Kornimate/medical-research-clean huggingface dataset:
a comparison of bupivacaine and ketorolac for postoperative analgesia after iliac crest bone harvesting

Conditions: Postoperative Pain

Summary: the efficacy of three postoperative pain management regimens will be compared in patients undergoing lefort i osteotomy or alveolar cleft repair with iliac crest bone grafts (icbg) to determine the best way of managing postoperative pain.

iliac crest bone grafts (icbg) are used for many types of surgeries including alveolar cleft repair, lefort i osteotomies, spinal fusion, and fracture management. icbg donor sites are notoriously painful, and the pain is often more severe than that from the primary operative site. postoperative pain management after operations that involve harvesting icbg usually includes opioids, which are most often delivered by a patient-controlled device. additional analgesics may include acetaminophen, non-steroidal anti-inflammatory (nsaid) drugs, and local anesthetic agents, such as bupivacaine or ropivacaine. local anesthetics may also be injected intermittently or continuously into the wound via an indwelling catheter inserted at the time of surgery. all but one of these studies have shown a significant reduction in pain scores and opioid consumption using local anesthetic through an indwelling catheter. only one study has investigated the effects of nsaids on postoperative icbg pain. this study found that intravenous ketorolac did not reduce morphine consumption. however, there was a trend to lower morphine use with ketorolac, and pain and patient satisfaction scores were not measured. currently, we do not use local anesthetic infusions via an indwelling iliac crest catheter for patients at our institution undergoing lefort i osteotomy or alveolar cleft repair with icbg since we find the above pain management regimen to be effective, with most patients using low to moderate amounts of morphine. to our knowledge, no study to date has compared the efficacy of ketorolac to local anesthetic infusions for patients undergoing lefort i osteotomy or alveolar cleft repair with icbg.

Eligibility criteria:
inclusion criteria: * alveolar bone graft patients age 10-13 years of age * lefort i osteotomy patients needing icbg age 14 to 20 years * able to operate a patient-controlled analgesia (pca) device exclusion criteria: * allergy, sensitivity or contraindication to any non-steroidal anti-inflammatory drugs * allergy, sensitivity or contraindication to morphine * history of gastric ulcer or bleeding diathesis

Keywords: pediatrics postoperative analgesia orthopedic surgery iliac crest bone graft osteotomy cleft palate
hias ii - study of nutritional supplementation in hospitalized children with persistent diarrhea or malnutrition

Conditions: Diarrhea, Malnutrition; Other Nutritional Deficiencies

Summary: this study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine on the damaged intestinal barrier function on day 8 in children with persistent diarrhea or malnutrition.

the purpose of this study is to determine the effect of 7 days supplementation of alanyl-glutamine or glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children with persistent diarrhea or malnutrition; on diarrhea frequency and duration, weight gain, protein loss, intestinal inflammation, and lactoferrin excretion.

Eligibility criteria:
inclusion criteria: 1. children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for \>2 weeks or height-for-age z-score (haz) less than negative 1, which is the median of haz score in children at hias. 2. be an inpatient and willing to stay for 7 nights at hias. 3. child´s parent or guardian must sign informed consent.. exclusion criteria: 1. children exclusively breast-fed (reason: the diet needs to be controlled in order to evaluate the study treatment effect) 2. children who participated in the community study or any other study within the past two years (reason: the children in the community study will have received glutamine.) 3. children with suspected other illnesses as indicated by fever \>102º f at time of screening off antipyretics 4. children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella 5. severe malnutrition defined as haz \<-3 or waz \<-3.5 or any child weighing \<10 lbs. (4.5 kg) or any child with a weight-to-height ratio \<60% of the nchs age adjusted norm.

Keywords: malnutrition, pediatric, brazil, alanyl-glutamine
discovering treatment reality of type 2 diabetes in real world settings

Conditions: Type 2 Diabetes Mellitus

Summary: discover is a non interventional study study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment.

discover is a nis study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment. this study is a multi-country, multicenter, observational, prospective, longitudinal cohort study. the patients will be recruitted from countries in latin america, europe and asia pac. it is estimated that approximately 13350 patients will be enrolled in total with each patient followed up for 3 years.

Eligibility criteria:
inclusion criteria: 1. provision of subject informed consent 2. female or male aged 18 years and over 3. diagnosed with type 2 diabetes mellitus 4. initiating a second line anti-diabetic therapy, either as add-on, or switching from one monotherapy to another. exclusion criteria: 1. diagnosis of type 1 diabetes mellitus 2. patient is pregnant 3. patients initiating a dual therapy after having previously received two different lines of monotherapy before (e.g.: metformin → su (sulphonylureas) → su+add-on) 4. current treatment with chemotherapy, oral or iv steroids 5. patient is on dialysis or has had a renal transplant 6. the patient is taking insulin as first line treatment 7. the patient is taking dual therapy or a fixed dose combination treatment as first line treatment. 8. the patient is taking herbal remedies / natural medicines as first line treatment 9. participation in an interventional trial 10. presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient for 3 years (e.g. lifethreatening co-morbidities, tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, dementia, alcohol or drug abuse). 11. not willing to sign the informed consent.

Keywords: type 2 diabetes mellitus anti-diabetic management patterns
positioning and the spontaneous breathing test in neonates

Conditions: Spontaneous Breathing Test; Infants; NICU

Summary: the spontaneous breathing test (sbt) is routinely performed on all intubated patients in the nicu who are potential candidates for extubation from mechanical ventilatory support. for all parents who consent, the routine sbt will be performed on all infants. in addition to the routine sbt the following will occur: 1. work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (rip). 2. performing the sbt in the prone position, in addition to the routine position (supine).


Eligibility criteria:
inclusion criteria: * infants who qualify for sbt as part of their normal care exclusion criteria: * previous history of abdominal or chest surgery (i.e. chest tube, pda ligation, surgical nec) * congenital malformation of the chest of abdomen * neuromuscular disorder * current medications affecting neuromuscular tone (ex morphine) * unable to be positioned either prone or supine as determined by the attending neonatologist.

Keywords: infants nicu intubated ventilator
fluid resuscitation in burn patients

Conditions: Severe Burns; Fluid Resuscitation

Summary: balanced solutions with low chloride concentration could represent an alternative to high chloride concentration solutions. such balanced solutions contain other acid as buffers (i.e. acetate and/or gluconate). however, acetate has been associated with alteration of cardiac function when used as buffer in dialysate when high acetate concentrations are used and could promote the development of metabolic acidosis if it accumulates. therefore, the safety of such solutions remains poorly explored. because critically ill patients receive large amount of fluid during the early phase of resuscitation, large amount of acetate are to be administrated if such solutions are used. while acetate-containing solutions have been suggested to be safe in this setting, studies are still lacking regarding clearance and accumulation in critically ill patients. it is expected to include 28 patients, the objective to analyze the data of 20 patients.

the main objectives of the study is 1) to determine whether plasmalyte® promote the development of metabolic acidosis in comparison with an acetate-free balanced solutions: ringer lactate (chloride concentration of 111 mmol/l) and 2) to determine acetate \& gluconate clearance during fluid resuscitation of severely burn patients plasmalyte® (chloride concentration of 98 mmol/l) . severely burn patients will be randomized to receive plasmalyte® or ringer lactate for initial fluid resuscitation during the first 5 days following admission.

Eligibility criteria:
inclusion criteria: * patients over 18 years * tbsa\>30% * admission to an intensive care unit within 12 hours after burn injury * signed informed consent to patient / parent / ( inclusion in emergency and consent is collected) * social insurance cover exclusion criteria: * decline to participate * pregnancy * metabolic alkalosis (excess of base\> 5mmol / l) * legal obstacle to participate

Keywords: burns critically ill acid-base status
comparison of combined serratus anterior plane block and thoracic paravertebral block

Conditions: Pain, Postoperative; Serratus Anterior Plane Block; Thoracic Paravertebral Block; Multimodal Analgesia; Thoracic Surgery, Video-Assisted

Summary: video-assisted thoracic surgery (vats) has become a common procedure in thoracic surgery. severe postoperative pain may be encountered in patients undergoing vats. analgesic methods such as thoracic paravertebral block (tpvb), intercostal block, serratus anterior plane block (sapb), and erector spinae plane block (espb) are widely used for vats. among these methods, ultrasound (us) guided tpvb is the most preferred method. in recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. espb and sapb are some of them. there are two techniques for sapb application. in deep sapb (dsapb) application, a local anesthetic agent is given under the serratus anterior muscle. in the superficial sapb (ssapb) application, the local anesthetic agent is given above the serratus anterior muscle. since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. the mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of dsapb and ssapb, as in the multimodal analgesia method. this study seeks to evaluate the effect of tpvb and combined sapb (csapb) after vats.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * asa physical status i-ii-iii * bmi 18 to 30 kg/m2 * elective video-assisted thoracoscopic surgery exclusion criteria: * patient refusing the procedure * emergency surgery * chronic opioid or analgesic use
appraisal of the modified cancer cachexia index in locally advanced gastric cancer patients undergoing neoadjuvant chemotherapy

Conditions: Gastric Cancer; Neoadjuvant Chemotherapy; Computed Tomography; Random Forest Model

Summary: in this study, consecutive 600 patients with lagc(ct2-4nanym0) who underwent nact between jan. 2010 and jun. 2022 were identified from two tertiary hospitals. the mcxi was constructed based on random forest model, calculated as (post-nact l3 subcutaneous adipose tissue area \[sat\])×(post-nact serum albumin \[alb\])/(post-nact platelet count \[plt\]). patients were categorized into two subgroups: mcxi-low and mcxi-high. mcxi is associated with the overall prognosis in patients with locally advanced gastric cancer underwent neoadjuvant chemotherapy, is superior to traditional cxi, and may serve as a decision-making tool for guiding personalized postoperative adjuvant chemotherapy.

this is a multicenter retrospective cohort study

Eligibility criteria:
inclusion criteria: * (1) locally advanced gastric cancer (ct2-4nxm0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy. exclusion criteria: * (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data.

Keywords: cancer cachexia index locally advanced gastric cancer neoadjuvant chemotherapy adjuvant chemotherapy survival
complementary and integrative medicine as an online intervention in patients with post-covid syndrome after covid-19

Conditions: Post-COVID Syndrome

Summary: the post-covid syndrome is a covid-19 sequelae disease with high individual burden. we conduct a prospective, two-arm, randomized-controlled intervention study with embedded qualitative and physiological sub-studies in a mixed-methods design.


Eligibility criteria:
inclusion criteria: * acute sars-cov2 infection at least 12 weeks ago (documented by pcr test results or sars-cov-2 antibodies) * history of chronic fatigue (after sars-cov-2 infection) * at least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance, headache, joint pain/muscle pain, anxiety/depression, memory impairment/concentration disturbance, postexertional malaise, dysosmia/anosmia * numerical rating scale (nrs, 0-10 points, 0 = not able to exercise at all; 10 = full exercise capacity) physical exercise capacity of max. 6 points ("what is your physical exercise capacity on average over the last 7 days?") * short form-36 physical function subscale (sf-36 pfs) of maximum 65 points * patient are technically equipped enough to participate in the online intervention and willing to follow the study procedure to perform the online intervention at home exclusion criteria: * fatigue already present before sars-cov-2 infection * presence of severe post-exertional malaise (pem) (according to dsq-pem tool question 7 or 8 with yes and \>14h condition worsening) * other underlying conditions leading to symptoms of chronic fatigue, such as unstable mental illness, oncological disease(s), ms, fibromyalgia, and substance abuse * other serious underlying medical conditions, such as severe pulmonary, cardiac, psychiatric, or infectious diseases that could interfere with study participation or affect results • ongoing opioid therapy or opioid therapy in the week prior to study entry * regular use of cannabinoids or other illicit drugs in the month prior to or during the study * restarting or discontinuing psychotherapy during study participation in the 6 weeks prior to study entry * pregnancy or breastfeeding * participation in another clinical intervention study during study participation 1 * regular use of complementary and integrative medicine self-help measures (e.g. meditation, kneipp hydrotherapiy, etc.) within the study period * current pension procedure or planned claiming of a pension procedure due to disability * planned rehabilitation measures during study participation due to post-covid syndrome inclusion and exclusion criteria of the sub-study focus group interviews with physicians inclusion criteria: * family physicians and general practitioners * regular outpatient care of patients with post-covid syndrome * willingness in principle to participate in a 2-hour interview on-site or online exclusion criteria: • no previous care of post-covid patients
vi-1121 for the treatment alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine whether vi-1121 is safe, well tolerated, and effective as a daily treatment for alzheimer's disease that is worsening despite current treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of alzheimer's disease * ct or mri within 2 years prior to study * stable dose of current alzheimer's treatment for at least 3 months exclusion criteria: * advanced, severe, progressive or unstable disease * history of cerebrovascular disease or myocardial infarction within 6 months

Keywords: donepezil vi-1121
non invasive measurement with trans cranial doppler versus invasive measurement in pediatric age

Conditions: Intracranial Hypertension

Summary: an increase of intracranial pressure (icp) is an important cause of secondary brain damage. the gold standard for measuring icp is represented by invasive positioning of intracranial icp devices. the most used non-invasive methods (nicp) are obtained through bed-side ultrasound, routinely used in the management of children in pediatric intensive care: arterial trancranial doppler (tcd) and ultrasound measurement of the diameter of the optic nerve sheath (onsd ). in this study it is proposed to compare the measurement of nicp obtained by tcd and onsd versus the measurement obtained by the invasive monitoring (iicp) already present.

an iincrease in intracranial pressure (icp) is an important cause of secondary brain damage. the cerebral perfusion pressure (cpp), defined as the mean arterial pressure value (map) minus the icp value (cpp = map-icp), represents the pressure gradient that is responsible for cerebral flow. the gold standard for measuring icp is represented by invasive methods that are intra-parenchymal or intra-ventricular catheters positions by neurosurgeons. the placement of these catheters can cause complications, mainly bleeding and infections. the most used non-invasive (nicp) methods are obtained through a medical device such as bed-side ultrasound, routinely used in the management of children in pediatric intensive care: arterial trancranial doppler (tcd) and ultrasound measurement of the diameter of the optic nerve sheath (onsd ). arterial tcd is one of the most studied methods in adults for the non-invasive estimation of icp. formulas derived from the measurement of cerebral flow velocities (vf) such as the pulsatility index (pi) and the formula based on the diastolic flow rate (fvdicp) have been shown to have a correlation with the iicp. according to the literature, a pi\> 1 is associated with an icp value\> 20 mmhg. schmitd, czosnyka et al. subsequently proposed a new formula for the non-invasive measurement of cpp and therefore of icp (fvdicp), demonstrating the accuracy of cpp measured with the invasive technique the onsd is a rapid and repeatable method for making a rapid diagnosis of increased icp not only in adults but also in children, considering the diameter of the optic nerve sheath equal to 4.5 mm in children as the upper limit of the norm. 1 year of age and 4 mm in children under 1 year. in this study it is proposed to compare the measurement of nicp obtained with the tcd and with the onsd versus the measurement obtained by the invasive monitoring (iicp) already present.

Eligibility criteria:
inclusion criteria: * invasive icp placement exclusion criteria: * cranial base fracture * absent informed consent

Keywords: intracranial hypertension children cerebral perfusion
the influence of anesthetic technique on cerebral oxygenation during spinal surgery

Conditions: Cerebral Oxygenation

Summary: postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. this is particularly relevant during spinal surgery with controlled hypotension. cerebral oximetry, monitored in the frontal cortex using an o3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios.

all patients will be monitored with standard monitoring, sedline sedation monitor, and o3 regional oximeter, masimo corp, irvine, ca. fentanyl, propofol, and cisatracurium will be administered for anesthesia induction. anesthetic agents will be maintained with intravenous anesthetic agents in one group and sevoflurane in another group to obtain the psi 25-50. mean blood pressure will be maintained 20-30% below baseline. map, hr, spo2, etco2, and sro2 will be assessed at supine position without oxygen administration (t1), supine position with oxygen administration (t2-baseline), intubation in the supine position (t3), just after prone positioning (t4), 10 minutes after prone positioning (t5), at the end of surgery in the prone position (t6) and at the end of anesthesia in the supine position (t7). data will be expressed as mean and standard deviation. the mean differences will be analyzed using the student's t test for quantitative variables in those cases in which those variables followed a normal distribution. distribution will be evaluated by kolmogorov-smirnoff's z test. differences in proportion will be conducted with contingency analysis using chi-square and fisher's exact test when needed. a p-value \< 0.05 will be statistically significant. statistical analysis will be performed using the spss-pc statistical software program (version 15.0; spss, inc., chicago, il, usa).

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i and ii * scheduled for elective spinal surgery * prone position * general anesthesia with controlled hypotension. exclusion criteria: * hypertension * coronary artery disease * renal, hepatic, or cerebral insufficiency, * patients with coagulopathy or receiving drugs affecting coagulation * grossly anemic * hypovolemic patients * chronically diseased and debilitated patients, * bleeding more than 200 ml * hemodynamic instability (decrease of 25% of baseline mean arterial pressure \[map\] for three minutes) * patients with significant baseline bradycardia.

Keywords: prone position controlled hypotension cerebral oximetry
monitoring of patients with chronic respiratory failure treated with non-invasive home ventilation: contribution of new monitoring tools

Conditions: Chronic Hypercapnic Respiratory Failure

Summary: single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the chru of nancy. the objective is to assess the contribution of reading the niv card with a standardized grid in their follow-up. the main objective is to assess the inter-observer agreement of a standardized niv card reading grid, the secondary objective is to compare the results of niv card reading between the usual niv card reading method in the service and this same method completed by the addition of the standardized reading grid. the hypothesis is that the use of a standardized niv card reading grid improves patient follow-up by standardizing their care.


Eligibility criteria:
inclusion criteria: * major patients * patients with chronic hypercapnic respiratory failure with a validated indication of long-term niv * follow-up at the chru of nancy at "unité de médecine ambulatoire" (uma) department between 11/01/2020 and 05/30/2021 exclusion criteria: * data not usable / missing * tracheal ventilation * patients' opposition to the use of their data for the purposes of this research

Keywords: chronic hypercapnic respiratory failure non-invasive ventilation standardized niv reading grid