Kornimate/medical-research-clean huggingface dataset:
alg-055009 in non-cirrhotic adults with mash (herald)

Conditions: NASH; MASH; Metabolic Dysfunction-Associated Steatohepatitis; Nonalcoholic Steatohepatitis

Summary: this is a phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (po) daily (qd) doses of alg-055009 (soft gelatin \[softgel\] capsule) for 12 weeks.

this is a double-blind, randomized, placebo-controlled phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (po) daily (qd) doses of alg-055009 (soft gelatin \[softgel\] capsule) for 12 weeks. the study will be conducted in approximately 100 adult non-cirrhotic subjects with presumed mash and liver fibrosis (f1-f3). the study will be conducted at up to approximately 45 sites throughout the united states of america.

Eligibility criteria:
key inclusion criteria: * male or female, 18 to 75 years of age * body mass index (bmi) ≥ 25 kg/m2 * diagnosis of presumed nash/mash with f1-f3 liver fibrosis based on one of the following: * liver biopsy within 6 months prior to screening showing a nafld activity score (nas) of ≥4 with at least a score of 1 in each of the nas components; or * having ≥2 metabolic syndrome criteria and a screening fibroscan liver stiffness measurement between 7 - 20 kpa * screening fibroscan with cap score of \>300 db/m * screening mri-pdff with ≥10% liver fat content key exclusion criteria: * history or clinical evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (masld) * history or current evidence of cirrhosis * history of liver transplantation or known planned liver transplantation * history or current evidence of a pituitary disorder or hyperthyroidism * untreated clinical or subclinical hypothyroidism; or on thyroid replacement therapy at screening or within the last 6 months prior to screening. * tsh, free t4, or total t3 \>1.1 x uln or \<0.9 x lln * clinically concerning abnormal ecg or cardiac history * hba1c ≥9.5% * platelet count ≤135,000/mm3 * alt or ast \>5 x uln * inr \>1.3 * albumin \<3.5 g/dl * egfr \<45 ml/min/1.73 m2

Keywords: nash mash metabolic dysfunction-associated steatohepatitis nonalcoholic steatohepatitis liver fatty liver disease liver disease thr-b thr b thr-β thr β
fludarabine/busulfan and cyclophosphamide conditioning for adult lymphoid malignancies

Conditions: Lymphoid Malignancies

Summary: allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. based on our previous study, the condition with iv-busulfan (iv-bu) and cyclophosphamide (ctx) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in cr2. in this study, the investigators aim to further improve the conditioning with fludarabine + iv-bu and to use ctx after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (gvhd) prophylaxis.

patients with adult lymphoid malignancies received conditioning with fludarabine + iv-bu. the gvhd was consisting of d+3 and d+4 ctx after stem cell transfusion. csa will be added for all patients after d+5.

Eligibility criteria:
inclusion criteria: * adult acute lymphocytic leukemia in 1st or second remission; lymphoid malignancies in 1st or second remission * age 16-60 years * with inform consent * no contraindication for allogeneic transplantation: active infection, allergy to flu/bu/ctx, liver and renal function damage * hla matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo) exclusion criteria: * age less than 16 years or over 60 years * liver function/renal function damage (over 2 x upper normal range) * with mental disease * other contraindication of all-hsct

Keywords: efficacy safety conditioning fludarabine busulfan cyclophosphamide adult
a professional development programme (prodevelop) for newly graduated nurses

Conditions: Professional Fulfillment; Professional Identity Formation; Professional Quality of Life; Support Program; Development; Nurse Role

Summary: this clinical study aims to implement and evaluate a professional development programme (prodevelop) designed to facilitate the transition of newly graduated nurses (ngns) into their new roles. ngns face several challenges in the work environment and in developing their professional competencies. the aim is to support ngns in a county hospital in central sweden to facilitate their professional development. data will be collected during the ngns' first year through intensive longitudinal measures, including weekly and quarterly questionnaires. this will be combined with individual interviews and focus groups with ngns, dialogue facilitators and managers.

the primary outcomes will be role clarity, task mastery, social acceptance, recovery and stress. the researchers will compare the results of the primary outcomes with those of a control group measure. secondary outcomes will be experience of the intervention, transition support, job satisfaction and intention to leave. informed consent was signed prior to participation in the study. the ethical application has been approved by the ethics authority is, diary number 2022-05682-0.

Eligibility criteria:
inclusion criteria: * registered nurses in sweden employed as newly graduated nurses (ngns) in a county in central sweden participating in the prodevelop, the intervention group. * registered nurses in sweden employed as newly graduated nurses (ngns) in a county in central sweden, ngns participating in the introduction programme prior to the study, not participating in the prodevelop, the control group. * experienced registered nurses as facilitators for the dialogue groups for the ngns in the intervention. * managers at the county hospital for the ngns participating in the intervention. exclusion criteria: • managers without ngns participated in the intervention.

Keywords: introduction programme newly graduated nurses professional development role clarity task mastery stress recovery reflection social acceptance transition support dialogue group registered nurse focus group intervention interview intensive measures
airway clearance using high frequency chest wall oscillation

Conditions: Cystic Fibrosis

Summary: high frequency chest wall oscillation (hfcwo) has been shown to increase tracheal mucous clearance compared with control. these observations led to the development of 'the vest' which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. the generator rapidly inflates and deflates 'the vest' which gently compresses and releases the chest wall between 5 and 20 times per second. this generates mini-coughs which are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. in addition 'the vest' has been shown to reduce the viscosity of mucus and this should further enhance mucous clearance. the technique has, for many years, been widely used in the united states of america as an alternative to the european airway clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure, but 'the vest' has only recently been registered for use in europe. it is important that the airway clearance regimen of 'the vest' be compared with the alternative airway clearance regimens widely used in europe. hypothesis: in people with cystic fibrosis 'the vest' will lead to the expectoration of an increased weight of sputum during treatment sessions compared with alternative airway clearance regimens.


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis * 16 years of age or over * forced expiratory volume in one second greater than or equal to 25 percent of predicted * hospitalised patients in a stable clinical state exclusion criteria: * current severe haemoptysis * rib fractures * pregnancy * inability to give consent

Keywords: airway clearance cystic fibrosis high frequency chest wall oscillation
safety and immunogenicity of a paediatric dose of virosomal hepatitis a vaccine

Conditions: Hepatitis A

Summary: the primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of epaxal vaccine against hepatitis a was not inferior to the protection afforded by the standard dose of epaxal. the aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis a vaccine (havrix junior).


Eligibility criteria:
inclusion criteria: original study: * males or females aged \>=12 months and 16 years of age at the time of the first vaccination. * written informed consent obtained from the subject when applicable and from the parent/legal guardian of the subject. - free of obvious health problems as established by medical history and/or clinical examination before entering the study. follow up phase: * subjects enrolled and randomized in the primary study and having received two doses of the study vaccine exclusion criteria: * use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (for corticosteroids, this means prednisone, or equivalent, \>=0.5 mg/kg/day. inhaled and topical steroids were allowed.) * planned administration/administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine * previous vaccination against hepatitis a * seropositive for anti-hav antibodies (\>=10 miu/ml) * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness * acute disease at the time of enrolment

Keywords: hepatitis a vaccination immunisation
hypertension and injury

Conditions: Arterial Hypertension; CAD

Summary: membrane microparticles are submicron fragments of membrane vesicles shed from various cell types. circulating endothelial microparticles have been proposed as markers of endothelial injury. however, which mechanical forces contribute to their release is not clear.

in a first series subjects (50% hypertensives) with and without arterial hypertension and no coronary artery disease (cad) (n=50) will be recruited. mp subpopulations will be discriminated by flow cytometry according to the expression of established surface antigens including cd31+/41-, cd144+, and cd62e+. besides office and ambulatory 24h blood pressure measurements, pulse wave analysis will be performed to determine central blood pressure, augmentation index (aix), and pulse wave velocity. endothelial function (flow-mediated dilation, fmd), arterial pulsatile stretch (fractional diameter changes, fdc), and wall-shear-stress (wss) will be measured in the same segment of the brachial artery (ba) by ultrasound. in a second series, the investigators will take measurements in subjects with hypertensive crises (sbp\>180 mmhg) (n=20) before and after 4h and normalization of arterial bp by urapidil. in a third series, the investigators will take measurement in subjects with stable cad (n=10) before and after transfemoral coronary diagnostic angiography.

Eligibility criteria:
inclusion criteria: * male subjects with or without arterial hypertension, hypertensive crises, stable cad * written informed consent exclusion criteria: * subjects with manifest peripheral artery, or cerebrovascular disease, acute inflammation (crp\>0.6 mg/dl), malignancies, arrhythmias

Keywords: arterial hypertension microparticle endothelial function
the efficacy of symbiotic on cytokines

Conditions: Necrotising Enterocolitis

Summary: the aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, l. rhamnosus, l. plantarum, bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama acting on th1 pathway, interleukin -5 acting on th2, interleukin -10 acting on t regulatory pathway, and interleukin -17 acting on th-17 pathway that were related with necrotizing enterocolitis pathogenesis in very low birth weight neonates.

inclusion criteria: 1. neonates who born 26- 32 gestational week and 750-1500 gram birth weights 2. neonates who tolerated minimal enteral feeding within postnatal first week exclusion criteria: 1. prom\> 24 hours and/or chorioamnionitis 2. mechanic ventilation supply more than 7 days 3. culture proven sepsis 4. major congenital anomaly 5. patients undergoing surgery intervention: the allocations will contain in opaque, sequentially numbered sealed envelopes. the study group will receive symbiotic preparation (probiotic atp, nobel, 1/2 sachet twice daily); whereas the control group will receive placebo (distilled water; 1 ml per dose twice daily) which will be added to breast milk or formula starting with the first feed.0.5 cc blood sampling will be taken from patients within postnatal 48 hours, 14+2.days, 28+2.days. this samples will turn by cold centrifugation and store at -20 °c temperature. the cytokines will be analysed by elisa multiplex method.

Eligibility criteria:
inclusion criteria: 1. neonates born 26- 32 gestational weeks and 750-1500 gram birth weights 2. neonates who tolerated minimal enteral feeding during first week of life exclusion criteria: 1. prom\> 24 hour and/or chorioamnionitis 2. mechanical ventilation supply more than 7 days 3. culture proven sepsis 4. major congenital anomaly 5. neonates undergoing surgery

Keywords: symbiotic,cytokines, necrotising enterocolitis
an observational study measuring outcomes in cancer patients treated for moderate to severe hyponatremia in italy

Conditions: Hyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion; Cancer

Summary: this observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to siadh. patients will be prescribed treatment(s) according with the clinical practice regardless of the patient participation in the study. the purpose of this nis is to collect additional scientific and clinical information that can help in describing the characteristics of cancer patients with hyponatraemia secondary to siadh, the current management of hyponatremia, the therapies to keep under control serum \[na+\] and the guidelines for the management of this population in italy.


Eligibility criteria:
inclusion criteria: 1. age \>= 18 years; 2. male or female patients with a cytologically or histologically documented cancer diagnosis; 3. moderate to severe hyponatremia: na+ level cut off: \[na+\] \< 130 mmol/l; 4. physician diagnosed moderate to severe hyponatremia secondary to siadh (clinical or laboratory determined as per normal routine practice of treating physician); 5. no use of diuretic agents within the week prior to evaluation; 6. willingness to participate in the study; subjects must give their written consent to participate. exclusion criteria: 1. use of concomitant medications including demeclocycline and/or urea, by themselves or in combination with fluid restriction; 2. subject is currently participating in a clinical trial in which the investigational medicinal product aims to treat the causes or symptoms of hyponatremia; 3. life expectancy is lower than 3 months.

Keywords: hyponatremia due to siadh cancer
biomarker targeted stimulation for epileptiform events

Conditions: Epilepsy

Summary: this is a multicenter, prospective, controlled study designed to evaluate treatment with the bts system.


Eligibility criteria:
inclusion criteria: 1. subject is greater than or equal to 7 years of age. 2. subject has focal onset seizures. 3. subject has failed treatment with a minimum of two aed's used in typical therapeutic dosages. 4. subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver. 5. subject can reasonably be expected to maintain a seizure diary and the bts system alone, or with the assistance of a competent individual. 6. for one month prior to enrollment, subject's anti-epileptic medication dosages and ketogenic diet (as applicable) have been stable (other than acute, intermittent use of benzodiazepines) and subject has had at least three primary, disabling seizures per month, on average. seizures must be separated by a minimum of eight hours not to be considered part of a cluster. a cluster, for the purpose of this criterion, shall be considered a single seizure. 7. subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements. 8. a female subject of childbearing age must have a negative serum pregnancy test within two weeks prior to implant of the insr, and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least two years post-menopausal. 9. subject has been informed of their eligibility for resective surgery as a potential alternative to the study, if such surgery is a reasonable option. 10. subject has had a brain mri epilepsy evaluation within the past two years. 11. subject's anatomy will permit implantation of the insr within 20 mm of the skin surface. exclusion criteria: 1. subject has a history of substance abuse within the preceding two years. 2. subject participated in another drug or device trial that may confound study results within the preceding 30 days. 3. subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the bts system or with which the bts system interferes. patients with a vagus nerve stimulator (vns) implanted may be enrolled, provided their clinical status has been stable for at least one month prior to enrollment at their current stimulation parameter settings. 4. subject has anatomy that may interfere with electrode placement. 5. subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or investigator. 6. subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate). if platelet dysfunction is suspected, subject can be enrolled only if a hematologist, the investigator, and the neurosurgeon judge it to be advisable. 7. subject has been diagnosed with psychogenic or non-epileptic seizures that cannot be distinguished from their epileptogenic events. 8. subject is ineligible for cranial surgery.
mensenchymal stem cell (msc) included in orthadapt membrane for rotator cuff tears repair

Conditions: Chronic Disease

Summary: surgical reconstructive procedures for rotator cuff tears present a number of limitations. the few studies in which the repair integrity is evaluated, have shown the existence of a high rate of reruptures in spite of the fact that the functional results obtained short-term are satisfactory. morphologic analysis from the sutures, after different follow-up periods, has not shown satisfactory results. thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells (mscs) included in a membrane into rotator cuff tears improves, the radiograms and the function compared to cell-free tendon defect treatment.

the investigators will include: patients with massive tears from the supraspinatus tendon, in which reconstructive surgery is indicated. patients will be randomly stratified into two groups. the first group will receive autologous mscs transplantation included in a collagen type i membrane (orthadapt) and the second group will serve as cell-free controls. the surgical procedure will be performed by arthroscopic and/or combined technique: arthroscopic subacromial decompression and mini-open rotator cuff repair. the orthadapt-cells composite will be put on the sutured area. the radiograms and function will be assessed by independently observers, who will no have knowledge of the study group from which they will have been obtained.

Eligibility criteria:
inclusion criteria: * subject providing informed consent. * comprised subject male/female aged 55-80. * subject has a supraspinatus tendon rupture. * subject has an unilateral injury. * rupture is enough to need medical assistance. * subject has an conventional medical treatment fail at least 3 months. * subject has a "reparable" injury according to goutallier´s criteria. exclusion criteria: * subject has a prior clinical history of arthritis, diabetes or inflammatory disease.

Keywords: supraspinatus tendon mesenchymal stem cells orthadapt rotator cuff
champ app feeding difficulties repository

Conditions: Feeding and Eating Disorders of Childhood; Gastrostomy; Feeding Disorder of Infancy and Childhood

Summary: this repository will consist of home monitoring data, videos, and images of patients with feeding difficulties for asynchronous remote patient monitoring of manually entered data sent by parents to the healthcare team using the champ app for children with feeding difficulties. this information will be collected under a research protocol and this repository is for future research applications.

around 25% of children are reported to have some degree of feeding issues of whom 3-10% have more severe feeding disorders1. many of these feeding issues and difficulties can also lead to a need for supplemental nutrition in a child's diet due to the impact on growth. those requiring supplemental nutrition may find themselves having to be fed using tube feedings (tf), which carries its own set of obstacles and factors to consider. while feeding problems have been estimated to occur in 25%-35% of children observed as exhibiting normal growth, that number may spike to 85% in those with gi-related growth disorders2. this highlights the need to ensure treatment plans and programs are in place to assist this patient population. at children's mercy hospital, gi specialists care for children who have a variety of conditions, caring for the whole child and addressing physical, mental, emotional, and social aspects. by using a combined approach, and promoting research that seeks to improve care, significant improvements in children's health have been reported. one specialty this has been evident in at children's mercy is the cardiac patient population. there have been improvements in growth, feedings, and timeliness of interventions seen with the use of champ® app in the single ventricle population (a statistically significant difference in the frequency of growth failure, with no patients having growth failure during champ use)3-4. by harnessing the experience and knowledge gained through the champ® app research study, there is a great potential for children suffering from gi conditions to also benefit from this form of remote patient management and monitoring, especially when it comes to treating children with supplemental nutrition needs. there are no known gastroenterology- feeding mobile health software platforms with a dedicated research repository in pediatrics.

Eligibility criteria:
inclusion criteria: * patients enrolling in this research repository must also be enrolled in an applicable study (study00002775, study00003221) wherein they have consented to use champ app * parent-legally authorized representative can read one of the eleven languages that the champ app is available in. exclusion criteria: • all patients and parents/legally authorized representative not meeting the above specified criteria

Keywords: mhealth software platform asynchronous remote monitoring