Kornimate/medical-research-clean huggingface dataset:
expanding health system intervention through the women, infants and children (wic) program partnership

Conditions: Obesity, Childhood

Summary: pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging wic nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled wic appointments in a small randomized trial among 30 wic-enrolled families.

this is a pilot 2-arm randomized trial among 30 wic enrolled families of children 6 months through 4 years old who currently over-consume sugary drinks. the study team will randomize families to either an intervention group, that will receive a behavioral intervention consisting of two educational videos, a water promotion toolkit, mobile phone app, series of educational phone calls and extra counseling from wic nutritionists, or to a control group that will not receive this intervention. the study team will compare 6-month change in child and parental beverage consumption between groups. exploratory analyses will examine child weight (kg) and body mass index (bmi) z-score (bmiz) outcomes, and compare intervention effects across race/ethnic groups.

Eligibility criteria:
inclusion criteria: * child 6 months - 4 years old who receives health care attention at wake forest pediatric or family medicine practices * child enrolled in wic * child consumes 2 or more ssb and/or fruit juice total per day * child with no chronic health condition * child has not seen nutritionist or visited our family-based weight management clinic in the past year * parent/caregiver who has not watch educational video "get in the zero zone" * parent/caregiver has a smartphone and reliable internet * parent/caregiver able to communicate well in english exclusion criteria: * child doesn't meet age criteria * child consumes less than 2 ssb and/or fruit juice total per day * child with a chronic health condition * child has seen nutritionist or visited our family-based weight management clinic in the past year * parent/caregiver has watched educational video "get in the zero zone" * parent/caregiver has completed interview or usability test * parent/caregiver doesn't have a smartphone or reliable internet * parent/caregiver not able to communicate well in english
this study will investigate the efficacy and safety of a4250 in children with pfic types 1 or 2

Conditions: PFIC1; PFIC2

Summary: double blind, randomized, placebo controlled, phase 3 study to investigate the efficacy and safety of low doses and high doses of a4250 compared to placebo in children with progressive familial intrahepatic cholestasis (pfic) types 1 and 2.

up to 50 sites in the following countries will take part in this study: australia, belgium, canada, france, germany, israel, italy, netherlands, poland, spain, sweden, turkey, united kingdom, united states, and saudi arabia

Eligibility criteria:
key inclusion criteria: * a male or female participant with a clinical diagnosis of pfic type 1 or 2 and with a body weight above 5 kg * participant must have clinical genetic confirmation of pfic-1 or pfic-2 * participant must have elevated serum bile acid (s-ba) concentration * participant must have history of significant pruritus and a caregiver reported observed scratching in the ediary * participant and/or legal guardian must sign informed consent (and assent) as appropriate. * participants will be expected to have a consistent caregiver(s) for the duration of the study * caregivers and age-appropriate participants (≥8 years of age) must be willing and able to use an ediary device as required by the study key exclusion criteria: * participant with pathologic variations of the abcb11 gene that predict complete absence of the bile salt export pump (bsep) protein * participant with past medical history or ongoing presence of other types of liver disease including, but not limited to, the following: 1. biliary atresia of any kind 2. benign recurrent intrahepatic cholestasis, indicated by any history of normal s bas 3. suspected or proven liver cancer or metastasis to the liver on imaging studies 4. histopathology on liver biopsy that is suggestive of alternate non-pfic related etiology of cholestasis * participant with past medical history or ongoing chronic diarrhea * any participant with suspected or confirmed cancers except for basal cell carcinoma * participant with a past medical history of chronic kidney disease with an impaired renal function and a glomerular filtration rate \<70 ml/min/1.73 m\^2 * participant with surgical history of disruption of the enterohepatic circulation (biliary diversion surgery) within 6 months prior to start of screening period * participant has had a liver transplant or a liver transplant is planned within 6 months of randomization * decompensated liver disease * participant suffers from uncontrolled, recalcitrant pruritic condition other than pfic * participant who has been previously treated with an ibat inhibitor whose pruritus has not responded to treatment

Keywords: pediatric cholestasis
manual therapy and splint therapy in patients with temporomandibular dysfunction

Conditions: Temporomandibular Disorder; Myofascial Pain; Bruxism

Summary: the aim of this study was to compare the efficacy of splint treatment and manual therapy in patients diagnosed with myofascial temporomandibular dysfunction with bruxism.

a total of 56 patients were evaluated. among those, 20 patients who did not meet the criteria were excluded. 36 patients met the inclusion criteria and were willing to participate in the study. the patients were randomly separated into two groups using the method of single- and double-digit numbers written on paper in a sealed envelope. those who selected a double-digit number were assigned to the manual therapy (mt) group (n:18) and those with a single-digit number to the splint therapy (st) group (n:18). after the further exclusion of 7 patients during the treatment period, the final evaluations were compared of 29 patients (15 mt and 14 st) who completed the 4-week treatment process.

Eligibility criteria:
inclusion criteria: * ages between 18 and 50 years old, * patients with a diagnosis of myofascial tmd with bruxism according to the diagnostic criteria for temporomandibular disorders (dc/tmd), * having pain severity ≥3 according to the visual analogue scale (vas), * probable sleep bruxism according to clinical evaluation and a questionnaire-based assessment. exclusion criteria: * patients with a diagnosis other than myofascial tmd according to the research dc/tmd, * a history of surgery associated with cervical and/or tmj problems, * a proven specific pathological condition such as cervical and/or tmj malignancy, fracture, or systemic rheumatoid disease, * a history of facial paralysis, a diagnosed psychiatric disease, * if they were undergoing orthodontic treatment, * had received physiotherapy within the last 3 months, * or could not be co-operative.

Keywords: temporomandibular dysfunction bruxism manual therapy splint
sleep quality and sleep-disordered breathing in bypass surgery patients

Conditions: Sleep Disorder; Coronary Artery Disease

Summary: patients undergoing non-emergency coronary artery bypass surgery (cabg) are included. all patients will be examined for transthoracic echo, blood samples will be collected, and an overnight sleep polygraph will be performed in a qualified sleep laboratory twice: once before cabg and again after surgery

detailed description: our hypothesis is that sleep-related apneas are increasing following coronary artery bypass surgery, and sleep quality may deteriorate. we are attempting to determine the causes of these difficulties, which are caused by microemboli in the brain from the use of a heart-lung machine, brain infarction induced by major surgery, thoracic tissue trauma following surgery, or complications during perioperative care. the hypothesis is that postoperative outcomes and recovery are related if a patient is identified with sleep apnea before cabg surgery. a sleep polygraph is performed before surgery and again around six months after, as well as a transthoracic echo and laboratory tests. if a link between sleep quality and coronary bypass surgery can be established, the results can be employed in clinical practice. the total amount of patients operated on heart-lung machine is anticipated to be 70. the off-pump patient sample size is remarkably smaller, so data is collected and compared with the main sample population. the operation technique is decided when the patient is scheduled for operation. emergency patients are excluded because pre-operative examinations cannot be performed. other exclusion criteria are nighttime cpap- treatment and other heart operations (for example valve surgery) during cabg. basic information including age, weight, height, diseases, medications, and medical history are collected from all patients. ecg is registered before and after surgery and sinus or other heart rhythms are recorded. sleep polygraph is done preoperatively and postoperatively when the patient is fully recovered from surgery (at 6 months or more).

Eligibility criteria:
inclusion criteria: elective coronary artery bypass surgery exclusion criteria: * emergency cabg * night time cpap- treatment * other heart operations (for example valve surgery)
cohort of stemi patients

Conditions: Myocardial Infarction

Summary: ischemic heart disease is the leading cause of mortality in industrialized countries. st elevated acute myocardial infarction is one of its most frequent and deadly manifestation. in the last 20 years, stemi mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention. however, death and heart failure incidence after stemi remain elevated: up to 20% at one year. also, therapeutic management following international guidelines is standardized toward a "one-size fits all" therapeutic management. in order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (lv) remodeling .... this knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine. the aim objective of this cohort of stemi patients is to identify new biological markers of injury and prognosis.


Eligibility criteria:
inclusion criteria: * age\> 18 years * diagnosis of stemi defined by st segment elevation ≥ 0.2 mv in 2 contiguous leads on a 12-lead ecg. * primary pci within 12 hours of symptoms onset. exclusion criteria: * diagnosis of stemi not confirmed by angiography * refusal to participate in the study or to sign the consent * inability to give information to the subject about the study * lack of medical social coverage * deprivation of civil rights

Keywords: myocardial infarction biomarkers stemi
examining the effects of a job entry intervention

Conditions: Autism Spectrum Disorder; Autism; ASD

Summary: the current study will examine the efficacy of a virtual reality (vr) intervention as well as a newly developed kessler foundation strength identification and expression tool (vr-stride) with adolescents diagnosed with autism spectrum disorder.

the current study will examine the efficacy of a virtual reality (vr) intervention entitled "improving expression of skills and strengths in interviewing in a virtual environment" (impressive) which targets social competency skills needed for successful job interviewing. specifically, 2 vr tools are utilized in the impressive intervention. the first tool is vr-job interview training, a vr program which offers the opportunity for repeated practice with a virtual human interviewer. preliminary evidence suggests that the vrprogram is successful in adults with asd and schizophrenia in improving interview abilities. however, the efficacy of it has not been evaluated in adolescents with asd. this represents a significant void in our knowledge, as we do not know whether this program is effective for youth. in addition to vr training, a newly developed tool is included in the currently proposed intervention: the kessler foundation strength identification and expression tool (vr-stride). kf-stride is focused on improving the ability to express personal strengths during the job interview, a skill that is not taught with vr training. the proposed impressive intervention, which combines the learning of 2 critical abilities (social skills and strength identification), has never been examined in individuals with asd. thus, the current proposal will be the first to examine the efficacy of these 2 combined tools in this at-risk population.

Eligibility criteria:
inclusion criteria: * diagnoses of asd * or am a typically developing adolescent * able to speak and read english fluently exclusion criteria: * history of stroke, traumatic brain injury, or any other neurological injury or disease * history of significant psychiatric illness (bipolar, schizophrenia or psychosis) * uncontrolled seizures * any other unstable medical complications

Keywords: autism asd job reentry employment intervention virtual reality vr
use of multi-parametric mri with prostate biopsy for cancer diagnosis.

Conditions: Prostate Cancer

Summary: this is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpmri. the primary evaluation involves comparing the rate of cancer diagnosis when using software-based mri-ultrasound image fusion guided biopsy to sample mpmri findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. the hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpmri findings as compared to visual guided biopsy of these areas


Eligibility criteria:
inclusion criteria: * no previous diagnosis of adenocarcinoma of the prostate * no contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations) * active urinary tract infection exclusion criteria: * prior pelvic radiotherapy * prior androgen deprivation therapy * evidence urinary tract infection or significant urinary retention * prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpmri. * contraindication to mri (severe claustrophobia, indwelling metallic objects incompatible with mri, pacemaker)

Keywords: prostate cancer prostate biopsy targeted biopsy
comparison of visual fields: humphrey field analyzer (hfa) sita strategy, scope (gate strategy) and humphrey matrix perimeter

Conditions: Glaucoma

Summary: the purpose of this study is to compare three perimetric techniques regarding progression of the visual field.


Eligibility criteria:
inclusion criteria: * max. ± 8 dpt sph, max. ± 3 dpt cyl * distant visual acuity \> 10/20 * isocoria, pupil diameter \> 3 mm * at least one risk of progression: optic disc (splinter) hemorrhage / cup to disc ratio (cdr) \> 0.7 / inter-eye asymmetry of cdr \>0.2 / notching of the optic disc /retinal nerve fibre layer (rnfl) defects / intraocular pressure( iop) \>22 mmhg / central corneal thickness \< 520 µm / advanced visual field defect stage aulhorn iii / elder than 70 years exclusion criteria: * pregnancy, nursing * diabetic retinopathy * asthma * hiv+ or aids * history of epilepsy or significant psychiatric disease * medications known to effect visual field sensitivity * infections (e.g. keratitis, conjunctivitis, uveitis) * severe dry eyes * miotic drug * amblyopia * squint * nystagmus * albinism * any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields,disc imaging or accurate iop readings * keratoconus * intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening * history or signs of any visual pathway affection other than glaucoma * allergies with regard to topic glaucoma medication * history or presence of macular disease and / or macular edema * ocular trauma * medications known to affect visual field sensitivity

Keywords: visual field perimetry glaucoma progression grid poag and glaucoma suspects with prostaglandin monotherapy
propagation analysis for arrhythmogenic conduction elimination to prevent atrial flutter and fibrillation (panacea-af)

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to perform ultra-high density mapping of the left atrium (a chamber of the heart) using the the rhythmia mapping system and to determine whether additional ablation in areas of wavefront discontinuities identified by the map will reduce the likelihood of both atrial fibrillation and atrial flutter.

catheter ablation (ca) is a class 1 indication for patients with symptomatic drug-refractory atrial fibrillation (af). with standard pulmonary vein isolation (pvi), the success rate ranges from 60-80% in patients with paroxysmal af. despite pvi, certain patients have recurrent af and often require a repeat ablation procedure. there is no standard ablation strategy for patients who undergo repeat ablation for recurrent af. the largest randomized trial to date comparing ablation strategies found that the addition of la roof and mitral isthmus ablation lines or ablation of la ganglia was no better than standard pvi. moreover, the addition of ablation lines in the la, if not complete, may be pro-arrhythmic and lead to the development of la afl, which is often more symptomatic that af itself. ultra-high density mapping during sinus rhythm allows for rapid creation of isochronal late activation maps (ilam) in patients with ventricular tachycardia. to date, creating ilam of the la has not been reported and it is not known whether additional ablation in these areas improves freedom from all atrial tachyarrhythmias at 1 year follow-up. moreover, ablation at the deceleration zones and/or gaps identified using ultra-high density mapping is a promising strategy to improve ablation success and decrease the potential for recurrent af. the rationale of the study is two-fold. 1. this study would be the first to report ilam in the la and confirm that the diseased la may behave similarly to the diseased left or right ventricle. 2. ablation of gaps and/or deceleration zones in the la would be a novel approach to treat patients with recurrent af after initial pvi, and if successful, provide another strategy to treat these refractory problems. co-pis: hemal nayak, md guarav upadhyay, md andrew beaser, md zaid aziz, md

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age * re-do af ablation with history of pvi * undergone at least 1 prior ablation exclusion criteria: * inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity * recent stroke within 6 months of planned procedure * inability to take oral anticoagulation

Keywords: paroxysmal atrial fibrillation ventricular tachycardia
real world study of efficacy and safety of atezolizumab plus chemotherapy in chinese patients with es-sclc

Conditions: Extensive-stage Small Cell Lung Cancer

Summary: the study is a prospective,multi-center,single arm,real world study to evaluate safety and performance of atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer,and also to explore potential biomarkers for immune-related adverse events.

in 2018,the results of impower 133 were reported on wclc.meanwhile,the data was published in nejm.atezolizumab combined with carboplatin and etoposide for extensive stage small cell lung cancer was recommended as the first by nccn guidelines quickly. atezolizumab plus chemotherapy was approved by nmpa on feb 13,2020,making atezolizumab for 1l es-sclc in china. real world study can reflect the efficacy and safety of treatment in clinical practice.based on the research of public database,the prospective cohort study had been reported,but the study based on chinese patients still left weak point.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed es-sclc (per the veterans administration lung study group \[valg\] staging system) * no prior systemic treatment for es-sclc * 18-80 years old, or more than 10 months of expected natural survival; * eastern cooperative oncology group performance status of 0 or 1 or 2 * measurable disease, as defined by recist v1.1 adequate hematologic and end organ function * treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage sclc * the subject must be willing and able to participate in the study procedures and to understand and sign the informed consent exclusion criteria: * pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose chemotherapy. women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. patients or family members cannot understand the conditions and goals of this study. the subject has an estimated life expectancy of less than 10 months the subject is unable or unwilling to comply with the study requirements or follow-up schedule

Keywords: 1l es-sclc