Kornimate/medical-research-clean huggingface dataset:
nonalcoholic steatohepatitis in chinese children

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: nonalcoholic steatohepatitis (nash) is now recognised as an increasing clinical problem in children. steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (nafld) in both adults and children. studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and nash is recognised as a potentially serious condition with significantly risk of morbidity and mortality. a growing body of evidence suggests that children with nash frequently show histopathological features that differ from those of adults. the prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with nafld remains to be determined. thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric nafld, to explore the natural history of paediatric nafld, and to determine the frequency and prognostic value of these features.


Eligibility criteria:
inclusion criteria: * age 1-18 with biopsy-proven nafld * alcohol consumption less than 20g/day and 10g/day for boys and girls respectively exclusion criteria: * with viral hepatitis, e.g. hbv, hcv * with a1-anti-trypsin disease * with autoimmune hepatitis * with wilson disease * with liver impaired by drugs
study comparing etanercept (etn) against a placebo for etanercept on a background nonsteroidal anti inflammatory drug (nsaids) in the treatment of early spondyloarthritis (spa) patients who do not have x-ray structural changes

Conditions: Spondylitis, Ankylosing

Summary: this is a two part study. during period one there will be a comparison of etanercept (etn) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their physician. the hypothesis is that etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving assessments in ankylosing spondylitis (asas)40 improvement at 12 weeks. this will be followed by 92 weeks extension where everyone in the trial receives etanercept (etn) and a background non steroidal anti inflammatory drug(nsaid).


Eligibility criteria:
inclusion criteria: * diagnosis of axial spondyloarthritis as defined by assessments in ankylosing spondylitis (asas)criteria * active symptoms defined as ankylosing spondylitis disease activity index{basdai) \> or = 4 * axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks exclusion criteria: * evidence of current or recent episode of uveitis * evidence of ibd flare within 6 months * previous treatment with an anti tumor necrosis factor(tnf) * active tuberculosis * radiographic sacroiliitis grade 3-4 unilaterally or \>= 2 bilaterally

Keywords: early ankylosing spondylitis (spa) study; efficacy and safety and health out comes
central executive training for adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: feasibility study of central executive training (cet) for adhd. the goal of the current project is to develop and assess the feasibility, acceptability, engagement, and usability of a novel, central executive (ce) working memory training intervention.

the goal of the core study is to develop a central executive training (cet) intervention for children with attention-deficit/hyperactivity disorder (adhd) and examine its feasibility, acceptability, engagement, and usability. this will involve early developmental work on software and treatment manuals followed by evaluation of the feasibility of enrolling, retaining, and treating adhd children with cet. an evidence-informed intervention targeting central executive functioning in children with adhd has the potential to result in clinically significant improvements in adhd symptoms relative to extant behavioral treatments and capacity-based (short-term memory) training interventions. the long-term goal is to develop an efficacious and acceptable cet intervention with the potential for generalized improvements in, or normalization of, adhd-related impairments in peer, family, and academic functioning.

Eligibility criteria:
inclusion criteria: * children ages 8-12 with principal adhd diagnoses (via k-sads) * parent behavior assessment system for children (basc) attention problems or hyperactivity subscale or adhd-5 in clinical/borderline range based on age and gender * teacher basc attention problems or hyperactivity subscale or adhd-5 scale in clinical/borderline range based on age and gender. exclusion criteria: * gross neurological, sensory, or motor impairment, history of a seizure disorder, or psychosis, bipolar disorders, substance use, or intellectual disability disorders * non-english speaking child or parent
effect of isometric handgrip training on cardiovascular risk in hypertensives

Conditions: Hypertension

Summary: the main purpose this study is to analyze the effects of isometric handgrip training on cardiovascular risk in hypertensive. for this, approximately 60 hypertensive, under anti-hypertensive medication, will be selected and randomly distributed into three groups: home-based isometric handgrip training (hbt), supervised isometric handgrip training (st) and control group (cg).subjects assigned to the hbt and st will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction. however, the subjects of the hbt group conduct the training without daily supervision. subjects randomized to the cg will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations.baseline and after 12 weeks of intervention, the following cardiovascular risk indicators will be obtained: blood pressure, arterial stiffness, cardiac autonomic modulation, vasodilatory capacity and oxidative and inflammatory stress markers, in addition to microalbuminuria. for data analysis, in addition to descriptive statistics, two-way anova for mixed model will be applied for within and between groups comparison. if the premises of this test are met. the level of significance that will be adopted is p\<0.05.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypertension; * must be under anti-hypertensive medications of three months or more; * may not present diabetes or other cardiovascular diseases; * may not engaged in regular physical activity; * may not have disabilities that compromise the physical activity practices. exclusion criteria: * not perform more than 85% of the training sessions; * present diagnosis of metabolic diseases, cardiovascular or pulmonary during the study; * adherence to other physical activity program beyond the training offered by this study; * change in class and / or dose of medication during the study; * not using the medication regularly; * worsening of the disease.

Keywords: isometric handgrip
study of vvn001 ophthalmic solution in dry eye disease

Conditions: Dry Eye

Summary: this is a phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of vvn001 ophthalmic solution versus vehicle in subjects with dry eye disease.


Eligibility criteria:
inclusion criteria: * provide written informed consent prior to any study-related procedures . * are 18 years of age or older. * are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study. * have a best corrected visual acuity (bcva), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by early treatment of diabetic retinopathy study (etdrs) at the screening visit and randomization visit. * have a history of dry eye disease in both eyes * are currently using artificial tears and have been using within 30 days of the screening visit. * have an eye dryness score ≥40 at visit 1 and ≥35 at visit 2, one score for both eyes (0-100 point vas) * have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at visit 1 and visit 2: * inferior cfs (icfs) score of ≥2 (nei; 0-4 scale; using 0.5 unit increments) * have a schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min. exclusion criteria: * have a known hypersensitivity or contraindication to the ip or components of ip. * have a schirmer score (without anesthesia) of \ 7 mm/5 min in the study eye. * have history of uncontrolled glaucoma, iop over 21 mmhg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
repository study of autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: the design and establishment of the polycystic kidney disease (pkd) data repository does not require, and may be constrained by, a narrowly conceived hypothesis. however, the pkd repository has been designed to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of the disorder and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including renal failure, cardiovascular disease, and stroke.

the goal of this project is to collect data from a large population of patients with pkd. based upon the estimated prevalence of pkd (1:500 and 1:1000 live births), it is estimated that there may be 10,000 pkd patients in the new york city area. this sample size far exceeds any database established thus far. as many as 40% of affected pkd patients are reportedly unaware of a family history of this disease, in part because many patients may go undiagnosed until they present with a medical complication (e.g., hypertension, kidney failure). furthermore, this initiative will provide an opportunity to compare data from racially diverse populations.

Eligibility criteria:
inclusion criteria: * males and females * age 18 years and older * previously diagnosed with adpkd exclusion criteria: * inability to provide informed consent

Keywords: polycystic kidney disease autosomal dominant polycystic kidney disease disease progression
evaluation of an ascensia lancing system

Conditions: Diabetes

Summary: the purpose of this study was to determine if untrained subjects with diabetes could perform basic tasks with the styx lancing device to obtain adequate blood volume from fingerstick and palm lancings for blood glucose meter testing.


Eligibility criteria:
inclusion criteria: * males and females, 18 years of age and older * people with type 1 or type 2 diabetes * people who regularly perform self-tests (at least once/day) with their own lancing device * able to speak, read, and understand english * willing to complete all study procedures exclusion criteria: * those with missing tips of the fingers indicated in the protocol or physically unable to lance the palm areas and all the fingers indicated in the protocol. * hemophilia or any other bleeding disorder * pregnancy * physical, visual or neurological impairments that would make the person unable to perform testing * persons who have used the styx device in a previous clinical evaluation * working for a competitive medical device company, or having an immediate family member who works for such a company * a condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
mtx and steroid for iii-iv agvhd treatment

Conditions: Acute Graft Versus Host Disease

Summary: the aim of the study is to identify the efficacy and safety of methotrexate (mtx) combined corticosteroid treatment for grade iii-iv acute graft-versus-host disease (agvhd) after allogeneic hematopoietic stem cell transplantation (allo-hsct).

allo-hsct is an effective treatment of malignant hematopoietic diseases. however, agvhd remains a major complication after allo-hsct and the destruction of recipient tissues by alloantigen-activated t cells is a key event in the development of agvhd. corticosteroid is the standard first-line therapy for agvhd due to their roles in suppressing t cell responses. however, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory gvhd were poor. thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for agvhd. the study hypothesis: mtx combined corticosteroid treatment could help to further ameliorate the activity of t cells and control agvhd.

Eligibility criteria:
inclusion criteria: 1. patients who are fully informed and sign informed consent by themselves or their guardians; 2. patients receiving allogeneic hematopoietic stem cell transplantation; 3. patients with acute graft-versus-host disease of grade iii-iv were diagnosed after transplantation; 4. patients with stable implantation of granulocytes and platelets. exclusion criteria: 1. patients who have received more than one transplant; 2. patients with overlap syndrome; 3. patients within six months after the failure of the first transplantation; 4. patients with uncontrollable active infection; 5. patients with recurrence of primary malignant hematopathy; 6. patients with donor lymphocyte infusion induced graft-versus-host disease after first intervention; 7. patients with serious respiratory diseases; 8. patients with severe renal insufficiency; 9. patients with serious and uncontrolled heart disease; 10. patients with severe hepatobiliary diseases unrelated to graft-versus host disease; 11. within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease; 12. patients who have participated in other clinical trials within 1 month; 13. the researcher judges that there are other factors that are not suitable for participating

Keywords: acute gvhd mtx corticosteroid
evaluation of perioperative cystoscopy and methylene blue test in detecting complications in tvt and tot procedures

Conditions: Incontinence Stress

Summary: comparison of complications detected by perioperative cystoscopy combined with methylene blue test and postoperative cystoscopy in tvt and tot operations.


Eligibility criteria:
inclusion criteria: * providing consent to participate in the study * being between the ages of 18 and 85 * having stress urinary incontinence * no active cardiac disease * no connective tissue disorders (e.g., marfan syndrome) * no known gynecological malignancy * bmi under 30 * no chronic constipation * no inflammatory bowel disease exclusion criteria: * not providing consent to participate in the study * being under 18 or over 85 years old * not having stress urinary incontinence * having active cardiac disease * having connective tissue disorders (e.g., marfan syndrome) * having a known gynecological malignancy * having a bmi over 30 * having chronic constipation * having inflammatory bowel disease

Keywords: tvt tot cystoscopy
psychological impact of armed conflict on sudanese diabetic patients 2024

Conditions: Psychological Impact of Armed Conflict; Diabetes Complications

Summary: the study focused on sudanese people with diabetes who experienced the ongoing war in sudan. some people were displaced and others were not. this would had an impact on their mental health. we have investigated this impact and any complications happened to them through self-administered questionnaire.


Eligibility criteria:
inclusion criteria: sudanese diabetic patients, both genders, above 18 years - exclusion criteria: * non diabetic, pre-existing psychological disorder

Keywords: dass-21 sudan psychological armed conflict diabetics
effect of dietary sodium intake on blood pressure in hypertensive patients in primary care

Conditions: Arterial Hypertension

Summary: there is strong evidence that our current consumption of salt is the major factor increasing blood pressure (bp). the current salt intake in most countries in the world is 9 to 12 grams per day (g/d), whil the world health organization's recommendation is \< 5 g/d. the aims of the present study is to determine if the overconsumption of salt influences the bp in patients with uncontrolled hypertension or frequently elevated bp. each study subject will complete questionnaires, and their usual dietary salt intake is estimated from food composition on 3 completed food diaries. this is also compared with a 24-hour urine sample collection. based on these results, the study subject receives personal advice to decrease sodium consumption and will change the diet for at least 28 days. during this diet, bp will be measured and food diaries will be completed. after the intervention, a questionnaire and a 24-hour urine sample collection will be collected.


Eligibility criteria:
inclusion criteria: * adults, 50 years of age or older with changing blood pressure (bp) with or without drugs and patients with uncontrolled bp despite drugs * an average systolic bp on 2 of the 3 previous visits of 140 mm hg or more (130 mm hg for diabetics) and an average diastolic bp of 80 to 100 mm hg. * blood analysis (fasting glycaemia, creatinin, total cholesterol, high- density lipoprotein cholesterol) in the last 6 months * at least 3 criteria of the following: * using table salt * 2-3/weeks consumption of prepared meals (butchery, warehouse...) * 2-3/weeks consumption of effervescent tablet * daily consumption of cheese/cold cuts * daily consumption of salted butter/margarine * 2-3/weeks consumption of smoked fish/meat * 2-3/weeks consumption of bouillon cube-soup (self-made or preserved) * 2-3/weeks consumption of cookies * 2-3/weeks consumption of vegetables preserved in jars * 2-3/weeks consumption of vegetable juice * 2-3/weeks consumption of snacks (chips, cheese, nuts...) exclusion criteria: * heart failure * renal insufficiency * secondary hypertension * isolated systolic/diastolic hypertension * bp difference of more than 10 mm hg between left and right arm * lactation or pregnancy * active malignancy * an active 'low in salt' diet * changing the use of antihypertensive drugs or other medication that would affect bp for the last 4 weeks * impaired cognitive functioning$ * planning a smoke cessation

Keywords: hypertension sodium diet
local and general immune response after coronavirus disease (covid-19) vaccination in volunteers

Conditions: Covid19

Summary: this study aims to gain more insight in the immunological characteristics and immune response on a local level (the nose) and systemic level (the blood) of healthy people vaccinated with the current available covid-19 messenger ribonucleic acid (mrna; bnt162b2) and viral vector based (chadox1) vaccines.

the immunological assays that will be performed on blood include immunophenotyping, serologic testing and cytokine analysis. deep characterization of patients' immune profile offers a unique opportunity for comprehensive understanding of the mechanisms behind severe acute respiratory syndrome coronavirus 2 (sars-cov2) vaccination. the investigators will study immunological functions on the level of both adaptive and innate immunity by performing extensive immunophenotyping, cytokine analysis and rna sequencing analysis. biomarker analysis will be performed on protein and on rna single cell level. infectivity of different cell types including macrophages will performed. these analyses will be performed at the human immunodeficiency virus (hiv) cure research center (hcrc) laboratory. nasal fluid: the investigators will compare the immune response and immunoglobulin production in nasal secretions before and after sars-cov2 vaccination. the investigators aim to compare the local versus the systemic (blood/serum) response to sars-cov2 vaccination. further, patients that had a proven sars-cov2 infection will be compared with patients that never had covid-19 symptoms nor antibodies. questionnaire: a questionnaire will be filled in by the individual to assess if the individual went through a previous sars-cov2 infection and experienced symptoms post vaccination. the questionnaires are available as supplementary documents.

Eligibility criteria:
inclusion criteria: * adult (18-100 years) exclusion criteria: * people with a compromised immune system active treatment with chemotherapy hiv infection with cluster of differentiation 4 (cd4) count below 200/µl combined immunodeficiency treatment with methylprednisolone \>16mg for more then 2 weeks transplant patients diagnosed chronic rhinosinusitis with nasal polyps * known pregnancy at the time of screening * inability to give informed consent or absence of legal representative who can give informed consent. * any contra indication for receiving the sars-cov2 vaccination

Keywords: serum nasal secretions immune response
pharmacogenomic-guided antidepressant drug prescribing in cancer patients

Conditions: Depression; Anxiety; Generalized Anxiety Disorder; Depressive Disorder; Major Depressive Disorder; Cancer

Summary: this is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. those enrolled onto the clinical trial will be randomized to either dna-guided choice of therapy or clinical management alone. scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.


Eligibility criteria:
inclusion criteria: * patients with a cancer diagnosis * be 18 years of age or older * patients who rate depression or anxiety \> 5 based on a 10 point scale * patients expected to live greater than 6 months * serum bilirubin and creatinine \< 1.5x upper limit of normal * ast and alt \< 3 times upper limit of normal * willing and able to provide written informed consent * able to complete self-assessment questionnaires exclusion criteria: * patients not diagnosed with cancer * antidepressant prescribing performed by a non-moffitt psychiatrist after enrollment onto the clinical trial * known pregnancy * history of liver or allogenic stem cell transplant * patients with a known cognitive impairment (e.g., delirium, dementia, etc.) or psychological impairment (e.g., schizophrenia, bipolar disease, etc.) other than depressive and anxiety symptoms.