Kornimate/medical-research-clean huggingface dataset:
efficacy of nanodropper-mediated topical anesthetic

Conditions: Corneal Diseases; Effectiveness of Microdrops

Summary: the goal of this clinical trial is to compare the onset and duration of numbness of the surface of the eye following the administration of numbing drops, called proparacaine, using either a standard eye drop bottle or a "nanodropper" adaptor. the nanodropper is designed to administer smaller-sized drops, or microdrops. participants will: 1. complete a baseline eye exam. 2. receive a numbing drop using a standard dropper in one eye and the nanodropper in the other eye. 3. have their eyes tested for numbness at specific time points (30 seconds, 1, 2, 5, and 10 minutes after getting the drops). 4. tell the researchers if they feel pain during the eye sensation tests. 5. complete a survey about their experience with the eyedrops and testing procedure. this study could help us find a way to use less medication while still effectively administering eye medications, potentially saving money and reducing medical waste.


Eligibility criteria:
inclusion criteria: 1. ability to provide informed consent for topical anesthesia delivery 2. ability to verbally respond to pain 3. at least 18 years of age exclusion criteria: 1. have a contraindication to local anesthetics 2. history of intravitreal injections 3. history of ocular surgery 4. history of vitreous or retinal surgery 5. preexisting diagnosis of ocular surface disease requiring punctal plug placement 6. evidence of any current ocular inflammation 7. any previous ocular condition (i.e., neurotrophic keratitis, herpetic eye disease, presence of a corneal graft, etc.) that has permanently altered the native sensation of the ocular surface 8. use of contact lenses in the past year 9. use of exclusionary medications: topical steroid drops, non-steroidal anti-inflammatory drops, intraocular pressure lowering eye drops, any anti-viral medications used for herpes, opioids

Keywords: corneal anesthesia nanodropper
optic nerve head shape as a predictor of the formation of acquired pits of the optic nerve (apons)

Conditions: Glaucoma

Summary: acquired pits of the optic nerve (apons) are an area of focal loss of neural tissue associated with a discrete area of depression/excavation within the optic cup at the level of the lamina cribrosa. it is commonly associated with glaucoma and can be seen on the optic disc when examining the back of a patient's eye. it causes a characteristic visual field defect in the central 5-10 degrees of vision which has a significant impact of a patient's daily activities. there is no treatment to restore vision once it has formed. previous studies suggest mechanical stress across this part of the eye may have role in the formation of apons. the investigators therefore hypothesise that if a patient has a more elliptical shaped optic disc, which would have more irregular mechanical stress across it, it may have a higher risk of an apon forming. patients with glaucoma attending the ophthalmology department at university hospital of wales have regular photographs taken of the optic nerve/optic disc as part of their routine clinical care in order to monitor the condition. the research team, who are all practicing ophthalmologists in the department, will review anonymised photographs to find optic discs with apons, and another group with glaucoma but no apons to use as a control. the research team will then measure the dimensions of the optic disc to determine if apons are more common in optic discs with a more elliptical shape. the patients' clinical notes will then need to be accessed to collect data on the age, sex and diagnosis. this data will be anonymised using id numbers once collected. the final outcomes of the study will the average measured dimensions of the optic disc in each group, and the position that the apon occurs.


Eligibility criteria:
inclusion criteria: * documented diagnosis of primary open angle glaucoma (poag) or normal tension glaucoma (ntg) * under the care of the ophthalmology department at university hospital of wales * available optic disc photograph * presence of an apon for disease group, no apon for control group exclusion criteria: * no documented diagnosis of poag/ntg * other form of glaucoma - e.g. traumatic glaucoma/juvenile glaucoma * poor photograph quality * optic disc tilted so that the margin is obscured and cannot be demarcated * coexisting disc pathology, e.g. congenital optic disc pit

Keywords: glaucoma
sarcopenia cut-points and functionality in older adults

Conditions: Sarcopenia; Diagnostic

Summary: this is a cross-sectional study conducted in older adults living in valencia province in order to establish the cut-off points of the multicriteria diagnostic of sarcopenia through functionality and frailty variables.

sarcopenia is a geriatric syndrome that involves a gradual and generalized loss of the mass and strength of the skeletal muscles. currently, there is an international debate about the criteria and reference values for the sarcopenia diagnosis, and the main scientific societies encourage improving research on this. the biggest problem lies in the assessment of the diagnostic criterion of muscle mass while the criterion of muscular strength seems safer and more robust. experts point out the need to adjust the muscle mass indexes to the characteristics of the population studied, and the convenience of relating the three diagnostic criteria of sarcopenia (muscle mass and strength, and walking speed) with other variables that report about functionality and frailty in older adults. the main objective is to establish different cut-off points for the diagnostic criteria of sarcopenia and relate them with other instruments for assessing functionality in older population of valencia province. to this purpose, data will be collected through various tests and questionnaires about: clinical, demographic and anthropometric characteristics; muscle mass; muscle strength; walk speed; physical and cognitive function; nutritional status; self-perception of health; comorbidity and frailty. with this information it will be possible, as primary outcome, to determine a more sensitive, reliable and valid muscle mass index to predict sarcopenia, and, as a secondary outcome, to establish the relationship between the multicriteria diagnostic of sarcopenia with the functional and frailty variables.

Eligibility criteria:
inclusion criteria: * people aged \> 65 years * residents in valencia province (living-community, day-centers and institutionalized) exclusion criteria: * lobo mini-exam cognoscitive \< 18 score * any disorder that prevents from performing the assessment tests. * recent hospitalization or who are in a acute process of any illness (less one month).

Keywords: older adult sarcopenia frailty functionality muscle strength muscle mass walk speed
psychological management by meditation of full conscience in virtual reality of people with amyotrophic lateral sclerosis: effects on cognition, behavior, quality of life and psychological well-being

Conditions: Lateral Sclerosis Amyotrophy; Mindfulness Meditation

Summary: amyotrophic lateral sclerosis (als) is a neurodegenerative disease that results in progressive paralysis of the muscles involved in voluntary motor skills, speech, swallowing and breathing. it also causes non-motor symptoms including psychological, cognitive and behavioral difficulties that have a negative impact on patients' quality of life, well-being and long-term development. there is no curative therapy for als and drug treatments have little effect on non-motor symptoms. interventions based on mindfulness meditation, defined as a state of consciousness that arises when one decides to focus attention in the present moment without judgment on the real experience, seem to be a promising tool for the reduction of non-motor symptoms in a number of progressive neurological conditions (alzheimer's disease, multiple sclerosis, etc.), suggesting that mindfulness significantly helps in the management of these symptoms. our project therefore aims to implement a mindfulness meditation program adapted to the management of non-motor symptoms in als based on virtual reality (vr).


Eligibility criteria:
inclusion criteria: * majors to inclusion * mother tongue: french * patients for whom als of bulbar or spinal form defined according to el escorial criteria is possible, probable or certain * able to carry out the investigations and interventions provided for in the protocol * signature of informed consent to participate in the study exclusion criteria: * participation in intervention research modifying management * history likely to disrupt cognition (constituted stroke, sequelae of traumatic brain injury, active epilepsy, learning disabilities, alcohol dependence syndrome, drug use, psychiatric disorders), severe cognitive impairment (mmse \<24) * people who meet the diagnostic criteria for frontotemporal dementia * pregnant or lactating women * persons deprived of their liberty by administrative or judicial decision * persons undergoing psychiatric care under duress * persons subject to a legal protection measure * persons unable to express their consent * persons not affiliated or not beneficiaries of a social security scheme
efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in subjects with complicated urinary tract infections or acute uncomplicated pyelonephritis

Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis; cUTI; AP

Summary: phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cuti) or acute uncomplicated pyelonephritis (ap).


Eligibility criteria:
inclusion criteria: 1. male or female patients at least18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the treatment period; 2. weight at most 140 kg; 3. expectation, in the opinion of the investigator, that the patient's cuti or ap will require treatment with at least 5 days of iv antibiotics; exclusion criteria: 1. has a known imipenem- and/or meropenem-resistant gram-negative uropathogen (at least 10\^5 cfu/ml), isolated from study-qualifying urine culture; note: if after randomization the susceptibility testing indicates resistance to imipenem and/or meropenem, the patient may remain on the study drug at the investigator's discretion. 2. has known or suspected single or concurrent infection with acinetobacter spp. or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives; note: patients with qualifying pathogen coinfected with a gram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly with the study drug at the investigator's discretion. 3. has only a known gram-positive primary uropathogen (at least 10\^5 cfu/ml), isolated from study qualifying urine culture;

Keywords: op0595 nacubactam integral
analysis of both sex and device specific factors on outcomes in patients with non-ischemic cardiomyopathy

Conditions: Cardiomyopathies; Gender; Implantable Defibrillator User

Summary: the purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for icd or crt-d implantation for the primary prevention of sudden cardiac death. differences in outcomes will be evaluated by sex and by device type.

the bio-libra study will gather information about women and men with non-ischemic cardiomyopathy who are treated with implanted icd and crt-d devices from many locations across the united states. the bio-libra study will look at the results of treatment in women and men enrollees. the two primary goals are: 1) to learn if there are differences in treatment response based on the patient's sex; and 2) to learn if there are differences in patient outcomes based on device type. there is a special focus on women in the bio-libra study. usually, only about 25% of people in prior device studies have been women. yet heart disease is the number-one cause of death for women - one in three deaths each year. the bio-libra study would like to have a more balanced study which includes more women than in prior studies. the goal is for at least 40% of the people participating in the study to be women. the study will observe up to 1,000 women and men over a three-year period following the device implant. utilizing information collected at annual doctor visits and scheduled transmission reports from the implanted device in between these visits, the bio-libra study will be able to evaluate some of the common risks of non-ischemic cardiomyopathy.

Eligibility criteria:
inclusion criteria: 1. patient meets current guideline-defined indication for de novo, primary prevention icd or crt-d implantation 2. patient has non-ischemic etiology of cardiomyopathy 3. patient is successfully implanted with a de novo biotronik icd or crt-d device and commercially available leads no more than 30 days prior to consent or is scheduled for de novo implantation of a biotronik icd or crt-d device no more than 30 days post consent 4. patient is able to understand the nature of the study and provide informed consent 5. patient is available for standard of care follow-up visits to occur at least yearly at the study site for to the expected 3 years of follow-up 6. patient is willing to utilize biotronik home monitoring® via cardiomessenger 7. patient age is greater than or equal to 18 years exclusion criteria: 1. patient meets secondary prevention icd indication 2. patient has ischemic etiology of cardiomyopathy 3. patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes 4. patient is expected to receive heart transplantation or ventricular assist device within 1 year 5. patient life expectancy is less than 1 year 6. patient reports pregnancy at the time of consent
evaluation of efficacy and safety of suzetrigine for pain associated with diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of suzetrigine (suz) in participants with pain associated with diabetic peripheral neuropathy (dpn).


Eligibility criteria:
key inclusion criteria: * body weight greater than or equal to (≥) 45 kilogram (kg) * body mass index (bmi) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2) * diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin a1c (hba1c) ≤9% and the presence of bilateral pain in lower extremities due to dpn * weekly average of daily nprs score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day baseline period key exclusion criteria: * more than 3 missing daily nprs scores during the 7-day baseline period * participation in a previous study in which the participant received suz * any sensory abnormality (excluding dpn) as pre-specified in the protocol other protocol defined inclusion/exclusion criteria may apply.
use of pupillometry for pain assessment in icu patients with delirium

Conditions: Delirium; Pain, Postoperative

Summary: pain assessment in intensive care patients is a constant challenge. approximately 50% to 80% of patients report pain at rest or during medical or nursing interventions (for example endotracheal suctioning, mobilization and rehabilitation, presence and care of invasive inputs, etc.). obstacles to pain assessment and management are most often due to interference with communication due to impaired consciousness, airway support and connection to artificial pulmonary ventilation, or the effect of administered medication. patients in intensive care are prone to delirium. delirium can compromise patients' ability to verbalise pain for a variety of reasons (e.g. due to impaired attention, memory, thinking and language barriers). also, pain and inadequate analgesia are risk factors for delirium. pupillary reflex changes and their identification by automated pupillometry have yielded positive results regarding nociception assessment in adult and pediatric patients and in perioperative and postoperative care. at the same time, the response of these patients to opioid administration was investigated. the aim was to improve their analgesia. the aim of this study is to find out whether, there is an association between automated pupillometry and selected objective pain measurement scales in the confusion assessment method for the intensive care unit (cam-icu) positive patients after surgery.

periodically after 6 hours, the incidence of delirium will be assessed using the cam icu questionnaire. subsequently, the incidence of pain will be assessed using 3 valid scales. the visual analogue scale (vas), the behavioral pain scale (bps) and the critical care observational tool (cpot) will be used. finally, automated pupillometry will be measured. the measurement values will be entered in the record sheet. information about the medications administered and the patient's vital signs will also be recorded.

Eligibility criteria:
inclusion criteria: * patient after surgery * possibility to perform cam - icu test (patients with richmond agitation-sedation scale -2 to +2) exclusion criteria: * eye diseases * brain injury * stroke * epilepsy * neuromuscular diseases

Keywords: pupillometry delirium pain
optivol diagnostic data for discharge in heart failure

Conditions: Heart Failure, Congestive; Cardiac Pacemaker, Artificial

Summary: the objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in conjunction with other traditional clinical practice methods to determine if heart failure patients are ready for hospital discharge.

implantable cardioverter defibrillator (icd) devices with or without cardiac resynchronization therapy (crt-d) have the ability to continuously monitor heart rate variability, daily heart rate, and patient activity. changes in these measures have been associated with heart failure prognosis. in addition, icd or crt-d devices also have the ability to measure daily intrathoracic impedance. previous data have demonstrated that device-based intrathoracic impedance measurements correlate with pulmonary capillary wedge pressure and fluid retention, both of which are common measures of heart failure status. the objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance can be used in conjunction with other methods to determine if patients are ready for hospital discharge. this will be the first step in potentially developing an inpatient care strategy which includes implantable device data. it is hypothesized that device diagnostic data will identify an appropriate and safe time to discharge patients admitted for worsening heart failure symptoms before usual clinical indicators. more specifically, we hypothesize that device data will "normalize" at least one day prior to the clinical indicators of readiness for discharge and patients discharged prior to "normalization" of the device data will be at greater risk for rehospitalization

Eligibility criteria:
inclusion criteria: * patients implanted with a medtronic insync sentry or subsequent fda-approved medtronic device with the optivol capability for \>30 days. * anticipated hospitalization stay \>48 hours * hospitalized patients experiencing worsening heart failure with symptoms of lung/pulmonary congestion. exclusion criteria: * anemia - admission hemoglobin \<8.0 g/dl * patients residing in convalescence center prior to admission or known to be discharged to a convalescence center or hospice, where discharge could be based on bed availability

Keywords: heart failure, congestive cardiac pacemaker, artificial ventricular pressure
mindfulness and compassive acceptance for chronic insomnia in comparison with cbt

Conditions: Chronic Insomnia; CBT

Summary: the main aim of this study is to test the efficacy of a compassive acceptance intervention protocol (developed by the research team) for chronic insomnia in comparison with the standard treatment (cbt-i).


Eligibility criteria:
inclusion criteria: * insomnia diagnosis (icsd-3; dsm-5) exclusion criteria: * comorbidity with severe psychiatric/psychological disorder (e.g. severe depression; psychotic disorder) * comorbidity with other untreated sleep disorder * altered sleep patterns due to factors different from insomnia (e.g. shift-work; pregnancy)

Keywords: chronic insomnia cbt-i act compassion
preventative delirium protocol in elderly patients

Conditions: Delirium

Summary: the current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery.

a comprehensive analysis of patient specific risk factors and predisposing perioperative risk factors will be completed. the objective is to see if delirium incidences are significantly lower in the group that receives a preventative delirium protocol compared to a control group, while not increasing other adverse undesirable side effects. we hypothesize that a preventative delirium protocol will reduce the incidence of delirium compared to the control group (primary outcome), but this protocol may lead to increased side effects such as ponv, poor pain control, and increased awareness (secondary outcomes).

Eligibility criteria:
inclusion criteria: * age \> 65 years * scheduled for elective surgery (outpatient/same-day admit) exclusion criteria: * need emergency surgery * need intracranial surgery * dependent on opiate narcotics * surgeon-specified perioperative procedures that precludes the current study's protocol