Kornimate/medical-research-clean huggingface dataset:
renal acute mi study

Conditions: Myocardial Infarction; Kidney Function

Summary: the purpose of this study is to determine if a sizable myocardial infarction (heart attack) results in negative changes to renal structure and function (i.e. has a negative impact on the kidneys). to determine if the renal response to a myocardial infarction is a predictor of the patients future health.

chronic heart and kidney disease are increasingly common in western society. both conditions are associated with frequent hospitalisation and increased mortality. furthermore, there are mechanistic reasons why one condition may beget the other; the so-called "cardiorenal syndrome". the investigators therefore wish to determine if a sizable myocardial infarction (heart attack) results in negative changes to renal structure and function (i.e. has a negative impact on the kidneys). the investigators also wish to determine if the renal response to a myocardial infarction is a predictor of the patients future health. to do this the investigators will measure markers of kidney function at the time of the heart attach, at discharge, 1 month, 6 months and 12 months and correlate this with the patients clinical condition.

Eligibility criteria:
inclusion criteria: age \> 18 years have provided written informed consent group 1: * non-q wave mi patients * normal cardiac and renal function * no use of contrast * egfr \> 60ml/min group 2: * patients undergoing coronary angiography +/- pci for stable cad or non-q wave mi * normal cardiac and renal function * egfr \> 60ml/min group 3: * acute stemi full thickness infarct (stemi) * egfr ≥ 60ml/min group 4: * acute stemi full thickness infarct (stemi) * egfr \< 60ml/min exclusion criteria: * unable or unwilling to comply with the study protocol * underlying medical condition which, in the opinion of the investigator, will effect the safely or efficacy of the study

Keywords: myocardial infarction (mi) kidney function bio-markers
evaluation of safety, growth, tolerance and effects on the intestinal fora of a new milk for healthy infants

Conditions: Growth

Summary: the purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.

this prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic, in term infants. term infants with a gestational age ranging from 37 to 42 weeks and whose parents chose formula feeding were enrolled during their first eight days of life. both parents provided informed written consent. infants were randomly assigned to receive either the new test formula or a control, a regular formula adapted for term infants (modilac®1). the control formula is formulated to meet the nutritional needs of infants. for each neonates, neonatal parameters were collected. 5 visits took place : v1 (inclusion), v2 (randomization), v3 (1 month), v4 (3 months) and v5 (6 months). during each visit, the investigator filled in observational book the anthropometric parameters (weight, height, head circumference, bmi) and pieces of information collected 3 days before by the parents (gastrointestinal tolerance parameters, daily infant behaviour and milk consumption). global parents' contentment was evaluated as well. in two investigation centers, at the end of the 6th month, immuno-allergic test was realised. stools were collected at the end of the first and sixth month from diapers, for microbiological analysis and measurements of faecal inflammatory markers.

Eligibility criteria:
inclusion criteria: * term health newborn infant with gestational age ranging from 37 to 42 weeks * eutrophic * non breastfed children * apgar score \> 5 to 7 minutes exclusion criteria: * infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study * evidence of protein cow milk allergy * infant presenting lactose intolerance * newborn whose parents did not provide informed consent * newborn currently participating in another trial

Keywords: infant formula alpha-lactalbumin symbiotic allergy gastrointestinal tolerance bacterial colonization faecal iga analysis
clinical trial of erlotinib and pemetrexed for maintenance treatment in lung adenocarcinoma

Conditions: Lung Adenocarcinoma

Summary: the purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance therapy for lung adenocarcinoma. primary outcome is the progression free survival (pfs). based on prediction of different potential benefit groups, this study may help the oncologist to optimize and improve the maintenance therapy plan for lung adenocarcinoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosed stage iii/iv lung adenocarcinoma; * age of 18-75years; gender not required; * received systemic clinical examination, including chest x-ray, abdomen b ultrasound, head ct scan, radionuclide bone scan; * received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is sd or above sd (efficacy evaluation time is 21 days, if it is sd, then the longest diameter of target lesions shall not increase); * adequate hematologic, renal, and hepatic function, specific index as follows: liver function: s-bilirubin ≤1.5 uln ; transaminase≤2 uln. renal function: s-creatinine ≤1.2 uln; blood urea nitrogen ≤1.2 uln . uln: upper normal limit. marrow hemopoietic function: wbc≥4.0×10\^9/l, anc≥2.0×10\^9/l platelet count ≥100×10\^9/l, hb≥100 g/l; * ecog ps 0-2,life expectancy ≥ 3 months; endure more than two cycle chemotherapy; * the patients have explicit lung tumor lesions and the lesions were measurable; (according to the standard of recist1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral ct, mri); * no history of serious drug allergy; * informed consent should be obtained before treatment. exclusion criteria: * not histologically or cytologically diagnosed as lung adenocarcinoma * the age of \>75 years or \<18 years. * major organ dysfunction and serious heart disease (congestive heart-failure, incontrollable high-risk arrhythmia, unstable angina, alular disease, myocardial infarct and resistant hypertension,); * serious complications and investigator consider it is unsuited enrolling; * pregnant or lactating women; * allergic to research drug; * received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is pd

Keywords: erlotinib pemetrexed maintenance therapy
endoscopic hand suturing in the prevention of gastrointestinal bleeding after gastric endoscopic submucosal dissection.

Conditions: Endoscopic Surgical Procedures

Summary: endoscopic hand-suturing (ehs) is a significant improvement in gastrointestinal advanced endoscopic procedures. evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. this study aims to demonstrate the feasibility of ehs following advanced endoscopic submucosal dissection (esd) in the stomach and investigate its potential to prevent gastrointestinal bleeding.

endoscopic hand-suturing (ehs) is a significant improvement in gastrointestinal advanced endoscopic procedures. evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. this study aims to demonstrate the feasibility of ehs following advanced endoscopic submucosal dissection (esd) in the stomach and investigate its potential to prevent gastrointestinal bleeding. the retrospective single-center study included individuals who underwent endoscopic submucosal dissection in the stomach. the resection site was either left open, clipped, or sutured. the study evaluated the overall procedure time (opt), bleeding rate (br), perforation rate, and length of hospital stay (hs). the assessment was conducted to compare the outcomes of "non-sutured vs. sutured" "no closure vs. closure" and "clipped vs. sutured" along with the propensity score matching analysis for reducing a potential selection bias.

Eligibility criteria:
inclusion criteria: * underwent gastric esd from june 2015 to june 2024 * eastern cooperative oncology group performance status score of 0 or 1 exclusion criteria: * none

Keywords: endoscopic hand suturing suturing techniques endoscopic submucosal dissection gastrointestinal bleeding endoscopic closure techniques
quality of life and psychosocial factors associated with severe psoriasis following treatment with adalimumab

Conditions: Psoriasis

Summary: the impact of psoriasis on an individual's emotional and social well-being goes beyond skin symptoms of the disease. data suggests patients with severe psoriasis experience a greater prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation. given the nature of the disease and the treatment failures which are required before a patient commences a biologic therapy such as adalimumab, the patient's mental health at initiation of biologics is an important consideration for clinicians. this study seeks to explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial factors and disease-related quality of life.

this was a multi-center, prospective, post-marketing observational study of participants with severe chronic plaque psoriasis who began adalimumab therapy in the united kingdom. although 153 participants enrolled in the study, data was only analyzed on 143 individuals and there were no interventions or changes to participant management for the study. prior to initiating adalimumab therapy (baseline), the dermatology life quality index (dlqi), self-administered psoriasis area severity index (sapasi), hospital anxiety and depression scale (hads), cutaneous body image (cbi) scale, short form 12 (sf-12) health survey, female sexual function index (fsfi) (female participants) and international index of erectile function (iief) (male participants) questionnaires were completed by participants and at 4 weeks, 16 weeks and 6 months following initiation.

Eligibility criteria:
inclusion criteria: * participants were eligible for adalimumab as determined by the national institute for health and clinical excellence (nice) criteria * participants had severe psoriasis as defined by a psoriasis area severity index (pasi) of 10 or more and a dermatology life quality index (dlqi) of more than 10 * participant's psoriasis did not respond to standard systemic therapies, to include: ciclosporin, methotrexate, and psoralen and long-wave ultraviolet radiation; or the participant was intolerant of or had a contraindication to these treatments exclusion criteria: * participants were previously treated with another biologic therapy * participants were unable or unwilling to complete the study questionnaires

Keywords: quality of life psychosocial factors
simulating psychotherapeutic sessions with generative artificial intelligence

Conditions: Mental Disorder

Summary: the study assesses the potential of using computational models, specifically large language models, to simulate psychotherapeutic sessions, aiming to improve therapy outcomes and advance therapist training through innovative technology.

health research has evolved significantly, increasingly incorporating computational models that improve our understanding and effectiveness of medical interventions. this shift from traditional to computational methods represents a major advancement in medical research, offering a more sustainable and innovative approach for conceptual advances and therapeutic discovery. in silico models, based on scientific simulation, use computational algorithms to mimic real-world systems or processes. this virtual environment allows researchers to explore phenomena impractical, unethical, dangerous, expensive, or impossible to study otherwise. psychotherapy is widely acknowledged as a primary treatment for a variety of mental health conditions, from depression and anxiety to personality disorders, offering significant pathways to recovery and improved quality of life. yet current methods have shown limited effectiveness, prompting a need for innovative research approaches. in silico psychotherapy research leverages computational simulations, large language models (llms), and generative artificial intelligence to explore and refine psychotherapeutic interventions. by simulating human-like conversations, this approach provides insights into therapy dynamics and holds promise for revolutionizing therapist training and expanding treatment techniques. this study aims to establish a proof-of-concept for simulating psychotherapeutic sessions using llms, focusing specifically on motivational interviewing. it involves the simulation of 512 psychotherapy sessions using llms as well as 8 real-world psychotherapy transcripts. by modeling human interactions, the study seeks to enhance healthcare delivery, therapist training, and personalized psychotherapy.

Eligibility criteria:
inclusion criteria: * simulation of psychotherapy sessions of conversations between an adult person presenting with a mental or behavioral health problem and a psychotherapist using large language models and 8 real-world transcripts exclusion criteria: * simulation protocols with severe simulation errors

Keywords: in silico psychotherapy artificial intelligence (ai) applications motivational interviewing
effect of cyclosporine a versus tacrolimus on response to antiviral therapy after hepatitis c genotype -4 recurrence post liver transplantation

Conditions: Liver Transplantation

Summary: background and aim: the immunosuppression influence on the response to antiviral therapy (avt) for recurrent hepatitis c virus (hcv) infection in liver transplant (lt) recipients remains controversial, especially for the rarely investigated genotype 4.this study aims to compare the effects of the two widely used calcineurin inhibitors(cnis)(cyclosporine a (csa) and tacrolimus (tac)) on the therapeutic response to different avt regimens. method: in126 living donor liver transplant (ldlt) recipients with recurrent hcv infection, participants were categorized to three groups according to avt. group one received pegylated interferon (peg ifn-α 2a) and ribavirin (rbv) (n= 44), group two received the direct antiviral agent (daa) sofosbuvir plus rbv (n=52) and group three received daclatasvir, sofosbuvir (other daas) plus rbv(n=30) each group was further subdivided according to primary immunosuppression (csa or tac). the sustained virological response (svr) and relapse rates were considered the primary therapeutic outcomes of avt. the virological response guided therapy end points for avt were considered the secondary outcomes.


Eligibility criteria:
inclusion criteria:group(i):participants received peg ifn-α 2a and rbv therapy who fulfilled the following inclusion criteria: * age between 18 and 65 years ; * elevated aminotransferase levels (alt and ast) * detectable hcv rna by polymerase chain reaction (pcr) * liver biopsy results consistent with hcv recurrence using the metavir scoring system (metavir ≥a1f1) * for group ii and iii: * age between 18 and 75 years * detectable hcv rna by pcr exclusion criteria:group i * if they were younger than 18 years or older than 65 years or had one of the following criteria * alcoholic * poorly controlled autoimmune disease * significant cardiac disease * suicidal ideation * a history of suicide attempt * major psychosis * serum creatinine ˃3 mg/dl * thyroid dysfunction * combined kidney-liver transplantation * were currently pregnant or planning pregnancy. group ii and iii: * younger than 18 years or older than 75 years * total bilirubin (t.bil) \>3 mg/dl * serum albumin\< 2.8 mg/dl * international normalized ratio ≥1.7 * platelet count \< 5000/mm3 * hcc, except 4 weeks after intervention with no evidence of activity using computed tomography or magnetic resonance imaging * extra hepatic malignancy except after two years of disease free-interval * uncontrolled diabetes evidenced by glycated haemoglobin \>9% * were pregnant .
reducing chronic kidney disease burden in an underserved population

Conditions: CKD; ESRD

Summary: to evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of ckd progression to esrd that could be implemented in other high risk communities and health care systems. this novel study will evaluate the feasibility and preliminary efficacy of providing f\&v to individuals identified at high risk study for ckd and esrd through community health screenings. further, it will evaluate whether providing education as to how to prepare f\&v for consumption, the latter being done for all f\&v recipients in pi's preliminary published studies but its efficacy was not specifically tested, increases f\&v intake and thereby reduces ckd progression risk as well as related clinical outcomes.

"fruits and veggies for health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and f\&v intervention to improve ckd outcomes in 140 aa adults (greater than 18 years). participants will be randomized to a 1) f\&v only (f\&v only), or 2) f\&v plus a nutrition/cooking program (f\&v + cook).

Eligibility criteria:
inclusion criteria: * willingness to participate in 6 month f\&v study * positive urine dipstick. * african american (self declared) race * access to internet via personal computer or mobile device * ability to read and write in english exclusion criteria: * negative urine dipstick * currently receiving dialysis or needing dialysis (stage 5 kidney disease) * have received or need kidney transplant * pregnant or plan to become pregnant in the next 6 months * baseline urine potassium \> 60 meq/g creatinine * nephrotic proteinuria demonstrated on urine acr measurement * lacking access to the internet via personal computer or mobile device * unable to read or write in english

Keywords: ckd low income diet fruits and vegetables
the safety and tolerability of alpha-1 modified process (mp) in subjects with alpha-1-antitrypsin (aat) deficiency

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the purpose of this clinical study is to assess the safety and tolerability of alpha-1 mp in adult alpha1-antitrypsin deficient patients.

the objective of this clinical trial (stamp: safety and tolerability of alpha-1 modified process) is to study the safety and tolerability of alpha-1 mp in adult alpha 1-antitrypsin deficient subjects as reported over 20 weeks of therapy. the primary objective is to describe the nature and frequency of treatment-emergent adverse events with "treatment-emergent" defined as any adverse event occurring after the start of the first study drug infusion.

Eligibility criteria:
inclusion criteria: * documented diagnosis of congenital alpha1-antitrypsin deficiency * documented forced expiratory volume in 1 second (fev1 ) between 20% - 80% of predicted value within last 6 months. * signed written informed consent prior to initiation of any study related procedures. exclusion criteria: * females who are pregnant, breast feeding, or if of child-bearing potential, unwilling to practice adequate contraception throughout the study * use of systemic steroids within the 2 weeks prior to receiving study treatment (this does not include the use of inhaled steroids used on a routine or as needed basis). * subjects who have had exacerbations of their disease within one month of trial entry

Keywords: alpha 1-antitrypsin deficiency alpha 1-antitrypsin pulmonary emphysema
a research study on how nnc0638-0355, a new medicine, works in people living with overweight or obesity

Conditions: Obesity; Overweight

Summary: the study is testing a new study medicine to treat people living with overweight or obesity. the aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. which treatment the participants get is decided by chance. the study medicine is a potential new medicine which cannot be prescribed by doctors.


Eligibility criteria:
key inclusion criteria * male or female. * age 18-55 years (both inclusive) at the time of signing the informed consent. * bmi between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator. * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. key exclusion criteria * known or suspected hypersensitivity to study intervention(s) or related products. * any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * hba1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening. * any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: 1. vitamin d (25-hydroxycholecalciferol) less than 12 ng/ml (30 nm) at screening 2. parathyroid hormone (pth) outside normal range at screening 3. total calcium outside normal range at screening
to assess neuroinflammation and neurocognitive function in patients with acute hepatitis c and chronic hiv co-infection

Conditions: Acute Hepatitis C; HIV; HIV Infections

Summary: this study plans to evaluate what happens to the brain in patients with hiv and early hepatitis c. the investigators will be comparing 3 groups of individuals: * group 1: individuals with hiv infection and acute (early) hepatitis c infection * group 2: individuals with hiv infection * group 3: healthy volunteers

subtle changes to the brain, which doctors find difficult to detect through conversation or examination, may occur in patients with hiv and/or hepatitis c infection. it is not currently known whether the brain is affected in early (or acute) hepatitis c. individuals wishing to take part will complete a series of tests assessing different aspects of their brain including: * 2 brain scans using different technology: * magnetic resonance imaging (mri) brain scan with spectroscopy * ct pet brain scan * a computer game test which measures brain function * 2 short questionnaires results of these tests will be analyzed and compared between 3 groups.

Eligibility criteria:
inclusion criteria: 1. hiv-1 antibody positive for at least 12 months 2. acute hcv (blood hcv pcr positive with negative pcr within past 8 months) 3. hcv genotype 1 4. ability to give informed consent 5. aged \> 25 years 6. male 7. abbreviated mental test score of at least 8/10 exclusion criteria: 1. evidence of established cirrhosis or encephalopathy 2. commencing or any change to hiv medications within 12 weeks 3. active opportunistic infection 4. taking anti-depressants or any psychoactive medications within past 4 weeks 5. use of benzodiazepines within past 4 weeks 6. recent significant head injury 7. established dementia 8. alcohol dependence or recreational drug misuse 9. untreated early syphilis 10. hepatitis b infection (hbsag positive) 11. pregnancy 12. unable to give informed consent 13. any contraindication to mr scanning

Keywords: acute hepatitis c hiv neurocognitive function neuroinflammation