Kornimate/medical-research-clean huggingface dataset:
improved hemodynamic tolerance of intermittent hemodialysis sessions in intensive care unite using citrate- vs acetate-based dialysate

Conditions: Intradialytic Hypotension

Summary: during intermittent hemodialysis (ihd), the occurrence of intradialytic hemodynamic instability (ihi) is frequent in icu and impacted morbidity and mortality. bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. however, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. they have the appropriate authorizations for routine use. the aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * patient hospitalized in an intensive care unit * patient with acute renal failure defined by a kdigo stage ≥ 1 and suspected non-obstructive * patient at risk of per dialytic hypotension (capillary refill time ≥ 3 seconds and/or cardiovascular sofa ≥ 1 and/or lactatemia \> 2mmol/l) * indication for extra renal replacement therapy with ihd. exclusion criteria: * pregnant or breastfeeding woman * known chronic renal insufficiency of any stage * cardio-renal and hepato renal syndrome * unstable hemodynamic state: refractory shock * patient included in another interventional study likely to modify the hemodynamic state * patient deprived of liberty * patient under guardianship or curatorship * patient not affiliated to a social security system

Keywords: citrate based dialysate acetate based dialysate hypotension hemodynamic tolerance
colchicine levels in the serum of fmf (familial mediterranean fever) patients

Conditions: FMF; Colchicine Resistance; Colchicine Toxicity

Summary: in this study the investigators will measure the colchicine trough levels in 80 fmf patients taking stable doses of colchicine

80 fmf patients will enroll: 20 taking 1 mg colchicine a day 20 taking 1.5 mg colchicine a day 20 taking 2 mg colchicine a day 20 taking 2.5 mg colchicine a day one blood sample for trough colchicine levels will be taken. response to treatment, colchicine side effects and anthropometric data will be collected.

Eligibility criteria:
inclusion criteria: * constant colchicine levels
muscle relaxation therapy with odorant cue

Conditions: Generalized Anxiety Disorder; Anxiety

Summary: a novel procedure for generalized anxiety disorder where an odorant cue is paired with the state of deep relaxation during training. it is hypothesized that by smelling the odor in an anxiety-provoking situation, the patient will more easily invoke a state of relaxation, providing greater relief from the distressing tension and worry that characterize gad.

we hypothesize that by presenting a novel odor to a patient in a state of deep relaxation, the odor will serve as a conditioned inhibitory stimulus, or safety signal, in anxiety-provoking situations. with the odor serving as a contextual cue for the state of relaxation.

Eligibility criteria:
inclusion criteria: * gad without a comorbid active major psychiatric disorder. * gad must be the primary active psychiatric disorder. * gad determined via the mini international neuropsychiatric interview (mini). exclusion criteria: * significant medical illness that might interfere with the relaxation therapy or with training using the odorant. * actively abusing alcohol. * illicit substances. * currently using rapid-acting anxiolytic agents (e.g. benzodiazepines, hydroxyzine). * started an antidepressant, antipsychotic or mood stabilizing agent within three months of screening visit.

Keywords: anxiety mental health
description of respiratory mechanics in patients with sars-cov-2 associated ards

Conditions: Acute Respiratory Distress Syndrome; COVID

Summary: the aim of this observationnal study is to describe respiratory mechanics and lung recruitement in patients with sars-cov-2 associated acute respiratory distress syndrome who underwent invasive ventilation on endotracheal tube, admitted to the medical icu of angers university hospital . statics measurements of respiratory system compliance were performed at 2 differents levels of peep (15 cmh2o and 5 cmh2o). the recruited volume is computed as the difference between the volume expired from peep 15 to 5 cmh2o and the volume predicted by compliance at peep 5 cmh2o . the recruitment-to-inflation (r/i) ratio (i.e. the ratio between the recruited lung compliance and crs at peep 5 cmh2o) is used to assess lung recruitability. a r/i ratio value higher than or equal to 0.5 was used to define highly recruiter patients.

the investigators perform an observational prospective study in patients admitted to medical icu in angers university hospital with a confirmed covid 19 pneumonia and who require invasive ventilation on endotracheal tube. participants receive initially deep sedation and neuromuscular blockers for 24 hours and are ventilated in volume-controlled mode with a tidal volume of 6 ml/kg of predicted body weight, a constant inspiratory flow of 60 l/minute and a respiratory rate adjusted to maintain ph above 7.35 when possible. a peep decremental trial from 15 to 5 cmh2o was performed (15 minutes by step). esophageal pressure monitoring and electrical impedance tomography (eit) are collected if available. arterial blood gases and respiratory mechanics are measured at the end of each step. the recruitment-to-inflation (r/i) ratio (i.e. the ratio between the recruited lung compliance and crs at peep 5 cmh2o) is used to assess lung recruitability. a r/i ratio value higher than or equal to 0.5 is used to define highly recruiter patients. by the end of the recording time, a low-flow (5 l/min) inflation from peep 5 cmh2o (tidal volume = 6ml/kg pbw) is then performed after a prolonged expiration to identify a potential airway closure and the corresponding airway opening pressure (aop). investigators perform these measurements at day 1, day 5 and day 10 from icu admission if participants still require controlled ventilation. the investigators also collect clinical data about each participant (past medical history, icu discharge, hospital discharge, date of death, ventilator acquired pneumonia, thromboembolic event, use of no, use of ecmo or renal replacement therapy).

Eligibility criteria:
inclusion criteria: * ards criteria according to berlin classification criteria * invasive mechanical ventilation on endotracheal tube * sars cov-2 infection exclusion criteria: * pneumothorax

Keywords: covid acute respiratory distress syndrome sars cov-2 lung recruitability respiratory mechanics
adasuve 2-dose thorough qt/qtc study

Conditions: Healthy Volunteers

Summary: assess the potential effects on the qt interval of 2 consecutive doses of adasuve administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

it has been shown in a pre-marketing clinical study that clinically relevant qt prolongation does not appear to be associated with a single dose of adasuve. the potential risk of qtc prolongation following repeat dosing is unknown. therefore the current study will assess the potential effects on the qt interval of 2 consecutive doses of adasuve administered 2 hours apart, in relation to placebo and an active control in healthy volunteers. the study hypothesis h0: placebo-subtracted max mean dqtc \> 10 msec

Eligibility criteria:
inclusion criteria: * male and female subjects between the ages of 18 to 65 years, inclusive. * body mass index (bmi) ≥18 and ≤32. * subjects who are willing and able to comply with the study schedule and requirements, and stay at the cru for a 4-day period and 2 consecutive 3-day periods. * subjects who speak, read, and understand english and/or dutch and are willing and able to provide written informed consent on an iec approved form prior to the initiation of any study procedures. * subjects who are in good general health prior to study participation * female or male participants who agree to use a medically acceptable and effective birth control method exclusion criteria: * subjects who regularly consume large amounts of xanthine-containing substances (≥ 5 cups of coffee/day). * subjects who have taken prescription or nonprescription medication within 5 days of visit 2. * subjects who have had an acute illness within the last 5 days of visit 2. * subjects who have smoked tobacco within the last 30 days or who have a positive cotinine test. * subjects who have a history of hiv, anti-hcv or hbsag positivity. * subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by dsm-iv. * subjects who test positive for alcohol or have a positive urine drug screen. * subjects who have a history of allergy or intolerance to loxapine or amoxapine or history of bronchospasm following inhaled loxapine treatment. * subjects who have an ecg abnormality. * subjects who have hypotension, or hypertension. * subjects who have a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure, transient ischemic attack, history of convulsions or other neurological disorder. * subjects who have a current history of asthma, chronic obstructive lung disease, or any other lung disease associated with bronchospasm. * subjects who use medications to treat airways disease, such as asthma or copd. * subjects who have any acute respiratory signs/symptoms (e.g., wheezing). * female subjects who have a positive pregnancy test at screening or at admission to any of the treatment visits, or are breastfeeding. * subjects who have received an investigational drug within 60 days prior to the screening visit.

Keywords: adasuve inhaled loxapine thorough qt/qtc study
a trial to assess a wearable patch's functioning to detect medication ingestion

Conditions: Mental Disorder; Schizophrenia; Major Depressive Disorder; Bipolar I Disorder

Summary: the primary purpose of the study is to evaluate the positive detection accuracy (pda) and detection latency measures of the d-tect patch.

this is an open-label study to determine the accuracy of ingestible event marker (iem) detection and detection latency of the d-tect patch by completing a series of patch applications and iem ingestions in the clinic. the participants were enrolled in two cohorts within this study- cohort 1: healthy participants received the placebo-embedded iem tablets, cohort 2: participants with serious mental illness (smi) i.e schizophrenia, major depressive disorder, or bipolar i disorder received abilify mycite® tablets (aripiprazole-embedded iem tablets). this single-center trial was conducted in the united states. the overall time to participate in this study is up to approximately 17 days.

Eligibility criteria:
inclusion criteria for cohort 1: * in good general health or medically stable. * is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing. * the participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant. inclusion criteria for cohort 2: * in good general health or medically stable. * has confirmed diagnosis of schizophrenia, major depressive disorder, or bipolar i disorder per diagnostic and statistical manual of mental disorders - 5th edition (dsm-5) criteria and currently prescribed and taking aripiprazole. * is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing. * participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant exclusion criteria for cohort 1 and 2: * any medical condition, treatment, or symptoms that, in the judgment of the trial clinician, could place the participant at more than the minimal risk from involvement in the testing. * hospitalization, emergency room visit, surgery or new medical treatment within 30 days before testing begins or planned during testing. * difficulty with or inability to swallow tablets. * active skin infection or active dermatitis, or history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis). * the investigator will determine if any participant should be excluded from the trial based on history of, or current, alcohol abuse, drug abuse or use of illegal drugs (e.g., amphetamines or heroin). * allergy to adhesive bandages/tapes (e.g., band-aids®) or latex. * positive urine pregnancy test at screening visit (dipstick). * participant is taking any concomitant medication that places the participant at a greater risk for skin reactions or skin sensitivity.

Keywords: d-tect patch
description of ophthalmologic injuries in intensive care during the sars-cov2 epidemic - covid19

Conditions: Covid19; Sars-CoV2

Summary: the management of patients with sars-cov2 in respiratory distress can expose to corneal or retinal lesions induced by the stay in intensive care. examination by ophthalmologists would make it possible to detect the most of the ophthalmologic problems known in intensive care and to provide an early, preventive or curative therapeutic response when possible, in order to avoid irreversible visual loss. the object of the research is to assess the presence and the importance of surface ophthalmologic lesions, the presence and the importance of retinal or optic nerve lesions, in order to improve the monitoring and primary prevention of this population


Eligibility criteria:
inclusion criteria: * patient sars-cov2 positive (rt-pcr or chest scanner) * hospitalized in intensive care exclusion criteria: * traumatic lesion of the face or any other condition preventing any ophthalmological evaluation

Keywords: ophthalmological lesions
graft-versus-host disease (gvhd) prophylaxis after allogeneic peripheral blood hematopoietic cell transplantation

Conditions: Acute Graft Versus Host Disease

Summary: the purpose of this research is to compare the effectiveness of tacrolimus and rapamycin to tacrolimus and methotrexate in the prevention of severe graft-versus-host-disease. graft-versus-host-disease (gvhd) is a risk associated with allogeneic hematopoietic cell transplants (hct). an allogeneic hematopoietic cell transplant is a transplant using bone marrow and blood cells that come from someone other than the patient (a donor).

all drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. tacrolimus and methotrexate used in combination are currently used as standard of care in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. tacrolimus and rapamycin is a newer combination we are testing to see if it would be better than tacrolimus and methotrexate.

Eligibility criteria:
inclusion criteria: * age ≥ 16 and ≤ 70 * signed informed consent * adequate vital organ function * no active infection, or asymptomatic infection well controlled by antibiotic hiv negative by elisa or rt-pcr \[if elisa is positive and rt-pcr is negative, the elisa is considered false positive\] * hepatitis b and c negative by serology or rt-pcr * performance status: karnofsky performance status score ≥ 60%. exclusion criteria: * those with any sorror's co-morbidity factors with score \> 3 * 2 or more sorror's factors with composite score of ≥ 3

Keywords: acute graft versus host disease (agvhd) gvhd graft-versus-host disease tacrolimus sirolimus methotrexate combination therapy gvhd prophylaxis
intraoperative three dimensional fluoroscopy compared to standard fluoroscopy for the assessment of reduction of ankle fractures with syndesmosis disruption

Conditions: Ankle Injuries

Summary: ankle fractures are common injuries that are being operated routinely. in order to restore the long term function and prevent arthritis of the ankle the broken fragments should be put in place precisely. inadequate reduction can result in pain and long term disability. recently, based on mri studies and clinical studies, a significant number of ankle fractures are apparently fixed with less than optimal results. we suggest that the use of a new device that enables better three dimensional imaging will improve the quality of operations performed for ankle fractures.


Eligibility criteria:
inclusion criteria: 1. patients with unstable ankle fractures (as classified by the ao as 44b 44c by lauge hansen per4 or ser4) amenable to open reduction and internal fixation. 2. patients with syndesmotic rupture as evident from the injury films or during clinical testing in the or be included in the study. 3. intraoperative testing will include both a cotton test and a stress view obtained after bimalleolar fixation has been attained. 4. a positive syndesmotic injury will be defined by the criteria of pettrone et al as follows: a tib/fib clear space \>5mm or tib/fib overlap of \<10mm (on the ap view), or a tib/fib overlap of \<1mm on the mortise view. exclusion criteria: 1. patients with a pilon fracture (i.e. plafond fractures ao type 43b and c) will be excluded even if associated with a fibula fracture and syndesmosis disruption. 2. patients with contraindications to operative treatment and diabetics 3. women of childbearing age will be excluded if they present with a positive pre-op beta hcg test or if they refuse a b hcg test.
reforça't: a community, social, and healthcare program for patients with cardiorespiratory conditions upon hospital discharge

Conditions: Chronic Obstructive Lung Disease (COLD); Heart Failure

Summary: the goal of this randomized clinical trial is to determine whether an interdisciplinary, community-based intervention can reduce 30-day hospital readmissions and improve functional outcomes in patients aged 65 or older with chronic cardiac, respiratory, or mixed conditions following hospital discharge. the main questions it aims to answer are: can the reforça't program reduce 30-day hospital readmission rates to 25% compared to standard care? does participation in reforça't improve functional outcomes, medication adherence, quality of life, and mortality rates in this patient population? researchers will compare patients enrolled in reforça't (intervention group) with those receiving standard care (control group) to determine whether the program leads to lower readmission rates, improved health outcomes, and higher cost-effectiveness. participants will: undergo a pre- and post-intervention assessment (30 days post-discharge). receive comprehensive, interdisciplinary care integrating medical, social, and rehabilitation services. be monitored for 12 months to assess readmissions, survival, nursing home admissions, and overall well-being.


Eligibility criteria:
inclusion criteria: * users admitted to the polivalent observation units, internal medicine, or hospital at home. * individuals aged 65 years or older. * hospital admission due to decompensation of a cardiac, respiratory, or mixed condition. * place of residence within the health coverage area of sant jaume de calella hospital - corporació de salut del maresme i la selva. * willingness to participate in the study as gathered by the signing of an informed consent document exclusion criteria: * users institutionalized in a nursing home * users already enrolled in home care programs * users in the advanced chronic care model program with a limited life prognosis * users on the waiting list for organ transplantation * users with language barriers * users with a gds (global deterioration scale) score of 5 or higher * users who have already been included in the reforça't program

Keywords: patient readmission cold heart failure frail elderly multidisciplinary care team
ologen (oculusgen)-glaucoma mmc control in pakistan

Conditions: Glaucoma; Trabeculectomy

Summary: the purpose of this study is to compare the safety and effectiveness of the ologen (oculusgen) biodegradable collagen matrix implant and the mmc group in filtration surgery.

1. study objective: to compare the safety and effectiveness of the ologen (oculusgen) biodegradable collagen matrix implant and the mmc group in filtration surgery. the primary endpoint is to prove the effectiveness via the reduction of iop, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. study design: the study is designed as an open-label, randomized, parallel, comparative study. patients who meet the inclusion/exclusion criteria and sign informed consent will be included. after enrollment, patients will be randomized into two groups: trabeculectomy with oculusgen implant or trabeculectomy with mitomycin-c. 3. follow-up: there will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. a window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. further follow-up of subjects after the trial will be the responsibility of the investigator.

Eligibility criteria:
inclusion criteria: * age 18 years or over. * uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy. * subject able and willing to cooperate with investigation plan. * subject able and willing to complete postoperative follow-up requirements. * subject willing to sign informed consent form. exclusion criteria: * known allergic reaction to mitomycin-c or bovine collagen. * subject is on warfarin and discontinuation is not recommended. * normal tension glaucoma. * participation in an investigational study during the 30 days preceding trabeculectomy. * ocular infection within 14 days prior to trabeculectomy. * pregnant or breast-feeding women.

Keywords: glaucoma collagen matrix ologen oculusgen antifibrotic trabeculectomy anti scarring tissue engineering high risk patient for trabeculectomy aeon astron
evaluation of frequency lowering technique

Conditions: Hearing Loss

Summary: the purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.

this is a controlled, single blinded and randomised comparative study which is conducted monocentric at hoerzentrum oldenburg, germany. the focus is to test two frequency lowering techniques with an amount of 30 moderate to severe, symmetrically sensorineural hearing impaired adult subjects. the subjects, all of them native german speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during 6 months including seven appointments of 2 hours.

Eligibility criteria:
inclusion criteria: * female and male adults (\>18 years old) * mild to severe hearing loss * symmetric hearing loss * german native speakers exclusion criteria: * persons who are not able to attend multiple appointments * persons who are not able to handle a hearing aid * persons with a mental handicap * persons with limited access to multiple hearing situations * persons with psychological disease * no acclimatization to hearing aids