Kornimate/medical-research-clean huggingface dataset:
a phase iii long term study of k-877 extended release tablet

Conditions: Dyslipidemias

Summary: to investigate the safety and efficacy of k-877 extended release (er) once daily for 52 weeks in the morning or evening in dyslipidema.the starting dose of the er tablet will be 0.2 mg/day. if the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.


Eligibility criteria:
inclusion criteria: 1. patients with dyslipidemia had to be age 20 years or older at written informed consent 2. patients who have received dietary or exercise guidance from 12 weeks or more prior to screening 3. patients with the fasting serum tg \>= 150 mg/dl twice consecutively at screening exclusion criteria: 1. patients with a fasting serum tg \> 1000 mg/dl at screening 2. patients who require administration of prohibited drugs during the clinical trial period after written informed consent 3. patients with uncontrolled thyroid disease 4. patients with type 1 diabetes and uncontrolled diabetes \[hba1c(ngsp) \>= 10.0 % at screening\] 5. patients with uncontrolled hypertension (sbp \>= 160 mmhg or dbp \>= 100 mmhg) 6. patients with an ast or alt three times the upper limit at screening 7. patients with an ck five times the upper limit at screening 8. patients with cirrhosis or those with biliary obstruction 9. patients with acute myocardial infarction within 3 months before obtaining informed consent 10. patients with heart failure class iii or higher according to nyha cardiac function classification 11. patients with malignant tumor or those who are judged to have a high risk of recurrence 12. patients with a history of serious drug allergies (anaphylactic shock, etc.) 13. pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods 14. patients who have collected 400 ml or more of whole blood within 16 weeks, or 200 ml or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before screening 15. patients who have received k-877 (pemafibrate) 16. patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks 17. patients who have been determined inappropriate by the investigator, etc
chatbot on the prevention of postoperative complications

Conditions: Visceral Surgery Complications

Summary: major visceral surgery encompasses a broad range of operations with a wide variety of procedures that fall under this category. the majority of patients undergoing major visceral surgery often present with cancer and other medical comorbidities and are put at an elevated risk of a large number of medical and surgical postoperative complications

complications following major visceral surgery are relatively common and are estimated to occur in 18-23% of patients . the management of complications is challenging for both the elderly patient and the perioperative team, and adds considerably to the cost of care particularly when further interventions involve readmission, unplanned admission to an intensive care unit, interventional radiology and/or an unplanned return to theatre. with the advancement of online patient portals, the use of internet to seek for health information is already a common phenomenon; chatbot may become a more significant source of information for patients.

Eligibility criteria:
inclusion criteria: * patients aged 60 years old and above, both sex, scheduled for elective major visceral surgery, able to communicate in the local language, and without any cognitive impairment. exclusion criteria: * elderly patients with a history of major psychiatric disorders, patients with a history of previous major visceral surgery, and patients who were unable to provide informed consent will be excluded from the study.
evaluation of ocular surface in hemodialysis patients by ocular surface analyzer

Conditions: Hemodialysis; Ocular Surface Disease; Dry Eye; OSDI

Summary: we clinically observed that some hemodialysis patients had corneal epithelial dryness, shedding, edema, and persistent epithelial nonunion after ocular surgery, which seriously affected the effect of surgery, and it is necessary to study the ocular surface characteristics of hemodialysis patients. in this study, we examined the ocular surface and analyzed and investigated the characteristics of the ocular surface in hemodialysis patients to provide a basis for ocular surface intervention or treatment in hemodialysis patients before ocular surgery in clinical practice.

this study is a clinical case-control study. a total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the nephrology department of the first affiliated hospital of jinan university .all the subjects in the hemodialysis group (n = 36, 72 eyes) and the normal group (n = 36, 72 eyes) were investigated with the osdi scale, and then bilateral ocular surface examinations were performed with keratograph5m eye surface comprehensive analyzer. non-invasive tear meniscus height (nitmh), first tear film break-up time (ftbut), average tear film break-up time (atbut), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.

Eligibility criteria:
the hemodialysis group inclusion criteria: * older than 18 * hemodialysis patient * the subject understands the purpose of this clinical trial and agrees to sign an informed consent form. the hemodialysis group exclusion criteria: * previous history of ocular trauma or surgery * history of wearing contact lenses * can not stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears * eyelid abnormalities (such as eyelid insufficiency, entropion and ectropion, tumor, severe trichiasis) * there have been peritoneal dialysis, kidney transplant surgery patients. the normal group inclusion criteria: * older than 18 * healthy people do not have other systemic diseases, such as diabetes and hypertension * the subject understands the purpose of this clinical trial and agrees to sign an informed consent form. the normal group exclusion criteria: * previous history of ocular trauma or surgery * history of wearing contact lenses * can not stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears.
a study to learn more about how a smartphone app called myius predicts future menstrual bleeding in women after they have begun using intrauterine birth control method (a birth control device is inserted into a woman's uterus by her doctor)

Conditions: Uterine Bleeding Profile Prediction

Summary: researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods. "intrauterine contraception" means that a device is inserted into a woman's uterus by her doctor. the device then releases a birth control treatment into the uterus. researchers have found that when women use intrauterine contraception, its effects on the menstrual cycle can cause changes to how often and for how long women will bleed. this is one of reasons women may stop using their intrauterine contraception. so, the researchers in this study wanted to learn about a tool that can be used to predict future bleeding events. this tool was developed based on the results of previous clinical studies that researched menstrual bleeding. this tool is a smartphone application called myius. this study will include about 3,000 women who have recently had intrauterine contraception inserted and who use the myius app. there will be no visits with a study doctor in this study. after the intrauterine contraception has been inserted, the women will start to record any events of bleeding in the myius app. after they have recorded events of bleeding for a total of 90 days, the myius app will give a prediction of menstrual bleeding expected for the next 180 days. the women who sign the electronic informed consent form will continue to record their bleeding events for a total of 6 months. the researchers will then collect this information. they will use this information to find out how well the myius app can predict future menstrual bleeding.

the aim of this study is to demonstrate that the bleeding prediction algorithm which was developed and validated based on clinical trial data also works in a real-world setting.

Eligibility criteria:
inclusion criteria: * insertion of kyleena, jaydess, or mirena ius * female (of legal age to provide electronic informed consent (eic)) using the myius app * submitted eic to use all data documented in the myius app exclusion criteria: - none

Keywords: prevention of pregnancy
safety of twice daily oxycodone hydrochloride controlled-release tablets in children with moderate to severe malignant and/ or nonmalignant pain requiring opioids

Conditions: Pain

Summary: the purpose of this study is to characterize the safety of oxycodone hydrochloride (hcl) controlled-release (cr) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.


Eligibility criteria:
inclusion criteria include: * male and female patients aged 6 to 16 years, inclusive, who are expected to require ongoing around-the-clock opioid treatment equivalent to at least 20-mg daily dose of oxycodone for at least 2 weeks for management of moderate to severe (based on the investigator's judgment) malignant or nonmalignant pain. * patients must be opioid tolerant, ie, have been treated with opioids for at least the 5 consecutive days prior to dosing and with at least 20 mg daily of oxycodone or the equivalent during at least the last 48 hours prior to the start of study drug dosing and have tolerated the therapy, as demonstrated at the start of study drug dosing. * patients who are currently using transdermal fentanyl should have been on the patch for at least 3 days before removing the patch and oxycodone hydrochloride (hcl) controlled-release (cr) treatment can only be initiated at least 18 hours following the removal of the transdermal fentanyl patch. * patients must not require more than a 240-mg total daily dose of oxycodone hcl cr tablets. * patients must be willing and able to swallow the oxycodone hcl cr tablets whole. * patients must not be currently on an investigational medication/therapy at the start of screening or during the study. exclusion criteria include: * female patients who are pregnant or lactating. * patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\]). * patients who have received epidural opioids \< 2 hours prior to the first dose of study drug or who have received epidural morphine \< 12 hours prior to the first dose of study drug. * patients who are contraindicated for the use of opioids. * patients who are contraindicated for blood sampling. * patients who are currently being maintained on methadone for pain. * patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices. * patients who have had surgery within 5 days prior to day 1 (day of first dose of study drug). * patients who, in the investigator's opinion, have an underlying gastrointestinal condition or other disorder that may predispose them to obstruction. other protocol-specific inclusion/exclusion criteria may apply.

Keywords: malignant pain nonmalignant pain pediatric opioid moderate to severe malignant or nonmalignant pain
safety and feasibility of the neurolyserxr for sacroiliac joint pain

Conditions: Sacroiliitis

Summary: pilot study to evaluate the safety and the effectiveness of the neurolyser xr as a treatment for sacroiliitis

pilot, interventional, prospective, open label, single arm study to evaluate non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (sij) using high intensity focused ultrasound delivered by the neurolyser xr. patient would be treated and then followed for up to 6 months. primary safety endpoint will be measured by the incidence and severity of treatment related adverse events primary effectiveness endpoint will be measured by the changes in average pain score and rolland morris disability questionnaire between baseline and 6 and 12 months

Eligibility criteria:
inclusion criteria: 1. adult male and females, legally able and willing to participate in the study and come for follow-up visits 2. able and willing to fill the research questionnaires and to communicate with investigator and research team 3. patient with bilateral or unilateral sacroiliac joint pain of \> 6 months duration 4. patients presenting with a) a positive (\>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (\>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months) 5. average pain score of 4 or higher in the last month, (on 0-10 scale). exclusion criteria: 1. pregnant or breastfeeding patient 2. patients younger than 18 or older than 80 years 3. patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain). 4. patients with history of lumbar and / or sacral spine surgery 5. patients with the presence of metal hardware at the lumbosacral spine 6. patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study pi) 7. patients unable to understand and complete the research questionnaires in hebrew. 8. patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome. 9. patient with extensive scarring in the skin and tissue overlying the treatment area. 10. patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
comparison of cloxacillin and benzylpenicillin in penicillin susceptible s. aureus bacteraemia

Conditions: Staphylococcus Aureus Bacteraemia; Staphylococcal Bacteraemia; Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia); Staphylococcus (S.) Aureus Infection

Summary: the goal of this study is to investigate if benzylpenicillin is a better treatment option than cloxacillin in patients with penicillin-susceptible staphylococcus aureus bacteraemia.

the overall research idea of is a rct is to test the hypothesis that benzylpenicillin is superior to cloxacillin in the treatment of pssa bacteraemia. population: adult patients (\>18 years) with pssa bacteraemia will be eligible for enrolment in the study. exclusion criteria are allergy to penicillin, inability to give informed consent, and concomitant growth of other clinically significant bacteria in blood cultures. we are planning a nation-wide study. intervention: benzylpenicillin treatment of pssa bacteraemia will be evaluated. as soon as s. aureus has been identified in blood cultures and the susceptibility testing indicates penicillin susceptibility (two-three days from start of treatment), patients will be randomized to continue therapy with either cloxacillin or benzylpenicillin. the duration of treatment depends on the type of infection, and details about length of therapy and dosage will be decided by the specific patient diagnosis (i.e., endocarditis, arthritis). repeated blood cultures and echocardiography are important in the diagnostic work-up of s. aureus bacteraemia and will be included in the study protocol. patients will also be monitored regarding adverse events, such as liver and renal impairment, rash, diarrhoea, thrombophlebitis et c., and treatment failure, relapse, and mortality. control: the study drug (benzylpenicillin) will be compared to cloxacillin, which is the current drug of choice for methicillin susceptible s. aureus in sweden. both drugs will be used at clinically recommended doses, with appropriate adjustments for renal impairment if needed. outcome: primary outcome is; to be alive for 90 days without any complications. complications are defined as having any of relapse (90 days after antibiotic finished), need of change or addition of antibiotics due to side effects or treatment failure or adverse events.

Eligibility criteria:
inclusion criteria: aged ≥18 with penicillin susceptible s. aureus bacteraemia (pssa), and able to provide written informed consent. exclusion criteria: * allergy to penicillin, * inability to give informed consent, * concomitant growth of other clinically significant bacteria in blood cultures * neutropenia -≥ 96h with prior antibiotics * when the per oral follow up medication can not be flukloxacillin or penicillinv/amoxicillin (ie prosthetic joint infection) * patients in terminal palliation, where death is expected within 7 days. * where the treating physician believes cloxacillin is not a first-line treatment.

Keywords: penicillin treatment benzylpenicillin cloxacillin penicillin susceptible s. aureus staphylococcus aureus bacteraemia
mucosal impedance balloon in diagnosis and treatment of eosinophilic esophagitis (eoe)

Conditions: Eosinophilic Esophagitis; Healthy

Summary: this study will evaluate the role the balloon mucosal impedance may have in diagnosing and monitoring the patients with eosinophilic esophagitis. we will compare the results of the balloon mucosal impedance in patients with eosinophilic esophagitis and controls.

the standard diagnostic evaluation for eoe includes upper endoscopy with esophageal biopsies. recently we completed the study "mucosal impedance in eosinophilic esophagitis and the effect of treatment" using a new technology allowing for direct assessment of mucosal impedance at the time of routine upper endoscopy to assess esophageal integrity and disease activity and alevate the need for biopsies. for this study, sandhill scientific has customized a mucosal impedance balloon (mi) assembly to provide precise measurements over a broad area of esophageal epithelium, while eliminating the fluids and spanning across a 10 mm luminal area using the same direct assessment as the mucosal impedance at the time of routine upper endoscopy.

Eligibility criteria:
inclusion criteria: * adults ages 18-90 undergoing clinically indicated upper endoscopy * patients with eoe, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy * patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or gerd with normal appearing esophageal mucosa. exclusion criteria: * medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy * patients with conditions known to be associated with esophageal eosinophilia, including crohn's disease, churg-strauss, achalasia, and hypereosinophilic syndrome * inability to read due to: blindness, cognitive dysfunction, or english language illiteracy
can risedronate prevent periprosthetic bone loss after total hip arthroplasty

Conditions: Bone Loss

Summary: can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?

periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the longevity of implants used for treatment of osteoarthritis. bone loss leads to implant destabilization. bisphosphonates, given for approximately 6 months after tha man prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis loosening. we perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss around a uncemented femoral stem.

Eligibility criteria:
inclusion criteria: * patients on the waiting list for a total hip arthroplasty * primary osteoarthritis * osteoarthritis secondary to congenital dislocation of the hip exclusion criteria: * rheumatoid arthritis * bisphosphonate treatment * osteomalacia * hypocalcemia * previous surgery of the affected hip

Keywords: periprosthetic bone loss risedronate bisphosphonates
effect of salsalate on bed rest-induced vascular dysfunction

Conditions: Insulin Resistance

Summary: physical inactivity induces vascular dysfunction and glucose intolerance during five days of bed rest. this study will investigate the effects of salsalate on these responses. subjects will be randomized to treatment with salsalate or placebo for four days prior to initiation of bed rest. vascular function in the brachial artery will be determined by ultrasound prior to treatment and before and after the 5-day bed rest protocol. we hypothesize that treatment with salsalate will be associated with protection again the development of glucose intolerance and vascular dysfunction in this setting.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * pregnancy * history of coronary artery disease * diabetes mellitus * hypertension * cigarette smoking * history or family history of deep vein thrombosis or pulmonary embolism * abnormal renal function * liver function tests greater than two times the upper limit of normal * anemia * use of viagra or other pde5 inhibitor * hypercholesterolemia * aspirin allergy/sensitivity * asthma with nasal polyps * peptic ulcer disease/gastrointestinal bleeding * any ongoing drug treatment
epithelioid hemangioma of bone and soft tissue

Conditions: Epithelioid Hemangioma of Bone; Epithelioid Hemangioma

Summary: the controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat aggressive clinical characteristics, including multifocal presentation and occasional lymph node involvement. the investigators reviewed the clinicopathologic and radiologic characteristics of bone and soft tissue epithelioid hemangioma in patients treated at our institution with available tissue for molecular testing. the hypothesis is that epithelioid hemangioma may present with multifocal involvement and rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent prognosis.

the investigators retrospectively reviewed patients treated for epithelioid hemangioma of the bone and soft tissue in a single insitution. the purpose of this study is to evaluate the pathological, clinical, and radiological characteristics of epithelioid hemangioma arising within bone and soft tissue, in the first cohort of cases where the definitive diagnosis is supplemented by molecular techniques. the hypothesis is that the improved knowledge regarding this rare entity can more definitively elucidate the benign biology of epithelioid hemangioma.

Eligibility criteria:
inclusion criteria: * patients with epithelioid hemangioma of bone and soft tissue in the extremities and pelvis exclusion criteria: * patients with epithelioid hemangioma of bone and soft tissue in the spine