Kornimate/medical-research-clean huggingface dataset:
evolution of ischemic stroke subtypes in hong kong

Conditions: Stroke; Stroke, Acute; Neurologic Symptoms

Summary: stroke is the 4th leading cause of mortality in hong kong. it also carries considerable socioeconomical consequences due to disability. ischemic stroke can be classified by the toast classification, which includes large artery atherosclerosis, cardioembolism, small-artery occlusion and other causes (1). among which, intracranial atherosclerosis (icas) had been major cause of acute ischemic stroke (ais) in the asia pacific. it was estimated as high as 24.1% of ais or transient ischemic attacks (tias) were attributed to icas in china (2). management of icas related strokes has been challenging owing to its high rate of recurrence despite medical therapy. recent randomized clinical trial suggested that aggressive medical therapy may result in reduction in recurrence compared with historical cohorts (3). our group has previously observed a 2.5-fold increase in atrial fibrillation related stroke over a 15-year period (4). the inverstigator also observed a decline in icas related ais as well as its recurrent stroke risk throughout the recent years. possible mechanisms include better management of metabolic risk factors and aggressive secondary prevention. other possible reasons are increased atrial fibrillation (af), small vessel disease (svd) or other stroke mechanisms. this study is aim to find the evolution of different stroke subtypes in relation to the characteristics of our stroke population over a 15-year period. this may influence territorial prevention strategy.

five time points, i.e. 2004, 2006, 2008, 2010, 2012, 2014, 2016, 2018 are selected for analysis. all consecutive stroke patients included in the prince of wales hospital stroke registry will be recruited. patients will be stratified according to their stroke subtypes with reference to the toast classification (1), which includes large artery disease, cardioembolism, small vessel occlusion, other determined causes, undetermined cause or incomplete investigations. stroke etiology is determined by stroke neurologists with reference to the history, physical signs, imaging including carotid duplex, transcranial doppler, computer tomography (ct), ct angiogram, magnetic resonance imaging (mri), mr angiogram, electrocardiography (ecg) and echocardiography. interobserver variability for stroke mechanism determination will be evaluated. pre-defined demographic data including age, gender, smoking status, vascular risk factors including hyperlipidaemia, hypertension, diabetes, prior stroke or tia, etc. will be retrieved from the stroke registry. the investigator will also compare the use of antiplatelet agents, anticoagulants, lipid-lowering agents, specific antihypertensives in the shatin territory across the 15-year period using the cdars.

Eligibility criteria:
inclusion criteria: * all consecutive chinese stroke patients included in the prince of wales hospital stroke registry at 2-year intervals, i.e. from 2004 to 2018 exclusion criteria: 1. uncertain diagnosis of stroke 2. non-chinese patients

Keywords: stroke
post market study for floshield 10mm reusable cannula and blunt obturator and robotic floshield

Conditions: Cholecystectomy; Benign Hysterectomy; Salingo-oophorectomy

Summary: this study evaluates the use of the floshield system with the floshield 10mm reusable cannula and oburator during standard robotic laparoscopic single-site surgery. the study will evaluate the compatibility of the floshield 10mm cannula and oburator with the davinci® robotic surgical system during single-site laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * male or female, 18 years or older * scheduled for a laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator * suitable candidate for surgery * is able to read and understand the informed consent form and has voluntarily provided written informed consent exclusion criteria: * unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator) * subjects with known allergy (hypersensitivity) to docusate sodium * use of surgiquest airseal during the laparoscopic single-site surgery * use of humidified insufflation

Keywords: floshield mid minimally invasive surgery minimally invasive devices robot-assisted laparoscopic surgery single-site laparoscopic surgery single incision laparoscopic surgery cannula blunt obturator cholecystectomy benign hysterectomy salpingo-oophorectomy
abatacept and the risk of cancer: a case non-case analysis in vigibase

Conditions: Rheumatoid Arthritis

Summary: there are very few data on the safety of biologic disease modifying anti-rheumatic drugs (bdmards), especially abatacept which compared to tumor necrosis factor α (tnfα) inhibitors has distinct mechanism of action. abatacept is a recombinant fusion protein of human cytotoxic t-lymphocyte antigen 4 (ctla-4) and the fc region of human immunoglobulin gamma-1 (igg1). this ctla4-fusion protein blocks the signal of t cell activation by binding to cd80 and cd86. recently, the investigator's study found in a us cohort of 64,000 patients with rheumatoid arthritis (ra) a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bdmards (article in press). these results were in accordance with another prospective cohort study of the public health care system in sweden, showing an increased risk of nmsc in abatacept users compared with tnfα inhibitors. as these results warrant replication, the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer, including breast, lung, lymphoma, cervical, melanoma and nmsc, compared to other bdmards.

a case non-case study using vigibase®, the world health organization global individual case safety reports (icsrs) database which includes more than 18 million reports forwarded to the who uppsala monitoring center by national pharmacovigilance systems from over 130 countries around the world since 1967. information on the adverse effects reported include patient demographics and medical relevant history, drugs recorded according to the who drug dictionary and adverse drug reactions coded with medical dictionary for regulatory activities (meddra) terms will be perform.

Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database of individual safety case report to 11/20/2018 * patient treated with at least one bdmard prescriptions * adverse events reported were including the meddra terms exclusion criteria: * chronology not compatible
preload, weight management, risk of cardiovascular disease

Conditions: Body Weight

Summary: investigators presumed that preload consumers will have more weight reduction and lower risk of cardiovascular disease

to our knowledge, all previous studies evaluated the energy intake in a dietary meal after consuming a low-energy-dense preload while none assessed the sustainability of lower amount of energy intake and body weight changes in a long-term. on the other hand, the sustainability of lower energy intake in a long term might be affected by higher dietary diversity score due to considering preload in diets. notably, increased diet variety is associated with higher overall dietary energy intake and weight gain.

Eligibility criteria:
inclusion criteria: * bmi \> 25, * older than 18 years exclusion criteria: * poor dietary compliance

Keywords: preload anthropometric measures cardiovascular risk factors
comparison of a septal stapler to suture closure in nasal septoplasty

Conditions: Nasal Obstruction

Summary: the primary objective of this study is to determine if there is a time savings in the operating room by using a septal stapler instead of suture in closure of primary septoplasty. the secondary objectives are to determine the subjective outcome of patients undergoing closure with the septal stapler instead of suture via questionnaire, and to determine if there is a difference in postoperative complications between groups.

nasal septoplasty is the third most common surgical procedure performed by otolaryngologists. the surgery is done to relieve nasal obstruction, which is often caused by a bend in the tissues in the middle of the nose. the current technique for completing a septoplasty involves elevating subperichondrial flaps bilaterally and resecting the deviated portion of cartilage and/or bone. the technique to prevent a septal hematoma by removing the potential dead space after cartilage resection has evolved over time. traditionally, the nose was packed with petroleum gauze, but using sutures to coapt the mucosa back together has become the preferred method of choice. placing sutures to reapproximate the mucosa is very effective, but can be challenging, particularly in a narrow nose. the amount of time required varies from 4 to 20 minutes for this part of the surgery, and is potentially associated with its own set of complications. the needle or suture can break, and the lateral nasal wall can be traumatized, leading to formation of scar bands to the septum. recently, a septal stapler has been developed that uses bioabsorbable staples. the staples are made of polylactide-co-glycolide (plg), the same copolymer found in vicryl sutures. it can provide a more uniform closure, is able to reach the posterior septum and could lead to a significant time savings in the operating room. the stapler has been demonstrated to be safe and effective, and required less than a minute to apply in most studied cases. the amount of time saved in the operating room has not yet been studied.

Eligibility criteria:
inclusion criteria: * primary septoplasty * age\>18 * septal deviation * ability to read and communicate in english * absence of allergic rhinitis * non-smoker exclusion criteria: * revision septoplasty * age \<18 * concurrent sinusitis or endoscopic sinus surgery * existing nasal septal perforation * smoker * diabetes mellitus * allergy to polylactide-co-glycolide (plg) * non-english speaker

Keywords: nasal septum nasal surgical procedures
study of psma-targeted 18f-dcfpyl pet/ct in the evaluation of patients with renal cell carcinoma

Conditions: Renal Cell Carcinoma; Kidney Cancer

Summary: in this study the investigators aim to evaluate diagnostic utility of prostate-specific membrane antigen (psma)-targeted 18f-dcfpyl pet/ct in patients with renal cell carcinoma (rcc).


Eligibility criteria:
inclusion criteria: * clinically diagnosed or histologically proven stage ii-iv renal cell carcinoma * completed staging evaluation with computed tomography (ct) or magnetic resonance imaging (mri) of the chest, abdomen and pelvis ≤90 days prior to study enrollment exclusion criteria: * history of other malignancy diagnosed within the last 3 years (with the exception of low risk prostate cancer, ductal carcinoma in situ of the breast, squamous cell carcinoma or basal cell carcinoma of the skin) * administered a radioisotope within 5 physical half-lives prior to study enrollment * pregnancy ((as determined in accordance with the policies of the positron emission tomography (pet) center)) * intention to enroll in a blinded therapeutic clinical trial following positron emission tomography-computed tomography (pet/ct)
a prospective epidemiological research on functioning outcomes related to major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.


Eligibility criteria:
inclusion criteria: * outpatients with a current or new diagnosis of major depressive episode (mde) according to the diagnostic and statistical manual of mental disorders iv text revision (dsm-iv-tr); diagnosis will be confirmed through the mini international psychiatric interview (mini) questionnaire (depression module) * outpatients starting an antidepressant treatment in monotherapy at baseline (treatment initiation or first treatment switch) as decided by the treating physician * the patient will present within the normal course of care, for either a first or subsequent episode of depression exclusion criteria: * schizophrenia or other psychotic disorders * bipolar disorder * dementia or other neurodegenerative disease significantly impacting cognitive functioning * mood disorder due to a general medical condition or substances * acute suicidality * patient treated for depression by a combination of different antidepressant treatments at the time of the consultation other exclusion criteria may apply.

Keywords: mdd non-interventional study observational study
perceptual deficits in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: in this study, participants with schizophrenia and schizoaffective are given computer exercises to complete. the goals of the study are to determine whether: 1) any of the computer exercises can improve information processing problems in schizophrenia, 2) improvements in information processing are related to other cognitive improvements, and 3) there are changes in brain activity associated with using the computer exercises. the study will involve clinical interviews, cognitive tests, and frequent computerized cognitive training over the course of 2 months. some participants will also have electroencephalography, a non-invasive test that measures brain activity, to determine whether there are changes in brain activity with the computer training.

schizophrenia is a disabling neurodevelopmental illness, affecting nearly 1% of the population. the disability of schizophrenia is due in large part to the effects of the illness on cognitive faculties. current medications for schizophrenia do not generally improve cognition, so a major contribution to disability remains undertreated. computerized cognitive remediation programs, which produce activity-dependent recruitment of neural resources to specifically enhance under-functioning brain systems, have been effective at improving both cognition and community functioning in patients with schizophrenia, but the effects are still modest. our preliminary work has suggested that our training is associated with improvements in visual memory, though visual memory has been a cognitive area more refractory to cognitive training. in this study, participants with schizophrenia or schizoaffective disorder will be randomized to receive different computer exercises to help determine whether computer exercises can improve memory in schizophrenia, and whether the cognitive training is associated with changes in neural activity.

Eligibility criteria:
inclusion criteria: * schizophrenia or schizoaffective disorder * english speaking and reading exclusion criteria: * current substance abuse * visual impairment * neurological conditions * current enrollment in another research study
anticancer activity of nicotinamide on lung cancer

Conditions: Non-Small-Cell Lung Carcinoma

Summary: nicotinamide is an inhibitor of human sirtuins (hdac iii), and is found to re-activate epigenetically silenced tumor suppressors, runx3 (runt-related gene 3) and others, in cancer cells. nicotinamide was found to be effective in several animal cancer models including lung, bladder, liver, etc. the purpose of this study is to determine whether nicotinamide is also effective in the treatment of human lung cancer.

the standard therapy to the egfr (epidermal growth factor receptor) mutation positive non-small-cell lung cancer patients who are not eligible to operation is to administer egfr-tkis (tyrosine kinase inhibitors, gefitinib or erlotinib). to determine the effectiveness of nicotinamide on lung cancer, nicotinamide or placebo tablet will be co-administered with gefitinib or erlotinib for two years until the event or censoring occurs. the stratified block randomization was designed with 3 covariates (egfr mutation status, kind of egfr-tki, ecog (eastern cooperative oncology group) performance status score variation). the size of lesions will be checked every other months by radiology. pd (progressive disease) will be assessed according to recist(response evaluation criteria in solid tumors)1.1. after observing 36 events, an interim analysis of hazard ratio by cox proportional hazard regression will be performed. the final analysis will be done by the same protocol after observation of 72 events. the significance level of the interim and final analysis were set to 0.0075 and 0.0209 respectively. response rate, quality of life (measured by 10 questions at every visit), and overall survival will be analysed together. all other adverse reactions will be analysed and reported, if there.

Eligibility criteria:
inclusion criteria: * operation-impossible stage 4 non-small-cell lung carcinoma (nsclc), or recurred terminal stage nsclc after previous operation or radiation therapy * egfr mutated (exon 19 deletion or l858r mutation) * life expectation more than 3 months * more than 1 measurable lesions by recist 1.1 which were not exposed to radiation previously * ecog (eastern cooperative oncology group ) performance status grade 0\~2 * who signed the informed consent form exclusion criteria: * who had received chemotherapy or egfr tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy * who has metastasized brain lesion that needs operation or radiation therapy * above grade 2, ctcae (common toxicity criteria for adverse effects) 4.0 criteria for blood, liver and kidney * who does not agree to contraception * who has allergy to nicotinamide

Keywords: egfr mutated lung cancer
a transition of care model from hospital to community for hispanic/latino adult patients with diabetes.

Conditions: Diabetes Mellitus

Summary: this pilot study was designed to address the existing gap in the transition of care of hispanic/latino adults with diabetes from hospital to community. the over arching goal of this study is to develop, test, and determine the feasibility of a transition of care (toc) model from the hospital to the community for adult hispanic/latino patients with diabetes.

this pilot study is designed to develop, test, and determine the feasibility of a transition of care model from the hospital to the community for adult hispanic/latino patients with diabetes. the proposed study originally designed was randomized pilot study with two arms: 1) the usual transition of care and (2) a transition of care model newly developed using information collected during our study aim 1. given the multiple challenges brought on by the covid-19 pandemic, we found it necessary to adapt and modify the original study design. the study designed with approval from our funding team was changed to utilize the plan-do-act-study (pdsa) as a framework. the pdsa is an iterative process that allows us to test on a small scale and document unexpected observations and determine what modifications should be made and prepare for next test. a transition of care (toc) model will be developed based on the following data: 1) results from semi-structure interviews from our first cohort of hispanic/latino participants with diabetes recently discharged from the hospital and providers from the hospital and community ; 2) feedback from participants in the community during the community consultation studio . once developed, the toc model will be tested with a total of 16 participants discharged from the hospital to the community. the model will incorporate the preference and perspective of providers and patients. participants will complete a set of of questionnaires (demographic, sociocultural and medical history) prior to discharge and a follow up telephone call interview 30-days post discharge. a total of 5 participants for the first set of participants will be interview. these interviews will be analyzed for common patterns and themes for which the results will inform improvement of the toc. a second cohort of participants (n=16) will be enrolled. and complete the same set of questionnaires along with the 30 day post discharge telephone call. finally, after implementing and enrolling the second cohort, as small subset will be interview including providers (n=3) to obtain additional information that will inform further improvement of the toc.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosis of diabetes mellitus * self-identified hispanic/latino * spanish or english speaking * currently hospitalized in the duke university health system * able to provide informed consent without a proxy exclusion criteria: * there is no exclusion criteria based on comorbidities

Keywords: diabetes mellitus spanish transition of care
validation of the french version of the stapesplasty outcome test 25 (spot-25)

Conditions: Otosclerosis

Summary: inclusion (j0): * audiometry (as part of the treatment, only for cases) * clinical evaluation (within the framework of care, only for cases) * passage of the french version of the spot-25 questionnaire visit 1 (d0 + 3 ± 1 week): only for cases second examination of the french version of the spot-25 questionnaire (re-test) either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame. visit 2 (3-6 months postoperatively): only for operated patients third examination of the french version of the spot-25 questionnaire either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.

inclusion (j0): * audiometry (as part of the treatment, only for cases) * clinical evaluation (within the framework of care, only for cases) * passage of the french version of the spot-25 questionnaire visit 1 (d0 + 3 ± 1 week): only for cases second examination of the french version of the spot-25 questionnaire (re-test) either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame. visit 2 (3-6 months postoperatively): only for operated patients third examination of the french version of the spot-25 questionnaire either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.

Eligibility criteria:
inclusion criteria: * patient aged\> 18 years * diagnosis of otosclerosis with indication for primary stapes surgery by the combination of the arguments: * clinical: normal eardrum and audiometry revealing conductive or mixed hearing loss with audiometric rinne of\> 15 db and absence of stapedial reflex. * radiological: otosclerotic foci on preoperative ct scan * non-opposition to participating in the study * good understanding of french * affiliate or beneficiary of a health insurance plan inclusion criteria for witnesses: * person aged\> 18 years * absence of known otological pathology * without otological surgical history * non-opposition to participating in the study * good understanding of french exclusion criteria: * comorbidity that may interfere with the interpretation of results * history of stapes surgery * person benefiting from a legal protection measure

Keywords: spot-25