Kornimate/medical-research-clean huggingface dataset:
fetal cardiac strain imaging research

Conditions: Myocardial Deformation

Summary: cardiac disease in children may start early in life and evidence of cardiac disease can be seen during prenatal life. a variety of diseases diagnosed during fetal life can put children at risk for cardiac disease. the accurate assessment of cardiac function is important in these patients. a type of imaging scan called "fetal echocardiogram" is used to measure the contractility or squeeze of the heart. the fetal echocardiogram is a painless test and completely non-invasive. this study aims to recruit women and fetuses to determine if this imaging scan can be used throughout the pregnancy to measure heart squeeze and develop normal values to help doctors better diagnose fetuses who may have cardiac disease before they are born.

the subject will have to complete 6 fetal echocardiograms. a fetal echocardiogram is picture of the unborn baby's heart in motion made by bouncing sound waves off the heart and recording the echo. the procedure will be very similar to the ultrasounds that the subject is already receiving as part of her prenatal care. the scans will start at week 20 of the subject's pregnancy and repeat every 3 weeks until week 38 of birth (whichever occurs first). the appointments will last approximately 30 minutes each and will be performed by one of two sonographers trained specifically in fetal echocardiography. one additional echocardiogram will be performed on the infant after birth, within the first two months of life. in addition to the scans, study staff will access the subject's medical record to collect information such as: age, ethnicity, race, medical history and health insurance status.

Eligibility criteria:
inclusion criteria: * patient at the obstetrics clinic at texas children's hospital pavilion for women at the time of their second trimester screening ultrasound * fetus must have no recognizable disease at the second trimester screening ultrasound * willing to participate in a total of 5 fetal echocardiograms and one within 2 months after delivery * english or spanish literacy * a four chamber view of the heart must be visible upon screening examination * no fetal anatomic or growth abnormalities suspected on screening examination. exclusion criteria: * subjects that meet the cutoff point for maternal obesity (bmi\>30) and have identified risk factors for fetal cardiac dysfunction as determined by medical team.

Keywords: heart disease echocardiogram ultrasound heart defect heart dysfunction pediatric cardiologists prenatal
a trial of neupro® (rotigotine transdermal patch) in patients with parkinson's disease undergoing surgery

Conditions: Parkinson's Disease

Summary: evaluation of efficacy and safety on the use of rotigotine in patients suffering from parkinson's disease during and after surgery requiring general anaesthesia.


Eligibility criteria:
inclusion criteria: * subject has idiopathic parkinson's disease (early- or advanced-stage), as defined by the cardinal sign bradykinesia, plus the presence of at least one of the following: resting tremor, rigidity, or postural instability and is without any other known or suspected cause of parkinsonism. * subject is scheduled for an operation requiring general anesthesia. exclusion criteria: * subject has previously been treated with rotigotine. * subject has a history of significant skin hypersensitivity to adhesives or other transdermals or recent unresolved contact dermatitis or has a known allergy or hypersensitivity to rotigotine or to other components of the patch. * subject is scheduled for a surgical procedure (surgery per protocol(spp)) that requires magnetic resonance imaging or cardioversion. * subject has a high probability to require extended postoperative ventilation (\> 24 hours). * subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial.

Keywords: rotigotine neupro® parkinson's disease (pd) perioperative use anaesthesia,
reliability, validity of the turkish version of the primary sjögren syndrome quality of life (pss-qol) questionnaire

Conditions: Primary Sjögren's Syndrome

Summary: the purpose of this study was to investigate adaptation, validity, and reliability of the turkish version of the primary sjögren's syndrome quality of life (pss-qol) questionnaire

primary sjögren's syndrome (pss) is a chronic systemic disease characterized by lymphocytic infiltration of exocrine glands. dryness, chronic pain, physical fatigue, glandular and extraglandular symptoms seen in pss cause deterioration of the health-related quality of life. the primary sjögren's syndrome quality of life (pss-qol) questionnaire has recently developed as a patient-reported condition-specific outcome measurement tool to assess the quality of life associated with pss. the pss-qol questionnaire consists of 25 questions with a physical and psychosocial dimension.the physical dimension consists of a numeric rating scale (nrs, ranging from 0 to 10) for pain and physical symptoms. the question related to vaginal dryness is intended to be answered by women only. each "yes" answer about physical symptoms-related questions adds 1 point to the score. the psychosocial dimension can be scored on a 5-point likert scale and contains 14 question with the following possible answers: never (0), rarely (1), sometimes (2), often (3), and always (4). the pss-qol score ranges from 0-96 (for women) and 0-92 (excluding the question of vaginal dryness for men). after questioning the sociodemographic characteristics of the individuals, pss-qol, euroquol-5d, the eular sjögren's syndrome disease activity index and eular sjögren's syndrome patient reported index will be used. test-retest will be re-applied to those of the same individuals who can be reached after 1 week. the results will be analyzed using the spss version 22.0 computer package program.

Eligibility criteria:
inclusion criteria: * diagnosed with primary sjögren's syndrome exclusion criteria: * having neurological and cognitive disorders, * having another rheumatological diseases

Keywords: primary sjögren's syndrome quality of life patient-reported outcome reliability validity
signature development and validation protocol for an epigenetic assay in diagnosing lung cancer

Conditions: Lung Cancer; Lung Cancer Screening; Healthy Volunteers (HV); Unhealthy Volunteers

Summary: the purpose of this research study is to test a new process for diagnosing lung cancer by examining changes to your dna that can be detected from a blood test. the information we learn by doing this study could potentially help people in the future. participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. blood sample collection will occur during normal routine clinic visits. participation in this study will last approximately 5 years.

this clinical testing research study outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host dna methylation signatures designed to diagnose lung cancer. the overall protocol process will involve three distinct stages representing three patient cohorts with up to 250 subjects per cohort across 5 populations of patients. cohort one will act as signature development phase; cohort two will act as signature finalization phase; and cohort three will act as a validation cohort phase. each cohort will include the following patient populations with up to 50 patients per population: 1. lung cancer; no chemotherapy. surgical resection or stereotactic body radiation therapy (sbrt) only 2. lung cancer; with chemotherapy. all stages including remission 3. at risk group (lung cancer screening population) 4. control group with mixed comorbid disease excluding tobacco use of greater than 10 pack years (py) or chronic obstructive pulmonary disease (copd) 5. healthy controls with no comorbid disease

Eligibility criteria:
inclusion criteria: * 18 years old or older * patient at university of maryland baltimore washington medical center * willing and able to consent to study procedures listed in the protocol * ability to speak and understand english exclusion criteria: * younger than 18 years old * patient not cared for at university of maryland baltimore washington medical center * unable to consent to study procedures listed in the protocol * unable to speak or understand english

Keywords: lung cancer lung cancer screening healthy volunteers unhealthy volunteers
determination of the minimal detectable change of the parkinson's disease questionnaire-8

Conditions: Parkinson Disease

Summary: this study is conducted to determine how many units of improvement the parkinson's disease questionnaire-8 (pdq-8), used to evaluate the quality of life of parkinson's patients, should have to express a significant change in the quality of life. patients for whom a 30-session physiotherapy program is recommended will be included in the study. patients will be asked to express the change in their quality of life at the end of treatment. the pdq-8 survey and global rating of patient-perceived changes (grp-pc) forms will be used to determine these changes. evaluations will be repeated at the beginning of the treatment program and at the end of the 30th session.


Eligibility criteria:
inclusion criteria: * having regular neurology follow-up and using medicine; * hoehn and yahr scale stage between 1-3 points; * mini-mental state assessment score \&gt;24 points; exclusion criteria: * having a secondary neurological disease; * any surgery and/or trauma affecting the upper extremity * having complaints of pain before the treatment program; * there was a change in medical treatment during the study; * with symptoms of anxiety and depression; * those who use alcohol and drugs; * individuals with vision defects that cannot be corrected by the use of glasses and those with hearing loss

Keywords: parkinson minimal detectable change minimal clinically important difference parkinson disease questionnaire-8
laparoscopic appendectomy for uncomplicated appendicitis: does antimicrobial prophylaxis really matter?

Conditions: Appendicitis

Summary: to compare surgical site infection (ssi) rate in patients undergoing laparoscopic appendectomy for acute uncomplicated appendicitis and treated with single dose regime of antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics treatment. patient will be given either single dose of perioperative antibiotics or no antibiotics before surgery.

laparoscopic appendectomies are performed by one of the 6 institutional attending surgeons. us and/or abdominal ct scans are obtained as clinically necessary to make the diagnosis of appendicitis. all of the appendectomies are initiated laparoscopically. postoperative orders are controlled via a standard electronic order set for all operations. patients found to have acute uncomplicated appendicitis at appendectomy will be randomized to either single dose of perioperative antibiotics /on the second post-operative day the patient who has no fever and tolerating a regular diet, will be discharged home without oral antibiotics. on the post-operative, day seven after surgery all patients will be examined in the outpatient clinic on the presence of surgical site infection. then will be followed for a 30 days after surgery .

Eligibility criteria:
inclusion criteria: * established diagnosis of acute appendicitis based on clinical examination, us and/or computed tomographic (ct) scan, and acute uncomplicated appendicitis at laparoscopic appendectomy. exclusion criteria: * patients with a documented allergy to any of the medications in the trial. * those with an abscess identified by computed tomographic (ct) scan before surgery are not included in the study
effects of 10 mg monacolins on vascular health: a clinical trial

Conditions: Atherosclerosis

Summary: this will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of ldl-cholesterolemia, following a mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin k per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (vicorder(r) apparatus)


Eligibility criteria:
inclusion criteria: * ldl-cholesterol between 130 and 190 mg/dl exclusion criteria: * secundary prevention for cardiovascular disease * type 2 diabetes * assumption of lipid-lowering drug or dietary supplements * previous intolerans to read yeast rice including dietary supplements
evaluating the user performance and experience of nucleus pen vs. commercially available pen needle

Conditions: Diabetes

Summary: this is a multi-site, prospective, open-label, randomized, 2 period cross over study comparing the subjects' current 32g pen needle (four groups of pen needles) to the bd nucleus pen needle. the study will consist of two 15 day periods ( in which the subject will use each pen needle \[bd nucleus pen needle or subject's current pen needle, order randomized\] for injection. at the end of the last study period, each subject will be asked to evaluate his or her perceptions using a 150mm relative vas scale.


Eligibility criteria:
inclusion criteria: 1. adults (18 - 75 inclusive) 2. diagnosed type 1 or type 2 diabetes 3. every effort will be made to recruit approximately 25% type 1 patients (of the total population, not of each subgroup) (minimum: 10%, maximum: 50%) 4. every effort will be made to recruit a minimum of 30 subjects with asian ethnicity (of the total population, not of each subgroup). ideally, 60 asian subjects are needed for the study 5. minimum within the last 4 months experience self-injecting insulin with a pen injector 6. minimum within the last 2 months experience self-injecting consistently with one of the following available pen needles or a subject may be enrolled that is using a 31g/32g pen needle that is not longer than 6mm in length who is willing to transfer to one of the following 32g pen needle with a 14 day wash-in period: * bd nano™ 32gx4mm * novofine® 32gx6mm * novotwist® 32gx5mm or * novofine® plus 32gx4mm * owen mumford pentips 32gx4mm or * perrigo / ypsomed clickfine 32gx4mm or * other 32g such as ultimed, mhc, or other private label. 7. able and willing to provide informed consent/participant form 8. able and willing to complete all study procedures exclusion criteria: 1. self-injecting insulin with a pen injector for less than 3 months 2. planned changes in insulin regimen (increasing or decreasing number of injections per day). 3. positive pregnancy test (urine) 4. currently taking anti-platelet therapy or anticoagulants (use of up to 81 mg per day of aspirin is permitted). 5. history of a bleeding disorder or easy bruising 6. blood borne infection(s) 7. history of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema) 8. gross skin anomalies and abnormalities (e.g., scars, stretch marks, discolorations, tattoos, superficial masses, acne, inflammation) located at or very close to the injection sites 9. fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections. 10. use of any prescription analgesic medications within 24 hours of first study injection, and during the study. 11. a current or previous medical or physical condition that, in the opinion of the investigator, would place the patient at risk or make them unable to perform study procedures or has the potential to confound interpretation of the study results. 12. currently participating in another study 13. employed by, or currently serving as a contractor or consultant to bd or any insulin, insulin pen, or insulin pen needle manufacturer
"assessing barriers to ada guideline adherence"

Conditions: Diabetes

Summary: this project involves a comprehensive assessment of barriers to diabetes guidelines adherence across 25 practices in the crozer-keystone primary care pbrn. a barrier assessment tool (bat) will be validated to correlate with provider and practice adherence to diabetes care guidelines. the network is part of the crozer-keystone health system located in delaware county, pennsylvania, in the southeast quadrant of the philadelphia metropolitan region.

study hypothesis: questionnaire responses about perceived barriers to implementation of diabetes care recommendations, administered to primary care providers and staff, will be shown to correlate with that provider's and practice's success at implementing care guidelines. diabetes care in the u.s. consistently fails to meet recommended quality standards. barriers impede the translation of evidence-based guidelines into sustainable practice. few studies have considered multiple barriers, and there is a lack of evidence-based strategy in choosing interventions to overcome barriers. this study involves a comprehensive assessment of practice barriers to diabetes guidelines adherence across a primary care network. the bat based upon a framework proposed by cabana, et al (1999) will be validated to correlate with provider and practice adherence to diabetes care guidelines. a diabetes flow sheet implemented in our network to track adherence to guidelines will be assessed and correlated with measured barriers. this organizational strategy will support an evidence-based approach to quality initiative interventions. the bat will be administered to practice team members: providers, support staff, and practice managers in our network of 25 primary care practices. five hypotheses are tested: a: the bat measures perceived barriers to adherence to diabetes guidelines, while showing adequate internal consistency and an identifiable subscale structure. b: the bat results inversely correlate with practice and provider adherence to ada guidelines. c: bat scores will inversely correlate with use of the diabetes flow sheet. d: the bat scores inversely correlate with clinical outcomes (glycemic and lipid control.) e: use of the diabetes flow sheet correlates with higher provider and practice adherence to ada guidelines. the bat would then provide the structure for comprehensive assessment of barriers. study of the crozer-keystone pbrn is a real-world laboratory for research in the translation of evidence into diverse practices. the network is optimally positioned to implement and study this organizational strategy.

Eligibility criteria:
inclusion criteria: * crozer-keystone health network primary care (internal medicine and family medicine) providers and support staff in the 25 primary care practices.

Keywords: guideline adherence
characterization of secondary hyperalgesia in healthy volunteers

Conditions: Experimental Pain in Healthy Males

Summary: in this prospective trial we aim to investigate the intra-individual and inter-individual variance in secondary hyperalgesia following pain elicited by the experimental pain model: brief thermal sensitization. furthermore we wish to investigate how precise the psychological tests, pain catastrophizing scale and hospital anxiety and depression scale predict the size of the area of secondary hyperalgesia.


Eligibility criteria:
inclusion criteria: * age \>18 years and \<35 years * speak and understand danish * male gender * test subjects who have understood and signed the informed consent * no prescription medicine during the last 30 days exclusion criteria: * test subjects that cannot cooperate to the test * test subjects with an alcohol and/or substance abuse, assessed by the investigator * test subjects, who have consumed one or several types of analgesics 2 \<days before the study * test subjects, who have consumed antidepressant medication during the last 30 days before the study * test subjects with chronic pain * test subjects with psychiatric diagnoses * test subjects with tattoos on the extremities * body mass index of \>30 or \<18

Keywords: pain secondary hyperalgesia thermal sensitization catastrophization anxiety
prospective evaluation of the clinical profile and treatment outcomes of proximal humerus fractures.

Conditions: Proximal Humerus Fractures

Summary: with an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. they significantly affect patients function and independence particularly in the elderly. currently, treatment options range from conservative treatment with an arm sling to fixation either with plates or intramedullary devices to arthroplasty ranging from a hemiarthroplasty to the latest reverse shoulder arthroplasty. while is there has been a global trend towards surgical treatment for such fractures, there is significant controversy regarding the best treatment with many studies reporting disappointing functional outcomes including residual shoulder pain, limitation in shoulder motion and decreased quality of life regardless of treatment option selected. in this day and age where healthcare cost is a big concern both at the individual patient level but at a government level as well, evaluating the cost effectiveness of treatment becomes essential as well. currently in singapore, there have been a significant trend of an increased use of surgical treatment of proximal humerus fractures however we have very little data in our local context not only to evaluate the clinical effectiveness but also the cost effectiveness of surgical treatment in comparison to conservative treatment. the primary aim of the study is 1. to understand the epidemiology and prognostic factors for proximal humerus fractures * incidence * health service utilization * clinical and functional outcomes 2. to estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures. we hypothesize that surgical fixation of the proximal humerus is both clinically and cost effective


Eligibility criteria:
inclusion criteria: 1. age 21 years old and above 2. radiologically confirmed proximal humerus fracture 3. within 3 weeks of their injury exclusion criteria: 1. open fracture 2. mentally incompetent patients 3. co-morbidities precluding anaesthesia 4. severe soft tissue compromise 5. neurovascular compromise 6. pathological fracture other than osteoporosis 7. surgery delayed \> 3 weeks 8. pregnancy