Kornimate/medical-research-clean huggingface dataset:
south korean study to prevent frailty and aging-related diseases through lifestyle intervention

Conditions: Frailty

Summary: the goal of this feasibility randomized controlled trial is to investigate the applicability of software that aims to improve symptoms of frailty by implementing customized interventions such as physical exercise and cognitive training implemented through a mobile app for 16 weeks for patients diagnosed with frailty or prefrailty. the primary outcomes are adherence, retention rates, and recruitment rates. participants will participate in customized interventions including physical exercise, cognitive training, nutritional guidance, and management of disease related to frailty for 16 weeks.

the physical exercise program will comprise aerobic exercise, balance-improving exercises, flexibility-enhancing activities, and strength-building exercises targeting major muscle groups through a mobile app . customized cognitive training, performed using a mobile app, targets the cognitive domains of prospective memory and executive function. nutritional intervention will be performed to treat frailty symptoms and disease related to frailty through a mobile app. education and management of disease related to frailty will be done through a mobile app.

Eligibility criteria:
inclusion criteria: * 60-90 years of age * residing in the community * total score of modified fried frailty phenotype score ≥ 1 point * korean mini-mental state examination-2 z-score ≥ -1.5 * can read and write * being able to use the a mobile app through education or having someone help a participant use the mobile app * having a reliable informant who could provide investigators with the requested information. * written informed consent exclusion criteria: * major psychiatric illness such as major depressive disorders * dementia * other neurodegenerative disease (e.g., parkinson's disease) * malignancy within five years * cardiac stent or revascularization within one year * serious or unstable symptomatic cardiovascular disease * other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease * severe loss of vision, hearing, or communicative disability * significant laboratory abnormality that may result in cognitive impairment * any conditions preventing cooperation as judged by the study physician * unable to participate in exercise program safely * coincident participation in any other intervention trial

Keywords: frailty intervention multidomain digital
ketamine add-on therapy for established status epilepticus treatment trial (kesett)

Conditions: Status Epilepticus

Summary: the goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.

kesett is a multicenter, randomized, blinded study to determine whether adding 1 mg/kg or 3 mg/kg dose of ket to 60 mg/kg lev can terminate status epilepticus (se) in a larger fraction of subjects with benzodiazepine-refractory se than those treated with lev (60 mg/kg) alone. the primary outcome is termination of se from 15 minutes after starting the study drug infusion, sustained until 60 minutes from enrollment without using additional anti-seizure medication. termination of se is determined by (1) improving consciousness and absence of clinically apparent seizures at 60 minutes or (2) absence of any electrographic se after 15 minutes in those with eeg monitoring and no improvement in consciousness. secondary objectives include determining the relative safety of the treatment arms on defined safety outcomes and all adverse events, analysis of secondary/exploratory efficacy outcomes, and evaluation of both effectiveness and safety in the pediatric subpopulation. the trial will initially allocate subjects equally (1:1:1) for the first 350 participants (burn-in period) before transitioning to response-adaptive randomization. interim analyses will be conducted for efficacy and futility beginning when 350 subjects have been randomized, and will occur every 100 subjects thereafter. a maximum of 770 participants will be enrolled.

Eligibility criteria:
inclusion criteria: * the patient was witnessed to have a convulsive seizure for greater than 5-minute duration * the patient received an adequate dose of benzodiazepines. the doses may be divided. * the last dose of a benzodiazepine was administered 5-30 minutes before study drug administration. * continued or recurring seizures in the emergency department. * age 1 years or older * known or estimated weight ≥10 kg exclusion criteria: * known pregnancy * prisoner * opt-out identification or otherwise known to be previously enrolled in kesett * treatment with a second line anticonvulsant (fos, pht, vpa, lev, phenobarbital, or other agents defined in the mop) for this episode of se * treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of se(propofol, etomidate, ketamine or other agents defined in the mop) * endotracheal intubation prior to enrollment * acute traumatic brain injury clearly precedes seizures * scalp injury or burn preventing eeg placement * known allergy or other known contraindication to ket or lev * hypoglycemia \< 50 mg/dl * hyperglycemia \> 400 mg/dl * cardiac arrest / post-anoxic seizures
retina biobank: retina biomarkers for a deeper understanding of vitreoretinal and systemic diseases

Conditions: Other Retinal Disorders; Retinal Disease; Retinal Vascular Disorder

Summary: the rbbk study is a non-interventional, prospective study that will characterize disease state biomarker levels from aqueous humor, vitreous humor, intraoperative tissue and saliva of subjects with various retinal and systemic pathologies.

the rbbk study is a non-interventional, prospective study that will characterize disease state biomarker levels from aqueous humor, vitreous humor, intraoperative tissue and saliva of subjects with various retinal and systemic pathologies. participants are eligible to be included in the study only if all of the following criteria apply: 1. men or women \> 18 years of age 2. subjects with vitreoretinal disease in at least one eye receiving a retinal treatment intervention 3. able and willing to provide signed informed consent the study will consist of a single visit and a retrospective chart review. the study visit will consist of: 1. screening for eligibility; 2. aqueous humor collection (if applicable); 3. vitreous humor collection (if applicable); 4. intraoperative tissue (if applicable); and 5. saliva collection if applicable, approximately 50 microliters (or more, up to 1000 microliters) of aqueous fluid will be collected by anterior chamber paracentesis according to standard clinical procedures. if applicable, up to 2 milliliters of vitreous fluid will be collected according to standard clinical procedures. specific tissue, such as scar tissue, are routinely removed from the eye during vitreoretinal procedures. when being removed during a standard of care surgical procedure, these tissues may be collected. saliva will also be collected according to instructions found in the saliva oragene dx collection kit.

Eligibility criteria:
inclusion criteria: 1. subjects with vitreoretinal disease in at least one eye receiving a retinal treatment intervention exclusion criteria: 1. prior intraocular or subtenon steroid injection in the study eye within the prior 1 month of signing informed consent 2. intraocular or refractive surgery in the study eye within 30 days of signing informed consent 3. systemic anti-vegf treatment within 90 days of signing informed consent
effects of kinesiology taping in stroke patients

Conditions: Stroke; Upper Extremity Dysfunction

Summary: the goal of this clinical trial is to learn if kinesiology taping works to treat stroke patients. the main question it aims to answer is: is kinesiology taping effective in stroke patients? researchers compare kinesiology taping to a placebo (visually similar but has no effects) to see if kinesiology taping works immediately to treat stroke patients.

this study aimed to evaluate the immediate effects of kinesiology taping (kt) on trunk control, posture, proprioception, and upper limb function in stroke patients, specifically focusing on the trunk-scapula-shoulder complex. a total of thirty-seven stroke patients participated in this placebo-controlled trial, where they were randomly assigned to either the kt group (n=19) or a placebo-controlled sham kt group (n=18). the kt group received kinesiology taping applied using facilitation and inhibition techniques, while the control group received sham taping without therapeutic tension. the application of kinesiology taping to the trunk-scapula-shoulder complex in stroke patients resulted in immediate enhancements in trunk control, shoulder posture, and proprioception. however, it did not significantly improve upper limb function in the short term.

Eligibility criteria:
inclusion criteria: * experienced a first-ever stroke * demonstrated a motor recovery level of brunnstrom stages 3 or 4 in the affected upper limb * no history of botulinum toxin-a therapy within the past three months * possess sufficient cognitive ability to understand and follow assessment instructions exclusion criteria: * individuals with movement or functional limitations due to prior shoulder injuries * exhibited allergic reactions or skin sensitivities to taping * patients with any existing skin conditions

Keywords: stroke trunk control kinesiology taping
an open-label interaction study to look at the effects of brivaracetam on phenytoin when taken together in 15 adult patients with epilepsy.

Conditions: Epilepsy

Summary: the primary objective of this phase i study in 15 adult subjects suffering from epilepsy and chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.


Eligibility criteria:
inclusion criteria: * well-characterized epileptic syndrome according to the ilae classification. * patients currently treated with stable phenytoin monotherapy for at least three months and with at least one plasma measurement of pheyntoin within the target range (7 - 23 µg/ml) during the screening period. exclusion criteria: * history of status epilepticus in the last year. * subjects taking any drug that may significantly influence the metabolism of ucb 34714 (cyp2c or cyp3a potent inducers/inhibitors) except if the dose has been stable at least three months before entry into the study and will be kept stable for the entire trial duration. * subjects with a creatinine clearance of ≤50 ml/min.

Keywords: partial onset seizures, phenytoin, dilatin, brivaracetam, interaction
assessment of the effectiveness of muscle activating training with the use of emg biofeedback in patients with neuromuscular diseases

Conditions: Neuromuscular Diseases

Summary: the aim of this study is to assess the impact of individually planned therapeutic procedures, using, among others, the concept of emg biofeedback, to improve the general functional state, selected motor activities, stimulation and strength of specific muscle syndromes as well as postural parameters in children, adolescents and adults with neuromuscular diseases.


Eligibility criteria:
inclusion criteria: * confirmed genetic duchenne muscular dystrophy (dmd) or becker muscular dystrophy (bmd), limb-girdle dystrophy, spinal muscular atrophy (sma), myopathy or neuropathy * continued/uninterrupted rehabilitation process for 3 months * patient's condition allowing full understanding of commands exclusion criteria: * patients using a respirator * painful complaints * after injuries and fractures in the last 6 months * significant weakening of muscle strength, preventing movements and activation of selected muscle groups, visible in the emg examination * cognitive impairment-lack of or poor cooperation between the patient and the therapist,
xience v at wake forest university baptist medical center (wfubmc)

Conditions: Percutaneous Coronary Intervention; Stents

Summary: the effectiveness, safety, and deliverability of second generation drug eluting stents (des), including xience v, will need to be examined in real world patients to provide the same level of evidence base and comfort that has accompanied the use of the first generation devices. randomized clinical trials provide the fairest evaluation of outcomes by controlling for confounding patient and procedural characteristics; however, randomized clinical trials also exclude the very high risk patients that account for upwards of 80% of real world patient populations such as those at wake forest university baptist medical center (wfubmc). clinical follow-up data including non-fatal mi, all cause mortality and stent thrombosis, as well as medications compliance, of patients undergoing stent therapy including xience v in a real world patient population will be collected at wfubmc. existing data for several control groups will be used to compare outcomes with xience v including a consecutively treated bare metal stent (bms) cohort of 1,200 patients, and a des cohort of 1,200 patients (900 sirolimus-eluting and 300 paclitaxel-eluting) treated between april 2004 and april 2005. patients undergoing stent therapy in the year prior to use of xience v, and contemporaneous patients receiving non-xience v stent therapy during xience v use will serve as additional controls. all patient data will be de-identified using unique blinded identification codes after data collection is completed. the null hypothesis of this study states that safety outcomes (stent thrombosis, non-fatal mi, death) with xience v will be equivalent to historical and contemporaneous controls; effectiveness outcomes (target lesion and target vessel revascularization) with xience v will be superior to historical and contemporaneous bms controls, and equivalent to historical and contemporaneous des controls; and the need for crossover to another stent type will be equal to that observed with historical des controls. outcomes will be reported using contemporary measures of clinical outcomes and analyzed using cox proportional hazards survival analysis methodology. these data should provide important information on the clinical effectiveness and safety of xience v in routine practice.


Eligibility criteria:
inclusion criteria: * percutaneous coronary intervention with stenting exclusion criteria: * none

Keywords: stents mortality revascularization stent thrombosis drug-eluting stents
effect of preoperative anxiety on fetus in pregnant women

Conditions: Preoperative Anxiety; Cytokines

Summary: in the preoperative period, 60-80% of the patients had anxiety symptoms. this rate increases even more during pregnancy. there are a number of studies examining the role of anxiety symptoms on fetal outcome, but the mechanisms that explain the effects of maternal stress are not fully understood. the most extensively studied cytokines in neuropsychiatric disorders are tnf-α and il-6 due to their effects on the central nervous system. tnf-α levels have been reported to be elevated in anxiety disorders. in our study, the investigators aimed to determine the relationship between preoperative anxiety levels and fetal cord blood tnf-α and il-6 cytokine levels in pregnant women.

this prospective observational study is planned to involve 30 volunteer patients between 18-40 years of age who will undergo elective caesarean section surgery. people with known psychiatric illness and medication use, illiterate, who do not have mental competence to understand survey questions and very urgent patients will not be included in the study. preoperative anxiety levels will be determined by the stai-continuity scale at the time of admission to the anesthesia outpatient clinic and by the stai-state scale 1 hour before surgery.the scales will be scored as normal, mild, moderate and severe anxiety. psychiatric consultation will be requested for patients with severe anxiety. at the end of the cesarean section, the concentration of tnf-α and il-6 cytokines in the blood remaining from routine blood gas taken from the umbilical cord will be determined to obtain information about the state of fetal well-being.

Eligibility criteria:
inclusion criteria: * between 18-40 years * undergo elective caesarean section surgery * volunteer patients exclusion criteria: * people with known psychiatric illness and medication use * who do not have mental competence to understand survey questions * very urgent patients * i̇lliterate

Keywords: preoperative anxiety umbilical cord blood cytokines
glutathione metabolism in adolescents with type 1 diabetes - study b

Conditions: Diabetes Mellitus, Type 1

Summary: glutathione is normally present at high levels in the blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by several reactive oxygen species produced by the metabolism of most nutrients, including glucose. glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and glycine. this study is looking at how blood sugar levels may affect the way glutathione is made and used by the body. since glutathione is continuously synthesized and broken down, the amount of glutathione present in the blood depends on the balance between its rate of synthesis and its rate of use. in earlier studies, we found that in poorly controlled diabetic teenagers, glutathione was low, not because it was not produced fast enough, but because it was used at an excessive rate. in this study, we want to find out whether improving blood sugar control will increase glutathione levels, and, if so, how long this will take. we also hope to find out if oral supplementation with a mixture of several antioxidant vitamins and minerals will increase glutathione levels more than taking a placebo.

forty adolescents with t1d will undergo a measurement of blood glutathione concentration and markers of oxidative stress (plasma protein-bound 3-nitrotyrosine, and urinary 8oh-2-dg, and f2-isoprostane excretion, markers of oxidative damage to protein, dna and lipids, respectively) while at near normoglycemia, on two separate occasions: * first, when in poor glucose control (hba1c\>7.5%); and * secondly, after 3 to 9 months months of improved blood glucose control, along with the administration of either a placebo, or a mixture of antioxidant minerals and vitamins based on a randomization scheme. between the two metabolic study days, patients will receive the same intensified diabetes regimen consisting of education and counseling, home blood glucose monitoring, multiple daily insulin injections (mdi), diet plan, and frequent phone contact with a certified diabetes educator.

Eligibility criteria:
inclusion criteria: * type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment * bmi \<25 kg/m2 * age 12-21 * hba1c\>7.5% * no evidence of diabetic complications * written informed consent from parents or legal guardian, and assent from patient exclusion criteria: * presence of significant anemia (hemoglobin \<11g/dl) * presence of intercurrent illness such as infection * presence of chronic disease such as other endocrine deficiency, chronic respiratory or cardiac disease * chronic use of medication other than insulin * use of vitamin or mineral supplements within 2 weeks of study

Keywords: glutathione
"novo c plus" vitamin c containing dietary supplement bioavailability in healthy subjects

Conditions: Vitamin C Deficiency

Summary: the aim of this study is to evaluate the bioavailability of "novo c plus" vitamin c containing dietary supplement compared to licensed vitamin c medications. the novelty of this product is the liposomal formulation.


Eligibility criteria:
inclusion criteria: * 21-65 years old healthy volunteers * body weight \>45 kg * body height \>150 cm * plasma ascorbic acid at screening \<75 µmol/l * signed written informed consent * subject agrees avoid vitamin c containing medications and dietary supplements from screening until v0 visit (maximum 15 days) * subject agrees to avoid high activity physical exercise 72 hours prior to v0 visit exclusion criteria: * confirmed or suspected active infection * liver or renal failure (equal or greater than ckd3) * chronic disease that affects absorption or vitamin c metabolism * severe metabolic disorder * body mass index \>35 kg/m2 * malabsorption syndrome that affects vitamin c metabolism * heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with \>100/min ventricular rate * gastrointestinal bleeding in past three months * uncontrolled diabetes mellitus (hba1c\>8,5%) * malignant disease * alcohol or drug abuse * active psychiatric disorder, intention for suicidal, disorders with unconsciousness * psychopathic disorder, lack of cooperation * known coagulopathy * chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months) * untreated hypertension if blood pressure is greater than 165/95 mmhg * gravidity or breastfeeding * taking more than 100 mg vitamin c daily within 2 weeks to screening

Keywords: vitamin c supplementation
the correlation between non-invasive indicators in patients with biliary atresia

Conditions: to Find Out Non-invasive Indices to Predict the Status of Hepatic Fibrosis in BA Patients.

Summary: we propose this study and try to find out possible clinical applicable non-invasive imaging indices or its combination with the laboratory indices to predict the status of hepatic fibrosis in ba patients.


Eligibility criteria:
inclusion criteria: * pathological proved diagnosis of biliary atresia, and without other distinct abnormality or malformations. all had undergone kasai portoenterostomy. all of them received abdominal mri study. exclusion criteria: * absence of laboratory data required.
the multitasking rehabilitation she enhanced walking speed compared to the simple post stroke rehabilitation task (avc)?

Conditions: Subacute Stroke

Summary: stroke is the leading cause of severe disability in adults. the first cause of alterations in the quality of life and autonomy in these patients are disorders of walking and the balance. they are the leading cause of falls responsible for important medical, surgical and economic complications as well as a reactionary social isolation. the techniques of rehabilitation of walking to the subacute phase of a stroke are usually based on automatic walking.off walking is a complex activity usually performed in everyday life in association with multiple tasks. it is therefore interesting to re-educate walking in dual task or even in multitasking.


Eligibility criteria:
inclusion criteria: * major: age between 18 and 90 years * hospitalized for ischemic or hemorrhagic hemispheric stroke confirmed by ct or mri \<6months * walking disorder with the possibility of walking 10 meters with or without technical assistance (speed \<1.2m / s) * verbal understanding with complex orders * affiliates to social security exclusion criteria: * brainstem stroke or cerebellar * hypoacusia annoying understanding * visual gene embarrassing awarding * severe aphasia: no understanding of complex orders * neurological or musculoskeletal history affecting walking * participation in interventional research protocol in motor rehabilitation of the lower limb or cognitive * patient under guardianship or deprived of liberty * pregnant women, parturient women or lactating (art l.1121-5)

Keywords: subacute stroke multitasking rehabilitation walking