Kornimate/medical-research-clean huggingface dataset:
education for children who will have planned surgery with web-based and therapeutic game method

Conditions: Day Surgery

Summary: this research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep. this study is a randomized controlled experimental study.

illness and especially hospitalization in the preoperative and postoperative period cause trauma with physiological, emotional and behavioral problems for children. with the help of web-based education and therapeutic game methods by pediatric nurses, anxiety, fear and pain seen in children and families can be reduced and skills to cope with negative emotions can be improved. this research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep. this study is a randomized controlled experimental study. the study is planned to be performed in the pediatric surgery clinic of the training and research hospital. for sample selection, children will be stratified in terms of age variables and divided into two strata as 7-9 years old and 10-12 years old. in order to ensure homogeneity between the groups, children will be selected into the study and control groups using a simple randomization method and a random numbers table. to the children in the study group and their parents; information about the child's surgery, educational brochures including the conditions to be considered before, during and after the operation, during the discharge period, operating room tour, educational games, etc. training will be given on the website using and a therapeutic game will be played in the game room at the hospital the day before the surgery. the children in the control group and their parents will be given routine care and information about the pre-operative preparation in the service. descriptive statistics, chi-square test will be used in the evaluation of the data. a value of p\<0.05 will be considered statistically significant.

Eligibility criteria:
inclusion criteria: * agreeing to participate in the research, * those who will have a planned surgery between the ages of 7-12, * having and able to use a computer/tablet and internet connection at home, * having the ability to use a computer / tablet, * pediatric patients given written consent by their parents exclusion criteria: * at least one previous experience of surgery * having communication problems (sight, hearing, mental), * diagnosed with anxiety disorder, * genetic/congenital disease,

Keywords: web-based education, therapeutic play anxiety pain fear
metabolic changes induced by nmn in healthy subjects with acute binge drink

Conditions: Binge Drinking; Liver Injury; Nutritional Supplementation; Hepatic Steatosis

Summary: the goal of this double-blinded, randomized, crossover trial is to investigate the effects of nmn supplementation on liver function, liver fat content and lipid metabolism in healthy young subjects with acute binge drink. the main questions it aims to answer are: 1. if nmn administration could accelerate alcohol metabolism and alleviate hangover symptom; 2. if nmn administration could alleviate alcohol-induced liver injury and hepatic steatosis.

the goal of this double-blinded, randomized, crossover trial is to investigate the effects of nmn supplementation on liver function, liver fat content and lipid metabolism in healthy young subjects with acute binge drink. the main questions it aims to answer are: 1. if nmn administration could accelerate alcohol metabolism and alleviate hangover symptom; 2. if nmn administration could alleviate alcohol-induced liver injury and hepatic steatosis. participants will be randomized into two groups (n=20), and take 4 nmn capsules (250mg/capsule) or 4 placebo capsules (maltodextrin), respectively. 15 minutes later, they are successively provided with same breakfast and then vodka with a dose of 1g/kg body weight. venous blood are collected at 0h, 1h, 2h, 3h, 4h, 8h, 12h and 24h from each subject, respectively. in addition, nuclear magnetic resonance imaging (mri) are taken at 0h, 4h and 24h after alcohol intake. after a 7-day washout period, volunteers are crossed over to another alternative group to receive the corresponding capsules and the test protocol repeats twice.

Eligibility criteria:
1. inclusion criteria: a. sign informed consent 2. exclusion criteria: 1. neurological disorders 2. alcohol allergy 3. alcohol addiction 4. gastrointestinal diseases 5. liver, kidney, cardiovascular or systemic diseases 6. antibiotics were administered within 2 weeks prior to the trial 7. participants who ate a vegetarian diet 8. unable to use a smartphone or computer with internet access 9. participate in another intervention study

Keywords: β-nicotinamide mononucleotide acute alcohol intake nutritional supplementation liver
remote monitoring of chronic illness patients with a ihap home wireless hub and vitals measurements

Conditions: Chronic Disease of Cardiovascular System

Summary: this is planned as a feasibility study. the primary objective is to evaluate a specially designed patient monitoring software vitalbeat and standard mobile device hub termed intel health application platform (ihap) in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction. the second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using the ihap wireless home hub device

the proposed study is a prospective single-center clinical feasibility study. all patients shall be monitored for a total period of 30 days from their date of recruitment. a total of 10 patients will be recruited from one center. the center will be provided with mobile devices which would be activated by a local mobile service provider. additionally a tablet computer will be provided to the local investigator for monitoring patient's data, providing portability and immediate access of information. an automated blood pressure (bp) monitoring apparatus and a weighing scale will be provided to the patient. vitalbeat software, with a mobile device home hub having a specially designed patient personalized software application ("vitalbeat" from aventyn, usa) for remote monitoring and a clinician monitoring software will be tested in the proposed study. the software has been developed in a manner which provides easy navigation and use, with provision of regular data entry of basic parameters used in chronic illness monitoring. the entered data is instantaneously available on the software monitored at the physician's end. this study is targeted towards chronic patients. a "chronic" patient is defined as a patient who has had within the last six months symptoms of chronic illness before enrollment. all patients above 18 years hospitalized and discharged alive with a primary diagnosis of a chronic illness shall be considered for recruitment. upon enrollment into the study, patients will have mobile device monitoring along with existing standard care monitoring available at the local center.

Eligibility criteria:
inclusion criteria: * subjects of either gender and 18 years or older * the subject is able and willing to provide written informed consent prior to enrollment in the study * symptoms of chronic illness. exclusion criteria: * disability of fingers or upper limbs (unable to use devices) * visually impaired * those unable to read and write * hearing dysfunction * significant cognitive disabilities / mental illness * those who are unable to handle electronic devices * those residing in places outside mobile phone coverage * patients who may not come for follow up or likely to drop out of the study * any illness which may preclude regular follow up
the relation between serum zinc and lupus nephritis

Conditions: Lupus Nephritis

Summary: the goal of this observational study is to investigate the relation between serum zinc and lupus nephritis by search prevalence of hypozincemia in lupus nephritis and association between serum zinc and urea, serum creatinine, hemoglobin, estimated glomerular filtration rate (egfr).

systemic lupus erythematosus (sle) is a chronic autoimmune disease affecting various organs including the skin, joints, kidneys, brain and heart... lupus nephritis (ln) is one of the most common severe organ manifestations of sle . ln is clinically evident in 50-60% of patients with sle , and it is histologically evident in most sle patients, even those without clinical manifestations of kidney disease. ln is associated with significant morbidity and mortality in sle patients, as up to 20% of patients progress to end-stage renal disease (esrd). the clinical manifestations of ln are variable, ranging from asymptomatic proteinuria to a myriad of manifestations associated with nephritic and nephrotic syndromes and esrd. zinc is a vital micronutrient involved in numerous physiological processes including immune function, antioxidant defense, and cellular repair. it is a cofactor for over 300 enzymes and plays critical roles in dna synthesis, protein production, and cell division. zinc deficiency can impair immune function, increase oxidative stress, and hinder tissue repair, which are all relevant factors in autoimmune diseases like sle, making its study in the context of ln particularly relevant. however, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in lupus nephritis patients.

Eligibility criteria:
inclusion criteria: * patients with lupus nephritis exclusion criteria: * other patients with other renal diseases . * patients with other autoimmune diseases. * patients on dialysis. * patients with diabetes mellitus. * patients with liver diseases.
clinical evaluation of the accuracy of the freestyle navigator continuous glucose monitoring system

Conditions: Diabetes Mellitus

Summary: to evaluate the clinical accuracy of the freestyle navigator continuous glucose monitoring system with respect to a reference standard.


Eligibility criteria:
inclusion criteria: * history consistent with type 1 diabetes * at least 18 years of age * available and capable of following the protocol instructions provided by the healthcare professional * signed and dated informed consent form exclusion criteria: * pregnancy * type 2, gestational, or secondary diabetes * known allergy to medical grade adhesives * skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin * seizure disorder * myocardial ischemia * history of stroke * severe hypoglycemia unawareness * other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety

Keywords: continuous glucose monitoring accuracy continuous glucose-error grid analysis
project prevam : prospective comparison of capsule endoscopy pillcam ii™ versus colonoscopy

Conditions: Adenomatous Polyps; Cancer

Summary: the aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, npv, ppv and diagnostic accuracy). the investigators will used the pillcam ii™ colon capsule (second generation) and a high resolution colonoscope (with high definition). both procedures will be perform in the same day with an adapted bowel preparation.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * patient with 40 years old and first degree relative affected by colo rectal cancer at age ≥ 60 ans * patient with 40 years old or ten years before the age at affected disease in case or first deree relative colo rectal cancer before 60 years old. * fecal occult blood test positive * personal history of adenomatous polyps * personnal history of acromegaly * patient with social insurance * persons already participating in another clinical trial.. * signature of informed consent exclusion criteria: * pregnancy or breast feeding woman * déficience mentale du sujet rendant sa participation à l'essai impossible * pacemaker or all electronic devices implanted * patient with swallowing disorder, or digestive stricture know or suspected by the investigator * previous history of intestinal surgery, radiotherapy or inflammatory bowel disease * previous history of polyadenomatous congenital disease, lynch syndrome * intolerance with dompéridon and/or bisacodyl * intolerance with oral intake of nap, polyethylen glycol (peg) or macrogol * colonoscopy contre indication for anesthesiologic reasons
safety, tolerability, and pharmacokinetic study of pregabalin in pediatric patients with partial onset seizures

Conditions: Epilepsies, Partial

Summary: the purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.


Eligibility criteria:
inclusion criteria: * partial onset seizures, incompletely controlled on 1-3 medications * at least 1 seizure per 28 days, on average exclusion criteria: * primary generalized seizures * progressive cns pathology

Keywords: partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics
experimental paradigm to investigate expectation change in depression 4

Conditions: Major Depressive Disorder

Summary: research has shown that people with depressive symptoms maintain negative expectations even if they have positive experiences that contradict their expectations. healthy people, however, change their expectations after unexpected positive experiences. in this experimental study, it will now be examined whether there are also differences between healthy people and people with depressive symptoms in dealing with unexpected negative experiences.

research has already shown that people with depressive symptoms continue to hold on to negative expectations even if they have positive experiences that contradict their expectations. by contrast, healthy people change their expectations after unexpectedly positive experiences. in this experimental study, the authors will now examine whether there are also differences between healthy people and people with depressive symptoms in processing unexpectedly negative experiences. it is hypothesized that people with depressive symptoms change their expectations in a negative direction after unexpectedly negative experiences, while healthy people continue to hold on to an optimistic view.

Eligibility criteria:
inclusion criteria (clinical sample): * diagnosis of major depression * at least 18 years old * sufficient german language skills exclusion criteria (clinical sample): * participation in previous studies on changes in expectations inclusion criteria (healthy sample): * at least 18 years old * sufficient german language skills exclusion criteria (clinical sample): * participation in previous studies on changes in expectations * current diagnosis of any mental disorder * diagnosis of major depression in the past * currently receiving psychotherapeutic treatment
a multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (tqj230) on the progression of calcific aortic valve stenosis

Conditions: Aortic Stenosis

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (tqj230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.


Eligibility criteria:
inclusion criteria: * male and female ≥50 to \<80 years of age * lp(a) ≥175 nmol/l at the screening visit, measured at the central laboratory * mild or moderate calcific aortic valve stenosis * at the randomization visit, participant must be optimally treated for existing cv risk factors exclusion criteria: * severe calcific aortic valve stenosis * uncontrolled hypertension * history of malignancy of any organ system * history of hemorrhagic stroke or other major bleeding * platelet count ≤ lln * active liver disease or hepatic dysfunction * significant kidney disease * pregnant or nursing women other protocol-defined inclusion/exclusion criteria may apply

Keywords: cardiovascular lipoprotein(a) lp(a) hyperlipoproteinemia(a) calcific aortic valve stenosis tqj230 pelacarsen aortic valve stenosis aortic stenosis
neuromuscular electrical stimulation and strength training in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to compare the efficiency of neuromuscular electrical stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and on recovering motor function of patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * american college of rheumatology criterion for osteoarthritis diagnosis exclusion criteria: * patients that have done knee replacement or are about to do. * patients with health conditions that are not compatible with the interventions * patients that have done intraarticular corticoid

Keywords: quadriceps strength osteoarthritis rehabilitation nmes
drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers

Conditions: Hypertension With Hyperlipidemia

Summary: study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers


Eligibility criteria:
inclusion criteria: * 19\~55 years healthy male * the result of body mass index(bmi) is not less than 19 kg/m2 , no more than 27 kg/m2 * subjects who agree to keep contraceptive methods during the clinical trial. exclusion criteria: * subjects who are allergic to investigational drug. * subjects who have a medical history which can affect the clinical trial. * hypertension(systolic bp ≥ 150mmhg or diastolic bp ≥ 100mmhg), hypotension(systolic bp ≤ 100mmhg or diastolic bp ≤ 70mmhg) * liver enzyme (ast, alt) level exceeds the maximum normal range more than one and a half times.
immunogenicity and safety of a trivalent inactivated influenza vaccine, formulation 2012-2013, in non-elderly adult and elderly subjects

Conditions: Influenza

Summary: the purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (hai) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current european union (eu) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (cpmp/bwp/214/96).


Eligibility criteria:
inclusion criteria: * males or non-pregnant females and aged ≥ 18 years; * willing and able to adhere to visit schedules and all study requirements; * subjects read and signed the study-specific informed consent. exclusion criteria: -

Keywords: influenza vaccine immunogenicity
skin cancer diagnostics using photoacoustic imaging

Conditions: Skin Cancer

Summary: in this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth.

the study will employ multispectral photoacoustic imaging in the spectral range between 680-970 nm to scan suspected skin tumors both in vivo and ex vivo. the hyperspectral data will then undergo rigorous spectral analysis with the objective to identify the spectral fingerprints associated with healthy tissue and tumor. thereafter, a classification algorithm will be used to determine whether a pixel in the acquired image more likely identifies with healthy tissue or tumor, which is then repeated for all pixels in the images. as such, a 3d image can be reconstructed in which the tumor is visibly contrasted from healthy tissue. achieving this goal will facilitate the diagnostic procedures and greatly reduce waiting times, clinical costs and potential patient suffering.

Eligibility criteria:
inclusion criteria: * patients scheduled to perform surgical excision of lesion(s) suspected to be tumors. exclusion criteria: -
endoscopic nebulizing device for surgical haemostatic-sealant glubran® 2 usability trial in emr and esd

Conditions: Gastrointestinal Cancer

Summary: the aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device endoneb.

single center, prospective, medical device usability and feasibility study. the study will be performed in fondazione policlinico universitario agostino gemelli irccs, rome. according to the recomandations of the italian ministry of health (28) regarding the sample size of pilot and feasibility studies, 15 applications underwent to mucosal or submucosal resection procedures will be evaluated. the recruitment period will be 36 weeks (9 months). the evaluation ends when endoneb has been used in the fifteenth subject or at one third of applications if the investigators will be able to give their evaluation of the feasibility of the endoneb technique, usability and safety. the endoneb medical device belongs to the family of "nebulizers" class iia accessory devices, used to apply glubran®2 in nebulized form in laparotomic, laparoscopic and thoracoscopic procedures. the endoneb medical device allows to apply the glubran®2 in nebulized form in digestive endoscopy interventions and can be used both with gastroscopes and colonoscopes with an operating channel not less than 2.6 mm. it is marketed in sterile presentation; the components are latex free and is for single use only.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of superficial neoplastic lesion to be resected by a gastrointestinal endoscopic resection (emr or esd) * older than 18 years of age at time of consent; * operable per institution's standards; * signed and dated informed consent form exclusion criteria: * any clinical conditions precluding the feasibility of gastrointestinal endoscopic resection (endoneb could be contraindicated in patients who are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment); * pregnant during period of study participation; * allergy history to cyanoacrylate.