Kornimate/medical-research-clean huggingface dataset:
the effect on blood loss of topical and intravenous tranexamic acid in cardiac surgery patients

Conditions: Blood Loss; Tranexamic Acid; Cardiac Surgery

Summary: it remains still unclear whether topical tranexamic acid has an added value besides the administration of intravenously tranexamic acid. we hypothesize that the addition of topical tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25% reduction of post-operative blood loss after cardiac surgery. the aim of this study is to determine whether the application of topical tranexamic acid reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated. just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic acid in 200 ml normothermic saline solution (nacl 0.9%), 250 subjects receives pericardial lavage with 200 ml normothermic saline solution without ta and 250 subjects (control group) receives no pericardial lavage. the main study parameter is 12 hours post-operative blood loss and is assessed by 12 hours post-operative chest tube production.


Eligibility criteria:
inclusion criteria: * gender; male/ female * age: ≥ 18 year * elective cardiac surgical patients * coronary artery bypass graft (cabg) (conventional, e.cco) * aortic valve replacement (avr) (conventional) * mitral valve replacement (mvr)/ mitral valve repairment (mpl) (conventional) * tricuspid valve replacement (tvr) / tricuspid valve repairment (tpl) * bentall * combined procedure (e.g. cabg/ avr, mvr/avr, avr/maze) exclusion criteria: * mvr/mpl (minimal invasive, port access surgery) * maze (minimal invasive, via thoracoscopy) * avr (minimal invasive, via mini sternotomy) * off-pump procedures * emergency operations * patient with increased or decreased blooding tendency (fv leiden, prot c, s deficiency, anti-thrombin deficiency, prothrombin mutation)

Keywords: blood loss tranexamix acid cardiac surgery
management of patients with keratoconus with intacs

Conditions: Keratoconus

Summary: purpose to evaluate long-term follow up of intacs microthin prescription inserts (addition technology inc, fremont, calif) for the management of keratoconus. design a long-term (five years) retrospective, follow-up study

subjects and methods ethical committee approval was obtained for the original trial, and patients were asked to sign an informed consent form (in accordance with institutional guidelines and to the declaration of helsinki) before treatment and for further follow-up examinations. the registration information for this clinical trial is available to the public through the national institute of health database. the surgical procedure was done under topical anesthesia. two intacs segments of 0.45-mm thickness were inserted so as to embrace the steepest keratoconus meridian, according to the topographic image, aiming at maximal flattening. the corneal thickness was measured intraoperatively at the incision site and peripherally in the cornea along the ring placement markings with ultrasonic pachymetry (sonogage, cleveland, ohio, usa). using a diamond knife, set at 70% of the thinnest corneal measurement, a 0.9-mm radial incision was formed, and corneal pockets were created using two sinskey hooks and a suarez spreader. two corneal tunnels were then formed using clockwise and counterclockwise dissectors under suction created by a vacuum-centering guide. the two polymethyl methacrylate (pmma) segments (0.45-mm thickness) were implanted in the respective corneal tunnels, maintaining a space of approximately 2.0-mm between their ends and 1.5 mm between the opposite edge of each segment and the edge of the incision. the incision site was sutured using a single 10/0 nylon stitch. postoperative evaluation postoperatively, all eyes received antibiotic/steroid combination eye drops 4 times per day for 2 weeks. in addition, all patients were instructed to use preservative-free artificial tears frequently. the sutures were removed 2 weeks after surgery. group differences for continuous variables were tested using the paired student t tests. the change in manifest refraction (spherical equivalent) (mrse) and topographic k values and topographic astigmatism were plotted over time to determine long-term stability, and the difference as a function of time was analyzed using paired 2-tailed t tests (at time intervals of preoperative to 1 month, 1 to 3 months, 3 to 6 months, 6 to 12 months, and every year of follow up period). results are presented as means + standard deviation \[sd\]. a p value less than .05 was regarded as statistically significant.

Eligibility criteria:
inclusion criteria: * all patients had clear central corneas and contact lens intolerance (rigid gas permeable contact lenses intolerance, frequent contact lens displacement, unsatisfactory visual acuity), exclusion criteria: * history of herpes keratitis; diagnosed autoimmune disease; and systemic connective tissue disease.

Keywords: keratoconus intacs
robotic utility for surgical treatment of groin hernias

Conditions: Hernia, Inguinal

Summary: the purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia's of 50 patients treated in maria middelares in laparoscopic rtapp technique.

minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients in maria middelares, ghent. a previously conducted study demonstrated that the symptoms of patients with inguinal hernias (verified via eurahs quality of life score) can be effectively treated and the technique has a low recurrence rate and low frequency of long-term side effects. robot-assisted laparoscopic surgery has become standard in urology for resection of the prostate carcinoma. in general abdominal surgery, a large group of surgeons are currently working on the introduction of robotic-assisted surgery for resection of colon and rectal cancer in their daily practice. the third generation robot (davinci xi), has extended the applicability of this technology within the field of general surgery. for the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and incisional hernia's), currently only surgeons in the us have experiences in structured treatment programs. from september 1, 2016 maria middelares hospital will introduce robot-assisted surgery, including the laparoscopic tapp inguinal hernia repair. main obstacles to the introduction of robot technology in abdominal wall surgery are prolonged preparation time in the operating room required for installation of the robot, and higher material costs related to the robot-assisted surgery. however, there are few precise data available on the exact size of extra time or increased costs related to the introduction of robotic assisted surgery in a program for abdominal surgery. the purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of inguinal hernias by 50 patients in maria middelares hospital.

Eligibility criteria:
inclusion criteria: * 50 patients selected and operated by the pi. exclusion criteria: * patients under the age of 18 * pregnancy * bmi \> 35 * recurrent groin hernia * no informed consent
detection of eeg-based biomarkers of chronic low back pain

Conditions: Chronic Low-back Pain; Healthy

Summary: chronic low back pain (clbp) is a pervasive disorder affecting up to one-fifth of adults globally and is the single greatest cause of disability worldwide. despite the high prevalence and detrimental impact of clbp, its treatments and mechanisms remain largely unclear. biomarkers that predict symptom progression in clbp support precision-based treatments and ultimately aid in reducing suffering. longitudinal brain-based resting-state neuroimaging of patients with clbp has revealed neural networks that predict pain chronification and its symptom progression. although early findings suggest that measurements of brain networks can lead to the development of prognostic biomarkers, the predictive ability of these models is strongest for short-term follow-up. measurements of different neural systems may provide additional benefits with better predictive power. emotional and cognitive dysfunction is common in clbp, occurring at the behavioral and cerebral level, presenting a unique opportunity to detect prognostic brain-based biomarkers. likewise, improvements in electroencephalogram (eeg) neuroimaging strategies have led to increased spatial resolution, enabling researchers to overcome the limitations of classically used neuroimaging modalities (e.g., magnetic resonance imaging \[mri\] and functional mri), such as high cost and limited accessibility. using longitudinal eeg, this patient-oriented research project will provide a comprehensive neural picture of emotional, cognitive, and resting-state networks in patients with clbp, which will aid in predicting symptom progression in clbp. through this award, the investigators will use modern eeg source analysis strategies to track biomarkers at baseline and 1- and 2-month follow-ups and their covariance with markers for pain and emotional and cognitive dysfunction. a 5-month follow up will also be used to only assess patient reported outcomes. in aim 1, the investigators will identify and characterize differences in resting-state, emotional, and cognitive networks between patients with clpb and age/sex-matched controls. in aim 2, the investigators will identify within-subject changes across time and their relationship with clinical symptoms. in aim 3, as an exploratory aim, the investigators will apply machine- and deep-learning strategies to detect a comprehensive signature of clbp using eeg features from resting-state, emotional, and cognitive networks.


Eligibility criteria:
inclusion criteria: * current diagnosis of chronic low back pain exclusion criteria: * current diagnosis of cancer * severe psychiatric conditions * pending personal litigation relating to an injury or receiving workers' compensation benefits * being a non-english speaker.
l-glutamine treatment in patients with diverticulosis

Conditions: Diverticulosis, Colonic

Summary: the purpose of the study is evaluate the safety and efficacy of l-glutamine as a treatment for patients with diverticulosis.

after being informed about the study and potential risks, all patients giving written informed consent will undergo a 4 weeks screening period to determine eligibility for study entry. at week 0, patients who meet eligibility requirements will be given l-glutamine (15 grams, twice daily)

Eligibility criteria:
inclusion criteria: 1. ≥50 years of age. 2. uncomplicated diverticulosis confirmed by colonoscopy. 3. colonoscopy indicates ≥5 colonic diverticula (pouches) in the descending/sigmoid colon and \< approximately10 colonic diverticula (pouches) per segment (e.g. proximal descending, distal descending, proximal sigmoid, and distal sigmoid.) 4. if the patient is a female of child-bearing potential, she agrees to avoid pregnancy during the study and is willing and agrees to practice a recognized form of birth control during the course of the study (e.g., barrier, birth control pills, or abstinence). 5. patients who have given their free and written informed consent. exclusion criteria: 1. acute diverticulitis (both complicated and uncomplicated). 2. acute colitis 3. history of inflammatory bowel disease, colon resection, polyposis syndrome, severe strictures, and perforation. 4. active bleeding 5. more than 40 diverticula 6. chronic renal insufficiency 7. chronic liver disease. 8. patient is pregnant or lactating or has the intention of becoming pregnant during the study (if female of childbearing potential). 9. inability to give a valid informed consent or to properly follow the protocol. 10. patients with an active malignancy of any type, or a recent history of malignancy within the last 5 years. 11. treated with an investigational medication/treatment within 30 days prior to the screening visit. 12. currently enrolled in an investigational study 13. patient is currently taking or has been treated with any form of glutamine supplement within 30 days of the screening visit. 14. previous difficulty pulling or passing of scope or difficulty completing colonoscopy. 15. there are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
the tosca registry: hormonal and metabolic deficiencies in chronic heart failure

Conditions: Chronic Heart Failure

Summary: the objective of this study is to determine whether the presence of metabolic alteration and anabolic deficiencies in patients with chronic heart failure are able to identify a subset of patients with poor outcome.

despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. there is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive. aim of this registry is to determine the prevalence of hormone/metabolic deficiencies in heart failure patients and to look for possible association with clinical variables. moreover, enrolled patients will be followed up for a mean of 2,5 years in order to collect outcome data including all-cause mortality, cardiovascular mortality, hospitalizations. this is a multi-center observational study involving several italian department of cardiology, endocrinology, internal medicine

Eligibility criteria:
inclusion criteria: * patients of either sex affected by chf, secondary to ischemic or idiopathic dilated cardiomyopathy * left ventricle ejection fraction 40% or less exclusion criteria: * severe liver disease * serum creatinine levels \>2.5 mg/dl * history of active cancer with life expectancy below 1 year * acute coronary syndrome in the previous 6 months

Keywords: heart failure growth hormone testosterone insulin resistance thyroid hormones survival
interventional validation of an mds-specific measure of quality of life: assessing the responsiveness of the quality of life in myelodysplasia scale (qualms-1) to different hypomethylating agent regimens for low and intermediate risk disease

Conditions: Leukemia

Summary: the goal of this research study is to test a quality-of-life questionnaire called qualms-1 in patients with mds. this is an investigational study. up to 240 participants will be enrolled in this multicenter study. up to 175 will take part at md anderson.

if you agree to take part in this study, you will be asked to complete questionnaires twice during your participation in the 2014-0112 study. during your first treatment visit, you will be asked to complete the qualms-1 questionnaire and another questionnaire that asks about your well-being. after your 4th cycle of treatment or when you stop receiving treatment, you will be asked to complete the qualms-1 questionnaire again and another questionnaire to rate any changes in your health since you started the study. it should take about 20 minutes total to complete the questionnaires each time. information will also be collected from your medical record. this information will include the results of lab tests and other information relating to your health. length of study participation: after you complete the questionnaires the second time, your participation in this study will be complete.

Eligibility criteria:
inclusion criteria: 1. sign an institutional review board (irb)-approved informed consent document. 2. age greater than or equal to 18 years 3. de novo or secondary international prognostic scoring status (ipss) low- or intermediate-1-risk mds, including chronic myelomonocytic leukemia (cmml)-1 4. eastern cooperative oncology group (ecog) performance status of greater than or equal to 3 at study entry 5. organ function as defined below: serum creatine greater than or equal to mg/dl x upper limit of normal (uln); total bilirubin greater than or equal to 2 x uln; alanine transaminase (alt; serum glutamic pyruvic transaminase=sgpt) greater than or equal to 2 x uln 6. women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. exclusion criteria: 1. breast feeding females 2. prior therapy with decitabine or azacitidine 3. prior participation in the development of the qualms-1 (dana-farber cancer institute=dfci) 4. non-english speaking patients

Keywords: leukemia myelodysplastic syndrome mds low- or intermediate-1-risk chronic myelomonocytic leukemia -1 cmml-1 quality of life in myelodysplasia scale qualms-1 anemia subset of fact fact-an questionnaires surveys
infusion set replacement intervals for critically ill patients

Conditions: Critical Illness

Summary: this study aimed to evaluate the efficacy of 24-hour versus 96-hour infusion set replacement to prevent central line-associated bloodstream infection (clabsi) in critically ill adults with central venous access devices.

up to 70% of patients in acute care hospitals need a central venous access, and the latter is also widely used in other clinical settings. however, the central venous access usually remains associated with increased infection risks, which can be severe and even lethal. most contemporary guidelines recommend infusion set replacement every 4 days with the cdc in us recommending replacement "no more frequently than 96 hours, but at least every 7 days". however, the national health commission of the people's republic of china recommend infusion set replacement every 24 hours in 2021. the previous evidence from neonate were in favor of the administration set changes of every 24 hours, compared with the longer time interval. however, it is unclear whether this conclusion applied to adult critically ill patients in icu. the purpose of the current study is therefore to compare the effectiveness of 24-hour versus 96-hours infusion set replacement to prevent central line-associated bloodstream infection (clabsi) in critically ill adults with central venous access devices. this study is a multicenter, single-blind randomized clinical trial designed to investigate the efficacy of the 24-hour versus 96-hours infusion set replacement to prevent central line-associated bloodstream infection (clabsi) in critically ill adults with central venous access devices. the trial will enroll up to 1240 participant. the primary endpoint for this trial is the clabsi rate. mortality rate is a key secondary endpoint for the trial. specific aims 1. to demonstrate the efficacy of 24-hour infusion set replacement to reduce the rate of clabsi, compared with 96-hours infusion set replacement. 2. to demonstrate the efficacy of 24-hour infusion set replacement to reduce the rate of crbsi, all-cause bloodstream infection, and mortality, compared with 96-hours infusion set replacement.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. able to provide informed consent 3. expected length of stay (los) \> 96 hours in intensive care unit (icu) 4. need for treatment with central venous access device 5. the central venous access device is expected to remain in place for at least 96 hours, with infusion set attached exclusion criteria: 1. those who with a bloodstream infection within the previous 48 hours after icu admission 2. those who have their vascular access device actually removed within 96 hours after icu admission 3. those who have participated in other clinical studies within the 2 months

Keywords: infusion set clabsi intensive care unit critical illness
a single center study on the effectiveness and safety of polyp classification with artificial intelligence

Conditions: Colonic Diseases; Artificial Intelligence

Summary: this is an artificial intelligence-based optical endoscopic polyp diagnosis system that can assist endoscopic doctors in diagnosing polyps and improve the quality of training in clinical settings.

large sessile and laterally spreading colorectal lesions(lsls) are increasingly encountered during colonoscopy. lsls have an increased risk of harbouring invasive cancer and can be challenging to excise endoscopically. wide-field endoscopic mucosal resection (wf-emr) is widely used in treating lsls. in the east, meanwhile endoscopic submucosal dissection (esd) is the dominant technique due to its ability to achieve en bloc resection in over 80% of cases. many papers have demonstrated that selective-esd has the highest economic benefit. the key is to find a reliable way to select.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 or above; 2. colonoscopy and related examinations should be performed to further clarify the characteristics of digestive tract diseases; 3. be able to read, understand and sign the informed consent; 4. the researcher believes that the subject can understand the process of the clinical study, is willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures; 5. patients with \> 1cm lesion detected by colonoscopy, requiring magnification staining or surgical resection. exclusion criteria: 1. have participated in other clinical trials, signed the informed consent and have been in the follow-up period of other clinical trials; 2. drug or alcohol abuse or psychological disorder in the last 5 years; 3. pregnant or nursing women; 4. subjects with previous history of intestinal surgery; 5. the researcher considers that the subject is not suitable for colonoscopy and related examination; 6. high-risk diseases or other special conditions that the investigator considers inappropriate for the subject to participate in the clinical trial.

Keywords: colonic neoplasms
to compare the safety and pk/ pd characteristics of adc189 between hepatic impairment and normal hepatic function subjects

Conditions: Influenza Type A; Influenza Type B

Summary: this study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of adc189 in subjects with hepatic impairment compared with subjects with normal hepatic function.

the evaluation of adc189/adc189-i07 in mild hepatic insufficiency (child-pugh a), moderate hepatic insufficiency (child-pugh b) the pharmacokinetic characteristics in subjects, compared with normal liver function subjects, which matched by sex, age, and bmi, in order to provide a scientific basis for a reasonable dosage in patients with liver dysfunction.

Eligibility criteria:
inclusion criteria: * 1) the subjects fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and can complete the entire trial process according to the requirements of the trial. * 2) age 18-75 years old (including the boundary value), both male and female. * 3) the body weight of male subjects was ≥50 kg, the body weight of female subjects was ≥45 kg, and the body mass index (bmi) was within the range of 18.0\~30.0 kg/m². exclusion criteria: * 1) known allergic history to test drug components, or allergic constitution, or history of allergic diseases. * 2) have malignant tumors, or have a history of malignant tumors within 5 years prior to screening. * 3) patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening. * 4) egfr (ckd-epi cr) \<60ml/min/1.73m2.