Kornimate/medical-research-clean huggingface dataset:
fibroscan-reproducibility and repeatability study

Conditions: Non-Alcoholic Fatty Liver Disease; Liver Disease; Alcohol-Related

Summary: chronic liver disease (cld) is a serious health issue worldwide, often progressing without symptoms until advanced stages with risks of complications like liver cancer and cirrhosis. early detection is crucial to help prevent these outcomes. liver stiffness measurement (lsm) can detect fibrosis (scarring) in the liver, a common issue in cld patients while traditional methods like liver biopsy are invasive and not ideal for regular screening and monitoring. fibroscan, a non-invasive device, measures the liver stiffness and fat content in the liver. this study will assess how reliable and consistent fibroscan results are when used by different operators and across different days, focusing on patients with liver conditions like metabolic-related liver disease (masld), alcohol-related liver disease (ald), and hepatitis b. this research also aims to test both the standard and guided vcte (vibration controlled transient elastography) fibroscan generations to evaluate their reproducibility and repeatability. as secondary objectives the control attenuation parameter (cap) results, and the fast, agile 3+, and agile 4 scores will be evaluated to compare their reproducibility and repeatability. adult participants will attend two visits within three days. during these visits, they will undergo multiple fibroscan scans that include five scans on day 1 (visit 1) and four scans on the follow up visit (visit 2), one blood sample for liver health assessment on each visit, and an audit questionnaire on day 1 (visit 1). some participants may undergo only two scans on the follow-up visit since this will depend on operator availability. each session will last 25-45 minutes including all examination types. the study is funded by echosens, the manufacturer of fibroscan, and will be conducted at uk healthcare facilities in england. by evaluating the variability of fibroscan results, this research could lead to a better understanding of the device's reproducibility and reliability in measuring liver stiffness across different operators and time points, potentially enhancing clinical confidence in its use for managing chronic liver diseases.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18 y.o) with metabolic dysfunction associated steatotic liver disease (masld), metabolic and alcohol-related liver disease (metald), and alcohol-related liver disease (ald). * adult patients able to give written informed consent. exclusion criteria: * vulnerable patients * patients with other chronic liver disease including but not limited to hepatitis b, hepatitis c, autoimmune hepatitis, cholestatic diseases * patients with ascites * patients with elevated conjugated bilirubin (\>1.5 uln) * patients with heart failure

Keywords: fibroscan reproducibility repeatability
atovaquone and azithromycin combination for confirmed covid-19 infection

Conditions: Covid19

Summary: this study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed covid-19 infection. the first combination to be evaluated is atovaquone and azithromycin.

this is an open-label, non-randomized study to evaluate anti-malarial/anti-infective single-agents and combination therapies for patients with confirmed covid-19 infection requiring therapy as determined by risk factors for complication (age, comorbid illness) or the presence of respiratory compromise. the first combination to be evaluated is atovaquone/azithromycin. other combinations may be added to the study at future amendments as information of potential benefit arises. the first part of the study will enroll 25 evaluable male and female patients 18 years of age or older with confirmed covid-19 infection.

Eligibility criteria:
inclusion criteria: * male and female patients age 18 years or older * covid-19 confirmed positive test results * high risk for complications including with medium (5-6) or high (more than or equal to 7) news score * hematology criteria: anc \>500 cells/mcl, hgb \>9 g/dl, platelet count \>75,000/mcl * metabolic criteria: serum creatinine \ 30 ml/min, ast/alt \<5x uln and total bilirubin wnl (for patients with gilbert's disease, direct bilirubin \<uln) exclusion criteria: * covid-19 negative test result * inability to adhere to study protocol requirements * inability to provide informed consent * other acute or chronic medical or psychiatric condition that in the judgment of the investigator would make the participant inappropriate to take part in the study * pregnant and breastfeeding individuals * qtc interval greater than 470 msecs at baseline * history of hypersensitivity to atovaquone and/or azithromycin. * history of known intolerance to atovaquone and/or azithromycin
assess the efficacy of whole brain radiation therapy in lung cancer patients with brain metastasis

Conditions: EGFR-mutated Lung Adenocarcinoma; Brain Metastasis

Summary: multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to gefitinib for the management of brain metastasis in lung cancer patients with a mutated egfr.

lung cancer patients with newly diagnosed cns metastasis with- at least one brain lesion measuring \> 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryopen-label, multicentre, national, randomised (1:1) phase ii trialarm a: wbrt and concurrent gefitinib followed by gefitinib maintenance arm b: gefitinib

Eligibility criteria:
inclusion criteria: * patients must have signed a written informed consent form prior to any study specific screening procedures * 18 years or older * kps ≥ 50% * histologically confirmed adenocarcinoma of the lung * activating mutation of egfr * newly diagnosed cns metastasis or in progression with at least one measurable lesion in the brain (defined as any lesion \> 1 cm on t1-weighted contrast enhanced mri) * patients could enter the study regardless of previous treatment (included chemotherapy) for metastatic extracranial disease, except tki. * no steroids or stable or decreasing dose of steroids for at least 5 days before the mri evaluation. * adequate hematologic, liver and renal functions: neutrophil count ≥ 1.5 x 109/l; platelets ≥ 100 x 109/l; hb ≥ 9 g/dl; total bilirubin \< 1.5 x uln; ast or alt \< 2.5 x uln (\< 5 x uln in patients with liver metastases); serum creatinine ≤ 1.5 x uln or creatinine clearance ≥ 50 ml/min exclusion criteria: * prior treatment of brain metastases with wbrt or tki * patient eligible for radiosurgery or surgical resection * contre indication at the radiotherapy * leptomeningeal disease * previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) within the the 5 years before study entry * prior treatment with gefitinib or other tki * pregnant or breast feeding women * women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception

Keywords: randomized brain radiation therapy lung cancer brain metastasis gefitinib
test-retest reliability of pulmonary function tests in patients with duchenne's muscular dystrophy

Conditions: Duchenne's Muscular Dystrophy; Scoliosis

Summary: nearly all patients with duchenne's muscular dystrophy (dmd) have scoliosis. posterior instrumented spinal fusion, which is a surgery to correct scoliosis, has been shown to improve quality of life and satisfaction of both parents and families. the progressive muscular weakness leads to the development of scoliosis soon after the child has become unable to walk. the muscular weakness and scoliosis also affect the pulmonary function of these children. pulmonary function tests (pft) have been used to determine "pulmonary fitness" prior to surgery as a way to determine how well or if the child will tolerate surgery. children with poor results on the pft are determined to be too fragile to tolerate such a large operation. the physicians conducting this study feel that the pft may be inaccurate and that this may not be the best single test to determine "pulmonary fitness". the physicians conducting the study think things like the time of day the study is done, how tired you are when you complete the test, and how well you understand the test may affect the results of the test.

all patients with dmd have routine pft's every six months as standard of care. you will be randomized in to one of two groups. the group assignment will be chosen by chance, similar to flipping a coin. if you are assigned to group one you will first have your regularly scheduled pft in the morning. you will be asked to complete a second pft that afternoon as least 4 hours after the first pft. you will then be asked to come back to the clinic in two weeks and repeat these pft's, once in the morning and once in the afternoon at least 4 hours apart. each pft will take approximately 10 to 15 minutes. if you are assigned to group two, you will have your regularly scheduled pft in the morning and then a second test in the afternoon at least four hours after the first test. after the second pft you will receive training from a respiratory therapist. you will receive teaching handouts to take home and an incentive spirometer and peak flow meter to practice with. you will be asked to practice these tests 2 times a day and record your results. you will then be asked to come back to the clinic in two weeks to repeat 2 pft's, once in the morning and again at least 4 hours later. all participants will be asked how they feel at the time of testing.

Eligibility criteria:
inclusion criteria: * male * duchenne's muscular dystrophy with diagnosed confirmed by a neurologist * no longer able to ambulate for any meaningful amount of time * no previous spinal operation exclusion criteria: * any other type of muscular dystrophy or spinal muscular atrophy * tracheotomy * contractures of the upper extremities that would preclude using arm span as an estimation for height * previous spinal surgery * asthma, recurrent pneumonia, or other chronic lung disease

Keywords: duchenne's muscular dystrophy scoliosis
reduction of staph aureus carriage by non-antibiotic nozin® nasal sanitizer® antiseptic

Conditions: Infectious Disease

Summary: the purpose of this study is to determine the extent to which bacterial growth in the nostrils by s. aureus, a common bacteria that is found in hospital environment, can be reduced by nozin® nasal sanitizer® antiseptic nasal swabs during the course of a typical 10-hour work period in participants known to have s. aureus in their nose passages.

the purpose of the proposed pilot study is to employ a repeated sampling protocol to test the effectiveness of a currently marketed, over-the-counter topical preparation to reduce carriage of staphylococcus aureus (s. aureus) in the nasal vestibules of health professionals working in an outpatient clinical setting. the product to be tested is the nozin® nasal sanitizer® antiseptic produced by global life technologies corp. it is an alcohol-based, non-antibiotic antiseptic preparationl the study has one primary specific aim: to determine the extent to which colonization of the vestibular region of the nares by s. aureus can be reduced by a regimen of nasal topical applications of the alcohol-based antiseptic during the course of typical 10-hour work day in subjects known to exhibit s. aureus nasal carriage. a secondary aim of the study will be to evaluate the concurrent effectiveness of the antiseptic applications on a measure of general bacterial colonization within the vestibules of each subject.

Eligibility criteria:
inclusion criteria: * all healthy health care professionals between the ages of 18 and 60 years of age who are regular full-time employees of the musc hospital, work a 10 or 12 hour work shift, and test positive for nasal vestibular s. aureus carriage within 10 days prior to their scheduled study day will be eligible to participate in the study. exclusion criteria: * excluded from the study will be individuals exhibiting symptoms of upper respiratory disease, including chronic rhinitis/sinusitis, seasonal allergies, upper respiratory infection during the previous four weeks, have known allergy to citrus or soy oil, or are "smokers". "non-smokers" will be defined as those individuals who have abstained from smoking for at least one year prior to the study. subjects must be able and agree to refrain from using prescription and non-prescription nasal spray or other nasal preparations or washes from the time of their screening up to and during their scheduled study day.

Keywords: nasal sanitizer® s. aureus general bacteria nasal carriage decolonization
non-randomized, open-labeled, interventional, single group, proof of concept study with multi-modality approach in cases of brain death due to traumatic brain injury having diffuse axonal injury

Conditions: Brain Death

Summary: this is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial iv laser and median nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (bd).


Eligibility criteria:
inclusion criteria: * individuals declared brain dead from a traumatic brain injury having diffuse axonal injury on mri * not willing for organ donation * written informed consent from the legally acceptable representative of the patient exclusion criteria: * metallic clips/ metal implants or intracranial implants in the brain. * pregnancy
change of nlrp3 inflammasome expression level, symptoms, and functional status in hfpef patients treated with arni

Conditions: Heart Failure

Summary: underlying inflammation has been increasingly recognized in heart failure with a preserved ejection fraction(hfpef). but there is no study reported the relationship between nlrp3 inflammasome and hfpef. in this study, investigators propose a scientific hypothesis that the expression of nlrp3 inflammasome is elevated in patients with hfpef, and the level of tnfα, il-1β and nlrp3 inflammasome is lower in patients treated with sacubitril/valsartan.

the study will integrate data from two trials involving a total of 90 participants with heart failure. depending on the using of arni, participants in hfpef group will be divided into two groups. the diagnostic criteria for hfpef is: (1) left ventricular ejection fraction ≥50%； (2）with the symptoms and/or signs of heart failure; (3) bnp≥35 pg/ml and/or ntprobnp≥125 pg/ml; (4) at least one additional criterion: a.relevant structural heart disease(lvh and/or lae); b.diastolic dysfunction. the primary outcome are the change from baseline in tnfα, il-1β, nlrp3 inflammasome, and so on assessed at 12 weeks. the key secondary outcomes include changes in echocardiographic measures, quality of life, etc. and then compare the rate of above indicators of two trials.

Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction ≥50%； * with the symptoms and/or signs of heart failure； * bnp≥35 pg/ml and/or ntprobnp≥125 pg/ml； * at least one additional criterion: relevant structural heart disease(lvh and/or lae) or diastolic dysfunction. exclusion criteria: * lvef less than 45% at any time; * severe infection; * acs; * pregnancy; * egfr \<30 ml/min/1.73 m2, etc.

Keywords: nlrp3 protein human
systemic therapy sequenced isolated palnd for mcrc

Conditions: Synchronous Isolated Para-aortic Lymph Node Metastasis; Colorectal Cancer

Summary: the study aims to estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer.

patients with synchrnous isolated para-aortic lymph node metastasis of colorectal cancer receiving systemtic therapy (at most two lines), radiologically assessed efficacious, and assessed by mdt that are potential to reach no evidence of disease (ned) were included in our trial. all included patients receive para-aortic lymph node dissection.

Eligibility criteria:
inclusion criteria: 1. age at enrollment is \>= 18 and \<= 75 years 2. ecog ps 0-1 3. histologically confirmed colorectal carcinoma 4. synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: in the preoperative examination of positron emission tomography ct and abdominopelvic ct, metastasis was noted when the diameter of the paln was 10 mm or greater and had irregular shape. 5. single-organ para-aortic lymph node metastasis (planm) who are potential to receive surgery and achieve no evidence of disease (ned). 6. adequate liver, renal and bona marrow function. 7. signing written informed consent exclusion criteria: 1. in addition to paln metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the ln metastasis. 2. unable to achieve ned 3. clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, new york heart association (nyha) class ii or more severe congestive heart failure or severe arrhythmia requiring medication intervention, or a history of myocardial infarction in the last 12 months. 4. those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. 5. organ transplantation requires immunosuppressive therapy
essential pro study ( repic04e-hk )

Conditions: Coronary Artery Disease; Ischemic Heart Disease

Summary: single center, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of essential pro to meet eu medical device regulation (mdr) requirements in all the consecutive patients treated with essential pro.

this study intends to analyze: * device effectiveness (in its individual use, technical performance) and procedural effectiveness (technical outcome at the end of lesion treatment with the device under study and any other device being used). * device safety (in its individual use, technical performance) and procedural safety (technical outcome at the end of lesion treatment with the device under study and any other device being used). * clinical outcomes at the end of the procedure and during the specified follow-up period for each device. the follow-up timeframe is established based on the conditions of use and type of device being used, according to the requirements established by the relevant notified body.

Eligibility criteria:
inclusion criteria: * patient treated with essential pro according to routine hospital practice and following instructions for use * informed consent signed exclusion criteria: * not meet inclusion criteria

Keywords: mdr (medical device regulations) pmcf (post-market clinical follow-up) paclitaxel eluting coronary balloon dilatation catheter
comparison between two concentration of hypertonic saline in intestinal obstruction surgery

Conditions: Intestinal Obstruction Fluid Management With Hypertonic Saline

Summary: background and rationale : perioperative fluid management is a challenging issue in surgical care especially in a procedure specific model. recently hypertonic saline (hs) has the advantage of using the patient's own total body water by drawing interstitial space. although it still controversial whether hs is associated with benefits in specific patient populations, particularly with respect to site of lesion and illness severity; these data provide insight into therapeutic modalities to curtail ileus formation. objectives : * measurement of total volume of fluid infused, the need of inotropic or vasopressor to maintain adequate hemodynamic parameters with assessment of electrolyte disturbances and s.lactate * the incidence rate of surgical complications; infection and anastomotic dehiscence study population \& sample size : there were no previous trials comparing the two studied groups of the current trial. we expected a small standardized effect size of 0.2. based on this effect size, 25 subjects will be needed to elicit the difference between the two groups at an alpha level of 0.05 and power of 0.9 (whitehead et al; 2016).


Eligibility criteria:
inclusion criteria: * age: 20-70 years old * asa≤iii * bmi 25-40kg/m. exclusion criteria: * severe cvs diseases (ef\<50%) * severe pulmonary diseases (pulmonary function test ≤ 50% of predicted) * neurological disorders; psychological diseases, demyelinating lesions, parkinsonism, motor or sensory disorders. * pregnancy. * severe chronic renal disease (s. creatinine\> 2gm/dl or patients on dialysis). * severe hepatic impairment (child \& pugh classification class c). * acid-base and electrolytes disturbances.
the effect of the association egcg, folic acid and vitamin b12 in preventing the persistence of hpv infection.

Conditions: HPV Infection

Summary: the purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (egcg), vitamin b12 and folic acid in the treatment of infections with papilloma virus of the cervix.


Eligibility criteria:
inclusion criteria: * hr-hpv dna test positivity exclusion criteria: * no hsil
prophylactic intravesical chemotherapy to prevent bladder recurrence after nephroureterectomy for primary upper tract urothelial carcinoma patients

Conditions: Bladder Recurrence; Upper Tract Urothelial Carcinoma; Nephroureterectomy

Summary: this clinical trial is designed to evaluate the efficacy of single immediate intravesical chemotherapy instillation in the prevention of bladder recurrence after nephroureterectomy for primary upper tract urothelial carcinoma (utuc) patients.

introduction upper tract urothelial carcinomas (utuc) are relatively uncommon compared to bladder cancer and account for only 5-10% of urothelial carcinomas, with an estimated annual incidence in western countries of \~2 cases per 100,000 inhabitants. in 17% of cases, concurrent bladder cancer is present. recurrence in the bladder after management of utuc occurs in 22-47% of utuc patients, compared with 2-6% in the contralateral upper tract. at our institution, we reported that 30.8% of utuc patients developed intravesical recurrence, which was in line with the global trend. generally speaking, the field cancerization hypothesis and intraluminal seeding are currently the two main concepts to explain multifocality of urothelial cancer and the recurrent bladder tumor. independent multiclonal tumor development after carcinogenic exposure of the entire urothelial and intraluminal implantation followed by clonally induced single progenitor cell evolution are the mechanisms suggested. while the two mechanisms could co-exist, the intraluminal seeding hypothesis is becoming more prevalent with the emergence of more evidence from molecular studies. thus postoperative intravesical chemotherapy could potentially remove the implantation cell and prevent recurrence. while intravesical instillation is widely used to prevent recurrence after transurethral resection for primary bladder tumors, there is still no consensus on the prophylactic capability of intravesical chemotherapy in preventing bladder recurrence after nephroureterctomy for utuc. according to a previous prospective, multicentre, randomised clinical trial, a single postoperative dose of intravesical mitomycin c appears to reduce the risk of a bladder tumour within the first year following nephroureterectomy for utucs. aim of the work this clinical trial is designed to evaluate the efficacy of single immediate intravesical chemotherapy instillation in the prevention of bladder recurrence after nephroureterectomy for utucs.

Eligibility criteria:
inclusion criteria: * suspected utuc patients without history of bladder tumor. * suspected utuc patients without synchronous bladder tumor. * suspected utuc patients without contralateral utucs. exclusion criteria: * patients with history of bladder tumor. * patients with synchronous bladder tumor. * patients with contralateral utucs. * patients with advanced stage (t4). * patients with other malignant tumors.