Kornimate/medical-research-clean huggingface dataset:
a comparative study on the efficacy of ai temperature-controlled radiofrequency technology and electrical stimulation in the treatment of vulvar leukoplakia

Conditions: Vulvar Lichen Sclerosus

Summary: the study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. the study population was patients with vulvar leukoplakia, and compared the efficacy and safety of ai temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. according to the research purpose, the sample size was calculated and determined to be 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.


Eligibility criteria:
inclusion criteria: 1. diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia; 2. 18 to 60 years old; 3. agree to sign the informed consent; exclusion criteria: 1. patients with severe liver and kidney dysfunction; 2. combined with hiv, syphilis infection, acute vaginitis, cervical cancer; 3. patients with cardiovascular disease; 4. people with hematological diseases; 5. patients with hypertension and diabetes; 6. people with mental illness; 7. pregnant and lactating women.
laryngeal injuries after removal of the tracheal tube: a comparison between sevoflurane and propofol

Conditions: Vocal Cord; Injury, Superficial

Summary: vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. volatile anesthetics increase neuromuscular block of muscle relaxants. thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.

volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. we tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. sixty five patients were randomly assigned to the sevo group (anaesthesia with sevoflurane) or tiva group (anaesthesia with propofol). vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.

Eligibility criteria:
inclusion criteria: * orotracheal intubation * surgery of the ear * written consent * asa i-iii exclusion criteria: * preexisting pathologies of the vocal cords * obesity * difficult airway

Keywords: hoarseness sore throat vocal cord injuries
optical biopsy of human skin in conjunction with laser treatment

Conditions: Malignant Melanoma; Merkel Cell Carcinoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; Atypical Nevi; Congenital Nevi; Seborrheic Keratosis; Paget's Disease; Dermatofibroma; Kaposi's Sarcoma; Port Wine Stain; Hemangioma; Tattoos; Scleroderma; Burns

Summary: this study is to compare the ability of optical biopsy. research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

the optical measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. each measurement requires less than 5 minutes to execute. the measurements will be taken before and after skin treatment.this non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.

Eligibility criteria:
inclusion criteria: * male or female age \> 18 years exclusion criteria: * current participation in any other investigational drug evaluation * inability to understand and carry out instructions
retinal and choroidal microvascular parameters in school-age children in a covid-19 infection pandemic peak in china

Conditions: COVID-19 Pandemic

Summary: we designed this study to examine whether covid-19 infection could lead to retinal and choroidal microvascular involvement in school-age children (6-18 years) in a pandemic peak in china.

this is an observational case-control study. one hundred school-age children who visited the department of ophthalmology at guangzhou first people's hospital in china from february 1, 2023 to march 31, 2023 were included in this study. eighty children with covid-19 infection were included in the case group. controls without covid-19 infection were matched to covid-19 infection cases by a ratio of 1:4 using frequency matching on age and gender. the primary end point of this study is the retinal and choroidal microvascular changes in school-age children during the covid-19 pandemic. secondary endpoint is the

Eligibility criteria:
inclusion criteria: totally 100 school-age children (6-18 years) were enrolled in this study. all subjects had visited the ophthalmology clinic for routine ocular examinations. refraction after ciliary muscle paralysis, myopia ≥ -6.0 spherical diopter, astigmatism ≤ 2.5 cylindrical diopter. exclusion criteria: 1. the child or guardian did not agree to participate in the study. 2. children could cooperate to complete the ocular examination. 3. the child had previous diseases affecting visual function and fundus, except for the diagnosis of refractive error.

Keywords: covid-19 infection retinal microvascular involvement choroidal thickness school-age children
registry investigating the clinical use and safety of the lutonix drug coated balloon for treatment of btk arteries

Conditions: Peripheral Artery Disease

Summary: the study will enroll patients presenting with claudication, or critical limb ischemia (rutherford category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. subjects will be treated with the lutonix drug coated balloon (dcb) carrying the ce mark per current ifu and followed clinically for a minimum of 2 years.

patients will be treated according to hospital routine with anticipated visits 30 days, 6 months, 12months and 24 months after the index procedure. data on rutherford grade, wound healing, patency of the target lesion, concomitant antiplatelet medication and adverse events will be collected.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-breastfeeding female ≥18 years of age; 2. rutherford clinical category 3-5; 3. patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen; 4. significant stenosis (≥70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment; 5. lesion(s) can be treated with available lutonix dcb device size matrix per current instructions for use (ifu); and 6. target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (\<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed). note: outflow must be assessed after pre-dilatation note: more than one artery allowed, but each target vessel must demonstrate inline inframalleolar outflow. exclusion criteria: patients will be excluded if any of the following conditions apply: 1. patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. lutonix btk registry); 2. inability to take recommended medications as stated in the ifu or non-controllable allergy to contrast; or 3. neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).
the role of wearable devices in cardiothoracic surgery: predicting and detecting early postoperative complications

Conditions: Surgery--Complications

Summary: the overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-of cardiothoracic surgical patients to assess recovery and detect complications at their earliest stage

this is a single-center non-randomized prospective cohort study using wearable devices in cardiothoracic surgery patients to detect post-operative complications. patients undergoing cardiothoracic surgery who meet the inclusion and exclusion criteria will be enrolled consecutively with verbal informed consent from the time this protocol is approved by the irb until 1,200 subjects are enrolled. at \~30 days preoperatively the subjects will have a wearable device (such as a fitbit) placed on their wrist and will wear the device until \~180 days post-operatively. this device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear and data will be analyzed by our collaborators at case western reserve university.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older undergoing cardiothoracic surgery that is male or a non-pregnant female and are amenable to using one of the wearable devices of interest (fitbit, iwatch, biostrap). 2. individuals willing to provide informed consent and who have capacity for all study procedures exclusion criteria: 1. individuals with mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with the study protocol. 2. any pregnant participant. 3. severe irreversible pulmonary hypertension. 4. congenital heart disease 5. chronic renal insufficiency or undergoing chronic renal replacement therapy 6. liver cirrhosis
a study of [14 c]-pevonedistat in participants with advanced solid tumors

Conditions: Advanced Solid Tumors, Neoplasms, Advanced Solid

Summary: the purpose of this study is to assess the mass balance (that is, cumulative excretion of total radioactivity \[tra\] in urine and feces) and to characterize the pharmacokinetics (pk) of pevonedistat in whole blood, plasma, and urine, and of tra in plasma and whole blood following a single 1-hour infusion of 25 milligram per square meter (mg/m\^2) \[14c\]-pevonedistat intravenous (iv) solution containing approximately 60 to 85 microcurie (mci) (approximately 2.22-3.145 megabecquerel \[mbq\]) of tra in participants with advanced solid tumors in part a.

the drug being tested in this study is called pevonedistat. pevonedistat is being tested to treat people with advanced solid tumors. the study will enroll approximately 4 to 6 pharmacokinetics (pk)-evaluable participants in part a. after completion of the mass balance and absorption, distribution, metabolism, excretion (adme) assessment in part a of the study, eligible participants will have the opportunity to continue into part b at a secondary study site, which would begin in approximately 2 weeks of completion of part a. * \[14c\]-pevonedistat 25 mg/m\^2 * part b (optional): pevonedistat in combination with chemotherapy regimens (pevonedistat 25 mg/m\^2 + docetaxel 75 mg/m\^2 or pevonedistat 20 mg/m\^2 + carboplatin 20 mg/m\^2 + paclitaxel 175 mg/m\^2) all participants will receive study drug via intravenous route. this multi-center trial will be conducted in hungary. participants will remain confined to the study site for 9 to 14 days in part a. participation in part b is optional, participants will be re-evaluated for inclusion/exclusion criteria before administrating treatment. participants will undergo treatment in part b for a maximum of 12 cycles (21 days cycle each) and will include approximately 36 weeks for part a and b combined. participants will attend an end of study visit 30 days after the last dose of study drug in both part a and b.

Eligibility criteria:
inclusion criteria: 1. have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is felt to be appropriate for treatment with one of the 2 chemotherapy regimens in part b of this study (carboplatin+paclitaxel or docetaxel), or have progressed despite prior standard therapy, or for whom conventional therapy is not considered effective. the tumor must be radiographically or clinically evaluable and/or measurable. 2. eastern cooperative oncology group (ecog) performance status of 0 to 1. 3. expected survival longer than 3 months from enrollment in the study. 4. recovered (that is, less than or equal to \[\<=\] grade 1 toxicity) from the effects of prior antineoplastic therapy. exclusion criteria: 1. has irregular defecation patterns (less than 1 defecation per 2 days or excessive diarrhea) and/or has a history of changes in bowel habits with daily routine or environment changes. 2. prior treatment with radiation therapy involving greater than or equal to (\>=) 25% of the hematopoietically active bone marrow.

Keywords: drug therapy
cirrhotic cardiomyopathy based on point-of-care echocardiography, biomarkers and histology

Conditions: Cirrhotic Cardiomyopathy; Cirrhosis, Liver; Cardiac Disease

Summary: cirrhotic cardiomyopathy is associated with increased risk of complications like hepatorenal syndrome, refractory ascites, impaired response to stressors including sepsis, bleeding or transplantation, poor health related quality of life and increased morbidity and mortality. left ventricular diastolic dysfunction (lvdd) is associated with risk of hepatorenal syndrome (hrs) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (tips) insertion . the echocardiographic e/e' ratio is a predictor of survival in lvdd, with multiple studies, including prospective data from our centre.

the inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to lvdd. in view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality. in this project the investigators will screen critically ill patients with cirrhosis admitted to the intensive care unit for presence of cirrhotic cardiomyopathy and perform point-of-care echocardiography, electrocardiography, and cardiorenal biomarker tests for determination of outcomes in ccm. in patients who do not survive, the cardiac histology will be assessed by ultrasound guided myocardial biopsy to assess degree of inflammation and fibrosis in ccm.

Eligibility criteria:
inclusion criteria: * patients with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following: * age range of 18-65 years * cirrhosis with critical illness admitted to the liver intensive care unit exclusion criteria: * age \>65 years * chronic renal disease * pregnancy and peripartum cardiomyopathy * valvular heart disease * sick sinus syndrome/ pacemaker * transjugular intrahepatic porto systemic shunt (tips) insertion * hepatocellular carcinoma * anemia hb \< 8gm/dl in females, and \< 9 gm/dl in males at the time of assessment
erectile dysfunction in severe obstructive sleep apnea: effects of cpap therapy

Conditions: Obstructive Sleep Apnea; Erectile Dysfunction

Summary: obstructive sleep apnea has been linked to erectile dysfunction. furthermore, small studies suggest that treatment of sleep apnea by continuous positive airway pressure (cpap) may reverse erectile dysfunction in affected patients. the present study aims to investigate in a larger cohort if severe sleep apnea is independently associated with erectile dysfunction and if 6-12 months of cpap therapy lead to an improvement of erectile dysfunction.


Eligibility criteria:
inclusion criteria: * apnea-hypopnea-index \> 30/h * no cpap therapy * male gender * 18-80 years of age * having or attempting to have regular sexual intercourse exclusion criteria: * apnea-hypopnea-index \< 30/h * already treated by cpap * female gender * age \ 80 years * not having or not attempting to have regular sexual intercourse
fingolimod in minimal invasive treatment of intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: intracerebral hemorrhage (ich) is a critical disease of public health importance. inflammatory mechanisms play a significant role in ich. thus, immune targets are supposed to be effective in protecting the neurological function of ich. fingolimod, a sphingosine-1-phosphate receptor regulator (fty720), is an effective immunology modulator. it has been widely used in autoimmune disease and has also been testified effective in ich who received conservative treatment. the present study aims to evaluate the efficiency and safety of fingolimod for ich with minimal invasive treatment.

40 ich patients who meet the inclusion criteria will be enrolled in the present study. all ich patients will be screened. if meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review. after obtaining written consent from the family, patients randomly assigned to the fingolimod group will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days. patients assigned to the control group will not receive fingolimod. all patients will receive minimal invasive puncture and drainage of hematoma. the investigators will evaluate the neurofunctional before and 30 days, 90 days and 180 days after oral fingolimod. ct scan will be performed at before, 7 and 14 days after oral fingolimod. 5ml intravenous blood for flow cytometry is also taken before and 1day, 3days, 7days after fingolimod use.

Eligibility criteria:
inclusion criteria: * spontaneous basal ganglia ich with volume larger than 20ml; * age: 18-80 years; * admission glasgow coma scale score: 5-12; * admitting to hospital with 24 hours after injury; * no fever or signs infection on admission to hospital; * admission heart rate≥60/min on admission. exclusion criteria: * refuse follow-up; * received operation before admitting to hospital; * hemorrhage by tumor, arteriovenous malformation, arterial aneurysm, hematological disease or traumatic brain injury; * severe vomiting; * mrs\>1 before ich; * prior history of bradycardia; * prior history of atrioventricular block; * prior history of traumatic brain injury, craniotomy or stroke; * expected lifetime less than 1 year; * undergoing antitumor, antiepileptic, immunomodulatory or immunosuppressive therapy; * admitting to other ongoing study; * systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence; * received anticoagulant or antiplatelet therapy within 7 days; * intraventricular hemorrhage requires intraventricular catheterization.
creation of a pace-mapping atlas on healthy and pathological hearts

Conditions: Ventricular Tachycardia

Summary: aim of this study is to collect data from pace mapping performed in three groups of patients : patients presenting ventricular tachycardia and infarction history, patients presenting infarction history without presenting ventricular tachycardia, and in patients without structural heart disease.

ventricular tachycardia (vt) represent an important problem in western countries. 350 000 deaths are attributable to ventricular arrhythmias in europe every year. the gold standard treatment is to implant a cardiac defibrillator that will be able to stop arrhythmia by delivering pacing or internal shocks. in order to avoid internal shocks, ablation techniques have been developed, consisting in placing catheters in the left ventricle, to induce the vt, and then to perform a mapping of its circuit. once this circuit is clearly defined, ablation of the critical part of the circuit, so called vt isthmus can be performed, using a radiofrequency power. one of the limitations of this technique is that it requires vt induction during the procedure, and that the vt lasts long enough to enable its mapping. nancy university hospital developed a technique using pace mapping to define the vt isthmus even when the vt is not sustained. the pace mapping technique enables to reveal conduction troubles in the studied ventricles, that correspond with the vt isthmus. during this study, the investigators will collect pace-mapping data from ventricles of patient presenting infarction history and vt, from patients with infarction history without vt, and from patients without ventricular pathology.

Eligibility criteria:
inclusion criteria: * presenting one of these conditions : * patients undergoing a vt ablation and myocardial infarction history * patients with myocardial infarction history without vt history * patients without myocardial infarction history but undergoing an invasive procedure in left atrium (atrial fibrillation or accessory pathway ablation) exclusion criteria: * pregnancy * lvef (left ventricular ejection fraction ) \<20 % * hemorrhagic stroke history

Keywords: sudden cardiac death electrophysiologic exploration myocardial infarction
deep brain stimulation of the anterior nucleus of the thalamus in intractable epilepsy

Conditions: Refractory Epilepsy

Summary: deep brain stimulation (dbs) of the anterior nucleus of the thalamus (ant) has been proposed in patients with severe intractable epilepsy. when used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. to avoid such a complication, the investigators used a transventricular microendoscopic technique.


Eligibility criteria:
inclusion criteria: * adult patients * treated between 2010 and 2019 for refractory epilepsy by dbs of the anterior nucleus os the thalamus using microendoscopy * minimum follow-up of 1-year * refractory epilepsy defined as failure of at least 3 antiepileptic drugs exclusion criteria: - age \< 18 years

Keywords: epilepsy deep brain stimulation thalamus endoscopy stereotaxy
short-course hypofractionated radiotherapy for localized prostate cancer

Conditions: Prostate Cancer

Summary: this study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

this study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Eligibility criteria:
inclusion criteria: * stage t1 and t2 prostate cancer * prostate specific antigen (psa)\>=20 and gleason score\<=6 * psa\<=15 and gleason score 7 * signed informed consent exclusion criteria: * no hip prosthesis, pins or screws * no previous pelvic radiotherapy * no inflammatory bowel disease

Keywords: prostate cancer radiotherapy hypofraction radiosensitivity image-guidance