Kornimate/medical-research-clean huggingface dataset:
ai-assisted migraine education: efficacy, safety and patients' acceptance

Conditions: Migraine

Summary: migraine affects 1 in 7 people globally, significantly impacting quality of life and economic productivity. despite its prevalence, limited awareness leads to misdiagnosis, inadequate treatment, and stigmatization. ai can enhance migraine management through improved diagnosis, prediction, and personalized education. the primary objective of this study is to determine if adding ai-assisted migraine education to standard education improves patients' understanding of their condition more effectively.

migraine affecting approximately 1 in 7 individuals globally, significantly impacts quality of life and economic productivity due to its associated healthcare and social burdens. despite its prevalence, awareness and understanding of migraine remain limited, contributing to misdiagnosis, inadequate treatment, and the perpetuation of stigmatization. artificial intelligence (ai) may advance migraine management by improving diagnosis, prediction, and educational outreach. ai applications are currently being employed in diagnosing migraines more accurately by analyzing comprehensive patient data, thus differentiating migraine from other types of headaches. additionally, ai algorithms predict migraine episodes, enabling preemptive measures. they also streamline medication management through reminders and monitor patient adherence, which is crucial for preventing medication overuse and optimizing treatment outcomes. moreover, ai can bridge the educational gap in migraine understanding. by using adaptive learning technologies, ai platforms can deliver personalized educational content, tailored to an individual's knowledge level and learning pace, enhancing understanding and engagement. this approach not only facilitates better management of the condition but also promotes a broader societal awareness essential for destigmatizing migraine. the primary objective of this study is to ascertain if the addition of ai-assisted migraine education to standard migraine education yields a superior improvement in the patients' understanding of their condition.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years at the time of signing the informed consent * newly diagnosis of migraine, confirmed through the medical chart * the participant must be capable of giving signed informed consent * access to a laptop, computer, smartphone, or tablet exclusion criteria: * insufficient knowledge of the protocol language (italian) * patients with cognitive impairment and/or unable to use or access the ai-powered learning platform developed in this study. * vulnerable participants (e.g. minors, participants incapable of judgment or participants under tutelage)
treatment of chronic hepatitis c with peg interferon alfa2a and ribavirin in hiv-infected patients

Conditions: HIV Infections; Hepatitis C, Chronic; Treatment Failure

Summary: combination of peg interferon and ribavirin is the standard treatment of chronic hepatitis c. efficacy of this treatment has never been evaluated in hcv-hiv infected patients, who have previously been treated with a first line anti-hcv treatment. the purpose of the study is to evaluate the combination peg interferon alfa2a-ribavirin in hiv-infected patients with chronic hepatitis c pretreated with interferon alone or interferon combined with ribavirin. the patients receive a dose of 180 µg of pegasys once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. primary outcome of the study is a sustained virological response, defined as an undetectable hcv rna level 24 weeks after the end of anti-hcv treatment.


Eligibility criteria:
inclusion criteria: * chronic hepatitis c : detectable hcv rna, previously treated with interferon or interferon combined with ribavirin, elevated alt level * hiv infection (cd4\>250/µl, hiv rna\<10 000 copies/ml) treated or not with antiretroviral therapy * signed informed consent exclusion criteria: * chronic hepatitis b * alcohol consumption\>40g/day * evidence of decompensated liver disease * hepatocellular carcinoma * other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease

Keywords: hepatitis c, chronic hcv infection hiv infection treatment failure peg interferon interferons/therapeutic use interferon alfa-2a/adverse effects ribavirin/therapeutic use ribavirin/adverse effects drug therapy, combination treatment experienced treatment naive
conditioned pain modulation using painful cutaneous electrical stimulation or simply habituation?

Conditions: Habituation

Summary: painful cutaneous electrical stimulation (pces) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (cpm). however, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. we compared the effects of cpm and habituation on pces-induced pain and pces-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * any kind of disease

Keywords: painful cutaneous electrical stimulation conditioned pain modulation
comparison of chs-0214 to enbrel (etanercept) in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this is a two part study comparing chs-0214 to enbrel in patients with active rheumatoid arthritis and an inadequate response with methotrexate (mtx) who are naive to biologic therapies. pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. the primary end point is 20% improvement in american college of rheumatology criteria (acr-20) at week 24. comparing chs-0214 to enbrel for efficacy and safety. pt. 2 is an open-label single arm study in which patients with at least an acr-20 response receive chs-0214. continued response and safety will be evaluated.


Eligibility criteria:
inclusion criteria: * male or female adults * ra (rheumatoid arthritis) diagnosis for 6 months * on stable dose of mtx of 8mg to 25mg per week * active disease: greater than 6 tender joints, greater than 6 swollen joints, c-reactive protein (crp) greater than or equal to 0.5mg/dl, and disease activity score (das) with 28 joints (das28-crp(4)) greater than or equal to 3.2 exclusion criteria: * use of prednisone greater than 10mg/day * use of greater than one non-steroidal anti-inflammatory drug (nsaid) * use of biologic therapies for any cause * chemistry and hematology values outside protocol specified range * positive quantiferon-tuberculosis (tb) gold test * evidence of active lung disease on chest x-ray * major systemic infections * presence of significant comorbid conditions * known allergy to latex * women who are pregnant or nursing

Keywords: chs-0214 enbrel ra biosimilar etanercept
covid-19 effects on arterial stiffness and vascular aging (cartesian)

Conditions: Covid19; Arterial Stiffness; Endothelial Dysfunction; Diastolic Dysfunction

Summary: the purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after covid-19 infection.

after being informed about the study and potential risks, all eligible patients giving written informed consent will undergo a comprehensive non-invasive assessment of vascular and cardiac function 6 months and 12 months after covid-19 infection. cardiovascular events and mortality will be collected 2, 5 and 10 years after inclusion

Eligibility criteria:
inclusion criteria: * age \>18 years, both sexes; * written informed consent; * affiliation to a social security regime; * a recent diagnosis of covid19 (6±3 months) proven by pcr or serology (for group 1,2,3) * hospitalization in intensive care unit for covid19 (for group 1) * hospitalization in a medicine unit for covid19 (for group 2) * no hospitalization for covid19 or hospitalization less than 24h (for group 3) * a negative test for sars-ncov2 infection (pcr or serology)(for group 4) exclusion criteria: * age \<18 years * inability to express consent of the study * diseases carrying out a life -expectancy \<1 year according to clinical judgment * pregnancy and breastfeeding * foreseen inability to attend scheduled visits
evaluating qtc, pk, safety of gemtuzumab ozogamicin (go) in patients with cd33+ r/r aml

Conditions: ECG; Pharmacokinetics; Safety

Summary: this is a single-arm, open-label, phase 4 study evaluating the effect of go on the qtc, pharmacokinetics, safety, and immunogenicity of go as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory cd33-positive aml.

this is a single-arm, open-label, phase 4 study evaluating the effect of go on the qtc, pharmacokinetics, safety, and immunogenicity of go as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory cd33-positive aml. approximately 50 adult (age \>=18 years) and 6 pediatric (12 years =\ =1,000/µl, and platelets \>=50,000/µl, except in patients with the bone marrow blasts \>=5%, the decrease in neutrophils and platelets thought to be due to the underlying leukemia. after go treatment, subsequent anticancer therapy such as consolidation or conditioning regimen and/or hsct could be considered at the investigator's discretion. a minimum interval of 2 months is recommended between the last dose of go and hsct.

Eligibility criteria:
inclusion criteria * refractory or relapsed (ie, bone marrow blasts \>5%) cd33-positive aml. * age \>=12 years. * eastern cooperative oncology group (ecog) performance status 0 to 2. * initial peripheral white blood cells (wbc) counts \>=30,000/ml; patients with a higher wbc count should undergo cytoreduction. * adequate renal/hepatic functions exclusion criteria * patients with prior treatment with gemtuzumab ozogamicin (go). * patients with prior history of vod/sos. * prior hsct is not allowed, if it was conducted within 2 months prior to study enrollment. * patients with known active central nervous system (cns) leukemia. * uncontrolled or active infectious status. * uncontrolled cardiac dysrhythmias of nci ctcae grade 2, uncontrolled atrial fibrillation of any grade. * sero-positivity to human immunodeficieny virus (hiv). * active hepatitis b or hepatitis c infection * chemotherapy, radiotherapy, or other anti-cancer therapy (except hydroxyurea as cytoreduction) within 2 weeks prior to enrollment in the study. * major surgery within 4 weeks prior to enrollment. * qtc interval \>470 milliseconds (msec) using the fridericia (qtcf), family or personal history of long or short qt syndrome, brugada syndrome or known history of qtc prolongation, or torsade de pointes (tdp). * the use of medications known to predispose to torsades de pointes within 2 weeks prior to enrollment * history of allergic reactions attributed to compounds of similar chemical or biologic composition to gemtuzumab ozogamicin (go).

Keywords: gemtuzumab ozogamicin mylotarg qt interval prolongation pharmacokinetics safety veno-occlusive disease anti-drug antibody
trigona honey and intestinal microbiota among obese people

Conditions: Obesity

Summary: objective : nutrition intervention is one of the approaches to deal with obesity. natural honey with its polyphenol component has an impact on the intestinal microbiota and lipid profile. intestinal microbiota such as lactobacillus and bifidobacteria produce exopolysaccharide which plays important roles against obesity. this research aims to assess the effect of trigona biroi honey on body mass index, lipid profile, and microbiota profile design a quasi-experimental study involving two arms (trigona honey) and control will be conducted. the outcome of interests are body mass index, lipid profile, and microbiota profile hypothesis using superiority trial, trigona honey will 1. improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium) 2. improving lipid profile 3. lowering body mass index

target population : this study will recruit healthy participants with a body mass index of more than 27 allocation : non-random with propensity score matching arms 1. trigona honey (intervention) composition : vitamin c 0.15%, protein 1.32%, lipid 0.23%, carbohydrate 64.12%, beta carotene 10.61 ppm, calcium 273,23, magnesium 338.94, zinc 12.49 ppm, and acidity 5.76. total polyphenol 133.52 ppm, total flavonoid 159.62 ppm. this liquid has a sour profile 2. active comparator commercial honey with fructose, glucose, pure honey (2,271%), citric acid, and lime extract (0,076%). intervention 8 weeks, once daily. this also applied to the control group outcome : 1. microbiota detected using polymerase chain reaction (pcr) 1. sample: stool 2. extraction with 70% ethanol primary pcr 3. primer (lactobacillus and bifidobacteria) 2. lipid profile using blood plasma and homogenous assay high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol 3. anthropometry body mass index, body composition (fat percentage), waist circumference sample size was calculated using the difference of hdl between groups with the following parameters : effect size =0.3 type 1 error = 5% power of study = 80% dropout = 20% total participant 336 analysis intention to treat will be applied. the descriptive statistic will be used to describe the baseline characteristic of participants. the bivariate analysis will be conducted to see the association of demographic factors to the outcome. if the matching of the participant yields a similar baseline characteristic, the difference of mean between the two groups will be analyzed using an independent t-test. otherwise, linear mixed model will be applied

Eligibility criteria:
inclusion criteria: 1. defined as obese with a body mass index of more than 27 2. not having a gastrointestinal disease 3. not allergic to the honey component exclusion criteria: 1. consuming probiotics for a minimum of one month 2. consuming antibiotics for a minimum of one month

Keywords: obesity trigona honey lipid profile microbiota anthropometry
fx-322 in sensorineural hearing loss

Conditions: Sensorineural Hearing Loss

Summary: this is a phase 1/2 study of fx-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

sensorineural hearing loss (snhl) accounts for about 90% of all cases of hearing loss. the study will assess the safety of fx-322 (laduviglusib and sodium valproate) given as a single intratympanic injection in subjects with a medical history of sensorineural hearing loss that is associated with noise exposure or sudden hearing loss. safety will be evaluated both systemically (lab and clinical monitoring) and locally (otoscopy and audiometry) in 24 subjects, and a blood pk profile of fx-322 will also be determined.

Eligibility criteria:
inclusion criteria: 1. adult aged 18-65 years. 2. established diagnosis of stable sensorineural hearing loss (no changes of 10 db or more at any frequency) by standard audiometric measures for \>6 months. 3. documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to screening required). 4. female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception or an intrauterine device and condoms) or remain abstinent. male subjects should use condoms with spermicide during the course of the study or remain abstinent. subjects should not donate sperm or ova during the study period. exclusion criteria: 1. perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in either ear. this includes a current tympanostomy tubes. 2. any conductive hearing loss of 10 db or more at two or more frequencies in either ear. 3. a pure tone average of 70 db or greater at 500hz, 1000hz, 2000hz, and 4000hz in the ear to be injected. 4. active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected. 5. subject has had an intratympanic injection in either ear within 6 months of the screening visit. 6. history of clinically significant vestibular symptoms at the discretion of the investigator. 7. history of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, sjogren's syndrome, multiple sclerosis, psoriasis). 8. history of head or neck radiation treatment or exposure. 9. history of substance abuse within 2 years of the screening visit. 10. positive urine pregnancy test or breast-feeding. 11. any known factor, condition or disease that, in the view of the investigator, might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease or suicidal tendencies.

Keywords: intratympanic administration hearing restoration
the effect of melatonin as an adjuvant therapy for preterm neonates with sepsis

Conditions: Sepsis Newborn

Summary: the goal of this clinical trial is to assess the effect of melatonin on mda serum, il-6, il-8 levels, anc, and sepsis score in preterm neonates with sepsis. the main question aim to answer : • does melatonin affect mda serum, il-6, il-8 levels, anc, and sepsis score in preterm neonates with sepsis? the participants in the treatment group will receive a single dose of oral melatonin 20 mg, meanwhile those the control group will receive placebo. the researchers will compare mda serum, il-6, il-8 levels, anc, and sepsis score before and after receiving melatonin, whether there are decreases of mda serum, il-6, il-8 levels, anc and increase of sepsis score


Eligibility criteria:
inclusion criteria: * newborns with gestational age of 28-36+6 weeks, birth weight according to gestational age, and diagnosis of sepsis based on hps and prs sepsis score criteria exclusion criteria: * major congenital anomalies of the gastrointestinal tract. * continuous vomiting. * newborns with hypoxic ischemic encephalopathy (hie), intracranial hemorrhage, feeding intolerance, necrotizing enterocolitis (nec) and hormonal disorders. * septic shock.

Keywords: melatonin sepsis preterm neonates
dose-dependent fodmap reintroduction in ibs

Conditions: Irritable Bowel Syndrome

Summary: the aim of this study is to evaluate whether symptom recurrence, after successful fodmap elimination, is dose-dependent in patients with ibs. the effect of a blinded reintroduction of fodmap powders fructans and mannitol will be investigated in a crossover dose-escalation scheme for the identification of the eliciting dose in individual patients. the reintroduction of fodmaps is performed after a successful elimination by the lfd.


Eligibility criteria:
inclusion criteria: 1. voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some iuds, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the trial treatment(s)) or commitment to a vasectomised partner. 3. patients with irritable bowel syndrome according to rome iv diagnostic criteria 4. patients ages between 18 and 70 years old exclusion criteria: 1. participant has a history of any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years 1. any disorder, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol 2. any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the trial 3. female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 4. participation in an interventional trial with an investigational medicinal product (imp) or device 5. patients presenting with predominant symptoms of functional dyspepsia (fd) and of gastro-oesophageal reflux disease (gerd) 6. patients following a diet interfering with the study diet in opinion of the investigator 7. patients who already followed the low fodmap diet under guidance of a trained dietitian without success.

Keywords: fodmap reintroduction fructans mannitol
orchidopexy randomized clinical assessment

Conditions: Unilateral Cryptorchidism

Summary: this is a randomized trial designed to evaluate testicular outcomes after a single stage versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in the abdomen. also to determine and compare the costs, surgical complications and the health related quality of life for the two procedures. testicular outcomes will be measured using a scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for those randomized to a 2 stage surgery).


Eligibility criteria:
inclusion criteria: * boys age 4 months to 36 months * undergoing diagnostic laparoscopy for unilateral non-palpable testis, who are found at laparoscopy to have an abdominal undescended testis, in whom a fowler-stephens orchiopexy would be appropriate. exclusion criteria: * age \> 36 months * age \< 4 months * bilateral cryptorchidism * solitary testis * findings at laparoscopy for which fowler-stephens orchiopexy would not be indicated * intra-operative mobility of the intra-abdominal testis such that, with no (or minimal) mobilization, the testis is able to reach the contralateral internal ring, without dividing the spermatic vessels. * assessment of whether a single stage primary orchidopexy will be performed, is entirely at the discretion of the attending surgeon.

Keywords: laparoscopic surgery orchiopexy