Kornimate/medical-research-clean huggingface dataset:
a phase 3b, single-center, open-label study to assess the immunogenicity and safety of novartis meningococcal b recombinant vaccine when administered at a 0, 2-month schedule in healthy at-risk adults aged 18 to 65 years inclusive.

Conditions: Prevention of the Meningococcal Disease

Summary: the study will evaluate the immunogenicity and safety of the rmenb+omv nz in an adult population potentially at risk for meningococcal disease (e.g. lab workers).


Eligibility criteria:
inclusion criteria: 1. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment; 2. who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); 3. in good health as determined by medical history, physical examination and clinical judgment of the investigator; 4. who are or might be routinely exposed to cultures of n. meningitidis serogroup b. sponsor's employees are considered eligible to participate in the trial as per inclusion criteria. exclusion criteria: 1. pregnancy or nursing (breastfeeding) mothers; 2. females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. if sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry; 3. any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); 4. individuals with history of any progressive or severe neurologic disorder, or seizure disorder. a single episode of febrile convulsion is not an exclusion criteria; 5. history of any serogroup b meningococcal vaccine administration; 6. previous known or suspected disease caused by n. meningitidis; 7. history of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine; 8. known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example): * receipt of any chronic immunosuppressive therapy * receipt of any chronic immunostimulants * immune deficiency disorder, or known hiv infection 9. subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study; 10. history or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 11. any significant chronic infection; 12. known bleeding diathesis or any condition that may be associated with a prolonged bleeding time; 13. family members and household members of research staff; 14. participation in another clinical trial within the last 30 days or planned for during study.

Keywords: meningococcal disease, adults
surgical treatment of tricuspid valve regurgitation in patients with cardiac implantable electronic devices: long term results

Conditions: Tricuspid Regurgitation

Summary: old trials aimed to evaluate implantable cardioverter-defibrillator (icd) safety and efficacy demonstrated a meaningful decreased rates of sudden death but an increased rate of hospitalization for heart failure . at the time, the chance that an endocardial lead could cause a significant tricuspid regurgitation (tr), leading to worsening heart failure, was not widely considered. whereas, it is now well established that in patients with cardiac implantable electronic device (cieds), moderate or severe tr occurs frequently and it is associated with increased mortality and hospitalization for heart failure. the present study aims to report the long-term results of tricuspid valve repair and replacement surgery in patients with cieds indeed, patients with tr and cieds can be divided in 2 categories: cieds induced tr and cieds associated tr. in patients with cieds induced tr, the valve dysfunction is directly caused by the lead with several mechanism such as mechanical interference with tricuspid valve (tv) leaflet mobility and coaptation (impingement), valve damage during lead placement or manipulation and sub-valvular entanglement. in patients with cieds associated tr the valve dysfunction is not directly caused by the lead. in 2009 approximately 720 000 cieds were implanted worldwide \[7\] and since then a continuous increase of cieds implantation was registered, with an estimation of 1.4 millions of cieds implantation in 2023. with this impressive number of cieds requirement, the need for surgical or trans-catheter treatment of severe tr cieds induced or associated, increased steadily in the past years and it likely will continue to increase in the next years. however, limited data are available regarding the outcome of tricuspid valve surgery in patients with cieds, particularly for the long-term results. with this study we aim to report the long-term result of tricuspid valve repair and replacement in patients with cieds.


Eligibility criteria:
inclusion criteria: * adult patients; * patients with significant, surgically treatable tricuspid regurgitation (tr) according to guidelines * patients with an implantable electronic heart device (cieds) * patients undergoing surgery, both repair or replacement, of the tricuspid valve, both isolated or associated with intervention on the valves of the left heart sections. * patients operated at the cardiac surgery department of the san raffaele hospital from 2000 to 2019. exclusion criteria: * patients without a cied
genetic risks for childhood cancer complications in switzerland

Conditions: Childhood Cancer; Genetic Predisposition; Late Effect

Summary: the objectives of the geccos project are to identify genetic variants associated with complications of childhood cancer using genotype-phenotype association studies. germline genetic samples and data of the "germline dna biobank for childhood cancer and blood disorders switzerland" (biskids) which is included in the geneva biobank for hematology and oncology in pediatrics (bahop) will be used with clinical data of swiss childhood cancer patients collected at the institute of social and preventive medicine in bern.

background and rationale : around 300 children and adolescents are diagnosed with cancer each year in switzerland. a wide range of acute and chronic complications have been linked to cancer and its treatments. cancer treatments, though highly curative, have a high incidence of adverse events, not only acutely but also chronically. depending on the type and dose of treatments, the complications vary. there are important inter-individual differences in the type and severity of complications associated with similar cancer treatments. genetic variation was identified to affect some complications and is suspected to play an important role in many of these differences. the geccos project on analysis of genetic risks for complications associated with childhood cancers fills the gap to analyze germline genetic data with clinical information on short- and long-term complications. this has not been done on a nationwide scale in switzerland yet. the geccos project will improve knowledge on germline genetic risks for complications and further personalize care during acute treatment and follow-up of childhood cancer patients. objectives: primary objectives: 1. identify genetic variants associated with complications after childhood cancer leading to specific organ dysfunctions and second primary neoplasms. 2. evaluate the functional importance of genetic variants for complications after childhood cancer through in silico and in vitro studies. secondary objective: assess genetic variants and their impact on multiple outcomes as a result of specific treatment exposures.

Eligibility criteria:
inclusion criteria: 1. registered in the swiss childhood cancer registry (sccr) since 1976; and 2. consented to the bahop (host biobank for the biskids biobanking project); and 3. diagnosed with cancer according to the international classification of childhood cancer, version 3, iccc-3, or langerhans cell histiocytosis (lch) before age 21 years. exclusion criteria: 1. lacking written consent signed by participant and/ or their legal representative to participate in the bahop (where applicable); or 2. died after study participation and declined use of their samples and data after their death in the original consent for bahop (as indicated on the bahop consent).

Keywords: childhood cancer late effects therapy complications second neoplasm registry biobank genetic variation genetic polymorphism pharmacogenetics genetic association studies
computer presented and physical exercises to maintain cognitive function and emotional health in older adults

Conditions: Cognitive Function; Depression in Old Age

Summary: the aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence.

the aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old will be invited to participate. after providing informed consent, in the case of subjects who are living on units for individuals with memory or other cognitive compromise, after assent from the individual and approval from facility staff, subjects will be randomly assigned to either receive the intervention for 18 weeks and then be followed for an additional 18 weeks, or to be followed for 18 weeks without intervention and then do the intervention for 18 weeks. the intervention will consist of 18 weeks of 60-minute pe sessions 3-4 times/week and 25-minute cbb training sessions 3-4 times a week. there will be 3 assessments of participants: before and after the first 18-week period and then again after the second 18-week period. assessments will be done in 2 sessions over a total of 90 minutes and will include demographic, health, physical activity and social activity questionnaires as well as the self-report measures of cognitive function, emotional state and weekly activities; quantitative assessments of physical balance, strength, flexibility blood pressure and heart rate; and tests of cognitive function. subject medications will be recorded at each assessment. the wait-list control group will receive the same assessments at the same time points.

Eligibility criteria:
inclusion criteria: * associated with whitney center as residents or participants in non-resident programs. * able to understand and read english. exclusion criteria: * not able to sit in a chair independently. * not able to move both arms in simple movement sequence. * hearing and vision insufficient to do the computer exercises or follow the pe instructions. * not able to remember 3 movements in succession.
bicarbonate epidural injection in emergency caesarian

Conditions: Emergency Caesarean

Summary: during labor, pain is systematic. in france, epidural analgesia is the gold standard to fight pain. sometimes, emergency situations involve the maternal or fetal prognosis and require an emergency fetal extraction by caesarean. when an effective epidural analgesia is in place, an injection of adrenaline lidocaine converts this epidural analgesia into an epidural anesthesia allowing a surgical procedure. sometimes, the time required to set up the anesthesia cannot be expected and a general anesthesia is performed. local anesthetics used during epidural analgesia have pka between 7.8 and 8.1. in solution, local anesthetics exist in two forms: an un-ionized form and an ionized form. the non-ionized form is liposoluble and crosses the lipid membranes to reach the site of intracellular action. the non-ionized form conditions the time taken to install anesthesia. when the ph of the solution is equal to pka, un-ionized and ionized form are present in equal quantity. commercial local anesthetic solutions have acidic ph and so contained a majority of ionized form. alkalinization of local anesthetics solution should bring the ph closer to pka and therefore to favor a greater proportion of non-ionized form.

the aim of this study is to evaluate impact of an alkalinization of adrenaline lidocaine solution for conversion of epidural analgesia into epidural anesthesia during an emergency caesarean.

Eligibility criteria:
inclusion criteria: * pregnant women followed up in the reims university hospital * women whose birth is expected by vaginal delivery in the reims university hospital * women wishing to benefit from epidural analgesia * women agreeing to participate in the research and having signed informed consent * women aged 18 years old and more * women affiliated to a social security system exclusion criteria: * women who don't benefit from emergency caesarian (vaginal delivery or scheduled caesarian) * women for whom epidural analgesia cannot be used * women for whom epidural analgesia is not effective
the improvement of limbal stem cell deficiency (lscd) in unilateral stem cell damage by amniotic membrane extract eye drop (ameed)

Conditions: Limbal Stem Cell Deficiency (LSCD)

Summary: corneal epithelial cells and limbal stem cells (lsc) are located in the limbus basal epithelium that are necessary for repair of corneal. about patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation. this study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency (lscd) in vivo by using of amniotic membrane extract eye drop (ameed).

the cornea is the eye anterior portion which its refractive power and transparent is essential for normal vision. the damaged cornea surface can reduce vision and leads to blindness, ultimately. corneal epithelial and some times, limbal stem cell (lsc) are involved in corneal injuries. limbal stem cells (lsc) are necessary for repair and reconstruction of corneal that reduction of these cells occurs by various causes including congenital causes, eye inflammatory diseases and burns. for cornea stem cell damages or limbal stem cell deficiency (lscd), cornea becomes conjunctivalization. lscd may involve one eye (unilateral) or two eyes (bilateral). due to autologous transplantation problems in patients with unilateral lscd and recent successes to resolve this problem, it seems that transplantation of cultured corneal stem cells on amniotic membrane is other way in treatment of unilateral lscd. it is called ex vivo. amniotic membrane can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. it is well accepted that amniotic membrane transplantation (amt) as a temporary patch normally dissolves within 2 weeks. consequent reapplication of membrane is difficult for the patient. on the other hand, in ex vivo, corneal tissue from healthy eye must be transported to laboratory for cell culture on am that is required equipment. there is, also, a risk of cell infection and transmission that is very important issue. however, in infected cells, re-biopsy of the healthy eye is required that is uncomfortable and difficult for the patient. other studies have been reported that amniotic membrane extract (ame) has same characteristics and features. we previously have reported an effective potential of ameed in limbal stem cell proliferation in vitro and also rabbit corneal epithelium healing in vivo. this study is a prospective clinical trial to use amniotic membrane extract eye drop (ameed) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage.

Eligibility criteria:
inclusion criteria: * patient with unilateral chemical burn (grade iii to up); estimation of chemical burns amount and classification was according to dua. * without age limitation exclusion criteria: * lack of timely referral of patients for examinations * simultaneous use of other drugs that cause impairment of the data

Keywords: limbal stem cell deficiency amniotic membrane extract eye drop in vivo cultivation
clinical trial of alanyl-glutamine or glycine in children with persistent diarrhea or malnutrition

Conditions: Diarrhea, Malnutrition

Summary: this is a double blinded randomized clinical trial of alanyl-glutamine or glycine in children with persistent diarrhea or malnutrition. the primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children at hias in fortaleza, ce, brazil, with persistent diarrhea (history \> 2 weeks duration) or malnutrition.

this is a double blinded randomized clinical trial of alanyl-glutamine or glycine in children with persistent diarrhea or malnutrition. the primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children at hias in fortaleza, ce, brazil, with persistent diarrhea (history \> 2 weeks duration) or malnutrition (assessed by height-for-age z-score less than -1). secondary objectives of the study include determining the effect of 7 days of supplementation of alanyl-glutamine or glycine on diarrhea frequency and duration; weight gain; protein loss and intestinal inflammation, and lactoferrin excretion; and weight gain at 2-4 weeks after treatment. one hundred and eight children who meet the inclusion criteria will be prospectively randomized to one of two treatment groups: (1) glycine or (2) alanyl-glutamine. all children will be given vitamin a and zinc supplementation; and if they have diarrhea, standard oral or iv rehydration therapy will be administered.

Eligibility criteria:
inclusion criteria: 1. children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for \> 2 weeks or height-for-age z-score (haz) less than -1, which is the median of haz scores in children at hias. 2. be an inpatient and willing to stay for 7 nights at hias. 3. child's parent or guardian must sign informed consent. exclusion criteria: 1. children exclusively breast-fed (reason: the diet needs to be controlled in order to evaluate the study treatment effect) 2. children who participated in the "community study" or any other study within the past two years (reason: the children in the "community study" will have received glutamine.) 3. children with suspected other illnesses as indicated by fever \>102 degrees f at time of screening off antipyretics. 4. children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella 5. severe malnutrition defined as haz \<-3.

Keywords: diarrhea, malnutrition, brazil
severity factors and needed observation time at ed of patients wih head injury

Conditions: Head Injury Other; Length of Stay; Delayed Complications

Summary: we know precisely which patients and when they should have an imaging test to evaluate a head injury (hi). but in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should remain under observation in the emergency department if no initial lesions are evident. our goal is to try to answer these two questions.

material: prospective study of patients treated of hi in the emergency department (ed) and to whom an image test is performed (cranial ct scan). collection of demographic, clinical, analytical, image tests, and observation time in the emergency department (from admission to medical discharge) methods: separation of subjects included in the study in 4 cohorts: patients without anticoagulant and / or antiaggregant treatment; patients with antiplatelet therapy (asa and / or clopidogrel); patients with anticoagulant treatment with acenocoumarol and inr \ = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (lmwh) ) follow-up through analysis of clinical history and telephone interview at 2, 7, 15, 30, 60 and 90 days. statistical analysis of the results.

Eligibility criteria:
inclusion criteria: * hi attended at ed * head ct performed as recommended by clinical guides * contact data available (phone number) exclusion criteria: * patients not able for follow up (foreigners or tourists or whatsoever whom are not going to stay on the country for at least 3 months)
small and steatotic hepatocellular carcinoma

Conditions: HCC

Summary: percutaneous thermoablation in an effective local curative treatment in patients with cirrhosis and hcc smaller than 3 cm in diameter (bclc 0-a). around 30% of hcc patients referred for percutaneous ablation were regarded as non-feasible because of a difficult-at risk location or undetectable nodules. we used percutaneous thermoablation to treat hcc on high risk locations (subcapsular or liver dome) with or without lipiodol marked (for undetectable hcc). no clinical study has been published so far to compare percutaneous thermoablation of hcc on liver dome ct guided with artificial pneumothorax and lipiodol marked, and percutaneous thermoablation of hcc guided by ultrasonography (non subcapsular, distent form diaphragm). this retrospective study evaluate the overall survival, the local tumor progression or distant liver progression after percutaneous ablation for hcc and determine prognostic factors.

we performed 412 percutaneous thermoablations on 238 patients for hcc between january 2015 and november 2019. all thermoablation procedures were performed percutaneously under ultrasound or ct guidance, with ou without artificial pneumothorax or ascites, with ou without lipiodol marked. purposes: * tumor response upon mrecist criteria * progression-free survival * overall survival * local tumor progression * distent liver progression * prognostic factors

Eligibility criteria:
inclusion criteria: * hcc according to histological examination or barcelona criteria * bclc0 or a * measurable targets according to mrecist v1.1 * child a or b7 cirrhosis * hcc \< 4 cm, \< 3 nodules, age ≥ 18 years * no extrahepatic metastasis, no vascular invasion * performance status 0 or 1 * thrombocytes ≥ 50 000/mm3, tp \> 50% exclusion criteria: * follow-up \< 1month * lobar/main portal venous thrombus * abundant ascites * antecedent of bilio-digestive anastomosis or endoscopic sphincterotomy * combined treatment with embolization or chemo-embolization

Keywords: microwave ablation percutaneous thermalablation high risk location articifial pneumothorax lipiodol marked prognostic factor