Kornimate/medical-research-clean huggingface dataset:
pathophysiology of perioperative fluid management in emergency laparotomy

Conditions: Intestinal Obstruction; Intestinal Perforation; Anastomotic Leak; Fluid Overload; Pathophysiology

Summary: pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.

in critically ill patients and patients undergoing major surgery, the combination of internal fluid shifts and fluid retention resulting in extravascular fluid accumulation and postoperative organ dysfunctions, complicates perioperative fluid management and influences patient outcome. changes in extravascular volume after surgery have been much debated, studies in major surgery suggest that extracellular volume expansion may correlate with intraoperative fluid administration, while other studies show the intravascular volume to be decreased after surgery. difficulty in obtaining accurate measurements of the fluid phases is recognized and despite years of research, perioperative extravascular volume changes have not been clarified in acute high-risk abdominal (aha) surgery. it is essential to be able to identify and characterize the transition from necessary fluid resuscitation to harmful fluid volume accumulation, intra- as well as extravascular. the present study seeks to investigate the perioperative fluid status and fluid shifts in patients undergoing aha surgery, specifically focusing on intra- versus extra-vascular fluid status in patients with intestinal obstruction versus intestinal perforation.

Eligibility criteria:
inclusion criteria: 1. adults (18 years or over) undergoing emergency high-risk abdominal surgery for following abdominal pathology: 1. perforated small intestine 2. perforated large intestine 3. perforated ulcer 4. intestinal obstruction 5. anastomotic leakage following elective surgery 2. provided verbal and written informed consent 3. must speak and understand the danish language exclusion criteria: 1. appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases. 2. primary surgery for intestinal ischemia, abdominal bleed 3. emergency re-operations after elective surgery owing to intraabdominal bleeding, paralytic/obstructive ileus, intestinal ischemia 4. reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery were excluded from the cohort. sub-acute surgery was defined as surgery planned within 48 hours. 5. traumas, gynecological, urogenital and other vascular pathology, pregnant patients. 6. dementia and/or cognitive dysfunction (diagnosed).

Keywords: emergency laparotomy ileus perforated ulcer intestinal perforation perioperative fluid management pathophysiology fluid overload
long term impact of pediatric acute renal injury in severe sepsis

Conditions: Acute Kidney Injury; Chronic Kidney Disease; Hypertension

Summary: sepsis is the most common cause of childhood death worldwide. millions of children survive, but are left with impaired health. sepsis-related acute kidney injury (saki) is increasingly recognized as a significant factor associated with long-term mortality among different patient populations. renal dysfunction and subsequent chronic kidney disease is implicated in the development of hypertension and cardiovascular disease. the investigators overall hypothesis is that, in the pediatric population, sepsis-related aki will have unrecognized, long-term consequences with regard to kidney function, endothelial function, blood pressure control, and overall health.

this will be a three-arm cross-sectional control-cohort outpatient evaluation. subjects with saki and a random selection of non-saki subjects who agree to participate in another study of quality of life survey will be asked to participate in the outpatient study. subjects will be asked to come in to the clinical research center for 24-hour monitoring and participate in the outpatient study where urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by blood pressure monitoring, peripheral arterial and applanation tonometry.

Eligibility criteria:
inclusion criteria: for non-acute kidney injury (aki) sepsis patients: 1. hospitalization with a diagnosis of sepsis from 1998-2014 2. failure to meet pediatric risk injury failure loss end stage (prifle) criteria for aki during incident admission. 3. participation in cognitive survey study with completion of survey for sepsis related aki patients: 1. hospitalization with a diagnosis of sepsis from 1998-2014 2. need for renal replacement therapy (rrt) 3. severe aki as defined by the prifle criteria (estimated crcl (ecrcl) decrease by 50%, ecrcl \<60 ml/min/1.73 m2, or a urine output \<0.5 ml/kg/h for 24 h or anuric for 12 h) during the sepsis admission 4. participation in cognitive survey study with completion of survey for healthy control patients: 1. identified from the neurology service who are scheduled for mri with gadolinium as part of their clinical care exclusion criteria: for all patients: 1. known pre-existing chronic kidney disease (ckd) as defined by history of kidney transplant or long-term dialysis 2. age greater than 18 years at the time of sepsis admission 3. aki from primary kidney disease including acute glomerulonephritis and obstructive uropathy 4. pregnancy at the time of enrollment 5. age younger than 5, between the ages of 12 to 17, or over the age of 24 at the time of enrollment. for healthy control patients: 1. chronic kidney injury (ckd) 2. history of acute kidney injury 3. history of any chronic illnesses (e.g. cancer)

Keywords: acute kidney injury
prenatal ultrasonographic assessment of fetal thyroid in patients with thyroid pathology

Conditions: Thyroid Disease Pregnancy

Summary: the goal of this observational study is to evaluate the possibility to use prenatal ultrasonography for diagnosis and prognostic guidance in cases of suspected fetal thyroid changes in fetuses belonging to women with thyroid disease and women with low obstetric risk (i.e., pregnancy not complicated by maternal and/or fetal pathology) between 14 and 37 gestational weeks. the main question it aims to answer is: is it possible to diagnose thyroid disease in fetuses early using measurable parameters of the fetal thyroid through ultrasonography?

current knowledge about fetal thyroid anatomy and the association between ultrasonographic alterations and maternal thyroid disease is not yet comprehensive. a number of observational studies have been conducted describing the possible changes found in fetal thyroid parenchyma in mothers with dysthyroidism. in addition, there are interventional studies that have attempted to modulate anti-thyroid therapy in hyperthyroid mothers depending on the ultrasound changes of the fetal thyroid found. however, to date, the possibility of ultrasound study of the fetal thyroid has not been established, and there are no universally recognized reliable nomograms for the assessment of fetal thyroid biometry. the present study will provide more information about the possibility to use prenatal ultrasonography for diagnosis and prognostic guidance in cases of suspected fetal thyroid changes. in the latter case, we will be able to more accurately delineate the indication for serious prenatal ultrasound checks, guide counseling with the parental couple, addressing them to possible consultation with pediatric specialist. women will be asked to undergo a single ultrasound scan, as per normal clinical practice. with the ultrasound scan it will also be possible to assess parameters that will allow the study of the biometry, morphology and volume of fetal thyroid.

Eligibility criteria:
inclusion criteria: * participants between 14 and 37 gestational weeks, who will be followed for the entire period of pregnancy, up to delivery, at the same enrolling center * obtaining informed consent for participation in the study * maternal age between 18 and 45 years (extremes included) * participants with good understanding of the italian language exclusion criteria: * smoking participants * patients with bmi\>30 * absence of correct dating of pregnancy within the first trimester * pathological conditions (e.g., malabsorptive or socioeconomic conditions that may interfere with fetal growth) * twin pregnancy * only for the low obstetric risk group of patients: fetus with malformative pathology

Keywords: fetal thyroid
single-dose ketamine for the reduction of pain and depression in the emergency department

Conditions: Acute Pain; Depression

Summary: in this proposal, the investigators will determine if a single dose of intravenous (iv) ketamine (in combination with midazolam) reduces pain severity, depressive symptoms and need for opiate analgesics both in the ed and in the acute recovery period after ed discharge. the investigators will compare the ketamine arm to an active placebo-controlled arm (with midazolam).

the investigators will enroll 120 medically stable adult patients who present to two emergency departments with a chief complaint of acute pain. the investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of iv ketamine (0.3 mg.kg) + midazolam, or 2) placebo + midazolam. ed providers and patients will be blind to treatment allocation. all participants will complete measures of pain and mood scores every 30 minutes, and the investigators will record any analgesics administered in the ed until discharge. at 7-days and 14-days post- discharge, the investigators will measure summary reports of pain severity, mood, and analgesic medication used.

Eligibility criteria:
inclusion criteria: 1. adults between the ages of 18-65 2. a chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale \[nrs\] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable") 3. expected to be in the ed for at least 2 hours exclusion criteria: 1. non-english speaking 2. not medically suitable for ketamine per treating md (e.g. medical condition where ketamine is contraindicated); ketamine or midazolam may be unsafe (e.g., known sensitivity, glaucoma, or other concerns) 3. not alert and oriented 4. active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team 5. seeking treatment due to a mental health or substance use disorder 6. history of chronic opioid use 7. prescribed opioid use within the past 24 hours 8. any use of recreational narcotics throughout lifetime 9. sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines 10. weight \> 170kg (375 lbs) 11. current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.) 12. pregnancy 13. prisoner
study of pegilodecakin (ly3500518) with folfox compared to folfox alone second-line tx in participants with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: to compare the efficacy of pegilodecakin in combination with folfox versus folfox alone in participants with metastatic pancreatic cancer as measured by overall survival.

this is an open-label, multi-center, randomized, phase 3 study designed to compare the efficacy and safety of pegilodecakin in combination with folfox versus folfox alone in participants with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.

Eligibility criteria:
inclusion criteria: 1. the presence of metastatic pancreatic adenocarcinoma 2. measurable disease per recist v.1.1 3. participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by ct or mri scan 4. eastern cooperative oncology group performance status of 0 - 1 5. participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to grade 1 or baseline 6. participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease. 7. participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study 8. no peripheral neuropathy 9. no known history of dihydropyrimidine dehydrogenase deficiency exclusion criteria: 1. diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma 2. participant on coumadin and not willing to change to lmwh or oral factor ii or xa inhibitor with half-life of less than 24 hours. 3. participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen 4. participants who were intolerant of a gemcitabine containing regimen. 5. history of positivity for human immunodeficiency virus 6. chronic active or active viral hepatitis a, b, or c infection 7. clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (gi) bleeding, intracranial hemorrhage) 8. pregnant or lactating women 9. participants with a history of immune-mediated neurological disorders such as multiple sclerosis, guillain-barré or inflammatory cns/pns disorders 10. clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks 11. major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period 12. prior history of receiving immune modulators including, but not limited to, anti-ctla4, anti-pd1, anti-pd-l1
e-polycaprolactone-containing membrane in alveolar bone regeneration

Conditions: Alveolar Bone Grafting

Summary: this study aimed to evaluate the effectiveness of synthetic polycaprolactone (pcl) bioscaffold membranes used for alveolar augmentation in maxillofacial surgery for increasing the amount of newly formed bone after three-dimensional application.


Eligibility criteria:
inclusion criteria: * (1) patients aged \>18 years without any systemic disease or with an established systemic disease that precluded the surgical procedure; (2) patients whose bone deficiency was augmented with pcl scaffolds; (3) patients with an indication for dental implant-supported prosthesis who lacked sufficient bone for dental implants according to cone beam computed tomography (cbct) evaluation and, therefore, needed bone augmentation; and (4) patients with preoperative and postoperative images. exclusion criteria: * patients (1) with uncontrolled systemic diseases, (2) who had undergone radiation therapy, (3) who were female and pregnant, (4) who had previously undergone any surgical procedure related to augmentation in the area of the defect, (5) who had incomplete files or lacked pre- and post-treatment radiologic records, or (6) who had psychological problems.

Keywords: alveolar ridge augmentation, alveolar bone loss, dental implant, guided tissue regeneration, polycaprolactone
study evaluating the effects of multiple doses of nsa-789 in subjects with schizophrenia or schizoaffective disorder

Conditions: Schizophrenia

Summary: this study will evaluate the safety of multiple doses of nsa-789 in subjects with schizophrenia or schizoaffective disorder. this study will also assess how nsa-789 is absorbed and eliminated, and its effect, if any, on the brain.


Eligibility criteria:
inclusion: * men or women of non childbearing potential (woncbp) aged 18 to 50 years, inclusive. * currently under the care of a physician for psychiatric illness. * clinical diagnosis of schizophrenia or schizo affective disorder in the opinion of the study psychiatrist based on review of all available clinical data. exclusion: * any unstable medical or psychiatric condition, which may prevent the successful and safe completion of the study.
a study to determine the pharmacokinetics of cediranib in chinese patients with advanced solid malignancies

Conditions: Advanced Solid Malignancies

Summary: this study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in chinese patients with advanced solid malignancies. the study will also assess the tolerability of 20 or 30 mg cediranib in chinese patients and how the tumour responds to treatment with cediranib.


Eligibility criteria:
inclusion criteria: * provision of informed consent * histological and/or cytological confirmed advanced solid malignancies * refractory to conventional therapeutic modalities, or for which no appropriate therapies exist exclusion criteria: * for the first question: patients with a history of poorly controlled hypertension with resting blood pressure \>150/100 mmhg in the presence or absence of a stable regimen of antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure. * significant haemorrhage (\>30 ml/bleeding episode in previous 3 months), haemoptysis (\>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months * recent(\<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.

Keywords: phase i advanced solid malignancies advanced solid tumour advanced cancer cediranib (recentin™, azd2171) china pk pharmacokinetics
carotid ultrasounds measurements in septic shock

Conditions: Septic Shock

Summary: the aim of the study is to assess carotid ultrasounds measurements, namely corrected flow time (ftc), velocity time integral (vti) and respirophasic variation in carotid artery blood flow peak velocity (δvpeak), as a predictor of fluid responsiveness in septic shock patients.

sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection . early identification and appropriate management in the initial hours after the development of sepsis improve outcomes. for patients with sepsis-induced hypoperfusion or septic shock it is recommended to give iv crystalloid fluid within the first 3 hr of resuscitation . however, fluid responsiveness varies widely between cases. determining the optimal amount of fluid to be administered remains a critical issue in clinical practice and research. recent studies have shown that not every patient advantages from intravenous hydration, only 40% of hypotensive patients with sepsis benefit, and the others who do not respond are liable to develop pulmonary edema with high associated mortality . studies have shown that aortic blood peak velocity had high sensitivity and specificity to predict fluid responsiveness, however, measurements of aortic blood flow velocity need a transesophageal ultrasound which is an invasive procedure . measurement of left ventricular outflow tract velocity time integral (lvotvti), derived stroke volume (sv), and cardiac output reliably predicts fluid responsiveness in critically ill patients but it is difficult and dependent on operator and echo windows . there is a need to find a non-invasive accurate and easy method to assess fluid responsiveness in septic shock patients. different measurements of carotid artery flow have been suggested recently to predict fluid responsiveness. a promising measurements are corrected flow time (ftc), velocity time integral (vti) and respirophasic variation in carotid artery blood flow peak velocity (δvpeak).

Eligibility criteria:
inclusion criteria: * adult patients (18-75 year old) diagnosed with septic shock (map \>65mmhg), within 6 hours of admission or development of septic shock if previously admitted with other diagnoses. exclusion criteria: * patients have any of these conditions: carotid artery stenosis ≥50%, known heart failure (ejection fraction ≤45%) or end stage kidney disease requiring haemodialysis.
effectiveness of interventions for hospital medical thromboprophylaxis: a bicentric swiss quality-improvement study

Conditions: Venous Thromboembolism

Summary: the primary objective is to evaluate and compare the short-term and medicum-term effectiveness of 2 types of interventions in 2 different hospitals to improve the adequacy of hospital thromboprophylaxis among acute medical inpatients.


Eligibility criteria:
inclusion criteria: * acute medical inpatients hospitalized at the geneva university hospitals or the lugano regional hospitals exclusion criteria: * patients already on therapeutic anticoagulation * patients with an estimated life expectancy of \<3 months * pregnancy * patients hospitalized for covid-19
randomised evaluation of sodium dialysate levels on vascular events

Conditions: End-Stage Kidney Disease

Summary: this global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

resolve is a pragmatic, cluster-randomised, open-label study designed to evaluate in real-world conditions the comparative effectiveness of two default dialysate sodium concentrations. dialysis sites will be randomised in a 1:1 ratio to a default dialysate sodium concentration of 137mmol/l or 140mmol/l. 'default' is defined as the use of the allocated dialysate sodium for ≥ 90% of delivered dialysis sessions in the unit. all other care will be according to standard local practices as determined by the site. outcomes will be assessed on individual patients dialysing at those sites. sites will be asked to consent to participation while waiver or opt-out consent will be sought for individual patients. it is anticipated that site accrual will occur over 5-7 years with average study duration expected to be approximately 2-5 years. the actual length of the study will be end-point determined.

Eligibility criteria:
the site inclusion criteria are: * predominantly dialyses adults (≥18 years old) receiving maintenance haemodialysis * rates of withdrawal within the first two years of commencing dialysis for social reasons have been less than 15% for the 2 years prior to recruitment and are not expected to increase above 15% * has a minimum of 10 dialysis recipients at time of randomisation * utilises a default dialysate sodium concentration at the time of recruitment (a substantial majority of dialysis sessions are conducted with the default dialysate sodium concentration) * is a self-contained unit (i.e. unit patients do not regularly rotate through another unit. brief trips by patients to a parent or other unit do not exclude a site) * willing to accept randomisation to either intervention (as determined by nominated director of unit) * is not a home dialysis training or support unit. \[sites that include both in-center/satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter/satellite component of the site\]. the exclusion criteria are: * not able to comply with data collection methods

Keywords: end-stage kidney disease hemodialysis dialysate sodium cluster-randomisation dialysis resolve