Kornimate/medical-research-clean huggingface dataset:
cryoballoon isolation of superior vena cava in paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: there is still unresolved question whether isolation of superior vena cava (svc) in conjunction to conventional pulmonary vein isolation (pvi) improves outcomes in the treatment of paroxysmal atrial fibrillation. the investigators are conducting a randomized study to determine if svc isolation (in addition to pulmonary vein isolation) with the cryoballoon technology can improve freedom from atrial arrhythmias in one year follow up after the ablation.

paroxysmal atrial fibrillation can be triggered by non-pulmonary vein foci, like the superior vena cava. there are some older publications showing improved result in terms of freedom from atrial tachycardias when electrical isolation of this vessel utilizing radiofrequency energy is achieved. recent retrospective studies showed that isolation of superior vena cava by the means of cryoballoon technology is safe and feasible procedure. furthermore, one retrospective cohort study showed improved outcomes of svc insolation + pvi versus pvi only strategy. to our knowledge there is still no randomized data that compared svc isolation + pvi vs pvi only strategy when using cryoballoon technology. the investigators want to determine if svc isolation by the means of cryoballoon technology in conjunction with pvi can improve the patients outcomes. also, there will be focus on the safety of the procedure, especially regarding the right sided phrenic nerve palsy. the primary objective of the study is freedom from atrial arrhythmias defined by standard postprocedural monitoring by ecg and holter monitors. the investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up. one group will receive conventional cryoballoon pulmonary vein isolation, and other group will receive svc isolation after the pvi procedure.

Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation scheduled for cryoballoon the ablation of atrial fibrillation (indication not related to the study) exclusion criteria: persistent atrial fibrillation * renal failure * contrast allergy

Keywords: pulmonary vein isolation superior vena cava isolation cryoballoon ablation
hpa axis study in japanese adults

Conditions: Atopic Dermatitis; Eczema

Summary: a multicenter, open-label study to evaluate the adrenal suppression potential of mapracorat 0.1% ointment in japanese adults with atopic dermatitis.

assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of mapracorat 0.1% ointment in japanese adults with atopic dermatitis.

Eligibility criteria:
inclusion criteria: * signed written informed consent * male or female subject aged \>= 20 years * diagnosis of atopic dermatitis according to the hanifin and rajka criteria * investigator's global assessment (iga) score of 3 (moderate) to 4 (severe) at baseline * normal acth response before start of treatment exclusion criteria: * pregnancy or lactation * clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results * concomitant medical or dermatological disorder(s), which could interfere with the investigator's ability to evaluate the subject's response to the investigational product * clinically manifest immunosuppressive disorder or known history of malignant disease
natalizumab temporary discontinuation study

Conditions: Multiple Sclerosis

Summary: this study evaluates the discontinuation of natalizumab either immediately or tapered off in the treatment of multiple sclerosis. half of the fifty (50) participants will discontinue natalizumab immediately and the other half will taper off the drug, having two additional infusions, one at six weeks- and one at eight weeks-post discontinuation.

natalizumab is a pharmaceutical intervention used in the management of multiple sclerosis. the decision to discontinue natalizumab therapy is often raised in patients defined as high-risk for pml despite good clinical efficacy. during the therapy cessation period following large phase iii trials, a return to the prestudy disease activity was reached by four months post-discontinuation. shorter therapy was associated with a trend for a more severe disease activity pointing to a possible 'rebound' effect after natalizumab discontinuation. this study focuses on two different approaches: an immediate versus a step-wise/tapered down natalizumab discontinuation protocol, both with reinstitution of a different disease modifying therapy (dmt) within 1-6 months from the last natalizumab infusion.

Eligibility criteria:
inclusion criteria: * patient with relapsing-remitting or relapsing-progressive (relapsing-remitting with incomplete recovery and secondary progressive with superimposed relapses) ms according to the mcdonald criteria who have been on natalizumab therapy for at least 12 months * age 18-65 * have edss scores less than or equal to 7.0 * positive john cunningham (jc) virus antibody results at screening * signed informed consent * none of the exclusion criteria exclusion criteria: * patients not willing or able to personally provide informed consent (subjects with cognitive impairment that effects the ability to provide informed consent for participation) * patients with active disease per clinical and mri evaluation at baseline * patients with renal disease that precludes having an mri with gadolinium contrast
efficacy of linaclotide to senna for cic

Conditions: Chronic Idiopathic Constipation

Summary: in this prospective, randomized, double blind study, the aim is to determine the efficacy of linaclotide in relation to senna in relieving the symptoms of chronic idiopathic constipation (cic). patients with cic, (age 18 - 70) will be enrolled in the study and randomized to senna or linaclotide. patients will be asked to complete questionnaires during the study and will be followed for 12 weeks. main outcomes include number of daily bowel movements and measures from surveys regarding bowel habits, relief, and satisfaction.

in this prospective, randomized, double blind study, the aim is to determine the efficacy of linaclotide in relation to senna in relieving the symptoms of chronic idiopathic constipation (cic). our hypothesis is that senna is not inferior to linaclotide in the treatment of cic. seventy patients aged 18-70 diagnosed with cic and seen by a gastroenterologist affiliated with trihealth or a patient of the faculty medical center clinic will be included in the study. after enrollment, subjects will be randomized to receive either linaclotide or senna over a 12-week period after a 1 week wash-out period. during th study period, subjects will complete a log to record the number of daily bowel movements. the subjects will also complete 3 validated surveys on a weekly basis: subject's global assessment sga of relief, subject's global assessment sga of bowel habit, and sga of satisfaction with their bowel habit. a research nurse will meet with subjects at the beginning of the study and then at 3 monthly visits to administer the study medication and distribute the surveys. the main outcomes measures are change in # of bowel movements and sga survey scores.

Eligibility criteria:
inclusion criteria: males and females 18 - 70 years of age. diagnosed with cic according to rome iii criteria. coherent and mentally competent patient to understand and consent for the trial unremarkable colonoscopy done in past 5 years exclusion criteria: significant diarrhea (defined as loose or watery stool and or more than three bowel movements daily associated with urgency more than 25% of the days in preceding 3 months) untreated hypothyroidism organic or structural disease as the cause of patient's symptoms (stricture or tumor) diseases that affect bowel transit time (gastroparesis, short bowel syndrome) evidence of cathartic colon history of alcohol, laxative abuse or illicit drug use pregnant or lactating women planning pregnancy or become pregnant during study period concomitant use of any medication that could alter gastrointestinal motility (calcium channel blockers, narcotics, anticholinergics, calcium and aluminium containing antacids, phenothiazines, ferrous sulfate)

Keywords: constipation bowel habits
post-operative pain management following spine surgery

Conditions: Pain Management; Analgesia; Anesthetic

Summary: the primary objective of this pilot study is to assess the feasibility of comparing two standardized approaches to manage post-operative pain following spine surgery: one approach using patient controlled analgesia (pca) devices to deliver opioid analgesics, and the other approach using exparel® infiltration at the site of surgery and nurse-administered opioid analgesics.

the study will assess the feasibility of the methods proposed, including recruitment, eligibility, standardization of both post-operative pain management approaches, and assessment of clinical, hospital efficiency, medication use, health services use, and economic outcomes.

Eligibility criteria:
inclusion criteria: * age 18-65 * ability to speak, read, and write in english or spanish * primary indication is low back pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or mild 1-level spondylolisthesis or deformity * scheduled to undergo primary, single level, lumbar fusion surgical procedure at the study center in the next 30 days * willing to provide informed consent, participate in study, and comply with study protocol exclusion criteria: * body mass index \>35 * pregnant or contemplating pregnancy prior to surgery * current or previous psychiatric, behavioral, or emotional disorder that may interfere with postsurgical pain, analgesia, or opioid use according to treating surgeon * prior treatment for alcohol, recreational drug, or opioid abuse * chronic inflammatory conditions (e.g. crohn's, lupus, rheumatoid arthritis) * chronic neurologic conditions (e.g. multiple sclerosis, parkinson's) * serious spinal conditions (e.g. cauda equina syndrome, infection, tumor, fracture) * hypersensitivity or allergy to local anesthetics * previous surgery in lumbar spine (i.e. other than microdiscectomy); * continuous (e.g. daily) opioid consumption for more than 30 days prior to surgery

Keywords: spine surgery post-operative pain patient controlled analgesia exparel® bupivacaine
effects of subanesthetic dose of ketamine given on postoperative mood in patients undergoing fractional curettage

Conditions: Ketamine; Minor Surgical Procedure; Total Mood Score; Woman

Summary: when given intravenously in doses below 1.2mg/kg, ketamine has been shown to work as an antidepressant. ketamine is a common induction drug used during general anesthesia. it is known to reduce postoperative pain in this instance. limited studies have evaluated the effect of a single subanesthetic dosage of ketamine administered as an adjunct to general anesthesia on acute mood states in patients undergoing minor surgery. the aim of this randomized controlled study was to examine if a single intravenous administration of 0.5 mg/kg ketamine given at the induction of propofol/fentanyl anesthesia has an effect on acute mood states before the discharge of women undergoing fractional curettage.

women admitted for fractional curettage between the ages of 18 and 75 were asked if they would like to participate in the study. exclusion criteria included uncontrolled hypertension, pregnancy, history of psychologic disorders, use of brain-affecting medicines, substance abuse, seizure disorders, or ketamine allergy. after receiving informed consent, the patient would be given a poms questionnaire. the participants were then assigned randomly to one of two groups. group a will receive ketamine intravenously at a dose of 0.5 mg/kg as part of the induction process for general anesthesia. in addition to their anesthetic, group b will get the same amount of saline instead of ketamine. patients were treated by a different anesthetic professional (who is blinded to the group the patient is in). all other induction medicines were administered at the discretion of the anesthesiologist. two hours after the surgery, participants were again administered the poms questionnaire, questioned about their pain level, and their data sheet was updated accordingly. during the trial, the levels of sedation, systolic and diastolic blood pressures and heart rate were measured. in addition, any adverse events were documented.

Eligibility criteria:
inclusion criteria: * consecutive patients (\>18 years) undergoing fractional curettage exclusion criteria: * american society of anesthesiologists' physical status ≥ 3 * history of psychological disorders * use of drugs affect central nervous system * substance abuse * chronic pain * pregnancy * seizure disorders * cardiovascular, hepatic or renal disease

Keywords: ketamine poms questionnary acute mood fractional curettage propofol
the real registry for utilization of ifr in assessing coronary stenoses

Conditions: Coronary Disease

Summary: the purpose of this registry is to collect real life information and to document the performance and user friendliness of ifr in daily diagnostic practice and treatment strategies for mvd patients undergoing cardiac catheterization.

the real registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple european and middle east countries, where product has received ce approval and is marketed. an average of 10 cases with a maximum of 50 patients will be enrolled per participating site. no follow-up will be performed. the real registry will only collect data during diagnostic angiogram or pci procedure, when performed.

Eligibility criteria:
inclusion criteria: * over 18 year of age * willing to participate and able to understand, read and sign the informed consent document before the planned procedure * eligible for coronary angiography and pci * coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment. exclusion criteria: * inability to obtain a signed informed consent from potential patient. * any contraindication for functional assessment as per the instructions per use and determined by the investigator.

Keywords: diagnostic coronary catheterization multi-vessel coronary disease percutaneous coronary intervention instantaneous wave free ratio fractional flow reserve
to evaluate the efficacy and the safety of monthly versus weekly oral risedronate with vitamin d in compliance, improvement of vitamin d and bmd in korean postmenopausal osteoporotic women

Conditions: Osteoporosis

Summary: the purpose of this study is to evaluate the efficacy and the safety of monthly(risenexm group) versus weekly oral risedronate(risenexsplus group) in korean postmenopausal osteoporotic women(phase iv)

the purpose of this study is to evaluate the efficacy and the safety of monthly(risenexm group) versus weekly oral risedronate(risenexsplus group) with vitamin d in compliance, improvement of vitamind and bmd in korean postmenopausal osteoporotic women(phase iv)

Eligibility criteria:
inclusion criteria: 1. female osteoporosis patients over 19years of age(with menopause). definition of osteporosis * they had a bmd t-score -2.5 or less at mean lumbar spine(l1\~l4), femoral neck or total. or evidence of at least one vertebral fracture. definition of menopause(can be one of three condition) * for 12months spontaneous amenorrhea * for 6months spontaneous amenorrhea with serum fsh(follicle stimulating hormone) is 40 mliu/ml and over * 6weeks after bilateral ovariectomy whether hysterectomy of not 2. patients who can be treated with oral bisphosphonate drugs 3. patients who have adequate to be measured dxa(dual energy x-ray absorptiometry) 4. patients who made a voluntary agreement after explanation of this study 5. patients who participated in clinical trial(hl_rsnp_401) must have taken the risenexplus and finish the study for 12 months. exclusion criteria: 1. patients with esophagus disorder. 2. patients administered with osteoprosis therapy(except calcium,vit.d medication) within previous 3 months 3. patients with serum calcium concentrations 8.0mg/dl under. 4. patients with severe nephropathy(serum creatinine\> doulble of normal level 5. patients with unable to sit upright or stand 30minutes.

Keywords: risedronate,cholecalciferol,bmd,montly,weekly,compliance
immunogenicity of concomitant administration of covid-19 vaccines with influenza vaccines

Conditions: COVID-19; Influenza; Vaccine Reaction; Contaminant Injected

Summary: the goal is to evaluate the in-depth immunogenicity analysis (including b-cell and t-cell response) of coadministration of a omicron-containing covid-19 vaccine and influenza vaccine among healthy adults during 2023-24 season.

this was an open-label, randomized clinical trial conducted at the international st. mary's hospital in incheon, south korea. this study included two study groups: concomitant administration of omicron containing messenger ribonucleic acid (mrna) covid-19 booster and quadrivalent influenza vaccination (qiv) and separate administration of influenza vaccination followed by mrna booster ≥4 weeks later * immunogenicity analysis : blood was drawn at baseline and follow-up visit 4 weeks, 3 months, 6 months, 10-12 months after immunization(for the covid-19 vaccine, additional blood sampling will be conducted one week after vaccination). * safety analysis : at 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (aes) through a standardized electronic questionnaire. participants were also asked to record any unsolicited aes during the 28 days after vaccination.

Eligibility criteria:
inclusion criteria: * who agreed to receive both booster covid-19 vaccine and influenza vaccine * individuals who have received the covid-19 vaccine three or more times and have passed at least 3 months after the last vaccination * individuals with a history of a single sars-cov-2 infection during the omicron outbreak period (january 2022-february 2023) exclusion criteria: * individuals with a contraindication to any of the vaccine compounds * individuals with a history of influenza infection within the past 6 months

Keywords: covid-19 vaccine influenza vaccine immunogenicity co-administration
insulin-sensitive obesity: lessons from longitudinal data

Conditions: Insulin Sensitivity/Resistance; Obesity

Summary: people who are overweight and/or obese are at risk of insulin resistance and type 2 diabetes. however, research has shown that some overweight and/or obese individuals remain insulin-sensitive and metabolically healthy despite their unhealthy body weight. the investigators hypothesise that overweight and/or obese people who were deemed insulin-sensitive in previous studies will maintain their insulin sensitivity and metabolic health over time. the investigators also hypothesise that the preservation of insulin sensitivity will be accompanied by key metabolic health markers.

while obesity is a risk factor for metabolic disease, sub cohorts with obesity not complicated by the metabolic syndrome have been described. these so called "metabolically healthy obese" may have reduced risk of type 2 diabetes, cardiovascular disease and all-cause mortality compared with individuals with obesity who present with components of the metabolic syndrome. longitudinal studies with diabetes and cardiovascular disease risk endpoints reported that individuals with obesity who are metabolically healthy (mho) held an intermediate health status, such that they were still worse off than the healthy normal-weight individuals. while there have been studies evaluating the stability of the mho phenotype over time, no study has reported the durability of insulin-sensitivity per se, as measured by the gold-standard hyperinsulinaemic-euglycaemic clamp. in the present study, we aimed to trace the change in insulin resistance/sensitivity, and to uncover predictors of insulin resistance in older age. the secondary aims were to trace the change in body composition, fat distribution and metabolic markers over time in a well-phenotyped cohort studied approximately 5-6 years apart.

Eligibility criteria:
inclusion criteria: * participation in two previous studies conducted at the garvan institute of medical research clinical research facility (described in the other publications 1-3). * willingness to give written informed consent and willingness to participate in the study. exclusion criteria: * pregnant and/or lactating women.

Keywords: hyperinsulinaemic-euglycaemic clamp body fat composition dual-energy x-ray absorptiometry obesity insulin resistance
dietary bioflavonoid supplementation for the prevention of neoplasia recurrence

Conditions: Colorectal Cancer

Summary: prove the hypothesis that dietary supplementation with bioflavonoids will diminish the recurrence rate of colonic neoplasia, we will implement a clinical trial comparing bioflavonoids and placebo in a double blind randomized clinical trial. to use a standardised supplementation of bioflavonoids, a commercially available preparation (flavo-natin®) will be used.

the preparation contains a mixture of 200mg chamomile and tea (green tea) extract which contains naturally occurring bioflavonoids (2%) together with vitamins and folic acid. this flavonoids mixture will be applied for 3 years and the compliance and effects of this treatment will be determined by measuring the serum concentrations of apigenin and egcg of the patients.

Eligibility criteria:
inclusion criteria: * patient who had a recent surgical resection of colorectal cancer with pathologically proven stage 2 or stage 3 (without adjuvant chemotherapy or after completion of adjuvant chemotherapy) according to uicc. the time interval for recruitment should be within 3-12 month after surgery. * male or female * caucasian * 50 to 75 years old * broca-index: between -20 and +25% * who are willing and capable to confirm written consent to enrolment after ample information has been provided * who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study exclusion criteria: * subjects with any major relevant clinical abnormality (as based on extensive medical history, physi-cal examination, vital signs) * subjects with active cancer * subjects with any major clinically relevant laboratory abnormality. * subjects who participated in another trial with any investigational substance within the last 4 weeks * subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol abuse during the active study phase * subjects who adhere to a extreme diet or lifestyle that might interfere with the investigation * subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy * subjects who are known or suspected not to be capable of understanding and evaluating the in-formation that is given to them as part of the formal information policy (informed consent), in par-ticular regarding the risks and discomfort to which they would agree to be exposed

Keywords: clinical trial flavonoid treatment neoplasia recurrence colorectal cancer polypectomy adenoma in colon neoplasia recurrence rates postpolypectomy patients