Kornimate/medical-research-clean huggingface dataset:
feasibility of immersive virtual reality dietician program in metabolic-dysfunction associated steatotic liver disease

Conditions: Fatty Liver, Nonalcoholic; Weight Loss; Virtual Reality; Implementation Science

Summary: metabolic-dysfunction associated steatotic liver disease, often referred to as "fatty liver disease", is a leading cause of liver failure. dietary weight loss is a cornerstone of treating fatty liver disease, but access to traditional in-person nutritional education is often limited by cost, availability, and transportation. immersive virtual reality (ivr) has the potential to not only overcome these barriers, but also provide an interactive learning experience, such as measuring and preparing foods. therefore, the investigators have created and validated an ivr dietician program known as the immersive virtual alimentation and nutrition (ivan) using evidence-informed practices from the academy of nutrition and dietetics. the goal of this project is to translate the ivan program from human and patient research to practice and community research. the investigators plan to accomplish this by performing a randomized clinical trial evaluating the effect of the ivan program in combination with synchronous audio/video dietary counseling on self-reported dietary intake and weight compared to in-person counseling. concurrently, the investigators will provide a survey assessing implementation outcomes to both groups as well as the dietician at each study visit, and crossover the intervention at study completion so all participants assess the ivan program. additionally, the investigators will have clinic health care providers experience the ivan program and assess implementation outcomes.


Eligibility criteria:
inclusion criteria: * adults age \>18 years * masld identified on imaging * possession of a smartphone exclusion criteria: * inability to provide informed consent * institutionalized/prisoner * pregnant * other causes of hepatic steatosis or chronic liver disease * severe medical/psychiatric comorbidities at the study pi's discretion
phase 1 trial of bevacizumab treatment for severe retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: the purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (rop), is effective in this study, and can be tested in future larger studies.

despite promising initial results using empirical doses of bevacizumab based on half the adult dose for treatment of acute severe rop, little is known about lower doses of bevacizumab for rop. an increasing number of ophthalmologists are treating premature infants with severe rop using bevacizumab. given the potential systemic and ocular adverse effects of intravitreal bevacizumab injections, determining a lower effective dose of bevacizumab is an important next step. the proposed study will test progressively lower doses to find a dose to take forward to a future larger study.

Eligibility criteria:
inclusion criteria: 1. type 1 rop; defined as: * zone i, any stage rop with plus disease, or * zone i, stage 3 rop without plus disease, or * zone ii, stage 2 or 3 rop with plus disease 2. no previous treatment for rop in the study eye; no previous bevacizumab treatment in the non-study eye exclusion criteria: the following exclusions apply to the study eye: 1. nasolacrimal duct obstruction 2. major ocular anomalies (e.g., cataract, coloboma) 3. any opacity that precludes an adequate view of the retina if purulent ocular discharge is present in either eye, then the infant is ineligible.

Keywords: retinopathy of prematurity bevacizumab rop
aspirin twice daily in diabetic patients with coronary artery disease

Conditions: Diabetes Mellitus

Summary: the aim of the study is to evaluate platelet function variations according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous coronary artery disease.

we have previously demonstrated that there was a time-dependant efficacy of aspirin on platelet function. in this study, we investigate platelet function (fundamental research) according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous coronary artery disease routinely treated with aspirin. in order to eliminate any variation linked to a cumulative dose effect of aspirn, platelet function is assessed 24 hours after a single 150 mg aspirin intake or 12 hours after a 75 mg aspirin intake given twice per day (corresponding to the same total dose of 150 mg /day). light transmission aggregometry triggered by arachidonic acid 0.5mg/ml (lta-aa) is the main endpoint of the study (intensity and velocity of agregation following exposure to arachidonic acid 0.5 mg/ml).

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * documented coronary artery disease * treatment with aspirin for at least 7 days before randomization * one of the following additional criteria defined from our previous study9: current smoking, hs-crp \> 4mg/l, fibrinogen \> 4g/l and/or platelet count \> 270 103/mm3 exclusion criteria: * oral anticoagulants, heparin, thrombolytic agents, non-steroidal anti-inflammatory drugs, prasugrel * family or personal history of bleeding or thrombophilic disorders * platelet count \> 600x103/mm3 or \< 150x103/mm3 * hematocrit \> 50% or \< 25% * creatinine clearance \< 30ml/min * low compliance before enrollment * cancer considered not in remission or those having undergone major surgery within the month prior to enrollment.

Keywords: aspirin diabetes mellitus coronary artery disease
effect of individualized exercise in elderly patients with coronary heart disease

Conditions: Coronary Heart Disease

Summary: the benefits of cardiac rehabilitation have been supported by a large amount of evidence-based medicine. cardiac rehabilitation can correct cardiovascular risk factors, reduce morbidity and mortality, and improve quality of life.

cardiac rehabilitation includes drug, exercise, nutrition, psychological and behavioral intervention, smoking and alcohol restriction five prescription comprehensive medical measures, so as to improve the symptoms and prognosis of patients. cardiac rehabilitation can not only delay the progress of the disease and improve the prognosis, but also improve the physical and mental state of patients, which has been recommended by the european cardiology association, the american heart association and the american heart association as class i in the treatment of cardiovascular disease. through the comprehensive intervention of patients, their physical, psychological and social functions can be restored to the best state, which can prolong life and significantly improve the quality of life, which is the essence of modern cardiac rehabilitation. exercise rehabilitation is the core content of cardiac rehabilitation, which refers to the use of appropriate body exercise to help patients promote physical and mental health through exercise prescription and exercise guidance on the basis of comprehensive evaluation. the realization of sports rehabilitation requires a reasonable exercise prescription, which refers to the method of prescribing patients' exercise content and amount of exercise in the form of prescription according to individual physical condition and combining with environment and preference as far as possible. the best exercise prescription should be able to comprehensively promote health-related physical fitness, that is, cardiopulmonary endurance, muscle strength and endurance, flexibility, body composition and neuromotor fitness, and should be formulated in accordance with the principles of fittvp, including frequency (several times a week), intensity (exertion), time (duration or total time), mode (pattern or type), as well as total and progress.

Eligibility criteria:
inclusion criteria: * coronary heart disease: coronary angiography confirmed patients with coronary heart disease. * age is 60-75 years old, and the clinical sinus rhythm is stable. * left ventricular ejection fraction was\> 40%. * informed consent and voluntary participation. exclusion criteria: * patients with severe organic cardiac and lung diseases. * patients with hemiplegia and other physical action disorders. * a history of mental illness. * uncontrolled hypertension, and hemodynamic instability. * severe nephropathy and severe peripheral artery disease. * patients with bone and joint diseases who are not suitable for exercise. * uncontrolled endocrine system and other diseases. * antibiotics and anti-diarrheal medications have not been used for at least 3 months.
a registry study of patients initiating a course of drug therapy for overactive bladder in taiwan, korea and china

Conditions: Overactive Bladder (OAB)

Summary: the purpose of this study is to observe and describe treatment patterns, like overactive bladder (oab) treatment discontinuation, switching to other therapies and persistence of oab therapies in routine clinical practice. this study will also evaluate effectiveness of oab therapies in routine clinical practice; identify factors associated with effectiveness and persistence of pharmacologic therapies in oab participants; evaluate the quality of life (qol) and treatment satisfaction of oab therapies; as well as evaluate health care resource utilization (hcru) and understand adverse events (aes), serious adverse events (saes) and adverse drug reactions (adrs) associated with oab therapies.

this is an observational registry study and will not provide or recommend any treatment; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with the treating physician's usual practices and all eligible participants will be enrolled in a certain timeframe. oab participants enrolled in the study will be categorized into one of two treatment groups, but the study does not plan to compare the two treatment groups.

Eligibility criteria:
inclusion criteria: * diagnosed with oab symptoms (with or without urgency incontinence) with symptoms for at least three months prior to study enrollment. * about to initiate monotherapy of mirabegron or any antimuscarinics therapy for oab symptoms, prescribed as part of routine clinical practice, which maybe the first course of any treatment for oab, lapsed of treatment, or switching from one drug to another. exclusion criteria: * currently receiving more than one medication (including chinese herbal medicine) for oab. * current participation in clinical trials of oab. * have undergone surgery for oab in the past. * mixed incontinence where stress incontinence is the predominant form. * oab has been treated with onabotulinum toxin a, sacral neuromodulation, percutaneous tibial nerve stimulation, external beam radiation (xrt), stents, surgery, or intermittent catheterization prior to or at time of enrollment. * at risk of acute urinary retention (aur). * neurologic conditions associated with oab symptoms. * hypersensitivity and contraindication(s) to mirabegron and antimuscarinics.

Keywords: betmiga oab ym178 overactive bladder mirabegron
neurotoxicity of anesthesia in middle aged patients

Conditions: Anesthesia; Adverse Effect

Summary: for the last 20 years, the increasing reports from non-human studies have raised suspicion that general anesthetics may cause neurotoxic changes in the developing brain that lead to adverse neurodevelopmental outcomes later in life.there are several case reports of reversible smell and taste dysfunction following exposure to general anesthesia suggesting a possible relationship between anesthetic agents and olfactory dysfunction. this study is to assess the possible neurotoxicity of sevoflurane,isoflurane,and propofol based anesthesia guided by olfactory changes

the primary inhibitory neurotransmitter gaba is found in neuronal synapses involving olfactory bulb. so, the involvement of common gaba pathway implies a possible interaction of general anesthetics with olfactory function. olfactory identification is an associative memory which is found to be facilitated by action of melatonin. involvement of gaba receptor in the transfer of light information from suprachiasmatic nuclei to pineal gland suggests possible interaction of melatonin and anesthetic agents. the aim of the study is to evaluate the possible neurotoxicity of sevoflurane,isoflurane,and propofol based anesthesia guided by olfactory changes

Eligibility criteria:
inclusion criteria: * patients aged 18-50 years * both sex * american society of anesthesiologists' physical status i and ii * elective surgery of duration 90-120 minutes exclusion criteria: * patients's refusal * recent airway infection * allergic rhinitis * nasal polyps * history of alcoholism * smoking * pregnancy * menstruating female * mental retardation * psychiatric illness * neurosurgical or oto-rhino-laryngeal surgery * history of olfactory deficits or cognitive impairment * cns disease e.g. epilepsy * history of first degree relative with alzheimer's disease,dementia, or cognitive dysfunction * those who are unable to answer the tests themselves
predictive value of β2-microspheres for postoperative delirium

Conditions: Postoperative Delirium

Summary: this study evaluated the predictive value of β2-microspheres for postoperative delirium (pod) in the elderly after orthopedic surgery. for this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the pod and non-pod groups.

in this study, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres before operation. also, the patients were interviewed one day before the surgery and on postoperative days 1-3 by the confusion assessment method and then divided them into pod and non-pod groups. the aim of the present study was to assess whether higher levels of β2-microspheres could predict the occurrence of pod.

Eligibility criteria:
inclusion criteria: * ≥65 years old, american standards associationⅰ-ⅲ, undergoing orthopedic operations under spinal anesthesia exclusion criteria: * decline to participate

Keywords: delirium β2-microspheres
efficacy and safety study of oral eligen® b12 in subjects with low serum cobalamin

Conditions: Vitamin B 12 Deficiency

Summary: the purpose of this study is to compare the efficacy and safety profile of a new oral vitamin b12 formulation (eligen® b12) with intramuscular b12 in restoring normal b12 (cobalamin) concentrations in subjects with low cobalamin levels (\<350 pg/ml).


Eligibility criteria:
inclusion criteria: * vitamin b12 deficiency defined as serum cobalamin below 350 pg/ml * age 60 or older; or age 18 or older with gastrointestinal abnormalities including but not limited to gastrointestinal surgery (e.g. gastrectomy, gastric bypass), ileal resection, gastric atrophy, celiac disease, crohn's disease, or prolonged use (\>3 months) of proton pump inhibitor drugs, or on a restricted diet (such as vegetarian or vegan). * general good health, as indicated by lack of significant findings in medical history, physical examination, clinical laboratory tests (chemistry, hematology and urinalysis), vital signs, ecg and normal kidney function as determined by estimated creatinine clearance computed with the cockcroft and gault formula exclusion criteria: * current treatment from a health care provider to treat vitamin b12 deficiency and/or symptoms; * daily use of neutralizing antacids (e.g. maalox®) * inability to ingest oral medication * clinically significant laboratory value at screening * hypersensitivity or allergic reaction to vitamin b12 * participation in a clinical research study involving a new chemical entity within 30 days of the first study dose * folate levels below the reference range provided by the clinical laboratory. * renal insufficiency * vitamin b6 deficiency

Keywords: cobalamin b12 homocysteine mma holotranscobalamin eligen
n-acetylcysteine for the treatment of cannabis dependence: working mechanisms

Conditions: Cannabis Use Disorder; Cannabis Dependence

Summary: this study investigates the effects of repeated nac administration on glutamate concentrations in the anterior cingulate cortex (acc), on neurocognitive functioning, and on neuro-inflammatory parameters in adult cannabis-dependent individuals.


Eligibility criteria:
inclusion criteria: * current dsm-iv diagnosis of cannabis dependence, \>1 week detoxified and abstinent; * able to provide written informed consent and to comply with study procedures. * dutch speaking (dutch as primary language). exclusion criteria: * currently dependent on any substance other than cannabis, alcohol or nicotine; * history of any major internal disease (including diabetes, cardiovascular disease, lung disease, liver or kidney disease); * an active or any history of neurological disorder, including but not limited to seizure disorder, epilepsy, stroke, neurological disease, cognitive impairment, head trauma with prolonged loss of consciousness (\>10 minutes), or migraine headaches; * an active or a history of a psychiatric disorder including, but not limited to, depression, schizophrenia, bipolar disorder, anxiety, or other psychiatric disorders; * asthma; * known hypersensitivity or allergy to n-acetylcysteine, or receiving chronic therapy with medication that could interact adversely with n-acetylcysteine within 30 days prior to randomization (i.e., nitroglycerin, ace inhibitors or antihypertensive drugs, anti-coagulants); * exclusion criteria for mri: having metal in the body and/or having claustrophobia
safety evaluation of lscd101 transplantation for limbal stem cell deficiency

Conditions: Limbus Corneae; Limbus Corneae Insufficiency Syndrome

Summary: clinical study objective: to evaluate the tolerability and safety after transplantation of lscd101 in patients with intractable limbal stem cell deficiency study method: subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the investigational product. adverse drug reaction will be confirmed during 24 weeks after transplantation.


Eligibility criteria:
inclusion criteria: * men and women aged 19 or older * diagnosed with intractable limbal stem cell deficiency in single eye, with severity in which corneal neovascularization invades more than two quadrants * no improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment * bcva 20/40 or less at screening in the eye with the limbal stem cell deficiency * voluntarily agreed to participate in this study and signed a consent form exclusion criteria: * inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet. * difficulty in reconstruction of the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency. * severe dry eye with problem with tear secretion in both eyes (value of schirmer i test without anesthesia \< 2 mm/5 min at screening) * acute ocular surface inflammation of both corneas at visit 2 * malignant tumor history (except in case of no recurrence more than 5 years after surgery) * uncontrolled comorbidities such as moderate to severe infections and bleeding * positive for virus infection (hbv, hcv, hiv, cmv, htlvⅰ/ⅱ, syphilis) * uncontrolled diabetes (hba1c ≥9.0%) * uncontrolled hypertension (sbp \> 140 mmhg or dbp \> 90 mmhg despite taking antihypertensives at screening) * uncontrolled glaucoma (iop \> 21 mmhg despite taking glaucoma medication) * pregnant or lactating women * women with childbearing potential, those who do not agree to contraception by medically accepted contraceptive methods during clinical trials * participation in another clinical study within 4 weeks * subjects judged by the investigator to be inappropriate to participate in the clinical study
integration of education based-application and "care coaching model" in management of type 2 diabetes mellitus patients using insulin

Conditions: Diabetes Mellitus, Type 2

Summary: diabetes mellitus is increasing in incidence worldwide. the goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. self-management becomes important in the management of diabetes mellitus. the use of mobile phone applications provides opportunities for the management of diabetics. in addition, health coaching is one of method used for empowering patients with chronic diseases, such as diabetes. this study aims to evaluate the impact of mobile application-based diabetes education and health coaching in management of type 2 diabetes mellitus.

a randomized control trial, pre and post study involving 105 subjects randomized into 3 arms: * control : received conventional education group * intervention 1 : received conventional education group + mobile application-based diabetes education * intervention 2 : received mobile application-based diabetes education + health coaching conventional education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes. mobile application-based diabetes education is using dm educorner (diabetes mellitus education corner) availablle in google playstore. education contents was delivered in articles, video and infographics. health coaching was given by a coach, a healthcare professional who undergo training to become a coach. health coaching delivered as face to face between subjects and coach. laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * multiple daily insulin injection (basal and rapid, or mixed) * 30 - 65 years old * hba1c \> 8% * using smartphone in daily lives. * willing to follow the research by signing an informed consent exclusion criteria: * patients with cognitive disease (such as dementia) * patients with hearing or sight problem * unable to live independently on daily basis * patients who have disease that may affect hba1c such as hemolytic anemia, thalassemia

Keywords: type 2 diabetes mellitus mobile application-based diabetes education health coaching
long-term safety and tolerability of alirocumab (sar236553/regn727) versus placebo on top of lipid-modifying therapy in high cardiovascular risk patients with hypercholesterolemia (odyssey long term)

Conditions: Hypercholesterolemia

Summary: alirocumab (sar236553/regn727) is a fully human monoclonal antibody that binds pcsk9 (proprotein convertase subtilisin/kexin type 9). primary objective of the study: to evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (lmt). secondary objectives: * to evaluate the effect of alirocumab on low-density lipoprotein cholesterol (ldl-c) levels after 24 weeks of treatment in comparison with placebo. * to evaluate the effect of alirocumab in comparison with placebo on ldl-c at other time points. * to evaluate the effects of alirocumab on other lipid parameters.

the maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-week randomized treatment period and 8-week follow-up period.

Eligibility criteria:
inclusion criteria: either a or b below and who were not adequately controlled with their lipid-modifying therapy: a) participants with heterozygous familial hypercholesterolemia (hefh) with or without established coronary heart disease (chd) or chd risk equivalents or b) participants with hypercholesterolemia together with established chd or chd risk equivalents. exclusion criteria: * age \< 18 years * ldl-c \<70 mg/dl (\< 1.81 mmol/l) * fasting serum triglycerides \> 400 mg/dl (\>4.52 mmol/l) the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.