Kornimate/medical-research-clean huggingface dataset:
the impact and coping strategy of covid-19 among taiwan society and medical and nursing institutes

Conditions: The Psychological Impact of COVID-19

Summary: the coronavirus disease 2019 (covid-19) had its outbreak in late 2019 in china and is considered a biological disaster. with medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term psychological and mental disabilities or danger factors that they might have faced. as such, the investigators can design and establish a set of evaluative indicators of the risks of biological disasters, and strategies to manage guide and cope, and internal/ external testing strategies. these work in guaranteeing quality and performance, and as such, establishing "digital platform for integrated research of coronavirus disease 2019 (covid-19)".


Eligibility criteria:
inclusion criteria: * 1.\>20 years old. 2. medical staff and patients from different tiers hospitals in taiwan. 3.community residents in taiwan exclusion criteria: * 1.\< 20 years old. 2. these cases who had disabilities can't complete our assessments.
safety and tolerability, pharmacokinetic and pharmacodynamic study with inzomelid

Conditions: Healthy

Summary: this is a first in human (fih), single-centre, double blind, randomised, cross-over, sad followed by a mad study of inzomelid. the study is designed to evaluate the safety, tolerability, pk, pd, and food effect of inzomelid in healthy adult participants and to evaluate the safety, tolerability, pk, pd, and preliminary clinical efficacy of inzomelid in adult patients with caps. oversight will be provided by a safety monitoring committee (smc) comprised of the investigator, the sponsor's medical monitor and an independent medical monitor.


Eligibility criteria:
inclusion criteria- healthy volunteers: * healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent); * participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening and/or before administration of the initial dose of study drug; * participants must have a body mass index (bmi) between ≥18.0 and ≤32.0 kg/m2 at screening; inclusion criteria- caps patients: \* patients with a confirmed diagnosis of caps (fcas, nomid, or mws) aged 18 to 70 years (inclusive at the time of informed consent); exclusion criteria- healthy volunteers: * pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; * prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the investigator's (or delegate's) opinion, could adversely affect the safety of the participant; * presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol; exclusion criteria- caps patients: * live vaccinations within 3 months prior to screening, for the duration of the study and for up to 3 months following the last dose of study drug; * positive quantiferon test at the screening visit or within 2 months prior to screening. participants who have a positive quantiferon test with documentation of bcg vaccination, who are at low environmental risk for tb infection or reactivation, and have a negative chest x-ray can be included; \* pregnant or lactating at screening or planning to becomepregnant (self or partner) at any time during the study, including the follow-up period;
treatment response prediction system of mcrc patients based on ctc

Conditions: Colorectal Cancer Stage IV; Circulating Tumor Cell

Summary: this study enrolling patients with metastatic colorectal cancer. detecting ctc at different points in the treatment process. descripting the molecular atlas of ctc in mcrc patients. building and validating a response prediction system of mctc patients.


Eligibility criteria:
inclusion criteria: * age 18-80 years; histologically proven colorectal liver metastasis with liver-dominant disease (extrahepatic metastases limited to lung metastases) ecog 0-1 a life expectancy of ≥ 3 months adequate hematologic function: absolute neutrophil count (anc)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (inr) ≤1.3 adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl written informed consent for participation in the trial. exclusion criteria: * other previous malignancy within 5 years have metastases other than liver and lung metastases receiving any treatment before first blood collection
screening algorithm for early detection of occult cardiac amyloidosis

Conditions: Cardiac Amyloidosis

Summary: early diagnosis of cardiac amyloidosis (ca) is crucial because of the poor overall survival, high mortality and the need for early therapy including new treatment possibilities for transthyretin amyloidosis. previously considered a rare condition, ca is being demonstrated to account for up to 17 % of heart failure with preserved ejection fraction cases as well as up to 16 % of patients with severe aortic stenosis, undergoing surgical of transcatheter aortic valve replacement. it seems that ca is being underdiagnosed as the data of post-mortem studies demonstrate that at least 25% of elderly individuals have histologic evidence of amyloid deposits. other common conditions with increased afterload such as hypertensive or hypertrophic heart disease that mimic echocardiographic features or clinical symptoms may be the reason of postponed recognition of ca. furthermore, the lack of definitive biomarkers makes the diagnosis even more challenging. however, it has been shown that some clinical, laboratory and echocardiographic findings, so called "red flags", may indicate occult ca. a deeper and constructive analysis of the findings and establishment of prediction criteria could possibly lead to improvement of early ca recognition and survival in subjects at risk. we aim to prospectively perform a systematic screening for ca in individuals at risk based on predefined selection criteria. our aim is to evaluate if specific criteria would lead to increased detection of ca and in this case, to define major and minor diagnostic criteria.

the study aims to perform a prospective screening and detect occult ca in subjects at risk with aortic valve stenosis, undergoing either transcatheter or surgical aortic valve replacement. the study has two main objectives. firstly, we aim to determine the real prevalence of ca according to the targeted "red flags" analysis and secondly, we aim to establish an algorithm for early detection of ca.

Eligibility criteria:
inclusion criteria: * fulfillment of following four criteria: 1) severe aortic stenosis. 2) age \> 65 years for male and \>70 years for female. 3) increased left ventricular wall thickness ≥14 mm. 4) blood pressure ≤ 140/90 mmhg and at least 1 major or ≥ 2 minor criteria. major criteria: 1. carpal tunnel syndrom 2. non-traumatic rupture of the biceps tendon 3. nt-probnp \> 1000 pg/ml 4. hs troponin value above the 99th percentile without dynamic changes (≤ 20%) minor criteria: 1. diastolic dysfunction (at least grade 2, e' \< 10 cm/s) 2. sinus bradycardia/av block/pacemaker 3. atrial fibrillation exclusion criteria: * known cardiac amyloidosis (attr or al) * unable to provide written informed consent * refusal to provide written informed consent * contraindications for study investigations

Keywords: cardiac amyloidosis aortic stenosis as-attr
24-week, multicenter, randomized, parallel-group, open-label, active controlled phase iv study to assess the efficacy, safety and tolerability of saxagliptin compared with acarbose when in combination with metformin in patients with t2d inadequately controlled with metformin monotherapy

Conditions: Type 2 Diabetes Mellitus

Summary: smart study - a 24-week, multicenter, randomized, parallel-group, open-label, active controlled phase iv study to assess the efficacy, safety and tolerability of saxagliptin compared with acarbose when in combination with metformin in patients with type 2 diabetes mellitus (t2d) inadequately controlled with metformin monotherapy


Eligibility criteria:
inclusion criteria: 1. diagnosed with type 2 diabetes mellitus 2. men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening. 3. t2d patients treated with stable metformin monotherapy for at least 8 weeks prior to screening. metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated dose), but not more than the maximum dose specified in the label 4. hba1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local laboratory) and hba1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central laboratory) 5. fpg ≤ 13.3 mmol/l (≤ 240 mg/dl) at pre-randomization visit (by central laboratory) 6. able and willing to provide written informed consent and to comply with the study protocol exclusion criteria: 1. women who are pregnant, intending to become pregnant during the study period, lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods. 2. diagnosis or history of: 1. type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or cushing's syndrome. 2. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months. 3. previous treatment with any dipeptidyl peptidase-4 (dpp4) inhibitor or glp-1 receptor agonists within the past one year. 4. history of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (dpp4) or acarbose. 5. treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 8 weeks prior to screening

Keywords: saxagliptin acarbose type 2 diabetes metformin
the effects of lactobacillus plantarum ps128 in self-reported insomniacs

Conditions: Insomnia

Summary: to determine whether ps128 (1) reduces the severity of anxiety and depressive symptoms, (2) adjusts autonomic nervous system functioning, and (3) improves sleep quality.

forty participants with self-reported insomnia between 20 and 40 years old were randomly assigned to two groups, the ps128 and a placebo group, under the double-blind trial. participants took two capsules with or without ps128 after dinner for 30 days. study measures included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature polysomnography (miniature-psg) recordings at baseline and on the 15th and 30th days after taking capsules.

Eligibility criteria:
inclusion criteria: * (1) aged 20-40 years old, * (2) 18.5 \< bmi \< 25, * (3) bp \< 140 mmhg/90 mmhg, * (4) psqi \>5, isi\>13, * (5) meet the dsm-5 criteria for chronic primary insomnia. exclusion criteria: * (1) used other probiotic products within the last two weeks, * (2) antibiotic treatment within the last month, * (3) taken sleep medication within the last two months or were on long-term use, * (4) reported tobacco, alcohol, caffeine or drug addiction, * (5) lactic acid bacteria allergy, * (6) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus or other sleep disorders, * (7) inflammatory bowel disease, * (8) hepatobiliary gastrointestinal tract surgery * (9) worked the night shift.

Keywords: ps128 anxiety depression electroencephalography
evaluation of the immune responses of gsk biologicals' hpv vaccine following manufacturing process adaptation.

Conditions: Infections, Papillomavirus; Papillomavirus Vaccines

Summary: human papillomavirus infection has clearly been recognized as the cause of cervical cancer. indeed, the infection of the cervix by certain oncogenic types of hpv, if not cleared , can lead over time to cervical cancer in women . this study will compare the immune response induced by different lots of the hpv-16/18 l1/as04 vaccine, following adjustments to the manufacturing process.


Eligibility criteria:
inclusion criteria: * a female subject between, and including, 18 and 25 years of age at the time of the first vaccination. * written informed consent obtained from the subject prior to enrolment. * subject must have a negative urine pregnancy test. * healthy subject before entering the study entry as established by medical history and physical examination. * subject must be of non-childbearing potential. exclusion criteria: * pregnant or breastfeeding subject. * previous vaccination against human papillomavirus (hpv). * known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality. * history of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.
clinical trial of a cox-2 inhibitor for the treatment of women with preeclampsia

Conditions: Preeclampsia

Summary: preeclampsia is a hypertensive disorder of pregnancy and a leading cause of fetal and maternal morbidity and mortality. recent findings indicate preeclampsia is an inflammatory disorder associated with increased expression of cox-2. this study will test the hypothesis that treatment of women with a cox-2 inhibitor, celecoxib, will stop the inflammatory process and reverse symptoms of preeclampsia.


Eligibility criteria:
inclusion criteria: * pregnant women with preeclampsia between 20 - 32 weeks gestation. preeclampsia is defined as a maternal blood pressure of \>140/90 mmhg on two readings at least 6 hours apart with proteinuria of \>300 mg/24 hours. exclusion criteria: * exclusion criteria includes patients with known sensitivity to celecoxib; patients who have demonstrated allergic-type reactions to sulfonamides; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. other exclusion criteria will include patients with known cardiovascular disease or risk factors for cardiovascular disease, a prior history of ulcer disease or gi bleeding, impaired renal function, or liver dysfunction. exclusion criteria will also include concomitant use of oral corticosteroids, anticoagulants, diuretics, ace inhibitors, aspirin, fluconazole, and lithium.
balance control and recovery in diabetes peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy; Diabetic Peripheral Neuropathy Type 2; Diabetic Peripheral Neuropathy Type 2 - Uncontrolled; Healthy Aging

Summary: in this study the effects of diabetic peripheral neuropathy will be assessed on balance control, balance recovery, and muscle electrical activity in adults over 50 years. aim 1: determine muscle activity and balance control during a sit-to-stand in adults age above 50 with and without diabetic peripheral neuropathy. aim 2: assess local balance recovery and latency responses to lateral surface perturbation during quiet standing.

diabetic peripheral neuropathy (dpn) is a common condition affecting patients with diabetes. the prevalence of dpn increases with age and the duration of having diabetes. approximately 30% of patients with diabetes have peripheral neuropathy globally, and 4.5 million americans have dpn. dpn typically affects more distal peripheral nerve branches, resulting in sensory loss. dpn causes axonal damage and leads to a loss of muscle strength. these degenerative effects significantly contribute to fall risks and feelings of instability. falls most commonly occur during transitional tasks such as the sit-to-stand (sts) and stand-to-sit (standts). the overall objective of this study to assess the effects of dpn on balance control and muscle activity during transitional tasks (sts and standts) and during lateral perturbation while standing. study procedures: 1. measures of body weight, height, and limb diameter and measuring including leg length, knee width, elbow width, wrist width, and hand thickness. 2. measures of sensation of the big toe and heel area for both legs. 3. surface sensors will be placed on the leg muscles using non-allergic double adhesive tape. 4. participants will sit down and stand up on a chair with adjustable height. 5. then, participants will be asked to stand on a treadmill holding a ruler. the treadmill will slightly move left and right, and the muscle activity and balance control will be evaluated. 6. finally, muscle strength of the legs' muscles will be collected.

Eligibility criteria:
inclusion criteria: * type ii diabetes with peripheral neuropathy exclusion criteria: * foot ulcer * partial amputation * have experience of stroke * painful neuropathy * inability to stand or walk independently

Keywords: diabetic peripheral neuropathy balance sensation aging older adult foot sit-to-stand falls falling
sports-related concussion: physiological, biomechanical and cognitive methodology

Conditions: Concussion (Diagnosis)

Summary: the study aims to investigate the changes in physiological, biomechanical and cognitive performance under a traumatic sport-event (i.e., rugby match).

background: regular participation in moderate-to-vigorous physical activity in contact sports may be related to increases in cerebrovascular injury and head trauma. the diagnosis of head injury is lacking in validated objective measures immediate post event. diagnostic markers may also be confounded by the exercise type and intensity. therefore, it deserves further examination on a variety of functional (biomechanical and motor control) performance and blood-based biomarkers to determine how these indicators are affected by contact sport and the incidence of head injury. the study aims to investigate the changes in physiological, biomechanical and cognitive performance under a traumatic sport-event. methods: the study will use a two-group randomized controlled trial (rct) with double-blinded approach, comprising a traumatic sport-event group and a control group. thirty rugby-7s players will be recruited and randomly assigned to one of the two groups, where the intervention group will play three consecutive rugby matches. data will be collected pre and post rugby match performance. particularly, demographic and anthropometric data will be collected at baseline and pre-match. venous blood, biomechanical data, and cognitive-motor task data will be collected at baseline, pre-match, and after each of 3 consecutive matches. notational analysis will be performed after each match. venous blood will be collected 24, 48, and 72 hours after the 3rd match. discussion: it is expected to see a reduction in whole-body movement, coordination, and cognitive-motor tasks as the number of games continues through fatigue and/or traumatic events. it is also expected that changes in blood-based biomarker concentrations to correlate with changes in biomechanical and cognitive-motor tasks. the proposed study will yield meaningful, ecologically valid research regarding the occurrence of concussive events, the influence of these on the biological system of the performer, with direct impact on clinicians, scientists, and sport governing bodies. the scope of this study will have implications on health and wellbeing within sporting populations at all levels, genders, and ages. additionally, the findings will facilitate greater understanding about the human responses to exercise induced trauma.

Eligibility criteria:
inclusion criteria: (1) participants should be 18 years old or above; (2) no restriction of physical mobility; (3) no uncontrollable mental disorders; and (4) professional rugby-7s player. exclusion criteria: (1) less than 18 years old; (2) have restriction of physical mobility; (3) have uncontrollable mental disorders; and (4) training duration of rugby is less than one year.

Keywords: blood-based biomarkers motor control cognitive function skill biomechanics sport-related concussion
evaluation of digestive damage and associated predictive factors in crohn's disease 5 to 10 years after diagnosis

Conditions: Crohn's Disease

Summary: the primary objective is to evaluate digestive damage in cd 5 to 10 years after diagnosis in the getaid centers included in the rapid study. secondary objective is to identify predictive factors of the evolution digestive damage.

background: crohn's disease (cd) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. the recent development of the lemann index allows us to precisely assess digestive damage in cd. the aim of the present study is to evaluate digestive damage and associated predictive factors in cd 5 to 10 years after diagnosis. methods: prospective, multicenter, international, transversal, observational study. patients who completed the rapid trial (evaluating the benefits on the course of cd of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. digestive damage will be assessed using methods described in the lemann index protocol, dependent on cd location (abdominal mri obligatory). the total duration of study participation for 1patient will be ≤4 months. aims: the primary objective is to evaluate digestive damage in cd 5 to 10 years after diagnosis in the getaid centers included in the rapid study. secondary objective is to identify predictive factors of the evolution digestive damage.

Eligibility criteria:
inclusion criteria: * male or female patients over 18 years old * active or inactive crohn's disease * previously enrolled in rapid clinical trial exclusion criteria: * pregnant or nursing woman * patient with a contraindication or who decline to have study exams (mri and endoscopy) * other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.

Keywords: crohn's disease digestive damage lemann index
efficacy and safety of 90y microsphere combined with folfiri and bevacizumab in second-line treatment of crlm

Conditions: Colorectal Cancer Metastatic

Summary: to observe the pfs of yttrium \[90y\] microsphere injection combined with folfiri and bevacizumab in second-line treatment of crlm.

this study is a prospective, multicenter, observational, cohort study to observe the efficacy and safety of selective internal radiation therapy (sirt) with yttrium \[90y\] microsphere injection combined with folfiri and bevacizumab as second-line therapy in patients with colorectal cancer liver metastases.

Eligibility criteria:
inclusion criteria: 1. 18 years old≤ age ≤ 75 years old 2. voluntarily signed informed consent 3. patients with liver metastases of colorectal cancer, colorectal cancer lesions have resection, liver metastases limited to a single lobe 4. the liver tumor progresses after first-line treatment, and folfiri combined with bevacizumab therapy is planned 5. on the assessment of the clinician, the patient was eligible for yttrium \[90y\] microspheres injection, and treatment with yttrium \[90y\] microspheres injection was planned 6. kras mutant 7. ecog ps: 0-1 8. child pugh score ≤7 9. adequate level of organ function：a) hematology: neutrophils (anc) ≥1.5×109/l, hemoglobin (hb) ≥90 g/l, platelets (plt) ≥75×109/l；b) liver function: albumin \> 3 g/dl; alt and ast≤ 5 x uln; tbil \ 50 ml/min；d) coagulation function: inr≤1.2. exclusion criteria: 1. after liver metastasis was diagnosed, the liver underwent external radiation therapy and transhepatic arterial chemoembolization 2. patients with extrahepatic metastases 3. pregnant and lactating women 4. history of severe arrhythmia or heart failure 5. other researchers considered it inappropriate to participate in this study

Keywords: yttrium[90y] colorectal cancer liver metastases, crlm