Kornimate/medical-research-clean huggingface dataset:
impact of fatty liver on hepatitis b therapy

Conditions: Fatty Liver Disease; Chronic Hepatitis B; Antiviral Treatment

Summary: the primary goal of treating chronic hepatitis b(chb) is to achieve maximal suppression of hbv replication, thereby reducing hepatocyte inflammation, necrosis, and liver fibrosis. among various treatment strategies, antiviral therapy plays a crucial role. the prevalence of fatty liver disease (fld) has continued to increase in recent decades. this study aims to accurately diagnose the pathological state of patients through liver biopsy and conduct a five-year follow-up to explore the impact of fld on the efficacy of chb treatment and to identify factors influencing adverse outcomes.

chronic hepatitis b (chb) remains a serious threat to people's health. as of 2019, approximately 296 million people (3.9% of the world's population) were infected with the hbv virus. in the treatment of chb, antiviral drugs can not only achieve long-term viral suppression for most chb patients, but also have a positive impact on other chb treatment goals and improvement of prognosis, but can not eliminate the risk of adverse clinical outcomes completely, which are partly attributed to concomitant diseases such as fatty liver disease (fld). both diseases can cause chronic liver injure and increase the risk of cirrhosis and hcc.all patients included in this study underwent liver biopsy to determine their pathological status, ensuring the reliability and accuracy of disease diagnosis. and based on biopsy results, patients were categorized into two groups:fatty liver combined with hepatitis b and hepatitis b alone. the main antiviral treatments used in the study include first-line nas, such as entecavir, tenofovir disoproxil fumarate (tdf), tenofovir alafenamide fumarate (taf), and interferons (ifn-α and peg-ifn-α). they were followed for five years to thoroughly assess the long-term efficacy of antiviral treatment. additionally, complications and liver fibrosis were evaluated using ultrasound and fibroscan to monitor the advancement of liver disease.

Eligibility criteria:
inclusion criteria: 1. aged ≥18 and ≤75 years old, regardless of gender; 2. the patient had a positive hepatitis b marker and met the criteria for current hepatitis b virus infection (hepatitis b combined with fatty liver group); 3. liver pathology indicated fatty liver (hepatitis b combined with fatty liver group); 4. all patients have complete medical history, b-ultrasound, fibrosan, hepatitis b five items, liver function and other laboratory test data. exclusion criteria: 1. aged \ 75 years old; 2. patients diagnosed with or previously diagnosed with hcc; 3. those who are co-infected with other hepatitis viruses (hav, hcv, hdv, hev) or hiv or syphilis; 4. the follow-up data of patients are seriously missing.
cerament g as part of the surgical treatment of osteomyelitis in a single-stage procedure

Conditions: Osteomyelitis

Summary: the study is a prospective cohort study of subjects where cerament g was used as part of the surgical treatment of osteomyelitis in a single stage procedure.

the study is a prospective cohort study of subjects where cerament g was used as part of the surgical treatment of osteomyelitis in a single stage procedure. the purpose of this post market prospective cohort study is to obtain longer-term clinical and radiographic data on the safety and effectiveness of cerament g as part of the surgical treatment of osteomyelitis in a single-stage procedure. detailed questions to be answered are: 1. what is the nature, severity, and frequency of incomplete new bone formation? 2. what is the nature, severity, and frequency of the risks of probable adverse events and serious adverse events associated with incomplete new bone formation, including pathologic fractures and reinfection?

Eligibility criteria:
inclusion criteria: subjects meeting the following inclusion criteria are to be included in the analysis: 1. patients receiving cerament g subsequent to surgical excision of osteomyelitis, with cierny-mader classification grades iii or iv, who require dead-space management of a bone defect following surgical debridement and excision of infection. 2. symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following: 1. the presence of a sinus 2. the presence of an abscess or intra-operative pus 3. the presence of positive supportive histology 4. two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., staph aureus) with similar antimicrobial sensitivity) notes: in cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. infected non-unions will be included only if the bone loss is \< 1cm after debridement and excision of bone has been performed. exclusion criteria: the subject will be excluded from the study if: 1. skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study) 2. those unable to give informed consent for inclusion in the trial, or those not willing to be included 3. a known allergy or reaction to gentamicin or calcium sulfate 4. treatment with a combination of different antibiotic-eluting bone graft substitutes 5. they have a segmental bone defect \> 1cm 6. infection of the spine
a study of sunitinib in young patients with advanced gastrointestinal stromal tumor

Conditions: Gastrointestinal Stromal Tumors

Summary: children and young adults with gastrointestinal stromal tumors (gist) will be treated with sunitinib. the safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. in addition, tumor responses and overall survival will be assessed.


Eligibility criteria:
inclusion criteria: * histological diagnosis of gist. * patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant stem cell factor receptor gene (kit) gist, or cannot obtain imatinib in their country * measurable by response evaluation criterion in solid tumors (recist) or evaluable disease. exclusion criteria: * current treatment with another investigational agent. * prior sunitinib treatment. * prior therapy with known risk for cardiovascular complications.

Keywords: children and young adults with gist sunitinib malate pharmacokinetics tumor response overall survival tumor kit mutation status
internet-based exposure therapy for panic disorder

Conditions: Panic Disorder With Agoraphobia

Summary: the purpose of this study is examine if an internet-based exposure therapy based on inhibitory learning is feasible, acceptable and effective in reducing panic symptoms amongst patients who suffer from panic disorder and agoraphobia.

trial objectives: primary objective is to examine if an internet-based exposure therapy based on inhibitory learning is effective in reducing panic symptoms. the secondary objective is to study if the protocol is feasible and acceptable. secondary objective is measured is examined on 1) number of participants completing the study protocol, 2) participants' satisfaction with the treatment, 3) therapists' ratings of acceptability. the aim of this study is to assess the feasibility, and pilot the design and delivery of a rct that will subsequently form the framework for a larger rct to evaluate the effectiveness of an exposure protocol based on inhibitory learning. trial design: randomized controlled pilot study with two groups randomly assigned to either internet-based exposure therapy based on the principles of inhibitory learning or internet-based exposure therapy based on the principles of habituation duration: eight weeks primary endpoint: change in panic symptoms from baseline to week 8. efficacy parameters: panic disorder severity scale - self rated (pdss-sr) safety parameters: adverse events is assessed weekly via the internet. description of trial subjects: patients \> 18 years old with a pdss-sr score more than 6 points number of subjects: 80

Eligibility criteria:
inclusion criteria: * outpatients * ≥ 18 years * situated in sweden * informed consent * panic disorder severity scale - self rated score more than 6 points exclusion criteria: * substance dependence during the last six months * post traumatic stress disorder, bipolar disorder or psychosis * symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder) * madrs-s score above 25 points * psychotropic medication changes within one months prior to treatment that could affect target symptoms. * received exposure based cognitive behavior therapy (cbt) for pathological worry the last 2 years
transobturator urethral sling placement with an autologous rectus facia

Conditions: Stress Urinary Incontinence; Surgery--Complications

Summary: the investigators aimed to evaluate outcomes of transobturator urethral sling placement using autologous rectus fascia for female stress urinary incontinence at perioperatively and at 2-year follow-up.

stress urinary incontinence (sui) is very common condition in middle-aged women, and can affect quality of life. some clinical trials reported that the lifetime risk of a woman undergoing surgery for sui is increase in up to 15%. the midurethral synthetic sling is the most common surgery performed for female sui. this procedure has high efficacy and low perioperative morbidity. although many clinical trials have demonstrated that synthetic mid-urethral slings are safe, effective and recommended by several guidelines (e.g. society of urodynamics, female pelvic medicine and urogenital reconstruction/american urogynecologic society and american urologic association), the safety and efficacy of surgery for sui using mesh devices has been questioned by a community of patients and clinicians. after food and drug administration notification on mesh use in pelvic surgery, many patients and providers begin to search of different surgery without synthetic mesh alternatives in sui. recently, female patients in england formed the campaign group "sling the mesh" to protest the synthetic mesh. several options such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection have some problems related to morbidity or efficacy. the autologous pubovaginal urethral sling is associated with a higher risk of postoperative voiding dysfunction. the investigators aimed to demonstrate the feasibility of an autologous transobturator urethral sling to avoid the related problems of synthetic mesh placement and the increased rate of voiding dysfunction with pubovaginal sling placement.

Eligibility criteria:
inclusion criteria: * female patients that underwent mid-urethral sling placement exclusion criteria: * active urinary infection * neurologic disorders * malignancies * history of radiotherapy

Keywords: midurethral sling placement synthetic mesh autologous rectus fascia transobturator approach
a trial to learn if a covid-19 therapeutic is safe and well tolerated, and how it works in the body of healthy adult participants

Conditions: Healthy

Summary: the primary objective of the study is to evaluate the safety and tolerability of regn14284 in healthy participants, as measured by all treatment-emergent adverse events (teaes) and treatment-emergent serious adverse events (saes). the secondary objectives of the study are: * to assess the concentration-time profile of regn14284 in serum * to assess the immunogenicity of regn14284


Eligibility criteria:
key inclusion criteria: 1. has sars-cov-2-negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol. 2. has received complete primary series of standard-of-care covid-19 vaccination per local guidance, completed at least 2 weeks prior to screening 3. has a body mass index (bmi) between 18 and 31 kg/m2 (inclusive) at the screening visit 4. is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety testing and ecgs performed at screening and/or prior to administration of study drug key exclusion criteria: 1. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol 2. presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study 3. was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit 4. has a history of alcohol or drug abuse as determined by the investigator 5. has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction to drugs or food as described in the protocol 6. use of any medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed as described in the protocol 7. participated in any clinical research study evaluating another investigational drug including biologics or specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit note: other protocol defined inclusion / exclusion criteria apply

Keywords: coronavirus disease 2019 (covid-19) vaccinated negative sars-cov-2 diagnostic test within approximately ≤72 hours of randomization
clinical effect of preventive use of tylenol on fever after removal of drainage tube in lumbar fusion surgery

Conditions: Lumbar Spinal Stenosis; Lumbar Disc Herniation; Lumbar Radiculopathy

Summary: this study evaluates the influence of non-steroidal anti-inflammatory drugs on preventing fever after the removal of drainage tube in the patients who suffered lumbar fusion surgery, if the outcome turn out positive, the preventive use of non-steroidal anti-inflammatory drugs could decrease the possibility of fever happening when we remove the tube.


Eligibility criteria:
inclusion criteria: * adult patient * diagnosis of lumbar spinal stenosis * perform decompression and fusion surgery and lay a drainage tube * understand the test and could sign the name exclusion criteria: * beside the inclusion criteria

Keywords: lumbar spinal stenosis lumbar fusion surgery drainage tube removal of drainage tube fever prevention of fever preventive use of non-steroidal inflammatory drug
a study to evaluate icu simulation experience in the cardiothoracic surgical population to reduce post-operative delirium

Conditions: Post-Operative Delirium

Summary: the purpose of this study is to evaluate the effect of a pre-icu admission virtual reality icu simulation on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.


Eligibility criteria:
inclusion criteria: * baseline normal neurological function pre-operatively. * planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure. exclusion criteria: * chronic dementia, alzheimer's disease, or other chronic neurological disease (i.e., bi-polar). * chronic use of neurological altering medications such as benzodiazepines, psychotropic, anti-depressants, anxiolytics. * patient undergoing emergent surgery. * use of post-operative cardiopulmonary support devices such as ecmo (extracorporeal membrane oxygenation), intra-aortic balloon pump, total artificial heart, or other similar device.
korean hereditary breast cancer study

Conditions: Breast Cancer; Ovarian Cancer

Summary: 1. to evaluate the prevalence of brca1/2 mutation of breast cancer patients with family history of breast/ovarian cancer. 2. to evaluate the prevalence of brca1/2 mutation of breast cancer patients without family history, but high risk of hereditary cancer. 3. to evaluate the prevalence of brca1/2 mutation of family member of brca1/2 mutation. 4. to evaluate the prevalence of ovarian cancer of population of above 3 groups.

1. to find founder mutation in korean 2. to correlation prevalence with risk evaluation 3. to find risk factors concerning life style

Eligibility criteria:
inclusion criteria: * over 19 years old * agree to this study * breast cancer patient with family history of breast/ovarian cancer (1 subgroup) * breast cancer patient; young age (\<40), bilateral, male, combined ovarian (2 subgroup) * family members with 1, 2 subgroups (3 subgroup) exclusion criteria: * under 20 years old * unable to decide for oneself
identifying oxytocin deficiency in adults with pituitary disease

Conditions: Arginine Vasopressin Deficiency; Oxytocin Deficiency

Summary: this is an open-label, pilot study, to characterize oxytocin response to a single dose of oral estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. the association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. we hypothesize that: 1. salivary and blood oxytocin response to estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control. 2. lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.


Eligibility criteria:
inclusion criteria: * avd group: adults 18-65 years old arginine-vasopressin deficiency stable pituitary hormone replacement * healthy control group adults 16-65 years old exclusion criteria for all participants: * history of pulmonary embolism, deep vein thrombosis, breast/endometrial cancer, stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral artery disease * pregnancy or breastfeeding within last 8 weeks * any significant illness or condition that the investigator determines could interfere with study participation, data collection, or safety
development of intravitreal ranibizumab by determining the pathogenesis of macular edema with retinal vein occlusion

Conditions: Macular Edema; Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion

Summary: the purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. in particular, we focus on the correlation between the treatment effectiveness of ranibizumab and the role of the cytokines involved in the cause of macular edema.

methodology: aqueous humor samples (0.1ml) were obtained during intravitreous injection of ranibizumab to measure the levels of cytokines. targeted cytokines are follows; il-1, il-2, il-6, il-8, il-9, il-10, il-12, il-13, ip-10, mcp-1, mmp-1, mip-1β, pdgf, vegf, plgf, icam-1, tnf-α, rantes, vegfr-1, vegfr-2, which has been reported that the expression level is increased in macular edema associated with rvo. cytokines are measured by multiple elisa (luminex). aqueous humor samples are obtained in the same manner from patients recurred after the first injection or continuous monthly injections. statistical analysis is conducted to examine the difference of cytokine levels between early or late/incomplete responders of ranibizumab, and predict the number of injections to stabilize cytokine levels. number of centers \& patients: single center, 100 patients sample size justification: sample size calculation was not done, since this study is a single-arm, observational study. population: inclusion criteria: patients with rvo and macular edema

Eligibility criteria:
inclusion criteria: * foveal thickness \> 300 μm * best corrected visual acuity \< 20/30 exclusion criteria: * history of retinal diseases other than brvo, glaucoma, uveitis, diabetes mellitus, rubeosis iridis, ocular infections, laser photocoagulation, and intraocular surgery

Keywords: macular edema branch retinal vein occlusion central retinal vein occlusion ranibizumab cytokines visual acuity central macular thickness
st. jude medical percutaneous mitral valve repair study

Conditions: Mitral Valve Prolapse

Summary: the purpose of this proof-of-concept study is to assess the relative safety and feasibility of the sjm percutaneous mitral valve repair (pmvr) device.

subjects will be followed-up through 6 weeks post implantation.

Eligibility criteria:
inclusion criteria: * subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation. * subject has an ejection fraction (ef) ≥ 30%. * subject is of legal age (≥18 years old). * subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse. exclusion criteria: * subject requires a complex mitral valve repair or has isolated anterior prolapse. * subject has mitral valve stenosis in which the annulus opening is \<10mm. subject has valve disease other than mitral which requires surgical intervention. * subject requires a concomitant procedure. * subject has a pre-existing prosthetic valve in any position. * subject had stenting or pci within 6 months before the planned procedure, or is anticipated to require stenting or pci within 6 months post-procedure. * subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device. * subject has renal insufficiency or is on chronic dialysis. * subject has had a cerebral vascular accident (cva) or transient ischemic attack (tia) within the past 6 months. * subject has a history of endocarditis or has active endocarditis. * subject has a history of autoimmune disease. * subject has significant known carotid artery disease. * subject has an aorto-mitral angle of \<110 degrees. * subject has hypertrophic obstructive cardiomyopathy (hocm's disease).

Keywords: mitral valve prolapse mitral valve disease mitral valve regurgitation mitral valve insufficiency mitral valve incompetence percutaneous mitral valve repair posterior leaflet prolapse mitral valve degeneration
cryoablation versus radiofrequency ablation for small renal masses

Conditions: Renal Cancers

Summary: the purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.

by enrolling all patients treated with ca or rfa, this study will document for the first time the safety and the short and long term efficacy of ca compared to rfa as well as provide urologists and decision makers currently unavailable information on ca in canada.

Eligibility criteria:
inclusion criteria: * patients with tumors that progress in size while on a watchful waiting protocol; * patients with multiple tumors; * patients with a tumor in a solitary kidney; * patients with poor renal function and a renal tumor; * patients with significant co-morbidities that may benefit from a less invasive approach. exclusion criteria: * large tumors \> 4.0cm; * unable to have a general anesthetic; * unable to comply with follow-up protocol (i.e., routine ct or mri and a follow-up biopsy); * uncorrectable bleeding diathesis; * evidence of metastatic disease.

Keywords: radiofrequency ablation cryosurgery renal cancers