Kornimate/medical-research-clean huggingface dataset:
the effects of a yoga program in heart failure patients

Conditions: Heart Failure

Summary: the proposed research will investigate the clinical outcomes associated with a modified yoga training program in patients with heart failure (hf). hf patients (15-20) will participate in a modified yoga program during an 8 week period, two times per week with instruction for home practice. baseline measures and follow-up will be taken after 8 weeks. the underlying hypothesis to be tested is that yoga-induced improvements in nervous system and skeletal muscle function will yield positive effects on clinical outcomes, functional ability, and health-related quality of life in patients with hf. the effect of combined yoga and breathing training on the natural history of hf and its potential to decrease negative clinical outcomes and improve symptoms is unknown. the relevance of this research is related to the important information it will provide to clinicians caring for patients with hf and will be the basis for pilot data for future nih funding applications.

the proposed research project is a pilot study designed to delineate the clinical outcomes associated with a modified yoga program in a population of adults with ventricular dysfunction and clinical heart failure (hf). the researchers hypothesize that patients in a modified yoga training program will have a significant improvement in clinical outcomes, functional ability, and health-related quality of life (hrqol). the researchers propose to evaluate 15-20 subjects with chronic hf and new york heart association functional class (nyha) ii-iii and obtain baseline physiological, functional, and hrqol measurements. after obtaining baseline measurements, patients will participate in a modified yoga program with instruction for home practice for 8 weeks. baseline measurements include: vital signs, oxygen saturation, heart rate variability, exercise distance, muscular strength and flexibility determination, and various indices of hrqol. at the conclusion of 8 weeks of yoga training the same measurements will be obtained. in a group of chronic hf patients, the specific aims are the following: 1. to develop a safe and feasible yoga program; 2. to determine whether clinical outcomes (vital signs, oxygen saturation, heart rate variability), functional ability (exercise distance, muscular strength and flexibility determination), and hrqol are positively affected by a modified yoga program.

Eligibility criteria:
inclusion criteria: * nyha class i-iii * normal sinus rhythm * able to walk * ability to read or understand english * age 30-75 exclusion criteria: * cognitive impairment * inability to consent * 100% paced with pacemaker * hospitalization within 3 months * mi or recurrent angina within 6 months * severe stenotic valve disease * history of sudden cardiac death * history of uncontrolled ventricular tachyarrhythmias * pulmonary hypertension * fev1 less than 1 liter by spirometry * orthopedic impediments to yoga * medication noncompliance

Keywords: heart failure yoga quality of life
safety, efficacy and pharmacokinetics of nnc-0156-0000-0009 in previously treated children with haemophilia b.

Conditions: Congenital Bleeding Disorder; Haemophilia B

Summary: this trial is conducted in asia, europe and north america. the aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of nnc-0156-0000-0009 (nonacog beta pegol, n9-gp) in previously treated children with haemophilia b.


Eligibility criteria:
inclusion criteria: * male patients with moderately severe or severe congenital haemophilia b with a factor ix activity level below or equal to 2% according to medical records * age below or equal to 12 years (until patient turns 13 years, at time of inclusion) * body weight above or equal to 10 kg * history of at least 50 exposure days (eds) to other fix products * the patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an electronic diary (ediary), capable of conducting home treatment and otherwise able to follow trial procedures exclusion criteria: * known history of fix inhibitors * current fix inhibitors above or equal to 0.6 bethesda units (bu) * congenital or acquired coagulation disorder other than haemophilia b * platelet count below 50,000/mcl at screening * alanine aminotransferase (alt) above 3 times the upper limit of normal reference ranges at screening * creatinine level above or equal to 1.5 times above the upper normal limit of normal reference ranges at screening * human immunodeficiency virus (hiv) positive, defined by medical records, and with a cd4+ lymphocyte count below or equal to 200/mcl * immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids) * previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)
monocyte chemoattractant protein-1 2518a/g polymorphism

Conditions: Diabetic Retinopathy

Summary: the pathogenesis of proliferative diabetic retinopathy (pdr) remains poorly understood. recent studies have implicated that monocyte chemoattractant protein-1 (mcp-1) is associated with diabetic microvascular or macrovascular complications. however, the relationship between snp polymorphism c.2518a/g in the mcp-1 gene with diabetic retinopathy remains controversial. in the present study, we evaluated the association of a single nucleotide polymorphism (snp) in the mcp-1 gene with diabetic retinopathy (dr) and diabetic macular edema (dme) in chinese population from southern china with type 2 diabetes.

the association between polymorphism of mcp-1 c.2518a/g and dr had been reported in japan and korea, but their opinion were inconsistent. however there is no report in china so far. this study was designed to clarify the relationship of polymorphism of mcp-1 c.2518a/g with type 2 diabetes with or without dr. the relationship between mcp-1 c.2518a/g and different stage of dr has also been studied.this article proved that the mcp-1 c.2518g/g genotype is a susceptibility gene for dr in chinese type 2 diabetic patients, especially the high-risk pdr. there is no association with dme and c.2518g/g.

Eligibility criteria:
inclusion criteria: * type 2 diabetic retinopathy * age at diagnosis ≥30 years and a known duration of diabetes of ≥5 years. exclusion criteria: * eyeball atrophy * epimacular membrane * age-related macular degeneration (armd) * intravitreal injection medicine * vitreous hemorrhage
biomarkers of developmental trajectories and treatment in autism spectrum disorder (asd)

Conditions: Children at Risk for ASD

Summary: the study will evaluate the efficacy of a novel intervention implemented in a classroom setting aimed at improving joint attention and joint engagement skills with infants who are at risk of developing an autism spectrum disorder.

the proposed intervention adapts a parent-mediated intervention that successfully improved outcomes in toddlers with autism. the intervention model (a) targets the foundations of social-communication (joint attention, imitation, play), (b) uses naturalistic strategies to increase the rate and complexity of social-communication and (c) includes parents as implementers of the intervention to promote generalization across settings and activities and to ensure maintenance over time. in addition to testing the primary effects of this early intervention on the developmental outcomes of children with signs of autism, we will examine whether this method is superior to an early intervention focused on global infant development. because brain development occurs rapidly in infants and toddlers, we will use high density eeg to investigate (1) biomarkers of change in these infants as a result of intervention and (2) biomarkers predicting response to treatment, with focus on the neural correlates of social attention and learning from joint engagement. study aims: aim 1: to examine the effects of the experimental intervention (baby jasper) on primary (joint attention) and secondary outcomes (receptive language, play, symbol-infused joint engagement and parent use of social communication support strategies). aim 2: to examine maintenance and generalization of the effects of the experimental intervention on children and their parents. aim 3: to examine electrophysiological biomarkers of change with treatment as well as predictors of social communication outcomes in children after intervention. aim 4 (exploratory): to examine the effect of potential child level and parent level moderators on the primary and secondary outcomes of the study across the two conditions.

Eligibility criteria:
inclusion criteria: * have elevated scores on the ados-toddler version and clinical concern from professional (pediatrician, psychologist, etc). because of the young age of children, we expect to intervene with children who do not yet have a diagnosis of asd but may only show some risk by virtue of elevated scores on the ados-t. * have a parent available for parent-mediated sessions 2 times per week in the classroom * do not have seizures * do not have associated sensory or physical disorders * are not co-morbid with other syndromes or diseases exclusion criteria: * other co-morbid syndromes or diseases * seizure activity * other sensory or physical disorders
satiety study of a carbohydrate meal to a highly viscous gel meal

Conditions: Obesity

Summary: to evaluate the effects of konjac on satiety and subsequent food intake in healthy individuals.


Eligibility criteria:
inclusion criteria: * men and women * age 18-65 years * having a bmi of 18.5 - 25 kg/m2 * no presence of major disease exclusion criteria: * known history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, gastrointestinal disease, aids or aids-related complications; subjects using prescription medications or natural health products; subjects will be excluded if they have any condition which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
hearing screening in adults over 50 years old

Conditions: Hearing Loss, Bilateral Sensorineural, Progressive; Hearing Loss, Bilateral (Causes Other Than Tumors); Hearing Loss, Bilateral or Unilateral; Presbyacusis

Summary: the goal of this single-arm quasi-experimental study is to evaluate the feasibility, effectiveness, and management of three different hearing screening methods in adults aged 50 years and older in the czech republic. the main questions it aims to answer are: are the selected hearing screening methods effective in detecting hearing loss in the target population? can these methods be successfully implemented within the national healthcare system to address gaps in current practices? participants will: 1. undergo hearing screening using all three methods, conducted by general practitioners, to assess their performance. 2. complete follow-up evaluations conducted by ent specialists to confirm diagnostic results.

this single-arm quasi-experimental study involves a total of 330 participants aged 50 and older. the study evaluates the feasibility and effectiveness of three distinct hearing screening methods, conducted first by general practitioners and subsequently confirmed by ent specialists, according to a standardized protocol. study population and interventions participants: a total of 330 adults aged 50 years and older will be enrolled in the study. interventions: the interventions are divided into two stages: general practitioners' offices: before the screening: explanation of the screening process. personal medical history review. otoscopy and patient instruction. screening procedures (performed for all participants in the same order according to the standardized protocol): 1. completion of the screening version of the standardized "hhia" questionnaire (czech version). 2. whisper test conducted following the standardized protocol. 3. screening pure tone audiometry performed according to the standardized protocol. ent clinics: before the evaluation: explanation of the evaluation process. ent-specific medical history review. otoscopy and patient instruction. diagnostic procedures (performed for all participants in the same order according to the standardized protocol): 1. pure tone audiometry conducted following the standardized protocol. 2. tympanometry. the findings will provide evidence for developing a comprehensive, national-scale hearing screening program for the aging population in the czech republic.

Eligibility criteria:
inclusion criteria: * signed informed consent (ic) and consent for personal data processing (cpdp). * age 50 years or older. exclusion criteria: * known diagnosed persistent hearing impairment. * inability to sufficiently understand study instructions due to language barriers. * medical condition preventing participation in all parts of the study. * inability or unwillingness to complete all parts of the study.

Keywords: screening hearing loss adults older presbyacusis
establishing the microcirculatory effects of ticagrelor on tissue perfusion in critical limb ischemia

Conditions: Peripheral Arterial Disease

Summary: this is a single center, prospective, randomized, unblinded, open-label, active controlled pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel plus aspirin in patients with rutherford stage iv to vi pad that have undergone a percutaneous transluminal angioplasty (pta) of the lower extremities in the past 2 weeks.

enrollment into the study will require severe symptomatic cli without wounds (rutherford stage iv) or cli with concomitant vascular insufficiency wounds (rutherford stage v-vi pad). potential participants will be identified and screened prior to discharge or at the time of the first out-patient visit (within 2 weeks after discharge) after a percutaneous lower extremity arterial angiography with arterial intervention (stent or balloon angioplasty) for the presence of lower extremity vascular insufficiency. participants will be classified as rutherford class iv - vi (with or without ulcerations). a total of 60 patients will be randomized into 2 treatment groups in a 1:1 ratio (ticagrelor to clopidogrel). patients are placed on clopidogrel after their arterial intervention per standard of care. they will remain on clopidogrel up to the time that randomization occurs. for patients that are randomized to ticagrelor, the clopidogrel will be stopped. patients will be randomized to either ticagrelor 90mg by mouth twice daily or clopidogrel 75mg by mouth daily.

Eligibility criteria:
inclusion criteria: 1. adults age 18-100 years with rutherford classification stage iv through vi pad with a recent percutaneous lower extremity arterial angiography with arterial intervention in the past 2 weeks 2. willingness to sign informed consent 3. ability to return for follow up visits 4. a female patient of childbearing potential who is sexually active must agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug. women not of childbearing potential are defined as those who have surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are post menopausal (defined as at least 2 years since last regular menses). the female patient should not be lactating and must have a negative pregnancy test at screening. exclusion criteria: patients will be ineligible for this study if they meet any one of the following criteria: 1. intolerance to thienopyridines 2. hypersensitivity to ticagrelor or any component of the product. 3. concomitant use of oral anticoagulation with vitamin k antagonist, factor xa inhibitor, or direct thrombin inhibitor 4. history of intracranial hemorrhage 5. history of severe hepatic impairment defined by baseline transaminase greater than or equal to 3x uln or any elevation in bilirubin 6. active bleeding 7. allergy to aspirin 8. baseline tcpo2 \< 10 mmhg post angiography 9. resting, pre- procedure heart rate \<50 beats-per-minute without a permanent pacemaker and not on an atrioventricular nodal blocking agent 10. severe copd on home oxygen therapy -
normative database and test-retest reliability for braincheck assessments

Conditions: Cognitive Change; Cognitive Decline; Cognitive Deterioration; Neurocognitive Deficit

Summary: the purpose of this study is to collect normative test values and demographic information for normative and referential data for a rapid, portable, computerized neurocognitive testing device from healthy adults 50 and older.

braincheck's battery of 12 cognitive assessments will be used in this study, which aims to measure a variety of cognitive domains (memory, attention, mental flexibility, executive function, processing speed, balance, reasoning, visuospatial construction, language, and visual hallucinations). with the decline in cognition occurring at a quicker rate at older ages, this study aims to collect additional data from healthy older adults to better capture the normative distribution among these age groups from existing and new assessments.

Eligibility criteria:
inclusion criteria: * aged 50 or older * willing and able to comply with study requirements and activities exclusion criteria: * tbi within the last 6 months * neurosurgery within the last month * experienced a stroke * self reported neurological condition (including mild neuropsychological impairment, dementia, parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, or long-covid)

Keywords: healthy volunteers dementia alzheimer's disease mild cognitive impairment older adults
new urine and blood markers for acute kidney injury in liver transplant patients

Conditions: Renal Insufficiency, Acute

Summary: the purpose of this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant.

patients with end stage liver disease that receive a liver transplant will be studied to determine if novel serum and urine biomarkers (serum cystatin c, urine interleukin-18 \[il-18\] and urine neutrophil gelatinase associated lipocalin \[ngal\]) can predict the outcome measures listed above.

Eligibility criteria:
inclusion criteria: * first time liver transplant recipient * cadaveric or living donor livers exclusion criteria: * unconscious patients or patients who cannot give consent * pregnant women * prisoners * patients receiving dialysis before or during liver transplant operation * patients receiving simultaneous liver-kidney transplants

Keywords: biological markers renal replacement therapy mortality
using ultrasonography to predict clinical response to intraarticular corticosteroids in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the primary purposes of this study are the following: 1. to evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids. 2. to prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee oa using a randomized, placebo controlled clinical design. 3. to evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection. the investigators hypothesize that patients with signs of inflammation by ultrasonography such as synovitis and effusion will respond better to intraarticular corticosteroid injection.

osteoarthritis (oa) has previously been thought to be a non-inflammatory condition whose pathologic hallmark is destruction of hyaline cartilage. it is now realized that oa results from a complex interplay of multiple factors, including local inflammatory processes. evidence suggests that synovitis which is the usual presenting sign of inflammatory arthritis is also frequently present in oa. the presence of inflammation in knee oa may explain why intra-articular (ia) corticosteroid injections have been shown to result in clinically and statistically significant reduction in osteoarthritic knee pain. randomized controlled trials have shown that treated patients were less likely to have continuing pain and had significantly lower scores on a visual analogue scale (vas) for pain. however, studies have failed to determine clinical predictors of response to ia steroid injection, including traditional indices of inflammation (heat, fluid, stiffness). one possibility is that local corticosteroids do no act to relieve pain by reducing synovitis. these putative mechanisms have yet to be elucidated. perhaps a more plausible explanation is that current methods of assessing local inflammation in oa are inadequate. recent studies involving ultrasonography (us) demonstrate that us is a valid and reproducible tool for the detection of synovitis in the knee. it has been shown to be more sensitive than clinical examination and is relatively inexpensive and noninvasive.

Eligibility criteria:
inclusion criteria: * both male and female patients are eligible for the study if they are between 40 and 80 years old, have symptomatic knee oa requiring treatment, and have not responded adequately to treatment with acetominophen or nsaids. exclusion criteria: * severe oa as defined by radiographic kellgren and lawrence grade iv * the patient being wheel-chair bound * previous knee operation on the affected side within the past year or history of total knee arthroplasty (affected side) * any ia steroid or injections in the last 3 months or viscosupplementation in the last 6 months * local sepsis * local skin conditions * serious concomitant medical illness.

Keywords: knee osteoarthritis ultrasonography corticosteroids
place of ultrasound guidance of surgery site in surgery for lumbar canal stenosis and lumbar disc herniations

Conditions: Lumbar Stenosis, Familial

Summary: the identification of the operative site of lumbar ductal stenosis and lumbar disc herniation is classically done by radioscopy, thus inducing irradiation of the patient. the use of ultrasound in spine surgery is little studied and poorly mentioned in the scientific literature. however, it is commonly used for other types of scouting (especially anesthetics). thus, in the absence of consensus and clear recommendations, some practitioners perform ultrasound scans . methodological developments also validate the feasibility of the ultrasound approach. the double benefit of an ultrasound identification is firstly a lack of exposure to x-rays for both the patient and the operating team and secondly a lower cost than a conventional radiography. the main objective is to demonstrate the interest of the ultrasound identification of the surgical site in the intervention of lumbar ductal stenosis and lumbar disc herniations in terms of concordance of the operating site between ultrasound and fluoroscopy.


Eligibility criteria:
inclusion criteria: * major patients * patients who gave their consent * patients requiring surgery for the treatment of lumbar stenosis or lumbar disc herniation exclusion criteria: * pregnant or lactating women according to article l1121-5 of the csp. * vulnerable persons according to article l1121-6 of the csp. * major persons placed under guardianship or curatorship

Keywords: ultrasound guidance surgery for lumbar spine irradiation wrong site surgery