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months. arm 2: Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.
Interventions: intervention 1: Enoxaparin intervention 2: warfarin intervention 3: Placebo for apixaban intervention 4: Placebo for enoxaparin intervention 5: Placebo for warfarin intervention 6: apixaban
Intervention descriptions: intervention 1: solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2. intervention 2: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months intervention 3: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months intervention 4: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2. intervention 5: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months intervention 6: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months

Protocol documents: