Kornimate/medical-research-clean huggingface dataset:
influence of glucagon inhibition in relation to the anti-diabetic effect of glucagon-like peptide-1 (glp-1) in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: incretinbased treatment of patients with type 2 diabetes mellitus (t2dm) has increasing interest. the incretin glucagon-like peptide-1 (glp-1) stimulates beta-cells to increased secretion and production of insulin. glucose sensitivity is enhanced, apoptosis inhibited - progression in disease is potentially stopped. the alpha-cell is also influenced by glp-1 as infusion lowers plasmaglucose (pg) levels in patients with type 1 diabetes mellitus (t1dm) (c-peptide negative) by inhibition of glucagon and thereby decreased hepatic glucoseproduction (hgp). further vilsboll et al has proved normalization of the glacgonostatic effect of glucose in patients with t2dm. as an attempt to elucidate glucose-intolerance in patients with t2dm further knop et al investigated the glucagonresponse to both oral glucose tolerance test (ogtt) and a following iso-glycemic clamp. he saw a sufficient suppression of glucagon when glucose was introduced intravenously but the suppression of glucagon was attenuated and delayed when glucose was given orally. the aim of this study is to elucidate the glucose intolerance further. due to the complex interactions and mutual feed-back regulation between the pancreatic hormones and the pg level this protocol includes five days. all days include a euglycemic-clamp, patients with t2dm (n=10) are clamped at their fasting pg as are healthy control subjects (n=10). during the clamp either glp-1 alone; glp-1 in combination with somatostatin, insulin and glucagon; or somatostatin, insulin and glucagon are infused and blood samples are drawn. the design of the study makes it possible to isolate the effect of each hormone. further the investigators will be able to enlighten the effect of glp-1 on the increase in glucose turn-over it induces. the essential part in this design will be hormone concentrations and the response parameter the amount of glucose (auc) it takes to create the euglycemic-clamp.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus according to criteria from who * normal hepatic and kidney function * no overt diabetic complications * treatment with insulin or glitazones * informed consent exclusion criteria: * bmi \< 23 * bmi \> 35 * hba1c \> 10% * pregnancy

Keywords: glp-1 glucagon secretion glucose turn-over
the effect of listening to music on chronic low back pain

Conditions: Pain, Chronic

Summary: the effects of passive music listening on pain, anxiety and quality of life in patients with chronic low back pain in addition to physical therapy will be examined.

the aim of the study was to investigate the effects of passive music listening in addition to physical therapy on pain, anxiety and quality of life in patients with chronic low back pain.there is no study in the literature examining the relationship between music listening and physical therapy in chronic back pain. since our study will be the first to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. in addition, national or international publications are planned after the study is completed.

Eligibility criteria:
inclusion criteria: patients with lbp for more than 3 months with pain severity of 5 or greater according to the visual analogue scale (vas) exclusion criteria: individuals who regularly take painkillers or anti-depressant and cortisone; pregnant individuals; and individuals having severe chronic illness and spine surgery were excluded from the study
gonadal function in young to middle aged hiv-infected men

Conditions: Human Immunodeficiency Virus; Hypogonadism, Male; Erectile Dysfunction

Summary: hiv infection is associated to premature decline of serum testosterone. however, prevalence and biochemical characterization of hypogonadism in hiv-infected men are still to be well defined. hiv-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.

the aim of this study is to evaluate the gonadal function of young to middle aged hiv-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either liquid chromatography tandem mass spectrometry (lc-ms/ms) or chemiluminescent immunoassay. furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (international index of erectile function (iief) 15 and 5).

Eligibility criteria:
inclusion criteria: * male gender * age 18-50 years * hiv-infection * ongoing highly active antiretroviral therapy exclusion criteria: * previous treatment with androgens, anti-androgens * severe liver insufficiency * severe renal insufficiency
urdu version of nottingham extended activities of daily living scale: reliability and validity study

Conditions: Stroke

Summary: the aim of the study is to know the validity and reliability as well as to translate and culturally adapt the nottingham extended activities of daily living scale into urdu language in pakistani population of stroke. this study also aims to correlate the scale with the modified barthel index and frenchay activities index.

as per previous recommendation the english version of nottingham extended activities of daily living scale will be translated into urdu and it will be culturally adapted. nottingham extended activities of daily living scale will be given to eighty individuals of stroke population which were selected on the basis of convenience sampling and the criteria of inclusion and exclusion. study will investigate both inter-observer and intra-observer reliability of nottingham extended activities of daily living scale, modified barthel index and frenchay activities index; the 2 set of questionnaire designed will be given to the participants on the same day to be filled, by two observers. and with a gap of half an hour between distributions of first two forms questionnaires will be given for inter-observer assessment. and after a time period of one week a third assessment will be collected by the first observer (intra-observer assessment). statistical package of social sciences version 24 will be used for data entry and analysis. cronbach alpha value will be used for checking internal consistency and intra-class correlation coefficient will be used to analyze test retest reliability.

Eligibility criteria:
inclusion criteria: 1. having age of 67 years or more 2. having stroke 3. both males and females exclusion criteria: 1. neurological condition other than stroke 2. any fracture of lower extremity 3. any amputation of lower extremity

Keywords: nottingham extended activities of daily living scale urdu version reliability validity stroke neurological disorders activities of daily living
a study to investigate the efficacy and safety of otl-203 in subjects with mps-ih compared with standard of care with allogeneic hsct

Conditions: MPS-IH (Hurler Syndrome)

Summary: a multi-center randomized clinical trial to compare otl-203 (gene therapy) with stem cell transplant (standard of care) in patients with mps-ih (hurler syndrome).

the study is a multi-center, randomized, active controlled clinical trial designed to evaluate the efficacy and safety of otl-203 in patients with mucopolysaccharidosis type i, hurler syndrome (mps-ih) compared to standard of care with allogeneic hematopoietic stem cell transplantation (allo-hsct). a total of 40 patients with a confirmed diagnosis of mps-ih who meet the study inclusion criteria will be randomized to receive either otl-203 or allo-hsct. the trial will comprise of a screening, baseline, and treatment period, with a follow-up period of 5 years post-treatment, and primary analysis performed at 2 years follow-up of the last treated subject.

Eligibility criteria:
inclusion criteria: 1. norm-referenced cognitive standard score of ≥70 measured by age-appropriate cognitive domains of either bayley scale of infant development (bsid)-iii or wechsler preschool and primary scale of intelligence (wppsi)-iv. 2. confirmed laboratory diagnosis of mps-ih as demonstrated by biallelic mutation(s) in the gene coding for idua enzyme 3. final confirmation of mps-ih diagnosis by a diagnostic review committee (drc). exclusion criteria: 1. previous allo-hsct or gene therapy 2. current enrollment or past treatment in any other interventional study/trial using a novel investigational agent and/or treated with prohibited medications listed in the protocol 3. positivity to serological testing for human immunodeficiency virus (hiv)-1 or hiv-2, human t lymphotropic virus (htlv)-1 or htlv-2, hepatitis b virus (hbv) core, hepatitis c virus (hcv), mycoplasma, active tuberculosis (tb) and not meeting the microbiology biological screening requirements. 4. malignant neoplasia (except local skin cancer). 5. myelodysplastic syndrome (mds) or acute myeloid leukemia (aml) 6. history of uncontrolled seizures 7. subjects with an active infection not responsive to treatment, end-organ damage, or any other disease that contraindicates performance of any of the procedures detailed in the protocol, or medical conditions or extenuating circumstances that, in the opinion of the investigator, might compromise the subject's well-being or safety, or the interpretability of the subject's clinical data. 8. subjects, who in the opinion of the investigator, may not be able to comply with protocol requirements or cooperate fully with the study procedures and necessary long-term follow up

Keywords: mps-ih hurler mps-i mucopolysaccharidoses mucopolysaccharidosis type i hurler syndrome mucopolysaccharidosis ih gene therapy transplantation autologous lentiviral vector
bioflow-iii sweden satellite registry

Conditions: Coronary Artery Disease; Myocardial Ischemia

Summary: this registry is a clinical post-market evaluation of the orsiro less in subjects requiring coronary revascularization with drug eluting stents (des).

for the majority of coronary artery disease (cad), treatment with percutaneous transluminal coronary angioplasty (ptca) provides high initial procedural success. however, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. the reported incidence of restenosis after ptca ranges from 30%-50%. such rates of recurrence have serious economic consequences. bare metal stents (bms), designed to address the limitations of ptca, reduced the angiographic and clinical restenosis rates in de novo lesions compared to ptca alone and decreased the need for cabg. bms substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. the invention of drug eluting stents (des) significantly improved on the principle of bms by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. the introduction of des greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to bms with systemic drug administration. these advantages and a lower cost compared to surgical interventions has made des an attractive option to treat coronary artery disease. this observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the orsiro drug eluting stent system in an all-comers patient population in daily clinical practice.

Eligibility criteria:
inclusion criteria: * symptomatic coronary artery disease * subject has signed informed consent for data release * subject is geographically stable and willing to participate at all follow-up assessments * subject is ≥ 18 years exclusion criteria: * subject did not sign informed consent for data release * pregnancy * known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for pci, stainless steel, sirolimus or contrast media * planned surgery within 6 months of pci unless dual antiplatelet therapy will be maintained * currently participating in another study and primary endpoint is not reached yet.

Keywords: international multicenter observational registry orsiro drug eluting stent (des) stenting treatment of coronary artery disease coronary revascularization percutaneous coronary intervention stemi nstemi ischemia angina subgroups acute myocardial infarction diabetes small vessels
ai performance for the detection of bone fractures in children

Conditions: Fracture

Summary: the artificial intelligence (ai) software boneview (gleamer company, paris, france) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs. the objective will be to assess the ai performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting. these patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. this readings will be compared with the ai results. hypothesis is that ai is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.


Eligibility criteria:
inclusion criteria: * aged less than 2 years old * whole body radiography performed for suspected child abuse setting * report available with a double blind reading (generalist radiologist and radiologist with expertise in child abuse) exclusion criteria: * radiograph not interpretable ( poor quality) * ai not applicable

Keywords: aged radiography paediatric imaging artificial intelligence child abuse
randomized, double-blind, single-dose, efficacy and safety study of test acetaminophen tablet in postoperative dental pain

Conditions: Post-operative Dental Pain

Summary: to evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two test acetaminophen 500 mg tablets (test acm) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (acm) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (ibu) in the dental pain model following third-molar extractions.

this is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of test acm 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. subjects will undergo dental extraction of three or four third molars.

Eligibility criteria:
inclusion criteria: 1. 17 to 50 years old 2. weigh 100 lbs. or greater and have a body mass index (bmi) of 18 to 30 (inclusive) 3. dental extraction of three or four third molars 4. meets post-surgical pain criteria 5. females of childbearing age must be willing to use acceptable method of birth control exclusion criteria: 1. currently pregnant or planning to be pregnant or nursing a baby 2. known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (nsaids) including aspirin, as well as hydrocodone or other opioids 3. inability to swallow whole large tablets or capsules 4. have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study 5. use of pain medications 5 or more times per week 6. have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years 7. history of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years 8. have a positive urine drug screen
intervention development for syndemics among pwh in sa

Conditions: HIV Infections

Summary: in south africa, the country with the highest hiv prevalence (19%), co-occurring problems such as depression, post-traumatic stress, and food insecurity interact to enhance one another (i.e., syndemic problems) and are associated with worse hiv outcomes such as worse antiretroviral therapy (art) adherence and worse viral load. this study proposes to: 1) explore how syndemic problems work together to make health worse for people with hiv (pwh) and explore what people think about a potential treatment; 2) develop a treatment to address syndemic problems and improve art adherence (cbt-sa); 3a) assess whether people are willing to receive the cbt-sa we it can actually be done; and 3b) identify factors that make it easier or more difficult to receive cbt-sa.

south africa (sa) has a generalized hiv epidemic, and the highest hiv prevalence rate (19%). psychosocial (e.g., depression, post-traumatic stress) and structural problems (e.g., food insecurity) are associated with worse antiretroviral therapy (art) adherence and higher viral load. depression, post-traumatic stress, and food insecurity are also highly comorbid and are thought to interact synergistically to confer greater risk for worse hiv outcomes (i.e., syndemic problems). the proposed specific aims are to: 1) explore the complex interrelationships between food insecurity, depression, and post-traumatic stress, as they relate to engagement in hiv care, and explore attitudes to potential intervention components; 2) develop a multilevel intervention to address syndemic problems and improve adherence (cbt-sa) and conduct an iterative proof-of-concept pilot trial use syndemic theory; 3a) assess the feasibility and acceptability of cbt-sa in a pilot rct; and 3b) identify barriers and facilitators of cbt-sa engagement among pwh and uptake among care providers and other key local partners to inform a future hybrid effectiveness/implementation r01 trial. if successful, this intervention would be further tested for effectiveness and implementation in a future application.

Eligibility criteria:
inclusion criteria: 1. patient receiving hiv care in khayelitsha (confirmed by medical record) 2. currently prescribed tdf-based art, with recent difficulties with art adherence (self-reported in past 30 days / confirmed by pharmacy refill data) 3. mild, moderate, or severe food insecurity (measured by hfias categories) and ≥1 of the following: * clinically significant depressive symptoms (ces-d ≥ 16) * clinically significant post-traumatic stress symptoms (span ≥ 5) 4. 18 years of age or older exclusion criteria: 1. unable or unwilling to provide informed consent 2. in the past year: received cbt for depression or ptsd, or received supplemental food parcels or nutritional counseling 3. current untreated or undertreated serious mental health issue that would interfere with participation

Keywords: syndemic problems art adherence food insecurity depression post-traumatic stress disorder
magnesium supplementation and blood pressure reduction

Conditions: Blood Pressure

Summary: this double-blind, placebo-controlled randomized clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure.

this double-blind, placebo-controlled randomized clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure in 60 adults aged 30-74 who have elevated blood pressure or stage 1 hypertension and are not taking anti-hypertensive medication. animal studies, epidemiologic studies, and small randomized trials suggest that supplemental mg may reduce blood pressure, but the evidence is not definitive. eligibility to participate in the trial will be determined by a 2-stage screening process -- completion of a pre-screening form online followed by an in-person screening clinic visit. eligible participants will assigned by chance (like a coin toss) to daily magnesium or to placebo and will receive a supply of study capsules via u.s. mail. participants will take 4 study capsules per day (2 capsules in the morning and 2 capsules in the evening). assessments at the screening visit include seated blood pressure; 24-hour ambulatory blood pressure (monitor will be worn by the participant for 24 hours and then returned via mail); pulse; weight, height, waist and hip circumference measurements; fasting blood and urine collection; and health and diet questionnaires. participants will return for clinic visits at 6 weeks and at 12 weeks to assess these measures, including 24-hour ambulatory blood pressure.

Eligibility criteria:
inclusion criteria: * self-report of systolic blood pressure 120-139 mmhg or diastolic blood pressure 80-89 mmhg at prescreening * measured seated systolic blood pressure 120-149 mmhg or measured seated diastolic blood pressure 80-94 mmhg at screening visit * body mass index less than 40 kg/m2 * total mg intake from supplements of no more than 100 mg/day * willing to maintain current diet and supplement use patterns during the intervention period exclusion criteria: * history of antihypertensive use * history of cardiovascular disease (myocardial infarction, stroke, revascularization \[coronary artery bypass graft or percutaneous transluminal coronary angioplasty\], or angina pectoris) * history of invasive cancer diagnosed within the last 5 years (non-melanoma skin cancer permitted) * history of type 1 or 2 diabetes * history of renal disease * history of kidney failure * history of dialysis * history of pancreatitis * history of inflammatory bowel disease * history of hypermagnesemia * women who are pregnant, nursing, or intend to become pregnant during the treatment period * plan to relocate out of boston area within the next year * unwillingness and/or inability to swallow 4 pills per day * inability to provide written informed consent * excessive antacid or laxative use within the past 3 months
acanthamoeba and artificial intelligence

Conditions: Acanthamoeba Keratitis; Artificial Intelligence

Summary: acanthamoeba keratitis, caused by the pathogen acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision. this observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models. the data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection. the laboratory tests considered for the division of patients into their respective groups are bacterial examination, pcr examination, and culture examination. patients were divided into two groups, the first comprising patients positive for acanthamoeba infection, while the second comprised patients negative for acanthamoeba but positive for other pathogens. the study will last for 18 months. the cohort under study includes 151 patients from the irccs san raffaele hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for acanthamoeba and 75 in the group of controls positive for other pathogens. the confocal images of this cohort will be fed into artificial intelligence software. to evaluate the model, the test set will be used, and the ai model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model.


Eligibility criteria:
inclusion criteria: * performed corneal scraping and subsequent bacterioscopic exam, pcr and bacterial colture analysis between 2004 and 2023. * patients positivity to corneal infection. exclusion criteria: - patients negativity to aforementioned exams.

Keywords: acanthamoeba keratitis artificial intelligence corneal scraping confocal images acanthamoeba pattern machine learning