Kornimate/medical-research-clean huggingface dataset:
novartis everolimus transition

Conditions: Graft Dysfunction; Interstitial Fibrosis

Summary: transition from tacrolimus based triple therapy with mycophenolate mofetil (mmf) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in glomular filtration rate (gfr) and allograft fibrosis.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age and able to give informed consent. 2. received a first or repeat cadaveric (including ecd) or living donor renal transplant. 3. patient has stable graft function, defined as no change of greater than 40% of baseline serum creatinine and no acute rejection during the past month. 4. currently receiving tacrolimus, mycophenolate mofetil and prednisone as their immunosuppression regimen exclusion criteria: 1. biopsy proven acute rejection episode that occurred within the past month. 2. malignancy within the past 3 years, except for non-melanoma skin cancer. 3. currently enrolled in an investigational drug trial. 4. woman of child bearing potential not utilizing an effective form of birth control. 5. patients with uncontrolled dyslipidemia, defined at serum fasting ldl \>200 mg/dl or serum fasting triglycerides \>500 mg/dl. 6. patients with a spot urine protein to creatinine ratio of \> 800 mg of protein per gram of creatinine. 7. wbc \< 2,000 cells/mm3 8. platelets \< 75,000 cells/mm3 9. patients who have received an organ transplant other than a kidney. 10. patients with a history of biopsy proven fsgs, mpgn, or pgn.

Keywords: everolimus graft dysfunction interstitial fibrosis
timing of indomethacin administration for the prevention of post-ercp pancreatitis (pep)

Conditions: Acute Pancreatitis

Summary: to determine if the timing of administration of indomethacin affects the primary outcome of post-ercp pancreatitis (pep). patients undergoing ercp will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of pep.


Eligibility criteria:
inclusion criteria: * all patients referred for ercp at the university of alberta * age greater than 18 years * ability to provide written informed consent exclusion criteria: * acute pancreatitis * active peptic ulcer disease * rectal disease * aspirin-induced asthma * nonsteroidal anti-inflammatory drug (nsaids) induced hypersensitivity * pregnancy * breast feeding * creatinine clearance \< 30 ml/min
evaluation of the heart's respiratory quotient as predictive value after extra-hospital cardiac arrest

Conditions: Cardiac Arrest

Summary: it has been shown that elevation of the heart's respiratory quotient after cardiac surgery is predictive of the complications occurrence. in addition, a high heart's respiratory quotient is predictive of anaerobic metabolism after cardiac surgery. in the wake of cardiorespiratory arrest, the presence of anaerobic metabolism reflected by hyperlactatemia is an important prognostic factor. however, this monitoring is invasive and discontinuous. the hypothesis of the study is to show that a rise in the respiratory quotient by a non-invasive monitoring is a factor of poor prognosis in the wake of a cardiac arrest.


Eligibility criteria:
inclusion criteria: * adult \>18 years * admission to intensive care unit after a non-hospital cardiopulmonary arrest. * resumption of spontaneous cardiac activity. * non-opposition of the patient or his relatives exclusion criteria: * pregnancy * prior neurological impairment * persons deprived of their liberty by a judicial proceeding, or administrative decision.

Keywords: heart's respiratory quotient cardiac arrest non-invasive monitoring poor prognosis
vasopressin and epinephrine versus epinephrine alone in cardiac arrest

Conditions: Cardiac Arrest

Summary: recent studies have suggested that arginine-vasopressin could be more effective in the treatment of cardiac arrests. the last published study did not outline obvious improvements in the prognosis of all cardiac arrests but pointed out a possible increased survival rate when arginine-vasopressin is associated with epinephrine. the aim of this study is to compare the efficacy of two successive injections of epinephrine (1 mg) with two successive injections of epinephrine associated with arginine-vasopressin (40 ui) in out-of-hospital cardiac arrests occurring in adult patients. the primary endpoint is the survival rate at hospital admission. the inclusion period lasts 18 months and 2416 patients are planned to be enrolled.


Eligibility criteria:
inclusion criteria: * out-of-hospital medical cardiac arrest in adult patients. exclusion criteria: * traumatic cardiac arrest * pregnancy * patients younger than 18 years old or older than 85 years old

Keywords: out-of-hospital cardiac arrest - vasopressin - epinephrine
clinical performance of ceramic cad/cam crowns

Conditions: Tooth Crown Fracture; Dental Caries

Summary: the purpose of this study was to evaluate the clinical performance of laboratory and chairside fabricated monolithic anterior and posterior ldgc cad/cam crowns performed by predoctoral students at the university of toronto and the effect of different patient and provider-related factors on their longevity and to compare them to the metal-ceramic (mc) crowns. a sample of ldgc cad/cam crowns (ips e.max, ivoclar vivadent) provided by predoctoral students was evaluated. crown preparations were made according to the specific criteria and were milled in-house using the cerec bluecam and omnicam systems. crowns were cemented with rely-x unicem (3m/espe) and calibra universal (dentsply sirona) resin cements. clinical assessment of the crowns and supporting periodontal structures was performed following the modified california dental association (cda) criteria. intra-oral photographs, periapical and bitewing radiographs were taken for further assessment by two evaluators. two-hundred and fifty-one patients with 275 crowns were examined with a follow-up period of up to 6 years.

the clinical success of the monolithic lithium-disilicate glass-ceramic (ldgc) crowns manufactured with computer-aided design (cad) / computer-aided manufacturing (cam) technology provided by predoctoral students was not investigated. thus, the purpose of this study was to evaluate the clinical performance of laboratory and chairside fabricated monolithic anterior and posterior ldgc cad/cam crowns performed by predoctoral students at the university of toronto and the effect of different patient and provider-related factors on their longevity and to compare them to the metal-ceramic (mc) crowns. a sample of ldgc cad/cam crowns (ips e.max, ivoclar vivadent) provided by predoctoral students was evaluated. crown preparations were made according to the specific criteria and were milled in-house using the cerec bluecam and omnicam systems. crowns were cemented with rely-x unicem (3m/espe) and calibra universal (dentsply sirona) resin cements. clinical assessment of the crowns and supporting periodontal structures was performed following the modified california dental association (cda) criteria. intra-oral photographs, periapical and bitewing radiographs were taken for further assessment by two evaluators. two-hundred and fifty-one patients with 275 crowns were examined with a follow-up period of up to 6 years. part 1 evaluated the performance of laboratory-fabricated ldgc cad/cam crowns. part 2 evaluated the performance of chairside ldgc cad/cam crowns. forty crowns were evaluated. part 3 evaluated the performance of ldgc cad/cam and mc crowns using split-mouth design. a total of 25 patients and 50 crowns (25 crowns for each group) were examined.

Eligibility criteria:
inclusion criteria: * healthy periodontal tissue adequate root canal treatment exclusion criteria: * parafunctional habits

Keywords: computer-aided design dental crowns survival
dichoptic video treatment for amblyopia

Conditions: Amblyopia

Summary: 1. to determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children 2. to compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)

contrast-rebalanced binocular ipad tablet games (with fellow eye contrast reduced) have been shown to be an effective treatment for amblyopia. however, the games can be challenging for some of the youngest children and boring for some of the older children with amblyopia. to provide additional treatment options using the same contrast-rebalancing approach, we have processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic eye and reduced contrast for the fellow eye. children will be randomly assigned to watch dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care amblyopia treatment) for 2 weeks. at the 2-week primary outcome visit, children in the patching group will cross over to the videos and return for a secondary outcome visit at 4 weeks. families will have the option to continue with the vdeos for up to 8 weeks.

Eligibility criteria:
inclusion criteria: * 3 to 7 years old * amblyopic eye visual acuity 20/32-20/125 * fellow eye visual acuity 20/16-25 * interocular visual acuity difference of at least 2 lines * anisometropia or corrected strabsimus (\<5pd) * in glasses at least 8 weeks or no change in visual acuity over two visits * no prior binocular treatment * must be able to see full video screen exclusion criteria: * prematurity of 8 weeks or more * coexisting ocular or systemic disease * developmental delay * poor ocular alignment (\>=5 pd)
optimizing dose of bupivacaine in combined spinal epidurals to reduce side effects

Conditions: Pregnancy

Summary: the purpose of this study is to determine what dose of medication administered through a combined spinal epidural (cse) provides the optimal pain relief with the minimal amount of side effects. the 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.

a combined spinal epidural (cse), which is the investigators' customary method of providing pain relief during your labor, is the identification of the epidural space in your lower back with a needle, followed by passing a thinner and longer needle through the first needle. this second needle will enter the patient's "spinal" (intrathecal) space by passing through the dura (thin covering separating the epidural space from the spinal space). the spinal (intrathecal) space is identified by flow of spinal fluid. the dura is the envelope around the spinal cord and the intrathecal space which is filled with spinal fluid. medication will be injected at once into the spinal space, the thinner needle removed and a fine tube (catheter) will be threaded through the first needle into the epidural space. this catheter is in the epidural space and medication can be given through this catheter later on (hence the term combined) if needed. this study is a comparison of three different dosages (1.25mg, 1.66mg and 2.5 mg) of the local anesthetic (bupivacaine) that we frequently use in the spinal, mixed with 20 mcg of fentanyl (also routinely used in standard of care practice), and of its effects on the patient's blood pressure (risk of maternal's drop of the blood pressure with possible bad effects on the blood flow to the baby), on the patient's baby's heart rate (risk of slowing down of the baby heart rate as a consequence of decreased blood flow to the baby), and the patient's pain relief (higher dose of medications are usually more effective for maternal pain relief but have side effects that can be bad for the mother and the baby). the doses of bupivacaine the investigator routinely use on the labor and delivery floor go from 1.25 to 2.5 mg depending on clinician preferences. these doses are considered standard of care in the literature.

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists physical status) 1-2 parturients at term requesting labor analgesia * between 37 and 42 weeks gestational age * maternal age of 18 years or greater exclusion criteria: * parturients with pre-eclampsia * history of pregnancy induced hypertension * patients in whom a spinal anesthetic is contraindicated (e.g. coagulopathy, local infection) or those in whom a cse cannot be performed * patients with non reassuring fetal heart rate tracings prior to placement of the cse

Keywords: pain control labor epidural pregnant
procurement of human specimens for the evaluation of early markers of sepsis

Conditions: Infection

Summary: procure blood specimens from individuals presenting to the emergency department (ed) with signs and /or symptoms of systemic infection or sepsis. the samples will be used for research and development activities related to sepsis, infections, etc.


Eligibility criteria:
inclusion criteria: * 18 yrs of age or older * for women of child bearing years: not known to be pregnant * blood culture ordered as part of the ed, icu (or equivalent) or hospital floor stay. exclusion criteria: * previously enrolled in this study * vulnerable individual * unable to speak and/or understand english

Keywords: emergency department infection sepsis
oct evaluation 3 months after sirolimus eluting stent implantation

Conditions: Coronary Artery Disease

Summary: prospective, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. patients will be followed at 30 days, 3, 6 and 12 months. at 3 months all patients will be submitted to angiographic and oct evaluation.


Eligibility criteria:
inclusion criteria: * one or two de novo lesions (\> 50% visual estimation) * lesion diameter between 2.5 and 3.5 mm * lesion length up to 33 mm. exclusion criteria: * mi within the last 72 hours * restenotic lesion.
study of the performance of stroke management in the rhône area

Conditions: Stroke

Summary: acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. however, only a small percentage of patients access to thrombolysis on time. various actions have been implemented since 2006 in the rhone area as part of research projects and of the 2010-2014 national stroke action plan: training of health professionals involved in the stroke management, increase of public awareness through sensibilization campaigns, implementation of telemedicine and increase of the number of hospital beds dedicated to stroke (stroke units beds). the main objective of the stroke 69 study is to assess the impact of these actions on intra-hospital acute stroke management times in the rhône area. the secondary objectives are to assess the impact of these actions on the rate and place of thrombolysis, the rate of post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of calls to samu centre 15 (french mobile emergency medical services, equivalent to 911) and management channels. the investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016 and data will be compared to data collected in a previous cohorts study, the avc-69 cohort study (porthault chatard et al, int j stroke. 2012 oct;7(7):e13), between 06/11/2006 and 06/06/2007, before the implementation of the actions in the rhône area. the cohort will be constituted of all consecutive patients treated for a stroke suspicion by the rhône samu centre 15, or in one of the emergency unit or stroke unit of the rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours. after collecting data in the acute phase, patients with a confirmed diagnosis of stroke or transient ischemic attack (tia) will be followed for 12 months after their inclusion by telephone calls at 3 and 12 months to assess the level of disability and mortality. avc 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan to include at least 1300 patients in the stroke 69 cohort with approximately 1000 confirmed strokes or tias.


Eligibility criteria:
inclusion criteria: * consecutive patients treated for a stroke suspicion at the acute phase , * with symptom onset (the last time the patient was seen without deficit ) less than 24 hours, * managed by the samu centre 15, in one of the emergency unit or stroke unit of the rhône area * regardless of their geographical origin exclusion criteria: * age under 18 years * symptom onset exceeding 24 hours * stroke during hospitalization

Keywords: ischemic stroke, acute phase, thrombolysis, management times
persistence-targeted smoking cessation

Conditions: Tobacco Use Disorder

Summary: the investigators propose to develop a theory-based smoking cessation intervention (called persistence-targeted smoking cessation; ptsc). ptsc includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. the investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence).

in this stage i behavioral \& integrative treatment development (r34) project, we propose to develop a theory-based smoking cessation intervention (called persistence-targeted smoking cessation; ptsc). ptsc includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. we will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). we hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial.

Eligibility criteria:
inclusion criteria: * must be between 18 - 64 years old * must smoke at least 10 cigarettes per day for past 6-months * expired breath carbon monoxide (co) \> 7 * must have a working cellular phone exclusion criteria: * must not be currently receiving tobacco dependence treatment counseling * must not currently be taking varenicline, bupropion, or any nicotine preparations (gum, lozenge, patch, spray, inhaler) * must have no contraindications to using nicotine lozenge

Keywords: tobacco smoking cessation nicotine dependence
solid organ transplant recipients with sars-cov-2 french registry

Conditions: SARS-CoV-2

Summary: patients with comorbid condition are known to be at high risk of severe forms of covid-19. it is highly probable that immunocompromised patients like solid organ transplant (sot) recipients are also at risk of severe forms of covid-19. for this purpose, the investigators conducted a nationwide multicentric and multiorgan registry to collect data about all french sot recipients who develop a sars-cov-2 infection. the aim is to describe the clinical, biological and virological characteristics of these patients and to give information about evolution and prognosis of these particular population


Eligibility criteria:
inclusion criteria: * all solid organ transplant recipients with a functioning graft and a high suspicion or a confirmed sars-cov-2 infection * adult and pediatric exclusion criteria: - there are no exclusion criteria, except for the patient's explicit refusal to participate

Keywords: sars-cov-2 covid-19 solid organ transplantation incidence prognosis cellular response humoral response
open label study of sildenafil in patients with pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: to assess the safety of sildenafil 20 mg tid orally given to japanese pulmonary arterial hypertension patients (part 1 and 2) to assess the efficacy after 12 weeks of treatment of sildenafil 20 mg tid orally given to japanese pulmonary arterial hypertension patients (part 1)


Eligibility criteria:
inclusion criteria: * subjects aged 16 and over, and classified as having pulmonary arterial hypertension * subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmhg and pulmonary capillary wedge pressure of ≤ 15mmhg at rest * subjects whose baseline 6-minute walk test distance is \>100 m and \<450 m exclusion criteria: * significant hepatic and/or renal disorder * subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (naion) * subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole

Keywords: pulmonary arterial hypertension, pah
observational study to evaluate safety of idarucizumab in pediatric patients

Conditions: Hemorrhage

Summary: idarucizumab is a humanized monoclonal antibody fragment (fab) that binds to dabigatran with very high affinity. idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. a clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.

purpose: study design:

Eligibility criteria:
inclusion criteria: * male or female, \<18 years of age * were administered idarucizumab at sites and usage identified by various methods (eg.through the idarucizumab drug administration surveillance program, spontaneous reporting) exclusion criteria: participation in a dabigatran or idarucizumab clinical trial