Kornimate/medical-research-clean huggingface dataset:
a pragmatic randomized trial to evaluate the effectiveness of high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in older adults

Conditions: Influenza

Summary: the purpose of this pragmatic randomized trial is to evaluate the relative vaccine effectiveness of high-dose quadrivalent influenza vaccine (qiv-hd) vs. standard-dose quadrivalent influenza vaccine (qiv-sd) in older adults. participants will be randomized 1:1 to either qiv-hd or qiv-sd.

the study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial. the danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. the study aims to randomize 339,700 participants over 3 influenza seasons. in each season, participants will be individually randomized 1:1 to receive either qiv-hd or qiv-sd. during the 2023/2024 and 2024/2025 seasons, up to 12,000 participants will be enrolled in a sub-cohort where participants are asked to perform home self-swabs and answer symptom questionnaires in case of influenza-like illness to enable further assessment of the impact of qiv-hd vs. qiv-sd on patient-reported outcomes among individuals with influenza-like illness and laboratory-confirmed influenza.

Eligibility criteria:
inclusion criteria: * age 65 years and above (this inclusion criterion will be modified according to the danish government's official recommendations for the 2022/2023 and 2023/2024 influenza seasons) * informed consent form has been signed and dated exclusion criteria: * there are no specific exclusion criteria for this study

Keywords: influenza vaccination pragmatic registry pneumonia respiratory cardiovascular
use of contrast enhanced spectral mammography (cesm) for women with palpable breast abnormalities

Conditions: Breast Abnormalities

Summary: contrast enhanced spectral mammography (cesm) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. this dye is the same dye that is used for ct scans. this type of mammogram includes a regular mammogram as well as additional pictures with the dye. this particular study is being done to determine if by adding the dye in the veins the investigators are better able to identify the cause of the lump than if they just did the regular mammogram alone.


Eligibility criteria:
inclusion criteria: * women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician exclusion criteria: * age \< 25 years old * male patients * pregnant or lactating patients * patients with allergy to iodinated contrast * patients with a history of renal disease or patients over 70 with a creatinine \> 1.3. creatinine must have been done within the last 12 weeks.

Keywords: mammography contrast enhanced spectral mammography palpable breast abnormalities 15-053
a gene transfer therapy study to evaluate the safety of and expression from delandistrogene moxeparvovec (srp-9001) in participants with duchenne muscular dystrophy (dmd)

Conditions: Muscular Dystrophy, Duchenne

Summary: this is an open-label gene transfer therapy study evaluating the safety of and expression from delandistrogene moxeparvovec in participants with dmd. the maximum participant duration for this study is 156 weeks.


Eligibility criteria:
inclusion criteria: * for cohorts 1-7: has a definitive diagnosis of dmd based on documented clinical findings and prior genetic testing. * cohort 1: is ambulatory, and ≥4 to \<8 years of age at the time of screening. * cohort 2: is ambulatory, and ≥8 to \<18 years of age at the time of screening. * cohort 3: non-ambulatory per protocol specified criteria at the time of screening. * cohort 4: is ambulatory and ≥3 to \<4 years of age at the time of screening. * cohort 5a: is ambulatory and ≥4 to \<9 years of age. * cohort 5b: non-ambulatory per protocol specified criteria at the time of screening. * cohort 6: is ambulatory, and ≥2 to \<3 years of age at the time of screening. * cohort 7: non-ambulatory per protocol-specified criteria at the time of screening. * ability to cooperate with motor assessment testing. * cohorts 1, 2, 3, 5, and 7 only: stable dose equivalent of oral glucocorticoids for at least 12 weeks before screening and the dose is expected to remain constant (except for modifications to accommodate changes in weight) throughout the first year of the study. * cohorts 4 and 6: do not yet require use of chronic steroids for treatment of their dmd, in the opinion of the investigator, and are not receiving steroids at the time of screening. * raavrh74 antibody titers are not elevated as per protocol-specified requirements. * genetic mutation inclusion criteria vary by cohort. exclusion criteria: * has a concomitant illness, autoimmune disease, chronic drug treatment, and/or cognitive delay/impairment that in the opinion of the investigator creates unnecessary risks for gene transfer. * exposure to gene therapy, investigational medication, or any treatment designed to increase dystrophin expression within protocol-specified time limits. * abnormality in protocol-specified diagnostic evaluations or laboratory tests. other inclusion/exclusion criteria apply.

Keywords: duchenne muscular dystrophy gene-delivery dmd ambulatory non-ambulatory pediatric dystrophin
breaks from sedentary behavior with dual tasks in elderly

Conditions: Aging

Summary: the aim of this project will be to compare the acute effects of breaks from sedentary behavior using dual-tasking on cerebral blood flow, vascular function, cognitive functions and blood pressure in elderly people. participants will perform, in random order, three experimental sessions (control, break with dual-task and standard break (\[walk\]). all sessions will have a period of 4 hours in sedentary behavior. in the standard break session and in the break session with dual-task participants will take walking and dual-task breaks every 30 minutes, and in the control session they will remain seated without breaks. before and after this period, cerebral blood flow, vascular function, cognitive functions and blood pressure will be assessed.


Eligibility criteria:
inclusion criteria: * aged 60 years or over * be physically independent based on the katz test * have no history of heart attack * not having suffered a stroke * not have heart failure * do not have joint problems that prevent them from carrying out experimental sessions * do not have a history of neurodegenerative diseases * obtain ≥ 26 points in the montreal cognitive assessment (moca) * are not involved in the practice of regular, systematic physical activity more than once a week over the last six months prior to the start of the study * not be smokers and morbidly obese.

Keywords: sedentary behavior physical activity cognitive function vascular function
acute health effects of ozone exposure

Conditions: Pulmonary Function

Summary: this is a randomized controlled human exposure crossover study. investigators aim to investigate the acute health effects of ozone exposure in healthy young adults.

the investigators will conduct a randomized controlled human exposure crossover study among 32 healthy young adults in shanghai, china. each subject will be exposed twice: once to clean air and once to 200 ppb ozone in a chamber for 2 hours. during the 2-hour exposure, each subject will be requested to alternate 20 minutes of rest and 10 minutes of exercise on a treadmill. the exercise workload will be adjusted to achieve the targeted ventilation of 25 \~ 27 l/min(approximately equal to 15 \~ 18l/min/m2 body surface area). ozone will be generated by a silent electric discharge method (htu-500, azco industries ltd., canada) and introduced into the chamber. the temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively. health examinations will be conducted immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning. health examinations include symptom questionnaire, skin tests, spirometry, and holter monitoring. we plan to collect blood, buccal, urine, nasal secretion, saliva, exhaled breath condensate, sebum, and d-squame samples.

Eligibility criteria:
inclusion criteria: * living in shanghai during study period; * ability to complete the exercise to achieve the ventilation of 15 to 18 l/min/m2 body surface area; * body mass index \>18.5 and ≤30.0 (30 is the lower limit for class 2 obesity for chinese). exclusion criteria: * smoking and alcohol abuse; * current drug and dietary supplements intake; * subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy; * subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension; * subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease; * subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease; * subjects who have a history of major surgery; * abnormal spirometry (fev1 and fvc ≤ 75% of predicted and fev1/fvc ≤ 0.65); * abnormal baseline 12-lead resting electrocardiogram; * abnormal blood index, such as cell counting, blood lipids, and glutamic-pyruvic transaminase (gpt).
high flow nasal oxygen therapy undergoing colonoscopy

Conditions: Apnea; Hypoxia

Summary: investigation of the clinical efficacy of high flow nasal oxygen in patients over 60 years of age undergoing colonoscopy

70 patients who underwent colonoscopy under elective conditions will be included in the study. routine monitoring will be applied to the patients in the outpatient room in accordance with the standard protocol and the findings in the preoperative period will be recorded. the dose and frequency of anesthesia applied in the routine will not be interfered with and the recorded data will be collected by an observer other than the practitioner. randomization between groups will be achieved by taking the patients on the surgical procedure list sequentially. for both groups, after positioning the patients and placing the cannulas, preoxygenation will be performed for 5 minutes before induction of anesthesia. oxygenation will be carried out at 35°c and 50 lt/min flow rate from the high flow nasal cannula device, with inspired oxygen fraction equivalent to 40% in both groups, 5 lt/min in group n, and inspired oxygen fraction equivalent to 40% in group h, and immediately anesthesia induction will then be applied.oxygen saturation and other hemodynamic data of the patients in the room air before preoxygenation,oxygen saturation and hemodynamic data before induction after preoxygenation, oxygen saturation and hemodynamic data every minute during the procedure,oxygen saturation and hemodynamic data at the end of the procedure will be recorded. interventions for respiratory safety, such as chin thrust, painful stimulus, inspired oxygen fraction increase, airway placement and mask ventilation, in case of apnea (stopping breathing for 10 seconds or more) or oxygen saturation ≤92% that may occur after induction until the end of the procedure , drug applications and other undesirable events will be recorded. as a result of the study, high flow nasal cannula and low flow nasal cannula, which is the standard conventional method, will be compared in terms of desaturation and hypoxemia in my colonoscopy procedures performed under sedation.

Eligibility criteria:
inclusion criteria: * colonoscopy under elective conditions * patients aged 60 and over * having an american society of anesthesiology score of 1, 2, 3 * approved and signed the informed consent form exclusion criteria: * patients younger than 60 years * patients with an american society of anesthesiology score of 4 and above * emergency cases * patients who did not accept informed consent * history of drug allergy and opioid tolerance * coagulation disorder * those who refused to participate in the study

Keywords: high flow nasal oxygen nasal cannula colonoscopy
ventilation strategies, anesthetic techniques and cerebral oxygenation in the beach chair position

Conditions: Stroke

Summary: the seated or "beach chair" position during surgery and general anesthesia decreases brain oxygen levels and can result in stroke. as such, poor neurological outcome following beach chair positioning is a growing concern. in the proposed study the investigators test the hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral oxygenation in anesthetized patients in the beach chair position.

this is a prospective cohort study with randomized nested design. patients presenting for shoulder surgery will be randomized to receive desflurane or total intravenous anesthesia with propofol. regional cerebral oxygenation will be measured using the invos 5100c monitor (covidien, boulder, co). depth of anesthesia will be maintained within a bispectral index range of 40-60. following positioning, inspired oxygen fraction and minute ventilation will be sequentially adjusted. at each set point, regional cerebral oxygenation will be recorded and venous blood gas analysis performed. statistical analysis will be repeated measures analysis of variance in which ventilation strategy is the within-subjects factor and anesthetic technique is the between-subjects factor; post hoc tukey's correction will be used for multiple comparisons. if simple maneuvers of ventilation and anesthetic technique can prevent low brain oxygen levels, patient outcome may be improved.

Eligibility criteria:
inclusion criteria: * scheduled for elective arthroscopic shoulder surgery in the beach chair position under general anesthesia with supplemental interscalene block exclusion criteria: * refusal to give consent * ineligible for interscalene block * history of cardiovascular disease * history of cerebrovascular disease * hypertension * respiratory failure * non-english speaker

Keywords: cerebral oxygenation beach chair position general anesthetic technique inspired oxygen fraction end tidal carbon dioxide
effects of grapefruit or grapefruit juice on anthropometry, dietary intakes, appetite, and metabolic profile in overweight and obese young and middle-aged adults

Conditions: Obesity

Summary: this trial examines the effects of grapefruit or grapefruit juice on anthropometry, dietary intakes, appetite, and metabolic profile in overweight and obese young and middle-aged adults.


Eligibility criteria:
inclusion criteria: * bmi 30-39.9 exclusion criteria: * pregnant or lactating * on medications that are interfered with by consuming grapefruit juice

Keywords: obesity diet weight loss metabolic syndrome
home and school visits intervention for children with dm type 1

Conditions: Diabetes Type 1

Summary: home and school visits by multidisciplinary team will improve metabolic control in kids having insulin dependent diabetes mellitus


Eligibility criteria:
inclusion criteria: * hba1c ≥ 8% at baseline, and diabetes duration of at least 7 months. exclusion criteria: * patients during honeymoon period * patients and their parents who do not speak hebrew or arabic * patients who were not under any educational system * patients who had other severe chronic disorders
lower uterine segment following a cesarean section with barbed suture

Conditions: Cesarean Wound; Dehiscence; Cesarean Section Complications

Summary: this aim of this study is to investigate the lus in the pregnancy following a previous cesarean section with the use of barbed or conventional smooth suture.

to better assess the risk of uterine rupture, some authors have proposed sonographic measurement of lower uterine segment (lus) thickness near term, assuming that there is an inverse correlation between lus thickness and the risk of uterine scar defect. recently, barbed suture has been employed for closing uterine wall after cesarean section, demonstrating the reduction of closure time of the uterine incision and estimated blood loss. until now, the impact of barbed suture in future pregnancies has not been investigated.

Eligibility criteria:
inclusion criteria: * pregnant women * being undergone a previous elective cesarean section at term of pregnancy (more than 37 weeks of gestation), in which barbed or conventional smooth suture was used for closing anterior uterine wall exclusion criteria: * having done more than one cesarean section * having done a previous urgent cesarean section * having done previous uterine surgical procedures with exception than one cesarean section

Keywords: barbed suture uterine lower segment cesarean section
non-inferiority clinic of kollagenase® compared iruxol® in treatment of cutaneous ulcers

Conditions: Ulcers

Summary: skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. chronic skin ulcer is any injury that heal in a period not less than 6 weeks. several etiological causes for the emergence of skin ulcers. around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes. clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.


Eligibility criteria:
inclusion criteria: * patients of both sexes aged over 18 years * people with skin ulcers of the lower limbs for at least 3 months exclusion criteria: * lesion with a diameter larger than 12 cm ² * injury over 2 years of evolution; injury infected * neoplastic lesions in activity * poorly controlled diabetes mellitus * has poorly controlled * signs of ischemia in the limb * not offset any disease * allergic to components of formula * urticaria * pregnancy * breastfeeding * emotional disturbance

Keywords: non-inferiority based on efficiency
multicentre prospective cohort study of patients with chronic alcoholic and/or metabolic liver disease

Conditions: Liver Diseases, Alcoholic; Metabolic Diseases

Summary: chronic alcoholic and metabolic liver diseases are the two main liver diseases in france. the long-term prognosis of these two diseases are not well known because main studies are retrospective and with only alcoholic patients. the knowledge of the natural history of these diseases should improve the management of patients with such diseases. the aim of this prospective cohort is to describe the natural history of patients with chronic liver disease due to alcohol or metabolic disease and to identify factors associated with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites. ..).

in 2010, the two most frequent chronic liver diseases are alcoholic and metabolic disease. the natural history of these two diseases is not well known. indeed, most of the studies were retrospective and evaluated alcoholic disease or metabolic disease but never both diseases. however, these two diseases have the same histological lesions and can be associated. the knowledge of the natural history of these diseases could improve the management of patients in order to decrease complications and improve survival. the aim of this prospective study is to describe the natural history of chronic liver disease due to alcohol and/or metabolic syndrome and to identify factors associated with complications (ascites, encephalopathy, death, complications of obesity, diabetes or chronic alcohol abuse). all patients will be followed every 6 months for 3 years with clinical, biological and morphological parameters.

Eligibility criteria:
inclusion criteria: * age over 18 years * chronic liver disease (liver biopsy with bridging fibrosis or cirrhosis) or non-invasive markers of fibrosis (fibrotest \> 0.58, fibroscan \> 7.9 kpa) * no decompensated cirrhosis * chronic alcohol use and/or metabolic syndrome (at least 3 criteria of metabolic syndrome) * written informed consent * patient covered by the french health insurance system exclusion criteria: * short term life threatening disease * other cirrhosis causes * impossibility of regular follow-up * under guardianship major patient * presence of focal hurt suggestive of chc * pregnant women * cirrhosis complication * child-pugh score superior or equal to 7

Keywords: liver diseases alcoholic metabolic diseases cohort liver disease
safety and efficacy of radiotherapy plus sintilimab for hcc with portal vein tumor thrombosis

Conditions: Hepatocellular Carcinoma; Portal Vein Tumor Thrombosis

Summary: the proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for hcc with pvtt.

the patients were divided into two groups. the first group: the single dose of radiotherapy was 200 cgy, once a day, the total dose was 5000 cgy. the second group: the single dose of radiotherapy was 300 cgy, once a day, and the total dose was 3000 cgy.

Eligibility criteria:
inclusion criteria: 1. ability to understand and willingness to sign a written informed consent document. 2. locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches) 3. has at least 1 measurable lesion 4. age ≥18 years 5. eastern cooperative oncology group (ecog) performance status 0 or 1 6. adequate organ function 7. child pugh class a 8. life expectancy ≥12 weeks. 9. antiviral therapy per local standard of care for hepatitis b 10. woman of child bearing potential must have a negative pregnancy test 11. must use acceptable form of birth control while on study exclusion criteria: 1. has previously been performed by raditotherapy for the area to be treated. 2. with extrahepatic metastasis 3. history of hepatic encephalopathy or liver transplantation 4. untreated hepatitis infection: hbv dna\>2000iu/mlor10000 copy/ml, hcv rna\> 1000copy/ml, both hbsag and anti-hcv body are positive 5. has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes 6. has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment 7. with serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable 8. evidence of active pulmonary tuberculosis (tb) 9. positive test of immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids) 10. history of allergic reactions to related drugs