Kornimate/medical-research-clean huggingface dataset:
computational modeling of 60 hz subthalamic nucleus deep brain stimulation for gait disorder in parkinson's disease

Conditions: Parkinson Disease

Summary: the objective of this study is to further the understanding and application of 60hz subthalamic deep brain stimulation (stn-dbs) in parkinson's patients with gait disorder. the investigators will achieve this through 2 study aims: 1. determine the impact of 60hz subthalamic deep brain stimulation on gait kinematics using wearable sensors 2. develop machine learning models to predict optimal subthalamic deep brain stimulation frequency based on wearable sensors

gait disorder, which manifests as shuffling, reduction in speed, multistep turning, and/or freezing of gait (fog), can arise later in the parkinson's disease (pd) course and cause significant disability. ultimately, patients are at risk for falls and can become socially isolated due to their mobility limitations. these symptoms tend not to respond to high frequency stn-dbs. however, lower frequency stimulation (60-80hz) of the stn in treating gait disorder and/or freezing of gait has demonstrated benefit. this study potentially can expand knowledge of 60hz dbs while improving its utilization in combination with pd medications-enabling sustainable and possibly predictable therapeutic benefit.

Eligibility criteria:
inclusion criteria: 1. male or female, aged 21-80 2. patients diagnosed with parkinson's disease (pd) 3. pd subjects who have bilateral stn-dbs (greater than 3 months) or in the preoperative stage of being implanted with bilateral stn-dbs 4. have underlying gait disorder 5. currently treated with oral levodopa therapy 6. willingness to comply with all study procedures exclusion criteria: 1. cognitive deficits based on historical record that limit participant compliance with study protocol 2. vestibular disorder or musculoskeletal problems affecting gait or balance

Keywords: deep brain stimulation parkinson's disease wearable sensors
esbl in patients returning to sweden with traveller's diarrhoea

Conditions: Antibiotic Resistant Infection; Antibiotic Resistant Strain; Traveler's Diarrhea

Summary: patients with traveller's diarrhoea frequently harbour extended spectrum betalactamase (esbl)-producing enterobacteriaceae (epe) returning from epe-endemic areas. this study investigates to what extent travellers returning to sweden with traveller's diarrhoea carry esbl in their stool. the isolates are examined further according to species, phenotype, antibiogram and whole genome sequencing.

samples sent to the department of clinical microbiology in lund, sweden for culture of salmonella, shigella, yersinia or campylobacter are also cultured selectively for esbl. all patients are contacted by mail with the results. esbl-positive patients are invited to submit further faecal cultures and blood samples during one year follow up time, to investigate how long the patient is colonized with esbl.

Eligibility criteria:
inclusion criteria: * travellers diarrhoea * foreign traveller exclusion criteria: * foreign traveller but no symptoms
creation of a bank of fibroblast from patients with amyotrophic lateral sclerosis: pilot study

Conditions: Amyotrophic Lateral Sclerosis

Summary: patients with als will be included in the reference center for als in hospital la pitié salpêtrière, paris. the study proposes to investigate the pathophysiology of als by setting up a fibroblast bank for studying molecular, cellular and genetic parameters of the pathology. ips (induced pluripotent stem cells) and then differentiated cells will be generated. the pathophysiology of als will be studied on the 3 types of cells (fibroblasts, ips, differentiated cells).


Eligibility criteria:
inclusion criteria: * patients over 18 years old * als sporadic or familial or unknown exclusion criteria: * known cutaneous disease not allowing the biopsy * platelets less than 10 000/m3 * suspected or known xylocain allergy
efficacy of repetitive transcranial magnetic stimulation in reducing cocaine intake in addicted patients

Conditions: Cocaine Use Disorder

Summary: the study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rtms), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (cud) versus placebo.

40 patients are expected and randomized in two groups: 20 patients with active rtms and 20 with placebo rtms. visit 1: 15 days (3 weeks of 5 consecutive daily sessions and 2 days of rest) 15hz rtms is performed during the following days in addition to a biweekly urine drug test and vas evaluation. visit 2: changes from baseline to week 8 in cocaine intake. evaluation of craving and of other assessments like mood and quality of life.

Eligibility criteria:
inclusion criteria: * male and female patients between 18 and 65 years of age * patients who meet the criteria for cud reported in the diagnostic and statistical manual of mental disorders fifth edition (dsm-v) * positivity to cocaine use, determined via an urine drug test * patients who are able to provide a written informed consent, after being notified about the treatment and the study protocol exclusion criteria: * major depression disorder, schizophrenia, bipolar disorder or other psychosis that meet the diagnostic criteria of the dsm-v * illiteracy or cognitive impairment disorders * women who are pregnant or lactating * other medical diseases that contraindicate rtms treatment such as epilepsy * presence of devices, i.e. pace-makers or cochlear prosthesis * previous rtms treatments in order to avoid confounding factors * patients who can not provide the written informed consent * dsm-v substance use disorders other than cud. only tobacco smoke is allowed to be recruited in the study protocol.

Keywords: rtms craving mood and cognitive behavior substance-related disorders
spanish registry of cryoballoon ablation

Conditions: Atrial Fibrillation

Summary: the purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy and results in these subjects.

with this study the investigators propose the performance of a prospective registry of pulmonary vein cryoablation in subjects with paroxysmal or persistent af at spanish sites to estimate evaluate the efficacy of the cryoablation procedure at 12 months, defined as the absence of recurrences of atrial fibrillation. secondary objectives are also defined as: * description of the profile of subjects who undergo this type of procedure (demographic factors, cardiovascular risk factors, medication, physical activity, sleep apnea, alcohol, smoking, chronic pulmonary disease, obesity, etc.). * to evaluate the acute efficacy of the procedure: complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure. * description of the complications related to the procedure. * to evaluate the use of healthcare resources which this cryoablation procedure entails.

Eligibility criteria:
inclusion criteria: * signature of the data release form * subjects ≥ 18 years old * subjects who meet the indication for the cryoballoon ablation procedure. exclusion criteria: * subjects with a life expectancy of less than 12 months. * subjects who meet the exclusion criteria defined by local legislation (e.g., age, pregnancy, breastfeeding, etc.). * subjects who may currently be enrolled, or who plan to take part, in a study with a drug or device that may cause bias during the course of this study. * co-participation in concurrent trials is only allowed when documented pre-approval is obtained from the medtronic study manager.
urine adiponectin concentration in prediction of contrast induced nephropathy

Conditions: Myocardial Ischemia

Summary: the present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of contrast induced nephropathy (cin) in the patients undergoing pci.

contrast induced nephropathy (cin) is a severe complication after percutaneous coronary intervention (pci). cin is responsible for approximately genic renal insufficiency and is the third cause of hospital-acquired renal failure and the injury of endothelial of renal tubule is responsible for the cin. however markers reliably identifying cin in the patients undergoing pci are rare. adiponectin is a 30-kda adipocyte-derived vasoactive peptide closely linked to components of the metabolic syndrome. recent study demonstrates that the quantification of urinary adiponectin excretion appears to be an independent indicator of vascular damage potentially identifying an increased risk for vascular events. therefore, the investigators presume that the adiponectin excretion may predict the incidence of the cin. the present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of cin in the patients undergoing pci.

Eligibility criteria:
inclusion criteria: * all patients \> 18 of age who are undergoing elective pci and are able to give informed consent are eligible for study. exclusion criteria: * the end-stage renal failure * the patients who are relieving dialysis

Keywords: contrast induced nephropathy percutaneous coronary interventions
home usability study of the sars-cov-2 (covid-19) test

Conditions: COVID-19

Summary: the primary objective is to determine the usability of the sars-cov-2 specimen collection materials for at-home collection and mailing of sample to the testing laboratory.

this study is a prospective observational human factors usability study designed to evaluate the instructions for use (ifu) in the sars-cov-2 specimen collection materials based on the successful completion of self-collection of a nasal swab sample, which includes a valid sars-cov-2 test result.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent exclusion criteria: * prior medical or laboratory training * prior experience with covid-19 specimen self-collection * prior sars-cov-2 testing

Keywords: covid-19 sample collection human factors study nasal swab
middle meningeal artery embolization for the treatment of subdural hematomas with trufill® n-bca

Conditions: Chronic Subdural Hematoma

Summary: this is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (soc) alone or soc and trufill n-bca mma embolization for the treatment of chronic subdural hematomas (csdh).

this is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (soc) alone or soc and trufill n-bca mma embolization for the treatment of csdh.

Eligibility criteria:
inclusion criteria: * pre-randomization mrs \</= 3 * confirmed diagnosis of chronic subdural hematoma * completed informed consent exclusion criteria: * acute subdural hematoma * prior treatment of target subdural hematoma * markwalder assessment \>/= 3 * glasgow coma scale \< 9 * presumed microbial superinfection * ct or mri evidence of intracranial tumor or mass lesion * life expectancy \< 1 year * women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study * current involvement in another clinical trial that may confound study endpoints

Keywords: chronic subdural hematoma, mma embolization
a trial comparing two breast pumps in mothers expressing milk for their preterm infants

Conditions: Milk Production

Summary: this is a randomised controlled trial investigating the performance of two, 'state of the art' electric breast pumps in mothers who have delivered preterm infants. the main data collection period will be up to day 10 post delivery data. data collected will include a record of the weight of milk produced during the first 10 days and a short questionnaire to find the mothers' opinions of the pumps used. on day 5 a timed and weighed expression of 15 minutes will be carried out. after the first 10 days, mothers will be asked to collect brief information on their continuing use of their pumps and subsequent duration of breast and bottle feeding, mothers will be contacted at 3 and 6 months post-term


Eligibility criteria:
inclusion criteria: * mothers who have delivered, preterm (before 34 weeks) infants who plan to express breast milk for their infant(s). their infants will need to be less than 72 hours old prior to enrolment and likely to remain in nicus for at least 10 days. exclusion criteria: * other mothers not fitting inclusion criteria.

Keywords: randomised trial breast pumps efficacy preterm mothers of preterm infants who plan to express milk for their infants.
eegcap application in paediatrics with reduced gcs in resus

Conditions: Status Epilepticus; Altered Level of Consciousness; Non-epileptic Seizures; Epilepsy; Encephalopathy

Summary: children frequently present with altered or reduced consciousness levels to emergency departments. by using eeg monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. post-ictal phases that may be interpreted as seizure activity may become less over-treated. a feasibility study will ascertain if eeg monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as \< 25% artefact). eeg recordings will not be used to guide clinical management during this feasibility study.

see study protocol attached

Eligibility criteria:
inclusion criteria: children between 0 and 15 years and 11 months who present to resuscitation room, ed, cuh with a glasgow coma scale (gcs) \< 11 or, a reduction in baseline gcs in the case of children with significant neurodisability at baseline exclusion criteria: * polytrauma * open head wounds * unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management

Keywords: eeg emergency department paediatrics reduced glasgow coma scale (gcs)
internet-based cognitive behavior therapy after myocardial infarction

Conditions: Depression; Anxiety; Myocardial Infarction

Summary: the overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an internet-based cbt-program in depressed and/or anxious patients after a myocardial infarction (mi).

major or minor depressive disorders and anxiety disorders are present in many patients with cardiovascular disease (cvd) and are associated with adverse cardiovascular outcomes, even after controlling for other risk factors. 500 patients with symptoms of anxiety and/or depression after mi will be randomized either to a 14 week internet-based cbt-program or to treatment as usual (tau) which is the control condition. a reference group of 250 participants without depressive or anxiety symptoms will also be studied during tau. data will be collected before, after and 7 months after treatment. anxiety and depression according to ratings on the hospital anxiety and depression scale (hads) are the primary outcome measures.

Eligibility criteria:
inclusion criteria: * patients younger than 75 years with a recent acute mi (\< 3 months) * depression and/or anxiety score of \> 7 on one or both of the hads subscales (concerns only the intervention, not the reference group) exclusion criteria: * patients that are scheduled for a coronary artery bypass surgery (cabg) * unable or unwilling to use computer or internet * difficulties in reading or understanding swedish * a life expectancy of less than a year * anticipated poor compliance (multi-disease, substance abuse etc.) * highly depressed or suicidal (madrs-score \> 29 or madrs item 9 \> 3)

Keywords: myocardial infarction depression anxiety internet-based cbt genetic disposition
training at different intensities in coronary artery disease -effects on myocardial function

Conditions: Coronary Artery Disease

Summary: the study investigated if aerobic endurance exercise of different intensity has different impact on the physical capacity and myocardial function in patients with coronary artery disease. patients with stable cad trained for 10 weeks, and oxygen consumption and myocardial function were measured before and after this period. patients were randomly assigned to each exercise group.

peak oxygen consumption was measured by gas-analysis. myocardial function was measured by echocardiography. exercise was performed on treadmills under close supervision of an exercise physiologist. patients had to complete over 70% of sessions to be included in analysis. three sessions were scheduled every week. heart rate (hr) was about 85 % of max hr in the high intensity group, and about 65 % in the moderate intensity group.

Eligibility criteria:
inclusion criteria: * stable coronary artery disease * over 4 months since cardiovascular event exclusion criteria: * heart failure * inability to exercise

Keywords: coronary artery disease exercise training intensity randomized echocardiography aerobic exercise
healthy children and virtual reality mediation of simulated pain

Conditions: Acute Pain; Experimental Pain in Healthy Human Participants; Children; Adolescents

Summary: the objective of this study is to develop central nervous system (cns) biomarkers of pain experienced during medical procedures and pain relief induced by virtual reality pain alleviation therapy (vr-pat). the study team plans to use innovative functional near-infrared spectroscopy (fnirs) to identify and quantify the targeted cns biomarkers. the ultimate goal of this project is to optimize the cns biomarkers for predicting and/or monitoring response to virtual reality (vr)-based pain reduction approaches for pain management in clinical trials. 20 healthy children will be recruited for a 1-hour research visit where they will wear a blood pressure cuff to simulate pain and an fnirs neuroimaging device while playing an immersive/engaging vr game, a passive vr video, and an ipad game.

the objective of this study is to develop central nervous system (cns) biomarkers of pain experienced during medical procedures and pain relief induced by virtual reality pain alleviation therapy (vr-pat). the study team plans to use innovative functional near-infrared spectroscopy (fnirs) to identify and quantify the targeted cns biomarkers. the ultimate goal of this project is to optimize the cns biomarkers for predicting and/or monitoring response to vr-based pain reduction approaches for pain management in clinical trials. collaboration will occur through a team science model to address the following three specific aims: aim 1: to quantify the central nervous system (cns) responses associated with self-reported pain intensity during a simulated pain condition. aim 2: to assess brain response patterns to virtual reality (vr)-based interventions for pain management. aim 3: to assess the degree to which objective brain measures and brain responses to vr intervention modulate objective brain markers of pain.

Eligibility criteria:
inclusion criteria: * age 6-17 years, inclusive * subjects and legal guardians can communicate (read and write) using english exclusion criteria: * currently experiencing any pain (acute or chronic) * took any pain medication within the past 12 hours * vision, hearing, or cognitive/motor impairments preventing valid administration of study measures * history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras * minors in foster care, incarcerated, or currently pregnant

Keywords: acute pain experimental pain virtual reality fnirs
comparison of scores for early brain damage assessment at intensive care unit admission after out of hospital cardiac arrest

Conditions: Cardiac Arrest

Summary: even in patients with successful return of spontaneous circulation (rosc), outcome after cardiac arrest remains poor. the overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. several studies have already shown that early interventions performed after rosc, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. however, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.


Eligibility criteria:
inclusion criteria: - all adult patients, major, admitted to intensive care after out-of-hospital cardiac arrest and comatose (defined by glasgow score ≤ 8) on admission. exclusion criteria: * cardiac arrest occurring intra-hospital, * minor patient, * major patient under guardianship, * protected persons, * prior inclusion in the study

Keywords: cardiac arrest hypothermia induced intensive care unit
sodium-glucose cotransporter-2 inhibitor (sglt2) in major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the primary purpose of this study is to determine whether empagliflozin, a medication in a class known as sodium-glucose cotransporter-2 inhibitors (sglt2) inhibitors, may reduce symptoms of depression. since this medication helps the body make metabolites known as ketone bodies which can serve as an alternate energy source for the brain, the investigators can also test whether ketone bodies help with depressed mood.


Eligibility criteria:
inclusion criteria: * provide written informed consent, as approved by the nyu institutional research ethic board (irb). * patients ages 18-65; * current/acute major depressive disorder (mdd) diagnosis, per mini psychiatric interview; * at least moderate severity of depression (montgomery-åsberg depression rating scale (madrs) score of at least 20 at initial screen); exclusion criteria: * dsm-5 diagnosis of bipolar disorders, cyclothymia, schizoaffective disorder, schizophrenia; any psychotic disorder or affective psychosis; * subjects that have had more than two failures of adequate anti-depressant trials in the current mdd episode; * subjects on psychotropic medications other than ssris, ndris, snris, or mirtazapine (occasional use of sleep agents, equivalent to lorazepam 1 mg or zolpidem 10 mg, will be allowed); * those that have previously been on sglt2 inhibitors; * a significant history of non-adherence to treatments; * history of neurologic / seizure disorder; * a significant history of non-adherence to treatments; * history of dementia/cognitive dysfunction (moca \< 22); * a primary diagnosis of a personality disorder, in the opinion of the screening clinician; * dsm-5 substance use disorder (drug/alcohol) active within the past 12 months, or positive urine toxicology at screening; * history of diabetic ketoacidosis; * history of recurrent genital mycotic infection; * gfr \<45; * hga1c.\>8.0% * history of an allergic reaction to an sglt2 inhibitor. * pregnancy or lactation (women of reproductive age, ie \<50 years old, should be on licensed hormonal or barrier method contraception). * any known pancreatic disease resulting in insulin deficiency (t1d, history of pancreatitis, pancreatic surgery); * history of liver or kidney disease; * hypersensitivity to empagliflozin or any of the excipients in jardiance.