Kornimate/medical-research-clean huggingface dataset:
study of stool microbiota in two diverse cohorts of asian and its influence on allergy development

Conditions: Eczema; Asthma; Allergic Rhinitis

Summary: this study aims to document prospectively the incidence of allergies of eczema, asthma and allergic rhinitis in 2 diverse cohorts (singaporean and indonesian) with contrasting lifestyles and socioeconomic development. the profile of microbial colonization in terms of species variety, as well as their genetic diversity will be studied in singapore and indonesia cohorts and to correlate these with clinical allergy.

the main objective of the current study is to establish the relationship of gut microbiota and development of allergy in 2 populations with different socioeconomic status and prevalence of allergy (high in singapore and low in indonesia). a cohort of children will be followed prospectively from birth up to 2 years. stool from different time points, environmental exposure data and clinical manifestations of allergy will be analyzed and recorded. singapore and indonesia will provide the south east asian context in resolving early life influences associated with divergent allergy prevalence. by studying subjects below age two, this will provide valuable knowledge regarding the epidemiology of allergy and atopy in the first years of life, which is poorly documented in this age group. more importantly, the prospective nature and varied parameters included in this study (colony counts, species variety and genetic diversity of microbiota) will add to the global data and scientific evidence for the role of these factors in allergy development.

Eligibility criteria:
inclusion criteria: * pre-delivery evaluation * either parent or sibling (ie first degree relative) has a history of atopy. this will be evidenced by a doctor-diagnosis of asthma, allergic rhinitis or eczema and a positive skin prick test/specific ige test to any of a panel of common allergens. * parents agree to the child's participation in the study and sign the informed consent. * the subject and the parents are willing to comply with procedures and both child and parents are able to keep to scheduled clinic visits. * both parents are at contactable range (with valid mobile or land line numbers) for study team to arrange and schedule clinic visits and complete telephone interviews. post-delivery evaluation * the subject is born full term (at least 37 weeks gestation). * the subject does not have major congenital malformations/major illness as judged by the doctor. * the subject is in otherwise good, stable health on the basis of medical history, physical examination. * family appears to be able to successfully complete this study. exclusion criteria: * the parent is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained. * the parent is unable/ unwilling to comply with procedures.

Keywords: eczema asthma allergic rhinitis singapore indonesia gastrointestinal flora
phase 3 study to evaluate the immunogenicity and safety of inactived split influenza vaccine in healthy korea infants

Conditions: Healthy

Summary: the purpose of this study is to evaluate the safety and immunogenicity of il-yang inactivated split influenza vaccine (il-yang quadrivalent seasonal influenza vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and \< 3 years)

the study is an randomized, double-blind, active controlled phase iii study.

Eligibility criteria:
inclusion criteria: * healthy men or women aged from 6 months to \< 3 years * subjects were born after full term pregnancy (37 weeks) * voluntary written informed consent was obtained from the subject and the subject's legally acceptable representative (consent of legally acceptable representative was required for subjects younger than 10 years of age (and for subjects younger than 7 years of age for the some institutions)). exclusion criteria: * subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components of the study vaccine * subject who had received an influenza vaccine within the last 6 months * subject who has, or has a family history of, an immune system disorder including immune deficiency disease * subject with a history of guillain-barre syndrome * subject with down's syndrome or cytogenetic disorders. * subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial * subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection * subject who had an acute fever with body temperature \> 38.0 cº within 72 hours prior to administration of the study vaccine * subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period. * subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine * subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study. * subject who had participated in another experimental study within 30 days prior to administration of the study vaccine * subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.

Keywords: influenza influenza vaccine split influenza vaccine seasonal influenza vaccine
genetic study of age related hearing loss

Conditions: Age-related Hearing Loss; Presbycusis

Summary: age-related hearing loss, or presbyacusis, is one of the most common chronically handicapped conditions for the elderly. many factors including genetics, diet, diseases, drugs, socioeconomic factors and environmental variables were considered to be related to the development of presbyacusis. evidences have shown that genetic factors play an important role on presbyacusis. however, which genes or their genotypes are associated with presbycusis remain unknown. the aim of this project was to evaluate the association between the genotype of candidate genes and presbyacusis by cross-section and case-control study. in the first stage, the investigators plan to select 700 healthy subjects older than 50 with symmetric, sensorineural hearing loss. the subjects will receive basic otologic examination, pure tone audiometry, questionnaire, and genotype analysis. because gender and age would affect hearing loss significantly, the investigators will convert the hearing level of all subjects into a gender and age independent z-score according to iso 7029 standard. and, the investigators define subjects within higher 30 % of z-score as the presbyacusis group, and subjects within lower 30% of z-score as the control group. finally, the investigators perform chi square analysis to test the association between genotype of candidate genes or their combinations in both groups, and calculate the odds ratio for presbyacusis between different genotype of candidate genes. further more, we will evaluate the effect of genotype of candidate genes, environment factors, and gene-environmental interaction on the severity of presbyacusis by multivariate logistic regression. in the second stage, the investigators wish to know the pattern of genotype and hearing level in the high risk families, according to results from the first stage, by description and case-control study. the investigators will perform t-test to evaluate the difference of z-score in both groups. besides, the investigators try to evaluate the effects of genotypes, environment factors, and gene-environmental interaction on hearing level in high risk families by multivariate logistic regression.


Eligibility criteria:
inclusion criteria: * subjects aged 45 or above, both male and female came to the hospital for health check up exclusion criteria: * known ontological disease age under 45 noise exposure history history of ototoxicity psychiatric diseases

Keywords: age-related hearing loss gene single nucleotide polymorphism environmental factors
the effectiveness of combining ursodeoxycholic acid with vitamin d in treating patients with primary biliary cholangitis

Conditions: Primary Biliary Cholangitis

Summary: the goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin d in treating patients with primary biliary cholangitis.

a prospective analysis will be conducted on 60 patients with primary pbc who were admitted to our infectious diseases department and outpatient clinic. all patients will take udca capsules orally and divide into two groups: the experimental group, which received udca combined with vitamin d(1200 iu per day) treatment, and the control group. the control group will receive udca treatment alone for one year, selected through a random number table method. after one year, the control group will be further divided into two groups using the same method. one group will continue to receive udca alone, while the other will receive a combination of udca and vitamin d for an additional year. clinical data, clinical manifestations, blood tests, and imaging tests will be collected during the initial and subsequent treatments. the efficacy will be evaluated using the paris i and barcelona standards.

Eligibility criteria:
inclusion criteria: 1. the patient must meet the diagnostic criteria for pbc ; 2. the patient must have been diagnosed at the age of 18 or older; 3. the patient must have completed at least 2 years of treatment and have complete and accessible clinical data; 4. the patient must have strictly followed the doctor's prescription during the treatment period and not have interrupted the treatment arbitrarily. exclusion criteria: 1. the study excluded patients with autoimmune hepatitis or primary sclerosing cholangitis. 2. patients with other acute and chronic liver diseases were also excluded. 3. patients with serious cardiopulmonary diseases were excluded as well. 4. pregnant or lactating women were not included in the study. 5. patients who randomly interrupted or adjusted their medication during the treatment period were excluded. 6. patients who lacked follow-up were also excluded.

Keywords: primary biliary cholangitis ursodeoxycholic acid vitamin d
study of the inflammation and airway changes that occur after exposure to allergen in asthmatics

Conditions: Asthma

Summary: this protocol describes a single site mechanistic study to investigate micrornas (mirnas) that are differentially expressed in the airway epithelium of patients with asthma at baseline and in response to allergen challenge. we hypothesize that allergen exposure enhances airway smooth muscle contractility and epithelial cell mrna/mirna production as a consequence of locally increased t-cell derived cytokine production. the study will involve three visits over the course of approximately 14 days. at visit 1, participants will be characterized in detail with lung function testing, methacholine challenge testing, and allergen skin prick testing. at visit 2, participants will undergo bronchoscopy with segmental allergen administration of either cat or dust mite standardized allergen extract. at visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to collect airway samples including bronchoalveolar lavage (bal), epithelial brushings and endobronchial biopsies. sample analysis will include measurement of mirna and mrna expression in epithelial brushings (rnaseq and qpcr); analysis of cell surface markers on bal cells and blood cells; and collection of endobronchial biopsies for immunostaining of immune cells localization, immunoblotting of smooth cell protein phosphorylation, analysis of mucin content and smooth muscle cell subculture. a total of 38 subjects (26 asthmatics with stable or well-controlled asthma, 6 allergic non-asthmatics and 6 non-allergic non-asthmatics) will complete the study.


Eligibility criteria:
allergic/non-asthmatic subjects and allergic/asthmatic subjects inclusion criteria: * positive skin test to dust mite or cat allergen non-allergic/non-asthmatic subjects inclusion criteria: * negative skin test to panel of 12 allergens, including dust mite and cat allergen all groups exclusion criteria: * history of intubation for asthma exacerbation * use of xolair (omalizumab) within the last 6 months * immunotherapy with cat or dust mite extract now or in the past 5 years * ≥ 10 pack-years smoking or any smoking in the past year * other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection * history of dermatographia * history of anaphylaxis to cat allergen * participation in another research study involving a drug or biologic during the past 30 days * presence of past or current medical problems/other factors that may pose additional risks from participation or influence study results, as determined per study investigator

Keywords: asthma allergen challenge
improved effects of mi plus alpha-la in pcos

Conditions: Polycystic Ovary Syndrome

Summary: pcos patients are initially treated with 2 g myo-inositol and 0.2 mg folic acid, two times per day by oral route, for three months. among them, the subjects who have not ovulated despite this treatment are administered with 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. most of them improve and achieve ovulation. therefore, the combination of α-lactalbumin with myo-inositol allows to get a significant result in the treatment of pcos patients.

polycystic ovary syndrome is a complex chronic condition inducing several related disorders, such as subfertility and pregnancy complications. so far myo-inositol, successfully used in pcos, has not been always effective in all patients. aiming at overcoming this drawback, we tested a new formulation with myo-inositol and α-lactalbumin, in consideration of the effects exerted by α-lactalbumin in favoring molecule passage among body compartments, and also in consideration of its anti-inflammatory activity. only pcos patients, according to rotterdam eshre-asrm criteria, with anovulation and infertility \> 1 year, were included in the study. following a treatment with 2 g myo-inositol and 0.2 mg folic acid, a part of them are resistant and do not ovulate. these non-responders to myo-inositol alone undergo the second phase of the study, receiving 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. after this combined treatment, the majority of them ovulate, showing a hormone and lipid profile improvement. in addition, myo-inositol plasma levels at the end of the treatment are significantly higher than at baseline and comparable to those patients who respond positively to myo-inositol alone.

Eligibility criteria:
inclusion criteria: * patients affected by pcos according to rotterdam eshre-asrm criteria, with anovulation and infertility \> 1 year exclusion criteria: * presence of other conditions causing ovulatory dysfunction, such as hyperprolactinemia or hypothyroidism, or androgen excess, such as adrenal hyperplasia or cushing's syndrome, and also in the case of intake of other drugs that can potentially influence the ovulation.

Keywords: myo-inositol alpha-lactalbumin anovulation infertility
analgesia following lumbar discectomy

Conditions: Analgesia; Disk Herniated Lumbar; Local Infiltration

Summary: lumbar discectomy surgeries are often the last option for patients with disc herniation who do not improve with conservative treatments. however, these procedures can lead to significant perioperative pain that may become chronic without effective management. while intravenous opioids are commonly used for pain control, they can complicate recovery and pose risks like dependence. in contrast, regional anesthetic techniques offer advantages such as quicker recovery, better postoperative pain relief, and reduced opioid use, which can lead to shorter hospital stays. our study aims to compare the effectiveness of the retrolaminar block with local wound infiltration for pain management following posterior lumbar discectomy surgeries, potentially improving patient outcomes.

lumbar discectomy surgeries are the last resort for disc herniation patients not responding to conservative treatment. however, these surgeries are associated with annoying perioperative pain that could be severe and progress to chronic pain if not managed properly. there is no consensus regarding the best approach for postoperative pain management following spine surgeries. intravenous opioids are still the primary agents used for perioperative pain control, which can complicate the postoperative recovery with the associated side effects and the risk of opioid dependence. regional anesthetic techniques for spine surgeries allow rapid recovery, prolonged postoperative analgesia, and less opioid consumption, which decreases hospital stays. the current study will compare the analgesic efficacy of the retrolaminar block to the local wound infiltration following posterior lumbar discectomy surgeries.

Eligibility criteria:
inclusion criteria: * elective surgical decompression of single-level herniated lumbar disc. exclusion criteria: * opioid-dependent patients. * known hypersensitivity to bupivacaine. * diabetic patients. * uncooperative patient or with altered mental status. * previous spine surgery.
reduction of metabolic acidosis in patients with chronic kidney disease in stage 4 and 5

Conditions: Kidney Diseases; Metabolic Acidosis; Renal Insufficiency; CKD; Pre-dialysis

Summary: this clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (ckd) patients, ckd stage 4 and 5. the trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for bicarbonate supplements.

observational studies indicate that diets with a low "potential renal acid load (pral)" is associated with a lower serum-bicarbonate value. therefore, we aim to investigate this association through an interventional study design. participants will be asked to follow a restricted diet with a low "pral" during a 6-week trial divided into three periods: two-week of free-living control, two-weeks of intervention, and a two-week free-living follow-up. the pral calculation tool will be used to create a diet low in acid and to develop individualized diet plans for each patient. the diet will comply with danish national guidelines on threshold for potassium and protein, due to the high risk of hyperkalemia in ckd patients. the patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal, over a 24-hour period.

Eligibility criteria:
inclusion criteria: * chronic acidosis (plasma-bicarbonate under 22 mmol/l at multiple measures within the last 12 months). * diagnosed with non-dialysis needed chronic kidney disease in stage 4 and 5 (egfr below 30 ml/min/1,73 m2) * of legal age and over 18 of years * understand danish and understand the written material * able to cooperate about the diet * able to take pictures with their phone or willing to learn exclusion criteria: * vegan and vegetarian with very low intake of animal protein (below 25 g/day) * pregnant or breast feeding * patients with short bowel syndrome, bricker bladder, pancreatitis or any other known malabsorption problem * potassium above 5 mmol/l * ongoing infection

Keywords: potential renal acid load pral study design diet humans elderly bicarbonate/blood muscle strength hand strength chair stand test calorimetry, indirect bone mineralization carbon dioxide/blood phosphor/urine potassium/urine urea/blood urea/urine
acute kidney injury in patients with liver cirrhosis

Conditions: Acute Kidney Injury in Patients With Liver Cirrhosis

Summary: in our locality, limited studies have discussed aki in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at sohag university hospital.

acute kidney injury (aki) is a common condition in patients with cirrhosis. it occurs in up to 50% of hospitalized patients with cirrhosis and in 58% of such patients in the intensive care unit. aki is one of the key predictors for short-term mortality in patients with liver cirrhosis with mortality rates as high as 90%. there is a remarkable increase in length of hospital stay with high financial burden on patients with aki. in general, the three main causes of aki are renal hypoperfusion (also referred to as prerenal aki), which in most cases is due to hypovolemia; intrinsic, structural kidney injury; and postrenal injury due to urinary obstruction. a unique cause of aki due to renal hypoperfusion in patients with cirrhosis is the hepatorenal syndrome (hrs), which is the result of renal vasoconstriction. early identification and management of aki may improve outcomes. in our locality, limited studies have discussed aki in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis.

Eligibility criteria:
inclusion criteria: * cirrhotic patients ( age more than 18 years old ) in sohag university hospital exclusion criteria: * patients with known preexisting chronic kidney disease * patients who had undergone renal transplantation * malignancy * pregnancy