Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy(immunogenicity) of gc3114 in healthy adults

Conditions: Influenza, Human

Summary: healthy adults will be once administered gc3114a(high-dose quadrivalent influenza vaccine) or gcflu quadrivalent pre-filled syringe inj..

healthy adults will be once administered gc3114a(high-dose quadrivalent influenza vaccine) or gcflu quadrivalent pre-filled syringe inj.. safety and immunological efficacy will be evaluated.

Eligibility criteria:
inclusion criteria: * healthy adults aged 19-64 years old * informed consent form has been signed and dated * able to comply with the requirements of the study exclusion criteria: * known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components * personal history of guillain-barre syndrome(gbs) * subjects with severe chronic disease who are considered by investigator to be ineligible for the study * subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study * immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy * pregnant or lactating women
macular degeneration and aging study

Conditions: Age-related Macular Degeneration

Summary: the purpose of this randomized trial is to examine the effectiveness of a psycho-social "preventive problem solving intervention" on emotional well-being, change in future outlook, and vision functioning in 250 age-related macular degeneration patients 60 and older.

loss of independence and valued activities places age-related macular degeneration (amd) patients at increased risk for depression, anxiety, and disability. patients' emotional and behavioral responses to amd can exacerbate the long-term health threat of the disease and contribute to preventable health care costs, loss of productivity, and burden to family members.this is a randomized controlled trial of a psycho-social intervention that addresses three mental health promotion goals: (1) increase emotional well-being, (2) improve future outlook, and (3) protect or enhance current and future-oriented functioning. the trial examines the effects of the prepsi for 250 amd patients, 60 and older, regardless of actual vision acuity. all study participants receive 4 group-based vision education classes and resource information. subjects are then randomized to preventive problem solving intervention (prepsi) consisting of 8 sessions with certified problem-solving trainers or to an enhanced attention control arm. assessors blind to treatment condition measure psychological well-being immediately post-intervention (week 16) and at 6-month follow-up, change in future outlook, including preparation for future care from baseline to 16 week and 6-month follow-up, and vision functioning at 6 month follow-up. measures include the psychological well-being scale (ryff \& keyes, 1995), the preparation of future care needs scale (sörensen \& pinquart, 2001), and the national eye institute vision functioning questionnaire-25 (stelmack, stelmack, \& massof, 2002). the primary hypothesis is that prepsi participants will report greater psychological well-being and more preparation for future care immediately post-intervention (at 16 weeks) and at 6-month follow-up. the prepsi is a short, standardized modification of problem-solving therapy that trains participants to identify and clearly define current and future problems, and then generate, evaluate, choose, and implement solutions. the long-term goal of the investigators research program is to improve quality of life in late adulthood by conducting basic and translational research on preventive future planning.

Eligibility criteria:
inclusion criteria: * diagnosis of amd * 60 years and older * able to communicate in english. exclusion criteria: * significant cognitive impairment at baseline (total score on mini mental state exam (mmse) for the blind \<18, equivalent to \<21 in the regular mmse); * residence in a nursing home (assisted living facilities are acceptable); * patient is acutely suicidal or psychotic

Keywords: aging, macular degeneration, preparation for future care, psychological well-being, problem solving prevention mental health promotion
buyang huanwu decoction and normal tension glaucoma

Conditions: Glaucoma; Visual Acuity; Visual Field; Chinese Medicine

Summary: the goal of this clinical trial is to test buyang huanwu decoction in normal intra-ocular pressure glaucoma. the main question to answer is: the effect of buyang huanwu decoction and its safety in patients with normal intra-ocular pressure glaucoma. participants will take 3 grams of buyang huanwu decoction or placebo for 12 weeks. researchers will compare treatment group and placebo group to see if the visual acuity, visual field would be improved.

there is currently no active and effective treatment for normal intra-ocular pressure glaucoma, and glaucoma patients often affect the optic nerve and cause visual acuity and visual field damage. studies have found that glaucoma patients have less blood flow to the optic nerve, retina and choroid than normal people. buyang huanwu decoction has the functions of invigorating qi, promoting blood circulation and dredging collaterals, and is often used in the treatment of stroke. therefore, the purpose of this study is to investigate the effect of buyang huanwu decoction on visual acuity, visual field and its safety in patients with normal intra-ocular pressure glaucoma. this study is designed as a randomized, double-blind, controlled clinical trial. a total of 60 subjects with normal intra-ocular pressure glaucoma were randomly divided into: 1) treatment group (30 subjects), oral administration of buyang huanwu decoction (3 grams), two times in a day after breakfast and dinner, for 12 consecutive weeks; 2) control group (30 subjects), the same method as the treatment group, but taking buyang huanwu decoction placebo (90% starch and 10% buyang huanwu decoction). primary outcome was changes in visual acuity, visual field, and optic nerve fiber layer, and secondary outcome was changes in quality of life scale scores.

Eligibility criteria:
inclusion criteria: * diagnosis of normal tension glaucoma for at least 3 months. * using less than 1 medicine for glaucoma. * without any eye disease other than normal tension glaucoma. * writing the informed consent form by themselves. exclusion criteria: * with other chronic diseases, such as diabetes, hypertension, cancer. * with polypharmacy. * had glaucoma surgery or myopia laser surgery before the study. * with mental disease and could not finish the study. * allergic to buyang huanwu decoction. * pregnancy or lactation.
a trial comparing yield of confocal endomicroscopy guided biopsies

Conditions: Barrett's Esophagus

Summary: we wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with barrett's esophagus who are being monitored with endoscopy.


Eligibility criteria:
inclusion criteria: * age at least 18. * barrett's esophagus * acid suppressive therapy * endoscopic surveillance exclusion criteria: * pregnancy or lactation * allergy to fluorescein * endoscopic esophagitis los angeles classification a to d * mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion * obvious mass lesions or cancer
prevention of asthma with levocetirizine (36 month treatment) in young children suffering from eczema (atopic dermatitis) and sensitized to grass pollen and house dust mite and having completed the previous epaac trial (nct00152464)

Conditions: Asthma

Summary: prolongation of the epaac™ trial - nct00152464 (the early prevention of asthma in atopic children). 36 months study to evaluate the efficacy and safety of levocetirizine (lctz) in preventing the onset of asthma in young atopic children.


Eligibility criteria:
inclusion criteria: inclusion criteria which must be verified at the end of first 18-months treatment (visit 9) * having completed the previous 18-month treatment period of the epaac trial - nct00152464 exclusion criteria: * none

Keywords: pediatry epaac atopic children prevention of asthma levocetirizine xyzal
efficacy of a short-term sequential therapy in non-complicated catheter related bacteremia by methicillin- susceptible s.aureus.

Conditions: Staphylococcus

Summary: evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by s. aureus methicillin-susceptible, selected based on a pre-established clinical and microbiological criteria.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years with a minimum weight of 40 kg. * microbiological isolation of s. aureus susceptible to meticillin. * start antibiotic treatment with drugs active against s. aureus within 72 hours from the onset of clinical manifestations. * women of childbearing potential, negative pregnancy test negative serum or urine or statement is not pregnant. * prescription prior treatment must be independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice. exclusion criteria: * polymicrobial bacteremia. * neutropenic patients. * patients addicted to intravenous drugs. * patients with malignancies with expected survival less than 6 months. * severe allergy to beta-lactams or fluoroquinolones. * creatinine clearance \<20ml/min. * need for hemodialysis, peritoneal dialysis or plasmapheresis. * clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of ie, embolic events, suppurative thrombophlebitis. * predictors of bacteremia complicated: * positive blood cultures for 48-96 hours of starting treatment antistaphylococcal * clinical instability * signs of sepsis or persistent fever at day 4 of treatment * existence of valvular or vascular prosthetic joints, vascular catheter not removed within three days * heart disease predisposing to endocarditis. * patients presenting diagnosis concomitant infection by another organism. * pregnant or breast-feeding. * patients with epilepsy. * patients with a history of tendon disorders related to fluoroquinolone administration. * not have signed informed consent.

Keywords: catheter-related bacteremia, sams catheter related bacteremia susceptible aureus meticillin
management tactics for patients high risk with acute coronary syndrome without st segment elevation and multivessel coronary artery disease

Conditions: Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients

Summary: the study will include patients with acute coronary syndrome without st segment elevation and multivessel ca lesion, who are subject to surgical treatment according to kg data (syntax score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). the patient should be suitable for both cabg and pci (confirmed by an x-ray surgeon and a cardiac surgeon). an x-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). thus, patients will be randomized into groups in a ratio of 1:1. each group will need to include 230 patients (a total of 460). in the main group, revascularization will be performed by pci, in the control group by cabg.


Eligibility criteria:
inclusion criteria: 1. acute coronary syndrome without st segment elevation of high risk: unstable angina pectoris or myocardial infarction requiring revascularization within 24 hours based on the risk of an unfavorable outcome (increase or decrease in the concentration of cardiac troponin in the blood that meet the criteria of mi; dynamic st segment displacement or changes in t; risk on the grace scale \>140 points) 2. the patient is suitable for both cabg and pci, confirmed by an interventional cardiologist and surgeon (multivessel lesion with a sintax score of 23-32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). 3. complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). 4. signed informed consent 5. age over 18 years. exclusion criteria: 1. myocardial infarction with st segment elevation 2. stable angina pectoris 3. patients with osn killip ii-iv class 4. patients required an immediate pci procedure (e.g. electrical instability) 5. a history of hemorrhagic stroke one year before the procedure 6. ischemic stroke or tia in the last 6 weeks 7. the final stage of chronic renal failure requiring dialysis. 8. preliminary pci for any other coronary artery lesion within 1 year prior to randomization. 9. pre-cabg at any time prior to randomization. 10. the need for concomitant cardiac surgery, except for cabg (for example, valve surgery, aortic repair, etc.). patients who require additional surgery (cardiological or extra-cardiac) for 1 year. 11. non-cardiac concomitant diseases with a life expectancy of less than 1 year (for example, oncological diseases). 13. the left ventricular ejection fraction is less than 40%. 14. severe degree of copd
spironolactone versus spironolactone plus furosemide (svssf)

Conditions: Cirrhosis; Ascites

Summary: the question whether the sequential diuretic therapy, that means using an antialdosteronic drug at first and adding a loop diuretic in nonresponders, is better than the combination of the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites in patients with cirrhosis is still open. therefore, the aim of the study is to compare sequential versus combined diuretic therapy in these patients. one hundred patients will be randomized into two groups. group a will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day. group b will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively. the percentage of responders to dthe diuretic treatment, the time to get the resolution of ascites and the rate of adverse effects will be compared between the two groups of patients.


Eligibility criteria:
inclusion criteria: * grade 2 ascites * serum creatinine less than 1.2 mtg/dl * serum sodium \> 130 mmol/l * serum potassium within 3.5 and 4.5 mmol/l * at least five days after the withdrawal of diuretics * a 90 mmol/day na diet. exclusion criteria: * any therapeutic paracentesis for ascites before inclusion * cardiac or respiratory disease * gastrointestinal bleeding, hepatic encephalopathy, bacterial infections in the last 4 weeks before inclusion. * the use of nsaids or other nephrotoxic drugs in the last 4 weeks before inclusion.

Keywords: cirrhosis ascites diuretic therapy potassium canrenoate furosemide hyperkalemia plasma renin activity nitric oxide serum sodium concentration refractory ascites nonazotemic patients with cirrhosis and moderate ascites
can additional preoperative skin cleaning on face, neck and chest with chlorhexidine reduce cutibacterium acnes contamination on sutures in arthroscopy rotator cuff repair?

Conditions: C. Acnes; Arthroscopic Rotator Cuff Repair

Summary: the purpose of our study was to investigate whether preoperative skin cleaning on face, neck, and chest with chlorhexidine could reduce suture contamination of c. acnes in arthroscopic rotator cuff repair. we hypothesized that preoperative skin cleaning on face, neck and chest with chlorhexidine can reduce c. acnes contamination on sutures in arthroscopic rotator cuff repair.


Eligibility criteria:
inclusion criteria: * primary arthroscopic rotator cuff repair exclusion criteria: * younger than 18 years * having previous shoulder surgeries or shoulder infection episodes * having a history of allergy to chlorhexidine * who refused to participate
cognitive support technology for postsecondary students with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this study will fill important knowledge gaps in the availability of best practices that use innovative methods to integrate the cognitive and vocational needs of students with autism spectrum disorder (asd) who will be transitioning from 2- and 4-year postsecondary education to employment. best practices exist from the assistive technology (at) field to help people compensate for cognitive impairments, and from the vocational rehabilitation (vr) field to enhance employment outcomes for individuals with disabilities. however, these practices have not been integrated to provide needed supports and services to improve the employment outcomes of students with asd. the study's goal is to expand the availability of innovative practices by testing the efficacy of a technology-driven, long-term, and resource-rich individualized support program that merges assistive technology for cognition and vocational rehabilitation practices. the end products will include technology application guidelines, training and procedural manuals, and resource information that rehabilitation professionals and students with ads can utilize to enhance technology and mentoring proficiency, academic success, self-determination, and long-term career success for students with asd. the knowledge to be gained from this research will have a beneficial impact on students with asd, rehabilitation professionals, higher education personnel, case managers, and employers who work with people with asd. there is strong potential for the students to develop skills that will help them succeed in learning as well as employment settings. the ultimate benefit of research activities for the target population will be seen in the improved capacity for postsecondary students with ads to utilize state-of-the-art technology to accommodate disability-related limitations, address career readiness, and to prepare for and obtain employment after graduation. because the risks to subjects are no greater than those associated with everyday life and because the study staff will refer students who are in psychological distress or medical emergency situations to appropriate resources in the community, the minimal risks of this study justify the considerable benefits that this study will yield. not only will the study benefit participating students, it stands to make important contributions to the knowledge bases in the fields of assistive technology and rehabilitation.


Eligibility criteria:
inclusion criteria: * must be a post-secondary student enrolled in degree programs at two-year and four-year colleges or universities within a 60-mile radius of kent, ohio * must have a clinical diagnosis of autism spectrum disorder exclusion criteria: * no other exclusion criteria will be applied
single-port versus multi-port robotic radical prostatectomy

Conditions: Malignant Neoplasm of Prostate

Summary: the purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. this surgery is called robotic radical prostatectomy. there are two robotic surgical systems approved by the food and drug administration (fda) to perform this surgery. first system is called the da vinci ® xi system. with this system, six small incisions are made during the surgery. second system is called the da vinci ® sp system. with this system a single incision is made during the surgery. same surgery is done with each surgical system. this study aims to understand whether a single incision surgery ends up with better recovery after surgery.


Eligibility criteria:
inclusion criteria: * participants must have histologically or cytologically confirmed prostate cancer, stage t1a, t2a or t2b prostate cancer using mri staging. * life expectancy greater than 10 years. * participants must have ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent for radical prostatectomy. exclusion criteria: * participants with any prior extensive pelvic surgery or pelvic fractures. * prior treatment for prostate cancer such as radiotherapy or focal therapy. * uncorrected coagulopathy. * active soft tissue or urinary infection. * poor surgical risk (defined as american society of anesthesiology score \> 3) * any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.) * participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
safety and efficacy of mk0594 to treat overactive bladder (0594-003)

Conditions: Urinary Incontinence; Overactive Bladder

Summary: this study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.


Eligibility criteria:
inclusion criteria: * patients with predominantly urge incontinence overactive bladder episodes * patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards exclusion criteria: * history of diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia * lower urinary tract symptoms associated with benign prostatic hypertrophy * active or current urinary tract infections (utis) * surgery to correct prolapsed uterus or stress incontinence
assessment of oxygenation with oxygen reserve index for general anesthesia

Conditions: Hyperoxia

Summary: to assess oxygenation with the oxygen reserve index in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) risk class i-ii, * undergoing tympanomastoidectomy exclusion criteria: * morbid obesity * opioid sensitivity alcohol or drug addiction * chronic obstructive pulmonary disease * coronary artery disease, * congestive heart failure * pronounced anemia * have a history of liver or kidney disease

Keywords: general anesthesia oxygen reserve index oxygenation hyperoxia