ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00235495
Conditions: Ischemic Stroke
Keywords: stroke
Sponsor: University of Miami
Start date: 2006-06-01; Completion date: 2013-02-01
Enrollment: 841 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the trial is to determine whether human albumin, administered within 5 hours of symptom onset, improves the 3-month outcome of subjects with acute ischemic stroke.

Detailed description:
Human serum albumin, at 2 g/kg, administered over 2 hours by intravenous infusion, will be compared to placebo (isovolumic normal saline) among patients with acute ischemic stroke. All patients will have a baseline stroke severity measured as NIH Stroke scale score \> 5. Patients will treated according to the best standard of care including concurrent treatment with intravenous or intra-arterial thrombolysis where appropriate. The primary outcome will be determined at 3 months. The primary hypothesis is that, using the composite outcome of a modified Rankin score 0-1 or NIH stroke scale score 0-1 at 3 months (or both), the proportion of patients with improved outcomes will be greater by 10% or more in the active treatment group. \[The current trial is termed "Part 2" and incorporates revisions to the initial protocol that were instituted after the Data Safety Monitoring Board (DSMB) suspended subject recruitment because of a safety concern after 434 subjects had been enrolled. The protocol revisions of Part 2 resulted from the study team's thorough review of the Part-1 safety data and were designed to optimize safety going forward.\]

Arms: arm 1: Albumin (human albumin, 25% solution, 2.0 g/kg), infused intravenously over a period of 2 hours arm 2: Saline (isotonic solution), 8 ml/kg, infused intravenously over a 2-hour period
Interventions: intervention 1: Albumin intervention 2: Saline
Intervention descriptions: intervention 1: human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset intervention 2: equivalent volume of isotonic saline control

Protocol documents:
Clinical trial NCT00406276
Conditions: Lung Cancer
Keywords: Lung Cancer
Sponsor: Emory University
Start date: 2006-11-01; Completion date: 2013-02-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-arm, Phase I/II trial to determine the safety of RAD001 in combination with docetaxel and compare the efficacy of RAD001 plus docetaxel versus published Phase II and III reports of docetaxel alone in patients with recurrent NSCLC.

Detailed description:
This is an open-label, single-arm, Phase I/II trial to determine the safety of RAD001 in combination with docetaxel and compare the efficacy of RAD001 plus docetaxel versus published Phase II and III reports of docetaxel alone in patients with recurrent NSCLC.

New agents and regimens are urgently needed for lung cancer treatment. With the development of novel agents and small molecules designed to curtail the aggressive aspects of this disease, some progress has been realized. However, much more effort and insight will be required for further real gains to be made. We propose that studying the mTOR axis, known to be abnormal in non-small cell lung cancer (NSCLC), and translating that knowledge into therapeutic adjustments can lead to meaningful advances in lung cancer treatment.

Approximately 58 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.

Arms: arm 1: RAD001 in combination with Docetaxel.
Interventions: intervention 1: RAD001 intervention 2: Docetaxel
Intervention descriptions: intervention 1: RAD001 will be given at a dose of 5mg/day in combination with docetaxel intervention 2: In combination with RAD001

Protocol documents:
Clinical trial NCT00413192
Conditions: Soft Tissue Sarcoma
Sponsor: Eisai Inc.
Start date: 2007-01-01; Completion date: 2013-02-01
Enrollment: 128 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: 1.4 mg/m\^2 administered as an intravenous (I.V.) bolus infusion on Days 1 and 8 of every 21 days.

Protocol documents:
Clinical trial NCT00443651
Conditions: Rheumatoid Arthritis
Keywords: Rituxan RA DMARD Active Rheumatoid Arthritis
Sponsor: Genentech, Inc.
Start date: 2007-01-01; Completion date: 2013-02-01
Enrollment: 578 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, open-label study of a total of approximately 560 subjects with active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Enrollment in the study was conducted in two stages. In Stage I of the study, approximately 400 subjects receiving non-biological DMARDs (with the exception of methotrexate \[MTX\] monotherapy or MTX and leflunomide combination therapy) were enrolled. In Stage II of the study, approximately 160 subjects receiving a Federal Drug Administration-approved biological DMARD at the time of screening were enrolled.

Detailed description:

Arms: arm 1: Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations. arm 2: Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
Interventions: intervention 1: Rituximab intervention 2: Anti-inflammatory drugs
Intervention descriptions: intervention 1: Rituximab was supplied as a concentrate for IV administration at a concentration of 10 mg/mL in 500 mg (50 mL) single-use vials. intervention 2: Each rituximab infusion was preceded by methylprednisolone 100 mg IV. Use of stable doses of oral corticosteroids was permitted (≤ 10 mg of prednisone or equivalent per day) as were stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs).

Protocol documents:
Clinical trial NCT00448591
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-09-01; Completion date: 2013-02-01
Enrollment: 2296 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Taxane-based chemotherapy
Intervention descriptions: intervention 1: 10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle intervention 2: As prescribed

Protocol documents:
Clinical trial NCT00470834
Conditions: Neoplasms, Prostate
Keywords: prostate cancer androgen deprivation therapy
Sponsor: GlaxoSmithKline
Start date: 2007-05-01; Completion date: 2013-02-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.

Detailed description:

Arms: arm 1: 50 mg bicalutamide and 3.5 mg Dutasteride (IP) arm 2: 50 mg bicalutamide and placebo
Interventions: intervention 1: dutasteride intervention 2: placebo intervention 3: bicalutamide
Intervention descriptions: intervention 1: 0.5mg dutasteride (Investigation Product) intervention 2: making placebo intervention 3: 50 mg Casodex or generic equivalent

Protocol documents:
Clinical trial NCT00540514
Conditions: Non-Small Cell Lung Carcinoma
Keywords: Advanced Non-Small Cell Lung Cancer
Sponsor: Celgene
Start date: 2007-11-01; Completion date: 2013-02-01
Enrollment: 1052 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. arm 2: Participants received 200 mg/m\^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21 day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
Interventions: intervention 1: Albumin-bound paclitaxel intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Administered by intravenous infusion. intervention 2: Administered by intravenous infusion. intervention 3: Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976).

Protocol documents:
Clinical trial NCT00586196
Conditions: Delirium
Keywords: Delirium Postoperative confusion Hip fracture Long bone fracture
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2007-01-01; Completion date: 2013-02-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at increased risk of developing delirium (acute confusion) which impedes functional recovery. This is a pilot study to test the tolerability and efficacy of donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for the prevention of new or worsening delirium in aged hip and other long-bone fracture patients. Additional purposes involve gathering a small amount of patients' serum to better understand the pathophysiology of delirium in this population.

The purposes of this pilot study are to determine: 1) the safety and tolerability a cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To obtain estimates of subject accrual and preliminary estimates of effect size on the development of new delirium symptoms to allow for planning of a larger, definitive trial, 3) To better understand the underlying causes of delirium by examining whether a measure of blood anticholinergic activity relates to the incidence and persistence of delirium symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and delirium symptoms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: donepezil intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg each day for 30 days intervention 2: Encapsulated cornstarch One capsule daily for 30 days

Protocol documents:
Clinical trial NCT00590902
Conditions: Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer
Keywords: non small cell lung cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2002-03-01; Completion date: 2013-02-01
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the major objective response rate of OSI-774 in participants with unresectable or metastatic bronchioloalveolar cell variant of non-small cell lung cancer.

This study is a Phase II study. The first study of OSI-774 was done to evaluate what dose should be given to patients with cancer has been completed. The purpose of this research study is to see whether this experimental treatment, called OSI-774, can cause a type of non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company called Genentech, and is being done at Memorial Hospital, as well as other cancer centers around the country interested in developing new drugs for the treatment of this type of cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OSI-774: erlotinib, TarcevaTM
Intervention descriptions: intervention 1: 150 mg, 100 mg and 25 mg tablets

Protocol documents:
Clinical trial NCT00654368
Conditions: Rheumatoid Arthritis
Keywords: Amgen
Sponsor: Amgen
Start date: 2008-06-01; Completion date: 2013-02-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period

Detailed description:
This noninferiority study was a multicenter, open-label, randomized trial of patients with rheumatoid arthritis (RA). Patients who did not have an adequate response to methotrexate (MTX) had etanercept (50 mg/week subcutaneously \[SC\]) added to existing MTX therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses of MTX) at baseline and were followed for 6 months. After 6 months of therapy, participants were randomized in a 1:1 ratio to one of the 2 treatment arms: either discontinue MTX (tapered over 6 weeks) and continue etanercept alone or continue both etanercept plus MTX for an additional 18 months.

Arms: arm 1: After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months. arm 2: After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
Interventions: intervention 1: Etanercept intervention 2: Methotrexate
Intervention descriptions: intervention 1: Commercially available etanercept administered subcutaneously at 50 mg/week. intervention 2: Commercially available methotrexate administed orally, subcutaneously or intramuscularly 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses)

Protocol documents:
Clinical trial NCT00672477
Conditions: Opioid-Induced Constipation
Keywords: opioid-induced constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2008-06-01; Completion date: 2013-02-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

Detailed description:

Arms: arm 1: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and \<62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information. arm 2: Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and \< 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.
Interventions: intervention 1: Methylnaltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00674297
Conditions: Antiphospholipid Syndrome
Keywords: Persistently Antiphospholipid Antibody Positive Patients
Sponsor: Hospital for Special Surgery, New York
Start date: 2008-05-01; Completion date: 2013-02-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and safe in reducing the risk of cardiovascular disease and blood clots in patients with antiphospholipid antibodies or Antiphospholipid Syndrome (APS).

Detailed description:
The primary objective of the study is to determine the effects of fluvastatin on pro-thrombotic and pro-inflammatory markers in aPL-positive lupus and non-lupus patients (primary endpoint) and to determine the safety of fluvastatin in aPL-positive lupus and non-lupus patients (secondary endpoint).

All eligible patients will sign an IRB-approved consent form during the screening visit and give blood for baseline laboratory tests. Within a week of the screening visit, all patients will be started on Fluvastatin 40 mg daily for three months. At three months patients will be instructed to stop the study medication and they will be followed for another three months. Thus, the total duration of the study is six months: first three months is interventional and the last three months is observational.

Arms: arm 1: All patients will take Fluvastatin 40 mg daily for 3 months.
Interventions: intervention 1: Fluvastatin
Intervention descriptions: intervention 1: Fluvastatin 40 mg daily for 3 months

Protocol documents:
Clinical trial NCT00714259
Conditions: Multiple Myeloma CLL / SLL Non Hodgkin's Lymphoma Waldenstroms Mantle Cell Lymphoma
Keywords: Low Grade B Cell Malignancies nonmyeloablative transplant allogeneic
Sponsor: University of Alabama at Birmingham
Start date: 2008-07-01; Completion date: 2013-02-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.

Detailed description:
Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.

Arms: arm 1: Non-myeloablative Transplant Conditioning Chemotherapy :

Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\*6 CD34+ cells per kilogram of recipient weight.
Interventions: intervention 1: Fludarabine intervention 2: Total Body Irradiation intervention 3: Infusion of Stem Cells
Intervention descriptions: intervention 1: Fludarabine 30 mg/m2/day x 3 days intervention 2: TBI 200cGy x1 dose on transplant day intervention 3: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\*6 CD34+ cells per kilogram of recipient weight.

Protocol documents:
Clinical trial NCT00718770
Conditions: Thyroid Cancer
Keywords: Not respond Radioactive iodine Therapy Shows signs Aggressive behavior
Sponsor: University of Colorado, Denver
Start date: 2008-11-01; Completion date: 2013-02-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study plans to learn more about a drug called bexarotene for the treatment of advanced thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that will not respond to radioactive iodine therapy and shows signs of aggressive behavior.

Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in the treatment of thyroid cancer.

The purpose of this research study is to test how well the study drug works in humans. The study doctors want to know if:

1. The subjects thyroid cancer gets smaller while you are taking the study drug.
2. The subjects thyroid cancer takes up radioactive iodine better after treatment with the study drug than before treatment.

Detailed description:

Arms: arm 1: Open label - all patients receive intervention
Interventions: intervention 1: Bexarotene
Intervention descriptions: intervention 1: Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.

Protocol documents: