Kornimate/medical-research-clean huggingface dataset:
rectal tumor resection using the uni-vec multichannel transanal access device

Conditions: Rectal Polyp; Rectal Polyps; Rectal Lesion; Sessile Colonic Polyp; Pedunculated Colorectal Polyps

Summary: the aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named uni-vec) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). this is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial).


Eligibility criteria:
inclusion criteria: * all polyps included in the paris classification (polypoid (0-i): sessile type (is), pedunculated type (ip), non-polypoid (0-ii, iii): raised type (iia), flat type (iib), depressed type (iic), excavated type (iii)) * lesions located from the anal margin to about 20 cm. * extent of at least 2 cm² (polyps 2 cm in diameter or areas of erm or esd 2 x 2 cm). * well or moderately differentiated tumours. t1: tumours confined to the mucosa (tis) and submucosa (t1). * no positive lymph nodes. * no lymphatic, vascular or perineural invasion. exclusion criteria: * are considered vulnerable subjects. * they suffer from hematological diseases with altered coagulation of their own or pharmacologically induced coagulation disorders (the use of acetylsalicylic acid (asa) in doses of 150 mg/day is permitted). * have rectal lesions that lie above the pectineal line or extend into the anal canal. * local or distant metastasis. * have a score of more than 2 points on the wexner faecal incontinence scale.

Keywords: first-in-human study transanal multi channel device medical device
the paternal clock: uncovering the consequences of advanced paternal age on sperm dna fragmentation

Conditions: Infertility, Male

Summary: sperm dna fragmentation (sdf) serves as a marker for chromatin and dna damage in sperm. assessing sperm dna integrity is crucial in male fertility evaluation since high levels of sdf are associated with a greater number of adverse reproductive outcomes, including an increased risk of miscarriage and birth defects. recent research suggests that advanced paternal age (apa) may lead to dna damage in sperm, however the precise age at which this risk becomes apparent has not yet been clearly defined, necessitating the identification of the point in time at which high sdf levels occur. with the help of this knowledge, male infertility can be diagnosed with greater accuracy, and infertile couples can receive appropriate care.


Eligibility criteria:
inclusion criteria: * male of at least 18 years of age
self-testing diagnosis imaging model for diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: this is a prospective clinical study. at the shaoguan diabetic eye screening programme, patients ages 30-80 will undergo the two diagnostic models: (1) in a remote diagnostic clinic site, patients undergo a self-testing device that provides both color retinal photography (crp) and optical coherence tomography (oct) imaging of nondilated pupils, and receive an online consultation provided by a retinal specialist; (2) on a separate day, patients visit the tertiary hospital, undergo traditional imaging of dilated pupils acquired by a non-expert imager using a traditional crp imaging device at the point of care, and receive a face-to-face consultation provided by a retinal specialist. within one week of receiving both diagnostic imaging services, patient preferences are assessed and they decide which diagnostic imaging model is preferred.


Eligibility criteria:
inclusion criteria: 1. who are enrolled in the shaoguan diabetic eye screening programme for their eye check-up 2. who are diagnosed with diabetes and aged between 30 years and 80 years 3. be able to sit for an imaging device for image acquisition 4. be capable of giving their own consent exclusion criteria: 1. who are pregnant or nursing women
calcitonin level and new-onset of post-operative atrial fibrillation

Conditions: Calcitonin Secretion Disorder; Post-operative Atrial Fibrillation

Summary: post-operative atrial fibrillation (poaf) is one of the common complicaiton following cardiac surgery, occurring in approximately 20%-40% patients. although poaf is associated with longer hospital stays, most poaf is short lived and resolves in the 2-4 days afer cardiac surgery. however, a recent meta-analysis showed significant increases in 1,5, and 10 year mortality in poaf patients (odds ratio:1.60, 2.60, 1.51;95% confidence intervals: 1.52 to 1.68, 2.00 to 3.38, 1.43 to 1.60;p \<0.0001), the combined adjusted risk of death (16 studies, n =84,295) was also significantly increased in patients with poaf (hazard ratio: 1.25;95% confidence interval: 1.2-1.3;p \< 0.0001). these data highlight the need to understand better the underlying mechanism of poaf. a latest research in nature reported levels of circulating calcitonin (ct), which is the main risk factor for atrial fibrillation (af). global disruption of ct receptor signalling in mice causes atrial fibrosis and increases susceptibility to af. here we will explore the relationship between ct and poaf.


Eligibility criteria:
inclusion criteria: * 1. clinical diagnosis of no history of atrial fibrillation/flutter; * 2. heart rate ≥50 beats/min; * 3. ef \> 40%; * 4. no history of emergency cardiac surgery in our hospital; * 5. participate voluntarily and sign the informed consent, and can accept the follow-up of more than 2 years. exclusion criteria: * 1. atrial fibrillation/flutter; * 2. left atrial diameter \>5.5cm; * 3. previous cardiac surgery or emergency surgery (\<12h); * 4. sick sinus node syndrome; * 5. ventricular preexcitation or preexcitation syndrome; * 6. second degree or above atrioventricular block; * 7.myocardial infarction occurred within 7 days; * 8. infection, sepsis, rheumatic or inflammatory diseases; * 9. abnormal liver and kidney function (three times higher than the upper limit of normal); * 10. uncontrolled hyperthyroidism, severe obstructive sleep apnea, and acute alcoholism; * 11. any ischemic events (stroke or tia) that occurred 180 days before the participant signed the informed consent, or any known unresolved complications from previous stroke/tia;thrombosis; * 12. patients with other diseases requiring radiotherapy, chemotherapy and long-term hormone therapy; * 13. patients' life expectancy makes it unlikely that follow-up will be completed; * 14. participate in, or are expected to participate in, other clinical trials of any drugs, devices or biologics during the study period; * 15. patients with contraindications to dynamic electrocardiogram; * 16. patients who are unwilling or unable to fully comply with study procedures and follow-up.

Keywords: post-operative atrial fibrillation calcitonin cardiac surgery
the covid-icu healthcare professional study

Conditions: COVID-19; Critical Care; Intensive Care Units; Health Personnel

Summary: the project is a longitudinal cohort study based on an electronic questionnaire on views and experiences of covid-icu health care professionals during the pandemic. in addition, a few of the informants participating in the cohort study will be asked to participate in focus groups to get a deeper understanding of the experiences of health care professionals. leaders at the randomized hospitals will be asked to participate in individualized interviews.

health care professionals in intensive care units (icu) are working front-line with coronavirus disease (covid-19) patients with severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in need of intensive care treatment. data collected will identify the health care professionals' (nurses, medical doctors, leaders) views and experiences from the planning period of covid-19 icu units until a follow-up at 12 months.themes to be covered in the survey are organization, information, communication across disciplines, education, practical implementation, use of personal protective equipment, daily working conditions and psychosocial aspects. the oslo university hospital/university of oslo, gdpr (general data protection regulation) compliant "tsd"-services for sensitive data web-based solution "nettskjema" will be used combined for consent form and data collection from the survey. it is within the scope of the study to perform sub analysis on background variables as profession related to daily working experiences on covid-icu and psychosocial aspects. a few of the informants (medical doctors, nurses, leaders) participating in the cohort study will randomly (computerized) be asked to participate in focus groups to get a deeper understanding of the experiences of the health care professionals during the pandemic and after the pandemic when they are back to a normal working condition. leaders at the randomized hospitals will be asked to participate in individualized interviews. data from the focus group interviews and individual interviews will be taped on a recorder approved by data protection officer at oslo university hospital and then stored at a secured computerized research place at oslo university hospital. the gained knowledge from both the survey, the focus group interviews and individual interviews in this study may guide hospital directors and the government in follow up of health care professionals and to prepare for a later pandemic.

Eligibility criteria:
inclusion criteria: all health care professionals (nurses, medical doctors, leaders) working in all covid-icus in norway will be invited to participate in this project. exclusion criteria: no exclusion criteria
blood biomarkers as predictors of covid-19 disease progression in recently infected kidney transplant patients

Conditions: Kidney Transplant; Complications; Coronavirus Infection

Summary: sars-cov-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (il-6). the apparently strong association between blood levels of inflammaory cytokines and sars-cov-2 disease severity has led clinicians to evaluate the administration of steroids or anti-il-6 antagonists in severely ill patients. as of this day, biomarkers capable of predicting clinical disease progression in covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal. because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis formulate and intend to test is that innate il-6 responsiveness varies between recently infected covid-19 patients and could predict disease outcome. to test this hypothesis, the investigator propose to follow recently infected kidney transplant patients with moderate covid-19 symptoms. these patients stand a higher risk to progress to severe disease. the staff plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. after incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for il-6 content. associations between il-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 covid-19 kidney transplant patients with moderate symptoms followed in 9 centers.


Eligibility criteria:
inclusion criteria: * kidney or kidney-pancreas or kidney-heart transplant patients; * sars-cov-2 positive (rt-pcr); * covid-19 symptoms at least once over a 8-day period preceding inclusion; * hospitalized or outpatients in one of the study centers: chu de nice, chu de strasbourg, hôpital necker (aphp), hôpital kremlin bicêtre (aphp), hôpital pitié-salpétriêre (aphp), hospices civils de lyon, chu de saint-etienne, chu de montpellier, hôpital la conception (aphm); * age \> 18 years; * free and informed consent. exclusion criteria: * age \> 85 years ; * kidney-liver transplant patients; * onset of symptoms (fever and/or cough) for more than 8 days; * acute respiraytory distress despite oxygen therapy, 02 ≥ 4l/min, arterial pressure \< 85/55 mmhg or hemodynamic instability at time of inclusion, encephalopathy with glasgow coma scale \< 14; * treatment with non-steroids anti-inflammatory agents within the last 14 days preceding onset of symptoms; * active bacterial or fungal infection documented at inclusion; * pregnancy; * under guardianship or curatorship; * non-affiliated person with social security
video discharge instructions (vdi) as adjuncts to written discharge instructions in the emergency department

Conditions: Urinary Tract Infection; Head Injury; Laceration

Summary: patients seen in the ed with either a laceration, minor head injury, or urinary tract infection will be randomized to one of two groups. both groups will receive the standard written discharge instructions; in addition, one group will watch video discharge instructions. each patient will be asked to complete a short survey with questions related to the discharge instructions received in the ed, and will be called 5-7 days after the ed visit to ask questions about discharge instructions and the ed visit.

patients will be enrolled in the study at george washington university hospital's emergency department. patients who consent will be randomly assigned to one of two groups; (1) standard written discharge instructions from the nursing staff (2) standard written discharge instructions from the nursing staff and watching the video discharge instructions on a tablet. subjects will complete a survey after they have received their discharge instructions and before leaving the er. several (5-7) days after leaving the emergency department, subjects will receive a phone call from one of the investigators staff members asking 2-3 questions about their ed visit and how they treated the condition at home. the survey questions at discharge and at follow-up will pertain to how to care for the condition and will be based on the discharge instructions. the study is designed to determine if patients retain health information more accurately if they watch a video in addition to being given written information. a total sample size of 200 participants will be recruited. enrollment for this study will begin june of 2016 and will continue until the investigators have enough participants. the data analyst will be blinded to treatment assignment when analyzing the data.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years of age * patient speaks english fluently * patient was diagnosed with urinary tract infection, laceration, or minor head injury exclusion criteria: * patient is presently a prisoner or in police custody * patient unable to understand consent * patient does not have a cell phone or house line * patient is blind or hearing impaired

Keywords: laceration urinary tract infection minor head injury concussion
lornoxicam with low dose ketamine versus pethidine to control pain of acute renal colic

Conditions: Renal Colic

Summary: patients with acute renal colic divided into 2 groups. group l administered ornoxicam and group p administered pethidine and vas was recorded for both groups.

prospective, randomized, double blind clinical study including 120 patients with acute renal pain admitted in emergency department. they were randomly assigned to one of two groups using a computer-generated table. group l received lornoxicam 8 mg iv plus 0.15 mg.kg-1 ketamine and group p received pethidine 50 mg iv. parameters were observed at baseline and after 0, 15, 30, 45 and 1 hour of drug treatment. the efficacy of the drug was measured by observing: patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue analgesia, adverse events and functional status.

Eligibility criteria:
inclusion criteria: * patients, who did not administer any analgesics at least within the last two hours. - - * patients aged between 20-60 years. exclusion criteria: * patients with previous renal surgery * liver and renal failure * hypersensitivity to lornoxicam, ketamine and pethidine, history of peptic ulcer, * gastrointestinal bleeding and perforation, * hypertensive and history of cardiac diseases * pregnancy and lactation and * urine examination showing more than 5 leukocytes suggestive of pyuria. * patients with hyperthyroidism are excluded

Keywords: renal pain lornoxicam pethidine emergency room ketamine
efficacy and safety of mg in the patients with alcoholic fatty liver disease and alcoholic hepatitis

Conditions: Alcoholic Fatty Liver Disease; Alcoholic Hepatitis

Summary: the purpose of a multicenter, randomized, double-blind, placebo-controlled to evaluate the efficacy, safety and pharmacokinetics of mg in patients with alcoholic fatty liver disease and alcoholic hepatitis.


Eligibility criteria:
inclusion criteria: * •patients over 18, under 70 years of age * the chronic alcohol intake patients * current the heavy drinker over 3month, day the average alcohol consumption male\>=60g, female\>=40mg y-gtp increase male\>=75, female\>=35 * over 1.5 ratio of ast to alt * patients who have chronoc alcohol disease exclusion criteria: * patients who have liver disease with the cause different with the alcohol except * patients who have pyridoxine allergy or history * patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc * patients taking other investigational product within 90 days prior to the participation in the study. * patients who has been taken any medications that could affect the treatment : hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, lont-term use of nsaids, statins, neuroleptics, anti convulsive medications, high-dose acetaminophen(\>=2.5g/day) * patients who have received treatment that may affect liver function within 1 month prior to the participation in the study * patient who considered ineligible for participation in the study as investigator's judgment
pul vs turp in bph patients with urinary retention

Conditions: BPH With Urinary Obstruction

Summary: the study will be a prospective, randomized controlled trial comparing prostatic urethral lift (pul) versus transurethral resection of prostate (turp) in benign prostate hyperplasia (bph) patients with urinary retention. the primary objective of this study is to compare the catheter-free rates of pul vs turp. secondary objectives include comparison of complications rates, cost effectiveness, patient satisfactory, symptom scores, quality of life measures and urodynamic parameters.

the study will be a prospective, non-inferiority randomized controlled trial with the aim of detecting a non-inferiority margin of 5%. after the potential subject has been informed of the study and the potential risks, he will be screened for eligibility within a 4 week period. assessment of eligibility will include questionnaires, blood tests, urine tests, uroflowmetry, flexible cystoscopy, transrectal ultrasound, and urodynamic study. suitable subjects will then be randomized in a 1:1 ratio to the prostatic urethral lift (intervention group) and turp (control group). patients in the prostatic urethral lift will have the procedure performed under local anesthesia or monitored anesthetic care while turp patients will be performed under spinal or general anesthesia. the subjects will have regular follow up 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-operatively. follow up assessments will include questionnaires, uroflowmetry, and occasional urodynamic study.

Eligibility criteria:
inclusion criteria: * male patients * age \>40 years old * urinary retention who failed trial without catheter exclusion criteria: * inability to provide consent or no guardians or relatives to help provide consent on patient's behalf * active urinary tract infection * previous surgical treatment for benign prostatic hyperplasia (i.e., turp, prostatic urethral lift, etc.) * bladder stones * urethral strictures or bladder neck contractures * prostate size \>100ml * solely obstructing median lobe * urinary retention not due to obstruction (i.e., bladder outflow obstruction index \<20 on urodynamic studies) * poor detrusor contractility (maximum detrusor pressure \<20cmh2o during voiding phase) * anticoagulant or antiplatelet agents that cannot be stopped

Keywords: bph urinary retention prostatic urethral lift pul turp
impact of self-tonometry on glaucoma treatment decision.

Conditions: Glaucoma; Glaucoma, Open-Angle; OHT - Ocular Hypertension; Glaucoma Capsulare

Summary: self-tonometry with icare home is performed by one hundred patients annually at sankt erik's eye hospital. the investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. the investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours.

since a few years back, self-tonometry has been available in glaucoma care. self-tonometry allows patients to measure their eye pressure themselves using a portable tonometer. sankt erik's eye hospital was the first healthcare provider in sweden to use this new technology. the investigators have previously conducted studies that have shown good agreement between the measurements made by patients and the gold standard method, e.g. goldman applanation tonometry (gat) (chen, querat et al. 2016, querat and chen 2017). about one hundred patients perform pressure curves with self-tonometry annually. as the method is used regularly, the investigators want to evaluate the impact of self-tonometry results on the clinician's choice of glaucoma treatment. the investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours and how much they differ from gat.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosed with poag (primary open-angle glaucoma), pex (pseudo-exfoliation glaucoma) or oht (ocular hypertension) * difference between patients' and staff's icare home® measurements less than 5 mmhg at baseline * difference between goldman applanation tonometry (gat) and patient's highest icare home® measurements less than 7 mmhg at baseline * monitoring over at least two days exclusion criteria: * more than one measurement with icare home® tonometer below 5 mmhg * missing more than one daily measurement with icare home® tonometer

Keywords: glaucoma self-tonometry treatment iop peaks