Kornimate/medical-research-clean huggingface dataset:
exercise and glp-1 ra on insulin secretion

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine the effect of endurance exercise on insulin secretory capacity, alone or in addition to treatment with the glucagon-like-peptide receptor agonist semaglutide, in patients with type 2 diabetes.

the effects of endurance exercise alone or in addition to treatment with glucagon-like- peptide receptor agonists on insulin secretory capacity, will be determined in patients with type 2 diabetes. included patients will be randomized to either 12 weeks of endurance exercise training 3 times a week or therapeutical treatment with semaglutide for 3 months followed by 12 weeks of endurance exercise training 3 times a week. insulin secretory capacity will be determined by hyperglycemic clamp method before and after.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * bmi 28-35 * moderately preserved insulin secretory capacity (determined by glucagon test) exclusion criteria: * insulin treatment * hypertension grade 3 * heart disease * medical history with pancreatitis * diagnosed with neuropathy * excessive alcohol consumption * any condition that would interfere with the protocol.

Keywords: insulin secretion beta cell function
emotion regulation training, nursing student, and alexithymia

Conditions: Alexithymia; Emotion Regulation

Summary: this study aimed to investigate the effects of emotional regulation training, which is a prepared based on the cognitive behavioral approach, on alexithymia in nursing students.

this study aimed to reduce alexithymia levels in nursing students with emotion regulation training based on a cognitive behavioral approach. the study was conducted with 74 nursing students, 37 in the intervention group and 37 in the control group, studying at a foundation university in the 2023-2024 academic year. the study data were collected using the data collection form and the toronto alexithymia scale-20 (tas-20). data collection tools were applied three times as pre-post and follow-up tests. male and female students who met the inclusion criteria of the study were determined by using the pre-test of the population. for the sample group to represent the population, students with high levels of alexithymia were identified by stratification by determining the class and gender ratios. then, students were assigned to intervention and control groups by randomization. the 7-session training program prepared for the students in the intervention group was applied. no intervention was made to the control group during the implementation. after the training sessions were completed, post-test data were collected. follow-up measurements were made three months later.

Eligibility criteria:
inclusion criteria: * to be a student of the nursing department * agree to participate in the study exclusion criteria: * having received psychological support within the last 10 years * having a psychiatric disorder * not being a citizen of the republic of turkey

Keywords: alexithymia nursing emotion regulation student
early infant micronutrition and development

Conditions: Vitamin B 12 Deficiency

Summary: globally, vitamin b12 deficiency is one of the most common micronutrient deficiencies. poor status is also seen in affluent countries such as in norway. vitamin b12 is crucial for normal cell division and differentiation and necessary for the development and myelination of the central nervous system. deficiency is also associated with impaired fetal and infant growth. in the proposed study we will measure the effect of daily oral vitamin b12 supplementation infants on neurodevelopment. we also aim to measure the impact of b12 supplementation on several other outcomes. study design: individually randomized double-blind placebo-controlled trial breastfed infants who will be assigned to a screening group (in which measurements will be obtained immediately) or a control group (in which serum will be stored and measurements done after one year). pregnant women will be informed about the study during their first antenatal visit at the clinic and that we will re-approach them on their 6-week visit to their public health nurse. infants who are deficient will be treated with peroral or intramuscular injections with 400 µg cyano-cobalamin. infants in the control group will not be offered any intervention their blood sample will be stored for one year and then analyzed for the same nutrients as the intervention group. outcomes: primary: (i) neurodevelopment in children measured at 12 months of age (ii) growth in children measured by attained weight and length at 12 months. secondary: (i) neurodevelopment and cognitive functioning in children later in life


Eligibility criteria:
inclusion criteria: 1. availability of informed verbal consent 2. plan to reside in the defined study area for the next 12 months 3. mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months exclusion criteria: 1. severe systemic illness requiring hospitalization 2. growth retardation 3. severe congenital malformations 4. plasma cobalamin concentration \<148 pmol/l (these children will be treated for vitamin b12 deficiency and not included in the rct, but will be included in the cohort design)

Keywords: nutrition vitamins breastfeeding infant neurodevelopment growth clinical trial
a long-term study on the side effects of tradiance in japanese patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: study objectives is to investigate the safety of long-term daily use of tradiance® combination tablets ap and bp in japanese patients with type 2 diabetes mellitus (t2dm) used in routine care.


Eligibility criteria:
inclusion criteria: * japanese patients with type 2 diabetes mellitus (t2dm) who are prescribed with tradiance® combination tablets ap or bp * patients who have never been treated with tradiance® combination tablets ap or bp before enrolment exclusion criteria: none
evaluation of dvd and internet decision aids for hip and knee osteoarthritis: focus on health literacy

Conditions: Osteoarthritis

Summary: the purpose of this study is to advance the evidence base regarding methods for facilitating informed decisions among patients with knee and hip osteoarthritis by comparing dvd and online formats of decision aids for these conditions. the project will assess how these different formats impact key outcomes including: patient knowledge about treatment options, decisional conflict, preparation for decision making, decision self-efficacy, stage of decision making, and acceptability and usability of the decision aids.

osteoarthritis (oa) is one of the most common chronic conditions and a leading cause of pain and disability. many patients with oa know very little about treatment options and are not well equipped to make informed decisions regarding these treatments. further, there are racial and gender disparities in perceptions of the risks and benefits of total joint replacement, which also highlights the need to improve facilitation of informed treatment choices in these patients. decision aids have great potential to improve patient satisfaction, safety, and outcomes for patients with oa, but there is no evidence base regarding best formats for delivering this information. this project will compare patient decision-making outcomes immediately following viewing of dvd and web-based versions of the health dialog das for hip and knee oa, as well as three days and one month later. patients with symptomatic knee and hip oa (n=200) will be enrolled from a primary care and orthopedic clinics. participants will be randomized, with stratification according to health literacy level, to view the dvd or web-based da. outcomes will include: knowledge about oa and treatments, decisional conflict, preparation for decision-making, decision self-efficacy, stage of decision making, acceptability and usability of the da, and home use of the da. this project will make a novel contribution with direct clinical applicability, providing information regarding best methods for disseminating tools to enhance informed decision-making among patients with hip and knee oa, with particular attention to patients with low literacy.

Eligibility criteria:
inclusion criteria: * clinician diagnosis of knee/hip oa, based on radiographic evidence in duke medical records. * moderate or worse current joint symptoms, assessed at telephone screening using standard items. exclusion criteria: * diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease. * active diagnosis of psychosis or dementia, or other cognitive impairment. * severe hearing or visual impairment that would prohibit effective use of the das. * planning, scheduled for or on a wait list for joint replacement surgery. * had a prior hip or knee joint replacement surgery. * inability to read english, since the das are in english. * current participation in another oa interventional study.

Keywords: osteoarthritis decision aids health literacy
assess the efficacy and safety of sildenafil when added to bosentan in the treatment of pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: to assess the efficacy and safety of sildenafil when added to patients with pah who are taking bosentan as all or part of their background therapy.


Eligibility criteria:
inclusion criteria: * subjects aged 18 and over above with pah and for which bosentan therapy is indicated according to national license * subjects with a mean pulmonary artery pressure of \>25mmhg and a pulmonary artery wedge pressure of \<15mmhg at rest via right heart catheterization within 3 years prior to randomization. * subjects whose baseline 6 minute walk test distance is \>100m and \< 450m. exclusion criteria: * pah secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria * subjects whose 6 minute walk test may be limited by conditions other than pah related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.
evaluate the efficacy and safety of dha in the adjuvant treatment of children with asd.

Conditions: ASD

Summary: in the etiopathogenesis of autistic spectrum disorder (asd) several hypotheses have been described that include inflammation, metabolic alterations, activation of oxidative stress, changes in the intestinal microbiota and in the elimination capacity of heavy metals. adjuvant therapies with omega-3 polyunsaturated fatty acids could modify these alterations.

several hypotheses have been described in the etiopathogenesis and evolution of asd, among which is that there is greater oxidative stress associated with a proinflammatory state, or even metabolic alterations after exposure to heavy metals, as well as differences in intestinal microbiota. this situation could negatively influence the correct establishment of neuronal synapses and their functioning, which have still been poorly investigated, especially in children. in this way, an early intervention with nutritional supplements with dha, which could be deficient in autism, could decrease the proinflammatory and oxidative stress state, favoring the formation of neuronal synapses as well as their activity. this intervention could positively influence to prevent the clinical deterioration associated with asd and it would be of special interest in early childhood since at this stage of neurodevelopment there is maximum neuronal plasticity.

Eligibility criteria:
inclusion criteria: * children and girls aged between 2 and 5 years diagnosed with autism spectrum disorder according to the dsm-v criteria and the observation scale for the diagnosis of autism (ados). * informed consent signed by one of the parents or legal representative. exclusion criteria: * children under 2 years old. * children diagnosed with asd over 4 years old. * coexistence of another diagnosis associated with autism. * patients who are receiving some type of supplement or concomitant medication that does not allow a period of washing. * patients diagnosed with other pathologies or with mediation that may affect the study variables (oxidative stress, inflammation, cell adhesion molecules, lipid profile or microbiota).

Keywords: autism spectrum disorders asd children autism docosahexaenoic acid inflammation oxidative stress intestinal microbiota heavy metals
a pharmacokinetic study to compare sustained release and standard paracetamol formulations.

Conditions: Pain

Summary: this proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. this study is also used for drug safety evaluation.


Eligibility criteria:
inclusion criteria: * body mass index (bmi): body mass index must be in the range 19-28 kg/m2. exclusion criteria: * disease: current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure). * current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
medical thoracoscopy in treatment outcomes of empyema management

Conditions: Empyema

Summary: to evaluate the efficacy of drainage achieved by thoracoscopy vs tube drainage alone. to compare clinical outcomes such as length of hospital stay, need for additional procedures, and treatment failure rates between the two drainage methods. to asses resolution of pleural infection and rates of fluid re-accumulation over follow-up. to compare safety profiles and complication rates of thoracoscopy versus tube drainage alone

empyema is a serious infection characterized by pus accumulation in the pleural space. effective drainage and treatment is necessary for resolution. traditionally, intercostal tube placement was standard initial management. however, recent studies have compared outcomes of early medical thoracoscopy or video-assisted thoracoscopic surgery (vats). thoracoscopy enables direct visualization for thorough pleural space cleansing and debridement under direct vision. medical thoracoscopy significantly improved drainage adequacy and reduced treatment failure risks compared to tube drainage alone. also reported shorter hospital stays and lower complication rates with early thoracoscopy-directed management. additional benefits of thoracoscopy include enabling talc pleurodesis for reducing empyema recurrence. thoracoscopy-directed pleurodesis achieved higher long-term success rates than tube drainage followed by pleurodesis. overall, current evidence indicates medical thoracoscopy provides superior empyema treatment outcomes to conventional tube drainage through optimized drainage and debridement under direct visualization.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of empyema via imaging tests (e.g. chest x-ray/ct scan) * age 18 years or older * clinical signs/symptoms consistent with empyema such as fever, chest pain, coughs * pleural fluid loculations/septations seen on imaging requiring drainage * no previous drainage procedures done for current empyema exclusion criteria: * age less than 18 years * immunocompromised state or other conditions contraindications to thoracoscopy * previous drainage procedure for current empyema * residual pleural fluid not amenable to drain
hair cortisol and testosterone in heart failure

Conditions: Systolic Heart Failure

Summary: the purpose of this study is to determine whether hair cortisol and testosterone levels correlate with heart failure status in patient with chronic congestive heart failure.

progression of chronic congestive heart failure (chf) is associated with abnormal secretion of several hormones including glucocorticoids and testosterone. a single study of patients with chronic heart failure has demonstrated that higher serum levels of cortisol are independent predictors of increased mortality risk. however, this study included patients with heart failure who were admitted to the hospital due to other causes and it might be speculated that the single serum cortisol measurement taken may have been influenced by the acute illness or by the emotional stress associated with the admission itself. currently, there are several modalities for measuring cortisol levels including serum, urinary and salivary techniques. however, all these methods represent indicators of acute cortisol secretion and do not reflect accumulation of the hormone over time. recently there has been a growing interest in measuring hair cortisol level. hair grows approximately 1 centimeter per month and therefore hair analysis accurately reflects long-term endogenous production of cortisol. this provides for the first time a reliable mode for the measurement of the accumulation of cortisol over time. we have recently demonstrated higher hair cortisol levels in patients with acute myocardial infarction compared with controls (the manuscript has been submitted for publication). regarding testosterone, several studies have recently demonstrated lower free serum testosterone levels in patients with heart failure compared with controls. furthermore, serum testosterone levels were inversely correlated with heart failure status. the longitudinal assessment of cortisol and testosterone levels over time using the hair technique may be superior to a single random serum sample for the assessment of chronic heart failure status and prognosis. if indeed, hair cortisol and testosterone levels would correlate with heart failure status, they may be used as a quantitative mode for clinical follow-up of chf patients (similar to the role of hba1c in the follow-up of diabetic patients). however this hypothesis has not yet been evaluated

Eligibility criteria:
inclusion criteria: * males * age \>18 * left ventricular (lv) systolic function (ef\<45 per echocardiography) exclusion criteria: * any corticosteroid treatment in the last 6 months * any treatment with testosterone in the last 6 months * diagnosis or cushing's or addison's disease * any hospital admission within 3 months prior to enrollment * inability to sign inform consent * patients with moderate or severe aortic stenosis * inability to provide 3 cm hair sample from vertex posterior. * dyed hair * morbid obesity (bmi\>35) * any symptomatic chronic lung disease

Keywords: heart failure cortisol testosterone
acute kidney injury in children operated for congenital heart disease

Conditions: Acute Kidney Injury

Summary: the purpose of this study was to investigate if repeated inflation of a blood pressure cuff applied around one leg causing mild ischemia ("remote ischemic preconditioning") could protect children operated for congenital heart disease from developing acute kidney injury.

remote ischemic preconditioning (ripc) refers to an intervention of remote, brief ischemia which confers systemic protection against consequences of reperfusion injury in distant organs. ripc has been shown to protect various organs during major surgeries. our hypothesis was that ripc could protect kidney function in children operated for complex congenital heart disease.

Eligibility criteria:
inclusion criteria: * children admitted for surgery for congenital heart disease exclusion criteria: * heart surgeries of low complexity such as closure of septal defects, aortico-pulmonary windows, establishment of glenn shunts, subaortic membrane resection, redirection of anomalous pulmonary veins, valvotomies, repair of pulmonary artery stenosis and surgeries without the use of extracorporeal circulation

Keywords: acute kidney injury ischemic preconditioning congenital heart defects cardiac surgical procedures infant child
a study to assess the efficacy and safety of voriconazole in chinese patients with serious deep tissue fungal infections

Conditions: Invasive Fungal Infections

Summary: to evaluate the efficacy and safety of voriconazole in chinese patients with proven or probable deep tissue fungal infections.


Eligibility criteria:
inclusion criteria: * subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by principal investigator and pfizer. exclusion criteria: * subjects who are showing continuing improvement with other antifungal agents, including amphotericin b, itraconazole, nystatin, fluconazole, flucytosine and miconazole. * subjects with an invasive fungal infection caused by a fungus (such as mucor) that is not in the antifungal spectrum of voriconazole.
a comparison of the effects of neuromuscular electrical stimulation and intermittent pneumatic compression on blood flow in the lower limb

Conditions: Venous Thrombosis

Summary: deep vein thrombosis (dvt) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. it involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. three mechanisms underlie dvt, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as virchow's triad. intermittent pneumatic compression (ipc) and neuromuscular electrical stimulation (nmes) have been shown to improve lower limb blood flow. however, few studies have directly compared the two methods and those that have, have used dated nmes techniques. the objective of this study is to compare the two methods in terms of blood flow, in both a young and an older population.

deep vein thrombosis (dvt) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. it involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. three mechanisms underlie dvt, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as virchow's triad. intermittent pneumatic compression (ipc) involves the use of an inflatable cuff placed around the limb. this cuff inflates and deflates intermittently in order to squeeze blood from the underlying veins. neuromuscular electrical stimulation (nmes) leads to a contraction of muscles by delivering a series of controlled electrical pulses via skin surface electrodes placed over the motor points of the targeted muscle.

Eligibility criteria:
inclusion criteria: * free from any known illness * between 18 and 40 years of age * between 55 and 65 years of age exclusion criteria: * history of heart/respiratory problems * pregnancy * presence of implants, including cardiac pacemakers and orthopaedic implants * history of neurological disorder * history of severe arterial disease or known dermatological problems

Keywords: deep vein thrombosis neuromuscular electrical stimulation intermittent pneumatic compression doppler ultrasound