Kornimate/medical-research-clean huggingface dataset:
covid-19 study to assess immunogenicity, safety, and tolerability of moderna mrna-1273 vaccine administered with casirivimab+imdevimab in healthy adult volunteers

Conditions: Healthy; Chronic Stable Illness

Summary: the primary objectives of the study are: * to evaluate the extent of effect, if any, of regn10933+regn10987 administration on vaccine-induced neutralizing antibody responses to sars-cov-2 by moderna mrna-1273 * to evaluate the time interval required between regn10933+regn10987 administration and moderna mrna-1273 vaccination, to ensure no meaningful impact on vaccine-induced neutralizing antibody responses to sars-cov-2 the secondary objectives of the study are: * to quantify the alteration of antigen specificity of vaccine-induced sars-cov-2 antibody responses when administered with different dose regimens of regn10933+regn10987 * to evaluate the safety and tolerability of regn10933+regn10987 and moderna mrna-1273 vaccine when administered in close succession * to assess the concentrations of regn10933 and regn10987 in serum over time in participants who receive regn10933+regn10987 and moderna mrna-1273 vaccine * to evaluate the immunogenicity of regn10933 and regn10987 over time


Eligibility criteria:
key inclusion criteria: 1. healthy or has chronic medical condition(s) that are stable and well-controlled in the opinion of the investigator and that are not likely to require significant medical intervention through the end of study 2. willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to sars-cov-2 infection and transmission key exclusion criteria: 1. positive rt-pcr test result for sars-cov-2 infection at screening or baseline 2. positive serology test result for anti-sars-cov-2 antibodies at screening or baseline 3. covid-19 diagnosis, positive sars-cov-2 infection, or positive sars-cov-2 serology at any time prior to screening 4. previously received an investigational, authorized, or approved coronavirus vaccine (eg, sars-cov-2 vaccine, mers-cov vaccine) 5. currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat covid-19 6. received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis ad defined in the protocol 7. received intravenous immunoglobulin (ivig) or blood products in the last 3 months 8. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation 9. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation 10. medically attended acute illness or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening 11. clinical history of myocarditis and/or pericarditis note: other protocol-defined inclusion/ exclusion criteria apply
clearing lungs with enac inhibition in primary ciliary dyskinesia

Conditions: Primary Ciliary Dyskinesia

Summary: to evaluate the safety and efficacy of treatment with vx-371 with and without ivacaftor, and the effect of vx-371 with and without ivacaftor on quality of life (qol) in subjects with primary ciliary dyskinesia (pcd).


Eligibility criteria:
inclusion criteria: * the subject must have evidence supportive of a pcd diagnosis. * subjects with percent predicted fev1 of ≥40 to \<90 percentage points * non-smoker for at least 90 days prior to the screening visit and less than a 5 pack-year lifetime history of smoking * stable regimen of medications and chest physiotherapy for the 28 days prior to day 1 * if currently using daily inhaled hs, must be able to discontinue its use for the duration of the study. * if taking daily chronic or chronic cycling antibiotics, has been on a consistent regimen for at least 4 months prior to the screening visit. * clinically stable (as deemed by the investigator) for at least 14 days prior to the screening visit * female subjects of childbearing potential must have a negative serum pregnancy test at the screening visit. subjects of childbearing potential and who are sexually active must meet the contraception requirements. exclusion criteria: * diagnosis of cf based on results of sweat chloride or nasal potential difference (npd) tests or presence of 2 cf-causing mutations in cftr gene. * history of any organ transplantation or lung resection or chest wall surgery. * significant congenital heart defects, other than a laterality defect, at the discretion of the investigator * diagnosis of cri du chat syndrome (chromosome 5p deletion syndrome). * inability to withhold short-acting bronchodilator use for 4 hours prior to clinic visit and long-acting bronchodilator use the night before the first and last clinic visit of each treatment period. * use of diuretics (including amiloride) or renin-angiotensin antihypertensive drugs * symptoms of acute upper or lower respiratory tract infection, acute pulmonary exacerbation, or treatment or was treated with systemic antibiotics for ear or sinus disease within 28 days before day 1 (topical otic antibiotics allowed). * history of significant intolerance to inhaled hs * pregnant and/or nursing females * any clinically significant laboratory abnormalities * history of chronic b. cepacia complex or m. abscessus or m. avium * surgery that required general anesthesia and hospitalization within 3 months of day 1 additional exclusion criteria for part b: * in addition to the exclusion criteria above, subjects who participate in part b and meet any of the following exclusion criteria will not be eligible to continue into part b * unable to swallow tablets. * concomitant use of strong or moderate inhibitors or inducers of cytochrome p450 (cyp) 3a, including consumption of certain herbal medications (e.g., st. john's wort), and grapefruit/grapefruit juice. * known hypersensitivity to ivacaftor.
continuous tql block for elective cesarean section

Conditions: Postoperative Pain; Anesthesia, Local

Summary: the aim of this study is to investigate whether it is possible to prolong time to first opioid with the tql block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective cs. our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours.


Eligibility criteria:
inclusion criteria: * 18+ years of age. * scheduled for elective caesarean section in spinal anaesthesia. * have received thorough information, verbally and in written, and signed the "informed consent" form on participation in the trial. exclusion criteria: * inability to cooperate * inability to understand danish * allergy to local anaesthetics or opioids * excessive daily intake of opioids, according to the discretion of the investigator * local infection at the site of injection or systemic infection * difficult visualisation of muscular and fascial structures on ultrasound, necessary to correct blockade and catheter placement.
comparison of treatments for barrett's esophagus with high-grade dysplasia/early adenocarcinoma

Conditions: Barrett's Esophagus

Summary: prospective randomized study comparing radiofrequency ablation and cryotherapy for the endoscopic treatment of barrett's esophagus. the study is powered to assess clinical equivalence (non-inferior) of the treatment regimens.

adult patients found to be suitable candidates for endoscopic treatment of barrett's esophagus (be) with high-grade dysplasia (hgd) and/or early adenocarcinoma of the esophagus will be asked to participate in this study. patients will be randomized to receive either radiofrequency ablation or cryotherapy. all treatments will be performed using standard mgh gi unit protocol. a total of fifty subjects will be enrolled. patients who have contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease) or who decline participation in the study will be ineligible. patients unable to provide their own consent will also be excluded. this is a single-site study to be conducted at mgh. after obtaining written informed consent, the patient will be randomized to receive either radiofrequency ablation or cryotherapy. treatments will be carried out in accordance with standard mgh gi unit practice. the primary endpoint of the study is the percentage of barrett's esophagus ablated at the first follow-up visit (typically 2-3 months following therapy). at this point, the patient's role in the study will be terminated. they will continue to receive routine follow-up by their physician as needed.

Eligibility criteria:
inclusion criteria: * suitable candidates for endoscopic treatment of barrett's esophagus (be) with high-grade dysplasia (hgd) and/or early adenocarcinoma of the esophagus exclusion criteria: * contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease) * refusal to participate in the study
early vitrectomy for macular tractional maculopathy

Conditions: Myopia, Degenerative

Summary: this study is designed to identify the effect of current vitreous surgery for symptomatic macular tractional maculopathy. characteristics of this study is as below 1. multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole formation or deterioration of visual acuity occurs) 2. non-randomized study (decision was made by patients after full explanation) 3. after 1 year follow up, functional change(visual acuity)and anatomical change would be evaluated

degenerative myopia is relatively common disorder, especially in korean, japanese and chinese. choroidal neovascularization is well-noted cause of va deterioration, but nowadays, with improvement of diagnostic tools, such as oct, va deterioration from myopic tractional maculopathy is being concerned as well. but till now, the necessity of early vitrectomy on mtm is controversial. by now some clinicians prefer conservative treatment, which means pars plana vitrectomy would be postponed till structural change such as macular hole formation is noticed. and the others prefer early vitrectomy, which means pars plana vitrectomy should be performed when the symptom begins. in this study, investigators try to verify the validity of early vitrectomy comparing conservative treatment.

Eligibility criteria:
inclusion criteria: * male or female with impending macular hole(identified with oct) * age: over 20 years * symptom duration \< 6 months * visual acuity on trial: more than 20/320 in etdrs chart exclusion criteria: * any vision disturbing disease other than impending macular hole * diabetic maculopathy or other retinal vascular disease * prior history of major trauma: if symptom begins after trauma * any evidence of atrophic change, scar or exudation on macula active intraocular inflammation * history of intraocular surgery other than uncomplicated cataract extraction 3 months before * uncontrolled iop \> 25mmhg

Keywords: macular tractional maculopathy pathologic myopia
imfinzi btc japan pms_japan post-marketing surveillance (pms) study - cei/scei

Conditions: Biliary Tract Cancer

Summary: to investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive imfinzi in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing setting.

this investigation will be conducted to investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive imfinzi intravenous infusion 120mg, 500mg in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing setting. the investigation will be conducted as one of the additional pharmacovigilance activities in the japan risk management plan of imfinzi in compliance with the ministerial ordinance on good post-marketing study practice (gpsp ordinance) and for the purpose of application for reexamination under article 14-4 of the act on securing quality, efficacy and safety of products including pharmaceuticals and medical devices. among the safety specifications defined in the japan risk management plan of imfinzi, the following items are set as the safety specifications for this study. interstitial lung disease, colitis/severe diarrhoea, hepatic function disorder/hepatis/cholangitis sclerosing, endocrine disorders (dysfunction thyroid, dysfunction adrenal, pituitary dysfunction), type 1 diabetes mellitus, renal disorder (interstitial nephritis, etc), myositis, myocarditis, myasthenia gravis, immune thrombocytopenic purpura, encephalitis, severe skin disorder, nerve disorder (including guillain-barre syndrome), infusion reaction, pancreatitis, gastrointestinal perforation, rhabdomyolysis, meningitis, febrile neutropenia during combination treatment with chemotherapy, embryo-fetal toxicity and use in patients with a history of organ transplant (including haematopoietic stem cell transplant).

Eligibility criteria:
inclusion criteria: * patients with curatively unresectable biliary tract cancer who receive imfinzi for the first time in combination with gemcitabine hydrochloride and cisplatin. exclusion criteria: -
metabolic effects of treatment in patients with recently diagnosed type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.


Eligibility criteria:
inclusion criteria: * recently diagnosed type 2 diabetes * no previous anti-diabetic medications exclusion criteria: * heart failure * renal disease * liver disease * life-threatening diseases

Keywords: rosiglitazone metformin
efficacy of intravenous dexamethasone on postoperative caudal analgesia in pediatric orchiopexy

Conditions: Pain

Summary: the purpose of this study is to evaluate postoperative pain control for pediatric patients.


Eligibility criteria:
inclusion criteria: * pediatric patients scheduled for elective day-case orchiopexy. exclusion criteria: * infants or children with history of steroid allergy, renal, hepatic disease, or contraindication for caudal analgesia.

Keywords: pediatric patients (6 months-5 years) scheduled elective day-case orchiopexy
a study of baricitinib in participants from 2 years to less than 18 years old with juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: the reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with jia from 2 years to less than 18 years old.


Eligibility criteria:
inclusion criteria: * participants must have had a diagnosis of active jia (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis \[era\] including jpsa). * participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (dmard). exclusion criteria: * participants must not have systemic jia, with or without active systemic features. * participants must not have persistent oligoarticular arthritis. * participants must not have been previously treated with a janus kinase (jak) inhibitor.

Keywords: polyarticular jia oligoarthritis juvenile psoriatic arthritis (jpsa) enthesitis-related juvenile idiopathic arthritis (era)
patient attitudes and preferences for outcomes of inflammatory bowel disease therapeutics

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn's Disease

Summary: the investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antitnf) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.

the investigators will conduct a comparative effectiveness study among medicare parts a, b, and d beneficiaries with inflammatory bowel disease. the investigators will compare the incidence of severe infection, bowel resection surgery, and death among new users of anti-tumor necrosis factor therapies and corticosteroids. the investigators will compute propensity scores to describe the propensity for treatment with anti-tumor necrosis factor drugs compared to corticosteroids, and will match corticosteroids and anti-tumor necrosis factor drug treated patients on the propensity score. cox regression will be employed to assess the hazard ratio for each of the outcomes.

Eligibility criteria:
inclusion criteria: 1. patients will be required to have at least two diagnosis of inflammatory bowel disease within the 6 months prior to initiating anti-tnf therapy or corticosteroids. to assure full coverage, patients will be required to have parts a, b, and d medicare coverage. exclusion criteria: 1. diagnosis of rheumatoid arthritis, psoriasis, ankylosing spondylitis, or psoriatic arthritis in the 6 months period prior to initiation of the therapy. 2. less than 6 months of follow-up time within the data source prior to initiation of the therapy. 3. diagnosis of cancer in the 6 months prior to initiation of the study medication. 4. initiation of anti-tnf therapies within the first 6 months following surgery. 5. patients who are in managed care plans (medicare part c).

Keywords: patient preference
the study for the reliability and validity of incremental shuttle walking test for copd patients in korea

Conditions: Chronic Obstructive Pulmonary Disease

Summary: investigators will perform this study to validate shuttle walking tests in korean patients with chronic obstructive pulmonary disease. this study will be performed as multi-center prospective observational correlation study in ulsan university hospital and asan medical center. 36 participants will perform the exercise stress test with cycle, 6 minutes walking test and shuttle walking test. investigators will analyze correlation 6 minutes walking test and shuttle walking test with exercise stress test.

investigators will perform this study to validate shuttle walking tests in korean patients with chronic obstructive pulmonary disease. this study will be performed as multi-center prospective observational correlation study in ulsan university hospital and asan medical center. 18 patients will be enrolled in each hospital. when then visit, patients will perform questionnaire and laboratory study for baseline characteristics. after that, patients select memo, in which order for the exercise stress test with cycle, 6 minutes walking test and shuttle walking test will be written. along that order, patients will perform each study at every two day in a week. investigators will analyze correlation 6 minutes walking test and shuttle walking test with exercise stress test. to analyze reliability in shuttle walking test, patients will shuttle walking test in two times. researchers will analyze correlation between them.

Eligibility criteria:
inclusion criteria: * patients with respiratory symptom * patients with forced expiratory volume 1/forced vital capacity \< 0.7 in pulmonary function test after bronchodilator * patients with informed consent exclusion criteria: * history of unstable angina or myocardial infarction within 1 month * more than 120/mins pulse rate in stable state * uncontrolled arrhythmia or history of syncope * symptomatic aortic stenosis or severe cardiac valve stenosis * acute pulmonary embolism, deep vein thrombosis, aortic dissection or pulmonary edema * difficult condition for shuttle walking test; visual, auditory or psychological disturbance * respiratory failure * oxygen saturation ≤ 85% in stable state * needs for oxygen supply during walking * active infection, acute infective endocarditis, renal failure, hyperthyroidism or significant pulmonary hypertension * left main coronary artery stenosis, hypertrophic cardiomyopathy * systolic blood pressure more than 180 mmhg * diastolic blood pressure more than 100 mmhg * pregnant women * patients with orthopedic disease
effectiveness and safety of 25-gauge needle-assisted phacoemulsification of dislocated intravitreal lens nucleus

Conditions: Dislocated Lens; Pars Plana Vitrectomy; Phacoemulsification; Needle

Summary: the goal of this observational study is to learn about the effects of 25-gauge (g) needle-assisted phacoemulsification to remove dislocated intravitreal lens nuclei.

patients with dislocated intravitreal lens nuclei who underwent 23g pars plana vitrectomy (ppv) and 25g needle-assisted phacoemulsification between july 2022 and september 2024 were included. primary outcomes included best-corrected visual acuity (bcva) and intraocular pressure (iop). secondary outcomes included corneal endothelial cell count (cecc) and the incidence of intraoperative and postoperative complications. these outcomes were statistically analyzed both preoperatively and postoperatively. a minimum follow-up of 6 months was completed for all eyes.

Eligibility criteria:
inclusion criteria: clinical diagnosis of dislocated intravitreal lens nuclei signed informed consent exclusion criteria: surgical contraindications
study for perioperative neurocognitive disorders after deep brain stimulation surgery for parkinson's disease

Conditions: Neurocognitive Disorders

Summary: perioperative neurocognitive disorders(pnd) is common to see in elderly patients. although pnd increases patient mortality as well as hospitalization time, apparent inflammatory factors, and related mechanisms are still unknown. metabolites could reveal chemical fingerprints left behind by cellular processes, which in turn provide a new aspect to understand the biological process behind. we aim to found the metabolomics can aid the development of diagnostic markers of pnd screening, early detection, and further, provide a basis for disease prevention and treatment.


Eligibility criteria:
inclusion criteria: * parkinson's patients undergoing elective deep brain stimulation * age ≥55 years * asa physical statusⅰ-ⅲ * elementary school or above exclusion criteria: * patients with asa physical status\>iii * patients with systemic immune diseases, hematological diseases (hematological tumors or leukemia), patients after transplantation, malignant tumors * patients with metabolic diseases such as diabetes, ketoacidosis, hyperosmolar syndrome, long-term hypoglycemia,gout * patients who refused to join the study and lost to follow-up