Kornimate/medical-research-clean huggingface dataset:
cardea solotm for paroxysmal atrial fibrillation diagnosis in esus patients with left atrial enlargement

Conditions: Embolic Stroke of Undetermined Source

Summary: the aim of the study is to evaluate the efficacy and safety of the cardea solo compared to 12 lead ekg for paroxysmal atrial fibrillation diagnosis in esus patients with left atrial enlargement.

the prospective, multi-center, open-label, randomized, controlled, investigator-initiated trial will be started on june 2022. randomized patients in two arms will receive cardea solo or 12 lead ekg respectively. cardea solo received patients will keep it for 7 days. 12 lead ekg received patients will discharge home. after 7 days, results of cardea solo auto reading will be evaluated by dependent committee including cardiologist.

Eligibility criteria:
inclusion criteria: inclusion no. 3 or 4 must be satisfied, and no. 2, 5 and 6 must be satisfied. 2. on the screening date, stroke onset date is not over 60 days. 3. esus diagnosis : all of a\~e must be satisfied. * a. ischemic stroke detected by ct or mri that is not lacunar * b. a person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site * c. during continuous monitoring or halter monitoring in the stroke intensive care unit, person without atrial fibrillation and persistent atrial fibrillation * d. when checked the transthoracic echocardiography, no major risk cardioembolic source of embolism. (ex. myocardial infarction within 4 weeks, mitral stenosis, artificial heart valve and so on) * e. no other specific cause of stroke identified(et, arteritis, dissection and drug abuse) 4. cardioembolism is classified by toast classification. 5. left ventricle enlargement(male \>40mm, female \>38mm, lavi \>35ml/m2 6. voluntarily sign the consent form exclusion criteria: 1. transient cerebral ischemic attack 2. active cancer 3. heart embolism, stroke of major heart embolism, stroke high-risk disease 4. left atrial thrombus 5. left ventricular thrombus 6. sick sinus syndrome 7. myocardiac infarction in 1 month 8. rheumatic left atrioventricular valve or aortic valve disease 9. artificial heart valve 10. myocardiac infarction (ef\<28%) 11. congestive heart failure (ef\<30%) 12. dilated cardiomyopathy 13. nonbacterial thrombotic endocarditis 14. endocarditis 15. intracardiac mass 16. atrial fibrillation 17. restriction for echocardiography (obesity, lung disease etc) 18. high risk pfo 19. patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis) 20. implant cardiac pacemaker 21. life-threatening arrhythmia 22. radiation therapy or mri scan 23. restriction for cardia solo attachment 24. the person who investigator judged unsuitable for the trial

Keywords: embolic stroke of undetermined source left ventricle enlargement paroxysmal atrial fibrillation
the choosing healthy eating for infant health (cherish) study

Conditions: Pediatric Obesity

Summary: the choosing healthy eating for infant health (cherish) intervention is a complex infant feeding intervention delivered at infant vaccination visits, alongside a healthcare professional (hcp) level implementation strategy to support delivery. the primary aim of cherish pilot feasibility study is to collect and examine data on the acceptability and feasibility of the delivery of the brief infant-feeding intervention by hcps to parents at child vaccination visits, and the strategy to support the implementation of this intervention in primary care for hcps. furthermore, half of all potential participants will be invited to provide maternal and infant biomarkers and/or take part in swat (study within a trial) which includes questions about infant feeding that were put together as part of a core outcome set. these questions are important as they give a better understanding about what works and what doesn't. this will facilitate the refinement of the intervention and its implementation strategy, and inform the next step of the cherish study, such as a definitive trial.

the choosing healthy eating for infant health (cherish) intervention is a non-randomised feasibility study of an infant feeding intervention and implementation strategy, with embedded process evaluation and economic evaluation. the cherish feasibility study will address the following research questions: 1. are the intervention content, delivery and implementation procedures acceptable to parents who will receive the intervention, and hcps who will deliver the intervention? 2. are the data collection processes, including mode and duration of data collection and outcome measures used, acceptable to parents and hcps? 3. is the intervention feasible to deliver in primary care practice, in terms fidelity of delivery and receipt of the intervention? 4. is the study feasible in terms of recruitment and retention procedures and data collection? 5. what are the costs associated with the intervention and its implementation strategy?

Eligibility criteria:
inclusion criteria (health care professionals): * involved in the delivery of routine infant vaccinations * completed training to deliver the intervention. inclusion criteria (parents): * parent of an infant ≤ 6 weeks of age at study recruitment. * intends to attend a participating gp and/or pn in the primary care centre for child's vaccination visits. * is over 18 years of age. * can provide written informed consent to participate. exclusion criteria: * n/a

Keywords: child obesity infant feeding feasibility study
finrisk 2002 re-examination

Conditions: Cardiometabolic Syndrome; Cardiovascular Diseases

Summary: the project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of cmd. to achieve this goal, repeat stool samples will be collected of \~2300 finnish individuals who gave stool samples in the year 2002. in addition, \~300 individuals will undergo a in-depth health examination in 2024.


Eligibility criteria:
inclusion criteria: * participation in finrisk 2002 fecal sampling
effect of oat compounds on postprandial glucose response

Conditions: Healthy Subjects

Summary: in this project we will investigate synergistic effects of oat polar lipids and beta glucans on postprandial glucose tolerance


Eligibility criteria:
inclusion criteria: * healthy * bmi 20-28 kg/m2 * diet which follows the nordic nutrition recommendations (non-vegetarian) exclusion criteria: * fasting glucose \> 6.1 mmol/l * metabolic diseases * gastrointestinal disease * chronic and/or psychological disease * food allergy * vegetarian or vegan diets, or other special diets

Keywords: prevention food diabetes type 2 postprandial glucose regulation appetite oat polar lipids obesity glucose tolerance
glumetinib combined with osimertinib treatment for non-small cell lung cancer patients

Conditions: Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression

Summary: to evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic nsclc.

in the phase ii stage, eligible subjects who have passed screening will be randomly assigned in a 1:1:1 ratio into the group 1, group 2, and group 3 to receive study treatment: in the phase iii stage, eligible subjects who have passed screening will be randomly assigned in a 1:1 ratio into the test group and the control group to receive the study treatments, and the rp3d obtained from phase ii will be used as the dose of glumetinib for the test group. randomization stratification factors include: c-met status (≥2+, ≥75% and 3+, \<50% vs 3+, ≥50% or fish positive), and egfr-sensitive mutation type (19del vs l858r). in both the phase ii and phase iii stages, each treatment cycle is every 3 weeks, with continuous treatment until progressive disease (pd) confirmed by the investigator, intolerable toxicity, withdrawal of informed consent by the subject, loss to follow-up, death, or other criteria for terminating treatment as specified in the protocol, whichever occurs first.

Eligibility criteria:
inclusion criteria: * 1. able to understand and voluntarily sign the written informed consent form (icf); 2. male or female subjects aged 18 to 75 years (inclusive). 3. patients with nsclc who have unresectable locally advanced or metastatic disease; 4. at least one measurable lesion, as defined by recist 1.1 criteria; 5. ecog performance status of 0 or 1; 6. expected survival ≥ 3 months; 7. adequate function of major organs and bone marrow; 8. women or man of childbearing potential must use highly effective contraception. exclusion criteria: 1. prior treatment with an egfr inhibitor or met inhibitor; 2. patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis; 3. patients who have taken strong inducers or inhibitors of cyp3a4 within 2 weeks prior to the first dose of the study drug, or who cannot discontinue the use of strong cyp3a4 inducers and inhibitors during the study; 4. patients with a history of autoimmune diseases, a history of immunodeficiency, including positive for hiv, or other acquired or congenital immunodeficiency diseases, or a history of organ transplant; 5. presence of active infection (e.g., subjects are receiving anti-infection therapy); 6. severe or uncontrolled cardiovascular disorder requiring treatment; 7. refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally; 8. women who are pregnant or breastfeeding;
safety and effect of adipose tissue derived mesenchymal stem cell implantation in patients with spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (mscs) in patient with spinal cord injury


Eligibility criteria:
inclusion criteria: * subjects who understand and sign the consent form for this study * age : 19-70 * clinical diagnosis of spinal cord injury(american spinal injury association\[asia\] impairment scale\[ais\] grade a or b or c) * duration of injury : \> 3 month exclusion criteria: * subjects who must put on a respirator * subjects who had malignant tumor within 5 years * subjects with a infectious disease include hiv and hepatitis * subjects who injured brain or spinal cord before spinal cord injury * subjects with anemia or thrombocytopenia * subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease * subjects with congenital or acquired immunodeficiency disorders * patients with clouded consciousness or speech disorder * treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials * participating another clinical trials within 3 months * other serious disease or disorder that could seriously affect ability to participate in the study
aggressive onset multiple sclerosis: a practical definition and study of its clinical course

Conditions: Multiple Sclerosis

Summary: chart review.

a chart review will be completed on patients with multiple sclerosis to determine potential early characteristics that might be helpful in defining aggressive onset ms and predicting subsequent disease course and disability

Eligibility criteria:
inclusion criteria: * two or more relapses in the preceding year and 2 or more gadolinium enhancing lesions on brain mri scan or a significant t 2 lesion burden or * one relapse if it results in sustained edss of 3.0 along with 2 or more gadolinium enhancing lesions or significant t2 lesion burden ( t2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location) exclusion criteria: -
vigorous cool room treadmill training

Conditions: Multiple Sclerosis; Rehabilitation; Gait Disorders, Neurologic; Neuronal Plasticity

Summary: people with multiple sclerosis (ms) are often offered walking aids and compensatory strategies rather than restorative rehabilitation. we have developed a cool room treadmill training method that uses body-weight support that people with ms fatigue and heat sensitivity can tolerate. our previous research shows that people with advanced ms use three times more energy for essential tasks such as walking. this project will test whether 10 weeks of body-weight supported treadmill training in a room cooled to 16°c improves walking, fitness and fatigue in people with advanced ms.


Eligibility criteria:
inclusion criteria: * clinically definite ms * relapse-free in the previous 3 months * requiring ambulatory assistive devices (edss 6.0-7.0) * negative par-q screen for risk factors * greater than 6-weeks post botulinum toxin injection (if received) in the lower extremity exclusion criteria: * pregnancy or intention of becoming pregnant * finished a drug/device study in the last 30 days * over 75 years of age * unable to control bowel and bladder on physical exertion * currently attending physical rehabilitation * having no difficulty walking in the community (self-selected walking speed \>120 cm/s)
ct-ultrasound fusion in guiding pcnl puncture

Conditions: Kidney Stone

Summary: kidney stone is a common urological disease. percutaneous nephrolithotomy (pcnl) is an important method for the treatment of kidney stones. the accuracy of puncture positioning affects the pcnl stone free rate and intraoperative/postoperative complications. currently, pcnl puncture positioning methods are mainly x-ray-guided or ultrasound-guided. the main disadvantage of x-ray is the lack of soft tissue imaging, and the problem of low puncture accuracy. although ultrasound is a commonly used real-time imaging tool, the image is not intuitive enough, and the puncture path is deviated from actual requirements . in order to improve the accuracy of pcnl puncture, this study intends to import ct images of both kidneys into a novel ultrasound machine through an image fusion system to achieve ct-ultrasound image fusion, and to simulate the puncture route to guide the pcnl puncture process. the study is mainly divided into two parts: (1) for patients with kidney stones who are planning to undergo pcnl, perform a preoperative simulated ct-ultrasound fusion examination to further clarify the condition of the kidney stones and simulate and optimize the puncture route; (2) apply ct- ultrasound fusion precise positioning to guide the intraoperative pcnl puncture process. on the basis of traditional ultrasound images, the ct-ultrasound fusion image display is added to provide the optimal puncture route to explore the effectiveness and safety of ct-ultrasound fusion precise positioning in pcnl puncture.


Eligibility criteria:
inclusion criteria: * (1) age ≥18 years old, gender is not limited, and can tolerate surgery; (2) kidney stone patients who intend to undergo pcnl surgery; (3) have kidney ct data; (4) volunteer to participate and sign informed consent. exclusion criteria: * (1) uncontrollable systemic hemorrhagic disease; (2) severe spinal deformity, severe hip deformity, and difficult lithotomy position; (3) uncontrolled urinary tract infection; (4) cavity caused by any urinary system anatomy internal surgery cannot be performed; (5) pregnant women, women who plan to become pregnant within 3 months, and lactating women; (6) patients with severe heart, lung and brain diseases that cannot tolerate surgery; (7) the investigator judges that the patient is not suitable for participating in this study , including (but not limited to): known to be carrying human immunodeficiency virus or suffering from aids; suffering from mental illness; infectious diseases, etc.
impact of omalizumab on quality of life measures and angioedema occurrence in patients with csu refractory to therapy

Conditions: Chronic Spontaneous Urticaria; Angioedema

Summary: this study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

this study will be conducted using a double-blind, placebo-controlled, randomized, multicenter design to investigate the impact of omalizumab on quality of life (qol) in chronic spontaneous urticaria (csu) and will assess its effectiveness in reducing and/or inhibiting the occurrence, time-course and severity of angioedema episodes. omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current approved treatment of adult csu patients. the treatment period is 28 weeks which is followed by an 8-week follow-up. the study aims to enroll approximately 70 patients. the study is divided into a 2-week screening period, a 28-week double-blind treatment phase with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic spontaneous urticaria (csu) refractory to h1-antihistamine treatment * presence of itch an hives for more than 6 weeks * uas7 score of more than 14 (range 0-42) * patient has history of insufficient response to 4x of the approved dose of h1-antihistamines * csu diagnosis for more than 6 months * angioedema at least 4x in the last 6 months exclusion criteria: * patients with non urticaria associated angioedema * history of hypersensitivity to omalizumab or the rescue medication or to drugs of similar chemical structure * evidence of parasitic infection * previous treatment with omalizumab within the last 6 months prior to screening * history of anaphylactic shock * woman who are pregnant or breast feeding * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic spontanous urticaria, refractory csu, angioedema
effect of the angiotensin ii receptor antagonist irbesartan on biochemical and functional markers of endothelial dysfunction in patients with hypertension

Conditions: Hypertension

Summary: primary: * to evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome. secondary: * to evaluate the oxidative stress status in patients with hypertension with metabolic syndrome. * to correlate the oxidative stress status with endothelial function in these patients. * to evaluate the effect of irbesartan on the oxidative stress stage in patients with metabolic syndrome and to correlate it with the effect on endothelial function . * to correlate the change in endothelial function and oxidative stress stage with the change of arterial pressure levels.


Eligibility criteria:
inclusion criteria: * hypertension grade 1 or 2 * with at least two of the following criteria for the diagnosis of metabolic syndrome: * body mass index \> or = 25 kg/m2 and waist circumference \> or = 100 cm. * dyslipidemia (triglycerides fasting serum levels \> or = 200 mg/dl or hdl serum levels \< or = 40 mg/dl) * fasting serum glucose \> or = 110 mg/dl but \< 126 mg/dl exclusion criteria: * known hypersensitivity to irbesartan * hypertension grade 3 * history of clinical vascular events such as tias, stroke, peripheral arterial disease * coronary artery disease * renal insufficiency (creatinine serum levels \> or = 1.2 mg/dl) * presence of clinical heart failure * asthma and copd * valvular cardiopathy clinically relevant * current therapy with antioxidant drugs, statins * therapy with aiira for at least 3 months during the last semester * presence of any acute illness or major trauma in the last 8 weeks * history of a chronic inflammatory disease such as rheumatoid arthritis, immune disorders or connective tissue disease. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of virtual reality game on upper limb movement in individuals with stroke

Conditions: Stroke; Movement, Abnormal

Summary: individuals with stroke show abnormal movement pattern of upper limb. the movement pattern needs to be corrected. there are several methods to train normal movement. exercise with technology is an active movement and affects sensory and cognitive systems. it may benefit to individuals with stroke in training.

individuals with stroke sign informed consent. they are trained with virtual reality game with and without feedback from a researcher. age-matched healthy play the same game as individuals with stroke do. both individuals with stroke and healthy are measured upper limb movement pattern.

Eligibility criteria:
inclusion criteria: individuals with stroke 1. 45 - 65 years old 2. first ischemic or hemorrhagic stroke 3. right hemiparesis 4. right dominant handedness 5. within 6 months after stroke 6. discharge from hospital and stay at home 7. normal dynamic sitting balance 8. at least 120 degrees of shoulder flexion and 45 degrees of shoulder extension by passive range of motion 9. active movement at least stage 3 by chedoke-mcmaster stroke assessment 10. muscle tone graded 1-2 by modified ashworth scale in 2 of 3 muscle groups including shoulder adductor, internal rotator or/and elbow flexor groups 11. no cognitive impairment healthy individuals 1. have same gender and age within range of ±5 years of individuals with stroke 2. right handedness 3. active range of motion of shoulder flexion and extension at least 120°and 45° respectively 4. no cognitive impairment exclusion criteria: individual with stroke and healthy 1. have cyber-sickness 2. obesity 3. ataxic movement 4. loss visual field or visual neglect 5. loss exteroceptive sensation 6. impaired or loss proprioceptive sensation 7. receive the occupation therapy on upper extremity 8. muscle contracture at the scapula, shoulder and elbow 9. pain at the scapula, shoulder and elbow 10. history of fracture or surgery at head, shoulder, scapula, and elbow 11. shoulder subluxation 12. other neurological disorders 13. uncontrolled hypertension 14. myocardial infarction 15. seizure or epilepsy 16. pacemaker or hemodialysis vascular access

Keywords: virtual reality feedback