Kornimate/medical-research-clean huggingface dataset:
the use of magnesium sulfate for prevention of postspinal shivering

Conditions: Prevention of Postspinal Shivering

Summary: shivering is an unpleasant experience after spinal anesthesia. shivering is defined as an involuntary, repetitive activity of skeletal muscles. the mechanisms of shivering in patients undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and systemic release of pyrogens. spinal anesthesia significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which plays a significant role in temperature regulation. spinal anesthesia also causes redistribution of core heat from the trunk (below the block level) to the peripheral tissues. these two effects predispose patients to hypothermia and shivering. the median incidence of shivering related to regional anesthesia observed in a review of 21 studies is 64.4%. shivering increases oxygen consumption, lactic acidosis, carbon dioxide production, and metabolic rate by up to 400%. therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves. the best way to avoid these intraoperative and postoperative shivering-induced increases in hemodynamic and metabolic demands is to prevent shivering in the first place. although magnesium is among several pharmacological agents used for the treatment of shivering, its effects on prevention of shivering during central neuraxial blockade have not been evaluated to date. henceforth, the aim of this study was to evaluate the effect of magnesiume on shivering during spinal anesthesia. aim: to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention of post spinal shivering in adult patients undergoing elective lower limb orthopedic surgeries.


Eligibility criteria:
inclusion criteria: * age between 20-45 years old * both genders * asa i, ii exclusion criteria: * patients with hemodynamic instability * cardiopulmonary * renal , liver disease * hypo or hyperthyroidism * cerebrovascular insufficiency * coagulation defects * those with psychiatric disorder * patients receiving vasoactive drugs or beta blockers * bmi \> 35 * allergic to study drug * height \ 190 cm * basal body temperature \>38°c or \<36°c * those who received blood transfusion or \>2000 ml fluid intra-operatively * surgery duration \> 3 hours

Keywords: magnesium sulfate - postspinal shivering -intrathecal - infusion
type 1 diabetes data acquisition and transfer adherence study

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have hba1c levels above target.


Eligibility criteria:
inclusion criteria: * diagnosis with t1d at least 6 months before consent is obtained * aged ≥ 2 years and ≤17 years at time of enrollment * must have access to a smartphone, tablet or computer at home with wireless connectivity * last hba1c of ≥7.6% and ≤11% * using fixed doses, multiple daily injections or an insulin pump as primary diabetes management regimen * ability to read and speak english * patient at uf health pediatric diabetes clinic exclusion criteria: * significant medical comorbidity in the child or adolescent that could, in the opinion of the pi, affect participant's capacity to complete study follow up * inability to read and speak english * not using insulin therapy * lack of access to mobile device or computer with wireless internet connectivity * unwilling or unable to use clinic's software (glooko) to facilitate glucose data upload
the status quo of diagnosis and treatment of pediatric outpatients with respiratory diseases

Conditions: Respiratory Diseases

Summary: a cross-sectional study is expected to conducted by inquiring about the history, diagnosis results and medication details of respiratory diseases of the outpatient pediatric patients with respiratory diseases in the pediatric departments at specialist children's hospital at the second class and above, general hospitals and maternal and child healthcare hospitals. about 10,000 electronic questionnaires are expected to be collected in total, with about 100 participating hospitals and 100 electronic questionnaires from each participating hospital.diagnosis and treatment information of pediatric patients are expected to be collected in the third week in april, july and october 2021 and in january 2022.

respiratory diseases are easy-to-transmit among and are common in children, especially acute respiratory infections in children which contribute to more than 60% of pediatric outpatient cases. in pediatric internal medicine outpatient cases, trachitis/bronchitis, acute upper respiratory tract infection, pneumonia, acute tonsillitis and asthma are the most common diseases torturing pediatric patients. children are prone to recurrent respiratory infections which may impose heavy burdens on their families. ten million children under 5 years old are killed by recurrent respiratory infections every year. in china, daily outpatient visits of children with recurrent upper respiratory tract infections account for 10%-20% of the total daily outpatient visits for respiratory diseases. the outpatient medication for pediatric patients is found of non-compliance issues. according to the data in 2014, more than 33.8% of pediatric patients of all ages were given off-label medication, and more than 30% were given off-label medication in treatment. the trial will be completed in 1 years with 10,000 participants taken from hospitals in partnership with clinical research collaboration of national clinical research center for respiratory diseases, china, and analyze the status quo of diagnosis results and medication details of respiratory diseases of the outpatient pediatric patients with respiratory diseases in china.

Eligibility criteria:
inclusion criteria: * all children participating in this clinical study must meet all of the following criteria. 1. age: 0-14 years old, male and female; 2. accord with diagnostic criteria of respiratory diseases 3. agreed to informed consent exclusion criteria: * all children with any of the following conditions must be excluded from this study: 1. children who visit hospital duo to discharge of hospital 2. children who visit hospital beyond 2 times in 7 days.

Keywords: respiratory diseases treatment medication children
bridge-enhanced acl repair-safety study (bear trial)

Conditions: Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Tear

Summary: this study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (miach™,) used to repair a torn anterior cruciate ligament (acl.) ten participants will undergo surgery with the new device (experimental group) and 10 will undergo a standard acl reconstruction surgery (control group.)

this is a first-in-human trial for evaluation of the safety (primary objective) and short-term efficacy (secondary objective) of the miach™ acl scaffold and will be carried out in form of an observational study of 20 patients: 10 experimental and 10 control.

Eligibility criteria:
inclusion criteria: * complete acl tear, confirmed by mri * time from injury to screening must be less than or equal to 90 days * acl tissue present on pre-operative mri exclusion criteria (before surgery): * prior surgery on affected knee * history of prior infection in affected knee * regular use of tobacco or nicotine in any form * use of corticosteroid within last 6 months * ever underwent chemotherapy treatment * history of sickle cell disease * history of anaphylaxis * any condition that could affect healing (diabetes, inflammatory arthritis, etc) * diagnosis of posterolateral corner injury (lcl complete tear, biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament) * diagnosis of grade iii medial collateral ligament injury * diagnosis of complete patellar dislocation exclusion criteria (during surgery): * acl deemed normal on arthroscopic inspection * time from injury to surgery is greater than 90 days (for comparator group) and greater than 30 days (for experimental group) * experimental group: less than 50 percent of acl remaining * displaced bucket handle meniscal injury requiring repair * diagnosis of full-thickness chondral injury on either condyle * grade iii medial collateral ligament injury
calculating the volume of the paravertebral space

Conditions: Vertebral Disc Degenerative Disease

Summary: volume of the paravertebral spaces of the tharic and lumbar regions will be measured.

paravertebral block is an effective regional anesthesia method and a golden standart technique for various operations. in addition, paravertebral block is a volume dependent technique. however, there are few cadaveric studies that investigates the volume of the paravertebral space. this study aims to calculate the volume of the paravertebral spaces of the lumbar and thoracic regions in the patients who had 3d computerized scan in kocaeli university hospital.

Eligibility criteria:
inclusion criteria: * patients who had a ct scan of the spine in our hospital exclusion criteria: * patients with scoliosis or known vertebral abnormalities
pilot study into ldn and nad+ for treatment of patients with post-covid-19 syndrome

Conditions: Covid19; Long COVID-19; Post-COVID-19 Syndrome

Summary: pilot study into low dose naltrexone (ldn) and nad+ for treatment of patients with post-covid-19 syndrome.

this interventional pilot study will assess the use of low dose naltrexone (ldn) and nad+ for the treatment of patients with post-covid-19 syndrome (long-covid-19). patients with a positive test for sars-cov-2 1-4 months before enrollment will be included. subjects should have self diagnosed post-covid19 syndrome and experiencing persistent fatigue since positive test. patients will be screened using the fatigue survey and cases with a moderate to severe score will be included. patients will receive ldn and nad+ treatment for 12 weeks. in this study, fatigue and quality of life will be assessed using validated surveys. surveys will be conducted at baseline (at the time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. the improvement of scores from baseline levels will be assessed.

Eligibility criteria:
inclusion criteria: * any ethnicity * adequate cognitive function to be able to give informed consent * technologically competent to complete web forms and perform video calls with the pi * positive pcr test (polymerase chain reaction) result for sars-cov-2 (severe acute respiratory syndrome coronavirus 2) 1-4 months before enrollment * a fatigue score above 9 in the chalder fatigue scale upon enrollment * willing to fill out regular questionnaires * willing to use ldn and nad patches exclusion criteria: * clinically significant kidney, heart, hepatic impairment as determined by clinical judgement * taking opioid analgesics, or undergoing treatment for opioid addiction * opioid dependence or withdrawal syndrome * known sensitivity to naltrexone * suspected or confirmed pregnancy or breastfeeding * known issues with using iontophoresis patches * active cancers * enrolled in another trial * current users of ldn or nad+

Keywords: covid-19 long covid-19 post-covid-19 syndrome naltrexone nad nicotinamide adenine dinucleotide low dose naltrexone ldn
vaccination against influenza to prevent cardiovascular events after acute coronary syndromes

Conditions: Acute Coronary Syndrome

Summary: cardiovascular disease has a great burden in the context of public health, as well as the low pharmacological adherence of patients who have chronic non-transmissible diseases. however, the investigators do not have data on the efficacy of vaccination to reduce cardiovascular events in the acute coronary syndromes, and the few studies evaluating the cardioprotective potential of the influenza vaccine were conducted in countries with well defined seasonalities, divergent of brazil, that presents a constant viral circulation during all months of the year and distinct among its regions. therefore, study evaluating higher dose vaccination in a period that contemplates the seasonality of the influenza virus in brazil may bring important findings to different scientific gaps, as well as clarify questions about the possible benefit of doubled vaccination - which does not present contraindications - immediately after a atherothrombotic event. if it shows real benefit, it could also be a future therapeutic tool adjuvant to traditional drug therapy in the prevention of cardiovascular events.

phase iii, randomized, controlled, multicenter, open-label, superiority, 1:1 allocation, blind assessment of clinical outcomes and intention-to-treat analysis clinical trial to determine whether increased doses(double dose) of influenza vaccine in the hospital phase, when compared to usual dose vaccination (30 days of randomization), decreases the risk of cardiovascular and respiratory events. hospitalizations due to covid-19 are excluded from the respiratory infection component of the primary outcome.

Eligibility criteria:
inclusion criteria * age \>= 18 years and older * acute coronary syndrome in hospital phase. exclusion criteria: * participation in another clinical trial with vaccines; * refusal to provide consent; * hypersensitivity and/or anaphylaxis to any component of the vaccine, or guillain-barré within 6 weeks after previous influenza vaccine; * have already received the influenza vaccine with the same strains used in the study within the last 12 months of inclusion in the study * breastfeeding women; * pregnant women; * presenting an acute coronary syndrome during months of december, january, and february. * acute coronary syndrome hospitalization \>7 days

Keywords: unstable angina non-st-elevation myocardial infarction - nstemi st-elevation myocardial infarction - stemi quadrivalent influenza vaccine - qiv
prediction of postoperative pain by an electrical pain stimulus

Conditions: Cesarean Section

Summary: the aim of this study is to evaluate a possible correlation between predictive precesarean section pain and development of postcaesarean section pain using the pm. patients and methods 46 healthy pregnant women scheduled for elective cesarean section is included after informed consent. the standard operation procedures included spinal anesthesia, paracetamol 1 g 8 hourly, diclofenac 50 mg 8 hourly and oxycontine 10 mg x 2. morphine was used for break-through pain. before cesarian section the threshold for sensory and pain were measured 3 times, and the average was used for analyses. after cesarian section a blinded midwife assess the pain at rest and during mobilization every 12th hours over 2 days score. data was analyzed using auc and non-parametric test, p \< 0,05.


Eligibility criteria:
inclusion criteria: * healthy pregnant women scheduled for elective cesarean section exclusion criteria: * asa iii -iv * chronic pain conditions. * pacemaker.
catheter contact force and electrograms

Conditions: Atrial Fibrillation

Summary: until recently, there was no way of telling how firmly the tip of the catheter was in contact with the heart and how this contact was orientated. the electrical signals measured through the catheters, known as electrograms, are used to guide the sites and duration of ablation, but the effect of catheter contact and orientation on these signals in human heart muscle that is fibrillating is not known. new catheters have now been developed which can measure the force of contact at their tip: using these, the investigators will examine how contact force affects the electrical behaviour of heart muscle tissue in atrial fibrillation. the effect the force of contact has on the electrogram recorded will also be investigated. in so doing we hope to gain a better understanding of the relationship between tissue contact and the electrograms we measure and in so doing improve the safety and effectiveness of ablation procedures. hypothesis: catheter contact force and orientation have a significant impact on the characteristics of bipolar electrograms in the fibrillating human atrium.


Eligibility criteria:
inclusion criteria: * persistent or paroxysmal atrial fibrillation * listed for ablation of atrial fibrillation on clinical grounds exclusion criteria: * contraindication to catheter ablation * contraindication to anticoagulation * contraindication to toe

Keywords: atrial fibrillation electrogram ablation contact force
evaluation of qsofa in neurosurgical patients

Conditions: Brain Injuries; Brain Trauma; Subarachnoid Hemorrhage

Summary: the aim of the study is to look if quick sequential organ failure assessment score score in detecting a eary sepsis is afflicted by neurosurgical disorders


Eligibility criteria:
inclusion criteria: one of the following diseases * subarachnoidal bleeding * traumatic brain injury * spondylodiszitis exclusion criteria: * intubated before income * age under 16
a pilot trial evaluating the effect of tropisetron on postoperative cognitive dysfunction after cardiac surgery

Conditions: Postoperative Cognitive Dysfunction; Postoperative Delirium

Summary: the purpose of this study is to assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery.

postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. it is characterized by cognitive decline, inattention and abnormal mental status following surgery. the presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality. tropisetron is a 5-ht3a receptor antagonist and is widely used to treat postoperative nausea and vomiting. previous studies found that tropisetron has positive effect on cognitive function. we have designed a randomized, double-blind, placebo-controlled trial to determine if tropisetron has a positive effect on postoperative coginitive function in patients after cardiac surgery. several assessements which are related to delirium, cognitive function, sleep and functional status, blood sample collection and eeg recordings will be involved in the trial. moreover, we have assumed a few long-term follow-ups. given the complexity of the trial, we have decided to implement a pilot trial to assess the feasibility and provide vital data for future formal trial.

Eligibility criteria:
inclusion criteria: 1. written consent given 2. scheduled to undergo elective coronary artery bypass graft surgery under general anesthesia 3. asa physical score i-iv exclusion criteria: 1. inability to give informed consent. 2. contraindications to tropisetron. 3. critical preoperative state, including preoperative left ventricular ejection fraction less than 30%, ventricular tachycardia or ventricular fibrillation, preoperative cardiopulmonary resuscitation, preoperative intra-aortic balloon pump (iabp) or mechanical circulatory requirement. 4. history of neuropsychiatric diseases (such as dementia, epilepsy, parkinson's disease, or schizophrenia). 5. history of antipsychotic drug use. 6. pre-existing severe cognitive impairment at baseline, defined as a montreal cognitive assessment (moca) score below 10
dose-escalating study of sb-485232 administered intravenously every 28 days to adults with solid tumors or lymphomas

Conditions: Solid Tumor Cancer; Lymphoma

Summary: sb-485232 will be administered as five daily intravenous (iv) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. three dose levels of drug will be investigated. safety evaluations, including blood sampling for various laboratory tests, will be conducted. additional blood samples will also be taken to measure the amount of drug in the body at specific times.


Eligibility criteria:
inclusion criteria: * histopathological confirmation of cancer limited to a solid tumor malignancy or follicular lymphoma. * advanced or metastatic disease. * measurable disease. * females of child-bearing potential must use adequate birth control. * karnofsky performance status of 70% or greater. * predicted life expectancy of at least 12 weeks in the estimation of the physician conducting the study (principal investigator). * adequate laboratory results. * subjects with history of coronary artery disease must have a stress test without clinically significant abnormalities. * subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy, must have a muga (multiple gated acquisition) scan which demonstrates a left ventricular ejection fraction equal to or greater than 40%. * signed informed consent form exclusion criteria: * female subject is pregnant or nursing (lactating). * active, chronic or uncontrolled infections requiring systemic antibiotic therapy. * serious medical or psychiatric disorder that would interfere with the subject''s safety or ability to sign the informed consent. * leptomeningeal disease or evidence of prior or current metastatic brain disease. * receiving concurrent chemotherapy, immunotherapy, radiotherapy, corticosteroid therapy, or investigational therapy. * received chemotherapy, radiotherapy, immunotherapy, hormonal therapy or biological therapy for cancer or underwent a surgical procedure (except for minor surgical procedures) within 4 weeks before beginning treatment with sb-485232 (6 weeks in case of nitrosureas or mitomycin c). * exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of sb-485232. * severe concurrent disease or condition, including clinically significant autoimmune disease, which in the judgement of the physician conducting the study (the principal investigator) would render the patient inappropriate for study participation. * history of ventricular arrhythmias requiring drug or device therapy. * an unresolved or unstable, serious toxicity from prior administration of another investigational product. * psychological, familial, sociological, or geographical limitations that do not permit compliance with this protocol. * received prior sb-485232 therapy. * poor venous access.

Keywords: advanced cancer il-18 repeat dosing phase 1 pharmacokinetics oncology