Kornimate/medical-research-clean huggingface dataset:
effects of repeated general anaesthesia on the level of pre-procedure anxiety in children undergoing radiotherapy.

Conditions: Anxiety

Summary: observation of pre-precedure anxiety in pre-operative suite in children from age 2-12yrs, undergoing radiotherapy under general anesthesia.

radiotherapy procedures are used to damage or destroy growing cancer cells.(1) this strategic use of ionized radiation is being practiced since the early 20th century and is very effective in destroying diseased cancer cells while sparing the healthy ones.(2) these procedures require patients to stay absolutely still, hence requiring general anesthesia in case of children compared to the adults. the treatment also requires multiple cycles of radiotherapy for which children have to undergo general anaesthesia multiple times.(3) multiple anaesthetics for the same child may lead to preoperative anxiety, increased autonomic fluctuations, increased demand for anaesthetics and nausea/vomiting.(4-5) pre-operative anxiety not only causes physical but also emotional and psychological trauma.(6) such patients, subjected to anxiety, may face fear and potential hesitance in visiting the pre-anesthesia clinics for evaluation, induction and problems in pre-operative and recovery span.(7-8)it is therefore important to gauge the extent of this anxiety and to see whether it increases or decreases with subsequent cycles of treatment .unless this is identified it will be difficult to put appropriate treatments in place. though previous studies are available on pre-operative anxiety in children but there has been little research about level of a child's anxiety under going repeated general anesthesia, especially during radiotherapy sessions. we were unable to identify any study on the subject in our literature search, a gap that needs research. several scales are available to evaluate anxiety in children(9), mypas scale is a standard it is also important to measure the anxiety levels of the parents accompanying the child, since this may have an effect on behavior.

Eligibility criteria:
inclusion criteria: 1. child of either gender 2. 2-12 years of age 3. asa status (1,2 and stable 3) 4. pre-school, school and non-school going 5. scheduled for a radiotherapy procedure under general anesthesia for at least 3 cycles under ga exclusion criteria: 1. procedure to be done under sedation alone 2. children with developmental delay 3. children coming with other relatives apart from parents.
clinical follow-up study of cd19 car-t expressing il7 and ccl19 for relapsed or refractory b cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma; Transformed Follicular Lymphoma; Primary Mediastinal Large B-cell Lymphoma

Summary: this study is designed to monitor all patients exposed to cd19 car-t expressing il7 and ccl19 for 5 years following infusion, to assess their long-term efficacy, including the car-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (aes).

patients are enrolled following completion from the early clinical study of cd19-7x19 car-t treatment ( nct03258047) and will be followed for 5 years post treatment from the last treatment. they will be monitored for safety and efficacy with the primary treatment protocols for the protocol defined duration. this long-term following up study allow an interim analysis to evaluate the outcomes of the study when it arrives in 2 years collection of such long term effects of car-t cell therapy will help to further define the risk-benefit profile of car-t therapies.

Eligibility criteria:
inclusion criteria: * all patients who have received the cd19-il7/ccl19 car-t therapy in the earlier enrolled clinical trail and met including and excluding criteria criteria (nct0325847) patients who have provided informed consent for the long term follow up study prior to their study participation . exclusion criteria: * there are no specific exclusion criteria for this study.
lynparza pancreas cancer japan post-marketing surveillance (pms)

Conditions: Pancreatic Neoplasms

Summary: to collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with brca mutated pancreatic cancer under the actual post-marketing use of lynpaza.

to collect and characterise the incidence of adverse events related to the safety specifications\*1 of the maintenance treatment after platinum-based chemotherapy in patients with brca mutated pancreatic cancer under the actual post-marketing use of lynpaza. this investigation will be conducted for application for re-examination specified in article 14-4 of the pharmaceutical affairs law. \*1: bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity

Eligibility criteria:
inclusion criteria: * patients who receive lynparza for the first time for the maintenance treatment after platinum-based chemotherapy in patients with brca mutated curatively unresectable pancreas cancer after the approval date of partial change application for the additional indication (25/dec./2020). exclusion criteria: * patients who have no treatment history with lynparza
relative bioavailability study of lipidil® supra (fenofibrate 160mg) versus syo-0805 (fenofibrate 65mg)

Conditions: Hyperlipidemia

Summary: the purpose of this study is to evaluate the bioequivalence of lipidil® supra (fenofibrate 160mg) versus syo-0805 (fenofibrate 65mg) in single dose oral administration.


Eligibility criteria:
inclusion criteria: * healthy adults 20-50 years of age * weight more than 55kg and within ±20% ibw(ideal body weight) * voluntary written informed consent exclusion criteria: * history or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease * drug allergies to fenofibrate * recent history or evidence of drug abuse * recent participation(within 2months) in other clinical studies * recent donation of blood(within 2months) or plasma(within 1months)
rct (randomized controlled trial) of iv acetaminophen for post operative vaginal reconstruction pain

Conditions: Post Operative Pain

Summary: this randomized controlled trial will evaluate the effects of perioperative intravenous (iv) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. one hundred subjects will be randomly assigned to receive either iv acetaminophen or iv placebo. those in the iv acetaminophen group will receive 1000mg iv every 6 hours for 24 hours beginning prior to anesthesia induction. the control group will receive placebo saline infusions at the same time intervals. all subjects will receive as needed (prn) iv narcotic for additional pain relief. visual analog scales (vas) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. we will also collect total iv narcotic consumption. we hypothesize that subjects receiving iv acetaminophen will have lower vas scores and decreased total narcotic consumption in comparison to the control group.

see brief summary

Eligibility criteria:
inclusion criteria: * women between the ages of 18 and 70 years * patients of the division of urogynecology at good samaritan and bethesda north hospitals in cincinnati, ohio * scheduled to undergo major vaginal reconstruction * must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. the addition of suburethral sling is not a cause for exclusion. exclusion criteria: * allergy to acetaminophen * liver disease (chronic or active) * chronic alcohol use (\>1 drink/day) * bleeding diathesis * renal disease * opiate dependent or daily use * history of chronic pain * mental or cognitive disorder preventing patient to accurately verbalize pain levels * undergoing abdominal or laparoscopic procedures at the time of surgery * allergy to hydromorphone * surgery is not performed under general anesthesia

Keywords: iv acetaminophen vaginal reconstruction pain, postoperative
open label study to assess the effectiveness of amlodipine-atorvastatin combination in hypertension and dyslipidemia.

Conditions: Hypertension; Hyperlipidemia

Summary: to evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (bp) and ldl-c targets as defined by their governing guidelines.


Eligibility criteria:
inclusion criteria: * treated or untreated subjects with concurrent hypertension and dyslipidemia with bp and ldl-c not at target according to governing guidelines exclusion criteria: * high liver enzymes
cost-effectiveness study of the treatment of attention deficit/hyperactivity disorder in brazil

Conditions: Attention-deficit/Hyperactivity Disorder

Summary: this study is an open-label, 6 month trial, of immediate release methylphenidate (mph-ir) for children with adhd aimed at assessing whether the observable behavioral changes seen during treatment are associated with potentially more stable underlying modifications in brain functioning (resting-state functional connectivity). additionally, we will also be looking at treatment effects on neuropsychological processes and reading skills. this information will contribute to the first brazilian study assessing the cost-effectiveness of the treatment of adhd. children with adhd will be compared to a sample of sex and age-matched sample of typically developing children.


Eligibility criteria:
inclusion criteria: the study will include 20 boys aged 8 to 10 years old, regularly enrolled in local schools and directed to the research through advertisement in the media, contact with schools or directly referred to the attention deficit/hyperactivity program (prodah/hcpa) by primary care services for assessment and treatment. only children with a primary diagnosis of adhd or with the comorbidity adhd + reading disorder or adhd + odd will be included. only drug-naïve subjects will be apt to participate in the study. exclusion criteria: children who fit into one or more of the following conditions will not be considered eligible to take part in the study: (1) they are outside the age range specified; (2) they are not regularly enrolled and attending school; (3) they have a history of prior or current treatment with psychoactive drugs or psychotherapy; (4) they are mentally retarded (overall iq\<80); (5) they have a main diagnosis differing from adhd, including children with other psychiatric or neurological diagnoses

Keywords: open label ritalin® adhd
association of hscar with mafld and liver fibrosis: a cross-sectional study

Conditions: Metabolic Dysfunction-associated Fatty Liver Disease; Hepatic Steatosis; Liver Fibrosis

Summary: the goal of this observational study is to investigate the associations between a novel inflammatory marker, high sensitivity c-reactiveprotein to albumin ratio (hscar), and steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (mafld). the main question\[s\] it aims to answer are: \[question 1\] can hscar serve as a clinical indicator to determine whether a patient has mafd? \[question 2\] can hscar determine whether mafld patients are complicated with liver fibrosis?

background inflammation is related to the occurrence and development of fatty liver. our research aimed to investigate the link between an inflammatory indicator, high-sensitivity c-reactive protein to albumin ratio (hscar), and metabolic dysfunction-associated fatty liver disease (mafld). methods ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis of participants from the nhanes database, respectively. the relationship between hscar and mafld was explored using multivariate logistic regression analysis, restricted cubic splines (rcs) as well as threshold analysis. finally, subgroup analyses were performed using the same methodology.

Eligibility criteria:
inclusion criteria: * total participants from nhanes 2017-2020 * participants diagnosed with mafld. metabolic dysfunction-associated fatty liver disease (mafld) is the term used to describe hepatic steatosis in the presence of metabolic abnormalities, excess weight, obesity, or type 2 diabetic mellitus. 1. diagnosis of diabetes mellitus: (1) taking glucose-lowering drugs; (2) hba1c ≥ 6.5% (48 mmol/mol); (3) fasting plasma glucose ≥ 7.0 mmol/l (126 mg/dl); (4) 2-hour plasma glucose (2hpg) ≥ 11.1 mmol/l (200 mg/dl). 2. overweight or obesity: defined as bmi≥25 kg/m2 in caucasians or bmi≥23 kg/m2 in asians 3. if presence of at least two metabolic risk abnormalities: * waist circumference≥102/88 cm in caucasian men and women (or≥90/80 cm in asian men and women) * blood pressure≥130/85 mmhg or specific drug treatment * plasma triglycerides≥150 mg/dl (≥1.70 mmol/l) or specific drug treatment * plasma hdl-cholesterol \<40 mg/dl (\<1.0 mmol/l) for men and \<50 mg/dl (\<1.3 mmol/l) for women or specific drug treatment * prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl \[5.6 to 6.9 mmol/l\], or 2-hour post-load glucose levels 140 to 199 mg/dl \[7.8 to 11.0 mmol\] or hba1c 5.7% to 6.4% \[39 to 47 mmol/mol\]) * homeostasis model assessment of insulin resistance score≥2.5 * plasma high-sensitivity c-reactive protein level \>2 mg/l exclusion criteria: * liver ultrasound data not available * participants without complete clinical data * participants under 18 years old * participants with cancer.

Keywords: high-sensitivity c-reactive protein to albumin ratio metabolic dysfunction-associated fatty liver disease national health and nutrition examination survey control attenuation parameter liver stiffness measurement inflammation
pilot study of lovaza (omega 3 fatty acids) to improve cardiac antioxidant/anti-inflammatory profile before cardiac surgery

Conditions: Mitral Valve Regurgitation; Left Atrium Dilatation and Hypertrophy; Mitochondrial Dysfunction in the Heart; Cardiomyocyte Apoptosis; Cardiac Inflammation

Summary: in the absence of treatment, severe mitral valve regurgitation (mr) results in left atrium (la) dilatation and hypertrophy, followed ultimately by left ventricular dysfunction and heart failure. one promising intervention for the prevention of the deleterious effects of pressure overload-induced cardiac hypertrophy and heart failure is dietary supplementation with n-3 polyunsaturated fatty acids (pufas). however, the molecular targets and mechanisms by which n-3 pufas exert their effects are not completely defined. a possible target of n-3 pufas is the mitochondrial membrane which has broad implications given that mitochondrial dysfunction and altered metabolism have been associated with cardiac hypertrophy and heart failure. the investigators have recently identified significant mitochondrial dysfunction in the la of patients with severe mr, as compared to their non-hypertrophied right atrium (ra). however, the investigators have not addressed the possibility that intervention with purified n-3 pufas (lovaza) could improve mitochondrial function. from a mechanistic perspective, the investigators have observed in vitro that n-3 pufas accumulate predominately into the mitochondrial membrane of cardiomyocytes where the investigators believe they exert their effects on the biophysical organization of the membrane. therefore, the central hypothesis is that administering lovaza to patients with severe mr will reduce apoptosis and improve mitochondrial function in la (aim 1). this change in mitochondrial function will be driven by significant biochemical and biophysical remodeling of the mitochondrial membrane (aim 2).


Eligibility criteria:
inclusion criteria: * patients age 18+ undergoing minimally invasive mitral valve repair surgery will be enrolled in this study. exclusion criteria: * patients with chronic renal insufficiency * chronic obstructive pulmonary disease * previous myocardial infarction * left ventricular dysfunction (ejection fraction \<40%) * use of anti-arrhythmic drugs other than beta blockers, and the presence of an implantable defibrillator. * in addition, patients that have a high dietary intake of fish (≥ 2 servings/week) or have been taking n-3 pufa supplements will be excluded. * also, patients that are allergic to fish or shellfish, or taking any anticoagulant/antiplatelet medications other than aspirin (e.g. plavix, coumadin) will be excluded from this study. * patients under the age of 18, and women who are pregnant will be excluded from this study.

Keywords: mitral valve regurgitation omega 3 fatty acids fish oil cardiac mitochondria apoptosis human heart
utilisation of angiox® in european practice

Conditions: Stable Angina (SA); NSTE-ACS (NSTEMI and UA); STEMI (STE-ACS)

Summary: the objective of this study is to determine utilisation patterns in patients receiving angiox® in participating european centres. additionally, through the collection of descriptive safety and outcomes data, this study will contribute to the risk management strategy for europe


Eligibility criteria:
inclusion criteria: * eligible for, and receive treatment with angiox®. * willing and able to provide written informed consent to the use of their data in accordance with relevant local data protection laws, policies and regulations exclusion criteria: * participation in other interventional clinical research studies involving the evaluation of investigational drugs, including angiox®, or devices at the time of enrolment. * patients not eligible for treatment for angiox®.
the clinical significance of minimal change in reflux esophagitis based on the gastroesophageal reflux disease questionnaire

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to define the endoscopic findings of minimal change that is significant to clinical significant reflux esophagitis. through this, the investigators want to estimate the applicability of minimal change findings of reflux esophagitis to the clinic.


Eligibility criteria:
inclusion criteria: * age ≥ 20 years old patients who consent to revealing their medical information and be able to respond to questionnaires regarding the symptom. * patients who had shown the reflux esophageal minimal change in the endoscopic finding: the reflux esophagitis exclusion criteria: * patients who had shown the mucosal break or barrett esophagus at gastric mucosal barrier or lower oesophagus in endoscopic findings * patient with a diagnosis of gastroesophageal reflux disease and who have received medication treatment * patient who had received h2-receptor antagonists, prostaglandin, ppi, nsaids or aspirin, high dose steroid and anticoagulants for at least 5 consecutive days in the 4-week period immediately preceding the diagnostic endoscopy * patients with a history of operation due to gastrointestinal disease, malignancy, alcoholism, pregnancy (in female), breast feeding (in female) or systemic disease

Keywords: minimal change gerd gerdq
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell iv infusion for systemic sclerosis

Conditions: Systemic Sclerosis

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of systemic sclerosis

studies have shown that stem cell treatment is safe and efficacious for the treatment of systemic sclerosis. patients with systemic sclerosis will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. for patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous t cell vaccine will be utilized created from the patient's own t cells obtained by apheresis.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic sclerosis * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: systemic sclerosis scleroderma stem cell treatment
background of different phenotypes of coeliac disease

Conditions: Celiac Disease; Dermatitis Herpetiformis

Summary: the main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.

the recognition of clinical heterogeneity has expanded the understanding of coeliac disease, but the factors contributing to this diversity remain unclear. moreover, since coeliac disease is highly heterogeneous, there is a need for more individualized follow-up and support and implementation of more personalized follow-up guidelines. in this study coeliac disease and dermatitis herpetiformis patients and healthy controls will be recruited. genetic, clinical, immunological, micobiata and novel biomedical markers are compared between coeliac disease phenotypes and also controls and their prognostic value is assessed.

Eligibility criteria:
inclusion criteria: * cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis * cohort 3: friend or non-related family member of coeliac disease or dermatitis herpetiformis patient exclusion criteria: * cohorts 1-3: age \<18 years * cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis not confirmed * cohort 3: coeliac disease or dermatitis herpetiformis diagnosis

Keywords: coeliac disease dermatitis herpetiformis gluten-free diet transglutaminase microbiata