Kornimate/medical-research-clean huggingface dataset:
post-authorisation safety study of lesinurad

Conditions: Gout; Hyperuricemia

Summary: non-interventional population-based prospective cohort study in multiple databases comparing patients with gout who initiate lesinurad in combination with an existing xanthine oxidase inhibitor (xoi) (lesinurad+xoi cohort) to a propensity score-matched cohort of similar patients from the same data source who continue treatment with xoi monotherapy (xoi mono cohort). study will characterize the cardiovascular safety of lesinurad in combination with xoi in patients with gout aged 18+ years compared with similar patients who continue xoi monotherapy. primary objective: to assess the relative incidence of major adverse cardiac events plus hospitalization for unstable angina (mace+ events) in patients with gout in both cohorts. secondary objectives: to describe the characteristics of the cohorts prior to matching; to assess the relative incidence of hospitalisation for acute kidney injury between the matched cohorts; to assess the relative incidence of individual mace+ components in the matched cohorts.


Eligibility criteria:
inclusion criteria: * more than one dispensing/prescription for an xanthine oxidase inhibotor (xoi) within the past 183 days prior to the index date and days' supply extending beyond the index date * a coded diagnosis of gout at any time in the past or on the index date * age 18 years or older * continuous enrolment in the database for the past 183 days exclusion criteria: * patients on urate-lowering therapy medications within 6 months prior to the index date to manage gout (probenecid, benzbromarone, or pegloticase) other than an xoi (allopurinol, febuxostat) or lesinurad (not including medications to treat gout flares). * patients with severe renal impairment defined using clinical diagnostic codes (i.e., a diagnosis code of ckd stage iv, end-stage renal disease, or an indicator that ecrcl is \< 30 ml/min at any time prior to the index date).
clinical value of g-eye colonoscopy in daily practice for adenoma detection and time for polyp removal

Conditions: Adenoma; Colo-rectal Cancer

Summary: colonoscopy parameters will be compared before the introduction of the g-eye endoscope and after the introduction of the g-eye endoscope

colonoscopy parameters such as demographics, findings and procedural times will be compared before the introduction of the g-eye endoscope and after the introduction of the g-eye endoscope

Eligibility criteria:
inclusion criteria: - indication for screening or surveillance colonoscopy based on the german guideline for colon cancer screening exclusion criteria: * emergency procedure * patients with known inflammatory bowel diseases * patients with hereditary cancer syndromes * patients with acute colonic inflammation (e.g. diverticulitis, ischemic colitis) * patients after radiation of the abdomen or pelvis * patients with colonic surgery (except appendectomy) * patients with incomplete colonoscopy * patients with insufficient bowel preparation

Keywords: adenoma colorectal cancer
rare variation and remote gene regulation of osteoporosis related phenotypes in han chinesse

Conditions: Senile Osteoporosis With Current Pathological Fracture Lower Leg (Diagnosis)

Summary: bone density is recognized as the most important factor to measure osteoporosis, and the prevalence of osteoporosis increases with age. risk factors for osteoporosis include age, weight, exercise, diet, smoking and alcohol consumption. what's more, osteoporosis has a strong familial aggregation, and the genetic value of bone density is between 0.6 and 0.85. therefore, it is necessary to conduct large-scale collection of population samples of osteoporosis fractures and relevant genetic studies.

from past linkage analysis and candidate gene association studies to genome-wide association studies and second-generation sequencing technologies, researchers have found hundreds of genes and snps associated with bone mineral density and osteoporosis fractures. however, current studies on osteoporosis and related phenotypes are mainly concentrated in the european and american populations, rare in asia and other regions, and even less in the chinese han population. it is one of the problems to be solved in this project whether the genes and snp loci associated with these strengths can also be applied to han chinese population due to the existence of racial differences. this project aims to collect the patients with primary osteoporosis and osteoporosis fracture in the chinese han population through the orthopaedics department, and verify the identified osteoporosis susceptibility genes in the chinese han population.

Eligibility criteria:
inclusion criteria: 1. from july 2018 to july 2021, patients admitted to the outpatient or inpatient clinic were diagnosed as primary osteoporosis fracture; 2. aged between 50 and 100; 3. this fracture was not treated with any anti-osteoporosis drugs before 4. subjects will participate in the study voluntarily and have signed the informed consent 5. patients with clear mind and independent behavioral ability exclusion criteria: 1. patients with malignant tumors are associated with bone metastases, such as lung cancer, prostate cancer, thyroid cancer, etc 2. hyperparathyroidism, cushing syndrome, hypogonadism, hyperthyroidism, pituitary prolactinoma, diabetes 3. systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, dermatomyositis, mixed connective tissue disease, etc.; 4. renal osteodystrophy caused by various chronic kidney diseases; 5. gastrointestinal diseases and nutritional diseases: malabsorption syndrome, subtotal gastrectomy, chronic pancreatic diseases, chronic liver diseases, protein-calorie malnutrition, long-term intravenous nutrition support treatment, etc.; 6. leukemia, lymphoma, multiple myeloma, hyperthermia and myelodysplastic syndrome; 7. hemiplegia, paraplegia, motor dysfunction, muscular dystrophy, catalepsy and myotonic syndrome caused by various reasons; 8. glucocorticoids, immunosuppressants, heparin, anticonvulsants, anticancer drugs, aluminum-containing antacids, thyroid hormones, gnrh-a or dialysate, etc. 9. unwilling to accept dietary management or unable to sign the informed consent
overall diet quality and breast cancer risk

Conditions: Invasive Breast Cancer; Incident Breast Cancer

Summary: the purpose of this study was to examine the relationship between indices of overall diet quality and incident breast cancer risk in a large prospective cohort of women.

this study examined the role of overall diet quality on the risk of developing invasive breast cancer among 96,959 women in the california teachers study, in which 4,826 women were diagnosed with breast cancer during follow-up (1995-2011). participants' dietary habits were recorded at baseline (1995) using a 103-item block95 food frequency questionnaire to allow for the assessment of overall diet quality. specifically, diet quality was characterized by the alternate mediterranean diet (amed), alternative healthy eating index-2010 (ahei-2010), dietary approaches to stop hypertension (dash), and paleolithic index scores. associations between diet quality and the risk of developing breast cancer were examined using multivariate cox proportional hazard regression models to provide hazard ratios and corresponding 95% confidence intervals.

Eligibility criteria:
inclusion criteria: * participants with no history of cancer diagnosis prior to baseline. * participants with no history of myocardial infarction prior to baseline. * participants with no history of stroke prior to baseline. * participants with no history of diabetes prior to baseline. * participants who are not missing excessive dietary data. * participants with energy intake values at ≥1% and ≤99% of the population distribution.
double filtration plasmapheresis combined with chemotherapy

Conditions: Multiple Myeloma

Summary: evaluation of double filtration plasmapheresis combined with chemotherapy for the treatment of abnormalities of m protein or renal function due to the multiple myeloma.


Eligibility criteria:
inclusion criteria: * multiple myeloma patients who are diagnosed by bone marrow morphology and immunology * patients with stable condition after conventional treatment * patients with renal insufficiency or abnormal m protein * patients over 18 years of age * liver function: blood bilirubin ≤ 35μmol/l, enzymes aspartate transaminase (ast)/aka alanine aminotransferase (alt) is less than 2 times the upper limit of normal * normal heart function * physical condition score 0-2 level (ecog score) * obtain an informed consent form signed by the patient or family member exclusion criteria: * allergies or obvious contraindications to any of the drugs involved in the plan * severe heart disease, including myocardial infarction and cardiac insufficiency. * suffering from other organ malignancies * active tuberculosis patients and hiv-positive patients * at the same time suffering from other blood system diseases * pregnant or lactating women * able to understand or follow the research plan * past history of intolerance or allergy to similar drugs * patients under 18 years of age * participating in other clinical researchers at the same time * there are any other circumstances that hinder the progress of the research
correlation of dry eye disease, problematic smartphone use and sleep quality in adolescents and young adults

Conditions: Dry Eye Disease (DED)

Summary: the goal of this observational study is to learn about the status quo and relationship of dry eye, problematic smartphone use, bedtime procrastination, and sleep in adolescents and young adults. the main questions it aims to answer are: * is there a positive correlation between problematic smartphone use and dry eye? * is problematic smartphone use positively correlated with bedtime procrastination? * is bedtime procrastination negatively correlated with sleep quality? * is there a negative correlation between sleep quality and dry eye? * is there a negative correlation between problematic smartphone use and sleep quality? * is there a positive correlation between bedtime procrastination and dry eye? * do bedtime procrastination and sleep quality serve as mediating factors in the relationship of problematic smartphone use and dry eye? participants will be asked to complete several questionnaires and dry eye related examinations.


Eligibility criteria:
inclusion criteria: * adolescents and young adults aged 14 to 35 (including 14,25 years old) ; * agree to participate in the studies exclusion criteria: * unable to communicate normally; * with ocular surface diseases other than dry eye and autoimmune diseases; * use drugs that may cause damage to the ocular surface, such as anti glaucoma drugs, antidepressants, sex hormones, chemotherapy drugs, etc.; * with a history of eye trauma or eye surgery; * with a history of wearing contact lenses within the past month; * pregnant and lactating women

Keywords: dry eye disease problematic smartphone use sleep quality bedtime procrastination adolescents and young adults
effectiveness of ultrasound-guided nerve stimulation for patients with post-surgical shoulder pain

Conditions: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation

Summary: the aim of this clinical trial was to demonstrate the effectiveness of the application of ultrasound-guided percutaneous nerve stimulation (us-pens) directed at the axillary nerve and the suprascapular nerve, in patients with post-surgical shoulder pain. this is a randomized, longitudinal, prospective and quasi-experimental clinical trial in which a total of 70 patients divided into two groups; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and a us-pens session was added (n=35). the intervention and follow-up period of the participants took place over 12 weeks.

the objective of this clinical trial is to evaluate the effects of including ultrasound-guided percutaneous nerve stimulation (us-pens) on the suprascapular nerve and axillary nerve, along with a manual physical therapy protocol in patients with pain and lack of function after a shoulder surgery. methods: 70 patients with shoulder pain undergoing arthroscopic surgery were recruited. they were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of us-pens were added (n=35). a series of variables were evaluated: pain, disability and functional impotence with the help of the nspr, spadi and dash scales. in turn, goniometry, dynamometry and calculation of the pressure pain threshold were performed. the intervention and follow-up period of the participants lasted 12 weeks.

Eligibility criteria:
inclusion criteria: * patients undergoing surgery using arthroscopic techniques for rotator cuff repair, shoulder instability injuries or arthrolysis; * be between the 4th and 6th week after surgery; * presence of pain and restriction in shoulder joint mobility in at least one of the movements analyzed after surgery; * patients without previous surgery on the shoulder girdle. exclusion criteria: having undergone previous physiotherapy treatment for the same reason; * having undergone previous physiotherapy treatment for the same reason; * belonephobia and/or electrophobia; * pharmacological treatment with antiplatelet agents; * patients infiltrated with corticosteroids and/or anesthetics after surgery.

Keywords: pens ultrasound axilar nerve supraescapular nerve shoulder postsurgery pain
22g-procore vs 22g-standard needle in diagnosis of lymphadenopathy by ebus-tbna

Conditions: Lymph Node Disease

Summary: the aim of this study is to compare the performance of 22g-procore and 22g-standard needle in diagnosis of mediastinal and hilar lymphadenopathy via ebus-tbna with the purpose to explore the optimal technique for obtaining diagnostic material.

ebus-tbna is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. the investigators will explore the performance of two kinds of needles and different methods to obtain tissues via ebus-tbna in the study. the study is designed as a prospective, single-center, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22g-procore group and the 22g-standard group. the primary aim is to compare the diagnostic yields of the two types of needles. the secondary endpoint is to assess the quality of histologic specimen. meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.

Eligibility criteria:
inclusion criteria: 1. imaging examination indicates enlarged intrathoracic lymph nodes need pathological diagnosis (any lymph node has a short diameter \> 1 cm in ct or pet-ct suv value \> 2.5). 2. accessible mediastinal and hilar lymphadenopathy to ebus-tbna. 3. inform consent signed. exclusion criteria: 1. contraindications of ebus-tbna. such as use of anticoagulant therapy or presence of a coagulopathy (platelet count \ 1.5). 2. severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy. 3. life expectancy less than 6 months. 4. uncooperative patients. 5. patients representing vulnerable populations (prisoners, pregnant women, etc). 6. researchers consider it inappropriate to participate in this study.

Keywords: procore mediastinal and hilar lymphadenopathy ebus-tbna diagnostic yield quality of specimen
transmembrane electromyography (tm-emg) for the assessment of neuromuscular function in the oropharynx

Conditions: Obstructive Sleep Apnea; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Healthy

Summary: this is a pilot study to examine the diagnostic utility of a novel transmembrane surface sensor, and compare signals obtained with the transmembrane sensor to conventional needle emg signals from healthy volunteers to those with documented neurologic pharyngeal muscle dysfunction (als and muscular dystrophy) and to those with severe osa.

transmembrane electromyography (tm-emg) may be a feasible and valid non-invasive emg technique for detecting neuromuscular (nm) impairment. this study will assess whether, in healthy volunteers and participants with known obstructive sleep apnea (osa) and other nm diseases involving the oropharynx, the same characteristic motor unit potentials obtained on conventional needle emg (nemg) can be obtained using a tm-emg sensor. the purpose of this study is to demonstrate whether the tm-emg sensor can provide the same diagnostic accuracy as the concentric needle electrode for the diagnosis of nm diseases. having demonstrated diagnostic similarity of tm-emg to nemg, the secondary aim of this study is to confirm that nm disturbance of oropharyngeal striated muscles in participants with osa can be elicited with the tm-emg sensor.

Eligibility criteria:
inclusion criteria: * age: 18-70 * must be able to pause use of anticoagulation, nsaid and multi-vitamins for appropriate period prior to study test. * must be willing to stop any type of smoking or vaping 10 days prior to testing a cohort of participants with documented neurological disorders involving upper airway striated muscles including als and muscular dystrophy with the presence of bulbar symptoms. a cohort of participants diagnosed with moderate to severe osa proven by an in-lab psg, including the following criteria: * ahi \> 25 * nadir sao2 \< 85% * not currently using cpap a cohort of healthy participants that meet the following criteria: * normal craniofacial anatomy * bmi \< 30 exclusion criteria: * allergy to topical anesthetic * 4 or more alcoholic drinks on the same occasion on 5 or more days in the past month * prior cancer, or radiation to the head or neck * craniofacial anatomical disorders * presence of any underlying medical, surgical or psychiatric disorder that would preclude participation as determined by the principal investigator
the bladder instillation comparison study

Conditions: Urinary Bladder Neoplasms

Summary: to compare the efficacy of mitomycin c vs. gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.

this study will compare standard of care treatment for patients with non-muscle invasive bladder cancer (nmibc). patients will be randomized to one of three arms, mitomycin c, gemcitabine or no additional treatment immediately following turbt in the operating suite. all treatment, surgical procedures and follow up care will be conducted according to standard of care treatment.

Eligibility criteria:
inclusion criteria: 1. sign an informed consent for the study 2. be scheduled for a turbt for suspected non-muscle invasive bladder tumor. exclusion criteria: 1. patients unable to consent for themselves 2. individuals under 18 years old 3. pregnant women 4. prisoners 5. patients with known allergy or intolerance to the mitomycin c or gemcitabine 6. any other sound medical, psychiatric and/or social reason as determined by the investigator.

Keywords: bladder tumors urinary tumors non-muscle invasive bladder tumors nmibc
effect of nutritional support and early rehabilitation on sepsis

Conditions: Life Quality; Hospital Mortality

Summary: sepsis is a syndrome of life-threatening organ dysfunction caused by a dysregulated host response to infection.acute catabolic response in critically ill patients struck by sepsis, manifested by massive protein breakdown in a short time.this pathology frequently leads to prolonged hospitalization and mechanical ventilation, increased mortality, and reduced quality of survival.it is uncertainty whether sepsis patients in icu can benefit from high protein intake combined with early exercise. even though the combination has been shown to be beneficial in other populations.in the present study, the investigator will evaluate the effects of a combination of high protein targets combined with early rehabilitation in sepsis patients in icu.

existing research results confirm that high target protein support can reduce the mortality of sepsis patients. early bedside rehabilitation has a good effect on cognitive function after icu. this study combined high-protein nutritional support with bedside rehabilitation to improve the quality of life in patients with sepsis after icu.

Eligibility criteria:
inclusion standard 1. patients with sepsis 2. patients aged 18-70 years 3. time of admission ≤48 h 4. non-terminal condition exclusion standard 1. severe acute kidney injury 2. severe chronic liver disease (meld score ≥20) or acute hepatic failure 3. protein allergy 4. pregnancy and lactation 5. bmi≥30 kg/m²
evidence of myogenic growth factors in 3d dynamic inguinal hernia scaffold proflor

Conditions: Inguinal Hernia

Summary: the study utilizes the same tissue specimens gathered for previous investigations and removed from 15 patients already operated for inguinal hernia, who for different reasons needed additional surgery in the previously operated groin.

among the individual of investigated the cohort, seven patients underwent groin revision for subsequent hydrocele, 4 for recurrence, and 4 for overlooked ipsilateral multiple hernia protrusions. made from low weight, large porous polypropylene, proflor is composed of a multilamellar cylindrical 3d core, 15 mm thick, with 2 different longitudinal dimensions, 25 or 40 mm. the center of the implant core is connected on one surface to a flat mesh of different width depending on the dimension of the 3d core. this flat part of the device is intended to be deployed to counterface the peritoneal sheath. the 3d core of proflor ® is arranged to be compressible on both planes, longitudinal and transversal. due to its proprietary centrifugal expansion, it can be positioned, fixation free, into the hernia defect for permanent obliteration. proflor owns an inherent dynamic responsivity as it contracts and relaxes in accord to the movements of the inguinal floor in which is positioned. the biopsies were excised from the anterior aspect of the 3d device. it should be noted that once deployed the anterior surface of proflor merely faces the external oblique fascia and has no contact with other structures of the groin. therefore, corruption by host native tissue can be excluded. the biopsies were carried out in ten patients, three in the short term postop. between 3 and 5 weeks, five in the mid-term between 3 and 4 months postop., four in the long-term between 6 and 8 months postop. and the latter three in the extra-long term postop., more than three years after implantation.

Eligibility criteria:
inclusion criteria: * patients already operated for inguinal hernia with proflor, who for different reasons needed additional surgery in the previously operated groin * asa score \>4 exclusion criteria: * patients who do not underwent inguinal hernia repair with proflor