Kornimate/medical-research-clean huggingface dataset:
neonatal pulse oximetry disparities due to skin pigmentation

Conditions: Skin Pigment; Pulse Oximetry

Summary: the goal of this clinical trial is to determine if pulse oximeters show an sao2-spo2 discrepancy that correlates with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. the main questions it aims to answer is if sao2-spo2 discrepancy varies with the degree of skin pigmentation among neonates, if gestational age has an influence on sao2-spo2 discrepancy, and if packed red blood cell (prbc) transfusion has an influence on sao2-spo2 discrepancy in newborns with various degrees of light and dark skin. researchers will compare sao2 and spo2 values in neonates of various skin pigmentation.

investigators will use a multicenter prospective cohort approach to measure spo2 and sao2 simultaneously in newborns of varying degrees of light and dark skin. the investigators will enroll 163 newborns of varying degrees of light and dark skin to assess the impact of skin pigmentation on the accuracy of pulse oximetry. data collection will occur during routine blood samples and will involve simultaneous measurement of oxygen saturation by pulse oximetry and additional data extraction from the ehr. the study consists of 4 main components: (1) skin pigment classification (2) race and ethnicity classification (3) spo2 measurement collection (4) emr data collection (including newborn screen hemoglobin type assessment and transfusion records). after adjusting for sao2, the sao2-spo2 discrepancy will correlate with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. the distribution of sao2-spo2 discrepancy will have more variance in the newborns with darker skin.

Eligibility criteria:
inclusion criteria: * newborns postnatal age \< 10 days admitted to intensive care unit * presence of arterial catheter or undergoing arterial stick blood gas sampling exclusion criteria: * presence of abnormal hemoglobin (including methemoglobin \> 3%) - likely to only be known after enrolled and the blood gas is obtained * those in whom spo2 cannot be measured in the same extremity as the arterial catheter.
detection of motor seizures using wban

Conditions: Seizures, Tonic-Clonic

Summary: this study aims to collect the motor movement data using sensors to detect generalized tonic clonic seizures . wearable sensors similar to smart watches will be used to detect seizures. the proposed system will consist of 3-4 wearable wireless sensor worn on the hands and legs. the data from these sensors will be send to the clod and collected to a central hub for analysis and detection of gtc seizures.

the key of the project is digital signal processing of the movement data collected. the medical application sensors from analog devices will be worn around the wrist and legs of the participants. these sensors will continuously collect the motor movement data. the data will be send to the cloud from where it will be collected at a central hub for digital signal processing and detection. the data analysis results will be compared with the standard eeg results for tonic clonic seizures and results will be verified.

Eligibility criteria:
inclusion criteria: * subject has seizures or symptoms of seizures exclusion criteria:
use of testosterone to prevent post-surgical muscle loss - pilot study

Conditions: Muscle Atrophy; Surgery; Knee Injuries and Disorders; Complication of Surgical Procedure; Trauma

Summary: the loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in patient's ability to return to activities. although the use of testosterone in aging and chronic muscle loss has been investigated, this study could prove short-term use of testosterone efficacious in preventing muscle atrophy due to surgery. we hypothesize that by bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical quadriceps muscle loss may be minimized. determination of the effect of intra-muscular (im) testosterone injections in preventing quadriceps muscle loss are measured by serial mri and manual measurements of quadriceps cross-section.

this is an in vivo study using serial im testosterone undeconate injections in participants undergoing knee surgery with limited weight bearing post-operatively which includes partial/total knee replacement, acl reconstruction/revision, meniscal allograft transplantation and articular cartilage paste grafting. the design is a randomized, controlled, double blind, longitudinal study of intra-muscular injections of testosterone versus saline control. pre-operative and post-operative assessments will include: serial mris and manual measurements of quadriceps cross-section and knee pain and function survey, koos. blood analysis will be performed for therapeutic assessment and safety. the participant will receive two testosterone undeconate injections, once during their pre-operative visit and once during their 1 month visit. timing of assessments will be pre-operative, 1-4 days post-operative and 1, 3, and 6 months. measurement of the control group versus experimental group at all time points may identify differences in participant response to testosterone injections.

Eligibility criteria:
inclusion criteria: * males age 18-65. * undergoing significant knee surgery such as partial/total knee replacement, ligament reconstruction, meniscus surgeries or articular cartilage paste grafting. exclusion criteria: * men with carcinoma of the breast or known or suspected carcinoma of the prostate. * men with bmi \> 30 and type i or ii diabetes diagnosis * men prone to deep vein thrombosis or sleep apnea. * men with pre-existing hematocrit abnormalities. * men with pre-existing cardiac, renal, hepatic disease. * men who are taking insulin, medicines that decrease blood clotting or corticosteroids. * men with known hypersensitivity to testosterone undecanoate or any of its formulation ingredients (testosterone, refined castor oil, benzyl benzoate). * subject's unable or unwilling to comply with the protocol. * subject's unable to provide informed consent. * subject's unable to understand verbal and/or written english.

Keywords: surgery testosterone muscle atrophy post-operative rehabilitation
nurse-led clinics training program on mild cognitive impairment patients

Conditions: Mild Cognitive Impairment

Summary: this trail is the first study to test the efficacy of nurse-led clinics cognitive training on mild cognitive impairment (mci) patients using a single-blind, randomized controlled trial design. the investigators hypothesize that nurse-led clinics cognitive training can (a)decelerate or ameliorate cognitive decline, (b)ameliorate anxiety and depressive symptoms, (c)increase the quality of life for both patients and family members, (d)improve the ability of daily life, (e)reduce the incidence of agitation.

introduction: globally, nurse-led clinics(nlcs) have been developed to serve and follow up on patients who have just been discharged from the hospital. nlcs cognitive training program as a potentially effective and promising treatment for mci patients. methods: the study is a single-blind, randomized-controlled trial. eligible patients need to be diagnosed as mci. participants will be randomized into either a nlcs training group or a home-based training group. both groups will undergo total 72hour across 12 months. the outcome measures will be assessed at baseline, at the 6 months and 12 months during the intervention. the primary outcome is global cognitive function, assessed by the 30-item the mini-mental state examination (mmse), and the secondary outcomes include changes in other neuropsychological assessments and in result of resting electroencephalography (eeg) . results: the trial is currently ongoing, and it is anticipated that recruitment will be completed in june 2025. discussion: this trial will evaluate the efficacy and safety of nlcs cognitive training in patients with mci, and further explore the potential mechanisms by analyzing teh results of neuropsychological assessments and eeg.

Eligibility criteria:
inclusion criteria: * subjects with informed consent; * literate han chinese, above the age of 18; * at least 6 years of education; * neither normal nor demented according to the criteria of the diagnostic and statistical manual of mental disorders, fourth edition, with a clinical dementia rating(cdr) ≥0.5 on at least one domain and a global score ≤0.5; a mini-menta state examination score ≥20 (primary school), or ≥24 (junior school or above). * having normal vision and hearing with/without corrective devices. exclusion criteria: * severe aphasia, physical disabilities, or any other factor that might preclude completion of neuropsychological testing. * clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction. * illnesses affecting mobility or are unable to accept assessments or interventions that are required in this study.

Keywords: nurse-led clinics computerized cognitive training randomized controlled clinical trial
infusion of 5-azacytidine (5-aza) into the fourth ventricle in patients with recurrent posterior fossa ependymoma

Conditions: Recurrent Ependymoma

Summary: this study seeks to determine the optimum dose frequency of 5-azacytidin (5-aza) infusions into the fourth ventricle of the brain. the study's primary objective is to establish the maximum tolerated dose for infusions of 5-azacytidine into the fourth ventricle in patients with recurrent ependymoma. the study's secondary objective is to assess the antitumor activity of 5-azacytidine infusions into the fourth ventricle based upon imaging studies and cytology.


Eligibility criteria:
inclusion criteria: * diagnosis: patients with histologically verified ependymoma, with recurrence or progression anywhere in the brain and/or spine. patients are also eligible if they have refractory disease, which will be defined as residual tumor which has not been completely cleared despite prior treatments. to be eligible, patients' disease must have originated in the posterior fossa of the brain * patient must have either measurable or evaluable tumor as assessed by mri of the brain and total spine * an implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached to a ventricular access device or agreement to have one placed. * a minimum of 7 days between last dose of systemic chemotherapy and/or radiation therapy and first infusion of 5-aza into fourth ventricle * life expectancy of at least 12 weeks in the opinion of the principal investigator * lansky score of 50 or greater if ≤16 years of age or karnofsky score of 50 or greater if \> 16 years of age * existing neurological deficits must have been stable for a minimum of 1 week prior to study enrollment * patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy * adequate bone marrow function defined by peripheral absolute neutrophil count (anc) ≥ 500/μl, platelet count ≥ 50,000/μl (transfusion independent), and hemoglobin ≥ 9.0 gm/dl (may receive rbc transfusions) * patient or patient's legal representative, parent(s), or guardian able to provide written informed consent. exclusion criteria: * enrolled in another treatment protocol * has received another investigational or chemotherapy agent or radiation therapy within 7 days prior to 5-aza infusion into the fourth ventricle * evidence of untreated infection * pregnant or lactating women
assessment of bone micro-architecture using hr-pqct

Conditions: Osteoporosis

Summary: in the context of male osteoporosis, we hypothesize that regional changes in trabecular bone, as well as changes in cortical porosity will play a major role, and thus also affect bone strength. in developing therapeutics the response of individual compartments, regional variations post-therapy will have considerable impact on selecting the therapies as well as monitoring response to therapy. this study, a precursor to other therapeutic trials, will lay the ground-work for the future.

we will recruit 80 subjects who will be stratified into groups based on their t-scores. all subjects will be imaged at baseline and 12 months. measures of bone micro-architecture in the tibia and radius using peripheral computed tomography, bone strength measures through finite element analysis will be obtained at all time points. dxa measures at the spine, femur and forearm will be obtained as reference measures. in addition whole body dxa scans will be performed for assessment of body composition.

Eligibility criteria:
inclusion criteria: 1. men 50-85 years old 2. patients must be willing to undergo a dxa scan. 3. patients should be willing to undergo hrpqct scan of the radius and tibia. exclusion criteria: 1. inability to tolerate ct scans 2. use of medications known to impact bone and mineral metabolism: * use of a bisphosphonate or teriparatide in the last year or for \>12 months ever; * current calcitonin; * prednisone \>5 mg daily or the equivalent glucocorticoid for \>10 days in the last 3 months; * current testosterone therapy; * current thiazolidinedione (tzd); * current androgen deprivation therapy; * current use of an antiepileptic agent that alters hepatic vitamin d clearance; * use of thyroid hormone replacement with current thyroid stimulating hormone \<0.1 miu/l 3. disease known to affect bone (e.g., primary hyperparathyroidism, pagets disease, clinically significant liver disease) 4. illicit drug use or alcohol use \>3 drinks/day 5. serum calcium \>10.2 mg/dl or calculated creatinine clearance \<30 ml/min 6. weight \>350 pounds (the maximum weight limit of the dxa) 7. hardware in the lumbar spine 8. history of bilateral hip replacement, or bilateral wrist or ankle fracture

Keywords: osteopenia and osteoporosis
influence of anaesthesia type on multiple sclerosis relapse

Conditions: Multiple Sclerosis

Summary: the influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited. the aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.

the influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited. a possible relapse after neuraxial anesthesia, it is believed to be associated with local anesthetic's toxicity and concentration. the aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.

Eligibility criteria:
inclusion criteria: * multiple sclerosis * surgical procedure under general anaesthesia * surgical procedure under neuraxial anaesthesia exclusion criteria: * patients (medical records) with incomplete data

Keywords: multiple sclerosis anaesthesia relapse
glibenclamide advantage in treating edema after intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: the purpose of the present study is to explore the efficacy of small doses of oral glibenclamide on brain edema after acute primary intracerebral hemorrhage (ich), and improving the prognosis of patients.

in order to explore the efficacy and safety of oral glibenclamide on brain edema after acute primary ich, a web-based 1:1 randomization process will be employed to assign 220 subjects to glibenclamide group (giving standard management for ich plus glibenclamide) or control group (giving standard management for ich). the investigators will make a neurofunctional assessment at baseline, and 3 days, 7 days, 90 days after enrollment. the investigators also assess the midline shift, and the change in the volume of ich and perihematomal edema (phe) from the initial to follow-up (3 days and 7days after enrollment). the serious adverse events of all-cause mortality, cardiac-related and blood glucose-related adverse events will be collected to assess the safety of glibenclamide.

Eligibility criteria:
inclusion criteria: 1. age 18-70 years with a primary ich 2. a baseline ct with basal ganglia hemorrhage of 5 to 30 ml 3. glasgow coma scale (gcs) score ≥ 6 4. symptom onset less than 72 hours prior to admission 5. informed consent exclusion criteria: 1. supratentorial ich planned to evacuation of a large hematoma 2. hemorrhage breaking into ventricles of brain 3. prior significant disability (mrs ≥ 3) 4. severe renal disease (i.e., renal disorder requiring dialysis ) or egfr \<30ml/min/1.73m2 5. severe liver disorder, or alt \>3 times or bilirubin \>2 times upper limit of normal 6. blood glucose \< 55 mg/dl (3.1 mmol/l）at enrollment, or with the history of hypoglycemia 7. with acute st elevation infarction, or decompensated heart failure, or cardiac arrest, or acute coronary syndrome, or known history of admission for acute coronary syndrome, or acute myocardial infarction, or coronary intervention in the past 3 months 8. treatment with sulfonylurea in the past 7 days, including glyburide, glyburide plus metformin, glimepiride, repaglinide, glipizide, gliclazide, tolbutamide and glibornuride 9. treatment with bosentan in the past 7 days 10. be allergic to sulfa or other sulfonylurea drugs 11. known g6pd deficiency 12. pregnant women 13. breast-feeding women disagreeing to participate the study or stop breastfeeding during and after the study 14. be enrolled in other non-observation-only study with receiving an investigational drug 15. life expectancy \<3 months due to other diseases rather than current ich 16. refusing to be enrolled, or having poor compliance, or tending to withdraw

Keywords: intracerebral hemorrhage perihematomal edema disability clinical trial
ringer acetate based modified del nido cardioplegia solution versus htk solution cardioplegia solution in cardiac surgery

Conditions: Cardiac Ischemia

Summary: low chloride solutions were proved to be better in resuscitation of emergency cases and decrease the resulting hyperchloremic metabolic acidosis in the last decade. in ringers' acetate solutions, there is acetate, which is metabolized in muscles to produce bicarbonate molecules, so neutralizing the ongoing lactic and hyperchloremic metabolic solutions. both solutions were proved to be superior to normal saline as a fluid therapy plan in most studies with much less ongoing hyperchloremic metabolic acidosis and inflammatory response. in this protocol, modified del nido formula will be involved using ringers' acetate instead of plasmalyte solutions and comparing the effects on myocardial protection versus htk solutions

first, fulfilling all inclusion criteria and consent acceptance for study are to be confirmed. preoperative evaluation is done for full laboratory investigations including cbc, coagulation, renal and liver functions, crp and troponin, full clinical examination for chest and heart, coronary angiography, echocardiography, carotid doppler and upper and lower venous and arterial doppler are to be done. all patients will be scheduled for on pump cabg surgery. low dose of midazolam will be given before surgery. intraoperative monitoring will involve invasive blood pressure, ecg, peripheral pulse oximetry, capnogram. after induction of anaesthesia and median sternotomy, patients will be randomly allocated into two groups: group (d) will receive modified del nido cardioplegia (ringer acetate 1000ml, mannitol 20% 17 ml, magnesium sulphate 10% 20ml, sodium bicarbonate 8.4% 16ml, potassium chloride 7.5% 13ml and lidocaine 2% 8 ml). crystalloid to blood ratio will be 80% to 20% respectively. dose will be 15 - 20 ml/kg in first dose then 8 - 10 ml/kg every 60 minutes. group (c ) will receive htk (histidine, tryptophan and ketoglutarate solution) consisting of (1000ml distilled water, sodium 15mmol/l, potassium 9mmol/l, magnesium 4mmol/l, calcium 0.015 mmol/l, histidine 129mmol/l, tryptophan 2mmol/l, ketoglutarate 1mmol/l, mannitol 30mmol and ph 7.02 - 1.2). dose will be 10 - 20 ml/kg and can be repeated once after 120 minutes. all patients will receive hypothermia 29 - 32 ℃ and cardioplegia will be injected between the aortic valve and aortic cross clamp in a pressure not less than 50 mmhg above systolic pressure. after removal of aortic cross clamping, the heart will be monitored for ventricular arrhythmias, early recovery, and postoperative 24 hours serum troponin and new changes in echocardiography.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old 2. any gender 3. surgery demands cardiopulmonary bypass and cardioplegia. 4. cabg surgeries exclusion criteria: 1. \< 18 years old 2. emergency surgeries 3. off pump cabg surgeries 4. taking cardioplegia other than del nido or htk cardioplegia
the effect of a healthy diet containing flaxseed and olive oil on cardiovascular disease risk markers

Conditions: Coronary Artery Disease

Summary: flaxseed and olive oil consumption have beneficial effects on cardiovascular risk factors. nonetheless the effects of their simultaneous consumption have not yet been studied.the purpose of this study is to investigate the effects of a healthy diet containing flaxseed and olive oil compared with healthy dietary advice on cardiovascular disease risk markers in patients with coronary artery disease (cad), in improving flow-mediated dilation, plasma lipid profile and fatty acids composition of red blood cells.

a randomized controlled clinical trial will be conducted in rajaie cardiovascular center in tehran, iran. after review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. the participants are 50 eligible coronary artery disease patients, aged 30-75 years. intervention group will be received a heart-healthy diet with a specified number of food servings from different food groups (including vegetables, fruits, grains, dairy products, meats) + daily consumption of 30 grams of flaxseed + 25 ml/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for lunch and 2 tablespoons for dinner); and control group will be received recommendations for a heart-healthy diet, such as those of the american heart association for 3 months. these include eating at least 5 servings of vegetables and fruits daily, reduction in the consumption of sources of saturated and trans fats by avoiding the consumption of high-fat red meats and replacing them with low-fat meat or with poultry and fish, replacing low-fat dairy sources with regular or high-fat ones; consumption of regular vegetable oils such as canola and sunflower; reduction in salt consumption; and reduction in the consumption of simple sugars, for 3 months. flow mediated dilatation (fmd) in brachial artery via ultrasonography, plasma levels of lipids and lipoproteins via enzymatic method, and fatty acids composition of red blood cells via gas chromatography method were measured.

Eligibility criteria:
inclusion criteria: 1. established coronary artery disease as verified by coronary angiography 2. body ass index \<30 kg/m2 3. men and postmenopausal women 4. willing to participate in the study exclusion criteria: 1. unwilling to follow the protocol and/or give informed consent 2. chronic kidney disease stage 4 or 5 or a reported history cancer 3. regular consumption of flaxseed or omega-3 supplements during previous month 4. any changes in the disease treatment plan including type or dose of lipid-lowering medications or coronary artery bypass graft during the study period