Kornimate/medical-research-clean huggingface dataset:
decision support intervention adapted for hiv pre-exposure prophylaxis for adoption and adherence for black canadians

Conditions: HIV/AIDS

Summary: aim 1: adapt ottawa decision support framework for the hiv prep decisional needs of african, caribbean and black (acb) canadian patients aim 2. pilot test the adapted decision-support intervention using a two-arm randomized controlled design

aim 1: adapt ottawa decision support framework for the hiv prep decisional needs of acb canadian patients. investigators propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with prep eligible patients and surveys with health professionals involved in hiv prep management. under this aim two research questions will be investigated. q1) what factors do acb canadian patients consider when deciding whether to adopt hiv prep? q2. how do sdt constructs of autonomy, competence and relatedness influence acb canadian's decision-making experiences regarding prep adoption? aim 2. pilot test the adapted decision-support intervention using a two-arm randomized controlled design.hypothesis testing will be de-emphasized in favor of generating effect size estimates. under this aim three research questions will be investigated. preliminary hypotheses include: h1: prep decision support increases decision quality in both ldq and hdq groups, h2: hdq + decision-support group more likely to initiate prep than hdq control, h3: hdq prep initiators are more likely than ldq initiators to have serum levels consistent with adherence at 60-days. data on decision quality survey and prep initiation data will generated by the subject from self-administered assessments via the decision-support app on the study-issued smartphone. investigators will also collect biological specimens to measure adherence to hiv prep at 60-days post enrollment. the study will take place in the toronto metropolitan area (pop. 2.5 million). over half (59%) of canada's acb population is settled in the province of ontario. moreover, the majority (70%) of acb people in ontario live in metro toronto, making it the ideal location for this study. the trial procedures will be conducted at sites within the st. michael's hospital (smh) system, including the smh li ka shing knowledge institute.

Eligibility criteria:
inclusion criteria * self identify as black african, caribbean and or canadian * hiv sero-negative * not in a monogamous sexual partnership with a recently tested hiv negative man * self report unprotected anal sex with a man in the past six months * diagnosed with gonorrhea, chlamydia or syphilis in the past six months * are in an ongoing sexual relationship with an hiv positive partner * currently live in the greater toronto metropolitan area * can speak and understand either english or french exclusion criteria * non black african caribbean and or canadian person * diagnosed with hiv and or aids * unable to consent to provide documentation of negative hiv status

Keywords: hiv prep decision support african caribbean black canadians
the efficacy and tolerability of two formulations of atorvastatin in korean adult with hypercholesterolemia

Conditions: Dyslipidemia; Cardiovascular Disease; Hypercholesterolemia

Summary: there will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these korean adults with primary hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had ldl-c level over 100 mg/dl in high risk group. * inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with ldl-c ≥100 mg/dl; patients with two or more risk factors and ldl-c≥130 mg/dl; patients with 0 or 1 risk factor and ldl-c \>160 mg/dl after therapeutic lifestyle changes exclusion criteria: * therapy with any other investigational drug within 30 days of randomization, * history of hypersensitivity to hmg-coa reductase inhibitors, * uncontrolled hypertension, * poorly controlled diabetes (glycosylated hemoglobin \[hba1c\] \>9%), * unstable angina or presented with new-onset myocardial infarction (within 6 months), * creatinine \>2.5 mg/dl, * alanine aminotransferase (alt) \>2 x upper limit of normal (uln), aspartate aminotransferase(ast) \>2 x uln, or creatine kinase (ck) \>2 x uln, * history of malignancy or psychosis; * chronic liver disease, * drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.

Keywords: statins cholesterol hypercholesterolemia atorvastatin dyslipidemia in cardiovascular disease (kolipinon)
staple-line reinforcement for prevention of pulmonary air leakage

Conditions: Lung Neoplasms; Pulmonary Surgical Procedures; Surgical Staplers; Tissue Adhesives; Chest Tubes

Summary: the aim of this study is to compare the efficacy of foreseal with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer. hypothesis: to show a significant difference of 1 day in the average duration of air leakage between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).

air leaks continue to be the most common complication after pulmonary resection even using a stapling device. double chest tubes after lobectomy is a well established method for drainage of the pleural cavity to allow adequate expansion of the remaining lung. foreseal has been developed to reduce air leaks by buttressing the staple line. it is a absorbable vegetal biopolymer in the form of sleeves, ce marked and indicated for prevention of air leakage after pulmonary resection with stapling device. it acts as a suture reinforcement as well as a sealant thanks to its jellification. sealants are also commonly used in addition to stapling to prevent air leakage. the aim of this study is to compare the efficacy of foreseal with stapling alone or associated with sealants. this is a multi centre, prospective controlled and randomised clinical study.

Eligibility criteria:
inclusion criteria: * patient 18 years old or over. * patient that undergoes a lobectomy or bilobectomy for lung cancer, * patient presenting an incomplete fissure, requiring stapling of at least 50% of the fissure and/or an emphysematous lung at the fissure point, requiring stapling. * patient that has signed the informed consent before the operation. * patient that benefits from a social security regime. exclusion criteria: * patient with history of thoracotomy on the side operated on. * patient with severe pleural infection and/or infection of parenchyma. * presence of air leakage after liberation of lung in cases of pleural symphysis. * patient pregnant, giving birth or nursing. * patient presenting a contra indication to the aerostatic products used. * patient already participating in biomedical research.

Keywords: absorbable implants humans alginates pneumonectomy/methods pneumonectomy/instrumentation surgical stapling thoracic surgery tissue adhesives prospective studies
pilot study evaluating the optimization of the orbeye blue light filter during fluorescence-guided resection of gliomas

Conditions: Malignant Glioma of Brain

Summary: fluorescence-guided resection using 5-ala induced tumor fluorescence of malignant gliomas allows for better identification of tumor tissue and more radical resection in select patients and improvements in progression-free and overall survival. with new developments in surgical microscopy, the development of digital exoscopes have provided advanced visualization as well as improvements in ergonomics and accessibility of the surgical field. the use of the exoscope in 5-ala fluorescence-guided tumor surgery has the potential to enhance the ability of the surgeon to remove brain tumors with high efficacy. while algorithms for use of 5-ala fluorescence have been optimized for use with traditional microscopes, the use of fluorescence techniques in newer digital exoscopes have not been developed. the primary outcome of the study is to obtain parameters to optimize visualization of fluorescence intensity and perform optimization based on the intensities achieved. the operating orbeye exoscope will be fitted with a blue light filter. all experiments will be performed in darkened operating rooms. the orbeye exoscope will be set up at constant distances from the target and incident light intensities. the focal distance and light intensity settings will be recorded from the data displayed on the microscope. patients (experimental group) will receive 5ala treatment before operation, blue light filter imagining will take place after tacking up dura and prior to direct resection. the expected outcomes of image analysis will be to have a set of exoscope parameters optimized for visualization of 5ala tissue in different tumor types. this 5ala characterization of visualization parameters has never been completed on an exoscope. optimizing orbeye exoscope parameters will define a standard in glioma resection using 5ala under a novel exoscopic filter as well as contribute insight into the use of the fluorescent filter for additional tumor types.


Eligibility criteria:
inclusion criteria: * male and female ≥ 18 years of age * must have a suspected or biopsy-proven glioma (world health organization grade ii or iv), new or recurrent * indication for craniotomy for removal of a suspected or recurrent brain tumor * karnofsky performance scale ≥ 60% * willing and able to provide informed consent or have surrogate consent by legally authorized representative exclusion criteria: * male and female \< 18 years of age * porphyria, hypersensitivity to porphyrins * renal insufficiency as defined by a creatinine \> 2.0 mg/dl * hepatic insufficiency as diagnosed in preoperative medical clearance evaluation * females of childbearing potential with a positive pregnancy test * nursing women * unwilling or unable to provide informed consent
manchester lung health study

Conditions: Lung Cancer

Summary: the manchester lung health study (quest) will assess the uptake of a community-based lung cancer screening service and its impact across a deprived area of north and east manchester, which has high rates of lung cancer. one measure will be to compare the number and stage of lung cancers detected through screening to those detected outside of screening. in addition we will investigate the potential of a blood and nose test to detect lung cancer or to help decide who would benefit from screening. we will also see if these samples can help with the interpretation of ct scans. one of the problems with lung cancer ct screening is that you detect lung nodules in which we are not sure if they are benign or cancerous. therefore we are also looking to see if a biomarker can help us work out which are cancerous and which are benign.


Eligibility criteria:
main data study: inclusion criteria: - any individual attending the manchester lung health service who has a lung health check as they meet the service inclusion exclusion criteria (see below): manchester lung health service inclusion criteria: * age 55-80 * ever smoker * registered with a gp in the north or east manchester area manchester lung health service exclusion criteria: * lung cancer diagnosis within 5 years * listed on a palliative care register * chest ct scan within 3 months exclusion criteria: - unable to give informed consent to study participation. biomarker sub-study: inclusion criteria: * any individual attending the m-lhc service who is eligible and agrees to undergo ldct screening. * has consented to the main study. exclusion criteria: * unable to give informed consent to study participation * decline participation in ldct lung cancer screening * known blood borne virus e.g. hiv or hepatitis b, c
prevalence of temporomandibular disorders in patients with fibromyalgia syndrome

Conditions: Temporomandibular Disorder; Fibromyalgia

Summary: one hundred fifty woman patients diagnosed with fibromyalgia according to the american college of rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included.demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be recorded. patients will be evaluated according to the diagnostic criteria for temporomandibular disorders: assessment instruments (dctmd: ai ). patients will be evaluated by diagnostic criteria for temporomandibular disorders: temporomandibular disorders (tmd) pain screener, symptom questionnaire, clinical examination form from assessment instruments axis i. pain drawing, graded chronic pain (version 2), jaw functional limitation scale-8 (jfls-8), patient health questionnaire (phq-4), oral behaviors checklist will be applied within the scope of axis ii.

in our study, the investigators aim to compare the frequency of temporomandibular disorders between healthy female participants and female patients diagnosed with fibromyalgia. our study will consists of 300 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic between may 2021 and august 2021. this case-control study will conducted according to the declaration of helsinki. participants gave written voluntary consent and enrolled in this case-control study. one hundred fifty woman patients diagnosed with fibromyalgia according to the american college of rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included. patients with temporomandibular region surgery, congenital teporomandibular joint pathologies, and previous temporomandibular region trauma were will be excluded from the study. because fibromyalgia is a disease that mostly affects women, the investigators designed our study so that all participants were women. in addition, demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be recorded. patients will be evaluated according to the diagnostic criteria for temporomandibular disorders: assessment instruments ( dctmd: ai ). patients will be evaluated by diagnostic criteria for temporomandibular disorders: tmd pain screener, symptom questionnaire, clinical examination form from assessment instruments axis i. pain drawing, graded chronic pain (version 2), jaw functional limitation scale-8 (jfls-8), patient health questionnaire (phq-4),oral behaviors checklist will be applied within the scope of axis ii.

Eligibility criteria:
inclusion criteria: * one hundred fifty woman patients diagnosed with fibromyalgia according to the american college of rheumatology 2010 diagnostic criteria * one hundred fifty womanhealthy volunteers exclusion criteria: * patients with temporomandibular region surgery * congenital teporomandibular joint pathologies * previous temporomandibular region trauma were excluded from the study.

Keywords: fibromiyalgia syndrome temporomandibular disorders
study of the immunological infiltrate and immunometabolic immunometabolic profile of patients with acute leukaemia

Conditions: Acute Leukemia

Summary: lthe main aim of this project is to provide an immunophenotypic and immunometabolic characterisation of patients with acute leukaemia, before and after therapy, and to understand how changes in the immune system impact the response to therapy. specifically: 1. the association between the molecular and metabolic characteristics of leukaemic cells and those of the surrounding immune system will be assessed, in order to identify immune-modulatory metabolic mechanisms activated by malignant cells. 2. the association between immunometabolic signatures and response to therapies will be assessed. 3. the role of evs as a vehicle for metabolic units capable of regulating the metabolism of immune system cells will be explored.

multicentre biological study, aimed at collecting and characterising human tissue isolated from acute leukaemia patients. in the context of routine care visits, peripheral blood (pb) and bone marrow (bm) samples will be taken from these patients at different time-points, which will be compared with samples obtained from healthy control subjects.patients belonging to the haematology ou of the irccs aou of bologna and to the haematology ous of the participating centres, suffering from acute leukaemia, will be enrolled. they must be eligible for a treatment scheme that includes either conventional chemotherapy or innovative therapies, such as monoclonal antibodies, molecular therapies with specific targets, metabolic and immunological therapies, as part of the normal care pathway. it is also planned to enrol healthy donors whose samples will be provided by: * irccs aou of bologna immunohaematology and transfusion medicine service (buffy coat) * italian association against leukaemia, lymphoma and myeloma in bologna (ail bologna odv), within the haematology unit of the irccs aou of bologna (peripheral blood).

Eligibility criteria:
inclusion criteria: patient * diagnosis of acute leukaemia. * eligibility for a treatment scheme involving either conventional chemotherapy or innovative therapies, such as monoclonal antibodies, molecular therapies with specific targets, metabolic and immunological therapies. * age ≥ 18 years. * signature of informed consent by patients at the time of diagnosis. healthy donors (ail bologna odv volunteers) * age ≥ 18 years. * signature of informed consent. exclusion criteria: * no one
assessment of the prognosis of persistent left bundle branch block (lbbb)after transcatheter aortic valve implantation (tavi ) by an electrophysiological and remote monitoring risk-adapted algorithm

Conditions: Post-TAVI

Summary: the replacement of the aortic valve by percutaneous approach (called tavi) is a therapy which is booming in the management of aortic stenosis. it concerns patients who have a high surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular replacement seems unreasonable. beyond its feasibility, the implantation of a tavi is less invasive and improves the patient's morbi-mortality. the appearance of a left bundle branch block (lbbb) is one of the most frequent complications of this procedure and represents an important risk of atrio-ventricular (av) high grade conductive disorders requiring permanent pacing in 5 in 15 % of the cases in 1 year. de novo lbbb is associated with a more important morbi-mortality in post-tavi situation. however, there are no predictive elements of these conductive disorders. besides, the incidence and the deadline of appearance of this av disorders are not established. it seems relevant to propose a new stratification based on ecg and endocavitary data. the monitoring of the conductive disorders is allowed by remote monitoring thanks to the implantation of a pacemaker or an implantable holter allowing to determine the incidence and the deadline of appearance of high grade av conduction disorders.

the aim of this protocol is to study the appearance of the high grade av conductive disorders at 12 months by monitoring for patients with a de novo lbbb after tavi from an adapated algorithm to the risk and based on an early electrophysiological evaluation. the recruitment of patients takes place in each cardiology department. the project is submitted to the ethics committee . the patients are informed about this study by the investigator. after a reflection period and an answer to the possible questions, the patient is included. the informed consent is signed. every patient included with a de novo lbbb, persistent that is observed beyond 24 hours after the tavi procedure, will benefit from an endocavitary electrophysiological exploration . according to the meditative delay of conduction, a pacemaker will be implanted in case of delay lengthened hv (\> 70 ms) or of infrahissian block, in the opposite case the implantation of an holter with remote monitoring will be made.

Eligibility criteria:
inclusion criteria: * patients over 18 year's old * patient implanted by a percutaneous biological aortic valve according to the recommendations of the european society of cardiology according to the guidelines of esc 2012 * life expectancy upper 1-year-old * sinusal rhythm * patient with a de novo lbbb post-tavi persitent and observed beyond 24 hours after the procedure of tavi. exclusion criteria: * patient with a pacemaker pre-tavi * patient with lbbb pre-procedure * pregnancy * permanent atrial fibrillation

Keywords: tavi de novo and persistent lbbb electrophysiology holter pacemaker
a pharmacokinetic study of ts-142 in patients with hepatic impairment

Conditions: Patients with Mild or Moderate Hepatic Impairment

Summary: this is an open-label pharmacokinetic study of ts-142 in patients with hepatic impairment


Eligibility criteria:
inclusion criteria: \ 1. japanese male and female who are aged 18 to 75 years at the time of informed consent 2. patients with cirrhosis or chronic hepatic impairment 3. patients classified as child-pugh classification a (mild) or b (moderate) by the principal investigator or sub-investigator at the screening test other protocol defined inclusion criteria could apply. \ 1. japanese male and female who are aged 18 to 75 years at the time of informed consent 2. body mass index (bmi) between 18.5 and 35.0 at the screening test other protocol defined inclusion criteria could apply. exclusion criteria: \ 1. patients who have a history of liver resection or liver transplant 2. patients with hepatic encephalopathy of grade ii or higher 3. patients with epidermal growth factor receptor (egfr) less than 45 ml/min/1.73 m2 at the screening test other protocol defined exclusion criteria could apply. \ 1. subjects who are judged to have any disease by the principal investigator or sub-investigator 2. subjects with egfr less than 60 ml/min/1.73 m2 at the screening test other protocol defined exclusion criteria could apply.