Kornimate/medical-research-clean huggingface dataset:
a research study to see how much cagrisema lowers blood sugar and body weight compared to tirzepatide in people with type 2 diabetes treated with metformin, sglt2 inhibitor or both

Conditions: Diabetes Mellitus, Type 2

Summary: this study will look at how much cagrisema lowers blood sugar and body weight in people with type 2 diabetes. cagrisema is a new investigational medicine. doctors cannot yet prescribe cagrisema. cagrisema will be compared to a medicine called tirzepatide. doctors can prescribe tirzepatide in some countries. participants will either receive cagrisema or tirzepatide. which treatment the participant will receive is decided by chance. for each participant, the study will last for up to 1 year and 4 months.


Eligibility criteria:
inclusion criteria: * male or female (sex at birth). * age 18 years or above at the time of signing the informed consent. * diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: * metformin * sodium-glucose co-transporter 2 inhibitor (sglt2i) * glycated haemoglobin (hba1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * body mass index (bmi) \>= 30 kilogram per square meter (kg/m\^2) at screening. bmi will be calculated in the electronic case report form (ecrf) based on height and body weight at screening. exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * renal impairment with estimated glomerular filtration rate less than \< 30 milliliter per minute per 1.73 square meter (ml/min/1.73 m\^2) as determined by central laboratory at screening. * treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. however, short term insulin treatment for a maximum of 14 consecutive days is allowed. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
incidence of urinary retention in patients undergoing unilateral total knee arthroplasty- comparison between continuous epidural analgesia and single shot femoral nerve block- a randomized controlled study (urikane)

Conditions: Acute Pain; Urinary Retention; Post Operative Pain

Summary: this study aims to compare the incidence of urinary retention and requirement of bladder catheterization in patients undergoing total knee arthroplasty while receiving either continuous epidural analgesia or single shot femoral nerve block.


Eligibility criteria:
inclusion criteria: * asa physical status i, ii \& iii * male and female patients age between between 30 and 70 years * unilateral total knee arthroplasty exclusion criteria: * patient refusal * allergy to local anesthetics, paracetamol or other study drugs * history of opioid dependence * contraindications to spinal/epidural anesthesia and femoral nerve block (coagulation defects, infection at puncture site etc.) * inability to use patient-controlled analgesia (iv pcia) (as assessed at the time of informed consent) * history of urinary retention, neurogenic bladder, or any urologic problem

Keywords: total knee arthroplasty femoral nerve block epidural analgesia urinary retention lumbar epidural
perioperative use of nac to prevent aki in patients with pre-existing moderate renal insufficiency following cardiac surgery

Conditions: Kidney Injury, Acute

Summary: acute kidney injury (aki) or renal impairment is an established complication of cardiac surgery occurring with an incidence up to 30%, to date, no agent has conferred renal protection. considerable interest has developed in the potential for nacetylcysteine (nac) to exert a renoprotective effect in patients undergoing cardiac surgery. due to the beneficial effect of nac on contrast nephropathy and its reported anti-inflammatory effects.

acute kidney injury (aki), is a well-known complication of cardiac surgery, with an incidence of up to 30% depending on the definition. aki caused by cardiac surgery is the second most common cause of aki in the intensive care unit and is a common and serious postoperative complication of cardiac surgery requiring cardiopulmonary bypass (cpb). the pathogenesis of aki after cpb is multifactorial, and is mostly due to hypo perfusion, reperfusion injury, activation of the systemic inflammatory response, and/or low cardiac output. reperfusion will result in the formation of reactive oxygen species, resulting in injury to tissues. the activation of the systemic inflammatory response is mostly due to the exposure of blood to the extracorporeal cpb circuit, resulting in the activation of the immune system, which is also mediated by the generation of reactive oxygen species. this results in increased recruitment of neutrophils, macrophages, and lymphocytes into the renal parenchyma, leading to aki. n-acetylcysteine (nac) is well known for its antioxidant and free-radical scavenging properties, as well as its vasodilator properties. its antioxidant properties enable it to prevent ischemic cell death, and as a free-radical scavenger, nac mitigates the effect of increased reactive oxygen species caused by reperfusion. hence, theoretically, nac is able to counteract several mechanisms of kidney injury during cardiac surgery, namely, the systemic inflammatory response, free-radical injury, and ischemia. in this study, we aimed to investigate if the perioperative use of acetylcysteine will prevent kidney injury after cardiac surgery.

Eligibility criteria:
inclusion criteria * scheduled for open heart surgery with cardiopulmonary bypass (cpb) pump. * pre-existing moderate renal insufficiency serum creatinine more than 1.5 mg/dl exclusion criteria: * patients on hemodialysis preoperatively * history of renal transplantation * iv contrast within 4 days prior to surgery * urgent/emergent surgery * preoperative hemodynamic instability (intra-aortic balloon pump support or vasoactive medications) * planned off-pump surgery; * planned deep-hypothermic-circulatory-arrest * known or suspected allergy to nac * patient refusal.

Keywords: n-acetylcysteine acute kidney injury cardiac surgery
the safety of four different dose levels of wobenzym in hiv-positive patients

Conditions: HIV Infections

Summary: to study the safety and efficacy of four different doses of wobenzym (an enzyme combination consisting of pancreatin, papain, bromelain, trypsin, lipase, amylase, chymotrypsin, and rutin) in patients with hiv infection whose cd4 count is between 250 and 400 cells/mm3. to evaluate the effect of wobenzym on certain surrogate markers associated with progression of hiv disease.


Eligibility criteria:
inclusion criteria patients must have: hiv seropositivity with cd4 counts between 250 and 400 cells/mm3. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known hypersensitivity to hydrolytic enzymes such as wobenzym. * known sensitivity to lactose. * presumption that the patient will not comply with the dosing schedule or follow-up appointments. concurrent medication: excluded: * concurrent use of immunosuppressive therapy or steroids.

Keywords: acquired immunodeficiency syndrome aids-related complex wobenzym hydrolases
imunomodulation in acute pancreatitis

Conditions: Acute Pancreatitis

Summary: acute pancreatitis is an acute inflammatory pathology of the pancreas with activation of both innate and adaptive immune system, including t and b lymphocytes and release of inflammatory cytokines. we aim to characterize the circulating profile of t and b cells, its regulatory populations and b cell maturation, as well as inflammatory cytokines, in a prospective way of 50 patients with acute pancreatitis admitted to hospital da luz lisboa. blood samples will be collected at hospital admission, 48h, one month and 6 months after hospitalization of patients, relating these values to the severity of acute pancreatitis. patients with acute pancreatitis in the previous 6 months, diabetes mellitus, pregnant women, uncontrolled comorbidity and terminal neoplasms will be excluded. a control group of 30 ambulatory individuals observed at the hospital da luz lisboa will be recruited. laboratory evaluation will be performed at the immunology laboratory of nova medical school.


Eligibility criteria:
inclusion criteria: * hospitalized patients with acute pancreatitis exclusion criteria: * acute pancreatitis in the last 6 months diabetes mellitus, pregnant women, uncontrolled comorbidity such as organ disease (cardiac, renal, hepatic) and terminal neoplasms
functional magnetic resonance imagine(fmri)navigation in intracranial arteriovenous malformation surgery

Conditions: Intracranial Arteriovenous Malformations

Summary: little is known about the effect of fmri navigation in the intracranial arteriovenous malformation surgery. the investigators aim to perform a multicenter prospective randomized single -blind clinical trial to assess the effect and safety of fmri navigation in the brain arteriovenous malformation surgery.

intracranial arteriovenous malformations (avms) are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without an intervening normal capillary bed. surgical removal is thought as a major treatment option for avms. however, compared with stereotaxic radiosurgery and endovascular embolization, microsurgery of avms is regarded with high mortality and morbidity, particular for high level classification avms . blood oxygen level dependent fmri can be used to mapping the motor and language regions of the brain noninvasively. it has been one of the most advanced functional imaging techniques and it has quickly grown to be a vital tool for clinical and cognitive neuroscience research. many clinical researches have been reported about the utility of fmri in brain tumor surgery. however, the effect of fmri navigation for neurofunction protection in the intracranial arteriovenous malformation surgery was unclear. we aim to perform a multicenter prospective randomized single -blind clinical trial to assess the safety and effect of fmri navigation in the intracranial avms surgery. we hypothesize that application of blood oxygen level dependent fmri is able to improve long term prognosis of patients.

Eligibility criteria:
inclusion criteria: 1. diagnosis of intracranial avm by dsa/ct/mri 2. age from 12-60 years 3. be suitable for microsurgery treatment 4. all patients are able to cooperate with the fmri examination 5. all patients gave written informed consent exclusion criteria: 1. patients with age \ 60 years 2. various conditions unable to meet the indications for microsurgery treatment 3. intracranial hemorrhage need emergency surgery 4. patients can not cooperate with fmri examination

Keywords: intracranial arteriovenous malformations functional magnetic resonance imaging neuronavigation
resistance training exercise using the swiss ball in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the aim of the present study is to assess the effectiveness of resistance training with swiss ball in the treatment of patients with ankylosing spondylitis.

a randomized, controlled, single-blind, prospective trial being conducted involving 54 patients with ankylosing spondylitis, selected from outpatient clinics - unifesp. they will be randomized in intervention group (n = 27) conduct training for muscle strengthening with the aid of the swiss ball and in the control group (n = 27) did not undergo any intervention. eight exercises will be conducted with intent to engage all muscle groups.

Eligibility criteria:
inclusion criteria: * patients with established diagnosis of as steinbrocker functional class i-ii * basic medication stable for at least three months * agreed to participate and signed term of informed consent exclusion criteria: * uncontrolled hypertension * coronary artery disease * history of revascularization * history of syncope or arrhythmias induced by exercise * decompensated diabetes mellitus * severe psychiatric illness * fibromyalgia * another medical condition more disabling than as * history of exercise regular (at least 30 minutes 2 times per week)

Keywords: treatment exercise resistance training swiss ball functional capacity
multicomponent risk factor intervention for people with a severe mental illness: a feasibility study

Conditions: Psychotic Disorder; Obesity; Behavior, Addictive

Summary: this study is a feasibility study of a multi-component intervention to enhance healthy living among young people with psychotic disorders, specifically targeting smoking and weight.

we propose a feasibility study of a multi-component intervention to enhance healthy living among young people (18 to 40 years) with psychotic disorders, specifically targeting smoking and weight. smoking is very common amongst people with psychotic disorders (around 70% of males, and over 50% of females) and this adds to the overall cardiovascular risk for this group. obesity is also a common problem for people with psychosis, with an estimated 40-60% being obese or overweight. obesity in this population may contribute to adverse medical and psychological consequences. for many obese people, targeted pharmacotherapy in addition to diet and increased physical activity can assist in both weight reduction and the maintenance of gains. similarly, smoking cessation is enhanced by use of adjunctive medications such as nicotine replacement; such strategies continue to produce abstinence rates for up to 10 years. the proposed study will assess the feasibility of a multi-component behavioural intervention focussing on smoking cessation/diet/physical activity. the primary outcome measures from the feasibility study are smoking cessation and reduction in body mass index (bmi). secondary outcomes will include tolerability and safety, as well as the impact the package has on other cardiovascular risk factors including serum lipids, blood sugar levels and depression in young people with psychosis. we will also establish whether smoking cessation and reduction in obesity is correlated with gains in terms of body image, quality and enjoyment of life and reduction in depression. based on published data, behavioural interventions for smoking cessation and diet and physical activity lead smoking cessation in 20% of people at 12 months and to modest weight loss (around 5%).

Eligibility criteria:
inclusion criteria: * 18-40 yrs * dsm-iv diagnosis of non-organic psychotic illness * obesity (bmi \> 30 or 27 if co-morbidities such as diabetes, hypertension or dyslipidaemia are present * current smoker ( \> 15 cigarettes per day) if also smoking cannabis regularly, they will still be able to participate exclusion criteria: * medical contraindication to exercise or use of the nicotine patch * intellectual disability that would significantly impair ability to participate in the program * inability to give informed consent (acutely psychotic potential participants will be reassessed one month post screening
sutureless technique and conventional repairs for total anomalous pulmonary venous connection

Conditions: Total Anomalous Pulmonary Venous Connection

Summary: the purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.

an observational, non-randomized multi-center study is proposed to compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection. subjects will be enrolled at guangdong provincial people's hospital (gpph) and three to five participating hospitals. all clinical interventions will follow the participating hospital's standard of care. informed consent will be obtained from all study participants before study enrollment. after undergoing their surgical repairs, study participants will be followed up at 1, 3, 6 and 12 months after initial surgery and annually thereafter. all preoperative and postoperative medical records data will be submitted to a centralized database at gpph through a secure online research platform. baseline and post-operative (6 months) assessments will include a history and physical examination, a quality of life survey, physical examinations, liver and kidney function assessments, serum brain natriuretic peptide (bnp), echocardiography and electrocardiography. besides, a small amount of common pulmonary vein tissue may be required for hematein and eosin staining.

Eligibility criteria:
inclusion criteria: 1. infants and neonates who are diagnosed with tapvc 2. infants and neonates who undergo initial surgical repair for tapvc. exclusion criteria: 1. concommitant diagnoses including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great arteries. 2. older than 1-year-old.

Keywords: tapvc surgical strategy pvo outcomes
validation of the stardust cardio-respiratory recorder

Conditions: Obstructive Sleep Apnea

Summary: introduction: the full night polysomnography (psg) in sleep lab is the gold standard to obstructive sleep apnea (osa) diagnosis. however, there is a need to evaluate simple and accurate home diagnostic equipment that can reliably detect or exclude osa. the aim of our study was to evaluate if an ambulatory portable monitor (sd) is accurate to measure apnea-hypopnea index (ahi) in osa patients referred to a sleep lab. methods: patients with clinical suspicion of osa were selected. three-order randomized evaluations had been performed within a period of two weeks: the 1) sd (stardust®, respironics, inc, usa) was used at patients home (sd home), 2) sd was used simultaneously with psg in the sleep lab (sd+psg lab) and 3) psg was performed without the use of sd (psg lab). four ahi were generated and analyzed: ahi from sd home, ahi from sd of sd+psg lab, ahi from psg of psg+sd lab and ahi from psg lab. the analyses of sds and psgs recordings were performed by two blinded technicians.


Eligibility criteria:
inclusion criteria: * patient referred to sleep disorder center because of: * excessive daytime sleepiness, * loud snoring, * witnessed apnea. * patient with ability to provide consent, ability and willingness to follow study procedures. exclusion criteria: * suspicion of insomnia, * restless leg syndrome, * periodic limb movements; or * other non-osa sleep disorders. * patient experiencing acute illness, patients who are medically complex, and patients requiring supplemental oxygen or mechanical ventilation.
comparison of intravenous injection of calcium antagonist and beta-blockade on endothelial shear stress of coronary artery

Conditions: Acute Coronary Syndrome; Coronary Artery Disease

Summary: both calcium channel antagonist and beta-blocker have cardioprotective effect. endothelial shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis. the present study aims at comparing the re-distribution of shear stress and blood velocity during whole cardiac cycle after trans-coronary injection of nicardipine and esmolol.

blood flow-induced endothelial shear stress has strong effect on endothelial function and development or progression of plaque formation. it is extensively accepted that low and/or oscillating shear stress causes endothelial dysfunction and is one of crucial factors in localizing early atherosclerosis .in contrary, normal and high shear stress is atheroma protective and is involved in compensatory remodeling . most studies reported that the endothelial shear stress distribution in often idealized geometrical models of human coronary arteries was the subject of numerous investigations , and in these studies it was shown that the geometry of coronary arteries is the main determinant of the observed shear stress distribution. generally, downstream of a plaque, low shear stress can be expected, several cardiovascular active drugs have been shown to be cardio-protective for patients with obstructive coronary disease. of these drugs, calcium channel blocker is one of most prescribed in everyday clinical practice. ninomiya et al. reported calcium channel blocker was associated with increased coronary diameter and blood fluid with dose-dependent pattern in patients with normal or mild stenotic coronary artery. however, no reports on the dynamic change of endothelial shear stress after calcium channel blocker in -vitron were published so far. as a result, the aim of this study was to evaluate the effect of intra-venous injection of nicardipine, one calcium channel blocker with shorter half-time, on the re-distribution of endothelial shear stress in patients with acute coronary syndrome and mild stenotic (\<50%) coronary artery disease.

Eligibility criteria:
inclusion criteria: * diagnosis of unstable angina and non-q wave myocardial infarction * age 18-75 yr. * diameter stenosis of coronary artery\<70% diameter stenosis by visual estimation * blood pressure \>110/70 mmhg * heart rate 60-\~100 bpm, no cardiac arrhythmias exclusion criteria: * st-elevation myocardial infarction * lower blood pressure(\<100/70mmhg) * heart rate \ 100 bpm, the presence of cardiac arrhythmias * allergy to study drugs * women in pregnancy * liver dysfunction * creatinine \>2.5mg/dl * bleeding stroke within 6 months * left ventricular ejection fraction\<30% before maximal medication

Keywords: endothelial shear stress calcium channel blocker
working memory training in young adhd children

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to investigate whether working memory training improves behavioral symptoms, neurocognitive performance, and neural functioning in young children with adhd.


Eligibility criteria:
inclusion criteria: * age between 4 years/6 months and 7 years/4 months * diagnosis adhd, classified by the dsm-iv (diagnostic and statistical manual of mental disorders, 2000) * a full scale iq \>= 80 * psychopharmaca- naïve or -free * access to a pc with windows vista or windows xp with internet connection and speakers at home exclusion criteria: * currently intensive (i.e. weekly) individual or group psychotherapy * regular use of medication * diagnosis of one or more of the following comorbid psychiatric disorders: major depression, bipolar disorder, psychotic disorder, chronically motor tic disorder or gilles de la tourette, conduct disorder, any other autism spectrum disorder except for pervasive developmental disorder not otherwise specified (pdd-nos), eating disorders, anxiety disorders * neurological disorders (e.g. epilepsy) currently or in the past * cardiovascular disease currently or in the past * serious motor or perceptual handicap * participation in another clinical trial simultaneously * educational level and/ or socio-economic situation that makes it unlikely for the family to fulfil this study

Keywords: attention deficit disorder with hyperactivity working memory training placebo behavioral symptoms neuropsychology electropsychophysiology