Kornimate/medical-research-clean huggingface dataset:
measuring outcomes of maternal covid-19-related prenatal exposure

Conditions: Prenatal Stress

Summary: the rapidly spreading coronavirus covid-19 pandemic is a major concern worldwide and italy is at the forefront of this emergency. at the present moment, the effects on the offspring of covid-19 disease in pregnant women and/or the indirect effect of covid-19-related prenatal maternal stress are poorly understood. epigenetic mechanisms - and especially dna methylation - are involved in the embedding of prenatal exposures to large-scale disasters into the epigenome and phenotypic outcomes of the offspring. specific target genes include slc6a4, nr3c1, oxtr, bdnf, and fkbp5. the central hypothesis of this project is that the exposure to the covid-19-related prenatal maternal stress may affect infants' outcomes from birth to 12 months partially through increased methylation of target genes involved in stress regulation. the main goal is to investigate the association between covid-19 disease in pregnancy or covid-19-related pms in women pregnant during the first 9 months of the year 2020 and the emotional, social, and cognitive developmental outcomes in their infants from birth to 12 months. additionally, the role of target genes methylation in mediating this association will be investigated. mothers and their infants will be enrolled from the delivery units of eleven neonatal facilities located in northern italy's covid-19 contagion hotspot. one group will be enrolled from april to october 2020 (covid-exposure pregnancy, cep), a second group will be enrolled from april to october 2021 (non-exposure pregnancy, nep). moreover, the cep group will include mothers positive or exposed to covid-19-related mps during different trimesters of pregnancy, allowing within-group comparisons on developmentally sensitive time windows. within 48 hours from baby delivery, saliva samples will be obtained from cep and nep newborns, immediately stored at -20°c and analyzed for epigenetic analyses using next-generation sequencing. at 3 and 6 months, mothers will be asked to fill-in validated and reliable questionnaires on the emotional and social-behavioral development of their infants. at 12 months, infants' stress regulation and maternal sensitivity will be evaluated through video recording of mother-infant interactions. this study will provide unprecedented relevant insights on the biochemical mechanisms underlying the impact of covid-19 disease and the related pms on human offspring's developmental outcomes.


Eligibility criteria:
inclusion criteria: * italian nationality or full mastery of italian language to access on-line questionnaires without support * no prenatal pathologies or perinatal risks * maternal age higher than 18 years * newborns' gestational age equal or higher than 37 weeks exclusion criteria: * single-parent mothers * medically assisted conception * infants' genetic or metabolic comorbidities * perinatal injuries or sensorial deficits

Keywords: covid-19 epigenetics prenatal stress stress regulation maternal sensitivity pandemics serotonin transporter glucocorticoid receptor oxytocin receptor brain-derived neutropic factor
the quebec family study (qfs): role of genetic factors in obesity and its related risk factors and diseases

Conditions: Obesity; Physical Fitness

Summary: the quebec family study (qfs) is an observational study that was planned to investigate the role of genetic factors in physical fitness, body composition, risk factors for common disease and health-related behaviour.

the quebec family study was an observational study with three cycles of data collection between 1978 and 1992. during the first cycle of data collection (phase 1: 1978-1982), a total of 1,650 subjects from 375 families were recruited. during the second cycle (phase 2: 1989-1997), 385 subjects from 105 phase 1 families were retested and an additional 372 subject from 74 families were recruited. during the third cycle (phase 3: 1998-2002), 204 subjects from phase 1 were tested a third time, 113 subjects from phase 2 were tested a second time and 194 new subjects from 44 families were recruited.

Eligibility criteria:
inclusion criteria: * age over 10 years exclusion criteria: * not applicable
sonoelastography of median nerve in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to assess the role of ultrasonography and se in detecting the median nerve changes before progression to cts in patients with ra.

rheumatoid arthritis (ra) presents with persistent pain, stiffness, progressive joint destruction, functional disability, and progressive morbidity and mortality, and is a chronic systemic autoimmune disease.1 the cause of ra remains unknown, but the pathological mechanism of synovial inflammation may result due to the complex interplay of genetic immunology and environmental factors.2 early diagnosis is fundamental to prevent the permanent sequel of ra. recent advances in diagnostic imaging in rheumatology have benefited patients clinically and also provided information related to the pathophysiology of diseases like arthritis. ultrasound (us) and magnetic resonance imaging were most commonly used in diagnosing and monitoring ra progression in joints and related joint structures.3 us elastography measures tissue elasticity using high-frequency sound waves to assess tissue's static or dynamic deformation behavior after a stimulus is applied. this technique has been described most commonly in the context of isotropic tissues, such as the liver and neoplastic diseases, but is now becoming of more interest in anisotropic tissues, such as those in the musculoskeletal system.4

Eligibility criteria:
inclusion criteria: * all patients diagnosed with ra and ruling out cts by clinical evaluation that included phalen's test, a manual muscle test of the abductor's muscle, and a search for tinel-like signs and thenar muscle atrophy. controls - age- and sex- matched cases without ra undergoing us for causes unrelated to ra or cts. the criteria for ra were adopted from the american rheumatism association (1987) for the classification of ra. exclusion criteria: * history of a condition other than ra that could cause cts (e.g., diabetes mellitus, acute trauma, pregnancy ,hypothyroidism, hyperthyroidism, connective tissue disease)history of surgery for a wrist or hand fracture. * history of other systemic neurological disorders or radiculopathy bifid median nerve or any mass lesion identified on us examination pregnant patients were excluded.

Keywords: elastography
effect of methylprednisolone on endothelial function in patients undergoing total knee-arthroplasty

Conditions: Osteoarthrosis

Summary: this study evaluates the pathophysiological effects of a single dose methylprednisolone administered prior to total knee-arthroplasty surgery (tka). the investigators examine the effect on the endothelial glycocalyx shedding due to surgical trauma. half of participants will receive intravenous solu-medrol 125 mg, while the other half will receive placebo. the investigators hypothesize that the group receiving methylprednisolone will experience reduction in glycocalyx degradation compared to the placebo-group, early after tka.

the anti-inflammatory effects of glucocorticoids are well known. the beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented. postoperatively, activation and / or dysregulation of the inflammatory system influence on the endothelial glycocalyx. damage of the vascular endothelia increases the risk of cardiovascular and thromboembolic complications. in animal studies glucocorticoids have been found to preserve the endothelial glycocalyx and the vascular barrier. the effect of glucocorticoids on human endothelial glycocalyx after surgery is unknown and calls for further investigation. this study is embedded in a primary study registrated as: nct02319343 for further details please view the eudract registration: eudract nr.: 2014-003395-23

Eligibility criteria:
inclusion criteria: * osteoarthrosis * undergoing total unilateral knee-arthroplasty surgery * speak and understand danish * have given informed consent exclusion criteria: * revision, bilateral og uni chamber knee-arthroplasty surgery * general anaesthesia * allergy or intolerance towards methylprednisolone * local or systemic infection * permanent systemic treatment with steroids within 30 days preoperatively * insulin-dependent diabetes * active treatment of ulcer within 3 months preoperatively * cancer disease * autoimmune disease incl. rheumatoid arthritis * pregnant or breast feeding women * menopause \<1 year

Keywords: glucocorticoid endothelial barrier glycocalyx knee arthroplasty, total
outcomes of elderly patients admitted to the intensive care unit with severe acute cholangitis

Conditions: Cholangitis Infective; Elderly Person

Summary: the aging of the population goes along with an increased demand for intensive care among very elderly patients (above 75-80 years old). at the same time, there is a decline in the supply of intensive care units (icu). the 1-year mortality of patients above 80 years old in icu ranged from 40 to 70%. moreover, many survivors suffer from long-term sequelae as poor quality of life, cognitive impairment and functional disability. it is unclear under what conditions older patients may benefit from icu admission. cholangitis frequently occured in older patient. moreover, severe acute cholangitis is a potentially life threatening disease characterized by a biliary obstruction and an infection of the bile possibly evolving towards systemic infection, shock and death. because of its potential rapid reversibility of symptom thanks to early intravenous antibiotics and biliary decompression with drainage, old patients suffering from acute cholangitis are easily admitted to intensive care unit. to date, there is a lack of data about the outcome in this population admitted to the intensive care unit with acute cholangitis. the aim of the current study is to describe the outcomes in elderly patients (\> 75 years old) admitted to the icu with acute cholangitis and to identify prognostics factors associated with long term mortality (6 months).


Eligibility criteria:
inclusion criteria: * \> 65 years old * icu admission for acute cholangitis * follow up in the same center after the icu stay exclusion criteria: * none

Keywords: critically ill mortality outcome treatment intensity level
comparison of a new formulation of insulin glargine with lantus® in japanese patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: to compare the efficacy of a new formulation of insulin glargine and lantus in terms of change of hba1c from baseline to endpoint (scheduled at month 6 \[week 26\]) in japanese patients with type 1 diabetes mellitus secondary objectives: to compare a new formulation of insulin glargine and lantus in terms of change in fasting plasma glucose (fpg), preinjection plasma glucose, 8-point self-measured plasma glucose (smpg) profile. to compare a new formulation of insulin glargine and lantus in terms of occurrence of hypoglycemia

the duration of study will consist of: * up to 2-week screening period; * 6-month open-label comparative efficacy and safety treatment period; * 6-month open-label comparative safety extension period; * 4-week post-treatment safety follow-up period

Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes mellitus exclusion criteria: * age \< 18 years at screening visit; * hba1c \ 10.0 % (national glycohemoglobin standardization program \[ngsp\] value) at screening visit; * patients less than 1 year before screening visit on any basal plus mealtime insulin; * patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit; * patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime rapid-insulin analogue in the last 3 months before screening visit; * use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months; * severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit; * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eq, laser, surgical treatment or injectable drugs) during the study period. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
short physical activity program in coronary artery disease.

Conditions: Coronary Artery Disease; Motivation

Summary: coronary artery diseases (cad) are multifactorial diseases which prognosis and risk factors are improved with increased physical activity (pa). thus, cad rehabilitation (cr) program is mainly based on recovering sufficient exercise capacity and promoting regular personalized pa associated to modifications in lifestyle habits to improve control of cardiovascular risk factors and health-related quality of life. however, most of patients do not achieve the recommended levels of pa which may be partly due to numerous barriers that hamper the return to a physically active lifestyle. one promising interventions strategy is so-called 'brief interventions' (bi) to increase pa in health care settings used to initiate change for an unhealthy behavior in individuals and consisting in "verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up". an 'extended brief intervention' (ebi) is similar but usually lasts more than 30 minutes and is delivered on a one-to-one or group basis and can be composed of multiple brief sessions. however, in cad patients, the effect of such interventions on pa level and behavior remains unclear, as well as predictor patterns associated with better outcomes. the investigators aimed to assess the effect of a 4-day pa education program with multiple ebi and exercise on the level and barriers to pa in cad patients and characterize the profile of participants (barriers to pa) with better outcomes.


Eligibility criteria:
inclusion criteria: * age 18 years and older * stable coronary artery disease with appropriate medical certificate of fitness and no current medical conditions affecting sports participation. exclusion criteria: * patients unable to give written constent * patients with impaired cognitive functions * patients with chronic motor deficiency or severe medical disorder (other than heart disease) significantly affecting functional abilities * patients with insufficient information about medical history of documented coronary disease
the therapeutic effect of computer-assisted cognitive function training on cognitive dysphagia after stroke

Conditions: Dysphagia; Cognitive Impairment; Stroke

Summary: this is a multicenter randomized controlled study. the study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland china as the participants (study subjects). the study duration for each participant was 15 days. the subjects were randomly divided into an experimental group and a control group. during the treatment, all patients received routine rehabilitation treatment. in addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

computer-assisted cognitive training is a rehabilitation method that uses computer technology and psychological principles to promote the recovery of cognitive function.this is a multicenter randomized controlled study. the study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland china as the participants (study subjects). the study duration for each participant was 15 days. the subjects were randomly divided into an experimental group and a control group. during the treatment, all patients received routine rehabilitation treatment. in addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * meeting the diagnostic criteria for traumatic brain injury, confirmed by magnetic resonance imaging or ct scan. * montreal cognitive assessment score \ 18 (adjusted by 1 point if the educational level is high school graduation or above). * confirmed swallowing disorder through fiberoptic endoscopic examination of swallowing. * duration of illness greater than three months. * patients or their family members are aware of and consent to participate in the study. exclusion criteria: * presence of other intracranial lesions, such as stroke. * cognitive impairment caused by other diseases. * mental abnormalities. * inability to complete treatment and assessments due to other impairments. * concurrent severe injuries.
longitudinal multi-omics phenotyping of kidney function alteration

Conditions: Chronic Kidney Diseases

Summary: this is a longitudinal observation of kidney function, immune system and gut microbiota before and 24 weeks after a live kidney transplantation conducted in donor and recipient pairs living in the same household. outcome measures include kidney function, body composition, blood pressure, gut microbiome composition, metabolomics and immune cell states.


Eligibility criteria:
inclusion criteria: * body-mass-index 18,5 - 34,9 kg/m2 * planned living kidney donation / transplantation exclusion criteria: * clinically relevant heart, lung, liver, and kidney diseases * postoperative phase * acute infections * vegan diet * change of body weight of more than 10% in the month prior to study entry * known drug or alcohol abuse

Keywords: short chain fatty acids shannon-index microbial diversity home sampling kidney transplant
observational cohort study of adult patients with congenital heart disease

Conditions: Adult Congenital Heart Disease

Summary: the aim of this retrospective and prospective single-center observational study is to evaluate the correct management of adult patients with congenital heart diseas (achd), based on the experience of a reference center such as the institute of pediatric cardiology at policlinico sant'orsola malpighi. the patients participating in this study will not be subjected to any procedures beyond normal daily clinical practice; likewise, the clinical variables that will be collected for the study are those that are commonly collected by the physician in daily clinical practice. this study therefore involves naturalistic observation of current clinical practice without the application of any kind of intervention.

to date, there are an estimated 1 million patients, a population that is expected to grow by about 5%.annually. given the increase in the number of such patients and their complexity, there is an increasing need to train experienced cardiologists and cardiac surgeons. our study is part of this panorama with the aim of assessing the correct management, taking into account the important psychological and sociological impact of these diseases, based on the experience of a reference centre such as the institute of paediatric cardiology of the policlinico sant'orsola malpighi. the primary objective of the study is to identify the clinical and epidemiological characteristics of adult patients with heart disease congenital heart disease (in natural history or previously undergoing corrective or palliative intervention) and to define the need for intervention at a distance, both in terms of interventional and surgical procedures. 1) to describe cardiovascular adverse events and mortality in the target population during follow-up and any non-cardiac comorbidities; 2) to provide data defining the level of utilisation of healthcare resources (diagnostic tests withhigh complexity/cost diagnostic tests, hospital admissions, hospital admissions in high intensity wardscare, percutaneous interventional procedures, surgical procedures); 3) to assess data on quality of life, reproductive health (for the sub-population of female sub-population).

Eligibility criteria:
inclusion criteria: * patients with congenital heart disease in natural history or previously undergoing palliative or corrective surgery in the time period after 14/02/2014 * obtaining informed consent exclusion criteria: * age \< 18 years * inability to obtain longitudinal data after the first follow-up performed at our center.
a study of valcyte (valganciclovir) cmv prophylaxis after renal transplantation

Conditions: Cytomegalovirus Infections

Summary: this 2 arm study will compare the efficacy of 100 days of valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active cmv infection, in cmv positive renal transplant recipients. the influence of the two prevention concepts on the occurrence of direct and indirect effects of active cmv infections will be compared. the anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * primary or secondary renal allograft within preceding 14 days; * igg seropositive for cmv; * receiving immunosuppressive therapy. exclusion criteria: * active cmv infection; * current/history of malignancy; * acute steroid resistant rejection episode since transplantation.
to evaluate the efficacy and safety of mg4101(ex vivo expanded allogeneic nk cell)

Conditions: Hepatocellular Carcinoma

Summary: to see the safety and efficacy of injecting mg4101 as a secondary treatment after curative liver resection on the patient with advanced hcc who has high risk of recurrence.

to see the safety and efficacy of injecting mg4101(ex vivo expanded allogeneic nk cell) as a secondary treatment after curative liver resection on the patient with advanced hcc who has high risk of recurrence.

Eligibility criteria:
inclusion criteria: 1. under the age of 20 to 69 years of age 2. child-pugh class a 3. after curative liver resection, diagnosed hepatocellular carcinoma 4. modified uicc staging : stage 3 5. the women who is childbearing age, agree to maintain adequate contraception measure during clinical trial period. 6. agreed to participate in this clinical trial, agree to the subject person or legal representative who agrees in writing exclusion criteria: 1. less than 20 years old, 70 years old or older 2. metastasis of hepatocellular carcinoma with external parties surgery 3. who had rupture of hepatocellular carcinoma (hcc) 4. hepatocellular carcinoma treated with radiofrequency surgery therapeutics (radiofrequency ablation, rfa), the carotid artery chemical embolization (transarterial chemoembolization, tace), underwent radiation therapy, such as topical therapeutics 5. suspected serious infection 6. who have severe cardiovascular disease (coronary artery disease requiring treatment, heart failure, arrhythmias, myocardial infarction, etc.) 7. pregnant, planning a pregnancy or breast-feeding women 8. autoimmune disease 9. those who latest within four weeks of administration of systemic steroids (however, inhalation, intranasal corticosteroids and topical administration of corticosteroids and short-time administration of a blood transfusion, if such reasons are excluded) 10. latest within four weeks of taking immunosuppressive drugs such as cyclosporine a 11. within the last 5 years diagnosed with liver cancer and other malignancies 12. investigator did not complete or the effectiveness or safety of pharmaceutical products of this clinical trial evaluation for any medical condition that can interfere with characters judged

Keywords: nkcell