Kornimate/medical-research-clean huggingface dataset:
assessment of heparin binding protein for the prediction of severe sepsis

Conditions: Sepsis; Septic Shock; Sepsis With Acute Organ Dysfunction

Summary: the purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the heparin binding protein (hbp) assay for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission.

the primary objective of this study is to use hbp concentration to indicate the presence, or outcome, of severe sepsis (including septic shock) at admission and to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission. the secondary objectives of this study are to separately evaluate the performance of hbp concentration to a) indicate the presence of severe sepsis (including severe sepsis) at admission and b) to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission. further exploratory objectives include evaluating the use of hbp measurement to indicate the outcome of severe sepsis (including septic shock) in patients with suspected infection 12-24 hours after emergency department admission, to compare the use of hbp to other markers of severe infection and to evaluate whether or not different cut-off values are required for the progression and outcome measures.

Eligibility criteria:
inclusion criteria: * \>18 years of age, suspected infection exclusion criteria: * none
cellular-mediated immunity in covid-19

Conditions: Covid19; Thromboembolism

Summary: in order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the sars-cov-2 infection. the first goal of this study will be to detect the cellular-mediated immune response in patients affected by covid-19 (with or without vaccination) and healthy subjects who undergone vaccination program. the second goal of this study will be to identify the genetic and epigenetic biomarkers that influence individual immunological response and clinical evolution to the severe manifestations of the covid-19.

first goal: characterization of the immune response using detailed phenotypic evaluation of the adaptive compartment comprising b, t, and nk cells. the investigators aim is to detect the cellular-mediated immune response in patients affected by covid-19 and subjects who undergone vaccination program. the investigators will recruit three classes of subjects: 1. patients with previous sars-cov-2 infection who did not undergo vaccination; 2. patients with previous sars-cov-2 infection who undergone vaccination; 3. subjects without previous sars-cov-2 infection who undergone vaccination. second goal: evaluation of genetic and epigenetic biomarkers that influence individual immunological response and susceptibility to thromboembolic manifestations in severe covid-19 hospitalized patients. the investigators will recruit: 1. a total of 50 severe covid-19 patients admitted to the sub-intensive care unit of a.o.r.n. ospedali dei colli, cotugno hospital, naples (italy) of which n=50 with thromboembolic complications (pe+) and n=50 without thromboembolic complications (pe-); 2. a total of n=50 healthy subjects (never diagnosed with sars-cov2 infection) among the volunteer blood donors attending the u.o.c. divisione di immunologia clinica, immunoematologia, medicina trasfusionale e immunologia dei trapianti, dipartimento di medicina interna e specialistica, aou, "l. vanvitelli" university of campania (naples, italy)

Eligibility criteria:
inclusion criteria: * age \> 18 years * previous diagnosis of covid-19 * absence of covid-19 diagnosis exclusion criteria: * age \<18 years * inflammatory diseases
audiovisual consultations in prehospital emergency care: randomised controlled trial

Conditions: Telemedicine; Emergency Medical Service

Summary: this study investigates safety and efficacy of the use of audiovisual consultations of emergency medical service (ems) doctor by paramedics for low urgency events in areas covered with paramedic crews only from emergency medical service stations with distant access to hospital.

the study will be realized on karlovy vary ems areas covered with paramedic crews only from emergency medical service stations with distant access to hospital. each call on emergency line during 6 weeks study period will be assessed for eligibility. if deemed as low urgency, the event will be randomised into 3 groups. control group: routine operation of paramedic crew with optional consultation with a doctor over the phone. in the phone group and in the video group, there will be a mandatory consultation of a doctor over the phone or by audiovisual constultation, respectively. the primary outcome of the study is the percent of patients treated on site without the need of hospital transfer. the secondary safety outcome is to evaluate repeated ambulance trips within 48 hours after the patient had been treated at home. moreover, a qualitative analysis of subjective perception of the event by the patients, paramedic and consulting doctor using the likert scales will be performed by survey at the end or immediately after the event.

Eligibility criteria:
each call on emergency line (in action radius of actual position of 11 of 19 karlovy vary ems paramedic crews) will be assessed for eligibility by ems call-taker in karlovy vary region. inclusion criteria are: 1. the call is evaluated as low urgency event (by criteria of karlovy vary ems call-taker manual; the event is dedicated for paramedic crew only, without dispatchig doctor on site), 2. the case is determined for and will be served by one of 11 for study dedicated of total 19 paramedic crews in karlovy vary ems, 3. dedicated doctor of karlovy vary ems will be available for consultation during his shift. exclusion criteria are: 1. need for escalation of the care: paramedics' requirement for the doctor to arrive at the scene of intervention, 2. consulting doctor is not available for the study at the moment of randomisation, 3. consultation with other than trained and for study dedicated doctors, 4. patient - crew language barrier, 5. study refusal by the patient or legal representative, or refusal of audiovisual consultation, 6. technical, logistic or other (agressive patient, patient detained by police) problems evaluated by paramedic crew (not to conduct a study in phone and especially video group)

Keywords: pre-hospital care audiovisual consultation non-transport low urgency
traumatic proximal femoral fractures in adults

Conditions: Proximal Humeral Fracture

Summary: statistical analysis for adult patients who were admitted to assiut university hospital within one year with proximal femoral fractures. protocol of management include lines of treatment , hospital stay and results

case series prospective study all adult patients who were admitted to auh with proximal femoral fractures within one year. we will evaluate the real treatment protocol which was applied for those patients. surgical procedures, as plating, proximal femoral nail , dynemic hip screw and others procedures according to needed for each types. this epidemological study in proximal femoral fractures will provide an update on incidence, admission, hospital stay and surgical procedures. this information will assist health providers in planning hospital beds, surgical intervention, and risk prevention, moreover, this data can be use for farther clinical studies.

Eligibility criteria:
inclusion criteria: * 1-adult age 2- closed \& open fracture exclusion criteria: * 1- childern 2-pathological fractures
a nasal treatment for covid-19

Conditions: COVID-19

Summary: the goal of this study is to test an investigational new inhaled medication called optate.

the goal of this study is to test an investigational new inhaled medication called optate. investigational means it has not been approved by the food and drug administration (fda) for this use. the investigators hypothesize that optate will reduce the length of symptoms and disease severity in patients with covid-19 (coronavirus disease of 2019) through inhibition of sars-cov-2 (severe acute respiratory syndrome coronavirus 2) viral replication within the upper and lower airways. testing this hypothesis is important because treatments for covid-19 are needed alongside vaccines. covid-19 begins in the nasal passages, so targeted therapies to the nasal passages at early stages of the disease may prevent severe disease from occurring.

Eligibility criteria:
inclusion criteria: subjects, 18 and above, with mild covid-19 upper respiratory tract infection symptoms * positive rapid covid-19 test * ordinal scale for clinical improvement \< 3 (osci, appendix 2) and/or * fever \> 100 degree f and/or * nasal congestion exclusion criteria: * fev1 (forced exhaled volume) \< 55% predicted on the day of study procedures * osci ≥ 3 (objective structured clinical exam) * pregnancy * inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication
a study of anti-pd-1/ctla-4 bispecific ak104 alone or in combination with lenvatinib in advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: an open-label multi-center phase ii study to evaluate the efficacy and safety of anti-pd-1/ctla-4 bispecific antibody ak104 alone or in combination with lenvatinib in patients with advanced hepatocellular carcinoma.

this is a multi-center, multi-cohort, open-label phase 2 clinical study to evaluate the anti-tumor activity, safety, pk profile, immunogenicity and potential biomarkers of ak104 alone or in combination with for the treatment of advanced hepatocellular carcinoma

Eligibility criteria:
inclusion criteria: * signed written informed consent form voluntarily. * histologically or cytologically documented hepatocellular carcinoma. * bclc stage c, and non-resectable bclc stage b . * at least one measurable lesion according to recist criteria. * ecog of 0 or 1. * adequate organ function. * estimated life expectancy of ≥3 months. * for women of childbearing potential: agreement to remain abstinent; for men: agreement to remain abstinent exclusion criteria: * histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc. * history of hepatic encephalopathy or liver transplantation. * clinical significance of hydrothorax, ascites or pericardial effusion. * central nervous system metastases and/or carcinomatous meningitis. * any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy. * occurred arteriovenous thromboembolic events within 6 months before the first administration. * tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus. * inadequately controlled arterial hypertension. * attack of symptomatic congestive heart failure (lvef\<50%); history of congenital long qt syndrome. * known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease. * severe infections. * receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy, * enrollment of another clinical study within 4 weeks prior to the first administration of study drugs. * unable to receive an enhanced ct or mri scan of the liver.

Keywords: anti-pd-1 anti-ctla-4 bispecific
fnb in meniscal tear under ga

Conditions: Meniscus Tear; Femoral Nerve Block

Summary: the investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under general anesthesia

this study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and mri or ultrasonography, and were diagnosed with meniscal tear from september 2023 to august 2028. the 100 patients will be assigned to group i (with femoral nerve block) or group ii (without femoral nerve block) under double-blinded randomization. the randomization will be performed by an independent nurse using a computerized random sequence generator. the operators who participated in the procedure will be blinded to the participant's information. both group will undergo general anesthesia for arthroscopic meniscal surgery. after anesthesia, sono-guided femoral nerve block will be performed. the injection for group1 is 20 ml ropivacaine and for groupii is 20 ml 0.9% saline. a visual analog scale (vas) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. vas scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

Eligibility criteria:
inclusion criteria: - individuals who are scheduled to undergo meniscal surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate. exclusion criteria: * who require simultaneous surgery for concomitant cartilage injury, collateral ligament tear. * who have previously undergone surgical treatment within the knee joint. * who have declined to participate in the research. * where medical, surgical, or anesthetic complications occurred during surgery. * other cases deemed necessary by the researchers.

Keywords: femoral nerve block meniscus tear
pilot randomized clinical study of the iliac arteries and common femoral artery with stenting and the iliac arteries with stenting and plasty of the common femoral artery

Conditions: Atherosclerosis of the Peripheral Arteries

Summary: according to the recommendations of the inter-society consensus for the management of peripheral arterial disease (tasc ii) statement and the russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type d lesions.

according to the recommendations of the inter-society consensus for the management of peripheral arterial disease (tasc ii) statement and the russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type d lesions. patients with type c lesions can be managed by either stenting or bypass surgery. despite the fact that aorta-femoral reconstructions long-term results are better than the diffuse aorta-iliac lesions endovascular treatment results, the surgery risk is significantly higher than the endovascular surgery risk regarding criteria of mortality, complications, and return to normal activity. all reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. the figure reaches 100% in the case of local lesions. the technical success of iliac arteries long occlusions recanalization reaches 80-85%. improvement of endovascular equipment designed for the total occlusions treatment increases technical success of recanalization. the tasc ii materials summarize the several large studies results which present the data on the operated segment artery patency at the level of 70-81% within 5-8 years of follow up. a large number of authors note the actuality of aortic-iliac type c and d segment lesions endovascular treatment recommendations revision according to the tasc ii.

Eligibility criteria:
inclusion criteria: * patients with occlusive lesions of c and d type iliac segment and cfa lesion, and with chronic lower limb ischemia (ii-iv degree by fontaine, 4-6 degree by rutherford), age: 47-75 years old. * patients who consented to participate in this study. exclusion criteria: * chronic heart failure of iii-iv functional class by new york heart association (nyha) classification. * decompensated chronic "pulmonary" heart * severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 ml / min); * polyvalent drug allergy * cancer in the terminal stage with a life expectancy less than 6 months; * acute ischemic * expressed aortic calcification tolerant to angioplasty * patient refusal to participate or continue to participate in the study

Keywords: tasc c, d cfa supera iliac arteries common femoral artery plasty of the common femoral artery stenting supera
the performance of renal doppler ultrasound in predicting outcome of dialysis weaning

Conditions: Acute Kidney Injury; Acute Kidney Failure Stage 3

Summary: acute kidney injury (aki) is a frequent problem in the intensive care unit (icu) affecting more than 50 % of patients. aki is associated with several adverse outcomes, including increased mortality and increased length of icu- and hospital stay, in particular in patients requiring renal replacement therapy (rrt). choosing the optimal time for attempting liberation from rrt is still unclear. with this study, we will describe the ability of renal ultrasound in predicting the outcome of dialysis weaning.


Eligibility criteria:
inclusion criteria: * all patients ≥ 18 years admitted to the icu, aarhus university hospital who are treated with dialysis as continuous renal placement therapy (crrt) and planned to undergo dialysis weaning exclusion criteria: * insufficient ultrasonographic imaging of the kidneys * known morphological kidney disease * previous need of chronic rrt * prior participation in the study * need of extracorporeal membrane oxygenation (ecmo) or other heart assist device

Keywords: ultrasound renal replacement therapy dialysis renal doppler ultrasound
effect of arista powder on bleeding in reductive mammary surgery

Conditions: Mammaplasty

Summary: to evaluate whether arista ah which contains microporous polysaccharides used as a powder applied to the wound area during mammary surgery reduces the amount of bleeding and the duration of surgery. both mammae are operated on in the same procedure, and one side without arista serves as control side

during the operation,before the first incision a randomization envelope is opened. always starts on the same side, with or without arista according to the envelope. after surgery, vacuum drains are placed and the amount of drained material and hgb content is measured 24 hours later by nursing staff blinded to what side had arista.patients scores postoperative pain with vas score bilaterally. three months postoperatively the patients are checked by a physician blinded for what side had arista

Eligibility criteria:
inclusion criteria: * all women for mammary hypertrophy day surgery. no exclusions in this group.

Keywords: mammary glands hemostasis mammaplasty
safety and efficacy of kpi-121 compared to placebo in subjects with dry eye disease

Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Summary: the primary purpose of this study is to determine the efficacy and safety of kpi-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. the product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (qid).

this is a phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of kpi-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Eligibility criteria:
inclusion criteria: * have a documented clinical diagnosis of dry eye disease in both eyes exclusion criteria: * known hypersensitivity or contraindication to the investigational product(s) or components * history of glaucoma, iop\>21 mmhg at the screening or randomization visits, or being treated for glaucoma in either eye. * diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening. * in the opinion of the investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Keywords: ocular discomfort pain corticosteroid hyperemia dry eye
postoperative effects of tap block versus qlb type 2 block

Conditions: Inguinal Hernia; Postoperative Pain

Summary: this study compares analgesic effectiveness of transversus abdominis plane block and quadratus lumborum block type 2 in open hernia repair surgery. all of the patients will receive routine intravenous analgesic regimen. in addition to that one-third of the patients will receive transversus abdominis plane block, one-third will receive quadratus lumborum block type 2. one-third of the patients will not receive any blocks and will constitute the control group


Eligibility criteria:
inclusion criteria: * patients who are over 18 years of age * patients who are scheduled for elective unilateral open hernia repair with tension free mesh techniques * patients who are in asa's physical status score group 1 or 2 exclusion criteria: * patients who are younger than 18 years of age * patients who have severe stenotic heart diseases * patients who have bleeding diathesis * patients who have true allergies to local anesthetics * patients who have neurologic deficits corresponding to effect site of the anesthetic techniques
donepezil in preventing delirium in hospitalized elderly

Conditions: Postoperative Complications; Delirium

Summary: the purpose of this study is to explore the efficacy of a perioperative daily dose of donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.

delirium is confusion or a sudden change in alertness which may happen after hip repair surgery. up to 65% of elderly undergoing surgical repair of hip fracture experience post-operative delirium. these individuals often stay in the hospital longer, have more complications, and are more likely to die. early studies suggest that delirium could be prevented by correcting the central cholinergic deficit that is associated with delirium. donepezil is currently being used to treat memory loss in patients with alzheimer's disease. this study will recruit 30 adults aged 65 or older who are undergoing hip fracture surgery. participants will be randomized to receive either donepezil or a matching placebo within 24 hours prior to surgery and for 4 days after the surgery. all material to be collected will be from interviews, questionnaires, and medical chart review at baseline and daily for the entire hospital stay. the confusion assessment method (cam) and memorial delirium assessment scale (mdas) will be used to evaluate the effect of donepezil on delirium incidence and severity. other assessments include cognitive deficit, length of hospitalization, discharge site, adverse effects, and psychotropic medications.

Eligibility criteria:
inclusion criteria: * community-dwelling individuals aged 65 or older * admitted to methodist hospital for surgical repair of hip fracture * no evidence of delirium at admission to hospital * mmse total score below 24 points after adjustment for education and age * consent to participate in the study exclusion criteria: * severely demented as defined by mmse score below 10 * metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months * multiple trauma or pathological fractures * aphasic, legally blind, or deaf * use of donepezil or other cholinesterase inhibitors within one month prior to surgery * allergy to donepezil

Keywords: hospital acquired complications adverse effects cognitive impairment aging