Kornimate/medical-research-clean huggingface dataset:
shock efficacy study comparing fixed tilt and fixed pulse width in a general implantable-cardioverter population

Conditions: Ventricular Arrythmia

Summary: this is a prospective, 1:1 randomized, interventional, multicenter and international trial. approximately 790 subjects are expected to be enrolled to 40 sites in the south of europe and middle east.

the objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an icd in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, fixed tilt with a value of 65% (control group), versus the exclusive waveform programmable in sjm icds, fixed pulse width (study group), in a standard population of subjects with icd indication.

Eligibility criteria:
inclusion criteria: * subjects who meet the current esc indications for icd or crt-d implant. this includes upgrades indications from pacemaker to icd or to crt-d or replacements of icds or crt-ds provided that there is no previous record of ineffective shocks * subjects who are willing to be registered on the merlin.net remote follow-up program * subject ≥18 years * subjects with life expectancy of at least 1 year * subjects who agree to comply with the follow-up program included in this protocol exclusion criteria: * • subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months * subjects with myocardial infarction or unstable angina within 40 days prior to enrollment * subjects who have undergone a recent cardiac revascularization (ptca, stent or cabg) procedure in the 4 weeks prior to enrollment * functional nyha class iv * subjects who are participating in another icd or crt-d study * subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives * any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)
impact of antibiotic treatment on outcome in patients with ventilator-associated tracheobronchitis

Conditions: Respiratory Tract Diseases; Nosocomial Infections

Summary: the aim of this study is to determine whether antibiotic treatment could reduce mechanical ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical ventilation.

rationale: ventilator-associated tracheobronchitis (vat) is common in intensive care unit (icu) patients, rates of 2.7%-10.6% are reported in the literature. this nosocomial infection is associated with weaning difficulties resulting in prolonged duration of mechanical ventilation (mv) and icu stay. a case-control study performed in chronic obstructive pulmonary disease (copd) patients with vat found antibiotic treatment to be significantly associated with reduced duration of mv. another case control-study, performed in vat patients without chronic respiratory failure, found no significant difference in duration of mv between patients who received adequate antibiotic treatment and those who received inadequate antibiotic treatment. in addition, antibiotic use is known to be associated with subsequent multidrug-resistant bacteria (mrb), longer duration of mv, and mortality rates. therefore, a randomized controlled study is necessary to determine the impact of antibiotic treatment on outcome in vat patients. patients and methods: 390 patients will be included in this prospective randomized open multicenter study. inclusion of 390 patients is required to demonstrate a significant reduction of mv duration of 5 days (α = 0.025, β = 0.10). an intermediate analysis will be performed. all patients intubated and ventilated \> 48h who developed a first episode of vat are eligible. primary endpoint is the duration of mv. secondary end points are icu length of stay, mortality, ventilator-associated pneumonia, icu-acquired infection, mrb, and yeast rates.

Eligibility criteria:
inclusion criteria: * patients with tracheobronchitis diagnosed after 48h of invasive mechanical ventilation exclusion criteria: * immunodepressed patients * patients with tracheostomy at icu admission * patients who developed ventilator-associated pneumonia before ventilator-associated tracheobronchitis

Keywords: ventilator-associated tracheobronchitis nosocomial tracheobronchitis
epidural magnesium sulfate for post-thoracotomy pain control

Conditions: Pain

Summary: pain after thoracotomy is very severe and may cause pulmonary complications. thoracic epidural analgesia has greatly decreased the pain experience and its consequences. however, new ways of decreasing post-operative opioid drugs consumption is an important issue of research. we aim to evaluate the effect of adding epidural magnesium sulfate to bupivacaine and morphine on pain control and the amount of opioid consumption after thoracotomy. eighty patients undergoing thoracotomy at a tertiary cardiothoracic referral center will be enrolled in a randomized double blind trial. patients randomly will be allocated in two groups. bupivacaine (12.5 mg) plus morphine (2 mg) will be administered epidurally for all patients at the end of operation. patients in group i will be received epidural magnesium sulfate (50 mg) and patients in group ii will be received normal saline as an adjuvant. visual analog scale (vas) score and the amount of morphine consumption will be measured during 24 hours post-operation.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical statuses i-iii * undergoing thoracotomy exclusion criteria: * known hypersensitivity to magnesium sulfate * renal failure * hepatic dysfunction * severe obesity * psychotic or neurologic diseases * currently taking opioid or calcium channel blocker * av block degree ii or iii * refused to participate in trial
thrombus elastography in venous thrombo-embolism.

Conditions: Venous Thromboembolism

Summary: venous thrombo-embolic disease (vted) is a serious and common ailment, defined by the growth of a clot - or thrombus - in a vein, and/or as the migration of this thrombus to a pulmonary artery. it represents the third cause of death after cardio-vascular disease and cancer, and encompass superficial, muscular and deep venous thrombosis (dvt), and pulmonary embolisms (pe), which can be isolated or associated. ultrasound is today the most frequently used exam to diagnose dvt. however, it's unable to provide information on thrombus age or cause. elastography is an imaging technic which aims to analyse elastic properties of a tissue, by applying a mechanical impulse on it, and could be an interesting tool in thrombus exploration, and provide additional information.

proximal deep venous thrombosis of a lower limb was defined as any venous thrombosis involving the ilio-femoral and/or femoro-popliteal axes, with or without cava thrombosis or distal dvt. a dvt was assumed provoked, as recommended by afssaps (2009) and accp (2012), when there was a major transient risk factor (surgery, prolonged immobilization ≥3 days, lower limb fracture) in the last three months, or a persistent risk factor (antiphospholipid syndrome, active cancer). in case of absence of at least one of these factors, dvt was considered unprovoked. a dvt was supposed recent when there was no known dvt in the patient medical history. the association with a pulmonary embolism was assessed by the presence of pe diagnosis in the medical report. it had to be diagnosed following the esc guidelines, with a thoracic ct scan and/or a v/q lung scan. in this study, we analysed the shear wave's velocity (expressed in m/s). acquisitions were obtained during the venous ultrasound realised for the diagnosis of dvt. all measures were made on the same ultrasonic device, with the shearwave module.

Eligibility criteria:
inclusion criteria: * over 18 years old. * suffering from a proximal dvt (dvt) of at least one lower limb. * thrombosis is assumed to be recent (no history of ipsilateral dvt). * non opposition obtained. exclusion criteria: * patient suffering from an inferior vena cava thrombosis with no extension to ilio-femoral veins. * physical or cognitive inability to consent. * patient refusal.

Keywords: elasticity imaging techniques venous thromboembolism
patientheque in patients with a psychosis .

Conditions: Schizophrenia Prodromal; Schizophrenia, Childhood; Schizophrenia

Summary: establishment of a patient library for patients who have had a first psychotic episode and who have an "at risk" status for psychotic disorder (grd, aps, blips group) or a psychosis threshold during caarms administration. samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.

the constitution of this patient library will include results of clinical tests carried out in current practice, neurocognitive tests, blood samples, audio recordings, clinical follow-up, urine samples, fecal samples, brain imaging, eeg.

Eligibility criteria:
inclusion criteria: * major and or minor aged 15 to 30 assessed within the cevup (consultation for the assessment of psychological vulnerability) and cared for at the psychiatry center as part of a first psychotic episode (diagnosis cim 10: f20 -f29 first hospitalization). these patients are referred by care and medico-social partners (general practitioners, school doctors, school nurses, educators, addictologists, psychiatrists * "at risk" status for psychotic disorder (grd, aps, blips group) or psychosis threshold during the caarms test (psychometric scale for the assessment of psychotic symptoms) * consent of the patient or his legal guardian exclusion criteria: * history of psychosis for more than one year * "not at risk" status for psychotic disorder on the caarms (psychometric scale for the assessment of psychotic symptomatology) * iq\<70 (wais) * neurological disorder or other health problem that may explain the disorders * refusal to participate - history of psychosis for more than one year

Keywords: schizophrenia patient library
pharmacokinetic and comparative bioavailability study of testosterone absorption after administration of testosterone gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites in hypogonadal males

Conditions: Hypogonadism

Summary: to evaluate the pharmacokinetics and comparative bioavailability of testosterone absorption in 36 hypogonadal males after administration of 5 g testosterone gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

to evaluate the pharmacokinetics and comparative bioavailability of testosterone absorption in 36 hypogonadal males after administration of 5 g testosterone gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

Eligibility criteria:
inclusion criteria 1. hypogonadal males 2. screening testosterone \<300 ng/dl exclusion criteria 1. smokers 2. previous history of or current or suspected prostate or breast cancer

Keywords: testosterone, hypogonadal, males
evaluation of topical pomegranate extracts in management of oral lichen planus (a randomized clinical trial)

Conditions: Oral Lichen Planus

Summary: this study was conducted to estimate the hypothesis that the pomegranate extracts have no role in management of oral lichen planus

lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. the treatment options for olp are numerous and include topical and systemic agents. steroids were found effective in management of olp with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. the recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of olp decreasing pain and discomfort associated with this chronic condition.the aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (olp).

Eligibility criteria:
inclusion criteria: * the study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type olp and signed the informed consent exclusion criteria: * patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. in addition, any previous history of allergy to pomegranate

Keywords: pomegranate, seeds, peel, topical, oral lichen planus, pain, ohip-14.
trigeminal nerve cardiac reflex during resection of cerebellopontine angle tumors and postoperative myocardial injury

Conditions: Myocardial Injury; Trigeminal Cardiac Reflex

Summary: myocardial injury after noncardiac surgery is significantly related to postoperative 30-day mortality. trigeminal cardiac reflex is one of the main causes of perioperative cardiac emergency. therefore, the investigators' aim is to test the hypothesis that trigeminal cardiac reflex associates postoperative myocardial damage in participants undergoing skull base tumor surgery. the investigators will observe the association between trigeminal cardiac reflex and myocardial injury by measuring the concentration of plasma high sensitivity cardiac troponin (hs-ctnt) in participants after skull base tumor surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing elective skull base tumor surgery. * age ≥ 18 years old. * asa class i to iii. * all those who sign the informed consent form. exclusion criteria: * patients with severe heart disease (including patients with preoperative heart rate \< 50 beats / min, severe arrhythmias, such as premature beats, paroxysmal supraventricular tachycardia, atrial flutter or fibrillation, patients with myocardial ischemia \< 6 months, heart failure, myocarditis, pericarditis or cardiomyopathy). * patients unable to complete preoperative cardiac assessment. * patients with chronic kidney disease.
sleep characteristics in post-covid-19 patients

Conditions: Post-COVID-19

Summary: after acute infection, patients with coronavirus disease 2019 (covid-19) often suffer from persisting symptoms for more than 3 months (post covid-19). sleep disorders (31%) have already been assessed by questionnaires and interviews in post-covid-19, but have not yet been proven by polysomnography (psg), the gold standard for sleep testing. this study aimed to measure sleep characteristics in post-covid-19 patients.

hypothesis: we hypothesize that post-covid-19 patients have a significantly higher apnea-hypopnea index (ahi) during sleep compared to healthy controls. 15 post-covid-19 patients and 15 healthy controls will perform a baseline assessment on day 1 including a 1-minute sit-to-stand test (stst), post-covid functional scale (pcfs), ordinal scale for clinical improvement (osci), history of covid-19, social anamnesis, pittsburgh sleep questionnaire and subjective limitations of sleep. on day 4, after an initialization phase for whoop strap (a digital fitness and health coach), all patients performed a single night sleep assessment in a sleep lab via polysomnography and whoop.

Eligibility criteria:
inclusion criteria: post-covid-19 group: * patients after sars-cov-2 infection with signs of post-covid-19 * ≥18 years * written informed consent healthy controls: * no history of sars-cov-2 infection * ≥18 years * written informed consent exclusion criteria: post-covid-19 group: * diagnosis of a breathing-related sleep disorder before sars-cov-2 infection * bmi \>25kg/m2 healthy controls: * diagnosis of a breathing-related sleep disorder * bmi \>25kg/m2

Keywords: sars-cov-2 infection rem sleep chronic fatigue whoop strap polysomnography
triamcinolone assisted anterior vitrectomy

Conditions: Vitrectomy; Cataract

Summary: injecting triamcinolone acetenoide for visualizing and removing vitreous from the anterior chamber.

the research followed the tenets of the declaration of helsinki, ;informed consent were obtained from patients where all details of the procedure were explained with emphasis on the intended outcome. the research was approved by the institutional review board. ten eyes of 10 patients were divided into 2 groups. group a included 6 eyes of 6 patients with accidental rupture of posterior capsule during cataract surgery (5 eyes underwent phacoemulsification technique and one underwent ecce). group b included four eyes of 4 patients undergoing anterior segment reconstruction (anterior vitrectomy, secondary iol implantation and iris repair by direct approximation using 10/0 prolene sutures). in group a the mean age was 68.1 ± 10.93 years (range 47 to 79 years), 3 were males and 3 were females. in group b the mean age was 14 ± 5.6 years (range 9 to 22 years), 3 were males and one female. demographic data and pre-operative information are presented in table 1 and 2. in all patients triamcinolone acetonide was prepared by keeping the bottle vertical to allow sedimentation of crystals thus removing the vehicle. it was then injected into the anterior chamber (2 ml with concentration 20 mg/ml) just prior to anterior vitrectomy. the direction of the tip of the needle was kept away from the corneal endothelium to minimize endothelial toxicity. triamcinolone was removed as quickly \& completely as possible after finishing anterior vitrectomy. postoperative regimen included topical steroids and antibiotics for about 4-6 weeks. topical anti-glaucoma drugs were used in cases of high postoperative iop for few days until stabilization of iop. follow up period ranged from 2 months up to 27 months.

Eligibility criteria:
inclusion criteria: * patients with vitreous in the anterior chamber whether in * complicated cataract surgery * disorganized anterior segment structures exclusion criteria: * glaucoma patients * intra ocular infections * bacterial or fungal

Keywords: triamcinolone acetenoide anterior vitrectomy presence of vitreous in the anterior chamber. effect of triamcinolone injection on iop,intraocular infection
personalized dose optimization of amikacin guided by pharmacokinetic modeling software in patients with septic shock

Conditions: Shock, Septic

Summary: amikacin dose optimization is challenging in critically ill patients. the use of bestdose software algorithm-based drug optimization could help to achieve the recommended target concentrations (60-80 mg/l) after administration of the second dose of amikacin, associated with improved outcome. the study investigators hypothesize that 80% of patients undergoing drug dosing optimization using the bestdose software in the interventional group will reach the predefined pk/pd targets.


Eligibility criteria:
inclusion criteria: * the patient or their legal representative must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * the patient has septic shock according to the sepsis-3 definition in the 24 hours preceding inclusion, regardless of the source of infection * patient having already received a first dose of amikacin in the 22 preceding hours * patient with an expectation of receiving at least 2 doses of amikacin * patient with available amikacin therapeutic drug monitoring exclusion criteria: * the subject is participating in an interventional study that could influence the primary outcome, or is in a period of exclusion determined by a previous study * the patient is pregnant, parturient or breastfeeding * patient has a contra-indication or an allergy to treatment by amikacin * patient is not expected to survive beyond 48 hours

Keywords: pharmacokinetics dose optimisation aminoglycosides
vaginal heat wash-out (hwo) in 4 groups of women (pre- and postmenopausal with and without female sexual arousal disorder (fsad)).

Conditions: Sexual Dysfunction, Physiological

Summary: the pfizer developed heat wash-out (hwo) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. a small vaginal probe is attached to a control unit. output data are collected on a pc. by measuring the clearance of heat from the heated probe, a direct measure of absolute blood flow can be obtained. the study will assess the technique's ability to differentiate between pre- and post-menopausal women; with and without female sexual arousal disorder (fsad).

medical device development

Eligibility criteria:
inclusion criteria: * pre-menopausal women aged 18-40 (with and without fsad) or * post-menopausal women aged 50-65 (with and without fsad. * fsad must have been present for at least 6 months. exclusion criteria: * pregnant or lactating women (pre-menopausal population) * systemic hormone replacement therapy (hrt) or selective estrogen receptor modulator (serm) (postmenopausal population) * subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease or other major psychological or sexual disorder.
a multicenter, randomized, double-blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in participants with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: the objectives of sub-study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (uc), and to identify the appropriate induction dose of risankizumab for further evaluation in sub-study 2. the objective of sub-study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active uc.


Eligibility criteria:
inclusion criteria: * male or female aged \>=18 to \<= 80 years at the baseline visit. where locally permissible, subjects 16 to \< 18 years of age who meet the definition of tanner stage 5 for development at the baseline visit. * confirmed diagnosis of ulcerative colitis (uc) for at least 3 months prior to baseline. * active uc as assessed by adapted mayo score and endoscopic subscore. * demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies. * females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control. exclusion criteria: * participant with a current diagnosis of crohn's disease (cd), inflammatory bowel disease-unclassified (ibd-u) or a history of radiation colitis or ischemic colitis. * participant receiving prohibited medications and treatment. * extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. * participant with currently known complications of uc (e.g., megacolon). * no known active coronavirus disease - 2019 (covid-19) infection.

Keywords: abbv-066 bi 655066