ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00604695
Conditions: Acute Myocardial Infarction
Keywords: ST-Elevation Myocardial Infarction Acute Myocardial Infarction No Reflow
Sponsor: C. Michael Gibson, MS, MD
Start date: 2008-07-01; Completion date: 2011-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during balloon angioplasty for heart attacks.

We hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the site of the culprit lesion leading to reduced damage to the heart muscle.

Detailed description:
The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Efficacy will be assessed by measurements of both the angiographic characteristics of the culprit lesion as well as by measurements of epicardial flow and myocardial perfusion in the territory of the infarct-related artery. This study will also evaluate the safety of administering low-dose IC tenecteplase to subjects undergoing primary PCI for STEMI treated with standard therapy (aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors). Safety endpoints include the incidence of death, recurrent myocardial infarction (MI), abrupt vessel closure, subacute stent thrombosis, and TIMI major and minor bleeding events.

Prompt reperfusion therapy with primary PCI in patients with STEMI improves clinical outcomes through salvage of myocardial tissue. The proposed pilot trial is a randomized, placebo-controlled trial to evaluate the effectiveness and safety of adjunctive low-dose IC tenecteplase in conjunction with standard medical therapy during primary PCI for STEMI. We hypothesized that low-dose IC tenecteplase will enhance fibrinolysis at the site of the culprit lesion leading to reduced microvascular dysfunction. As reduced dose tenecteplase will be injected directly into the coronary artery increasing local concentration of the drug with minor systemic effects, an improved safety profile is also expected from this mode of administration.

Arms: arm 1: Two (4mg) doses of tenecteplase arm 2: Two (4mL) doses of sterile saline
Interventions: intervention 1: Tenecteplase intervention 2: Sterile Saline
Intervention descriptions: intervention 1: Intracoronary injection of IV tenecteplase. intervention 2: Intracoronary injection of IV sterile saline

Protocol documents:
Clinical trial NCT00605423
Conditions: Age Related Macular Degeneration
Keywords: AMD Almera Steroid Macular ARMD
Sponsor: Johns Hopkins University
Start date: 2008-01-01; Completion date: 2011-11-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections.

Detailed description:
Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. The use of the glucocorticoids such as triamcinolone acetonide as adjunct treatment for exudative age-related macular degeneration has been reported to enhance the efficacy of photodynamic therapy with Visudyne® (verteporphin for injection). It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections. This study is a pilot phase 2b study to test this hypothesis. The safety assessments will continue through 36 months.This study will compare the safety 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau.

Arms: arm 1: Dose 0.2 ug/day Medidur implant arm 2: Dose 0.5 ug/day Medidur implant
Interventions: intervention 1: Fluocinolone Acetonide/Medidur intervention 2: Fluocinolone Acetonide/Medidur
Intervention descriptions: intervention 1: 0.2 ug/day implant intervention 2: 0.5 ug/day implant

Protocol documents:
Clinical trial NCT00612586
Conditions: Colorectal Cancer
Sponsor: Eli Lilly and Company
Start date: 2008-02-01; Completion date: 2011-11-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.

Detailed description:

Arms: arm 1: 5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin arm 2: 5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo
Interventions: intervention 1: Enzastaurin intervention 2: Placebo intervention 3: Leucovorin (LV) intervention 4: 5-fluorouracil (5-FU) intervention 5: Bevacizumab (Bev)
Intervention descriptions: intervention 1: 1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease intervention 2: oral, daily (up to 1 yr or until progressive disease) intervention 3: 400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease) intervention 4: 400 mg/m\^2 bolus then 2400 mg/m\^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease) intervention 5: 5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Protocol documents:
Clinical trial NCT00647348
Conditions: Secondary Progressive Multiple Sclerosis
Keywords: Secondary progressive Multiple Sclerosis Simvastatin MRI
Sponsor: Imperial College London
Start date: 2008-01-01; Completion date: 2011-11-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.

Detailed description:
The study has now completed see Primary publication:

Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial.

Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR, Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas R.

Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4.

Arms: arm 1: Simvastatin 80mg OD arm 2: Placebo
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 80mg simvastatin oral once daily for 24 months intervention 2: Oral placebo tablet once daily for 24 months

Protocol documents:
Clinical trial NCT00670930
Conditions: Allergic Asthma
Keywords: Asthma, adults, anti-immunoglobulin E ( IgE), omalizumab, airway inflammation, airway remodeling, allergy
Sponsor: Novartis Pharmaceuticals
Start date: 2008-04-01; Completion date: 2011-11-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.

Detailed description:

Arms: arm 1: Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment. arm 2: Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
Interventions: intervention 1: omalizumab at a dose of 0.016mg/kg/IU/mL intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00671515
Conditions: Depressive Disorder, Major Metabolic Syndrome X
Keywords: Depressive Disorder, Major Metabolic Syndrome X pioglitazone
Sponsor: Joseph Calabrese, MD
Start date: 2008-04-01; Completion date: 2011-11-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to begin to test whether or not pioglitazone, an FDA approved medication used to treat high blood sugar, may be safe and effective in treating Major Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).

Detailed description:

Arms: arm 1: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Interventions: intervention 1: Pioglitazone
Intervention descriptions: intervention 1: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.

Protocol documents:
Clinical trial NCT00674661
Conditions: Ectasia
Keywords: ectasia cross-linking crosslinking cornea riboflavin UVA
Sponsor: Glaukos Corporation
Start date: 2007-12-01; Completion date: 2011-11-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.

Detailed description:
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Arms: arm 1: riboflavin ophthalmic solution and UVA irradiation arm 2: riboflavin opthalmic solution without UVA irradiation
Interventions: intervention 1: riboflavin ophthalmic solution intervention 2: UVA Irradiation
Intervention descriptions: intervention 1: riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) intervention 2: UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes

Protocol documents:
Clinical trial NCT00700570
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-08-01; Completion date: 2011-11-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: capecitabine [Xeloda] intervention 3: oxaliplatin
Intervention descriptions: intervention 1: 5mg/kg iv on day 1 of each 2 week cycle. intervention 2: 1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle intervention 3: 85mg/m2 iv on day 1 of each 2 week cycle

Protocol documents:
Clinical trial NCT00714948
Conditions: Bladder Cancer URINARY BLADDER
Keywords: Bladder Urinary SORAFENIB CISPLATIN GEMCITABINE
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-07-01; Completion date: 2011-11-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Standard chemotherapy drugs generally work by killing rapidly dividing cells in your body. Cancers cells are some of the most rapidly dividing cells and that is why chemotherapy can be effective in some patients. Gemcitabine and Cisplatin are an effective and standard drug combination used to treat locally advanced and metastatic urothelial cancer. However, these drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer.

New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Sorafenib is an example of a drug that works in this way.

In some patients with advanced kidney cancer, sorafenib alone has been shown to slow the progression of their disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, cisplatin, and sorafenib has on you and your cancer.

Detailed description:

Arms: arm 1: This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.
Interventions: intervention 1: gemcitabine and cisplatin plus sorafenib
Intervention descriptions: intervention 1: Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months. The total chemotherapy dose for gemcitabine and cisplatin (GC) may be modified for patients with severe obesity (e.g. body surface area (BSA) \> 2.1), after consultation with the Principal Investigator.

Protocol documents:
Clinical trial NCT00735904
Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC)
Keywords: AG-013736 axitinib cisplatin gemcitabine NSCLC squamous cell lung cancer
Sponsor: Pfizer
Start date: 2008-12-01; Completion date: 2011-11-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: AG-013736 intervention 2: gemcitabine intervention 3: cisplatin
Intervention descriptions: intervention 1: AG-013736 5 mg tablets orally, twice daily, until disease progression intervention 2: 200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m\^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles intervention 3: 1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m\^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles

Protocol documents:
Clinical trial NCT00764738
Conditions: Neovascular Age Related Macular Degeneration
Keywords: ARMD AMD exudative AMD
Sponsor: Retina Macula Institute
Start date: 2008-10-01; Completion date: 2011-11-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.

Detailed description:

Arms: arm 1: Ranibizumab injections every month for 12 months. arm 2: Ranibizumab injections monthly for 4 months then as needed thereafter.
Interventions: intervention 1: OCT, Multifocal ERG, Microperimetry intervention 2: Ranibizumab Ophthalmic
Intervention descriptions: intervention 1: OCT performed monthly. Fluorescein Angiography performed at baseline, month 3, month 5, month 8 and month 12.

Microperimetry performed at baseline, month 3, month 5, month 8, and month 12 for monthly ranibizumab and at baseline, month 3, month 5 through month 12 for as needed ranibizumab.

Multifocal ERG done at the same monthly visits as the microperimetry. intervention 2: 0.5 mg ranibizumab vs 2.0 mg ranibizumab

Protocol documents:
Clinical trial NCT00819403
Conditions: Metabolic Syndrome
Keywords: triglycerides hypertension low hdl obesity
Sponsor: University of Maryland, Baltimore
Start date: 2009-01-01; Completion date: 2011-11-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.

Detailed description:
1. To assess the ex vivo effects of ezetimibe/simvastatin (E/S) (Vytorin 10/40mg) and simvastatin (S) (Zocor 40mg) on platelet and inflammation biomarkers in patients with documented metabolic syndrome.
2. To compare platelet-related effects including PAR-1 receptor inhibition of E/S with those of the established anti-platelet agents including aspirin, clopidogrel, intravenous and oral glycoprotein IIb/IIIa inhibitors.
3. To determine whether the addition of ezetimibe will yield extra protection beyond lipid modulation in the reduction of inflammation and platelet activation.

Arms: arm 1: Simvastatin 40 mg daily arm 2: Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
Interventions: intervention 1: simvastatin intervention 2: ezetimibe/simvastatin
Intervention descriptions: intervention 1: Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. intervention 2: Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

Protocol documents:
Clinical trial NCT00833365
Conditions: Patent Ductus Arteriosus Prematurity
Keywords: premature infants PDA ibuprofen
Sponsor: University of Utah
Start date: 2009-01-01; Completion date: 2011-11-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.

Detailed description:
Infants with birth weight at \<1200gm and/or \<28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of \<96 hrs old and \>96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.

Arms: arm 1: Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old arm 2: Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
Interventions: intervention 1: Ibuprofen intervention 2: Ibuprofen
Intervention descriptions: intervention 1: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose intervention 2: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Protocol documents:
Clinical trial NCT00848549
Conditions: Epilepsy
Keywords: Epilepsy Monotherapy
Sponsor: Eisai Inc.
Start date: 2008-10-01; Completion date: 2011-11-01
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Zonisamide intervention 2: Carbamazepine
Intervention descriptions: intervention 1: Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week. intervention 2: Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.

Protocol documents: