Kornimate/medical-research-clean huggingface dataset:
on-table renal perfusion evaluation renal artery stenosis or obstruction

Conditions: Renal Artery Stenosis; Aortic Dissection; Renal Perfusion; Renal Artery Obstruction

Summary: 1. evaluate the feasibility for the on-table evaluation of the renal perfusion by using syngo dyna parenchymal blood volume(pbv) body; 2. explore the clinical benefits of this application during procedure to help the physician to determine the procedure endpoint.

renal artery stenosis (ras) is one of the potential manifestations of peripheral artery diseases and it is often observed in patients with evolving renal function impairment and concomitant coronary artery disease, or in those suffering from hypertension refractory to medical therapy.percutaneous renal artery stenting is an effective therapeutic tool and represents the treatment of choice for ras. identification of parameters able to discriminate patients who benefit from ras stenting, thus, has become of crucial importance if this technique has to survive. aortic dissection represents a common cardiovascular disease and it is responsible for the most commonly encountered pathologies in aortic emergency. renal dysfunction is a common complication associated with aortic dissection, with resultant high mortality rate. the antegrade propagation of the dissection from the proximal aorta to the level of renal arteries and the intervention during surgery may both increase the risk of renal malperfusion; thus, it is important to assess renal function for pre- and post-operative evaluation and guidance for treatment. this can be achieved through perfusion imaging. presently, c-arm cone beam computed tomography (cbct) perfusion is well established, in particular, in the diagnostic assessment of acute stroke and cerebral ischemia. the main novelty of our study lies in the fact that intra-procedural renal perfusion assessed for the first time semiquantitatively by syngo dyna parenchymal blood volume(pbv) software, discriminate patients who will benefit from the intervention procedure. in conclusion, our study suggests that a routine assessment of pre, and post-stenting renal perfusion could help to identify patients at higher risk of no improvement or even worsening of renal function after stenting and, perhaps, more aggressive medical therapy.

Eligibility criteria:
inclusion criteria: * renal artery stenosis ≥ 60% and \< 100% by doppler ultrasonography, ct angiography or magnetic resonance angiography; * target kidney remains functional (gfr determined); * the length of target kidney is \>8cm; * resistance index tested by doppler ultrasonography \<0.8; * comply with the protocol exclusion criteria: * severe cardiopulmonary insufficiency, hepatic dysfunction, renal inadequacy and clotting mechanism abnormality; * pregnancy or lactation; * history of renal artery surgery; * allergy of contrast agent; * other known reason nonischemic kidney disease
epidemiological study for psychiatric disorder among children and adolescents

Conditions: Mental Disorders

Summary: this 3-year school-based epidemiological study on child and adolescent mental disorders aims to obtain the prevalence rate and identify the psychosocial, individual, environmental, and familial risk factors for mental disorders including learning disability, autism spectrum disorder, attention-deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, mood disorders (major depression, dysthymia, bipolar disorder), anxiety disorders, phobia, obsessive compulsive disorder, sleep disorders, eating disorders, and substance use disorders in taiwan.

despite several waves of epidemiological studies in adult and elderly mental disorders in the past decades, revealing inconsistent results, little is known about the prevalence of mental disorders in the child and young adolescent population in taiwan. however, there is an increasing trend of child and adolescent mental disorders over the past decades consistently reported across countries. with the revision of the diagnostic and statistical manual of mental disorders to the current version-5th edition (dsm-5), there has been no epidemiological study using dsm-5 in youth population in the world. the dsm-5 was published in october 2014. it warrants an epidemiological study on child and adolescent mental disorders using the dsm-5 as diagnostic criteria in taiwan. this is a two-stage design to conduct screening for mental disorders including autism and all neuropsychological studies in addition to questionnaires. moreover, clinical assessment will be conducted among urban students (n = 3000) and rural students (n = 1500) from a three-stage cluster sampling. all the screen positive (estimated n = 900) and 10% of screen negative (estimated n = 360) will receive the full diagnostic interview (k-sads-e to obtain the pregnancy, developmental and medical history. for students who leave of absence, we will visit them at home to complete all the assessments. the investigators anticipate this study will provide the prevalence of a wide range of developmental and psychiatric disorders in children and our results will also provide a comprehensive risk factors for each psychiatric disorder identified in this study, including neurocognitive, developmental, familiar, and environmental factors. the individual, combined, and interactive effects of these predictors can be identified in this study. this study will definitely provide precious data for the government to develop a preventive program for mental disorders and a promotion program for mental health and well-being.

Eligibility criteria:
inclusion criteria: * urban students (n = 3000) and rural students (n = 1500) from a three-stage cluster sampling exclusion criteria: -
pd-l1 pet-imaging during car t-cell therapy

Conditions: Large B-cell Lymphoma

Summary: this is a single-center, single-arm pilot trial designed to evaluate the expression of pd-l1 in patients with large b-cell lymphoma (lbcl) and its role in non-responsiveness to chimeric antigen receptor (car) t-cell therapy in a non-invasive manner. moreover, within this trial 89zr-atezolizumab pet/ct imaging as a tool to distinguish lymphoma activity from a treatment-related inflammatory signal (histiocytic/sarcoid-like reaction) in patients with an end-of-treatment positive fdg pet/ct signal will be evaluated.


Eligibility criteria:
inclusion criteria: * histologically confirmed lbcl and associated subtypes, defined by who 2016 classification * tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures. * measurable disease, as defined by lugano criteria. * if has history of central nervous system (cns) disease, then must have no signs or symptoms of cns disease, no active disease on magnetic resonance imaging (mri) and absence of large cell lymphoma in cerebral spinal fluid (csf) on cytospin preparation and flow cytometry, regardless of the number of white blood cells. * if has history of cerebral vascular accident (cva), the cva event must be 12 months prior to apheresis and any neurological deficits must be stable. * signed informed consent. * age \>18 at the time of signing informed consent. * life expectancy \>12 weeks. * eastern cooperative oncology group (ecog) performance status 0-1 * ability to comply with the protocol. exclusion criteria: * signs or symptoms of active infection within 2 weeks prior to 89zr-atezolizumab injection, unless treated to resolution. * prior cd19-directed car t-cell therapy or other bi-specific antibodies targeting cd19 receptor (e.g.blinatumomab). * history of severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of 89zr-atezolizumab, or that may affect the interpretation of the results or render the patient at high risk for complications.

Keywords: pd-l1 car t-cell therapy imaging
addressing inequity in dermatology

Conditions: Dermatologic Disease

Summary: the objectives of this study are to understand the variation in dermatoses presenting in individuals from different ancestry backgrounds. this will be conducted at multiple nhs hospitals in england. the investigators specifically aim to 1) assess features of dermatoses in individuals of different ancestry. 2) understand the language used by patients describing their condition.


Eligibility criteria:
inclusion criteria: * dermatologist diagnosed disease, with visible active dermatological disease exclusion criteria: * no dermatological disease, no active pathology identifiable, aged 18 and above but lacks capacity to consent.
use of midodrine in septic shock patients

Conditions: Sepsis; Low Blood Pressure

Summary: this study is being done to determine if early administration of midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. researchers want to see if midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall.


Eligibility criteria:
inclusion criteria: patients diagnosed with sepsis within 24 hours of meeting all of the following criteria will be eligible to participate in the study: * sepsis-3 criteria: acute hospital admission for suspected infection with new or worsening organ dysfunction measured by the increase in sequential organ failure assessment (sofa) score of 2 points or more. * iv vasopressor use or persistent hypotension (map \< 65 mm hg) after initial fluid resuscitation in the ed or icu (30 ml/kg unless deemed excessive by the treating clinician). exclusion criteria: * high-dose vasopressors (norepinephrine equivalent \> 0.3 µg/kg/min). * inadequately controlled source of infection. * cardiogenic or obstructive (massive pulmonary embolism) shock. * clinical suspicion or confirmed diagnosis of bowel obstruction, bowel ischemia, or ileus. * contraindication to enteral intake (ileus, vomiting, gastrointestinal bleeding, endoscopic procedures etc.). * recent myocardial infarction (within the past 3 months). * recent treatment for peripheral vascular disease (within the past 3 months). * current use of monoamine oxidase inhibitors. * recent stroke (within the past 3 months). * prior use of midodrine as a home medication. * known allergy to midodrine. * comfort care measures. * pregnancy. * fludrocortisone acetate as a current home medication. * bradycardia (heart rate \< 50 beats/min). * untreated pheochromocytoma. * untreated thyrotoxicosis. * open-angle glaucoma. * treating emergency or critical care physician unwilling to enroll patient in trial. * inability to give consent for participation and no representative or surrogate available to consent.

Keywords: vasopressors
salipen human factors study for otc labeling

Conditions: Xerostomia

Summary: this human factors validation testing will assess user interactions to verify the capability of potential users to assess if the study product fits their needs and if they can use it correctly based on the provided information for user (ifu)? more specifically, this is a non-comparative case series study and is subdivided into two major parts. those parts are: 1. phase i: aimed at testing if, based on the ifu, the potential subjects can decide whether the study product is or is not appropriate to treat their condition and, 2. phase ii: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.

phase i to simulate an otc setting, potential subjects will be requested to read the label text on the outside of the study product package (external labeling) and determine whether the study product addresses their needs, without a provider direction or assistance. phase ii the study product will be dispensed only to those subjects who will indicate that they voluntarize to participate in this phase of the study. at phase ii subjects with xerostomia and that are willing to try the study product, will be requested to use it with no training, except for their understanding of the user manual (internal labeling). those subjects will use the study product in a supervised clinical setting. subjects who report any discomfort will be offered the option to pause and remove the device upon such a request. correct use verification will be performed by the study investigators. subjects will answer questions regarding product use, clarity of the ifu, ease of use, etc. subjects will also receive an exam of their oral cavity.

Eligibility criteria:
inclusion criteria: for phase i: 8 subjects with xerostomia and 8 without that are 18 years old or older for phase ii: subjects with xerostomia that are 18 years old or older exclusion criteria: for phase i: * children and adolescents (persons under 18 years of age) * persons with experience in the use of salipen for phase ii: subjects for them the study product is not indicated and/or do not agree to participate in phase ii. for the avoidance of doubt, the following conditions are exclusion criteria: * persons with experience in the use of salipen * children and adolescents (persons under 18 years of age) * epileptic disorder * persons that are allergic to the surface materials of the device * electrodes: coated with gold * body: made of methyl vinyl silicone rubber * use of a pacemaker * pregnancy * psychiatric or psychological disorders * involuntary muscle movement disorder (such as parkinson's) * neurologic disorder in head and neck area
clinical evaluation of use of prismocitrate 18 in patients undergoing acute continuous renal replacement therapy (crrt)

Conditions: Regional Citrate Anticoagulation (RCA); Continuous Renal Replacement Therapy (CRRT); Acute Kidney Injury

Summary: the purpose of this research is to determine if an investigational new drug solution called prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (crrt). patients who receive crrt treatment with prismocitrate 18 as the anticoagulant will be compared to patients who receive crrt treatment with no anticoagulation.


Eligibility criteria:
inclusion criteria: 1. patient must be receiving medical care in an intensive care unit (icu) (e.g., medical icu, surgical icu, cardiothoracic icu, trauma icu, mixed icu, other). 2. adult patients with aki or other serious conditions who require treatment with crrt. 3. patients are expected to remain in the icu and on crrt for at least 72 hours after randomization. 4. patients already receiving standard-of-care crrt must be randomized within 24 hours of initiation of their standard-of-care crrt. exclusion criteria: 1. patients requiring systemic anticoagulation with antithrombotic agents for reasons other than crrt. the exception is patients receiving subcutaneous heparin for deep vein thrombosis prophylaxis according to institutional practice or patients on aspirin may be enrolled. 2. patients in whom citrate anticoagulation is contraindicated such as patients with a known allergy to citrate or who have experienced adverse events associated with citrate products including patients with a prior history of citrate toxicity or patients with uncorrected severe hypocalcemia (whether in the context of current citrate administration or due to the underlying disease state). 3. patients who are not candidates for crrt. 4. patients who are receiving extracorporeal membrane oxygenation (ecmo) therapy. 5. patients with severe coagulopathy \[i.e., platelets \ 2, partial thromboplastin time (ptt) \> 50 seconds\] including severe thrombocytopenia (platelets \< 30,000/mm3), hit (heparin induced thrombocytopenia), itp (idiopathic thrombocytopenia purpura), and ttp (thrombotic thrombocytopenia purpura) should not be enrolled in the trial. 6. patients with fulminant acute liver failure or acute on chronic liver failure as documented by a child-pugh liver failure score \> 10. 7. patients with refractory shock associated persistent, worsening with lactic acidosis (lactate \> 4 mmol/l). however, patients with improving subsequent serum lactate levels may be enrolled. 8. patients unlikely to survive at least 72 hours. 9. female patients who are pregnant, lactating, or planning to become pregnant during the study period. 10. patients who are currently participating in another interventional clinical study. 11. patients with a medical condition that may interfere with the study objectives.

Keywords: regional citrate anticoagulation (rca) continuous renal replacement therapy (crrt) acute kidney injury
distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after 4 weeks treatment with azd 5069

Conditions: Asthma

Summary: distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after 4 wk treatment with azd 5069

the purpose is to investigate the bronchial tissue neutrophil counts and distribution in asthma patients after 4 week oral treatment with azd 5069

Eligibility criteria:
inclusion criteria: 1. male or female patients of caucasian origin, aged between 18 to 65 years, inclusive, at the time informed consent is obtained. 2. physician based (according to gina 2011) diagnosis of asthma for at least 6 months prior to the date informed consent is obtained and confirmed by 1 of the detailed respiratory criteria stated in the csp 3. morning prebronchodilator (ie, after abstinence from short-acting and long-acting ß-agonist treatment for ≥ 6 and ≥ 12 hours, respectively) fev1 of ≥70% of predicted normal (pn) for age, sex and height at enrolment 4. increased number of neutrophils in induced sputum samples at baseline, with a relative neutrophil count of ≥ 50% of total sputum cell count 5. physician prescribed daily use of medium or high dose ics (≥ fluticasone 250 μg to ≤ 1.000 µg or the equivalent daily, as defined in gina 2011; see csp appendix e) plus laba. exclusion criteria: 1. history of clinically relevant allergies or idiosyncrasies to azd5069 or other investigational cxcr2 antagonists, or any inactive ingredient(s) of the imp, or tool-substances (eg, salbutamol, local anaesthetics) used for the purpose of this study 2. history of severe asthma exacerbation requiring hospitalization within the last 12 months before screening. 3. asthma exacerbation requiring a treatment course of systemic (ie, oral or parenteral) corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12 months before screening. 4. moderate to severe airflow limitation (fev1 \<70% pn) 5. any chronic lower respiratory disease other than asthma (see csp for details) that, as judged by the investigator or medical monitor, would interfere with the evaluation of the imp or interpretation of patient safety or study results. -

Keywords: asthma
clinical evaluation study for assessing the visual performance of hanita lenses trifocal iol

Conditions: Cataract

Summary: hanita lenses trifocal iol, seelens afr (intensity iol).prospective, single-arm single-center, open-label study.

device: hanita lenses trifocal iol, seelens afr (intensity iol). indication studied: the hanita lenses trifocal iol is intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near and intermediate visual functions, and reduced spectacle dependence. study description: this study is a prospective, single-arm single-center, open-label study.

Eligibility criteria:
inclusion criteria: * age over 45 years and under 75 years. * patients with bilateral age-related cataracts, require bilateral cataract phacoemulsification combined intraocular lens implantation; * patients with an axial length of 22-24.5mm. * normal corneas with less than 0.75d of regular corneal astigmatism. * post-operative best-corrected visual acuity projected to be 0.3 logmar or lower. * patient motivated for trifocal iol after screening by the surgeon. * fundus visualization is possible. * absence of retinal or optic nerve diseases * signed informed consent exclusion criteria: * previous ocular/corneal surgery that may affect refraction accuracy or visual acuity. * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * history or evidence of any ocular disease that may affect visual acuity (i.e. uncontrolled glaucoma, ocular injury, corneal pathologies, retinal pathologies in general and macular pathologies in particular, diabetic retinopathy, uveitis, aniridia or iris atrophy, vitreous pathologies (patients with vitreous separation or floaters can be included). * rubella cataract. * amblyopia * any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the trifocal lens. * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions) * patients with pupil diameter greater than 4mm in photopic conditions. * pregnant, lactating or planning to become pregnant during the course of the trial. * allergy or intolerance to required study medications (including antibiotic). * subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days. * traumatic cataract.
evaluation of an intervention model for family crisis and support

Conditions: Traumatic Brain Injury; Brain Injury, Chronic

Summary: to learn more about how a family treatment program helps people after brain injury. specifically, do families feel better and function better after going through the program, and do patients feel better and function better after going through the program.

to evaluate the efficacy of a structured outpatient family intervention program (bifi) on family members' emotional well being, life satisfaction, needs, and family functioning; and to evaluate the impact of the bifi on the emotional well being, life satisfaction, functional independence, vocational status, and neurobehavioral functioning of persons with acquired brain injury (abi).

Eligibility criteria:
inclusion criteria: * family members/caregiver friends and persons with acquired brain injury (abi) who are at least three months postinjury. abi is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (pta), objective neurological findings, or skull fracture. exclusion criteria: * families including individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators. * individuals under 18 years of age.

Keywords: brain injury, family treatment
a combined tdap vaccine used as a booster compared to licensed td vaccine

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Summary: this study will evaluate the safety and immune response to glaxosmithkline tdap vaccine compared to licensed td vaccine when used as a booster in healthy adolescents (10-18 years of age).

a combined tdap (tetanus, diphteria, acellular pertussis) vaccine used as a booster compared to licensed td (tetanus and diphteria) vaccine

Eligibility criteria:
inclusion criteria: * healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (dtp). exclusion criteria: * use of any other investigational drug or vaccine 30 days preceding study vaccination. * chronic administration of immunosuppressants. * administration of pre-school dtp vaccine within previous 5 years. * administration of td booster within previous 10 years.

Keywords: prevention of diphtheria, tetanus, pertussis