Kornimate/medical-research-clean huggingface dataset:
evaluating the safeness of trivalent subunit inactivated influenza vaccines in preventing flu on vietnamese volunteers

Conditions: Seasonal Influenza

Summary: the present study will evaluate the safety in healthy people aged 1- 45 years (male and female) after single intramuscular (im) dose of trivalent subunit inactivated influenza vaccine till the 30-days follow-up period.


Eligibility criteria:
inclusion criteria: 1. healthy people with aged 1 to 45 years; 2. previous history of not being vaccinated by any flu vaccines; 3. women of childbearing potential agree to apply the contraceptive measures during the study period; 4. do not have any acute or chronic diseases by screening; 5. having the abilities of understanding and conforming the study plan; 6. volunteer to the study; 7. agree to vaccinate completely and conform the follow up procedure within 30 days after the first vaccination. exclusion criteria: 1. having the suspected symptoms of infecting flu: cough, sore throat, stuffy or running nose, headache, malaise, myalgia and arthralgia, weakness, chilly or sweat; 2. a prior history of allergy to any components of candidate vaccine; 3. sensitive to eggs or chicken protein, kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (ctab) and polysorbate 80; 4. females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination; 5. being immuno deficiency due to treatment; 6. using immunosuppressive drugs (belong to steroid group) within 06 months before vaccination; 7. being sickness or cancer or hiv (+); 8. participating in other study on drug or vaccination; 9. receipt of other vaccine within 04 weeks before participating in the study; 10. congenital malformation, mental disorder or members of family having the mental disorder; 11. using immune globulin or blood products within 03 months before vaccination; 12. having an acute or chronic diseases that can cause influence on the safety including: hepatic, renal, mental diseases or diabetes and transplantation; 13. body temperature over 37.5 degree celcius within 01 week before vaccination; 14. history of alcohol or drugs addicted within 05 years; 15. planning to travel away from the study site among the visits.

Keywords: seasonal influenza vaccine
super: a joint system in a rehabilitation educational digital platform

Conditions: Autism Spectrum Disorder; Telerehabilitation

Summary: due to its complexity and variability, autism spectrum disorder (asd) requires multidisciplinary and multidimensional interventions. super (in italian: sistema unitario in una piattaforma riabilitativa ed educativa) is an italian digital platform, implemented to facilitate collaboration between families, health services, and schools and to promote personalized intervention for children with asd. the research protocol, aimed to test super's feasibility and usability, foresees the enrollment of 12 asd children in the experimental group (eg) and 12 asd children for the control group. all families, teachers, and clinicians will perform usual rehabilitative and educative interventions, but the eg will use super, in addition to ordinary programs. the feasibility and acceptability of super will be assessed through usability scales and questionnaires realized ad hoc for the purpose. at baseline and established endpoints, asd patients will be evaluated with different assessment tools.


Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder * access to child neuropsychiatry or pediatric rehabilitation services participating in the study * age of patients from 3 to 7,11 years * informed consent freely acquired before the start of the study by the patient's parents exclusion criteria: * patients with severe genetic degenerative diseases * patients with severe sensory disabilities * patients with severe medical complications
effect of citrus bioflavonoids/vitamin e in conjunction with fish oil supplementation

Conditions: Hyperlipidemia

Summary: the purpose of this 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin e) plus fish oil supplementation in healthy hyperlipidemic subjects


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 and ≤ 72 years old * generally healthy * bmi \> 18 and \< 38 * ldl cholesterol ≥ 130 mg/dl and \< 270 mg/dl * triglycerides ≥ 150 mg/dl and \< 400 mg/dl * ability to understand and the willingness to sign a written informed consent exclusion criteria: * use of nutritional supplements and medical foods for dyslipidemia within 30 days prior to the study * use of omega-3 fatty acid dietary supplements within 30 days prior to the study * use of prescription hmg-coa reductase inhibitors, bile acid sequestrants, fibrates, cholesterol absorption blocking agents, or niacin * use of prescription medications and/or nonprescription medications for acute and semi-acute medical conditions * history of cardiovascular disease, type i diabetes, autoimmune disease, liver or kidney disease, malignancy, and serious mental illness. * known infection with hib, tb, hepatitis b or hepatitis c * history of allergy or intolerance to study products * smoking, use of nicotine-containing products, or use of drugs of abuse 30 days prior to the study * history of regular intake of \> 14 alcoholic drinks per week for females and \> 21 drinks per week for males
compression and co2 laser for leg wounds

Conditions: Wound Healing

Summary: the purpose of this study is to determine the efficacy and safety of compression bandaging with fractional ablative carbon dioxide laser (facl) compared to compression and standard dressings alone for healing of post-operative wounds of the leg. this is a randomized, smart design, clinical trial. approximately 80 participants will be randomized to initially receive compression bandages or standard wound dressings after surgery on the lower leg. after 4 weeks, the group assigned to compression bandages will be further randomized to either continue with the compression bandages only or continue with the compression bandages and also receive (facl). the study is designed as an 6-month study. this study was a pilot study designed to determine feasibility of these procedure. subjects currently living in the chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility criteria:
inclusion criteria:patients will be identified through the clinic where their skin is to be treated by excisional surgery on the lower leg. those considered for enrollment must also meet the following criteria: 1. \>18 years of age 2. wound size of at least 1 cm in width 3. cutaneous excision of the lower leg 4. surgeon elected repair of healing by secondary intention 5. participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study exclusion criteria: 1. current smoker 2. uncontrolled diabetes mellitus 3. uncontrolled hypothyroidism 4. severe renal impairment or hypoalbuminemia 5. chronic lymphedema 6. severe venous insufficiency (large varicose veins, atrophie blanche) 7. arterial insufficiency (abi \< 0.8) 8. rubber or rubber accelerator allergy 9. prior radiation to the surgical site 10. history or evidence of a clinically significant medical or psychiatric disorder, condition or disease that in the opinion of the treating physician would pose a risk or interfere with evaluation or completion of the study 11. subject un willing to sign an irb approved consent form 12. participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
thiol disulfide balance in cervix cancer

Conditions: Cervix Cancer; Oxidative Stress

Summary: the aim of this research is to evaluate thiol-disulfide balance in cervix cancer patients

to date various oxidative stress parameters were studied in patients with cervix cancer, however dynamic thiol disulfide hemostasis has not been previously investigated. the thiol-disulfide balance in the circulation will be measured by the automated system created by erel \& neselioglu (1). references 1- erel o, neselioglu s. a novel and automated assay for thiol/disulphide homeostasis. clin biochem 2014;47:326-32. doi:10.1016/j.clinbiochem.2014.09.026.

Eligibility criteria:
inclusion criteria: • histopathologically confirmed diagnosis of cervix cancer exclusion criteria: * pulmonary disease * pulmonary hypertension * cardiac dysfunction * renal dysfunction * liver disease * chronic ischemia * systemic inflammation * concomitant malignancy * patients who use vitamin a,c or e (antioxidant vitamins) * patients who use smoke * patients who use drink alcohol * patients who use addictive for any drug

Keywords: thiol disulfide hemostasis screening early diagnosis
cross-over study of armodafinil treatment of daytime sleepiness associated with treated nocturia

Conditions: Nocturia; Daytime Sleepiness

Summary: the objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.


Eligibility criteria:
inclusion criteria: 1. receiving standard-of-care therapy for nocturia based on assessment by study physician 2. evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis. 3. mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary 4. epworth sleepiness scale score of at least 10 5. clinical global impression of sleepiness at least moderate 6. age 18-90 years inclusive exclusion criteria: 1. medications affecting urinary or sleep-wake function other than therapy for oab o or np within 5 half-lives of baseline assessment 2. sleep disorders other than nocturia based on history and screening assessment 3. unstable medical or psychiatry conditions 4. medical or psychiatric conditions affecting sleep/wake or urologic function 5. apnea-hypopnea index (ahi) ≥ 15 on screening polysomnogram 6. periodic leg movement arousal index (plmai) ≥ 15 on screening polysomnogram 7. history of substance abuse or dependence in the last year 8. regular consumption of over 800 mg of caffeine use 9. shift-work in the 3 months prior to or during the study

Keywords: nocturia daytime sleepiness
relationship between parameters of vot using nirs and clinical outcomes in pediatric cardiac surgery

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to evaluate the ability of vascular occlusion test (vot) during cardiac surgery to predict postoperative outcomes in pediatric patients.

after induction of anesthesia, pediatric somasensor for invos 5100c is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. vot is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmhg over than systolic blood pressure. after 3 minutes of ischemic time, cuff pressure is rapidly decreased. it is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass. postoperative outcome variables are recorded after surgery : major adverse event, use of inotropic and vasoactive drugs, duration of mechanical ventilation and icu stay. the relationship between the results of vot and postoperative outcome will be investigated.

Eligibility criteria:
inclusion criteria: * pediatric patients aged under 8 years old who are scheduled for cardiac surgery exclusion criteria: * skin disease * skin preparation involving thigh * peripheral vascular disease

Keywords: vascular occlusion test near infrared spectroscopy
single nucleotide polymorphisms (snps) associated with postherpetic neuralgia

Conditions: Postherpetic Neuralgia

Summary: postherpetic neuralgia (phn) is a common condition and affecting 5 to 30% of the herpes zoster patients. in some cases, the pain remained refractory after first and second line treatment for herpes zoster. this suggests that there may be genetic variants that make some patients susceptible to phn. using saliva samples from herpes zoster patients the investigators are going to analyze the relationship between single nucleotide polymorphisms (snps) in genes that are known to be involved in pain and phn.


Eligibility criteria:
inclusion criteria: * age more than 50 years * clinically defined herpes zoster patients exclusion criteria: * patients not able to provide informed consent
pet response during chemoradiation of lung cancer

Conditions: NSCLC

Summary: a prospective observational study to determine the prognostic value of the timing of 50% reduction in metabolic activity (t50) during ccrt for nsclc for treatment outcome (pfs).

this is a single-centre observational study. patients with proven locally advanced nsclc will be treated with concurrent chemoradiotherapy according to the standard clinical protocol of the nki-avl. during treatment, the biological behaviour of the tumour will be monitored with serial quantitative fdg (fluorodeoxyglucose) pet/ct scans. from these images, the time during treatment where a 50% reduction in fdg uptake relative to day 1 is reached (t50) will be derived. the t50 of progression-free surviving patients will be compared with that of relapsed or deceased patients, in order to find a value that predicts early treatment failure. an additional fdg pet/ct scan at the same day as regular follow up ct scan will be made, two months after treatment, to have a baseline after treatment for follow up.

Eligibility criteria:
inclusion criteria: * cytologically or histologically proven nsclc * t2-4 n0-3 m0 disease (stage ii or iii, inoperable) * scheduled for standard concurrent chemoradiation * primary tumour minimal diameter 3 cm * primary tumour suvmax \> 5 on routine diagnostic pre-treatment fdg (fludeoxyglucose) pet/ct * who performance 0-1 * written informed consent according to gcp (good clinical practice) and national regulations exclusion criteria: * age \< 18 years, incapacitated subjects * pregnant or lactating women * diabetes mellitus requiring medication * participation in dose escalation studies * other neoplasms in the last 3 years, with metastases

Keywords: nsclc ccrt fdg pet/ct
essential fatty acid status & immune function in parenteral nutrition patients

Conditions: Intestinal Failure

Summary: the purpose of this study is to determine if patients on long-term olive oil-based parenteral nutrition have an adequate essential fatty acid status and immune status, compared to age- and sex-matched healthy controls.

patients, who suffer from severe chronic intestinal failure and whose nutritional intake cannot be met by oral food intake, have as their final option total parenteral nutrition, which contains all necessary macro- and micronutrients. lipid emulsions are essential for these patients as they are a source of non glucose fuel calories, and they contain (essential) fatty acids which are important as structural component for many cells in the human body. home parenteral nutrition patients are at risk for essential fatty acid deficiency. data are lacking that indicate the optimal amount of essential fatty acids required for these patients. the latter seems especially relevant for patients receiving lipid prescriptions which are low in essential fatty acids, like clinoleic®. long-term parenteral nutrition dependent patients successfully use clinoleic®. it is however unknown whether these patient remain to have an adequate essential fatty acid status in the long run.

Eligibility criteria:
home parenteral nutrition patients: inclusion criteria: * home parenteral nutrition: at least 6 months with a minimum frequency of 5 times a week exclusion criteria: * active immune modulating (underlying) disease * use of immune suppressives * use of oral fish oil substrates * smoking more than 5 cigarettes/day * do not eat more than 5 portions of fatty fish per week healthy controls: inclusion criteria: * age and sex matched healthy volunteer exclusion criteria: * active immune modulating (underlying) disease * use of immune suppressives * use of oral fish oil substrates * smoking more than 5 cigarettes/day * do not eat more than 5 portions of fatty fish per week

Keywords: fatty acid, essential immune system home parenteral nutrition
the effect of basic body awareness therapy on musculoskeletal disorders and psychological symptoms

Conditions: University Students

Summary: during the coronavirus disease (covid-19) pandemic, stay-at-home isolation as a precaution to alleviate the disease has affected the physical and mental well-being of individuals. university students spent time in front of the screen with online education and developed a sedentary lifestyle during the academic term. in this process, musculoskeletal disorders increased more in university students due to the increase in the use of laptop or computer, smartphone, and social media. the covid-19 pandemic has caused psychological disorders as well as physical health problems. general population studies have shown that all forms of depression, anxiety, stress, sleep problems, and psychological distress are highly increased during this period. in a study conducted in turkey, it was reported that students' negative well-being, anxiety, and physical inactivity significantly affected perceived stress during the covid-19 pandemic, and students' mental health was at high risk. it has been stated that providing mental health supportive systems in students and encouraging physical activity regularly can reduce perceived stress levels. on the other hand, psychological interventions via video conferencing platforms have been proposed to promote mental health due to the limited and delayed face-to-face healthcare as a result of the covid-19 pandemic. it has been stated that the use of telemedicine or e-health applications together with body-mind approaches such as yoga, tai chi, qigong may be beneficial in order to encourage physical activity and protect mental health in this critical period. basic body awareness therapy (bbat), which is among the body-mind approaches, is also frequently used in the rehabilitation of patients with psychiatric disorders, pain, and chronic musculoskeletal system problems. therefore, the aim of this study is to evaluate the effect of bbat on musculoskeletal disorders and psychological symptoms in university students who participated in the hybrid (online + face-to-face) education program during the covid-19 pandemic. the importance of this study is that it is the first study on physical and psychological symptoms of bbat in university students.


Eligibility criteria:
inclusion criteria: * being studying at bandirma onyedi eylul university, faculty of health sciences, department of physiotherapy and rehabilitation * volunteering to participate in the study * being between the ages of 18-25 exclusion criteria: * having any diagnosed psychological disorder * regularly doing body-mind approaches such as yoga and tai chi * having any condition involving the musculoskeletal system * having a rheumatic disease

Keywords: basic body awareness therapy covid-19 musculoskeletal pain telerehabilitation mental health
evaluating xihuang pill to improve the efficacy of neoadjuvant chemotherapy for breast cancer

Conditions: Breast Cancer; Chemotherapy Effect

Summary: evaluate the effectiveness of xihuang pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer

1. to evaluate the safety and effectiveness of xihuang pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer under the condition of widespread use. 2. to provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical breast cancer patients.

Eligibility criteria:
inclusion criteria: 1. biopsy of breast mass was performed under ultrasound-guided treatment before neoadjuvant chemotherapy, and the diagnosis of breast cancer was confirmed pathologically, followed by immunohistochemical examination. pathological sections before and after neoadjuvant chemotherapy were jointly diagnosed by 3 or more senior pathologists, and there were consistent definite conclusions. 2. have detailed and complete clinicopathological data; 3. diagnosis data of tcm syndrome type; 4. no biopsy-confirmed lymph node metastasis; 5. no serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgical treatment; 6. at least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy of chemotherapy was evaluated at the end of chemotherapy and after surgery; 7. under the guidance of doctors, take xihuang pills in a standardized way throughout the whole process and review regularly; 8. the patient did not receive any antitumor therapy drugs associated with the tumor prior to neoadjuvant chemotherapy; 9. all patients were newly diagnosed exclusion criteria: 1. concurrent malignant tumors of other sites; 2. patients with distant metastasis 3. male breast cancer 4. patients who did not receive full-course standardized neoadjuvant chemotherapy; 5. lost contact or dropped out of the study, unable to follow up; 6. inability to tolerate chemotherapy responses; 7. intolerant to xihuang wan and unable to take it; 8. the patient has strong side effects of chemotherapy and cannot tolerate chemotherapy drugs; 9. inflammatory breast cancer, bilateral breast cancer, paget's disease and other special types of breast cancer; 10. various other possible influences.
the effectiveness of global postural reeducation on alzheimer disease patients

Conditions: Alzheimer's Type Dementia; Cognitive Decline; Postural; Strain

Summary: this research study is developed on an experimental design with randomized controlled intervention were participated 135 subjects with ad including 45 of the control group. it lasted 6 months with pre-post tests (t0-t1) executed before and after six months of treatment. by having in focus the evaluation of gpr therapy effects on cognitive, proprioceptive, depressive, autonomy, gait and life quality of the above mentioned subjects.

in order to assess the cognitive abilities of the patients a cognitive test was administered which acts through a scale concerning depression and mood evaluation as well as a questionnaire was developed aiming to evaluate the examined subjects' functional abilities: mini mental state examination (mmse), quality of life in alzheimer disease (qol-ad), geriatric depression scale (gds), barthel index (bi), neuropsychiatric inventory (npi), tinetti scale (ts).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of alzheimer's disease * older than 40 years of age * male and female * intellectual disability * cognitive impairment * able to do daily activities on his own * no presence of any other neurological and psychological disease * no presence of brain tumors exclusion criteria: * no presence of alzheimer's disease * under 40 years old * presence of brain tumors * neurological patients * presence of psychiatric disease * depression symptoms * presence of neuromuscular disease * ictus * aggressive patients