Kornimate/medical-research-clean huggingface dataset:
evaluation of cognitive state using neurosteer eeg system

Conditions: Cognitive Decline

Summary: this is an observational study. patients who fulfill all inclusion criteria and none of the exclusion criteria will be enrolled in the study, be neurologically evaluated and will go through eeg recordings while listening to an auditory cognitive assessment tool and preforming tasks. eeg recordings will be analyzed using proprietary computational analyses.

one of the major problems in the prevention and treatment of neurological disorders, is the lack of cost effective and reliable tools to assess neurodegeneration on a large scale at a very early stage. although current imaging methods give a clear image of the brain atrophy involved in neurodegenerative disorders, there are deficiencies prohibiting their usage for prevention-scanning of large high-risk population such as high price, long set-up time and the need for trained personnel to conduct the test. an objective tool to asses the level of cognitive decline is therefore needed. such a tool may be used to determine the level of cognitive decline independent of personal interpretation and/or variance between clinicians and provide consistency in assessment across patients and between medical facilities. the neurosteer system provides objective neurological biomarkers using a wearable easy-to-use affordable system. the system facilitate the capture and interpretation of eeg data with only a single patch of electrodes, attached on the subject's forehead. neurosteer examination includes completing auditory tasks while measuring brain activity with the device. the data is analyzed using machine learning methods to produce biomarkers, enabling a report of the patient's activity in real time and offline. the examination is easy to preform and can be conducted in every clinic or in patients' homes. in this study, clinical staff will identify potential subjects and will examine the eligibility of subject according to inclusion and exclusion criteria. patients (or legal guardian) will sign the informed consent form (icf). research staff will set up an assessment session using neurosteer system. in this session the patient will listen to the auditory assessment battery and perform tasks. level of cognition will be assessed by neurosteer technology and statistical analysis will be performed to validate the results.

Eligibility criteria:
inclusion criteria: * men and women over the age of 45. * mmse score \< 30. * mmse score ≥ 10. * patient is able to collaborate. * no other cognitive comorbidity. * no seizure event. exclusion criteria: * advanced stage of cognitive decline (mmse \< 10). * any verbal or non-verbal form of objection from patient or form patient's family member or significant other. * presence of several cognitive comorbidity. * damage to integrity of scalp and/or skull. * skin irritation in the facial and forehead area. * significant hearing impairments. * history of drug abuse.

Keywords: cognition neurology eeg neurosteer
experimental study to evaluate the impact of 18 fluoro-psma (18f-psma) pet / ct in the management of patients with prostate cancer.

Conditions: 18F-PSMA; Prostate Cancer

Summary: single-center, prospective, open-label, not randomized, diagnostic phase ii trial in the management of patients with prostate cancer.

single-center, prospective, open-label, not randomized, diagnostic phase ii trial in the management of patients with prostate cancer. the aim of this study is to evaluate the additional diagnostic role of 18f- psma pet /ct (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. the primary objective is to evaluate the sensitivity of 18f-psma pet/ct defined as the ratio between the number of 18f-psma pet/ct positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.

Eligibility criteria:
inclusion criteria: 1. patients must have histologically or cytologically confirmed prostate cancer 2. male, aged \>18 years on the day of signing and dating the informed consent form. 3. previous radical treatment for prostate cancer (radiotherapy or surgery) 4. negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18f-fmc pet/ct 5. patients with psa progression defined as psa ≥ 0.2 ng/ml and psa rising defined as 2 subsequent values showing psa increase at least 1 week apart. 6. male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter 7. participant is willing and able to give informed consent for participation in the study. exclusion criteria: 1. hormonotherapy in the last 6 months 2. no radiotherapy in the last 6 months. 3. participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date 4. history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent. 5. medical or psychological conditions that would not permit the subject to sign the informed consent

Keywords: 18f-psma pet/ct prostate cancer diagnostic biochemical relapse negative standard imaging radically treated
desi - düsseldorfer esd study

Conditions: Oesophageal Tumour; Gastric Tumours; Duodenal Tumours; Colon Tumours; Rectal Tumours

Summary: safety and effectiveness of endoscopic submucosal dissection

background and study objective the standard of care for premalignant and malignant mucosal lesions in the gastrointestinal track with limited submucosal invasion is an endoscopic resection. a curative resection of the neoplasia often necessitates an en-bloc resection, where the resection ends within healthy tissue (r0 resection). endoscopic submucosal dissection (esd) is a highly sophisticated resection technique for lesions in the oesophagus, stomach, duodenum, colon and rectum. multiple studies in asia already established the safety and efficacy of esd. in several spezialized centres in the western world the esd already replaced the endoscopic mucosal resectiona (emr) as standart of care. the en-bloc resection facilitates an exact histopathological evaluation, thus leading to lower recurrence rates. besides specified mucosal lesions, there is an increase in the use of esd to resect expansive and submucosal lesions. specialised centres like evangelisches krankenhaus düsseldorf have a high number of esd cases and use ubiquitous in the gastrointestinal tract. besides the many advantages over emr there is still the risk of peri- and postinterventional complications with esd due to the highly demanding technique and the longer procedure duration. this is why patient selection is crucial factor (in this study). to evaluate the safety and efficacy of esd more prospective data analysis in western centres are necessary. this data will be useful to develop new approaches to improve the method concerning safety and efficacy and patient selection.

Eligibility criteria:
inclusion criteria: * signed consent form * indication for an esd in the oesophagus, stomach, duodenum, colon or rectum * age \>18 years exclusion criteria: * age \< 18 years

Keywords: esd
an observational study to assess rsv-associated illness in adults with copd and/or chf

Conditions: Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure

Summary: the primary objective of this observational study is to determine the incidence of medically attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease \[aecopd\] or worsening chf) associated with rsv infections in high-risk adults (ie, those with severe copd and/or advanced chf) across multiple consecutive rsv seasons.

it is expected that this observational study will provide further understanding of the clinical impact and true incidence rates of rsv-associated hospitalizations and medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status in adults with copd and/or chf who are at increased risk for serious sequelae associated with rsv infections. as part of the evaluation, this study will collect symptom and physiologic data, and blood, nasal swab, and sputum in order to investigate the relationship of rsv infections with clinical endpoints.

Eligibility criteria:
key inclusion criteria: * age 50 years or greater * hospitalization due to worsening copd and/or chf * severe copd subjects (global initiative for obstructive lung disease stage iii/iv); fev1 \<50% * chronic chf subjects (new york heart association class iii/iv or american college of cardiology-american heart association stage c/d); ejection fraction \< 40% * expects to have direct contact with children at least once a month key exclusion criteria: - participation in another clinical study involving the use of investigational product

Keywords: respiratory syncytial virus, chronic obstructive pulmonary disease, congestive heart failure, observational
the molecular mechanism of cmv-driven nkg2c+nk cell expansion in human

Conditions: Acute Leukemia; CMV Viremia; Hematopoietic Stem Cell Transplantation

Summary: this is an observation study to investigate the molecular mechanism of nkg2c+nk cell expansion after hcmv infection

according to the changes of molecular and gene expression in nk cells at different time points after infection, we want to find out the mechanism by which hcmv promotes the expansion of nkg2c + nk cells.

Eligibility criteria:
inclusion criteria: 1. aml or mds or cml or all undergoing haploidentical stem cells transplantation 2. no severe organ dysfunction or failure 3. subjects must be capable of, and willing to provide written informed consent to participate in the study. subjects unable to provide written informed consent by themselves may be consented through their legal representative. exclusion criteria: 1. participation in another industry-sponsored clinical study where treatment for cmv is already specified by the study protocol. 2. patients received other adoptive immunotherapy such as donor lymphocyte infusion (dli), epstein-barr virus (ebv)-specific t cells and so on.
personalized nutrition to improve recovery in trauma

Conditions: Abdominal Trauma

Summary: the purpose of this study is to determine if a particular method of providing nutrition improves the outcomes of patients in the intensive care unit (icu) who have undergone abdominal surgery following trauma and would require nutrition delivered via the bloodstream (called total parenteral nutrition or tpn). the nutrition method being tested is a structured nutrition delivery plan, called the send home pathway, that involves tpn, oral nutrition supplements, and the use of a device (called an indirect calorimeter or ic) to measure calorie needs. participants will be randomly assigned (like the flip of a coin) to the send home program or standard of care nutrition. in the send home program, participants will receive tpn, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. the control group will follow standard of care nutrition delivery that begins during icu stay and concludes at hospital discharge. participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass and complete walking and strength tests, and surveys about quality of life.

severe abdominal trauma can impact patients in a variety of ways. current data shows that trauma patients can experience problems with physical function, muscle weakness, and poor quality of life after they are released from the hospital. there is a critical need to improve nutrition in trauma patients with severe abdominal injuries to optimize the recovery process. the purpose of this study is to evaluate if the use of a planned nutrition delivery plan with early intravenous (iv) nutrition will improve outcomes. participants will be randomly assigned 1:1, like flipping a coin, to the send home program or routine care. participants in the standard of care program will receive standard nutrition delivery as determined by clinical care providers. this may include tpn. participants in the send home program will receive tpn within 72 hours of abdominal surgery. indirect calorimetry will be used to determine nutrition needs.once participants are able to have a liquid diet they will receive nutrition shakes up to 3 times a day while in the hospital and for 4 weeks after discharge. participants will undergo tests to measure muscle mass, have blood draws, complete walking and strength tests, and surveys about quality of life. these tests will be done at several times throughout hospitalization and participants will be asked to return for a 3 month follow-up visit.

Eligibility criteria:
inclusion criteria: * 18+ years old * penetrating abdominal trauma requiring emergent major abdominal surgery * admitted to the surgical icu * not expected to receive oral nutrition for 72 hours or more exclusion criteria: * patients who are unable to ambulate at baseline * expected withdrawal of life-sustaining treatment within 48 hours * prisoners * positive pregnancy test for women of child bearing potential.

Keywords: precision nutrition critical care trauma parenteral nutrition indirect calorimetry
electronic compliance monitoring in opioid substitution treatment

Conditions: Opiate Dependence

Summary: the purpose of this study is to improve unsupervised dosing of opioid substitution medications. the aim of the study is to examine whether electronic compliance monitoring provides some advantages to patients'treatment and what kind of patients especially benefit from monitoring. we would also like to know if electronic compliance monitoring can prevent the abuse/diversion of medications and how implementing this method to wider treatment facilities succeeds.


Eligibility criteria:
inclusion criteria: * opiate dependence f11.22 according to icd-10 * suboxone treatment * the duration of substitution treatment before study at least one month * stable medication dose exclusion criteria: * unstable situation in life according to treatment staff's opinions

Keywords: opiate dependence substitution treatment unsupervised dosing monitoring
embrace and quality of life

Conditions: Epilepsy, Tonic-Clonic

Summary: a prospective, open, randomized, pilot clinical trial which aims the assessment of quality of life (qol) in epilepsy outpatients equipped with a wrist-worn biosensor that provides measures of electrodermal activity and accelerometry. these measures are used to automatically detect epileptic seizures that are transmitted to a mobile phone-based system for alerts and recording.


Eligibility criteria:
inclusion criteria: * male or female aged \>18 years old * clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure * primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic convulsion * seizure frequency \> 1 seizure/month during the last three months * signed the informed consent form * own a mobile phone device compatible with the embrace apps * able to use the device without help from caregivers exclusion criteria: * patients aged less than 18 years old * epilepsy diagnosis remains uncertain * evidence of psychogenic non epileptic seizures * seizure frequency below 1/month during any of the three previous months * past-history of nickel allergy and contact dermatitis * did not sign the informed consent form * does not own mobile phone device compatible with the embrace apps * cognitive or behavioral impairment preventing compliance or correct use of the device and app.

Keywords: epilepsy mhealth quality of life
study evaluating retinal health monitoring system visual acuity module.

Conditions: Age Related Macular Degeneration

Summary: assess the performance and usability of the rhms visual acuity module.

this 510(k)-enabling study is designed to assess the performance and usability of the rhms visual acuity module in normal patients and patients with neovascular amd.

Eligibility criteria:
inclusion criteria: cohort 1 - normal subjects 1. age ≥ 50 years 2. corrected distance or near visual acuity (va) of ≥ 20/25 snellen equivalent, in the study eye 3. able to perform self-testing with the visual acuity module of the rhms after training 4. able and willing to give informed consent cohort 2 - subjects with neovascular amd 1. age ≥ 50 years 2. history of neovascular age-related macular degeneration, in the study eye 3. corrected distance or near va of ≥ 20/200 snellen equivalent, in the study eye exclusion criteria: cohort 1 - normal subjects 1. history of ophthalmic disease resulting in decrease in visual acuity per the investigator, in the study eye 2. use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days cohort 2 - subjects with neovascular amd 1. history of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye 2. history of macular hole in the study eye 3. use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days

Keywords: age-related macular degeneration visual acuity
ocular surface tolerability study of prostaglandin analogues in patients with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (lumigan® 0.01%), travoprost ophthalmic solution 0.004% (travatan z®) and latanoprost ophthalmic solution 0.005% (xalatan®) in patients previously treated with xalatan® who have open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication * best corrected visual acuity score of 20/100 or better in both eyes * females on birth control pills must be on same type of pill and dose for at least 3 month exclusion criteria: * use of lumigan® 0.01%/lumigan® rc, lumigan®, travatan® or travatan z® within 6 months * history of or active ocular infection/inflammation (eg, uveitis) * punctal plug use * required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable) * intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months * history of corneal refractive laser surgery (eg, lasik, lasek) in study eye(s) * planned contact lens wear during study
evaluation of monthly replacement lenses in habitual soft contact lens wearers who report frequent digital devise use

Conditions: Ametropia

Summary: to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (frp) lenses when worn for 1-month.

this study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different frp lens types. each lens type will be worn for approximately one month.

Eligibility criteria:
inclusion criteria: 1. is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. self-reports having a full eye examination in the previous two years; 5. self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone; 6. has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator; 7. anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; 8. habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (note: the habitual contact lens brand was restricted such that no more than one third were to be biofinity energys brand (or their equivalent private label brand name) and no more than one third were to be alcon brand); 9. has refractive astigmatism no higher than -0.75dc in each eye; 10. can be fit and achieve binocular distance vision of at least 20/30 snellen (available lens parameters are sphere +6.00 to -6.00d, 0.25d steps). exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active ocular disease and/or infection that contraindicates contact lens wear; 3. has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; 5. has known sensitivity to the diagnostic sodium fluorescein used in the study; 6. self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. has undergone refractive error surgery or intraocular surgery.
differences in urine ngal levels in patients undergoing rirs with or without ureteral access sheath

Conditions: Urolithiasis

Summary: this study will include patients aged between 18 and 65 who will undergo retrograde infrarenal surgery (rirs) due to renal stone(s). a total of 60 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 30 patients in each group. the first group of patients will undergo rirs with a ureteral access sheath (uas) positioned prior to surgery; and the second group will undergo rirs without uas. as use of uas decreases the pressure in the renal pelvis during rirs, it is aimed to evaluate whether using uas or not affects the kidney functions. besides the routine kidney function tests, namely urea and creatinine, neutrophil gelatinase-associated lipocalin (ngal) (a more specific and early marker of kidney function) will be used to assess the differences in the kidney functions. preoperative blood urea and creatinine levels and urine ngal levels will be studied for all patients. after the surgery, blood urea and creatinine levels will be again studied as well as urine ngal levels at postoperative 2nd hour, 72nd hour and 1st week.


Eligibility criteria:
inclusion criteria: * being between 18-65 years old * having an indication of retrograde infrarenal surgery (rirs) due to kidney stone exclusion criteria: * patients with uncontrolled diabetes mellitus and diabetic nephropathy * patients with blood pressure \> 140/80 mmhg despite regular use of antihypertensive agent(s) * patients with chronic kidney failure who need dialysis * patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier * patients who have had pyelonephritis 3 months or much earlier * patients younger than 18 years or older than 65 years * patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests * patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session

Keywords: kidney kidney stone ngal ureterorenoscopy intrarenal surgery kidney function