Kornimate/medical-research-clean huggingface dataset:
changes in dietary behaviours during the covid-19 outbreak confinement in the adult population (covidiet_int)

Conditions: COVID-19

Summary: this cross-sectional study will allow to collect eating behaviours data during the covid-19 confinement, some of them related to the mediterranean diet to better understand the eating behaviours of adult population during this novel and exceptional situation. hypothesis: the eating habits of the population together with physical activity level will change during the covid-19 outbreak confinement.

around thirty thousand adults (18 years old and older) will be recruited from 22 different countries (i.e. including bosnia and herzegovina, colombia, croatia, denmark, egypt, germany, greece, india, ireland, italy, kosovo, kuwait, lithuania, montenegro, north macedonia, poland, portugal, serbia, slovenia, spain, turkey and united kingdom). a self-administered web-based questionnaire with questions aimed at assessing the dietary behaviours of the adult population during the covid-19 confinement and before it started, will be distributed using social media and snowball sampling. the questionnaire is based on 44 items including socio-demographic data, mediterranean diet adherence screener (medas) as a reference of a healthy diet, processed foods intake, changes in their usual food choices and weight gain. all data will be collected online to reach the largest number of participants from all territories. the main objectives of this study are: 1) to examine whether the covid-19 outbreak confinement has influenced eating habits among the adult population from the 22 countries previously detailed, and 2) to assess the differences in eating behaviours between the countries involved in the study to have a global overview of the behaviour in the face of confinement that helps in public health decision making related to positive impact on the prevention of chronic diseases and covid-19-related complications.

Eligibility criteria:
inclusion criteria: * adults aged from 18 years old and over living in the countries involved in the study. exclusion criteria: * people under 18 years of age living in countries different from those involved in the study.

Keywords: eating behaviours mediterranean diet covid-19 confinement dietary habits physical activity
clinical success of different percutaneous transhepatic biliary drainage procedures

Conditions: Extrahepatic Cholestasis

Summary: the clinical success of percutaneous transhepatic biliary drainage procedures (ptbds) is usually measured by the the decrease of the serum bilirubin value. however, the bilirubin value can be biased by other disease conditions. furthermore, the time course of the decrease of the bilirubin value after technically successful ptbd is not well known. serum gamma-glutamyl transferase (ggt), a liver enzyme which is typically elevated in cholestatic liver diseases, might be a good alternative to bilirubin as an indicator for the clinical success of ptbds. the aim of this study is to analyse the bilirubin level and the ggt level in patients with technically successful ptbd.

the medical records of adult patients who have received a technically successful ptbd will be screened sytematically in terms of bilirubin and ggt values in the follow up of 4 weeks after the intervention. bilirubin and ggt values have been routinely examinated every 1 to 3 days. ptbd comprises external plastic endoprosthesis, combined external and internal endoprosthesis and primary metal stent insertion. the respective three procedures are considered separately. as ptbd is a rare intervention which is used after failed or impossible endoscopic retrograde cholangiopancreaticography (ercp) medical records will be screened from 2002 to 2022 (20 years). it is expected that for example a decrease of ggt after three days might indicate a successful procedure. this in turn might has an impact on the early demission of the patient. on the other side, the precise definition of successful ptbd by bilirubin or ggt value might help to make this procedure better comparable to other alternative biliary drainage procedures such as endoscopic ultrasound-guided biliary drainage.

Eligibility criteria:
inclusion criteria: * technically successful ptbd exclusion criteria: * technically not successful ptbd

Keywords: extrahepatic cholestasis self expandable metallic stents drainage
hiv-1 and brain interaction on smoking comorbidity

Conditions: Smoking

Summary: people living with hiv-1 have high rates of cigarette smoking, which may be related to nicotinic interaction with hiv-1 infection and brain function levels. the proposed project aims to understand these pathways using translational brain imaging and hiv-1 reactivation studies. the study proposes a targeted nicotine-brain investigation of the nicotinic effects in hiv-1 infection from cellular to brain circuitry levels.

smoking remains the leading cause of preventable morbidity and mortality in the united states. the alarmingly high smoking rates and unsatisfactory performance of standard smoking cessation efforts in people living with hiv/aids (plwh) interfere with the overall progress in the treatment of hiv-1 infection. our understanding of nicotine addiction mechanisms in plwh, and how they are related to and interact with hiv-1 neuropathology, is limited and thus hindering the development of more effective, targeted treatments. the study will directly address neurological complication of this hiv-associated comorbidity at the brain circuitry level using state-of-the-art imaging tools and methods.

Eligibility criteria:
inclusion criteria: 1. subjects between ages 18-60 in good health 2. ability to give written informed consent 3. for people living with hiv: should be diagnosed with hiv two years or more and on art two years or more 4. for people living with hiv: should have achieved virologic suppression (defined as viral loads of ≤ 200 copies/ml), and without current signs of reactivation exclusion criteria: 1. inability to sign informed consent 2. unable to undergo mri scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner 3. any major medical illnesses to include, but not limited to, uncontrolled high blood pressure or high blood sugar, cardiovascular disease, asthma, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis as per medical history 4. current substance-induced psychiatric disorders 5. significant alcohol or other drug use, other than nicotine dependence or marijuana use 6. gross structural abnormalities and/or have a history of syncope 7. positive urine pregnancy tests 8. any neurological illnesses to include, but not limited to, seizure disorders, multiple sclerosis, movement disorders, or history of head trauma, cva, cns tumor, 9. for people living with hiv: having aids or non-aids-defining cancer or active cns and other opportunistic disease 10. for people living with hiv: on active treatment of hepatitis c virus (hcv)

Keywords: hiv nicotine brain smoking
odevixibat for the treatment of progressive familial intrahepatic cholestasis

Conditions: Progressive Familial Intrahepatic Cholestasis

Summary: to provide treatment access to patients with pfic in the us who have pruritus and elevated serum bile acids and who are not able to enroll in a4250-008 (pedfic2) for the following reasons: 1) do not meet eligibility criteria for pedfic 2; 2) are not able to get to a pedfic 2 site for geographical reasons, and 3) do meet the eligibility criteria for pedfic 2 after recruitment has been completed

eligible patients will be enrolled into this expanded-access program and treated with an oral dose of 120 μg/kg/day of odevixibat and evaluated on an ongoing basis.

Eligibility criteria:
inclusion criteria: 1. a male or female patient of any age, with a clinical diagnosis of pfic, and with a body weight ≥5 kg at screening visit 2. patient must have a clinical diagnosis of pfic 3. patient must have clinically confirmed pruritus 4. patient must have elevated serum bile acid levels, specifically measured to be ≥2 × the upper limit of normal (uln) prior to start of medication 5. patient and/or legal guardian must sign informed consent (and assent) as appropriate. patients who turn 18 years of age (or legal age per country) during exclusion criteria: 1. patient is expected to have a liver transplant within 6 months of screening 2. decompensated liver disease, coagulopathy, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy 3. international normalized ratio (inr) \>1.4 (the patient may be treated with vitamin k intravenously, and if inr is ≤1.4 at resampling the patient may be started on program medication) 4. serum alt \>10 × uln at screening 5. serum alt \>15 × uln at any time point during the last 6 months unless an alternate etiology was confirmed for the elevation 6. total bilirubin \>10 × uln at screening 7. any patient who is pregnant, lactating, or planning to get pregnant 8. patients who qualify for enrollment in other phase 2 or phase 3 trials intended to support marketing approval in pfic

Keywords: pfic pediatric cholestasis
continuous versus intermittent phototherapy in treatment of neonatal jaundice

Conditions: Neonatal Jaundice; Phototherapy Complication

Summary: one of the most common diseases in the neonatal period is indirect hyperbilirubinemia (ihb). after phototherapy was discovered accidentally in 1958, it has been used as the most effective treatment method for ihd for more than 60 years. sources that provide phototherapy are developing rapidly technologically. however, there is no clearly defined usage table in the literature for applying phototherapy with faster effects and fewer side effects. in recent years, the use of intermittent phototherapy has been recommended with similar effectiveness. phototherapy has significant side effects such as dehydration, diarrhea, chromosome breaks, retinal damage, skin rashes, hypocalcemia, thrombocytopenia. as phototherapy exposure decreases, its side effects decrease.in our study; we plan to find the most ideal method in the treatment of ihb by comparing intermittent pt with continuous phototherapy in terms of effectiveness. we aim to achieve the best bilirubin reduction and minimal side effects with less exposure to phototherapy.

n the intermittent phototherapy group, phototherapy will be applied for 1 hour and phototherapy will be turned off for 2 hours, allowing time for the skin to be cleaned. the 3-hour cycle is completed twice and the 6-hour session is completed, and at the end, the total bilirubin will be measured and the hourly bilirubin decrease rate will be calculated. in the continuous phototherapy group, total bilirubin will be measured at the end of 6 hours of uninterrupted phototherapy and the hourly bilirubin decrease rate will be calculated. it was planned to compare the effectiveness of the two groups in terms of the bilirubin level reduced as a result of 6-hour sessions, hourly reduction rate, rebound bilirubin level, total phototherapy time received, hospitalization time, and additional treatments required. it was planned to compare both groups in terms of the frequency of side effects such as the number of defecations, body temperature changes, and skin rash during the phototherapy session.

Eligibility criteria:
inclusion criteria: the inclusion criteria was being a late preterm or term neonate who had ihb in the first 15 days of life- exclusion criteria: * those who had stb values at the blood exchange limit according to the nomogram, any associated congenital anomalies including chromosomal anomalies or were less than 34th gestational week were excluded.

Keywords: indirect hyperbilirubinemia continuous phototherapy intermittent phototherapy phototherapy side effects
light exposure patterns and symptoms among patients with erythropoietic protoporphyria

Conditions: Erythropoietic Protoporphyria

Summary: background: erythropoietic protoporphyria (epp) is characterized by development of painful skin symptoms upon exposure to visible light dye to accumulation of the photoactive substance protoporphyrin ix (ppix) in the skin.this study aimed to quantify the actual light exposure of patients with epp during everyday life. the investigators further aimed to establish the associations between symptoms and light exposure, use of protective clothes, and erythrocyte ppix concentration.


Eligibility criteria:
inclusion criteria: * diagnosed with erythropoietic protoporphyria * informed consent exclusion criteria: * none
cannabidiol oral solution for treatment of refractory infantile spasms

Conditions: Spasms, Infantile

Summary: infantile spasms (is) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. there is a great need for safe and effective therapies in the treatment of is. this need is even more important for infants and toddlers still sick after being treated with medicine that is already available. this is a multi-center study to evaluate the efficacy and safety of cannabidiol oral solution (cbd) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies. the overall study duration is expected to be 64 weeks for those subjects who respond to cbd treatment. the maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.

a protocol amendment in may 2016 created two parts to this trial: part a (the extended treatment period) and part b (the safety treatment period), whose objectives are as follows: primary part a: to evaluate the efficacy of cannabidiol oral solution in treating refractory infantile spasms (is). secondary: part a: * to evaluate the safety of cannabidiol oral solution in treating refractory infantile spasms. part b: * to assess the long-term safety of cannabidiol oral solution as an adjunctive treatment for subjects with infantile spasms (is) * to establish the continued efficacy of cannabidiol oral solution in maintaining seizure control in subjects with is * to assess the global status of subjects taking cannabidiol oral solution for an extended period of time determined by various qualitative assessments * to monitor for changes in plasma levels of cannabidiol oral solution during long-term treatment of subjects with is

Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification, including infantile spasms * parent(s)/caregiver(s) fully comprehend and sign the informed consent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator. exclusion criteria: * history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters * signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the analysis of results * during the safety treatment and follow-up periods, subjects are not to receive the following: 1. any cannabinoids (cbd, δ9-tetrahydrocannabinol (thc), hemp oil, realm oil or marijuana) 2. any other investigational drug or investigational device
determination of reference values for handgrip strength and bioimpedance values in healthy turkish children

Conditions: Sarcopenia; Child Development

Summary: in this study, our aim is to determine the reference values for the handgrip force and bioimpedance values in healthy turkish children.

in this study, our aim is to determine the reference values for the handgrip force and bioimpedance values in healthy turkish children. the study was planned as a cross-sectional clinical study. all healthy children studying at hamdi akverdi primary school and halil bedii management secondary school in the bakırköy region of istanbul will be included. the date of birth of the children will be learned. it will be determined in which city in turkey the population is registered. tanita bia analysis and hand grip strength (with jamar) measured in the dominant hand were planned for all children. in addition, the calf circumference of all children will be measured. written consent forms will be obtained from the families of the children before the evaluation. it was planned to include 1500 children in the study.

Eligibility criteria:
inclusion criteria: * healthy children * children under 18 * turkish children exclusion criteria: * children with malignancy or known chronic disease

Keywords: children muscle strength bioimpedance
cpap therapy in patients with idiopathic pulmonary fibrosis and sleep apnea

Conditions: Obstructive Sleep Apnea; Idiopathic Pulmonary Fibrosis

Summary: the recent literature shows an increased incidence of obstructive sleep apnea (osa) in patients with idiopathic pulmonary fibrosis (ipf). on the other hand there are no published studies related to cpap treatment in this patient group. the investigators aim was to assess the effect of cpap on sleep and overall life quality parameters in ipf patients with osa and to recognize and overcome possible difficulties in cpap initiation and acceptance by these patients.

recently published studies report a high incidence of obstructive sleep apnea (osa) in patients with ipf. underlying, and usually under-diagnosed osa in these patients may be a reason for impaired sleep quality and may consequently have a negative influence on their daily activities and overall quality of life. in addition, underlying osa may have a negative influence on the already impaired ipf-related morbidity and mortality. the absence of any effective treatment for ipf so far indicates that the recognition and treatment of generally under-diagnosed osa in ipf patients should be a primary goal. therefore, our primary aim in this study was to assess the results of effective cpap therapy in terms of sleep quality and overall quality of life in ipf patients with moderate to severe osa. the investigators used generally accepted instruments to assess quality of sleep and overall life. in addition, the investigators tried to determine and overcome the reasons for poor cpap compliance in these patients

Eligibility criteria:
inclusion criteria: * patients with apnoea-hypopnoea index \>15/h * newly diagnosed ipf exclusion criteria: * congestive heart failure * chronic renal failure

Keywords: obstructive sleep apnea idiopathic pulmonary fibrosis
clinical study of immunity duration of yellow fever vaccine in military

Conditions: Yellow Fever Vaccine

Summary: yellow fever is an acute viral disease transmitted by mosquitoes in south america, central america and africa. it is more prevalente in males gender and the age above 15 years due to the greater exposure in the wild endemic area of yellow fever. according to the world health organization (who), a single dose of the yellow fever vaccine is sufficient to maintain protective immunity against yellow fever for a lifetime, therefore a booster dose is not required. this issue is difficult to evaluate because there is no serological correlate of protection against yellow fever and seropositivity is defined with several cut-off points. although studies indicate that the duration of protection after vaccination is long, many studies have demonstrated a reduction of the antibody titrer over the years. consequently, there is more concern about people who live in endemic areas. for this reason, brazil recommends revaccinating once at least until additional studies are performed. it is important to know the duration of immunity induced by lower doses of yf vaccine. in our knowledge, there is a lack of clinical studies evaluating the immunity duration of the yellow fever vaccine with lower doses. this information is relevant to subsidize the routine recommendation of yf vaccine fractional dose for adults.

this is an observational study in young adult males who received the first dose of the yellow fever vaccine in 2009 when they participated in the "dose-response study of the yellow fever vaccine 17dd produced by bio-manguinhos / fiocruz.

Eligibility criteria:
inclusion criteria: * participated in the "dose-response study of the yellow fever vaccine 17dd produced by bio-manguinhos / fiocruz" in 2009. * not been revaccinated during the "dose-response study of the yellow fever vaccine 17dd produced by bio-manguinhos / fiocruz" of 2009. * not having received another dose of the 17dd yellow fever vaccine after participating in the 2009 "bio-manguinhos / fiocruz" 17dd yellow fever vaccine dose-response study. * provide name, address, telephone and other information so that you can contact if necessary. * ability to understand and sign the tcle. exclusion criteria: * impossibility or refusal to collect blood

Keywords: immunity duration
previous cardiovascular disease, cardiovascular risk factors and chest pain in first myocardial infarction

Conditions: Myocardial Infarction

Summary: some myocardial infarctions (mi) occur as the first manifestation of atherosclerotic disease. such mis are important because of the high likelihood of missed opportunities for prevention. a recent analysis using caliber data estimated this proportion at 60%. further to this research, another level of complexity can be added to improve our understanding of these mis. this is the concept of a completely 'unanticipated' mi, which can be defined as: mi occurring as the first manifestation of atherosclerotic disease and without any traditional cardiovascular risk factors and without any prior chest pain. such 'unanticipated' mis cannot be foreseen by the medical profession and their frequency in the population is unknown. therefore the aim of this study is to describe the distribution of previously diagnosed cardiovascular disease, cardiovascular risk factors and chest pain in patients with first mi. this will provide an estimate of the number of 'unanticipated' mis and of the levels of risk factors in unheralded, compared to heralded mi.

this study is part of the caliber (cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the nihr and wellcome trust. the central theme of the caliber research is linkage of the myocardial ischaemia national audit project (minap) with primary care (gprd) and other resources. the overarching aim of caliber is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. caliber has received both ethics approval (ref 09/h0810/16) and ecc approval (ref ecc 2-06(b)/2009 caliber dataset). using data from gprd, minap, ons mortality data and hospital episode statistics (hes), this study will identify patients with a first mi (stemi and non-stemi). information from in-patient hospital visits, general practice data and self-reported data in minap, this study will allow the quantification of the level and timing of cardiovascular disease before first mi. it will also measure the levels of cardiovascular risk factors and chest pain occurring before mi.

Eligibility criteria:
inclusion criteria: * patients in gprd practices which are deemed "up to standard" by gprd criteria will be included if their practice agreed to be linked to the minap dataset. * age over 18. exclusion criteria: * patients will be excluded after experiencing their first mi. * patients will be excluded if they do not fulfil one of the inclusion criteria.

Keywords: manifestation coronary heart disease myocardial infarction angina pectoris unheralded general practice research database myocardial ischaemia national audit project caliber