Kornimate/medical-research-clean huggingface dataset:
amplatzer cardiac plug (acp) latin american post market observational

Conditions: Atrial Fibrillation; Left Atrial Appendage; Stroke

Summary: the acp device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.


Eligibility criteria:
inclusion criteria: * subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (documentation may include an electrocardiogram (ecg), holter, or event recorder) * subject must have a laa closure procedure that has already been planned or scheduled by his/her attending physician before entry in the study * subject must be greater than or equal to 18 years of age exclusion criteria: * subject with an implanted atrial septal defect (asd) device or patent foramen ovale (pfo) device * subject underwent laa closure procedure prior to study entry (i.e. before signing informed consent * subject who has a history of surgical asd or pfo repair * subject with a history of stroke and unrepaired pfo * subject who has moderate to severe aortic or mitral valve stenosis or regurgitation requiring surgical or percutaneous intervention as assessed by the investigator * subject who has a mitral or aortic prosthetic valve * subject with nyha grade 4 * subject with evidence of moderate pericardial effusion at baseline evaluation * subject who has complex atheroma with mobile plaque of the descending aorta and/or aortic arch * subject who has an intracardiac thrombus * subject who has carotid disease as assessed by the investigator, requiring treatment, which includes revascularization and/or medical treatment * subject with active infection or active endocarditis * subject who has an acute or recent myocardial infarction (mi) or unstable angina (recent is defined as within 3 months of implant date) * subject who has had recent major cardiac surgical procedure (recent is defined as within 6 months of implant date) * subject with malignancy or other illness where life expectancy is less than one year * subject who is pregnant, breastfeeding, or desires to become pregnant during their first six months of follow-up * subject or legally authorized representative who is unable to provide informed consent * subject who will not be able to be followed for the duration of the clinical study * subject with any medical disorder or severe disability that would interfere with completion or evaluation of clinical study results (for example uncontrolled hypertension, uncontrolled diabetes, blood disorder, renal failure, in situ ivc filter)
fibroblast activating protein inhibitor pet imaging in lupus nephritis

Conditions: Lupus Nephritis

Summary: abnormal high expression of fibroblast activating protein (fap) has been found in inflammatory reactions and benign fibrosis tissue. autoimmune nephropathy such as lupus nephritis (ln) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased expression of activated fap in kidney tissue, and lead to renal fibrosis and long-term renal failure. this makes 68ga-labeled fap inhibitor (fapi) positron emission tomography (pet) imaging the potential to early assess disease severity, predict disease progress and aid treatment planning in patients with ln. compared to renal pathological puncture, 68ga-fapi pet is a new tool for non-invasive, repeatable assessment of renal fibrotic activation.


Eligibility criteria:
inclusion criteria: * be between 18-80 years old; * confirmed sle: meet the 2019 eular/acr classification standards; * there are signs of renal involvement and indications for renal puncture: proteinuria\> 0.5g/24 hours (or urine protein creatine ratio (upcr) \>500mg/g), unexplained decrease of glomerular filtration rate (gfr) exclusion criteria: * the pathology of renal puncture is not consistent with lupus nephritis; * previous history of other kidney diseases; * there are contraindications to renal puncture: (1) obvious bleeding tendency, (2) severe hypertension, (3) psychosis or non-cooperative patients, (4) isolated kidney, (5) small kidney; * history of malignant tumors within 5 years.
a home-based training program for elderly patients with dementia

Conditions: Dementia

Summary: the illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes. family caregivers' stresses change during the illness trajectory as well. the purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in taiwan.

the illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes. family caregivers' stresses change during the illness trajectory as well. thus, the needs of the elderly persons with dementia and their family caregivers differ in different stage of dementia, and the services they require are multidimensional. according to the researchers' previous 2-year study, behavioral problem management and service utilization were found to be the most difficult and least prepared caregiving activities and the family caregiver's needs for assistance of these two caregiving activities differed in different stage of dementia.the purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in taiwan.

Eligibility criteria:
inclusion criteria:(patients) * diagnosed with dementia by a psychiatrist or neurologist * age 65 years or older * living in a community of northern taiwan * living in a home setting * scored \>50 on the chinese version cohen-mansfield agitation inventory (cmai). exclusion criteria:(patients) * diagnosed with critical illness. inclusion criteria:(caregivers) * primary caregiving responsibility and be at least 20 years old. exclusion criteria:(caregivers) * diagnosed with critical illness.

Keywords: elderly dementia intervention program
effect of neuromuscular electrostimulation on sympathetic nerve activity in patients with type 2 diabetes (electrosymp2)

Conditions: Type 2 Diabetes; Insulin Resistance

Summary: physical activity (pa) is recommended for the treatment of subjects with type 2 diabetes to increase insulin sensitivity and improve metabolic control. however, adherence to pa is often poor, due to a lack of motivation or due to disabling complications or comorbidities. neuromuscular electrostimulation (nmes) is a physical treatment commonly used to improve muscle strength and volume in several situations: after stroke, after limb trauma or during chest rehabilitation in deconditioned patients. the investigators have already shown in a first pilot study (manuscript in preparation) that nmes improves insulin sensitivity : in the study electrodiab (no. id-rcb: 2011-a00930-41), the investigators showed a 25% insulin sensitivity improvement after a week of daily 25-min bi-quadricipital nmes session, in a population of patients with orally-treated type 2 diabetes. insulin sensitivity increased up to 50% in the most deconditioned subjects. discrepancy between this result and the very low energy expenditure measured during sessions suggests that the metabolic effect was not solely mediated by muscle contractions. the investigators hypothesize the involvement of neurological pathways. indeed, it is demonstrated that the autonomic nervous system is an important regulator of glucose metabolism with pancreatic action, a key role in energy metabolism and a complex relationship with insulin resistance. muscle activity, whether static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy subjects but its effect in type 2 diabetic subjects is not known. the investigators hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity by nmes could be involved in the improvement of insulin sensitivity. to address this question, the investigators propose to assess sympathetic nerve activity with the gold standard method of microneurography before and after a single bi-quadricipital nmes session. the impact of neuro-electro-stimulation (nes) (a sensitive stimulation under muscular threshold) and the impact of voluntary isometric muscle contractions (vc) will also be evaluated. these procedures will also be applied in healthy control subjects.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 month * treatment by oral hypoglycemic agents and/or glp1 agonists * hba1c : 6-10% * suspected insulin-resistance (at least one criteria below) : * waist circumference \> 80cm (female); \> 94cm (male) * triglycerides \> 150 mg/dl * hdl-cholesterol \< 50 mg/dl (female); \< 40 mg/dl (male) * low background physical activity (ricci-gagnon score \< 27) exclusion criteria: * type 1 diabetes * treatment with insulin * seizure * pace maker

Keywords: sympathetic nerve reactivity neuromuscular electrostimulation
relationship between prophylactic drainage and postoperative complications (ppoi) in crohn's patients after surgery

Conditions: Crohn's Disease

Summary: for patients with crohn's diseases，whether prophylactic abdominal drainage is necessary need further exploration. the present study is focusing on the necessity of prophylactic abdominal drainage in cd patients after surgery.

in the past decades, surgical dogma meant the correct placement of a prophylactic drain, with the aim of reducing the incidence of anastomotic leakage, decreasing the needs of reoperation and avoiding potential postoperative ascites. however, recent randomized controlled trials (rcts) and meta-analyses have suggested that prophylactic peritoneal drains have no benefits on postoperative outcomes. crohn's disease (cd), which is definitely different from crc, is a chronic inflammatory disease with unknown pathogenesis. cd itself was the independent risk factor of multiple postoperative complications, including anastomotic leakage, intraperitoneal abscess and catheter-associated bloodstream infection. in the present rct, we hypothesize that non-prophylactic peritoneal drainage is associated with increased incidence of postoperative non-septic complications.

Eligibility criteria:
inclusion criteria: * stricturing cd patients with american society of anesthesiologists (asa) score of 1 to 2 undergoing elective small bowel or ileocecal resection and anastomosis. exclusion criteria: * coexisting penetrating disease (fistula, abscess or phlegmona), enterostomy, strictureplasty only, short bowel (less than 150 cm), preoperative hypokalemia, diabetes or hyperglycemia (fasting plasma glucose \>126 mg/dl), as well as chronic systemic disease of cardiovascular, respiratory et al. * patients who received ≥20 mg/d prednisolone or equivalent for over 6 weeks within 4 weeks before surgery; patients who received steroids, biologics or gastrointestinal motility drugs within 4 w prior to surgery; patients who remained on steroids within 1 day before surgery.
d-dimer vs serial compression ultrasound study

Conditions: Deep Vein Thrombosis

Summary: to determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis


Eligibility criteria:
inclusion criteria: * first suspected deep vein thrombosis * no previous venous thromboembolism * referred to thromboembolism outpatient clinic exclusion criteria: * comorbid condition limiting survival to less than six months * contraindication to venography (contrast allergy, etc.) * receiving long term warfarin therapy * receiving full dose heparin therapy for more than 48 hours * absence of symptoms during the five days immediately prior to presentation * symptoms of pulmonary embolism * pregnancy * geographic inaccessibility which precludes follow-up

Keywords: deep vein thrombosis d-dimer serial compression ultrasound
correlation between refraction and biometric parameters

Conditions: Refractive Errors

Summary: to document the refractive status of chinese schoolchildren and evaluate the association between the degree of refraction and biometric parameters.

in this study, we will analyze the refractive status of schoolchildren and compare the ocular biometrics, including spherical equivalent refraction (ser), pupil distance (pd), corneal curvature (cc), high order aberration (hoa), and central corneal thickness (cct) between boys and girls. additionally, we investigate the correlation between the ser in diopters and the other biometric parameters, including pd, cc, hoa, cct, and body mass index (bmi).

Eligibility criteria:
inclusion criteria: * schoolchildren aged from 6 to 15 years exclusion criteria: * with previous histories of cataracts, keratitis, strabismus, or other visual impairments * with history of previous eye surgery * with unreliable auto-refraction values * unwilling to participate
magnetic resonance imaging combined with venous ultrasonography of the legs for pulmonary embolism

Conditions: Pulmonary Embolism

Summary: magnetic resonance imaging (mri) represents a promising technique but can not be used as an alternative test to multidetector ct in patients with suspicion of pulmonary embolism (pe) due to its low sensitivity and high proportion of inconclusive mri. the purpose of this study is to evaluate diagnostic performances of mri combined with venous ultrasonography of the legs in patients with suspicion of pe.


Eligibility criteria:
inclusion criteria : * age \> or = 18 years * clinical suspicion of pe * affiliate (e) to a social security * provide written informed consent exclusion criteria : * unstable patient clinically in shock on arrival at the emergency department * current pregnancy * life expectancy less than 3 months (eg terminal cancer) * follow up at 3 months impossible * anticoagulation curative\> 48 hours prior to inclusion * cons-indication to spiral chest ct: allergy to contrast or creatinine clearance below 30 ml / min calculated by the cockcroft * cons-indication to mri claustrophobia, presence of intraocular metallic implant or a pacemaker, an allergy to gadolinium, morbid obesity (weight\> 130 kg, anteroposterior\> 60 cm diameter)

Keywords: pulmonary embolism magnetic resonance imaging venous ultrasonography of the legs diagnostic performances
the indonesian version of ages and stages questionnaire iii accuracy compared to bayley scales of infant development iii

Conditions: Child Development; Child Development Disorder; Development Delay; Developmental Delay; Global Developmental Delay; Motor Delay; Speech Delay

Summary: this study aimed to evaluate the concurrent validity information of the 24-, 30-, and 36-month indonesian asq-3 with the bayley scales of infant and toddler development 3rd edition (bsid-iii) in indonesian children. children living in tanah tinggi subdistrict, central jakarta, were recruited conveniently from november to december 2019. children within the 24-, 30-, or 36-month age group were assessed for indonesian asq-3 concurrently with bsid-iii as the reference standard according to their age groups. screening test accuracy was measured in sensitivity, specificity, and predictive values for both overall dan specific domains.


Eligibility criteria:
inclusion criteria: * parents with children aged 23 - 38 months * parents who finished at least elementary school exclusion criteria: * parents with communication difficulties * parents who could not speak indonesian language

Keywords: asq-3 bsid-iii child development indonesia screening test validity
high tibial osteotomy with/without arthroscopy.

Conditions: Osteoarthritis, Knee; Meniscus; Degeneration

Summary: this study will compare hight tibial osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of osteoarthritis.the purpose of this study is evaluate if addition of arthroscopy to hto provides better clinical, radiological and laboratory outcomes.

intraarticular knee lesions are often in patients with early stages of osteoarthritis. the most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. in the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. by this time the choice of performed surgery depends on surgeons personal assessment. the investigators believe that concomitant intraarticular procedures added to hto will provide better clinical outcomes.

Eligibility criteria:
inclusion criteria: * knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination * intraarticular lesions in mri * confirmation of cartilage degeneration/damage and knee malalignment in radiological tests exclusion criteria: * no informed consent to participate in the study * age under 18 years or above 65 * multilligament injury or single plane knee instability * another musculoskeletal disorders in lower limb * lower limb deformity requiring axis correction below 4o or above 12.5o • joints inflammatory diseases * asa score \> ii

Keywords: hto degenerative meniscus osteoarthritis microfracture
trans alveolar pressure measurement as an index for lung recruitment.

Conditions: Hypoxia

Summary: the study is conducted on hypoxic adult patients underwent open heart surgery after arrival to the intensive care unit and stabilization of patients' hemodynamics to assess the efficacy of transalveolar pressure measurement as an index for lung recruitment.

after one hour from the patient's icu admission and after stabilization of the patient's haemodynamics, alveolar recruitment will be done for hypoxic patients with hypoxic index less than 250. the recruitment will be started in the adaptive ventilation mode (avm mode) using modified stepwise staircase recruitment maneuver in which every 2 minutes positive end-expiratory pressure (peep) is increased in increments of 2 cmh2o and the driving pressure will be regulated by avm mode. the increase in peep will be guided by improvement of dynamic compliance, oxygen saturation and transalveolar pressure (pta) till near overdistention. overdistension will be detected if there are decrease in the mean arterial pressure 25% from the base line value reported after stabilization of the patient's haemodynamics, or decreased oxygen saturation or sudden decrease in dynamic compliance, or inspiratory pta more than15 cm h2o. then peep is decreased 2 cm h2o every 3 minutes till a decrease expiratory pta less than 1 cm h2o, or a decrease in dynamic compliance or a decrease in oxygen saturation ≥ 1% from maximum oxygen saturation is observed (the derecruitment point) then return to a peep level 2 cm h2o above the derecruitment point (the optimal peep). alveolar recruitment will be done once.

Eligibility criteria:
inclusion criteria: * post cardiac surgery hypoxic adult patients exclusion criteria: 1. patients with contraindications for the use of esophageal catheter including esophageal ulcerations, tumors, diverticulitis, bleeding varices, recent esophageal or gastric surgery, sinusitis, epistaxis and recent nasopharyngeal surgery. 2. postoperative severe haemodynamic instability on high inotropic support. 3. ejection fraction less than 35%. 4. severe restrictive or obstructive lung disease. 5. extremes of age (\ 75 years). 6. morbid obese patients with bmi \> 40kg/m2.

Keywords: post cardiac surgery, lung recruitment trans alveolar pressure
a study to evaluate the drug levels, efficacy, and safety of deucravacitinib (bms-986165) in pediatric participants with juvenile psoriatic arthritis

Conditions: Juvenile Psoriatic Arthritis

Summary: the purpose of this study is to evaluate the drug levels, efficacy, and safety of deucravacitinib (bms-986165) in pediatric participants with juvenile psoriatic arthritis.


Eligibility criteria:
inclusion criteria * participants must have been diagnosed with juvenile psoriatic arthritis (jpsa). * participants must have at least three joints that are affected by arthritis. * participants must have tried at least one type of medicine for jpsa for at least three months, but it didn't work well or caused problems. exclusion criteria * participants must not have been diagnosed with jpsa before 5 years of age. * participants must not have other types of juvenile idiopathic arthritis (jia) that aren't jpsa, * participants must not have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: juvenile psoriatic arthritis (jpsa) juvenile idiopathic arthritis (jia) pediatric psa deucravacitinib bms-986165
pharmacokinetic study of dexmedetomidine after intra-nasal and buccal dosing in children

Conditions: Heart Diseases

Summary: this research study is a continuation of a previous dex pk study. it is examining the absorption of dexmedetomidine (dex) in the blood when given orally and as a nasal spray. this study will help us determine the best dosing amount for children undergoing sedation or anesthesia with dex.

the study will be a prospective study of plasma concentrations after intranasal or buccal dex to determine the early pharmacokinetics and bioavailability of a single dose via nasal or oral administration. dexmedetomidine sedation is commonly used at cincinnati children's medical center and other pediatric institutions. this compound is typically delivered intravenously or intranasally for sedation in children with or without congenital heart disease. intranasal dex is very effective for sedation although it has significant variability in the onset and peak effect. patient care will be improved if factors that determine this variability can be determined. investigators will determine the important clinical variables of peak plasma dex concentration (tmax and cmax) of intranasal and buccal dex in children.

Eligibility criteria:
inclusion criteria: * children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery * the subject must be a candidate to receive dex as determined by one of the study cardiac anesthesiologists * the attending cardiac anesthesiologists for the case and the chief of anesthesia cardiac anesthesia will concur with or veto this decision * the subjects legally authorized representative has given written informed consent to participate in the study exclusion criteria: * post-natal age less than 6 months * the subject is allergic to or has had a contraindication to dex * severely depressed ventricular function on preoperative echocardiogram * the subject has a high risk of cardiac conduction system disease in the judgement of the attending anesthesiologist or cardiologist * the subject has a hemodynamically significant aortic coarctation or other left heart outflow obstruction * the subject has received digoxin, beta-adrenergic antagonist, or calcium channel antagonist on the day of surgery * the subject has received dex within 1 week of the study date * patients who are to receive intranasal dex are excluded if they have nasal/respiratory symptoms, which in the opinion of the study anesthesiologist, may affect intranasal drug absorption

Keywords: pediatric sedation dexmedetomidine