Kornimate/medical-research-clean huggingface dataset:
pmdt in thoracic surgery--the process implementation stage

Conditions: Pain, Postoperative

Summary: the risk of acute and chronic pain after thoracic surgery is high. the multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. through nearly one year of experience in implementation of the pmdt in the thoracic surgery department of peking university people's hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

the postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that occurs immediately after surgery, and its nature is traumatic pain. it may develop into a chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at the initial state. it will seriously impact the physiology and psychology of a patient. according to the study, the postoperative acute pain is one of the risks for postoperative complications, and it may result in the death of a patient. however, the alleviation of a postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall cost for treatment of a patient. the risk of acute and chronic pain after thoracic surgery is high. the multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. through nearly one year of experience in implementation of the pmdt in the thoracic surgery department of peking university people's hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 75, asa i-ii; * patients undergoing thoracoscopic surgery; * patients who can understand and fill in the self-evaluation; * patients who signed the informed consent form. exclusion criteria: * pregnant women; * patients with preoperative chronic pain and long-term opioid use; * patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.

Keywords: pmdt pain thoracic surgery
a study to examine the efficacy and safety of regn5069 in patients with pain due to osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee; Pain

Summary: the primary objective of the study is to evaluate the efficacy of regn5069 compared to placebo in patients with pain due to radiographically-confirmed oa of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy. the secondary objectives of the study are: * to characterize the concentrations of functional regn5069 in serum over time when patients are treated for up to 12 weeks * to assess the safety and tolerability of regn5069 compared with placebo when patients are treated for up to 12 weeks * to measure levels of anti-drug antibodies (adas) against regn5069 following multiple iv administrations


Eligibility criteria:
key inclusion criteria: * generally in good health at the screening visit * body mass index (bmi) ≤39 kg/m2 at the screening visit * clinical diagnosis of oa of the knee on the american college of rheumatology criteria (altman, 1986) with radiologic evidence of oa (k-l score ≥2) at the index joint at the screening visit * moderate-to-severe pain in the index joint * a history of inadequate pain relief from or intolerance to analgesics used for oa key exclusion criteria: * diagnosis of systemic diseases that may affect joints * history or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. presence of subchondral insufficiency fracture on screening films or mri as assessed by the central imaging reader. * is scheduled for a joint replacement surgery to be performed during the study period * received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit * systemic (ie, iv, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit (topical, intranasal, or inhaled corticosteroids are permitted). * history or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy * significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study * history of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit note: other protocol defined inclusion/exclusion criteria apply.
cost-effectiveness of different antiretroviral treatment in patients hiv naive

Conditions: Patient Compliance; Antiretroviral Therapy Intolerance

Summary: the main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.

secondary objectives: * patients with virologic response ratio at 48 weeks (less than 50 plasma viral load) * change in the number of cd4 cells at 48 weeks * change in body composition and mineral density bone (body and lumbar) measurement with dexa (bone mineral density scan) at 48 weeks * change in markers of renal function (creatinine clearance, glomerular filtration rate - egfr - estimated rate) and renal tubular function at 48 weeks * rate of mortality and clinical progression at 48 weeks * general tolerability and safety: adverse events (aa) and serious aa description

Eligibility criteria:
inclusion criteria: * 1-negative pregnancy test in women of childbearing age * 2- stable hiv-1 infection clinically and not take antiretroviral therapy * 3- viral load hiv \<100,000 copies * 4- cd4 cells \>100 cels/mm3 * 5- glomerular filtration \>70mlmin * 6- have a negative hla b5701 * 7-.patients should have given informed written consent * 8- in the opinion of the investigator, be able to follow the design of the protocol visits exclusion criteria: * 1-. patients who had virologic failure with any antiretroviral therapy * 2- evidence of prior mutations of the study drugs * 3- use of any anti-retroviral treatment in the 6 months prior to the entry of the study * 4- contraindication to the drugs study * 5- any condition that does not allow to ensure the correct compliance to the study * 6- uncontrolled previous psychiatric illness * 7- current or active addiction or alcoholism

Keywords: comparative effectiveness
low level laser therapy for treatment of tinnitus in red sea scuba divers

Conditions: Tinnitus

Summary: scuba diving has become a popular hobby, for a leisure activity, diving puts the auditory system at the risk of a wide variety of complaints including tinnitus, low level laser therapy is a new modality in treatment of tinnitus. this study evaluates effect of laser therapy on tinnitus of scuba divers in red sea.


Eligibility criteria:
inclusion criteria: - scuba divers exclusion criteria: * other ear or neurological diseases
study of resilience and loneliness in youth (18 - 25 years old) during the covid-19 pandemic lock-down measures.

Conditions: Resilience, Psychological; Loneliness; Youth; Surveys and Questionnaires

Summary: the outbreak linked to sars-cov-2 pandemic resulted in lock-down measures in almost all european countries. this online survey assesses these measures implications on mental health in emerging adults. the questionnaires evaluate two psychometric variables (resilience and loneliness) and mental health status (mental health professional help-seeking, use of psychotropic drugs, or possible diagnosis) before and during lock-down measures. at least 600 healthy participants aged form 18 to 25 years old will be attended to fill the survey during the sars-cov2 pandemic lock-down measures.


Eligibility criteria:
inclusion criteria: * french-speaking or italian-speaking * subjects who accepted to participated to the online survey * inhabitants of a european country where sars-cov2 pandemic lock-down measures are underway * survey filling date up to one week after the end of lock-down measures in the country of residence exclusion criteria: * incomplete surveys

Keywords: mental health emerging adulthood
impaired decision making in pedophilic offenders

Conditions: Pedophilia

Summary: pedophilic behaviors represent a public health problem with serious consequences. the investigators hypothesize a disruption in the decision-making strategies among sex offenders pedophiles. highlight this type of abnormality would offer a specific treatment of a possible neuropsychological deficit (with cognitive remediation for instance) and perhaps avoid recurrences of this type of behavior.

cross-sectional study, comparing a group of 64 pedophilic offenders inmates condamned with a group of 64 volunteers non-pedophiles matched by age and level of study.

Eligibility criteria:
inclusion criteria: * for the controls, lack of diagnosis of disorders of sexual behavior (paraphilias) current or past (dsm iv) * for the pedophilic offenders: * placement and conviction for rape or sexual assault of a minor under 15 years * recognition of the facts * existence of a current or past diagnosis of pedophilia (according to the dsm iv). exclusion criteria: * presence of a current major depressive episode (dsm iv - mini) * history of cerebral neurological disorder or a cranial trauma with loss of consciousness current * igt test already done * schizophrenia or other current psychotic disorders(according to the criteria dsm iv of mini test). * taking psychoactive drug

Keywords: pedophilia impaired decision making insight cognitive distorsions impulsiveness
exploratory drug interaction study between smis and doacs

Conditions: Solid Tumor; Cancer, Lung

Summary: the main objective of this study is to investigate the effect of small molecule inhibitors (smis), used in targeted therapy for tumours, on direct oral anticoagulants (doacs).

patients who receive anticoagulant therapy in the form of a direct oral anticoagulant (doac) and simultaneously receive anti-cancer targeted therapy with a small molecule inhibitor (smi), potentially have an increased risk on thromboembolic complications and bleeding events due to interfering drug-drug interactions. some smis influence cyp3a4 and/or p-glycoprotein (p-gp) for which doacs are substrates. in this study, the effect of theoretically relevant smis on the pharmacokinetics, efficacy and safety of doacs in patients with solid tumours will be investigated. for this purpose, plasma concentration analyses will be performed.

Eligibility criteria:
inclusion criteria: * diagnosed with a solid tumour * 18 years of age or older * patients receive or start treatment with an smi-doac combination, that may cause a clinically significant ddi at the level of cyp3a4 and/or p-gp, based on the smpc * combined use of a doac-smi combination is expected to be continued at the same dose for at least three weeks * the doac is used for at least seven days and the smi has already been used for at least 21 days at time of blood collection to ensure steady-state * patients receive a doac at maintenance dose exclusion criteria: * unable to understand the information in the patient information letter * any concurrent medication beside the smi and doac that is known to strongly inhibit or induce cyp3a4 or p-gp * patients who are pregnant or lactating

Keywords: direct oral anticoagulant targeted therapy small molecule inhibitors therapeutic drug monitoring
comparative study of micafungin (fk463) versus placebo as prophylactic antifungal therapy in the icu

Conditions: Invasive Fungal Infections

Summary: the purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.


Eligibility criteria:
inclusion criteria * meets entry criteria for high risk exclusion criteria * evidence of active invasive fungal infection * received more than one dose of systemic antifungal agent within 72 hours prior to first dose of study drug * known to be hiv positive who have cd4 count less than 500 cells/mm3 * has life-expectancy of less than 72 hours or moribund

Keywords: anti-fungal therapy preemptive anti-fungal therapy invasive fungal infection micafungin icu
exercise capacity, cardiovascular risk factors and disease-related variables in axial spondyloarthritis

Conditions: Exercise Capacity; Axial Spondyloarthritis

Summary: the investigators aimed to study the associations between exercise capacity and cardiovascular (cv) risk factors in axial spondyloarthritis (axspa) patients and to determine possible relationships with disease-related variables. thirty eight patients and 38 controls were recruited in our cross-sectional controlled study. comprehensive systemic and musculoskeletal examinations were carried out in both of the groups. cardiovascular risk profile data, asdas-crp, 10-year cv event risk, physical activity levels (ipaq) were recorded. a maximal treadmill exercise test by bruce protocol was administered to all participants.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of axial spa * must be able to walk exclusion criteria: * established cardiac disease including structural heart diseases, * uncontrolled hypertension, * cardiac rhythm disorder, * unstable angina pectoris, * chronical renal and/or hepatic disease, * malignancy, * neuromuscular disease * musculoskeletal deformity * the history of an inflammatory arthritis for control group

Keywords: axial spondyloarthritis exercise capacity cardiovascular risk factors nonradiographic axial spondyloarthritis cardiorespiratory fitness
promise: percutaneous peripheral cannulation for minimally-invasive heart valve surgery

Conditions: Heart Valve Diseases; Mitral Valve Disease; Aortic Valve Disease; Tricuspid Valve Disease

Summary: in addition to conventional heart valve surgery (hvs) via full-sternotomy, which is still the most prevalent therapeutic strategy to address valvular heart disease (vhd), minimally-invasive approaches evolved as safe alternatives, resulting in lower postoperative ventilation times, transfusion rates and shorter in-hospital stay. femoral artery cannulation is traditionally performed via surgical cutdown to establish cardiopulmonary bypass during minimally-invasive hvs. to avoid groin incision associated infection and lymphocele formation, and further minimize surgical trauma, the use of percutaneous cannulation including novel endovascular closure devices increases as an alternative but remains to be investigated. the percutaneous peripheral cannulation for minimally-invasive heart valve surgery (promise) registry aims to elucidate the safety, feasibility, and effectiveness of newly developed vascular closure devices during minimally-invasive hvs. acute intra- and perioperative complications will be evaluated according to modified definitions of the valve academic research consortium (varc)-3. in addition, based on the initial results, the comparison of percutaneous cannulation with conventional surgical cut-down techniques is planned.


Eligibility criteria:
inclusion criteria: * retrospective analysis of all patients undergoing minimally-invasive heart valve surgery using novel endovascular closure devices for percutaneous cannulation within 6 high-volume heart valve centres in germany. exclusion criteria: * none

Keywords: minimally-invasive heart valve surgery percutaneous cannulation endovascular closure device
sex related differences in cardiac function

Conditions: Heart Failure With Preserved Ejection Fraction; Diastolic Dysfunction; Systolic Dysfunction

Summary: the aim of the study is to investigate sex-specific differences in lv and rv function (systolic and diastolic) with regarding the development and progression of heart failure with preserved ejection fraction based on a retrospective data analysis. lifestyle modification factors will be assessed for multivariate analyses in order to detect influencing factors. progression will be analysed in a retrospective time series analysis.

compared to men, women show a different cardiovascular risk profile, in this context, it has already been shown that mortality in women with cardiovascular diseases is increased. along with this, there are first indications of an echocardiographic altered cardiac function. it was shown that women are more prone to heart failure with preserved ejection fraction. however, the underlying mechanisms and driving factors have not yet been fully explored. moreover, the role of associated factors such as smoking, bodyweight or cardiovascular risk factors and menopause status remain nut fully understood. in this project differences differences in sex-specific lv and rv function depending on defined risk factors will be investigated. for this purpose, a retrospective follow-up analysis willl be carried out. this is based on test results from patients who underwent transthoracic echocardiography in the echocardiography department of the department of cardiology, pneumology and angiology university hospital düsseldorf. the aim is to evaluate possible differences in the sex-specific risk profile. this may allow us to define the cardiovascular risk profile in dependence from each sex more concretely.

Eligibility criteria:
inclusion criteria: * patients who underwent at least one transthoracic echocardiography in between 2019-2022 exclusion criteria: * \< 18 years

Keywords: sex-related differences cardiovascular disease cardiovascular disease transthoracic echocardiography myocardial strain cardiomyopathies
impact of teeth brushing in ventilated covid-19 patients.

Conditions: Microbial Colonization; COVID-19 Respiratory Infection; Dysbiosis; VAP - Ventilator Associated Pneumonia; HAI

Summary: the aims of this study were: 1. observation of dynamics in oral microbiota and its association with the incidence of hais and vap in mechanically ventilated covid-19 patients in an icu setting 2. evaluation of the incidence of hais and vap and their association with oral bacteriobiota in mechanically ventilated covid-19 patients in an icu setting 3. assessment of impact of different oral hygienic procedures on oral microbiota, the incidence of hai and patients' safety in mechanically ventilated covid-19 patients in an icu setting approaches to oral care in an icu setting intervention of oral hygienic procedures implemented in study: patients were divided into 2 groups depending on the oral care procedure: 1. standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid) 2. extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid)


Eligibility criteria:
inclusion criteria: * sars-cov-2 infection confirmed by real-time reverse transcriptase-polymerase chain reaction (rt-pcr) assay of nasal and pharyngeal swabs upon hospital admission * signed consent to participate in the study * patients admitted to icu * intubation due to covid-19 related pneumonia and acute respiratory distress syndrome (ards) within 24 hours preceding study procedures exclusion criteria: * no consent to participate in the study

Keywords: oral microbiota healthcare-associated infection
dialysis chw pilot

Conditions: Chronic Kidney Diseases; RENAL INSUFFICIENCY, CHRONIC

Summary: to determine the acceptability and feasibility of a community health worker intervention that assists dialysis patients with low socioeconomic status navigate community resources to address health-related social needs. findings will be used for a future randomized trial that determines the efficacy of the chw intervention on mental health, quality of life, addressing social needs, and clinical outcomes. this study is intended to be generalizable in all dialysis centers.

the research team will conduct a single-arm 6-month pilot study testing the feasibility of implementing a tailored, health-related social needs intervention among dialysis patients. the research teamwill recruit 30 dialysis (all modalities) patients aged≥18 years with low socioeconomic status to participate in a chw intervention. the chw intervention will be modeled after impact (individualized management for patient-centered targets), a 6-month chw intervention that addresses "upstream" socioeconomic and behavioral barriers to treatment for individuals with chronic diseases, which has been adapted to numerous populations and shown to improve care and reduce hospitalizations. the chw will identify health-related social needs and help participants navigate community resources to meet needs. all participants will receive the intervention. all participants will also participate in a chw-led support group, that will occur monthly. the research team will compare outcomes during the 6-months before and during the intervention period. this pilot study aims to (1) assess the feasibility of recruiting dialysis patients experiencing health-related social needs to an intervention trial, and (2) assess the feasibility of implementing the intervention within this population, in a fashion deemed acceptable.

Eligibility criteria:
inclusion criteria: * have kidney failure and be receiving dialysis exclusion criteria: * live in a nursing facility or institution * physically or mentally unable or unwilling to participate