Kornimate/medical-research-clean huggingface dataset:
a study of evacetrapib (ly2484595) in participants with high cholesterol

Conditions: Hyperlipidemia

Summary: the purpose of the accentuate study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ascvd) and/or diabetes.


Eligibility criteria:
inclusion criteria: * must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening * have an ldl-c \>70 mg/deciliter(dl) or non-hdl-c \>100 mg/dl * have screening triglycerides ≤400 mg/dl (≤4.5 millimoles/liter) * individuals with ascvd and/or individuals with type 1 or type 2 diabetes exclusion criteria: * have a hemoglobin a1c (hba1c) \>9.5% * new york heart association (nyha) class iii or iv congestive heart failure * history of either a transient ischemic stroke or ischemic stroke \<30 days * history of acute coronary syndrome (acs) \<30 days
fondaparinux 1,5 mg for the prevention of venous thromboembolism (vte) in medical patients with renal insufficiency

Conditions: Medical Patients; Renal Insufficiency

Summary: fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. a relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. this risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 ml/min. no clear indications are available to reduce such risk in patients who require thromboprophylaxis. a lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 ml/min (european marketing authorization). however, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.


Eligibility criteria:
inclusion criteria: * age \> 60 years * acute medical disease requiring thromboprophylaxis according to international guidelines * anticipated immobilization of at least 4 days * renal insufficiency defined by creatinine clearance between 20 and 50 ml/min according the mdrd formula * written informed consent exclusion criteria: * active bleeding or bleeding in the previous 3 months * known bleeding diathesis * platelet count \< 100.000 * ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin k antagonists * use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours * life expectancy \< 1 month

Keywords: renal failure medical patient venous thromboembolism prophylaxis fondaparinux
comparison of breath-enhanced and t-piece nebulizers in children with acute asthma

Conditions: Asthma

Summary: this is a blinded observer randomized controlled trial comparing two nebulizer devices. the objective of this study is to evaluate the efficacy of two different nebulizers.

the investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in fev1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. the primary aim will be to study changes in forced expiratory volume in one second (fev1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. secondary aims will include evaluation of hospital admission rates, emergency department (ed) length of stay (los), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ed. a distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.

Eligibility criteria:
inclusion criteria: * age ≥ 6 years and \< 18 years * history of physician diagnosed asthma * presenting to ed with breathing difficulty or cough * initial fev1 25%-70% predicted * parent or guardian speaks english or spanish. exclusion criteria: * pediatric asthma score of 0 * pregnancy or breast-feeding * immediate resuscitation required * chronic lung disease (other than asthma) * congenital heart disease * neuromuscular disease * suspected intrathoracic foreign body * allergy or other contraindication to study medication
lebanese interhospital pneumococcal surveillance program

Conditions: Pneumonia; Meningitis; Sepsis; Bacteremia

Summary: streptococcus pneumoniae (pneumococcus) is a bacterium that causes severe infections in children and adults such as meningitis, pneumonia, and blood stream infection. there are many types of these bacteria defined by the type of sugar coat that they have. these are classified as serotypes. there are common serotypes that cause severe disease and are preventable by vaccination of children. other less common types are more difficult to prevent. the investigators aim to determine the serotypes that cause invasive pneumococcal disease in lebanon and to study their sensitivity to different antibiotics. the investigators will collect bacterial isolates from different hospitals in lebanon isolated from the blood or spinal fluid of patients with invasive pneumococcal disease. this information will help the investigators determine the usefulness of available pneumococcal vaccines in preventing these infections. the data will be distributed to all primary care physicians treating children in lebanon and will be shared with the ministry of health.


Eligibility criteria:
inclusion criteria: * samples included in the study are those that are: * culture proven * invasive pneumococcal infections * in patients of all ages admitted to different hospitals all over lebanon * acceptable samples include: * positive isolates from blood * cerebrospinal fluid * other normally sterile body sites such as empyema fluid, abscesses, joint fluid, middle ear fluid obtained by tympanocentesis in the operating room, and lung needle aspiration exclusion criteria: * non s. pneumoniae isolates

Keywords: streptococcus pneumoniae pneumococcus pneumonia meningitis serotypes bacteremia sepsis
evaluation of safety of glaxosmithkline (gsk) vaccines' quadrivalent seasonal influenza vaccine, fluarix tetra when administered according to the approved prescribing information (pi) in korea.

Conditions: Influenza, Human

Summary: the purpose of this study is to collect safety information on the use of fluarix tetra according to the approved pi, in korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over a period of 4 years from children between 6 months and 35 months of age.

adults and previously vaccinated children aged ≥6 months, a single dose of fluarix tetra will be administered. to previously unvaccinated children aged 6 months to less than (\<) 9 years, two doses will be administered with a second dose at least 4 weeks apart from the first one as per the local pi in korea. fluarix tetra may be administered to pregnant women/lactating women as per pi, if there is a clear need. pregnancy outcome (whether full-term or premature, information on the status of the mother and child) in vaccinated pregnant subjects will be followed-up at 6-8 weeks after delivery, if possible.

Eligibility criteria:
inclusion criteria: * male or female subjects who were vaccinated with fluarix tetra or eligible to receive fluarix tetra according to the locally approved pi. * signed informed consent as informed consent form (icf)/informed assent form (iaf) obtained from the subject/subject's parent(s)/legally acceptable representative(s) \[lar(s)\]. exclusion criteria: * those who are not eligible for vaccination with fluarix tetra according to the local pi. * hypersensitivity reaction to fluarix tetra. * history of hypersensitivity reaction to influenza vaccine. * history of guillain-barre syndrome or other nervous system abnormalities to influenza vaccine within 6 weeks post-vaccination. * those who are not eligible for vaccination with fluarix tetra according to the medical judgement of physician.

Keywords: safety post-marketing korea drug utilization study fluarix tetra
a randomised, parallel-group, double-blind, double-dummy study to compare the effects of lacidipine versus bendrofluazide on markers of platelet activation and haemorheological factors in hypertensive patients

Conditions: Hypertension

Summary: the aim of this study is to compare the effects of lacidipine on markers of platelet activation and other rheological factors in hypertensive patients with those of bendrofluazide


Eligibility criteria:
inclusion criteria: * age 18 or over * hypertensive at screening: diastolic blood pressure (dbp) 95 - 115 mm hg and / or systolic blood pressure (sbp) \>= 160 mm hg on no therapy or on monotherapy. if currently on monotherapy, dbp could have been \< 95 mm hg and sbp \< 160 mm hg, but the patient must have been experiencing unacceptable side effects from their current treatment. patient must then be able to stop treatment for the placebo run in phase of four weeks without endangering their health (at investigator's discretion) * hypertensive at randomisation: dbp 95-115 mm hg and or sbp \>=160 * able to give written informed consent exclusion criteria: * grad iii or grad iv hypertensive retinopathy * renal impairment; serum creatinine \> 150 µmol/l * heart failure. (new york heart association (nyha) class iii or iv) * liver impairment (abnormal liver function test (lft) with aspartate-amino transferase (ast) / alanine-amino transferase (alt) \> 2x upper normal limit or bilirubin \> 2x upper normal limit) * recent (\< 2 months) history of unstable angina * recent (\< 2 months) history of myocardial infarction * recent (\< 2 months) history of stroke * history of diabetes mellitus or impaired glucose tolerance or random blood glucose \>= 9 mmol/l * any acute systemic illness or infection * any severe disease which could interfere with survival or well-being during the study (e.g. malignancy) * patients of child bearing potential * current or previous drug and / or alcohol abuse * severely limited venous access * haemoglobin \< 10g/dl (male patients), haemoglobin \< 9g/dl (female patients) * requirement for anticoagulant therapy * severe valvular heart disease (investigator's discretion) * atrial fibrillation or other serious cardiac dysrhythmia * history of thyroid disease or abnormal thyroid function test (thyroid stimulating hormone (tsh) \ 5.4 mu/l) * history of connective tissue disorder * concurrent participation in any other clinical trial or participation within two months enrolment * requirement for restricted drugs * patients currently on treatment with lacidipine or bendrofluazide (bnfz) * patients unable to attend clinics * any clinical condition which in the opinion of the investigator, would preclude the safe fulfillment of the protocol and the safe administration of trial medication * seated blood pressure (bp) exceeding either 210 mm hg (systolic) or 115 mm hg (diastolic) at screening or randomization * standing bp \< 140 mm hg (systolic) and \< 95 mm hg (diastolic) at randomization
novel text-messaging bot in patients undergoing joint arthroplasty

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: this study evaluates the addition of an automated physician-specific text-messaging (sms) bot in patients undergoing total joint arthroplasty. half of the patients received the traditional perioperative education and instructions (control group), while the other half were enrolled in their physician's sms bot (intervention group).

in an era of value-based reimbursement and high-volume surgery, the patient experience is becoming increasingly important. despite publicized efforts to place a greater emphasis on patient-centered care, patients often report poor access to their physician, lack of effective perioperative education, and frustration as their care is commoditized. a text-messaging (sms) bot has the potential to help fill some of these voids. bots are computer programs that are inherently automated to simulate human-like tasks. while a physician may wish he or she could contact each of their patients daily, it would be an impossible undertaking for most. an sms bot could make daily contact possible by automating it, potentially improving patient education and engagement before and after surgery. standard sms has been previously reported to be an effective means for delivering timely information, increasing patient compliance and outcomes (medication adherence, decrease surgical infections with antiseptic showers), and reaching a socioeconomically diverse patient population. further benefits may be seen with an sms bot due to its automated capabilities.

Eligibility criteria:
inclusion criteria: * inclusion criteria consisted of patients over 18 years of age, scheduled for primary total hip \& knee arthroplasty, with smart phone capability, and proficiency in english. exclusion criteria: * patients less than 18 years of age, no smart phone capability, poor english proficiency.

Keywords: total knee arthroplasty total hip arthroplasty
observational study of effectiveness and safety of trastuzumab emtansine (t-dm1) in her2-positive breast cancer patients with residual invasive disease following neoadjuvant chemotherapy and anti-her2 target therapy

Conditions: Breast Cancer

Summary: this is an observational, multi-centre study analysing data from patients treated with t-dm1 within the compassionate use program al41711. during the compassionate use program al41711, subjects received t-dm1 treatment for a total of 14 cycles or less, in case of disease recurrence or unmanageable toxicity. after the completion of the treatment, and 90 days of wash-out period, they can be enrolled in the study. after the signature of the informed consent form, all their data reported in the medical charts up to then (as detailed in section 12 of the protocol) will be extracted retrospectively and inserted in the study database. from the end of the washout period following the last treatment with t-dm1, each subject will enter in an observation phase for a maximum of 3 years, or until death whichever happens first. this phase will be prospective after the signature of the informed consent form.


Eligibility criteria:
inclusion criteria: * signed written informed consent * patients who have received t-dm1 treatment within the compassionate use program al41711 and have completed the entire treatment for at least 90 days or have interrupted it prematurely, due to disease recurrence or unmanageable toxicity, for at least 90 days, corresponding to the wash out period; exclusion criteria: * na
deep vs moderate neuromuscular blockade with rocuronium in patients undergoing endolaryngeal procedures

Conditions: Laryngoscopic Surgical Procedures

Summary: it is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex as an reversal in endolaryngeal surgery. we will conduct a clinical study aiming to compare two treatment strategies; deep neuromuscular blockade and moderate neuromuscular blockade. we hypothesize that deep nmb will offer better stillness. we will also descriptively examine if patients would be safely discharged from a recovery room.


Eligibility criteria:
inclusion criteria: * male or female aged 18 - 60 years; asa i-iii. * subjects have been planned for elective endolaryngeal. procedures (direct laryngoscopy with laser (micro-)surgery in patients with tis, t1, t2, supraglottis and glottis carcinoma) exclusion criteria: * any renal impairment (crcl \< 80 ml/ min) * any hepatic impairment; child pugh a, b or c * bmi \> 30 kg m2 * known or suspected generalized neuromuscular disorders * allergies to rocuronium, sugammadex, sevoflurane, propofol, fentanyl used during general anesthesia * hypersensitivity to the active substance or to any of the excipients * female patient who are pregnant and breastfeeding. * patient with poor glasgow coma score and mental derangement who is unable to give informed consent. * patient with tracheostomy tube.

Keywords: "surgical conditions" "deep neuromuscular blockade" "deep neuromuscular paralysis"
efficacy of the quell wearable device for chronic overlapping pain conditions

Conditions: Chronic Pain; Adults 21 and Older; Multiple Chronic Overlapping Pain Conditions; Hypersensitivity

Summary: this study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a quell for persons with multiple chronic overlapping pain conditions.

this study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a quell for persons with multiple chronic overlapping pain conditions. participants will attend two quantitative sensory testing visits in order to determine their level of pain sensitivity, one at the beginning of the study and the second at the 3-month follow-up session. participants will be asked to test out the quell device to check for sensation tolerance, and will then be randomized into one of the two treatment groups: the high intensity quell group or the low intensity quell group. participants will be asked to wear the device for at least 3 hours every day and to complete daily assessments, along with a total of three sets of questionnaires: one at the start of the study, the second 6 weeks from the date of consent, and the third 3 months after the date of consent. a member of the research staff will call participants once a week for a brief phone interview throughout the study. participants will be in this study for 3 months.

Eligibility criteria:
inclusion criteria: * ages 21 and older * pain duration \> 3 months * diagnosed by physician with multiple chronic pain conditions * have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other copcs) * average 4 or greater on pain intensity scale of 0 to 10 * pain is not accounted for by any other progressive disease (e.g., cancer, ms) * meets sensory hypersensitivity cutoffs based on qst-assessed evidence * own a smartphone (iphone or android device) and can download the pain app (mastermypain) and the quell relief mobile app onto their device * able to speak and understand english exclusion criteria: * diagnosis of cancer or any other malignant disease * acute osteomyelitis or acute bone disease * present of past dsm-v diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation * pregnancy * any clinically unstable systemic illness judged to interfere with treatment * a pain condition requiring urgent surgery * an active substance use disorder, such as cocaine or iv heroin use that would interfere with study participation * have an implanted cardiac pacemaker, defibrillator, or other implanted device. * reynaud's syndrome * open cuts/sores

Keywords: multiple chronic overlapping pain conditions adults 21 and older
post traumatic stress among relatives of brain-dead, withdrawal of life support, and sudden death patients

Conditions: Stress Disorders, Post-Traumatic

Summary: this study concerns the nearest relatives of patients who have passed away within 3 days of admission to an icu due to: (1) brain death with multiple organ donation +/- tissues or (2) death via limitation and / or cessation of active treatment (lata) without brain death or (3) sudden death of a previously healthy patient (no physical or mental limitations; maccabe score = 0) within 3 days of admission to icu without lata nor brain death. our primary objective is to determine the proportion of nearest relatives at risk for post traumatic stress disorder as defined by an impact of event scale score greater than 37, and to compare this factor between the three above-mentioned groups.


Eligibility criteria:
inclusion criteria: * participants are the nearest relatives (or "person-of-trust") of a patient who has passed away in an intensive care unit (icu). the cause of death must fall into 1 of the following three categories: (1) brain death with multiple organ donation +/- tissues; (2) death via limitation and / or cessation of active treatment (lata) without brain death; (3) sudden death of a previously healthy patient (no physical or mental limitations; maccabe score = 0) within 3 days of admission to icu without lata nor brain death * the participant must be one of the following (roman numerals indicate prioritization in choice of participants, if needed): (i) designated "person-of-trust"; (ii) spouse/partner of the deceased; (iii) parent of the deceased; (iv) child of the deceased; (v) sibling of the deceased. exclusion criteria: * patient deceased after 3 days of icu care without lata * the deceased was under 18 years old * the deceased was over 70 years old * refusal to participated * participant does not speak french * the participant is under judicial protection, under tutorship or curatorship * the participant is deaf or mute * the deceased has no nearest relative

Keywords: tissue donors tissue and organ procurement brain death withdrawal of life support
tms pilot in early ad ii

Conditions: Alzheimer Disease

Summary: alzheimer's disease (ad) is a progressive neurodegenerative condition affecting 6.2 million individuals in the united states, resulting in an annual cost of care of $305 billion. ad is functionally characterized by progressive degeneration of large-scale brain networks (lsbns), including the default mode network (dmn) presumably from the deposition of amyloid plaques and neurofibrillary tangles. available fda-approved medications for ad such as donepezil and memantine offer limited benefit and modest impact on quality of life. transcranial magnetic stimulation (tms) with intermittent theta burst stimulation (itbs) offers a non-invasive alternative to pharmacotherapy in persons with ad. we propose a case series study to compare sham with itbs.


Eligibility criteria:
inclusion criteria: * established diagnosis of mild cognitive impairment (mci)/mild ad * evidence for central nervous system (cns) amyloidosis (e.g., amyloid positron emission tomography (pet) or cerebrospinal fluid (csf) biomarkers consistent with ad) * prior brain imaging performed * mini mental status examination (mmse) \>24 * clinical dementia rating (cdr) 0.5-1 * stable dose of cholinesterase inhibitors and memantine for at least one month * subjects are between 40-90 years of age exclusion criteria: * non-ad dementia including, but not limited to, lewy body dementia, frontotemporal dementia, vascular dementia, jakob-creutzfeldt disease, etc. * inability to tolerate resting state-function magnetic resonance imaging (rs-fmri) * contraindication of rs-fmri due to implants or metal * seizure disorder

Keywords: transmagnetic stimulation functional mri guided theta burst stimulation intermittent theta burst stimulation
the correlation between the new sepsis scores - sofa, quick sofa and calibrated automated thrombogram values

Conditions: Sepsis; Coagulopathy

Summary: in total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial. after signing an informed consent a blood sample will be obtained from each participant. the investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (cat). sequential organ failure assessment score sofa will be calculated. the relation between sofa score and thrombin measurements will be determined.


Eligibility criteria:
inclusion criteria: * age above 18 * sepsis diagnosis exclusion criteria: * oncology patient. * anticoagulant treatment * pregnancy