Kornimate/medical-research-clean huggingface dataset:
a non-interventional study of ability and willingness to pay for biasp 30 in a real world population with type 2 diabetes mellitus (t2dm)

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to collect information about the participant's ability and willingness to pay for novomix 30 using a modern device, which is prescribed to the participant by the study doctor for type 2 diabetes mellitus according to routine clinical practice. the study aims to obtain data that can guide prescribers' understanding of the ability and willingness to pay for novomix 30 flexpen or penfill among participants in the growing middle class in india and egypt. the decision to prescribe novomix 30 flexpen or penfill has been made independent from this study.


Eligibility criteria:
inclusion criteria: - the decision to initiate treatment with commercially available biasp 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study - patients selected by their physician for participation in the study, who are likely to be able and willing to pay for the biasp 30 treatment for at least 12 weeks from baseline visit as assessed by the treating physician - signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - male or female greater than or equal to 18 years at time of informed consent - diagnosed with t2dm and treated with bhi in vials for at least three consecutive months at time of informed consent exclusion criteria: - previous participation in this study. participation is defined as having given informed consent in this study - concurrent participation in any other clinical trial or study - patients previously treated with insulin analogues - known or suspected hypersensitivity to study product (or any of the excipients of the study product; a full list of excipients is provided in summary of product characteristics (smpc) of novomix® 30) or related products - mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation - patients who are unable to read or write (illiterate)
hfnc flow titration and effort of breathing in the picu

Conditions: High Flow Nasal Cannula

Summary: high-flow nasal cannula (hfnc) is a method of non-invasive respiratory support used to decrease the effort of breathing (eob) in patients with a wide variety of respiratory diseases in the pediatric intensive care unit. while its use has shown association with decreased rates of mechanical ventilation, there is a paucity of data examining its direct effect upon objective measurements of eob. this study will aim to evaluate objective measurements of eob in response to different levels of hfnc support, characterize the natural course of respiratory diseases treated with hfnc, evaluate changes in eob secondary to the administration of supplemental medical therapies used in conjunction with hfnc, and compare different physiologic metrics for quantifying eob in patients on hfnc.


Eligibility criteria:
inclusion criteria: * all participants less than or equal to three years old admitted to the picu placed on high flow nasal cannula will be considered eligible for the study. exclusion criteria: * participants will be excluded if they have a corrected gestational age less than 37 weeks or contraindications to nasoesophageal catheter placement (nasopharyngeal or esophageal abnormalities) or rip bands (abdominal wall defects such as omphalocele). patients greater than three years of age will be excluded.

Keywords: effort of breathing high flow nasal cannula respiratory distress
study of screening brain mris in stage iv breast cancer

Conditions: Triple Negative Breast Cancer; HER2-positive Breast Cancer; Hormone Receptor-positive Breast Cancer

Summary: the study is a single arm, nonrandomized phase ii prospective study, with the goal of investigating the role of screening brain mris in neurologically asymptomatic patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of breast cancer with documentation of er/pr/her2 status * radiographic evidence of stage iv extracranial diease having progressed past first line therapy in hr+/her2- patients * radiographic evidence of stage iv extracranial disease in tn and her2+ patients * age ≥ 18 * life expectancy ≥ 6 months * eastern cooperative oncology group performance status 0 to 2 * patients must be able to understand and the willingness to sign an informed consent for study procedures * stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: * prior diagnosis or treatment of brain metastases or leptomeningeal disease * patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years * neurologic symptoms warranting standard screening brain mri in the judgement of the treating physician at time of enrollment * indications warranting brain mri for other neurologic conditions at time of study entry * contraindication towards mri imaging with contrast * chronic kidney disease stage iv or v or end stage renal disease

Keywords: stage iv breast cancer
flexible band vs rigid ring for degenerative mitral valve disease

Conditions: Mitral Regurgitation

Summary: the study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease

currently, mitral ring selection is based on a surgeon's preference rather than evidence. semirigid rings combine flexibility and stability; however, their clinical benefit has not been completely clarified. the present study aimed to compare the outcomes of mitral valve repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients with degenerative mitral valve disease.

Eligibility criteria:
inclusion criteria: * severe primary mitral regurgitation due to degenerative mitral valve disease exclusion criteria: * previous open cardiac surgery, * indication for concomitant aortic valve replacement, * left ventricle impairment (ejection fraction \< 40%).
effects of transcranial direct current stimulation (tdcs) and motor learning in children with cerebral palsy (cp)

Conditions: Cerebral Palsy

Summary: in this study, the investigators aim to assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tdcs)- on cortical plasticity and motor learning in children with cerebral palsy. investigators will use different assessment techniques, such as transcranial magnetic stimulation (tms) and kinematics (sensors) to measure changes through the trial.


Eligibility criteria:
inclusion criteria: * age of participants must be between 8 and 18 years old. * diagnosis of spastic or mixed cp with distribution of diplegia and/or hemiplegia form. * gross motor function classification system for cerebral palsy (gmfcs) level ii and iii. * manual ability classification system for children with cp (macs) level ii up to iv. * ability to cooperate and follow directions. exclusion criteria: * muscle tone reduction therapy in the past 3 months prior to study onset. * upper limb orthopedic surgery in the past 3 months prior to study onset. * any other form of therapy or procedure involving motor neuron junction inhibition; either by biochemical and/or mechanical denervation, in the past 3 months prior to study onset. * history of convulsive disorder in the past 2 years prior to study onset. * current use of carbamazepine as anticonvulsive therapy. * presence ventriculoperitoneal shunt.

Keywords: motor learning cortical plasticity direct current stimulation
mindfulness interventions and chronic widespread pain in adolescents

Conditions: Fibromyalgia; Chronic Widespread Pain

Summary: the primary objective of this study to determine the feasibility and acceptability of a mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain and other similar chronic symptoms.

the primary objective is to test the feasibility, safety, tolerability and acceptability of a mindfulness meditation intervention for adolescents with juvenile fibromyalgia/chronic widespread pain. the purpose of the program is to test how effective an 8-week meditation and stress reduction class is in helping adolescents with chronic symptoms (including but not limited to fibromyalgia or chronic widespread pain, irritable bowel syndrome, joint pain, chronic fatigue, and others). participants will attend group sessions led by an instructor experienced in mbsr in an academic setting. the mindfulness meditation group sessions will take place at the yale school of medicine. participants will attend 90-minute weekly group sessions and a 4-hour retreat with approximately 6-8 other study participants at yale school of medicine. participants are asked to practice at home by listening to pre-recorded 15-20 minute guided meditations.

Eligibility criteria:
inclusion criteria: * 2010 american college of rheumatology (acr) criteria based on the widespread pain index (wpi) and symptom severity (ss) checklist. * functional disability score ≥13 indicating at least moderate disability * average pain intensity in the past week ≥ 4 on a 0-10 cm visual analog scale. * access to mobile telephone/smartphone with text messaging plan in order to receive survey questions. * chronic symptoms such as fatigue, pain, bowel dysfunction, perceived cognitive impairment, or other non-specific symptoms persisting for 3-months or more, severe enough to have led to more than one visit to a medical provider. these symptoms must have not been found to be due to a definable general medical disorder despite adequate evaluation. exclusion criteria: * diagnosis of an autoimmune or rheumatologic disease * current regular mindfulness meditation activity * serious illness (including mental illness/psychopathology) within 90 days prior to screening * inability or unwillingness of a parent to give consent/permission or child to assent * current use of opioid analgesics * current prescription for antidepressant medications * screening positive on the columbia suicide screen (css) * active participation (weekly or more often) in a fibromyalgia or chronic disease support group

Keywords: fibromyalgia juvenile fibromyalgia juvenile primary fibromyalgia syndrome (jpfs) adolescent pain mindfulness mbsr
defocus-enhanced vs. single vision spectacles in myopia control visual function training

Conditions: Myopia

Summary: the purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (dims) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years.


Eligibility criteria:
inclusion criteria: * aged 6-18 years. * diagnosed myopia with ser between -0.50d and -4.00d. * astigmatism ≤ 2.50dc. * anisometropia \< 1.25d. exclusion criteria: * suspected genetic syndromes (e.g., stickler, marfan). * other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus). * myopia progression \<0.50d ser in the last year.

Keywords: myopia visual function training defocus-enhanced spectacles single vision spectacles
function and composition of regulatory b cells in participants with glioblastoma

Conditions: Glioblastoma, Adult

Summary: rationale: this project elaborates on a novel finding of the investigators that has not yet been reported in literature, namely the presence of elevated levels of atypical b cells in participants with glioblastoma. ln the period 2015 2018 the investigators analysed the blood immune subset composition of a cohort of 180 participants undergoing neurosurgery. the most relevant finding was the presence of an abnormally elevated level of b cells in the blood of the great majority of participants with glioblastoma. these b cells may be involved in the immunosuppression associated with glioblastoma that makes this tumor refractory to immunotherapy. multiple regression analysis indicated that the increase in the frequency of atypical b cells in participants' peripheral blood was related with the administration of dexamethasone prior to surgery. however, this study design did not allow the investigators to address the causality of the relationship between dexamethasone and atypic b cell dysregulation. alternative treatments to dexamethasone exist. objective: to investigate the effect of dexamethasone in the dysregulation of atypic b cells in participants with glioblastoma. study design: observational case control pilot study with 20 participants (10 per group). study population: newly diagnosed participants with glioblastoma. intervention (if applicable): observational study. main study parameters/endpoints: changes in the immune subset composition and functionality in the peripheral blood of participants with glioblastoma upon administration of dexamethasone for neurological signs of peritumoral edema (oral dexamethasone). nature and extent of the burden and risks associated with participation, benefit and group relatedness: the investigators will collect blood (28 ml) during the first visit and again (28 ml) at the time of surgery (2 weeks ± 3 days). there will not be additional site visits, physical examinations or any other tests, questionnaires. blood collection is only a minor discomfort and it does not represent any additional risk.


Eligibility criteria:
inclusion criteria: clinical diagnosis glioblastoma patients are 18 years or older at first diagnosis exclusion criteria: no indication for surgery to confirm radiological diagnosis not able or willing to give informed consent allergy or intolerance to dexamethasone

Keywords: glioma glioblastoma adult dexamethasone b cells regulatory b cells
effects of respiratory muscle training in individuals with long-term post-covid-19 symptoms

Conditions: Covid19; Post-acute COVID-19 Syndrome

Summary: the main objective of the present study is to observe the short-term effects of respiratory muscle training combined with an exercise training program on quality of life and exercise tolerance in individuals with long-term post-covid-19 symptoms. as secondary objectives, the effects on respiratory muscle function, physical and lung function, as well as on the psychological state of these individuals.

it is a double-blind randomized clinical trial study. each participant will be randomly assigned to one of the following groups: 1) exercise training program + inspiratory muscle training + expiratory muscle training, 2) exercise training program + sham inspiratory muscle training + sham expiratory muscle training. the exercise training program will be delivered in hospital and will be applied 2 sessions per week during 8 weeks. the exercise component will be lasted for 1hour and it consisted of cardiovascular exercises. the respiratory muscle training program will be applied twice a day, 3 sessions per week during 8 weeks by a threshold device. the evening sessions will be supervised by a physiotherapist through a virtual platform. participants received baseline assessments at the beginning of the intervention and post-intervention assessments at the end of the 8th week.

Eligibility criteria:
inclusion criteria: * over 18 years who presented long-term post-covid-19 symptoms of fatigue and dyspnoea for at least 3 months after the covid-19 diagnosis exclusion criteria: * progressive respiratory, neuromuscular or neurological disorders and/or psychiatric or cognitive conditions that hindered their ability to cooperate * comorbidity that could interfere with the study interventions * any contraindication to the training interventions * previous inclusion in a rehabilitation program for their long-term post-covid-19 symptoms (previous 3 months)

Keywords: respiratory muscle training tele-rehabilitation quality of life exercise
shear wave elastography registry study

Conditions: MASLD; MASH; Fibrosis, Liver; Chronic Liver Disease

Summary: this study shall be a prospective, multicenter, single arm, consecutive, blinded, study conducted in a post-market setting using commercially available devices. consecutive, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. eus shearwave elastography technology will be compared to fibroscan. the data collected during this study will be evaluated in accordance with the procedures set forth in this protocol.

a total of up to 300 subjects will be enrolled and treated at four us sites. enrollment is expected to be completed within 18 months. each subject will undergo both procedures (fibroscan and eus with sw elastography), end of study will be reached after pathology results have been obtained (within a week of the initial procedure). this study has been designed as a post-market clinical registry to evaluate the effectiveness of endoscopic ultrasound with shear wave elastography to estimate hepatic fibrosis in patients with chronic liver disease. all consenting, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. willing and able to provide informed consent 3. patient scheduled to undergo eus with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the eus (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight 4. patient scheduled to undergo or have undergone fibroscan, which should be performed within 3 months of the eus (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight 5. bmi \>/=28 6. clinical suspicion of masld (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low hdl-c, 4) hypertension, and/or 5) hypertriglyceridemia) or mash (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, fibroscan) exclusion criteria: 1. patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma 2. prior history of hepatitis b or c infection 3. decompensated cirrhosis (gi bleeding, ascites, encephalopathy) 4. histological evidence of other concomitant chronic liver disease on biopsy 5. inadequate liver biopsy

Keywords: shearwave shear wave fibroscan
magnetic resonance with gadoxetic acid for the diagnosis of hepatocellular carcinoma in patients with liver cirrhosis. evaluation of its impact for the non-invasive diagnosis

Conditions: Hepatocellular Carcinoma

Summary: this is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma

the investigators plan to define the imaging patterns of hepatocellular carcinoma in cirrhotic patients when studied with gadoxetic acid magnetic resonance imaging including the dynamic phase and the hepatobiliary phase at 10 and 20 minutes after contrast injection and to evaluate the usefulness of liver magnetic resonance imaging with gadoxetic acid in the differentiation between benign and malignant nodules in the cirrhotic liver. to determine the diagnosis and clinical significance of the infracentimetric additional nodules detected in the hepatobiliary phase

Eligibility criteria:
inclusion criteria: * more than 18 years old * patient with diagnosis of liver cirrhosis child pugh a-b * patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm * patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication * patient that agree to participate signing informed consent form exclusion criteria: * patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (child-pugh c) * patients with previous diagnosis of hepatocellular carcinoma * patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma * patients with severe clotting alterations that contraindicate the fine-needle biopsy -patients with chronic kidney disease or glomerular filtration rate \< 30 ml/min * patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...) * known hypersensitivity to study drugs or excipients * pregnancy or breastfeeding
quantitative eeg during anesthesia emergence in children

Conditions: Anesthesia, General; Electroencephalography; Brain Waves; Psychology, Children; Child Behavior

Summary: most drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. after the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. in this process, various side effects may occur. emergence delirium (ed) is a representative behavioral disturbance after general anesthesia in children and that can cause several problems during the recovery period. previous eeg studies reported that this phenomenon is related to hyperexcitation of the brain, and occurrence of epileptiform discharges during anesthesia induction may indicate an increased vulnerability for the development of a functional brain disorder in these children. however, to the best of our knowledge, there is no studies concern evaluating quantitative eeg parameters for prediction of this postoperative negative behavior in children.


Eligibility criteria:
inclusion criteria: * children aged between 2 and 10 years of american society of anesthesiologists physical status (asa ps) i or ii who are planned to receive surgery under general anesthesia exclusion criteria: * if the guardian and the subject are difficult to evaluate normally due to language barriers/language disorders/delay or autistic disorder * with developmental delay, neurological disorders or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc * refusal of consent * recent history (within a month) of received general anesthesia or surgery * presence of congenital or other genetic conditions thought to influence brain development