Kornimate/medical-research-clean huggingface dataset:
prospective randomized evaluation of an ultra conservative approach to implantable defibrillator (icd) programming in patients with a left ventricular assist device (lvad).

Conditions: Heart Failure

Summary: we propose to study a strategy empirically applied for the past 6 months at a high volume lvad center (vanderbilt heart and vascular institute). this utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (icd) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. avoiding cied (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.


Eligibility criteria:
inclusion: * age ≥ 18 * advanced heart failure * scheduled for heartmate ii lvad implant * with existing icd exclusion: -age \< 18

Keywords: heart failure advanced heart failure lvad left ventricular assist device heart-assist devices
retrospective analysis of nephrotoxicity during daptomycin versus vancomycin treatments in high risk patients

Conditions: Infective Endocarditis; Infection Related to Ventricular Assist Device; Infection Related to Vascular Prothesis; Surgical Site Infection; Mediastinitis

Summary: acute kidney injury (aki) is a frequent complication that occurs in 15 to 25% of patients after vascular surgery, and up to 40% of patients after cardiac surgery. aki compromises seriously short and long-term prognosis of critically ill patients. several aki risk factors have been identified including a chronic pathology of the patient such as kidney failure or diabetes, acute kidney injury related to hemodynamic disorders during surgery, including cardiopulmonary bypass, or sepsis, and the use of nephrotoxic agents such as some antibiotics, colloids or iodine contrast agents. avoiding nephrotoxic agents is therefore strongly recommended in icu patients, to reduce the incidence of aki, or to reduce its severity. the aim of this cohort study was to assess whether the use of daptomycin, was associated to a lower incidence of aki than vancomycin in cardiovascular icu patients, with similar efficacy. this is a retrospective observational study with a propensity score adjustment to reduce the bias of selection for a comparative analysis between two antibacterial treatments used in routine care. since treatments were not randomized, the investigators used the propensity score method for primary endpoint analysis. for this, the investigators included the covariates potentially related to treatment and outcome in a multivariate logistic model explaining the choice of treatment. this propensity score was used in the second model as an adjustment covariate included in the multivariate analysis to determine factors independently associated with the primary endpoint (aki within 7 days). the main hypothesis is the first line antibiotic treatment with daptomycin leads to less nephrotoxicity than vancomycin in a population known at high risk for aki and with at least a similar efficacy on clinical success rate.


Eligibility criteria:
inclusion criteria: * patient older than 18 years * admitted in icu from january 2010 to december 2012 * suspected or proven cardiac, vascular or profound surgical site infection with gram-positive cocci (gpc) methicillin-resistant (mr) strains (including probabilistic treatment for patients with acquisition of mr risk factors) * treatment duration greater than or equal to 48 hours (at least 2 doses of daptomycin administered or 2 days of vancomycin infusion) * antibiotic treatment started in peri-operative (from 48 hours before the onset of surgery) or in postoperative period (during icu stay) exclusion criteria: * prophylaxis indication of antibiotics * kidney disease on chronic dialysis * acute onset of rrt before initiation of dap or van treatment * staphylococcus pneumonia

Keywords: vancomycin daptomycin acute kidney injury nephrotoxicity infective endocarditis foreign body associated infection cardiovascular surgery
efficacy, safety and acceptability of nastent™ in snoring and obstructive sleep apnea

Conditions: Snoring; Obstructive Sleep Apnea

Summary: this study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, nastent, for the treatment of mild to moderate osa and snoring in european adult patients without cardiovascular and/or respiratory comorbidities/disorders.


Eligibility criteria:
inclusion criteria: * subject with newly diagnosed osa (5≤ahi≤30 ev/h) or for whom treatment has failed (cpap, mandibular repositioning device), or patients with snoring only (5\<ahi) * bmi≤30kg/m² * patient with good motivation to use the nasal device, * informed consent signed, * patient with social protection. exclusion criteria: * cardiovascular comorbidities (resistant hypertension, recurrent atrial fibrillation, left ventricular failure, coronary heart disease and stroke), * respiratory comorbidities (respiratory failure, chronic obstructive pulmonary disease (copd), * patient with one or more documented contraindication to use nastent™, * no regular partner, * contraindication for sleep endoscopy, * psychiatric or neurological disorders (epilepsy), * progressive cancer or chronic inflammatory disease, * ahi including more than 5 central apnea per hour, * allergy to one component of nastent™.
alcohol and employment

Conditions: Alcohol Abuse

Summary: the purpose of the study is to determine whether welfare-to-work schemes combined with alcohol treatment are more efficient than a welfare-to-work scheme alone, for unemployed citizens with alcohol problems.

background and purpose: the tryg foundation denmark has awarded funds for a study that tests how to most efficiently combine welfare-to-work schemes with efforts against alcoholism, in relation to a return to the labour market. the study will be carried out in a number of danish municipalities in the time frame 2011-2014. the purpose of the study is to determine whether a welfare-to-work scheme combined with alcohol treatment is more efficient than a welfare-to-work scheme alone, for unemployed citizens with alcohol problems. design: if the welfare recipient meets the inclusion criteria, then the recipient is provided with information about the project by the caseworker. if the recipient wishes to participate in the project he/she is asked to fill out a consent form and a questionnaire regarding employment status, alcohol consumption, other habits of abuse, health status and background information. welfare recipients who do not wish to participate will as usual be referred to the welfare-to-work schemes deemed most appropriate by the caseworker. the intervention is designed as a randomized controlled trial, where heavy drinkers who meet the inclusion criteria and wish to participate will be allocated to either: a) an intervention group receiving welfare-to-work scheme combined with alcohol treatment. or b) a control group receiving only welfare-to-work scheme. after 6 and 12 months there will be a follow-up where participants will be asked to answer a questionnaire with questions about their employment status, alcohol consumption, other habits of abuse, health status and background information. in this study ancova is chosen to analyses the effective of the intervention.

Eligibility criteria:
inclusion criteria: * participants must have an audit-score above 7. * participants must be unemployed and receive welfare-to-work schemes when included. exclusion criteria: * participants who have an audit-score below 8. * participants who have a normal job.
vit d3 for early symptoms of covid-19

Conditions: Covid19

Summary: this study is aimed to investigate the treatment vitamin d3 as complementary therapy with routine care for early mild symptoms of covid-19 in outpatients setting.

there is currently no specific early-stage therapeutic treatment available for covid-19. vitamin d3 is a strong antioxidant, and anti-inflammatory/immunomodulatory agent. the present study is aimed to investigate the treatment benefits of vitamin d3 as add-on therapy to the routine care for early mild symptoms of covid-19 infection in outpatients setting.

Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older, of either gender * patients must be tested positive for sars-cov-2 by rt-pcr * patients must exhibit typical symptoms of covid-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc. * patients must be in the early stage of covid-19 disease who do not require hospitalization at the time of screening * patients must be under the care of a physician for diagnosis of covid-19 * patients who have signed informed consent exclusion criteria: * patients with proven hypersensitivity or allergic reaction to quercetin or curcumin * patients with known chronic kidney disease with estimated creatinine clearance \< 50 ml/minute or need for dialysis * patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure * patients taking anticoagulant/antiplatelet drugs such as coumarine, heparine, aspirin, clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin. * patients with gallstone obstruction * hypothyroid suppering patients * patients with moderate or severe thrombocytopenia (platelet count \<100 ×10⁹/l); * pregnant patients
exploring brain molecular imaging and blood biomarkers in subjects with glucocerebrosidase mutations: toward a precision medicine approach to characterize parkinson's disease clinical trajectories

Conditions: Parkinson Disease

Summary: glucocerebrosidase (gba) mutations are the most common risk factor for parkinson's disease (pd). gba-related pd(gba-pd) exhibits a more malignant phenotype as compared to no-carriers. still, the mechanisms behind the increased malignancy in gba-pd are not well understood. the definition of biomarkers able to stratify pd clinical trajectories in pd is therefore crucial to identify effective treatments and support diagnosis.the investigators will examine the role of gba-mutations in accelerating a-synuclein (a-syn) and synaptic pathologies in pd by combining neuroimaging (positron emission tomography-pet), biochemical and clinical features. this will illuminate the pathophysiology underlying gba-mutations in pd and identify biomarkers for the malignant pd phenotype. also, the investigators will combine longitudinal clinical and imaging/biochemical features to define a prognostic algorithm for predicting disease faster progression in gba-pd and monitoring disease trajectories in unaffected gba carriers.


Eligibility criteria:
inclusion criteria: * pd diagnosis according to mds-pd criteria and for gba-pd group, presence of heterozygous gba mutations; * disease duration 3-7years. exclusion criteria: * other neurological or systemic diseases; * presence of mutations in another pd gene; * impossibility or unwillingness to perform fdg-pet.
a clinical trial to evaluate the clinical efficacy of cyclosporine 0.1% (ikervis®) for moderate to severe dry eye patients. (ike-03-switching)

Conditions: Moderate to Severe Dry Eye

Summary: a clinical trial to evaluate the efficacy and safety of cyclosporine 0.1% (ikervis®) for moderate to severe dry eye patients who changed to cyclosporine 0.1% eye drop(ikervis®) due to lack of treatment effects of the previous cyclosporine 0.05% eye drop.

eligible patients who agree to participate in the clinical trial in writing will be administered cyclosporine 0.1% eye drop(ikervis®) one drop once daily for 12 weeks. efficacy and safety will be evaluated at baseline, 4 weeks, 8 weeks, and 12 weeks.

Eligibility criteria:
inclusion criteria: 1. age between 19 and less than 80 years old 2. a patient with moderate or severe dry eye who has used cyclosporine 0.05% eye drop for more than 3 months and has no or insufficient treatment effect - no or insufficient treatment effect should meet the following criteria through tests used to diagnose dry eyes * a sande (symptom assessment in dry eye) score of 40 or more on the severity and frequency of dry eye symptoms. * cornea staining score (nei scale) 3 or more points * tear break up time(tbut) 10 seconds or less * tear volume tested by tear meniscometry less than 5mm * has one or more of the dry eye symptoms; stinging, irritating, itching or blurred vision. * use of diquafosol tetrasodium 3% eye drop and/or artificial tears are allowed with no change of products and dosage throughout the trial period 3. a person who voluntarily agrees in writing to participate in this clinical trial exclusion criteria: 1. use of eye drops within four weeks of the consent date such as steroids, glaucoma, allergies and anti-inflammatory drugs, etc. 2. systematic steroid within four weeks of the consent date 3. patients with pterygium 4. start new immunosuppressive drugs or change in dosage that can affect immune function within four weeks of the consent date due to an unregulated systemic disease. 5. severe mgd patient 6. ophthalmic surgery (including lasik/lasek) and trauma in eyes within the last three months 7. wearing contact lenses during a clinical trial period 8. planning an eye surgery (including lasik/lasek) during the clinical trial period 9. hypersensitivity to the clinical trial drug 10. active or suspected eye infections 11. pregnant or breastfeeding, or women planning to become pregnant 12. participation in other clinical trials within three months 13. any person who is deemed unfit for clinical trial by a investigator

Keywords: dry eye
light therapy for obsessive-compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to examine the effect of a light-based circadian treatment on ocd symptoms in adults with ocd and late bedtimes. this study will have important implications for understanding the role of circadian rhythms in the etiology and treatment of ocd.

prior to the start of this study, there are screening procedures to ensure participants meet the criteria for the study. at the first consent screening appointment, participants will learn more about the study and answer questionnaires. all of the results of the screening procedures are confidential and will only be used by the study staff to determine eligibility for the study. this study is 5 weeks long and involves 4 in-person lab visits at the sleep and chronobiology lab. participants will be randomly assigned to either an active or placebo light therapy treatment condition. visit 1 will involve additional screening to determine eligibility, including questionnaires and interviews. if eligible, participants will then track their sleep for 2 weeks at home with a wrist-worn activity monitor and a sleep diary. visit 2 will take place in the lab from 5:30pm until 1 hour after participants typical bedtime. the investigators will ask participants to provide saliva samples hourly to measure melatonin and complete questionnaires. the investigators will provide treatment instructions at this visit. investigators will then ask participants to engage in the treatment at home for 3 weeks. investigators will schedule 1 in-person visit (visit 3) and 1 phone call to assess adherence to the treatment during these 3 weeks. visit 4 will take place in the lab after the treatment is finished. visit 4 will last from 5:30pm until 1.5 hours after participants typical bedtime and will involve hourly saliva samples to measure melatonin, questionnaires, and interviews.

Eligibility criteria:
inclusion criteria: * primary ocd diagnosis (according to the diagnostic and statistical manual of mental disorders 5) * bedtime 0100 or later * age 18-35 * english speaking exclusion criteria: * subjects must not be currently participating in another research study that would influence their participation in our study. * past 6-month substance use disorder * lifetime psychosis or bipolar disorder * current sleep disorder (dswpd and insomnia excepted) * significant, active suicidal ideation or behaviors in the past 6 months * intellectual disability * engaged in evidence-based psychotherapy for ocd * history of light therapy or cognitive behavior therapy for insomnia * night shift work or travel outside of mountain standard time in the past month * pregnant, trying to become pregnant, or breastfeeding * change in psychotropic medication in the past month * prescribed or over the counter sleep medication use in the past month * beta-block or monoamine oxidase inhibitor use in the past month

Keywords: circadian sleep anxiety ocd
a study of csl112 in adults with moderate renal impairment and acute myocardial infarction

Conditions: Acute Myocardial Infarction; Moderate Renal Impairment

Summary: this study is a phase 2, multicenter, double-blind, randomized, placebo controlled, parallel-group study to investigate the renal safety and tolerability of multiple dose intravenous (iv) administration of csl112 compared with placebo in subjects with moderate renal impairment (ri) and acute myocardial infarction (ami).


Eligibility criteria:
inclusion criteria: • men or women, at least 18 years of age, with evidence of moderate renal impairment (an egfr ≥ 30 and \<60 ml/min/1.73 m2) and myocardial necrosis in a clinical setting consistent with a type i (spontaneous) acute myocardial infarction (ami). exclusion criteria: * symptoms, biomarker elevation or electrocardiogram (ecg) changes other than those of the index event that are consistent with a diagnosis of ami but are likely not due to primary myocardial ischemia * ongoing hemodynamic instability * planned coronary artery bypass surgery * evidence of hepatobiliary disease * history of acute kidney injury (aki) after previous exposure to an intravenous contrast agent. * history of nephrotic range proteinuria. * known history of allergy to soy beans or peanuts, immunoglobulin a (iga) deficiency, antibodies to iga , or hypersensitivity to csl112 or any of its components. * other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study.
assessment of the safety and efficacy of rgn-259 ophthalmic solutions for dry eye syndrome: arise-1

Conditions: Dry Eye Syndrome

Summary: the objective of this study is to compare the safety and efficacy of rgn-259 ophthalmic solutions to placebo for the treatment of the signs and symptoms of dry eye.

dry eye can be caused by many variable factors. some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. patients with dry eye often have damage on the surface of the eye. in previous studies, rgn-259 has been shown to promote healing of the surface of the eye and decrease inflammation. it suggests that rgn-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a subject reported history of dry eye for at least 6 months * have a history of use or desire to use eye drops for dry eye symptoms within 6 months * have a schirmer's test score of ≤10mm and ≥1mm * have a tear film break-up time (tfbut) ≤10 seconds * have a corneal fluorescein staining score of ≥2 in at least one region of the cornea exclusion criteria: * have any clinically significant slit-lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 6 months; * have an iop \> 25 mmhg at visit 1; * have any planned ocular and/or lid surgeries over the study period; * be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of visit 1; * be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (otc) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); * have corrected visual acuity greater than or equal to logmar +0.7 as assessed by early treatment of diabetic retinopathy study (etdrs) scale in both eyes at visit 1;

Keywords: dry eye syndrome dry eye des
bioceramics pain control

Conditions: Endodontically Treated Teeth; Post Operative Pain

Summary: postoperative pain in endodontic retreatment cases presents a challenge to any endodontist. tricalcium silicate materials as mineral trioxide aggregate (mta) and bioceramics have shown favorable periapical tissue reactions and healing when used as part of the root canal filling material. this study was conducted to compare the difference in the postoperative pain when resin cements are used versus bioceramic cements in the obturation of root canals.

the faculty of dentistry ain shams university's research ethics committee reviewed the current proposal for ethical approval. one hundred patients with permanent molar teeth requiring endodontic non-surgical retreatment were treated in this study. teeth with fractured instruments were excluded. patient ages ranged from twenty to fifty years, both men and women were treated in the current study. infants, children, people unable to take decisions, university students, orphans, mentally or physically disabled patients were excluded from the current study. preoperative assessment of the degree of the patient's pain was done using the visual analog scale. fifty teeth were obturated with gutta percha using the epoxy resin-based sealer (ah plus) as the control group, and in the other fifty bioceramic based cement (endosequence) was used. all teeth were prepared by the protaper next rotary files (dentsply sirona) under copious irrigation with 30ml of 2.6 % sodium hypochlorite throughout the procedure. ethylamine diamine tetracetic acid (edta) 17% was used to remove the smear layer before the obturation commenced. obturation was done using the cold lateral compaction technique in the resin group and single cone technique in the bioceramic group. postoperative pain assessment was done for each patient after six hours, twenty-four hours, four days and one week.

Eligibility criteria:
inclusion criteria: * • mandibular molars with fully formed roots that need retreatment. * age range 20 - 50 years. * teeth having a baseline periapical lesion (pai score ≥2) in the affected root. exclusion criteria: * • patients with separated files that need to be retrieved or bypassed. * pregnant females. * patients suffering from a systemic disease. * teeth with lesions connected to adjacent teeth. * teeth with root fractures or perforations. * teeth with lesions communicating with the alveolar crest. * patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency * teeth with damaged or resorbed peri- apex * teeth that were treated with a fiber post and teeth with canal curvature more than 30 degrees.

Keywords: bio-ceramic postoperative pain sealer