Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of risperidone oral solution combination clonazepam versus haloperidol intramuscular (im) injection for treatment of acute psychotic agitation in schizophrenia

Conditions: Schizophrenia

Summary: this is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study. after screening period, eligible subjects will be entered 5 days treatment session i to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol im injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session ii for exploring the effect of medicine switching from im injection to oral.

acute psychotic agitation is a common problem in many patients with schizophrenia that includes agitation, aggression, excitement and violence. an investigation showed that about 26% psychotic patients were brought to the psychiatric emergency room because of the psychotic agitation symptoms. the primary objective is to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol im injection on controlling psychotic agitation in patients of acute schizophrenia and schizophrenic-affective disorder. the secondary objectives are: (1) to explore the possibility of decreasing efficacy of acute 6 weeks treatment from im injection to oral; (2) to compare the safety between risperidone oral solution combination clonazepam oral and haloperidol im injection.

Eligibility criteria:
inclusion criteria: * men or women aged 18 to 45 years * dsm-iv diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders * a score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the pnass * the total scores ≥60 on the panss exclusion criteria: * women who are pregnant or breast feeding, or who plan to become pregnant during the study * the psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances * clinical laboratory values indicating serious medical illness * known hypersensitivity to any of the study medications * treatment with a depot antipsychotic with 1 cycle of screening * using of disallowed medication

Keywords: acute psychotic agitation schizophrenia risperidone oral solution clonazepam haloperidol
af ablation in brady-tachy syndrome

Conditions: Brady-tachy Syndrome

Summary: the aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the af burden. the hypothesis of the study is that af ablation prevents not only from af episodes recurrence but also from bradycardic episodes.

the study is a randomized study 1:1 af ablation vs non af ablation. patients are followed for 1 year. 38 patients will be required to show a significant reduction in af burden.

Eligibility criteria:
inclusion criteria: * paroxystic af * symptomatic pauses (\>5s at night or 3s during daytime) exclusion criteria: * permanent af * age \> 80 y * pregnant women * minors

Keywords: brady-tachy syndrome af ablation
spatial analysis and validation of glioblastoma on 7 t mri

Conditions: Glioblastoma

Summary: currently, patients with a glioblastoma multiforme (gbm) are treated with a combination of different therapeutic modalities including resection, concurrent chemo- and radiotherapy and adjuvant temozolomide. however, survival is still poor and most of these tumours recur within one to two years within the previously irradiated target volume. the radiation target volume encompasses both the contrast-enhanced lesion on t1-weighted magnetic resonance imaging (mri), plus a 1.5 - 2 cm isotropic margin in order to include microscopic speculated growth. these margins result in a high dose to surrounding healthy appearing brain tissue. moreover, the short progression-free survival indicates a possible geographical miss. there is a clear need for novel imaging techniques in order to better determine the degree of tumour extent at the time of treatment and to minimize the dose to healthy brain tissue. the development of ultra-high field (uhf) mri at a magnetic field strength of 7 tesla (t) provides an increased ability to detect, quantify and monitor tumour activity and determine post-treatment effects on the normal brain tissue as a result of a higher resolution, greater coverage and shorter scan times compared to 1.5 t and 3 t images. up to now, only few investigators have examined the use of uhf mri in patients with malignant brain tumours. these studies show its potential to assess tumour microvasculature and post-radiation effects such as microhaemorrhages. this study analyzes the accuracy of the 7t mri in identifying the gross tumour volume (gtv) in patients with an untreated gbm by comparing biopsy results to 7t images. these biopsies will be taken from suspected regions of gbm based on 7t mri that do not appear as such on 3t mri. we hypothesize that with the 7t mri the gtv can be more accurately and extensively identified when compared to the 3t mri.


Eligibility criteria:
inclusion criteria: * supratentorial tumour * suspected gbm on diagnostic mri * eligible for biopsy * minimum age 18 years or older * world health organization (who) performance scale ≤2 * american society of anaesthesiologist (asa) class ≤ 3 * understanding of the dutch language * ability to comply to study procedure exclusion criteria: * recurrent tumour * tumour location deemed unfit for extra biopsies * prior radiotherapy to the skull * prior chemotherapy * world health organization (who) performance scale ≥ 3 * american society of anaesthesiologist (asa) class ≥ 3 * eligibility for immediate debulking * contra-indications for gadolinium * contra-indications for the mri

Keywords: 7 t mri radiotherapy glioblastoma biopsy
experimental study to validate the modified glucose disposal test

Conditions: Diabetes

Summary: evaluate the modified gdt as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * clinically healthy * drug naive or on a stable dose of metformin monotherapy and/or a secretagogue exclusion criteria: * type 1 diabetes * history of significant heart disease. * bariatric surgery * exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or dpp-iv inhibitors
a comparison of videolaryngoscope and direct laryngoscope in iop changes, throat pain, it and hemodynamic variables

Conditions: Intraocular Pressure; Intubation;Difficult

Summary: the aim of the study was to compare intraocular pressure, intubation time, throat pain and hemodynamic variables using direct or videolaryngoscopy under general anesthesia requiring endotracheal intubation

introduction videolaryngoscopes are the new generation devices which were introduced into the difficult intubation algorithm by the american society of anaesthesiologists (asa) in 2013 (1). videolaryngoscopes are known to be superior to traditional direct laryngoscopy in cases of difficult airway, glottic visualisation is obtained more easily and less airway trauma is seen (2). portable videolaryngoscope which is used in difficult airways (3). there are 2, 3, and 4 numbered blades. in the light source of the blade of the videolaryngoscope, there is a camera which is connected to a video screen monitor. in addition to passing soft tissues by visualisation, the camera is helpful in defining the glottic appearance (1). there are studies which have compared the hemodynamic response and increase in iop in intubation using direct laryngoscope and various videolaryngoscopes and airway devices . however, to the best of our knowledge there is no study comparing the effect on the increase in iop of videolaryngoscope and direct laryngoscope. the aim of the current study was to compare iop, hemodynamic parameters and throat pain in the use of videolaryngoscope and the direct laryngoscope.

Eligibility criteria:
inclusion criteria: * elective surgery under general anaesthesia exclusion criteria: * history of glaucoma * history of hearth disease * history of alzheimer

Keywords: videolaryngoscope intraocular pressure direct laryngoscope
evaluation of tl-925 for the treatment of allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: in this prospective, phase 2, randomized, double-masked, vehicle controlled study, approximately 66 eligible subjects will be randomized 1:1 to receive either tl-925 or placebo as topical ophthalmic eye drops administered bilaterally. the study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate tl-925 for the treatment of allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * individuals aged 18 years or older * female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study. * documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at visit 1 or within the past 60 months. * calculated best-corrected visual activity of 0.7 logmar or better * positive bilateral cac reaction exclusion criteria: * any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study. * any ocular surgical intervention within the last 3 months or refractive surgery within the last 6 months * any ongoing ocular infection (bacterial, viral or fungal)
study of the safety and efficacy of apadenoson for detection of myocardial perfusion defects using spect mpi

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial spect-imaging (spect-mpi)to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). the study will also look at whether apadenoson is better tolerated than adenosine when used in spect-mpi.

adenosine is an effective vasodilator used in spect-myocardial perfusion imaging (spect-mpi). however, it produces transient symptoms that are poorly tolerated by most subjects. this is a multi-center, randomized double-blind study to compare the tolerability and effectiveness of apadenoson to adenosine (adenoscan®) in spect-mpi. subjects who are clinical candidates for spect-mpi will be enrolled to undergo two sequential spect-mpi studies. the first study will use adenosine as the stress agent in approximately 1250 subjects. eligible subjects will then be randomized in a 1:1 assignment ratio to receive a second spect-mpi using either adenosine or apadenoson as the pharmacologic stress agent, with the goal of obtaining a total of 670 subjects who complete both studies. the agreement of the results from the two adenosine:adenosine stress tests will be compared to that from the adenosine:apadenoson tests to assess efficacy. the incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.

Eligibility criteria:
inclusion criteria: * referred for a clinically indicated rest/pharmacologic stress spect-mpi test * high pretest probability (90% or greater) of cad based on the acc/aha guidelines for relative risk, or past medical h/o cad exclusion criteria: * acute mi, new onset of ischemia or pci within 30 days prior to spect-mpi at either period 1 or period 2; or cabg within 90 days prior to spect-mpi at either period 1 or period 2 * active severe asthma or severe chronic obstructive pulmonary disease (copd) which, in the investigator's opinion, places the subject at risk for severe bronchoconstriction * history or evidence of clinically significant cardiac condition and rhythm disorder, in the absence of a functioning permanently implanted pacemaker * hemodynamically significant valvular disease, outflow tract obstruction, or uncontrolled severe hypertension * known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent * current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug

Keywords: coronary artery disease myocardial perfusion imaging
a pilot study of edoxaban in patients with non-valvular atrial fibrillation and left atrial appendage closure

Conditions: Non-Valvular Atrial Fibrillation; Left Atrial Appendage Closure

Summary: this is a single arm, open label, single site study assessing the feasibility of post-procedural edoxaban therapy in atrial fibrillation (af) patients after clinically indicated watchman left atrial appendage (laa) closure.

this is a single site, pi initiated pilot study. this study will enroll up to 75 patients who are clinically indicated for a left atrial appendage (laa) closure with the commercially available watchman device. subjects will be enrolled if they meet study inclusion/exclusion criteria and have a successful laa closure. all patients enrolled in the study will receive 6 weeks of edoxaban therapy. at 6 weeks post laa closure a transesophageal echocardiography (tee) will be performed. if the result is acceptable, edoxaban will be discontinued and the patient will be treated with dual antiplatelet therapy (aspirin and clopidogrel) until 6 month follow-up. after study completion, patients may be treated with aspirin monotherapy according to the fda instructions for use for the watchman device, or according to operator discretion.

Eligibility criteria:
inclusion criteria: * the patient has documented paroxysmal, persistent, or permanent non-valvular af (i.e., the patient has not been diagnosed with rheumatic mitral valve disease). * laa closure with the watchman device is planned * the patient fulfills the fda indication for watchman laa closure * the patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial * the patient is able and willing to return for required follow-up visits and examinations. * the patient is 18 years of age or older exclusion criteria: * conditions other than atrial fibrillation that require anti-coagulation (e.g., a prosthetic heart valve) * stroke within the previous 7 days * hypersensitivity to edoxaban * moderate or severe mitral stenosis * a need for aspirin at a dose of \>81 mg a day * a need for on-going treatment with dual antiplatelet therapy with aspirin and clopidogrel * a need for on-going treatment with ticagrelor or prasugrel * no laa closure device implanted during procedure * procedural complication of laa closure (e.g., stroke, systemic embolism, bleeding, vascular complication \[e.g., groin hematoma \>10cm, av fistula, or pseudoaneurysm), or serious pericardial effusion) * planned surgery or invasive procedure within 6±2 weeks of enrollment

Keywords: edoxaban watchman device
registry to evaluate maintenance treatment with venofer in pediatric patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the current registry is being undertaken to assess the long-term (12 month) safety and tolerability of venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy.

this will be a multicenter, observational, prospective registry collecting long-term (12-month) safety, tolerability, and laboratory data. subjects will be screened for inclusion criteria if on hemodialysis (hd), peritoneal dialysis (pd) or have non-dialysis dependent (ndd) chronic kidney disease (ckd). treatment-emergent adverse events (adverse events starting from the time of the 1st dose of venofer administered on study) will be collected via site entry of data into a web-based system. each research investigator will be responsible for entering adverse event information on the appropriate clinical research form as well as reporting such events to the sponsor. number of subjects: 50 evaluable subjects (i.e., took at lease one dose of venofer and have safety data recorded at the 12 month time point).

Eligibility criteria:
inclusion criteria: * age greater than or equal to 2 to less than or equal to 17 years * subjects must have a diagnosis of either ndd-ckd, pd-ckd or hd-ckd * dialysis patients must be on a stable periotoneal (pd) or hemodialysis (hd) regimen for 1 month * patient agrees to participate in the registry (i.e., provide adverse event information) for 12 months exclusion criteria: -
embedded palliative care in the micu

Conditions: Critical Illness; End of Life; Quality of Life

Summary: the goal of this study is to investigate whether embedding a hospice and palliative care practitioner within a medical intensive care unit will improve patient outcomes and healthcare usage. the practitioner will work solely within the medical intensive care units and offer timely as well as proactive consultations based on clinical criteria and estimated mortality risk. the study team will compare patients seen by the practitioner to patients in an adjacent icu and historical patients to determine whether patient care is improved by this intervention.

the study goal is to determine whether an embedded palliative care practitioner in the medical icu improves patient outcomes, palliative care/hospice utilization, and healthcare quality metrics. the medical icus included in this study are comprised of two geographically co-located units that provide care for medically complex patients from a large tertiary referral area. palliative care services are currently available as a consultative service at the icu clinicians' discretion for patients with palliative needs such as complex goals of care, advanced symptom management, or chronic critical illness. under the current consultation model, palliative care consultation is requested in a minority of critically ill patients and consults occur on average 5-14 days after a patient's admission. hospice services are similarly available on a consultative basis for patients that the primary team has determined are suitable for hospice, however, logistical limitations of hospice consultation may lead to delays in inpatient hospice transfers and home hospice discharges. this study's intervention is to embed a palliative care/hospice practitioner within the medical icus as a dedicated palliative care and hospice consultant who will offer proactively triggered palliative care consultations early in a patient's icu stay as well as immediate availability for standard-of-care palliative care and hospice consultations.

Eligibility criteria:
inclusion criteria: * patients admitted to the medical intensive care units at a tertiary referral center * patients must be at least 18 years of age exclusion criteria: * none

Keywords: palliative care hospice medical icu
prevalence of undernutrition in assiut university children hospital

Conditions: Undernutrition

Summary: to describe the prevalence of undernutrition in infants and children admitted to assiut university children hospital and to describe risk group and decrease length of stay in hospital.

malnutrition is defined as a state in which a deficiency (or excess) of energy, protein, and other nutrition causes measurable adverse effects on the body and on growth (in children), and may impact clinical outcome. recent studies in developed countries have estimated the prevalence of malnutrition in hospitalized children as 12% to 24%. causes of malnutrition: there are many types of malnutrition, and they have different causes. some causes include: poor diet, starvation due to food not being available , eating disorders, problems with digesting food or absorbing nutrients from food , certain medical conditions that make a person unable to eat malnourished children were classified according to the type of malnutrition into: acute malnutrition (wasting) , chronic malnutrition (stunting) , micronutrient malnutrition. malnourished children experience more complications, such as infections after surgery, than well-nourished children, also leading to increased length of stay. in infants, early malnutrition is associated with delayed physical as well as intellectual development.

Eligibility criteria:
inclusion criteria: * all infants and children from 2 months to 6 years admitted to assiut university children hospital . exclusion criteria: * infants less than month ,children over the age of 6 years .
trial of tocilizumab for treatment of severe covid-19: architects

Conditions: COVID-19

Summary: the overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe covid-19. the study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching placebo iv. the dose may be repeated in 8-12 hours if clinical symptoms worsens, (e.g. increase in oxygen requirements). participants will be followed for 28 days.


Eligibility criteria:
inclusion criteria: * ii. hospitalized with covid-19 pneumonia, based on chest x-ray or ct scan and iii. evidence of hyperinflammation: il-6\>40pg/ml (if available) or crp \>2 mg/dl or ferritin \>2000 ng/ml and iv. one or more of the following: impending need for requiring invasive or non-invasive mechanical ventilation or shock requiring vasopressor (without evidence of bacterial / fungal infection) or need for extracorporeal membrane oxygenation (ecmo) or severe, refractor ards (pao2/fio2\<200 mmhg) exclusion criteria: known severe allergic reactions to tocilizumab or other monoclonal antibodies * active tuberculosis infection based on history * suspected active bacterial, fungal, viral, or other infection (besides covid-19) * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * have received oral anti-rejection or immunomodulatory drugs (including tocilizumab) with the past 6 months * participating in other drug clinical trials (participation in covid-19 trials allowed) * self-reported pregnant or breastfeeding * any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 10 x upper limit of normal (uln) detected within 24 hours at baseline * absolute neutrophil count (anc) \< 1000/ml at baseline * platelet count \< 50,000/ml at baseline
nurse-led reminder program for therapy adherence, clinical outcomes and trust in nurses in diabetic patients

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: a number of strategies have been evaluated to improve clinical outcomes in diabetics patients, however no studies explored the efficacy of a nurse-led reminder program through email (nrp-e) to improve medication adherence, even if it is fundamental in the management of diabetics. the study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (nrp-e) to improve medication adherence in diabetic patients.


Eligibility criteria:
inclusion criteria: to be elegible, all subjects had to be diabetics (diabetes mellitus, non-insulin-dependent) * speaking and reading italian * having an active phone number and an email address * providing a signed a informed consent exclusion criteria: * mental illness * hospitalized patients and who refused to partecipate