Kornimate/medical-research-clean huggingface dataset:
seizure prophylaxis in aneurysm repair

Conditions: Intracranial Aneurysms; Seizure

Summary: after a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. in other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. the utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. the investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. the study will be extended to june 2024 to allow for a 5 year follow up of the last enrolled patient in june, 2019.


Eligibility criteria:
inclusion criteria: * adult (≥18 years) * presence of intracranial aneurysm (with or without rupture) * treating surgeon has recommended surgical repair of the aneurysm exclusion criteria: * history of seizures within last 10 years * history of epilepsy * history of prior stroke * currently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.) * brain tumor * pregnant or nursing woman * known levetiracetam allergy
a study of sintilimab combined with concurrent chemoradiation therapy in locally advanced cervical cancer

Conditions: Uterine Cervical Neoplasms; Sintilimab

Summary: this is a single-arm, single-center phase ii clinical study to explore the efficacy and safety of sintilimab combined with concurrent chemoradiation therapy as treatment in women with locally advanced cervical cancer.


Eligibility criteria:
inclusion criteria: * has high-risk locally advanced cervical cancer (lacc): the international federation of gynecology and obstetrics (figo) 2018 stage ib3 or figo 2018 stages iia2-iva. * has an eastern cooperative oncology group (ecog) performance status of 0 or 1 * has radiographically evaluable disease, either measurable or non-measurable per recist 1.1 * adequate hematological, renal and hepatic functions:hemoglobin \> 9.0 g/dl; neutrophils \> 2000 cells/μl; anc \> 1.5 × 10\^9/l;platelets \> 100 × 10\^9/l; exclusion criteria: * has received prior therapy with an anti-programmed cell death receptor 1 (pd-1), anti-programmed cell death receptor ligand 1 (pd-l1), or anti-programmed cell death receptor ligand 2 (pd-l2) agent or with an agent directed to another stimulatory or co-inhibitory t-cell receptor (eg, cytotoxic t-lymphocyte-associated protein 4 (ctla-4), ox-40, cd137). * has a known history of human immunodeficiency virus (hiv) infection. * prior malignancies (other than curable non-melanoma skin cancer) within 5 years
assessing the usability and clinical utility of the congo red dot test: a case-control study

Conditions: Preeclampsia

Summary: a case-control study will evaluate the clinical utility of the congo red test gv-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period

a case-control study (n=150) will evaluate the clinical utility of the congo red test gv-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period. women with preeclampsia (n=100) (cases) and clinically healthy women (n=50)(controls) who are hospitalized postpartum will be recruited for the trial. all women will be asked to provide a urine sample. samples will be collected daily during a woman's hospitalization. the congo red test gv-005 and a standard urine dipstick proteinuria test will be performed by a lab technician within 72 hours of sample collection. the purpose of this research is to evaluate progression of urine congophilia postpartum by following patients diagnosed with preeclampsia and clinically healthy women.

Eligibility criteria:
inclusion criteria: * postpartum * clinical diagnosis of preeclampsia (severe, mild or superimposed) including eclampsia (n=100) or clinically healthy (n=50) * eligible to consent for research * agree to comply with study procedures * able to give informed consent exclusion criteria: * none

Keywords: congo red test gv-005
therapeutic response of sodium-glucose co-transporter type-2 inhibitor in non-diabetic mafld patients: a pilot study

Conditions: Metabolic Associated Fatty Liver Disease

Summary: the goal of this single arm, prospective study is to test the therapeutic response of oral dapagliflozin (forxiga) 10 mg/day for 24 weeks in non-diabetic mafld patients. the primary outcomes are the improvement of liver inflammation or fibrosis parameters after 24 weeks treatment. the adverse events were also recorded.

this is single-arm, prospective study and 50 non-diabetic mafld patients are enrolled consecutively at taipei tzu chi hospital. the non-diabetic definition is no previous history of diabetes mellitus and hba1c \ 35 u/l in male and \>25 u/l in female) or fib-4 \>=1.45. those with cancer history, systolic blood pressure \< 100 mmhg, or egfr \< 30 ml/min/1.73m2, or history of urinary tract infection/genital yeast infection were excluded. they received oral dapagliflozin (forxiga) 10 mg/day for 24 weeks. the primary outcomes are the change of liver inflammation marker (serum alt level)or fibrosis parameters after 24 weeks treatment. the adverse events were also recorded. the severity of liver fibrosis was determined using nafld-fibrosis score and ultrasound-based elastography method (arfi). total 6 visits visit 1 (screening): us, arfi, body composition measurement, bp, bmi, waist circumference, body fat (%), ast/alt, albumin, ggt, cr, tg, cho, hdl/ldl, glucose ac, hba1c, platelet, insulin, crp visit 2 (2 weeks): bp, ast/alt, cr visit 3 (4 weeks): bp, bmi, waist circumference, body fat (%), ast/alt, albumin, ggt, cr, tg, glucose ac, hba1c, platelet visit 4 (3 months):bp, bmi, waist circumference, body fat (%), ast/alt, albumin, ggt, cr, tg, glucose ac, hba1c, platelet visit 5 (6 months): us, arfi, body composition measurement, bp, bmi, waist circumference, body fat (%), ast/alt, albumin, ggt, cr, tg, cho, hdl/ldl, glucose ac, hba1c, platelet, insulin, crp visit 6 (month 3 off-therapy): bp, bmi, waist circumference, body fat (%), ast/alt, albumin, ggt, cr, tg, cho, hdl/ldl, glucose ac, hba1c, platelet record adverse events and number of pills left in each visits

Eligibility criteria:
inclusion criteria: * mafld patients (hepatic steatosis plus metabolic dysfunction * alt elevation (\>35 u/l in male and \>25 u/l in female) or fib-4 \>=1.45 exclusion criteria: 1. diabetes history or hba1c\> 6.5 2. cancer history 3. systolic blood pressure \< 100 mmhg 4. egfr \< 30 ml/min/1.73m2 5. history of urinary tract infection/genital yeast infection
predictivity of hemogasanalysis and lung ultrasound in determining covid-19 severity

Conditions: Covid19

Summary: this retrospective-prospective longitudinal observational study was designed to evaluate the role of bedside lung ultrasound per se and in association with hemogasanalysis parameters in predicting the severity of covid-19 patients in the emergency departement (ed). retrospective data regarding patients who presented at the ed of irccs san raffaele hospital from 10/11/2020, together with those acquired by the observation of patients who will access to the ed until 10/05/2021 will be collected, configuring a total enrollment period of 6 months. clinical informations about patients' medical history will be recorded, with particular focus on the type and date of onset of the symptoms. the diagnostic and therapeutic strategy will be chosen according to the current standard of care. results of bedside lung ultrasound, together with vital parameters, blood gas analysis, laboratory and other findings will be recorded. the primary outcome will be defined as patients' outcome at time of discharge from the ed, in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death). secondary outcomes will be patients' prognosis 30 days after access to ed and the required intensity of care (eg need for non-invasive ventilation, oro-tracheal intubation).the follow-up 30 days after access to the ed will be evaluated by telephone survey or by consulting medical records.


Eligibility criteria:
inclusion criteria: * sars - cov 2 infection confirmed by positive rt-pcr on nasopharyngeal swab exclusion criteria: * impossibility to perform lung ultrasound due to technical limitations.
memory enhancement using transcranial alternating current stimulation

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Summary: the 32 million alzheimer's disease (ad) and 69 million prodromal ad patients worldwide contribute to a large economic burden. effective and safe therapies that slow or prevent the progression from mild cognitive impairment (mci) to ad are therefore of high priority. transcranial alternating current stimulation (tacs) is a safe and patient-friendly non-invasive brain stimulation technique that serves as a potential candidate for reducing and/or slowing cognitive impairment. application of tacs in the gamma frequency range, specifically around 40 hz, has been studied in patients with ad and mci due to ad. in these patients, a single session of 40 hz tacs at the precuneus showed to improve episodic memory and to increase gamma power, as measured with electroencephalography. these findings will be replicated in the current study in patients with mci due to ad, using magnetoencephalography (meg) recorded before, during and after tacs. in this way, brain activity and network changes that underlie this improvement in episodic memory can be studied with greater temporal and spatial detail.


Eligibility criteria:
inclusion criteria: * recent (not more than 6 months ago) amnestic mci diagnosis, which consensus is obtained in a multidisciplinary meeting after an extended multidisciplinary test battery at the memory clinic, including confirmation of ad pathology with cerebrospinal fluid biomarkers: abnormal p-tau/aβ42 ratio of \> 0.023 exclusion criteria: * suffering from serious neurological, psychiatric or somatic comorbidity * suffering from epileptic seizures or severe claustrophobia * intensive use of psychoactive medication * having a cardiac pacemaker, internal cardiac defibrillator or other intracorporeal device that interferes with meg recordings

Keywords: alzheimer's disease transcranial alternating current stimulation episodic memory magnetoencephalography
jab-2485 activity in adult patients with advanced solid tumors

Conditions: Solid Tumors; ER+ Breast Cancer; Triple Negative Breast Cancer, TNBC; ARID1A Gene Mutation; Small Cell Lung Cancer, SCLC

Summary: this study is to evaluate the safety and tolerability of jab-2485 monotherapy in adult participants with advanced solid tumors.

the primary objective of this study is to evaluate the safety and tolerability of jab-2485 monotherapy to determine the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d) during dose escalation phase when administered in participants with advanced solid tumors; then to further evaluate preliminary antitumor activity of jab-2485 monotherapy at the rp2d during dose expansion phase in patients with advanced solid tumors such as er+ breast cancer, triple negative breast cancer (tnbc), at-rich interaction domain 1a (arid1a) mutant solid tumors and small cell lung cancer (sclc).

Eligibility criteria:
inclusion criteria: * must have eastern cooperative oncology group (ecog) performance status of 0 or 1 * must be able to provide an archived tumor sample * must have histologically or cytologically confirmed metastatic or locally advanced solid tumor * dose expansion phase cohorts must meet specific expression or gene mutation where indicated * must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition * must have at least 1 measurable lesion per recist v1.1 * must have adequate organ functions * must be able to swallow and retain orally administered medication exclusion criteria: * has central nervous system (cns) metastases or carcinomatous meningitis, except if cns metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days * active infection requiring systemic treatment within 7 days * active hepatitis b virus (hbv), hepatitis c virus (hcv), or hiv * any severe and/or uncontrolled medical conditions * left ventricular ejection fraction (lvef) ≤50% assessed by echocardiogram (echo) or multigated acquisition scan (muga) * qt interval using fridericia's formula (qtcf) interval \>470 msec * experiencing unresolved ctcae 5.0 grade \>1 toxicities * clinically significant eye disorders
effects of the micro reinjection of autologous adipose tissue in the face of patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: this prospective single-center study evaluates a current care procedure. it includes 14 patients diagnosed with ssc according to the acr/eular criteria or the leroy \& medsger criteria of the disease. patients are enrolled if they wish for a therapeutic care of their face, have a mouth handicap in systemic sclerosis (mhiss) score greater than 20 (scale 0-48), a modified rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth opening less than 55 millimeters. they should not have anticoagulant, anti-platelets aggregation medication or a daily steroid dose upper 20mg per day. their bmi should exceed 17. micro fat grafting is a minimally invasive and usual procedure performed under local anesthesia. fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm diameter cannula from areas around the knees, the abdomen or the hips under a gentle aspiration. lipoaspirated fat is then filtrated by the puregraft system that offers a sterile, closed, single-use system, leading to a fast, consistent and controlled preparation. then, 10 to 25 milliliters of this purified fat product is transferred through a 21 gauge or 0.8 mm diameter cannula in two or four points of the face, with the entry points located around the mouth.


Eligibility criteria:
inclusion criteria: * patients older than 18 or younger than 80 years. * suffering from systemic scleroderma. * patient follow-ap-hm. * score of 20 or greater mhiss. * score rodnan level greater than or equal to one face. * mouth opening (inter-incisor distance) \<5.5 cm * wishing to receive surgery at the face. exclusion criteria: * less than 18 or greater than 80 age. * decaying history of abdominal surgery. * body mass index lower than 18. * coagulation disorders. * allergy to xylocaine. * greater than 20mg / d steroids. * severe infection. * inmates. * pregnant women. * adults protected by law (under guardianship and trusteeship). * no affiliation to a social security scheme.
intracardiac echocardiography guided watchman device implant

Conditions: Atrial Fibrillation; Left Atrial Appendage Thrombosis

Summary: this study is to look at the success of intracardiac echocardiography (ice) in the watchman procedure. currently the process is to use a transesophageal echocardiography (tee) to place the watchman in patients. this study is aiming to show how the ice is just as effective in placing the device correctly and effectively.

left atrial appendage occlusion is approved as an indicated therapy for patients with non valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance of long term use of oral anticoagulants. concurrent procedural tee is an integral part of the procedure. it is used to guide trans-septal puncture, device sizing and assessment of final adequacy of device implant. tee requires the participation and guidance of a cardiac imager and because the tee probe is in place for a relatively long duration the procedure, the procedure is most commonly performed under general anesthesia. furthermore tee can be associated with risk of injury to the oropharynx and esophagus. our ongoing clinical experience and known literature suggest that tee may not be necessary for the overall success of the procedure. the objective of the study is to investigate a new work flow that may ultimately demonstrate that intra-procedural tee may not be necessary, obviating the need for additional personnel, general anesthesia and decreasing overall risk. ice has been widely used to aid trans-septal puncture and visualize left atrial anatomy. smaller studies and case series have reported the use of ice as an alternative to tee in guiding watchman device implant. this has not been compared systematically with tee in a large patient sample.

Eligibility criteria:
inclusion criteria: * all patients who meet guideline established criteria for commercially available watchman device implant and not enrolled in an active clinical trial exclusion criteria: * patients in whom a procedural tee cannot be performed and an ice only implant is needed. * patients receiving a concomitant ablation procedure * patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures * patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (pfo) or atrial septal defect (asd) closure devices in place).
the effect of hot perfoming on the soles of the feet in the first stage of labor on labor

Conditions: Pregnancy Related

Summary: this research was conducted to determine the effect of applying heat to the soles of the feet during the active phase (5-10 cm dilation) of the first stage of labor. it is a randomized controlled experimental study. in the intervention group, hot gel packs with a temperature of 40-42°c were applied to the soles of the feet for 20 minutes when the cervical dilation was 5 cm. these applications were repeated in the same manner at one-hour intervals until the cervical dilation reached 10 cm. the procedure was terminated when the cervical dilation reached 10 cm. routine services were applied to the control group. data were collected using a personal information form, partograph form, apgar score, visual analog scale (vas), and birth satisfaction scale short form (bss-sf)

this research was conducted to determine the effect of applying heat to the soles of the feet during the active and transition phase (4-10 cm dilation) of the first stage of labor. the research is a randomized controlled experimental study and is conducted in sivas cumhuriyet university practice and research hospital maternity unit. when the sample size was taken as α = 0.05 and β = 0.10 and 1-β = 0.90 to represent the population in the research, there were 30 individuals in each group and the power of the test was found to be p = 0.90640. the application procedure started with the application of hot gel packets at a temperature of 40-42°c to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm. the first visual analog scale (vas) evaluation was conducted after the application. conduction is followed by more evaluations at the 25th (5 minutes after the application), 35th (15 minutes after the application), and 50th minute (30 minutes after the application). these applications were repeated every hour until cervical dilation reached 10 cm. the applicatilon procedure has been stopped after cervical dilation reached 10 cm. the control group received routine service and vas at the same times. data were collected with personal information form, partograph form, apgar score, visual analog scale (vas) and birth satisfaction scale short form (bss-r) wilcoxon test, mann whitney u test, chi-square test, exact test, friedman test, t test were used to evaluate the data. the data error level was accepted as 0.05.

Eligibility criteria:
inclusion criteria: * 1. the pregnant woman must be 19 years or older 2. 38-42. being in the gestational age, 3. having a singleton pregnancy, 4. the fetus is in a vertex position, 5. cervical dilatation is 5 cm. to be, 6. not having a diagnosed chronic physical disease, 7. not having a diagnosed psychiatric disease, 8. absence of risky pregnancy and birth, 9. there is no abnormality in the fetus, 10. being able to speak turkish and be literate 11. having a primigravida exclusion criteria: * not meeting inclusion criteria

Keywords: labor pain, birth satisfaction, midwifery, heat application
pleural effusion drainage in mechanically ventilated patients monitored by eit

Conditions: Pleural Effusion; Drainage; Electric Impedance Tomography

Summary: evacuation of pleural effusion (pe) represents a disputable therapy in mechanically ventilated patients. patients on mechanical ventilation indicated by the physician to pleural fluid evacuation will be monitored throughout the procedure by electrical impedance tomography (eit) and concurrently end-expiratory lung volume (eelv) will be measured in order to describe impact of pe evacuation on aeration and ventilation of the lungs.

critically ill patients treated in intensive care units have a disorder of distribution and volume of body fluids due to principal illness and some therapeutic interventions. one of its manifestations is pleural effusion (pe) formation. patients on mechanical ventilation indicated by treating physician to pleural fluid evacuation will be monitored throughout the procedure by electrical impedance tomography (eit) and concurrently end-expiratory lung volume (eelv) will be measured. the purpose of the study is to better understand impact of pe evacuation on aeration and ventilation of the lungs.

Eligibility criteria:
inclusion criteria: * mechanical ventilation, presence of pleural effusion, decision of the treating physician to drain it exclusion criteria: * impossibility to apply eit belt or to find suitable save point for drainage when the eit belt is attached * standard eit exclusion criteria according to the device manufacturer

Keywords: mechanical ventilation pleural effusion eit
development and management of registry in patients with gynecologic cancer in korea

Conditions: Cervical Cancer; Endometrial Cancer; Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: the goal of this observational study is to identify and analyze the characteristics, treatment trends, prognostic factors and survival prognosis of korean gynecologic cancer patients. ultimately, the final goal is to contribute to the development of safe surgical methods and treatment for gynecologic cancer to improve survival rates.

cervical cancer, endometrial cancer, and ovarian cancer represent gynecologic cancers. there are many open issues that need to be addressed, specifically the surgical method, disease recurrence and survival outcome in the so called "real world" setting. the aim of this observational study is to collect both retrospective and prospective medical information of gynecologic cancer patients.

Eligibility criteria:
inclusion criteria: * female patients 18 years or older * written informed consent (prospective cohort) * confirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer exclusion criteria: * unconfirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer
study on cardiovascular health, nutrition and frailty in older adults in spain

Conditions: Physical Disability; Cardiovascular Risk Factors

Summary: the purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles, biological risk factors, either well-established or emergent, and the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).


Eligibility criteria:
inclusion criteria: * non-institutionalized spanish resident * 60 years and over exclusion criteria: * none

Keywords: cardiovascular health diet functional limitations frailty older adults