Kornimate/medical-research-clean huggingface dataset:
a phase i study to evaluate the safety, reactogenicity, and humoral immune responses to an inactivated h5n1 influenza vaccine

Conditions: Bird Flu; Avian Influenza; Influenza A(H5N1)

Summary: the focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg ha, 15 µg ha, or 30 µg ha to human subjects.

since 1997, avian h5n1 influenza in southeast asia has caused several human infections and has a high mortality rate. experts warn that the next influenza pandemic is imminent and could be severe and prevention and control will depend on the rapid production and worldwide distribution of specific pandemic influenza candidate vaccines. an h5n1 influenza vaccine was successfully produced from whole virus grown in mdck (madin-darby canine kidney) cells. these purified inactivated vaccine antigens were safe and could induce immune responses in animal studies. moreover, when formulated in aluminum phosphate a stronger response was generated even at low doses in animals (chong et al., 2008; hu et al., 2008). however, further investigations are necessary before their human safety and immunogenicity can be established. this human phase i clinical study, therefore, evaluates the safety and immunogenicity of adjuvanted h5n1 virion influenza vaccine.

Eligibility criteria:
inclusion criteria: * male or female ≥20 and ≤60 years of age * in good health as determined by medical history, physical examination, and clinical judgment of the investigator * willing and able to comply with all required study visits and follow-up required by this protocol * must provide written informed consent exclusion criteria: * known or potential exposure to avian influenza virus or any h5n1 ha antigen vaccine * had any influenza vaccine within 6 months * administered with any vaccine within 30 days * a history of hypersensitivity to vaccines or inflammatory or degenerative neurological disease * receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months * known hiv, hepatitis b (hbsag) or hepatitis c seropositivity * any medical illness including clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests * receiving immunoglobulins and/or any blood products within the three months * acute disease at the time of enrolment * psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance * breast feeding or pregnant women

Keywords: avian influenza influenza a virus subtype h5n1 inactivated h5n1 influenza virion vaccine phase i preventive h5n1 vaccination
small bowel obstruction. a prospective multicener study

Conditions: Small Bowel Obstruction

Summary: to get an overview of patients hospitalized with mechanical small bowel obstruction and the evaluate the use of contrast media as part of conservative management. to analyze how many patients were operated on and in how many cases conservative measures helped.

this is a multicenter prospective study conducted at two regional hospitals of estonia: tartu university hospital and north estonian medical center. the data of the patients' hospitalized for sbo between may 2021 and april 2022 were collectedafter patients gave their informed consent to be enrolled in the study. eligible patients were adults aged 18 years or older with mechanical small bowel obstruction. patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study. characteristics of abdominal pain (absent/intermittent/permanent), presence of nausea/vomiting, absence of flatus, results of blood tests (white blood cell count (wbc), c-reactive protein (crp), lactate level (lac), estimated glomerular filtration rate (egfr)), radiology imaging techniques used, previous abdominal/pelvic surgeries, previous episodes of bowel obstruction. it was documented whether immediate surgical treatment was implemented, or whether conservative management was initiated. in the case of conservative treatment, it was recorded whether contrast media (cm) was or was not used. in the case of surgical treatment, the type of surgery (adhesiolysis/ bowel resection/ other) was recorded.

Eligibility criteria:
inclusion criteria: * aged 18 years or older with mechanical small bowel obstruction who signed an informed consent form exclusion criteria: * patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study
register of patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: prader-willi syndrome (pws) is a rare syndrome with a prevalence of 15 to 20 000 at birth. pws represents a large fraction of mental retardation syndromes due to a genetic cause and the most frequent cause of genetic obesity. the majority of the patients are seen by paediatricians. this syndrome is responsible for severe physical, psychological and social impairments. the diversity and the severity of the manifestations of this disease explain the requirement of multidisciplinary care which deserve specific evaluation. today the follow-up and management of a great proportion of these patients are greatly insufficient if not absent. teams strongly lack information on the natural history of this severe disease and on the factors involved in its evolution and the outcome of these patients throughout life. the present project is to implement a register in the whole country for children and adult patients


Eligibility criteria:
inclusion criteria: * all subjects with a prader-willi syndrome exclusion criteria: -
pet myocardial blood flow comparison to coronary cta and ct-ffr

Conditions: Coronary Artery Disease

Summary: the broad, long-term objective of this pilot study is to develop an optimal, clinically usable, non-invasive evaluation of coronary artery disease (cad) in the setting of stable angina which provides both anatomic and functional information. patients already scheduled to undergo invasive coronary catheterization (ica) for the clinical indication of angina will be recruited to under go stress-rest positron emission tomography-coronary ct angiography-fractional flow reserve (pet-ccta-cffr)

this is a single cohort, technology assessment study. thirty-five patients presenting with stable angina and a moderate pretest likelihood for cad who are already scheduled to undergo invasive coronary angiography (ica) for the clinical indication of angina will be recruited to undergo a ccta examination with ffr followed immediately by regadenoson stress-rest pet on the same pet/ct scanner. sensitivity, specificity, npv, ppv of cta-cffr will be obtained using the reference standard of standard of care ica with ffr for each epicardial coronary artery. segmental stress pet mbf will be compared to presence or absence of a coronary artery stenosis ≥ 50% diameter on ccta and ica.

Eligibility criteria:
inclusion criteria: * 18-90 years of age, of either sex * patients presenting with stable angina and a moderate pretest likelihood for cad and scheduled to undergo ica for the clinical indication of angina. subjects will undergo this study within 45 days prior to the cardiac catheterization. this study can also be performed 45 days after the cardiac catheterization if the patient had no interventions. exclusion criteria: * prior history of stenting, coronary artery bypass graft surgery, or myocardial infarction, unstable angina, atrial fibrillation, second or third degree atrioventricular block, class iv heart failure * iodine allergy * renal dysfunction (creatinine above normal laboratory limits) * symptomatic asthma * women who are pregnant or breast-feeding
phase i/ii combination with irinotecan- erbitux

Conditions: Metastatic Colorectal Cancer (MCRC)

Summary: part 1: to define the recommended dose of brivanib that can be safely administered in combination with erbitux (cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (mcrc) part 2: to compare median duration of progression free survival (pfs)


Eligibility criteria:
inclusion criteria: * biopsy proven mcrc * prior irinotecan allowed * prior erbitux allowed exclusion criteria: * no prior brivanib * no prior combination of irinotecan with erbitux * no secondary malignancies * no anti-coagulation therapy * no prior history of blood clots requiring anti-coagulation
the role of prehospital efast in accelerating time to diagnostics or definitive treatment in the emergency department

Conditions: Trauma Splenic; Trauma Abdomen; Liver Injury

Summary: actual literature has demonstrated that prehospital extended focused assessment sonography for trauma (efast) could impact on logistic and treatment decisions such as mode of transportation and choice of hospital destination. however, there are no data with regard to in-hospital effects of a positive prehospital efast. the main objective of this study was to evaluate the effects of prehospital efast driven decisions on in hospital time-to-definitive diagnostics or time-to definitive treatment, whichever came first, in a level 1 trauma center. the goal is to define if this information could have a role in prioritizing patients' access to care in a population of abdominal trauma patients with a-ais \> 1 and a documented liver or spleen injury.


Eligibility criteria:
inclusion criteria: * patients admitted to emergency department with a icd-9-cm diagnosis of traumatic liver or spleen injury (codes 8640x, 8641x, 8650x, 8651x) * abdominal ais ≥ 2 * ct scan or operating theatre admission performed within 180 minutes from ed admission exclusion criteria: * death before ct scan or or/angio suite admission (missing primary outcome measure) * transferred to other hospitals before ct scan or operating room admission * missing data

Keywords: trauma liver spleen
patient blood management program in total hip or total knee arthroplasty

Conditions: Knee Arthropathy; Hip Arthropathy

Summary: total hip and knee arthroplasty are among the most common surgical procedures for which blood transfusion is prescribed. patient blood management program has been proposed to decrease the need for transfusion. this program involve three pillars: preoperative improvement of erythropoiesis, intraoperative reduction of bleeding and postoperative management of anemia. among the different steps of this program, reduction of bleeding and optimization of anemia are gaining popularity, but preoperative improvement of erythropoiesis is underused. the preoperative step of the blood management program is not systematically used because it requires a complex organization, is considered expensive, and finally because the others available techniques to reduce blood transfusion are easier to implement. the aim of this study was to assess, within a patient blood management program, the effectiveness of erythropoietin on reducing allogenic blood transfusion and anemia in patients requiring elective total hip or knee arthroplasty. "

this is a post-hoc analysis using part of the patients involved in the cross iron study (anesthesiology. 2018 oct;129(4):710-720 ) included patients were all the patients scheduled for elective primary total hip or knee arthroplasty and assessed by an anesthesiologist involved in the cross iron study. exclusion criteria were pregnancy, age under 18 years old, systemic infection, bilateral arthroplasty, revision arthroplasty, and participation in a preoperative autologous donation program. this was a observational study. the patient blood management program included: erythropoietin with iron supplementation if preoperative hemoglobin was lower than 13 g/dl; tranexamic acid during surgery; intravenous iron postoperatively and use of prespecified thresholds for homologous blood transfusion. blood transfusion and anemia were assessed until day 5 or discharge, whichever came first. major thromboembolic or cardiovascular events were assessed during admission and one month after discharge.

Eligibility criteria:
inclusion criteria: * patient from the flow chart of the cross iron study (anesthesiology. 2018 oct;129(4):710-720 ) * patient scheduled for elective primary total hip or knee arthroplasty exclusion criteria: * pregnancy patient, * patient under 18 years old * systemic infection * bilateral arthroplasty * revision arthroplasty, * participation in a preoperative autologous donation program.

Keywords: patient blood management program transfusion postoperative anemia
patient-reported quality of life in patients with an implantable-cardioverter defibrillator - a longitudinal observational study

Conditions: Implantable Cardioverter Defibrillator (ICD)

Summary: patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (icd), which has repeatedly shown improved survival. however, living with an icd may pose several challenges and affect quality of life (qol). this prospective longitudinal observational cohort studies will provide detailed insights in the change of patient-reported qol after icd impalntation. the aim is to study the change in time of the qol perspective of patients who have an icd, including physical and emotional health; icd acceptance; concerns of icd patients with regard to physical and sexual activity.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * patients either scheduled for a new icd implantation or scheduled for an elective generator change * willing and able to provide signed written informed consent. exclusion criteria: * patients with a mental disability

Keywords: quality of life implantable cardioverter defibrillator (icd)
evaluation of contact phase activation during hemodialysis

Conditions: End Stage Renal Disease

Summary: every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (pmma, ps, an69st). the order of the membranes used will be randomized. during each conventional and standardised hemodialysis treatment, 6 blood samples will be taken at different time points (t0, t5, t15, t30, t90, t240) to evaluate coagulation activation (tat, pf1+2, d-dimers, tf) and, more specifically, activation of the contact phase pathway of coagulation (kallikrein, fxia, fxiia).


Eligibility criteria:
inclusion criteria: * patients treated with hemodialysis since at least three months. * hemodialysis treatment schedule of 3 x 4 hours weekly. * arteriovenous fistula (avf) use for vascular access. * treatment with oral acetylsalicylic acid 80 or 100mg q every day. * ≥ 18 years of age. * patients able and agree to provide signed informed consent. exclusion criteria: * use of vitamin k antagonists or novel oral anticoagulant therapy. * use of chronic heparin treatment, ufh or lmwh. * use of clopidogrel. * use of ace-inhibitors. * known allergy against one of the dialysis membranes used during this study (pmma: bku®, toray; ps: phylter®, bellco; an69st: evodial®, gambro). * known heparin-induced trombopenia type 2. * active infection and/or ongoing systemic antimicrobial treatment. * presence of central venous catheter, tunnelled or non-tunnelled and/or av graft. * hospitalized patients. * planned surgery during study period. * mean qb of \<300ml/min during one of the last 3 dialysis sessions before inclusion. * vascular access dysfunction defined as (a) known av access outflow tract stenosis, (b) planned vascular access intervention, (c) planned vascular access conversion. * planned conversion of dialysis modality during study period.

Keywords: hemodialysis coagulation activation
benign paroxysmal positional vertigo in older adults

Conditions: Benign Paroxysmal Positional Vertigo

Summary: despite the growing research on benign paroxysmal positioning vertigo (bppv), the impact and treatment efficacy on balance, physical activity (and consequently) frailty in elderly is lacking. also, the added value of the video head impulse test (vhit) in this population has never been studied before. with insights gained from this research, we hope to contribute to an efficient treatment of bppv in this growing population and to minimize its impact and healthcare burden.


Eligibility criteria:
inclusion criteria: * persons ≥ 65 years old * able to stand independent for at least 30 seconds * able to walk (with or without) walking aid for at least 10 meters * patients diagnosed with posterior semicircular canal bppv * patients diagnosed with lateral-semicircular canal bppv exclusion criteria: * unable to understand and follow simple instructions (e.g. due to severe dementia, hearing loss or visual impairment) * persons temporarily or permanently living in a residential or psychiatric care centre, a home for the disabled or rehabilitation centre * persons with contra-indications for the diagnostic maneuver, vhit or caloric irrigation test (e.g. severe limitation in mobility of the cervical spine of perforation of the tympanic membrane) * persons with other (acute) vestibular disorders and who as a result no longer meet the above mentioned diagnostic criteria for bppv * persons with evolutionary disorders of the central nervous system (e.g. multiple sclerosis, parkinson's disease, amyotrophic lateral sclerosis). * persons who are already taking antivertigo drugs. * persons still in the rehabilitation phase after an orthopedic or cardiovascular incident.
food intake of hospitalized elderly and its influence on muscular and clinical outcomes

Conditions: Atrophy, Muscular; Undernutrition

Summary: the objectives of the present study are: 1) to characterize the energy-protein intake of the elderly during hospitalization; 2) to verify the influence of energy-protein intake during hospitalization on muscular (i.e., cross-sectional area of the rectus femoris and vastus lateralis muscles, muscle strength, functionality and level of independence) and clinical (i.e., length of hospital stay, hospital readmission and mortality) at the time of hospital discharge, 2 and 6 months after hospital discharge and; 3) to verify whether energy-protein intake during hospitalization is a significant predictor of loss of function and muscle mass, length of hospital stay, hospital readmission rate and mortality.


Eligibility criteria:
inclusion criteria: * both sex; * 65 years and older; * hospital stay less than 48 hours; exclusion criteria: * cancer in the last 5 years; * delirium; * cognitive deficit that impossibility the patient to read and sign the informed consent form; * neurological disease; * neurodegenerative muscular disease; * patients receive nutrition via enteral and parenteral routes.
comparing behavioral therapies for treating adolescents with post-traumatic stress disorder related to sexual abuse

Conditions: PTSD

Summary: posttraumatic stress disorder (ptsd) is the most common disorder among childhood sexual abuse survivors and is associated with substantial psychosocial and medical problems, but evidence-based treatment for ptsd in adolescents is lacking. this study aims to examine the efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered therapy.


Eligibility criteria:
inclusion criteria: female gender, age 13-18, and a primary dsm-iv-tr diagnosis of chronic or subthreshold ptsd related to sexual assault exclusion criteria: current suicidal ideation with intent, uncontrolled bipolar disorder, schizophrenia, other thought disorders, or conduct disorder, the presence of a pervasive developmental disorder, initiation of treatment with psychotropic medication within the previous 12 weeks, and current inpatient psychiatric treatment

Keywords: ptsd cognitive behavioral treatment child sexual abuse
24-hour intraocular pressure control with travoprost/timolol fixed combination versus travoprost

Conditions: Glaucoma

Summary: this 8-week, crossover study will compare the quality of 24-hour iop control with ttfc versus travoprost when both medications are dosed in the evening. such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. the results should enhance the investigators understanding on the best dosing of ttfc and may influence its clinical use in europe. finally, the results would better delineate the future role of ttfc in glaucoma management after pg monotherapy, or instead of unfixed therapy with pg analogs and timolol. this study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.


Eligibility criteria:
inclusion criteria: * consecutive adults with primary open-angle glaucoma (poag) who exhibit a mean untreated iop greater than 23 m hg at baseline (10:00). * patient has poag and is older than 29 years * the iop without treatment is greater than 23 mm hg and lower than 38 mm hg at baseline (2 readings at 10:00) * patient can be safely washed out without risk for significant deterioration * distance best corrected snellen visual acuity better than 1/10 * patient can understand the instructions and comply to medications * open normal appearing angles exclusion criteria: * contraindications to prostaglandins or β-blockers * history of lack of response (\<10% reduction) to any medication * female of childbearing potential or lactating mother * history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses * sign of ocular infection, except blepharitis, corneal abnormality that may affect iop measurements etc

Keywords: travoprost/timolol fixed combination
database surveillance safety study of pentacel® vaccine

Conditions: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae

Summary: the objective for this study is to characterize the safety profile of pentacel® vaccine for identification of potential vaccine-related adverse events not currently associated with pentacel® vaccine administration.

the study will be conducted at kaiser permanente northern california and will commence with first use of licensed pentacel® vaccine within that organization. vaccination databases will be reviewed to identify diphtheria and tetanus toxoid with acellular pertussis (dtap) vaccinations of accrued subjects. medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.

Eligibility criteria:
inclusion criteria: * receipt of dtap vaccine during the study period by a previously unvaccinated child exclusion criteria: * none

Keywords: daptacel® pentacel® diphtheria tetanus pertussis haemophilus influenzae type b
icbt and abm for reducing depressive symptoms in firefighters

Conditions: Depression

Summary: the study aimed to examine the impact of a combined internet-delivered cognitive behavioral therapy (icbt) and attention bias modification (abm) intervention to reduce depressive symptoms in firefighters. the study was a randomized controlled trial carried out in kunming, china, and involved the recruitment of 138 active firefighters as participants. the intervention lasted for an 8-week duration, during which participants participated in abm exercises on alternating days and concurrently underwent four modules of icbt courses delivered through a smartphone application.


Eligibility criteria:
inclusion criteria: * being an active firefighter and aged between 18 and 50 * having a score greater than zero on the patient health questionnaire-9 (phq-9) * with no history of severe depression exclusion criteria: * having suicidal ideation or intent * having an active psychotic disorder other than depression * prior participation in a cognitive-behavioral intervention * concurrent participation in another study.