ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01399268
Conditions: Postoperative Inflammatory Response
Keywords: Bilateral total knee replacement cytokine desmosine
Sponsor: Hospital for Special Surgery, New York
Start date: 2009-02-01; Completion date: 2011-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status changes and possibly other complications. It is known to lead to shock and participate in the inflammatory state seen in sepsis. High levels have further been linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low dose steroids given in two doses in the initial perioperative period decreased the amount of IL6 released compared to placebo, but this was not sustained past 24 hours.

Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in urine samples. It is considered to be a marker of lung injury and is found to be elevated in patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the investigators have found that urine desmosine levels rise with bilateral total knee replacement compared to unilateral total knee replacement indicating possible lung injury.

Therefore the investigators hypothesize:

Continued low dose steroids given three times over a 24 hour period will:

1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
2. Decrease urinary desmosine levels, and hence be protective of lung injury.

Detailed description:

Arms: arm 1: Hydrocortisone 100 mg IV Q 8hrs x3 arm 2: Saline IV Q8hr x3
Interventions: intervention 1: Hydrocortisone intervention 2: Saline
Intervention descriptions: intervention 1: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times intervention 2: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times

Protocol documents:
Clinical trial NCT01404078
Conditions: Ischemic Heart Disease Ischemic Stroke Peripheral Vascular Disease Type 2 Diabetes Mellitus
Sponsor: St. John's Research Institute
Start date: 2010-04-01; Completion date: 2011-02-01
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL.

To evaluate the tolerability and safety of low dose potassium supplementation compared to placebo in patients with stable cardiovascular disease.

Approximately 500 patients are planned to be randomized.

Detailed description:
Mean change in blood pressure between those taking 2capsules of the polycap versus one Difference in Rates of early discontinuation between 2 capsules of polycap versus one Rates of reported adverse effects among those taking the polycap

Arms: arm 1: Single dose polycap without pottasium arm 2: Double Dose polycap with potassium
Interventions: intervention 1: Single Dose Polycap intervention 2: Double dose Polycap
Intervention descriptions: intervention 1: Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin intervention 2: 2 Capsules of low strength polycap with 30mEq of Potassium

Protocol documents:
Clinical trial NCT01542125
Conditions: Pain
Keywords: Patients aged 3 to 16 years presenting for removal of smooth percutaneous interosseus pins after orthopeadic surgery
Sponsor: University of Alberta
Start date: 2008-09-01; Completion date: 2011-02-01
Enrollment: 281 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation, occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH), this frequently performed procedure is currently done without anesthetic, making it a painful and uncomfortable experience for the child and their caregiver(s). Liposomal Lidocaine is a relatively new effective and "needle-free" topical anesthetic. The investigators were interested in examining its effectiveness in pain reduction in children undergoing Perc Pin removal. Objective: To determine if Liposomal Lidocaine is effective in reducing pain in a pediatric population undergoing Perc Pin removal compared to a placebo. Hypothesis: The investigators hypothesize that Liposomal Lidocaine would significantly reduce pain during Perc Pin removal compared to a placebo. Research Design: This was a triple-blinded, randomized placebo-controlled clinical trial with 281 patients (140 patients each in the Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher Scale (children) and a 10-cm Visual Analog Scale (parents and caregivers) were collected prior to randomization and immediately after Perc Pin removal. Data was analyzed using a Student's t-test and the Wilcoxon signed ranks test.

Detailed description:

Arms: arm 1: Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing arm 2: This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.
Interventions: intervention 1: Liposomal Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: 4% Liposomal Lidocaine intervention 2: Tubes were visually identical to the Liposomal Lidocaine tubes.

Protocol documents:
Clinical trial NCT01565382
Conditions: Alzheimer's Disease
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2011-02-01; Completion date: 2011-02-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).

Detailed description:

Arms: arm 1: Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)

Protocol documents:
Clinical trial NCT01631656
Conditions: Rosacea
Keywords: Rosacea, Laser, Finacea Gel, Azelaic Acid,
Sponsor: Wake Forest University Health Sciences
Start date: 2010-07-01; Completion date: 2011-02-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects will be screened for study enrollment and topical treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea 15% gel and will be instructed to apply the study drug to one half of the face, twice daily. Drug application will be modified just prior to and after the subjects' laser treatment to reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over the whole face two weeks after initiating Finacea treatment. Subjects will continue to use Finacea gel to one half of the face for the duration of the study.

Detailed description:
This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects will be screened for study enrollment and topical treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea 15% gel and will be instructed to apply the study drug to one half of the face, twice daily. Drug application will be modified just prior to and after the subjects' laser treatment to reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over the whole face two weeks after initiating Finacea treatment. Subjects will continue to use Finacea gel to one half of the face for the duration of the study. Assessment of acneiform lesions, redness, and telangiectasias will be performed at Screening/Baseline, Week 2 (prior to laser treatment), and week 6/End of Study. Photography will be performed at Screening/Baseline and End of Study visits. Adverse events will be assessed at each visit, and a patient survey will be completed at Baseline and at Week 6/End of Study visits.

Arms: arm 1: Azelaic acid 15% twice daily on half the face for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks. arm 2: laser treatment on all face once at 2 weeks with no azelaic acid on one side of the face
Interventions: intervention 1: Azelaic acid intervention 2: Nd:Yag laser
Intervention descriptions: intervention 1: 15% gel on half the face, twice daily, 6 weeks intervention 2: Treatment with Nd:Yag laser , once at Week 2.

Protocol documents:
Clinical trial NCT00589420
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2007-07-27; Completion date: 2011-02-02
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the proportion of patients achieving a 50% reduction in serum PSA from baseline in patients with androgen-independent prostate cancer (AIPC) receiving sorafenib tosylate and docetaxel.

Secondary

* To estimate the progression-free survival of patients with AIPC.
* To quantify the number and percent of patients who have stable disease at 6 months of therapy (failure to progress).
* To estimate median time to progression for all patients.
* To estimate the objective response rate of patients with AIPC treated with this regimen.
* To measure the percentage of patients surviving at 2 years.
* To determine the toxicities and estimate toxicity rates for patients treated with this regimen.
* To measure changes in tumor vasculature in response to therapy in selected patients with dynamic contrast-enhanced MRI (DCE-MRI) and correlate primary and secondary objectives to these measurement changes.
* To measure changes in serum HMGB1 in response to therapy and correlate primary and secondary objectives with these changes.
* To measure changes in serum cathepsin D in response to therapy and correlate primary and secondary objectives with these changes.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 2-19 and docetaxel IV on day 1. Treatment repeats every 21 days for up to 10 courses. Patients then receive oral sorafenib tosylate alone twice daily on days 1-19 with treatment repeating every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically to measure serum HMGB1 and cathepsin D levels before and after therapy.

Arms: arm 1: All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks
Interventions: intervention 1: docetaxel intervention 2: sorafenib tosylate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01119105
Conditions: Bacterial Infections Infection
Keywords: acute bacterial skin and skin structure infection bacteria
Sponsor: Nabriva Therapeutics AG
Start date: 2010-05-01; Completion date: 2011-02-03
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II, multi-center, randomized, double-blind study comparing the safety and efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and skin structure infection.

Detailed description:
The purpose of the study is to determine the efficacy of 2 dose regimens of BC-3781 versus the licensed medicinal product vancomycin over 5 to 14 days. The population in this study will be patients with an acute bacterial skin and skin structure infection (ABSSSI) and they will receive treatment with one of two doses of BC-3781 or vancomycin, a standard treatment for this condition.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: BC-3781 intervention 2: BC-3781 intervention 3: Vancomycin
Intervention descriptions: intervention 1: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. intervention 2: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. intervention 3: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Protocol documents:
Clinical trial NCT00985621
Conditions: Osteoarthritis
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor OA pain arthritis
Sponsor: Pfizer
Start date: 2009-10-30; Completion date: 2011-02-04
Enrollment: 614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

Detailed description:
This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: tanezumab 10 mg intervention 2: tanezumab 5 mg intervention 3: oxycodone intervention 4: placebo
Intervention descriptions: intervention 1: tanezumab 10 mg one dose at weeks 0 and 8 intervention 2: tanezumab 5 mg one dose at weeks 0 and 8 intervention 3: oxycodone CR, 10-40 mg q12h intervention 4: placebo

Protocol documents:
Clinical trial NCT01054885
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD Chronic Obstructive Pulmonary Disease Efficacy FEV1 Safety
Sponsor: GlaxoSmithKline
Start date: 2009-10-19; Completion date: 2011-02-08
Enrollment: 1226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)

Detailed description:

Arms: arm 1: Inhaled Corticosteroid (ICS) arm 2: Inhaled Corticosteroid (ICS) arm 3: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 4: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 5: Long Acting Beta Agonist(LABA) arm 6: Placebo
Interventions: intervention 1: FF Inhalation Powder intervention 2: FF/GW642444 Inhalation Powder intervention 3: GW642444 Inhalation Powder intervention 4: Placebo
Intervention descriptions: intervention 1: Inhaled Corticosteroid (ICS) intervention 2: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD intervention 3: Long Acting Beta Agonist(LABA) intervention 4: Placebo

Protocol documents:
Clinical trial NCT01279057
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Rhinitis Seasonal Allergic Rhinitis Fluticasone furoate Equivalence Hay fever
Sponsor: Sandoz
Start date: 2010-12-27; Completion date: 2011-02-08
Enrollment: 727 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

Detailed description:
The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of fluticasone furoate, 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Veramyst® nasal spray (GlaxoSmithKline) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 110 mcg was 4 actuations, each containing 27.5 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Arms: arm 1: Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days. arm 2: Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days. arm 3: Placebo nasal spray administered once daily for 14 days.
Interventions: intervention 1: Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) intervention 2: Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray intervention 3: Placebo
Intervention descriptions: intervention 1: Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days. intervention 2: Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days. intervention 3: Placebo nasal spray administered once daily (4 actuations) for 14 days.

Protocol documents:
Clinical trial NCT00950989
Conditions: Rheumatoid Arthritis
Keywords: Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases
Sponsor: Amgen
Start date: 2009-12-30; Completion date: 2011-02-11
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study in participants with RA who have an inadequate response to methotrexate.

Detailed description:

Arms: arm 1: Placebo on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week). arm 2: 70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week). arm 3: 140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexateand folic acid supplementation (at least 5 mg per week). arm 4: 210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
Interventions: intervention 1: Brodalumab intervention 2: Placebo intervention 3: Methotrexate intervention 4: folic acid
Intervention descriptions: intervention 1: 3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10 intervention 2: 3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10 intervention 3: Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study. intervention 4: at least 5 mg per week

Protocol documents:
Clinical trial NCT00730275
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-07-18; Completion date: 2011-02-14
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.

Detailed description:

Arms: arm 1: Participants were randomized to sitagliptin 50 mg arm 2: Participants were randomized to sitagliptin 100 mg arm 3: Participants were randomized to a single dose of sitagliptin 200 mg arm 4: Participants were randomized to matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg
Interventions: intervention 1: Sitagliptin phosphate intervention 2: Comparator: matching placebo
Intervention descriptions: intervention 1: Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg. intervention 2: Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.

Protocol documents:
Clinical trial NCT00996203
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-10-31; Completion date: 2011-02-14
Enrollment: 201 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: DMARDs (disease-modifying antirheumatic drugs)
Intervention descriptions: intervention 1: 8 mg/kg iv every 4 weeks for 24 weeks intervention 2: stable doses at investigator's prescription

Protocol documents:
Clinical trial NCT00424554
Conditions: Glioma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-09-26; Completion date: 2011-02-16
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to assess the effect of a two-week pre-surgery treatment with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid) methyltransferase (MGMT) activity in patients with gliomas.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: temozolomide
Intervention descriptions: intervention 1: Temozolomide 75 mg/m\^2 daily for 14 days prior to surgery.

As standard of care, it could also be given at the same dose for up to 28 days after surgery, per investigator discretion.

Protocol documents: