Kornimate/medical-research-clean huggingface dataset:
retrospective study for identificatiopn of a link between doxycycline and covid-19 treatment

Conditions: COVID-19

Summary: a new coronavirus, the third documented animal-to-human passage, emerged in wuhan , china in the last quarter of 2019. acne patients on doxycycline escaped seasonal viruses, showing the interest of this antibiotic as a possible treatment against covid-19. the antiviral action of tetracyclines can be explained by different mechanisms. first of all, tetracyclines are modulators of innate immunity by decreasing nf-b expression, inhibiting inflammatory cytokines such as tnf-α, il-1β and il-6, inflammatory granulomas and free radical release . this action is obtained at doses lower than those necessary to obtain an antibiotic effect. another possible action of tetracyclines is their ability to chelate zinc from matrix metalloproteinases (mmps). the coronavirus family is known to bind to host mmps, particularly for viral survival. their chelating activity may help inhibit sars-cov-2 infection by limiting its ability to replicate in the host. finally, tetracyclines could have a direct action by inhibiting the replication of single-stranded rna virus, such as the sars-cov-2 coronavirus.we therefore propose a larger comparative study using data from the french national health data system.

doxy-covid study is a national, observational, retrospective cohort study to compare the risk of severe covid-19 in doxycycline-treated patients versus non-doxycycline-treated control patients (so-called case-cohort study). the patient inclusion period corresponds to the main waves associated with the covid-19 epidemic in france, i.e. from january 1, 2020 to november 30, 2021. indeed, the time of data access, expected during 2022, would not allow reasonable follow-up of doxycycline-exposed patients from december 1, 2021. data of interest collected on these patients are requested over the period from january 1, 2016, through december 31, 2021: * from january 1, 2016, in order to be able to define a pre-exposure phenotype over a follow-up period of at least 4 years in the french health insurance databases (period 2016-2019 inclusive) * until december 31, 2021, in order to have at least one month's hindsight on the risk of occurrence of severe forms of covid-19

Eligibility criteria:
inclusion criteria: * male or female, ≥ 12 years old * affiliated with the french social security system or equivalent system * having been dispensed oral doxycycline at a dose of 100 mg between january 1, 2020 and november 30, 2021

Keywords: covid-19 doxycycline treatment
transform™ occlusion balloon catheter registry

Conditions: Intracranial Aneurysms

Summary: the primary objective of this registry is to collect real world data on the safety and performance of the transform™ occlusion balloon catheter when used in current neurointerventional procedures

* this is a prospective, single-arm, non-randomized, multi-center, observational registry. * the expected duration for study enrollment is approximately 6 months-1 year. * study participation for each subject will be completed upon removal of the guide catheter post-procedure. * up to 140 subjects will be enrolled at up to 15 study sites. a given site will be allowed to enroll a maximum of 20 subjects. * enrollment in the registry occurs after a signed informed consent form has been obtained, and the index procedure starts.

Eligibility criteria:
inclusion criteria: 1. subject or legal representative is willing and has provided informed consent. 2. subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter. 3. subject is over 18 years of age. exclusion criteria: 1. subject's anatomy precludes safe delivery of the transform occlusion balloon catheter. 2. subject's pregnant

Keywords: coil embolization transform™ occlusion balloon catheter registry neurointerventional procedures
pattern of congenital hypothyroidism in newborns.

Conditions: Pattern of CH

Summary: 1. study the pattern of congenital hypothyroidism in newborns after positive newborn screening results. 2. assess the characteristics of the cases (permanent congenital hypothyroidism and transient neonatal hyperthyrotopinemia).

thyroid hormone is essential for normal somatic growth and neurological development in infants and children. deficiency of thyroid hormone in the first 2 years of life results in congenital hypothyroidism (ch). ch manifests by mental retardation and growth retardation in newborn. newborn screening (ns) for ch aims to early diagnosis and treatment of hypothyroidism. ch occurs about one in 3000-4000 infants . ch is suspected in neonatal screening when capillary thyroid-stimulating hormone (tsh) concentrations are elevated (\>15 mu/l in germany). the diagnosis is confirmed by measuring venous tsh and free thyroxine levels (ft4) concentrations before the start of treatment. ch can be classified into permanent or transient congenital hypothyroidism (tch). while ch is a persistent deficiency of thyroid hormones that requires lifelong treatment, tch is a temporary deficiency that reverts to normal concentrations with proper medical management, usually during the first few months of life and not after the age of 3 years. transient neonatal hyperthyrotropinemia (tnh) is defined as temporary postnatal elevation of tsh levels (10 miu/l-20 miu/l) with normal ft4 levels but tsh returning to normal (\<10 miu/l) when measured at 14 d of life. it is important to recognize tnh as these newborns have a higher risk of developing permanent hypothyroidism with repercussion on developmental status. thus, we aimed at evaluating the neonatal and maternal factors associated with tnh . so that, identifying these factors may be considered as an appropriate strategy to prevent these possible disorders. there is a gap in studying the prevalence and the predictors of transient neonatal hyperthyrotropinemia particularly in assiut governorate.

Eligibility criteria:
inclusion criteria: * for the case series study: all positive newborns cases with raised tsh level (the confirmed raised tsh cases after thyroid hormone screening) within one month after birth will be taken during one year. * for the secondary outcome to study the predictors of permanent congenital hypothyroidism and transient neonatal hyperthyrotropinemia, control group with matched age and gender with normal tsh at birth according to the neonatal tsh screening will be taken. matched normal neonates will be selected to be compared with permanent congenital hypothyroidism cases and transient neonatal hyperthrotropinemia cases. exclusion criteria: * cases that refused to participate in research. * cases that missed for follow up.
safety and tolerability of lixisenatide in monotherapy in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in japan secondary objective: to assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on: * hba1c (glycated hemoglobin a1c) reduction; * fasting plasma glucose; * body weight.

* group 1: 60 weeks ± 11 days * group 2: 32 weeks ± 7 days

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus diagnosed for at least 2 months. * not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (oad) for at least 3 months prior to screening visit. previous oad (if any) have to be stopped at visit 1.1 to be washed out during the run-in period at least for 6 weeks; * signed written informed consent. exclusion criteria: * at screening * age \<20 years; * hba1c \ 9.5% (for patients on oad \ 8.5%); * fasting plasma glucose \>250 mg/dl (\>13.9 mmol/l); * use of more than one oad within 3 months prior to screening; * use of thiazolidinedione (tzd) within 6 months prior to screening; * use of insulin within 3 months prior to screening; note: short time use (≤10 days) of insulin due to acute illness or surgery (eg, infectious disease) is allowed. * any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other glp-1 receptor agonist; * type 1 diabetes mellitus * women of childbearing potential with no effective contraceptive method; * pregnancy or lactation; * laboratory findings at the time of screening: oamylase and/or lipase \>3 times the upper limit of the normal laboratory range (uln); * alt \>3 uln; * calcitonin ≥20 pg/ml (5.9 pmol/l); * positive serum pregnancy test in women of childbearing potential; * history of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease; * personal or immediate family history of medullary thyroid cancer (mtc) or genetic conditions that predispose to mtc (eg, multiple endocrine neoplasia syndromes); * allergic reaction to metacresol. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
arrow:identification of postprandial biomarkers towards cardiovascular prevention

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to better understand the association between the postprandial biomarker responses after a food challenge with the development of cardiovascular diseases in healthy subjects


Eligibility criteria:
inclusion criteria: 1. willing and able to sign written informed consent in english or chinese prior to trial entry 2. 40-54 years old 3. both male and female subjects 4. chinese ethnic group (having both grandparents chinese) 5. low framingham risk of chd (\<10%) 6. apparently healthy (i.e. no chronic or ongoing acute disease), based on investigator's clinical judgement exclusion criteria: 1. food allergy to any of the constituents of the meal challenge (milk proteins, lactose, soy). 2. subjects not willing or not able to comply with scheduled visits and the requirements of the study protocol. 3. contraindication to mri 4. pregnant or lactating women based on investigator's clinical judgement. 5. morbid obesity (bmi ≥ 40 kg/m2). 6. previous myocardial infarction (mi). this will include st-elevation mi (stemi) and non-st-elevation mi (nstemi). 7. known coronary artery disease - prior coronary revascularization. 8. known documented peripheral arterial disease. 9. previous stroke (defined as new focal neurological deficit persisting more than 24hours). 10. use of anti-hypertensive agents. 11. prior history of cancer (excludes pre-cancerous lesions). 12. life expectancy less than 1 year. 13. known definite diabetes mellitus or on treatment for diabetes mellitus. 14. known autoimmune disease or genetic disease. 15. known endocrine and metabolic diseases, even on treatment, including hyperlipidemia. 16. psychiatric illness. 17. asthma or chronic lung disease requiring long term medications or oxygen. 18. chronic infective disease, including tuberculosis, hepatitis b and c; and hiv. 19. currently participating or having participated in another clinical trial within 4 weeks prior to trial start (except for biobank study and singheart).
safety & efficacy of qurs e fishar in mild to moderate hypertensive patients in pakistan

Conditions: Hypertension

Summary: the herbal medicine qurs-e-fishar to treat mild to moderate high blood pressure or hypertension comprises of rauwolfia serpentina. a product of hamdard laboratories (waqf) pakistan. a phase iii safety \& efficacy open-label, single-arm, interventional, multicenter, study in mild to moderate hypertensive, adults (30 to 60 years of age) prescribed with study product for 12 weeks (84 days). primary end points: 1. reduction in diastolic blood pressure less than 130 / 80 mmhg at the end of the study period (accepted by who) or if there was a fall of 20 / 10 mmhg or more in diastolic blood pressure as compared to baseline. 2. type, frequency and severity of adrs during the study period. secondary end points: 1. compliance of the prescribed study medication.


Eligibility criteria:
inclusion criteria: * ability to sign icd * participant(s) are willing and able to fulfill the requirements of the study protocol * mild to moderate hypertensive * mild hypertension range (140-159/90-99 mm hg) * moderate hypertension range (160-179/100-109 mm hg) * be between the age of 30 to 60 year exclusion criteria: * patients with recent history of following will be excluded: * severe hypertension, * congestive cardiac failure, * left ventricular failure, * myocardial ischemia, * renal failure or * cerebrovascular accidents

Keywords: htn hypertension qurs e fishar
follow-up study of patients who experienced thromboembolic events in the enable studies

Conditions: Hepatitis C

Summary: the objective of this observational study is to characterize long-term (5 years post event) clinical outcomes in patients who experienced a thromboembolic event (tee) during participation in the gsk enable clinical trials. patients eligible for the study are patient who experienced a tee during participation in the enable trials. each included patient will be followed for a period of 5 years from the date of their first tee. demographic and clinical characteristics will be collected for the index date (time of tee) and every sixth month during the follow-up period, information will be collected for the outcomes of interests: mortality, new tee, hepatic decompensation, evaluation for liver transplant and result of evaluation, and liver transplantation. all information will collected by medical record review.


Eligibility criteria:
inclusion criteria: * patients with portal vein thrombosis (pvt) * patients with deep vein thrombosis (dvt) * patients with pulmonary embolism (pe) * patients with myocardial infarction (mi) * patients with unstable angina * patients with transient ischemic attack (tia) * patients with ischemic stroke * patients with other tee including embolism, thrombosis, phlebitis, and thrombophlebitis at other locations exclusion criteria: * there are no exclusion criteria for this study

Keywords: liver transplantation enable observational mortality thromboembolic events hepatic decompensation long-term follow-up tee
covid-19 disease duration and git manifestations. a new disease severity classification. an egyptian experience

Conditions: Covid19; Diarrhea

Summary: the present study conducted to correlate symptoms not only constitutional and respiratory, but git as a principle presentation, with laboratory markers and covid-19 severe acute respiratory syndrome (sars-cov2) disease outcomes, as the duration of symptoms varies substantially between patients; the investigators undertook this study to determine the optimal time to predict covid-19 outcomes based on real-time experience.

this observational retrospective cohort single center national study was conducted on patients who tested positive covid-19 infection by the polymerase chain reaction (pcr) of nasopharyngeal sample in the period from first june to the med of july 2020. patients were recruited from kasr al-aini school of medicine, covid-19 out-patient clinic, cairo university hospitals. the diagnosis and classification of severity of covid-19 infection were made according to the clinical management of covid-19, released by the world health organization (who), mild and moderate case were recruited, the treatment protocol used was according to the egyptian ministry of health treatment recommendations, which met in part the criteria that was later on published by the national institute of health, mild and moderate cases once diagnosed by pcr received hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. also they received anticoagulants, vitamin c and zinc. in case of secondary bacterial infection, empiric antibiotics are started till result of sputum culture and sensitivity. steroids were initiated in hypoxic cases that required supplemental oxygen and in cases of persistent symptoms. any adult patient (age ≥18 years) suffering from mild or moderate covid-19 infection was included in this study. while severe cases according to who classifications and patients aged less than18 were excluded from the study.

Eligibility criteria:
inclusion criteria: * mild and moderate covid-19 patients: exclusion criteria: * age less than 18 years * severe covid-19 patients: with dyspnea, hypoxia, or \>50 percent lung involvement on imaging within 24 to 48 hours * critical covid-19 patients: with respiratory failure, shock, or multiorgan dysfunction

Keywords: covid-19 disease outcomes and duration git manifestations diarrhea
a single escalating dose study of ertugliflozin (pf-04971729, mk-8835) under fed and fasted conditons in healthy volunteers (mk-8835-036)

Conditions: Type 2 Diabetes Mellitus

Summary: ertugliflozin (pf-04971729, mk-8835) is a new compound proposed for the treatment of type 2 diabetes mellitus. the primary purpose of this study is to evaluate the safety and tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin under fed and fasted conditions in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non childbearing potential. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Keywords: single ascending dose study in healthy subjects
toleromune grass follow on study

Conditions: Grass Allergy; Rhinoconjunctivitis

Summary: grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. toleromune grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy. the purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to grass in the eeu among subjects who completed all dosing visits in study tg002 approximately one year after the start of treatment.

subjects who completed all dosing visits and the post treatment challenge (ptc) in study tg002 will be invited to attend the screening visit for tg002a. subjects will attend for 4 visits to the eeu on successive days. following the last eec visit a follow-up visit will be performed 3-10 days later.

Eligibility criteria:
inclusion criteria: * previously randomised into study tg002, completed all treatment visits and ptc during calendar year 2012. exclusion criteria: * "partly controlled" and "uncontrolled" asthma * history of anaphylaxis to grass allergen * fev1 \<80% of predicted. * treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactive drugs * symptoms of a clinically relevant illness * subjects who cannot tolerate allergen challenge in the eec

Keywords: grass allergy rhinoconjunctivitis environmental exposure unit immunotherapy toleromune grass
a real-world study of long-acting growth hormone injection for turner syndrome

Conditions: Turner Syndrome

Summary: this study is divided into two parts: part a: a multicenter, retrospective, observational study to evaluate the effectiveness of peg-rhgh in the treatment of turner syndrome with domestic real-world data on rhgh as external controls. the collection and arrangement of real world data is the content of the real world study (rws); part b: meta analysis (ma) was conducted based on the previous literatures on rhgh in the treatment of turner syndrome, and ma results were used as external controls to evaluate the effectiveness of peg-rhgh. real-world data on rhgh treatment of turner syndrome in china were obtained from the his system and/or paper medical records of participating domestic centers and/or photocopied/printed medical records of other hospitals. data on the efficacy of peg-rhgh injection in the treatment of turner syndrome were obtained from the 0.2mg /kg/ week group in the phase ii clinical trial of peg-rhgh injection in the treatment of turner syndrome (multicenter, randomized, blank control, superior efficacy) conducted by changchun genescience pharmaceutical co., ltd (protocol number: gensci032-02, version date: april 27, 2015). the ma study data of rhgh in the treatment of turner syndrome in foreign countries came from the relevant literature retrieved from the approved drug database of fda, pubmed and web of science database.


Eligibility criteria:
inclusion criteria: * patients diagnosed with turner syndrome by a clinician; * the first treatment was short-acting rhgh, and the first administration date was not earlier than july 1, 2008; * follow-up data are available at the center before the first dosing and after at least one dosing. exclusion criteria: ● none.
effectiveness of sealants and fluoride varnish in caries prevention in children with autism spectrum disorders

Conditions: Autistic Disorder; Dental Caries; Pit and Fissure Caries

Summary: the aim of the study is to compare application of sealants together with fluoride varnishes versus only fluoride varnishes in preventing caries lesions development in the occlusal surface of first permanent molars of children with asds.

the aim of the study is to evaluate if the application of pit and fissure sealants together with fluoride varnishes is more effective than the application of the only fluoride varnishes in preventing caries lesions development in the occlusal surface of first permanent molars of children with asds. patients with at least 10-year follow-up and asds are recruited and allocated to two cohort according to the strategy adopted for prevention of caries in first permanent molars: fa group (only fluoride varnishes) and fa+s group (sealants together with fluoride varnishes). caries incidence and sealants retention after the follow-up period are recorded. demographic and clinical characteristics of patients at first dental visit are also recorded (age, level of cooperation, presence of systemic diseases other than asds, caries severity) to evaluate if they play a potential protective and/or risk factors for caries development. logistic and multivariate analysis are run to evaluate caries incidence and retention rate of sealants in first permanent molars over a period of at least 10 years.

Eligibility criteria:
inclusion criteria: * asds * age less than 14 years * written declaration of informed consent signed by parents/guardians exclusion criteria: * incomplete clinical records * missing five or more dental check-ups over the follow-up period * oral or dental care provided in sedation or general anesthesia * follow-up less than 15 years

Keywords: dental sealant pit and fissure sealant preventive dentistry fluoride varnish