Kornimate/medical-research-clean huggingface dataset:
modulation of the brain excitatory/inhibitory (e/i) balance in autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: this study investigates the brain response to a single acute dose of arbaclofen, the r-enantiomer of the gaba-b agonist baclofen, compared to a single dose of placebo in healthy men with and without autism spectrum disorder.

previous research suggests that gabaergic drug compounds could shift brain excitation and inhibition (e-i) in the healthy brain and in neurodevelopmental psychiatric conditions, such as autism spectrum disorder (asd) - where this balance is disrupted. a study by ajram et al. (2017) has shown an e-i shifted towards more gaba in individuals with asd, and not in controls, after a single dose of the anti-glutamatergic and pro-gabaergic drug riluzole. moreover, brain connectivity patterns in asd patients where shifted towards the ones observed in the control group. however, it was unclear whether this changes could be driven by gaba receptors, thus more specific probes may help to clarify the mechanism underlying the e-i coordination in asd. therefore, this study will use neuroimaging and electrophysiology to investigate the brain e-i coordination in asd compared to control participants when the system is responding to a single dose of the specific gaba-b (stx209) receptor agonist. 50 adult individuals with asd and 50 neurotypical adults (25 males and 25 females per group) will be invited to participate. each participant will receive a single dose of the drug (15mg or 30mg arbaclofen) or matched placebo). brain activity and neurochemistry will be investigated using magnetic resonance imaging. further data will be collected through questionnaires, behavioural tasks, blood samples, and sensory tasks using electroencephalography and retinal imaging.

Eligibility criteria:
inclusion criteria: * asd participants must pass diagnostic threshold for asd on the autism diagnostic interview-revised (if and informant is available) * asd participants must be currently symptomatic on autism diagnostic observation schedule (ados) * age 18-60 years * can give informed consent * medication free in the month preceding participation; but regular medication (used in a stable dose over the two months previous to participation) with drug which does not affect glutamate or gaba directly may be permitted * iq\>70 exclusion criteria: * iq\<70 * history of psychosis, co-morbid major mental illness, significant physical illness (heart disease, high blood pressure, seizures) habitual substance misuse (including alcohol) * asd caused by a known genetic syndrome e.g. fragile x or 22q11 deletion syndrome, * past/present treatment for epilepsy * change of medication dose/start of a new pharmacological therapy in the month prior to participation

Keywords: autism spectrum disorder arbaclofen e-i balance pharmacological imaging gaba
neonatal cerebral blood flow and the neurobehavioral and handedness outcomes in term and preterm adolescents

Conditions: Preterm Children

Summary: the results will provide insightful information to understand the process of neural development and the predictive value of early cerebral blood flow measures on longitudinal neurodevelopment and handedness outcomes in preterm and term adolescents. the findings also contribute to the understanding of effectiveness of early intervention on long-term neurodevelopmental outcome in preterm children at adolescence. our study has three hypotheses as below: 1. the preterm intervention group have higher neuromotor scores, lower behavioral problem scores and higher incidence of right-handedness than the preterm control group. 2. the preterm intervention group have comparable neuromotor scores, behavioral problem scores and incidence of right-handedness than the term adolescents. 3. the neonatal cerebral blood flow velocity asymmetry measures are significantly associated with the infant, preschool, school and adolescent neurodevelopment and handedness outcomes in preterm children with very low birth weight and term children.

the term and preterm children have previously been administered cranial doppler ultrasound and neurobehavioral assessment at term age, and neurodevelopmental assessment in the neonatal period, infancy, preschool and school age (bayley scales of infant and toddler development-3rd edition, movement assessment battery for children-2nd edition, child behavior check list/4-18, wechsler pre-school and primary scales of intelligence-revised, and developmental test of visual-motor integration - 6th edition). all families will be contacted via phone call and mail to participate in this study. children and their parents will be examined for child neuromotor development, handedness and behavior when the children reach 12-14 years of age. all measures will be conducted at the infant motor development laboratory, school of physical therapy, national taiwan university. the outcome measures in this study will consist of the growth (weight and height), neuromotor function (movement assessment battery for children-2nd edition), handedness (edinburgh handedness inventory) and behavior (child report and parent report of child behavior check list for ages 4-18 years).

Eligibility criteria:
inclusion criteria: joined our previous study * preterm group: (1) birth weight \<1,500 g; (2) gestational age \<37 weeks; * term group: (1) birth weight \>2,500 g; (2) gestation age within 38 and 42 weeks; (3) intrauterine growth status as appropriate for gestational age. exclusion criteria: * severe neonatal diseases included major neurologic abnormalities, necrotizing enterocolitis, and severe cardiopulmonary disease and major congenital abnormality.

Keywords: handedness neonatal cerebral blood flow neurodevelopment
diagnosis and treatment of acs in the ed: the impact of rapid bedside ctni testing on outcomes

Conditions: Angina, Unstable

Summary: in a randomized, controlled clinical trial, point-of care testing at the bedside using the cardiac biomarker troponin i in ed patients with possible acs will be compared to traditional testing of this assay for myocardial necrosis obtained in the central laboratory. our hypothesis: point-of-care testing for troponin i will decrease the time for disposition of patients with possible acs in the emergency setting and decrease the time required for administering appropriate therapies for these patients.

cardiac troponin i is routinely used in the emergency department as a risk stratification tool for detecting myocardial necrosis in patients with possible acute coronary syndrome. it is our hypothesis that having bedside, point-of-care testing for tni in the ed will decrease time needed to disposition patients to home from the ed or send to the cardiac catheterization laboratory or intensive care setting. similarly, having point-of-care testing in the ed should decrease the time required to deliver anti-platelet drugs such as aspirin and glycoprotein iib/iiia inhibitors and anti-thrombin agents such as heparin to high risk patients found to have a positive tni test. this will be evaluated in a randomized, controlled clinical trial of 2000 patients. half will have the test performed in the ed at the bedside (point-of-care) while the other half will receive the usual lab results obtained from the central lab (typically requiring 1.5-2 hours to return).

Eligibility criteria:
inclusion criteria * age \>21 years old * chest pain or other symptoms that lead to drawing cardiac bio-markers for possible acs diagnosis exclusion criteria * presentation with chest pain in the presence of a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation) * presentation with ecg diagnostic for stemi

Keywords: unstable angina non-st-segment myocardial infarction myocardial necrosis troponin i
analgesic effect of m-tapa on lc

Conditions: Post Operative Pain

Summary: objective: to investigate the postoperative analgesic efficacy of m-tapa block and its effect on opioid consumption in patients undergoing laparoscopic cholecystectomy (lc) surgery. place and duration of study: department of anesthesiology and reanimaton, sivas cumhuriyet university, sivas, turkey, from april 2023 to may 2023. methodology: there were two randomized groups: group m-tapa (n=21) and group control (no block) (n=21). all patients had standard general anesthesia. group m-tapa patients had bilateral m-tapa block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. group control had only tramadol for posteperative pain. numerical rating scale (nrs) and visual analogue scale (vas) were used to assess postoperative pain. total tramadol consumption was calculated.


Eligibility criteria:
inclusion criteria: * adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were american society of anesthesiologists (asa) i-ii-iii according to the asa risk classification. exclusion criteria: * patients who did not give consent, * patients with coagulopathy, * patients with signs of infection at the block application site, * patients using anticoagulants, * patients with local anesthetic drug allergies, * patients undergoing open surgery, * patients with unstable hemodynamics, * patients who could not cooperate during postoperative pain assessment

Keywords: modified thoracoabdominal nerve block through perichondrial approach postoperative pain laparoscopic cholecystectomy
egfrdelex19 and kras exon 2 mutation detection in ebus-tbna

Conditions: Lung Adenocarcinoma Metastatic

Summary: first-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (nsclc) harboring egfr exon 19 deletion mutations. conversely, somatic kras mutations are negative predictors for benefit from egfr-targeting agents. in this study we want to compare a new highly sensitive method for the detection of egfrdelex19 and kras exon 2 with targeted-resequencing multiplex-pcr (ngs).

first-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (nsclc) harboring egfr exon 19 deletion mutations. conversely, somatic kras mutations are negative predictors for benefit from egfr-targeting agents. rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments. endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) is well-established for lung cancer diagnosis and staging. next generation sequencing (ngs) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. rt-pcr using light-cycler technology (lc-rtpcr) is a rapid and sensitive assay to detect somatic mutations in various tissues from nsclc patients. the study's aim was to analyze if lc-rtpcr is feasible for rapid egfrdelex19 and kras exon 2 mutation detection in ebus-tbna samples and to compare results with results obtained via standard ngs mutation analyses.

Eligibility criteria:
inclusion criteria: * lung adenocarcinoma positive ebus-tbna specimen exclusion criteria: * other diagnosis
cmt-07-08: the prostate bed evaluation study

Conditions: Prostate Cancer

Summary: this is an observational study to collect placement and tracking data for patients who have the calypso transponders implanted into the peri-prostatic tissue.

use of real-time tracking using calypso electromagnetic beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.

Eligibility criteria:
inclusion criteria: 1. patients with recurrence of prostate cancer following radical prostatectomy for prostate adenocarcinoma 2. patients with initially undetectable psa following prostatectomy for prostate adenocarcinoma with subsequent psa relapse 3. patients being planned for radiation therapy 4. patient is being planned for implant with calypso transponders in the prostate bed 5. no evidence of distant metastases 6. age ≥ 18 years 7. informed consent exclusion criteria: 1. the patient has received other investigational therapy in the last 60 days 2. the patient has previously been implanted with permanent beacon transponders 3. the patient has a prosthetic implant in the pelvic region that contain metal or conductive materials 4. the patient has any other medical or other condition that would, in the investigator's opinion, make them a poor candidate for the study

Keywords: prostate prostate bed periprostatic
safety study of hmn14 to treat either colorectal or breast cancer

Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Breast Cancer; Breast Neoplasms

Summary: the purpose of this trial is to determine the safety of hmn14 at different dose levels in the treatment of either colorectal or breast cancer.


Eligibility criteria:
disease characteristics: * histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma * measurable lesion diagnosed by ct scan * recurrent/metastatic disease considered surgically unresectable. prior/concurrent therapy: * chemotherapy: patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (enrollment must occur at least 4 weeks beyond last treatment) * other: prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study patient characteristics/inclusion criteria: * performance status: patients with a karnofsky performance status \> 70% (or equivalent, ecog 0-1) and expected survival of at least 3 months. * hematopoietic: wbc \>/= 3000 mm3, neutrophils \>/= 1500 mm3, platelets \>/= 75,000, cea \< 300 ng/ml * hepatic: serum bilirubin \</= 2.0 mg/dl, alt \< 2.5 x iuln * cardiovascular: patients with lvef \>/= 40% by required muga/2d-echo study. * pulmonary: patients with fev1 \>/= 60% by required pulmonary function tests * other: patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. a pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent. patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.

Keywords: colorectal cancer colon cancer rectal cancer colorectal neoplasms colorectal carcinoma breast cancer breast neoplasms
breath analysis and arterial stiffness in patients with respiratory diseases

Conditions: Chronic Respiratory Diseases; Cystic Fibrosis; Lymphangioleiomyomatosis; Hypersensitivity Pneumonitis; Interstitial Lung Diseases; COPD; Bronchial Asthma

Summary: assessment of cardiovascular disorders using echocardiography and arterial stiffness; comparative noninvasive assessment of volatile organic compound (evoc) exhale breath patterns in patients with different chronic respiratory diseases with age and gender-matched healthy adults in order to identify a disease-specific exhaled evocs profiles and markers of respiratory and cardiovascular disorders.

evaluating of evocs profiles by proton mass spectrometry with a time-of-flight (ptr-tof) in patients with different chronic respiratory diseases is of great interest for assessing the prognosis and development of severe ventilation and cardiovascular disorders. the aim of our study is to determine the diagnostic significance of ptr-tof analysis in patients with chronic respiratory diseases and to identify specific evoc markers of a severe ventilation and cardiovascular disorders in patients with different chronic respiratory diseases.

Eligibility criteria:
inclusion criteria: 1. written informed consent to participate in the study; 2. age 18 and over; 3. clinical diagnosis of one of chronic respiratory diseases (copd, bronchial asthma, cystic fibrosis, lymphangioleiomyomatosis, hypersensitivity pneumonitis or other interstitial lung disease). exclusion criteria: 1. unable to sign informed consent; 2. respiratory disease (for controls); 3. mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis); 4. acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism within the last 3 months; 5. oncology; 6. previous lung transplantation (for patients with respiratory diseases); 7. diseases and conditions that can change the ecg picture and complicate the analysis of the ecg (conduction disturbance, pacemaker); 8. inability to use a heart monitor (congenital developmental anomalies, traumatic amputation of the upper limbs, essential tremor, parkinson's disease); 9. pregnancy.

Keywords: proton-transfer reaction mass spectrometry (ptr-tof-ms) exhaled volatile organic compounds (evocs) endothelial function arterial stiffness cardiovascular disorders ventilation disorders gas exchange disorders
us 10 ml bronchoscopic lung volume reduction (blvr) phase 1 emphysema study - initial formulation

Conditions: Pulmonary Emphysema

Summary: the purpose of this study is to determine whether the aeris bronchoscopic lung volume reduction (blvr) system is safe in patients with advanced emphysema.

patients with emphysema currently have limited treatment choices. many patients are treated with steroids and inhaled medications, which often provide little or no benefit. recently, lung volume reduction surgery has become an accepted therapy for emphysema. lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. this procedure, although effective, is complicated and risky. aeris therapeutics has developed the aeris bronchoscopic lung volume reduction system for treatment of patients with advanced emphysema. the aeris blvr system is designed to reduce lung volume without surgery. patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. the treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. the purpose of the current study is to find out whether the aeris blvr system is safe in patients with advanced emphysema. the risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.

Eligibility criteria:
inclusion criteria: * advanced emphysema * limited exercise capacity and persistent symptoms despite medical therapy * age between 18 and 75 * no significant heart, kidney or liver disease * willingness and ability to tolerate bronchoscopy * no prior lung volume reduction surgery or lung transplantation * screening test results indicating that the procedure is appropriate

Keywords: emphysema chronic obstructive pulmonary disease lung volume reduction bronchoscopic bronchoscopy bronchoscope
pilot study of autoarterial remodeling of bifurcation of the common carotid artery

Conditions: Stenosis, Internal Carotid Artery

Summary: comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery


Eligibility criteria:
inclusion criteria: * stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ica stenosis more than 70% symptomatic ica stenosis more than 65%) * the length of the atherosclerotic plaques in the ica than 1 cm * personally signed informed consent for participation in the study exclusion criteria: * chronic heart failure iii-iv functional class nyha classification * chronic decompensated "lung" heart * decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l) * severe hepatic or renal insufficiency (bilirubin \>80 mmol/l, creatinine \>200 mmol/l) * polyvalent drug allergy; * malignant tumor in the terminal stage with life expectancy of up to 6 months; * acute disruption of cerebral blood flow * extensive occlusion of the internal carotid artery. * exacerbation of systemic diseases. * pregnancy and lactation. * the refusal of a patient to sign informed consent for participation in the study

Keywords: carotid endaretectomy
a study to evaluate the blood glucose regulation and safety of ppb-r-203-02 based noodle versus commercially available wet noodle in patients with diabetes

Conditions: Diabetes Mellitus

Summary: to evaluate the result of ppb-r-203-02 based noodle and commercially available wet noodle on blood glucose control in 24 patients with diabetes for 2 days.

the minimed medtronic cgms (continuous glucose monitoring system), the first model approved by fda, was used for subcutaneous glucose monitoring. the cgms continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.

Eligibility criteria:
inclusion criteria: 1. diabetes mellitus patient. 2. aged between 20 to 65 years old. 3. informed consent form signed. exclusion criteria: 1. a recent history of drug or alcohol abuse. 2. sensitivity to analogous product. 3. serious cardiovascular disorders. 4. participation in another clinical investigation study. 5. ongoing influenza, autoimmune disease and other metabolic diseases. 6. pregnant or lactating women. 7. individuals are judged by the investigators or co-investigator to be undesirable as subjects.
evaluation of intravascular irradiation of blood in children with sleep bruxism

Conditions: Sleep Bruxism; Sleep Bruxism, Childhood

Summary: background: the objective of this study will be to evaluate the effect of intravascular irradiation of blood (ilib) combined with myofunctional exercises for sleep bruxism in pediatrics. methods: this study will be a randomized controlled clinical trial. a triage of individuals between 4 and 17 years old with a diagnosis of sleep bruxism will be carried out at the clinic of the catholic university of uruguay, and in a private office referred by different private care centers. the selected participants will be evaluated before and after treatment by means of questionnaires on bruxism, sleep quality and nocturnal oxygen saturation measurement. for this, 46 patients with sleep bruxism will be recruited, who will be divided into 2 groups: control group (cg), which will undergo an application of placebo ilib and an orofacial myofunctional therapy (mft) exercise protocol; and na ilib group, which will carry out an active application of ilib and an exercise protocol, this being once a week for 8 weeks. the laser treatment (808 nm) will be performed twice a week for 8 weeks. the values will be tested for normality by the kolmogorov-smirnov test. for the comparison between the groups, t-test will be carried out, considering a level of significance of 0.5% (p\<0.05). discussion: although local photobiomodulation (pbm), acupuncture pbm and physiotherapy have been studied in the treatment of bruxism, this is the first study to evaluate the effect of ilib combined with myofunctional exercises for sleep bruxism in pediatrics.


Eligibility criteria:
inclusion criteria: * in the mixed dentition phase (permanent incisors and first molars erupted); * adolescents with an established permanent dentition. exclusion criteria: * people with dental caries; * those taking medications, such as inflammatory agents, muscle relaxants, corticosteroids, anticonvulsants, and antidepressants; * those with chronic diseases that affect muscles or motor coordination, and those who do not cooperate during the evaluation will be excluded from the study; * children with cerebral palsy; * patients whose guardians do not sign the informed consent or the user does not sign the assent.