Kornimate/medical-research-clean huggingface dataset:
ankle-brachial index to predicte all-cause and cardiovascular mortality in framingham risk score patients

Conditions: Ankle Brachial Index

Summary: framingham risk score (frs) included age, gender, body mass index (bmi), cigarette smoking, blood pressure, total cholesterol (tc), ldl-cholesterol (ldl-c) and diabetes mellitus (dm). previously, framingham cohort study and other study has confered patients with medium or high frs had worse prognosis. however, the score list was tending to over-estimate risk in medium frs or under-estimate risk in high frs patients . for this reason, acc/aha cholesterol guidelines also recommend the use of additional markers to improve atherosclerotic cardiovascular disease (ascvd) risk assessment and medical decision making. meanwhile, the abi, which was the ratio of systolic pressure at the ankle to that in the arm, was quick, easy and used to diagnosis and assess the severity of peripheral artery disease (pad) in the legs. several research have shown its low value as an indicator of general atherosclerosis and independently risk associated with cardiovascular events in prospective studies . in addition, abi aggressively modified risk factors and accelerated the adverse prognosis of ascvd. however, whether frs or abi, were all related to participants and race. and, most studies were from western countries, lack of asian date, especially aimed at risk prediction model research. therefore, this research was aimed to validate incorporating abi and relevant framingham risk variables whether could improve prediction all-cause mortality and cardiac mortality in medium and high framingham risk score (frs) patients.

the study is a longitudinal cohort study. the first cross-sectional survey was conducted in 2011.

Eligibility criteria:
the inclusion criteria: 1. patients were age older than or equal to 18 years 2. patients with medium and high framingham risk score，namely, framingham risk score (frs) 10%-20%,or frs \> 20%. 3. all participants gave written informed consent to this study, which was approved by the ethics committee of tongji university. exclusion criteria: 1. patients were suffering from mental illness. 2. life expectancy of patients were less than 1 year.

Keywords: atherosclerosis risk ankle brachial index framingham risk score prediction model all-cause mortality cardiac mortality
randomized parallel group trial of the efficacy and safety of ezetimibe with a statin versus statin dose doubling in patients with persistent primary hypercholesterolemia (0653-152)(completed)

Conditions: Hypercholesterolemia

Summary: to compare the percent (%) change in plasma ldl-c concentration, after a six week course of treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of the existing statin dose


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of primary hypercholesterolemia and * who are defined as being "high risk" (10-year risk of coronary artery disease \> 20 % based on the framingham model or history of diabetes mellitus or any atherosclerosis disease) * and have not reached their recommended ldl-c target levels of 2.5 mmol/l while on a statin alone exclusion criteria: -
acupuncture for olfactory dysfunction in infected covid-19 patients

Conditions: Olfactory Dysfunction; Covid19

Summary: in this a 12-week, single blinded, randomized sham controlled, and cross-over clinical trial. it will be conducted to explore the safety and efficacy of acupuncture for olfactory dysfunction in infected covid-19 patients in hong kong.

this is a single blinded, randomized sham controlled, and cross-over clinical trial. 40 post covid-19 patients presenting to olfactory dysfunction will be recruited. 40 patients will be randomly assigned into 2 groups, the acupuncture group (ac) and the sham acupuncture group (sac) with 1:1 ratio, for 4-week treatment and 2-week follow-up. after the follow-up, the sham group will be conducted with real acupuncture for another 4 weeks and the real acupuncture group will be conducted with the 4-week sham acupuncture.

Eligibility criteria:
inclusion criteria: patients who have been previously diagnosed to be infected with covid-19 and are discharged from local hospitals with all the follows: 1) post covid-19 olfactory dysfunction with moderate or severe grades (base on upsit-tc scores, the cutoff scores are set at 29.5 for male and 30.5 for female); 2) post covid-19 olfactory dysfunction who did not undergo treatment; 3) no history of trauma, injury or surgery to head or nose or any bleeding from the nose; 4) aged 18 to 80 years who are able to read and write chinese. exclusion criteria: patients will be excluded if they have one or more of follows: 1) patients with olfactory or gustatory dysfunctions before the covid-19 epidemic; 2) patients with history of chronic rhinosinusitis or nasal polyposis; 3) history of nasal surgery (including rhino/septoplasty with or without functional endoscopic sinus surgery; 4) pregnant or breastfeeding women.; 5) medical history: cancers, conditions that affect the nervous system, such as parkinson's disease or alzheimer's disease, and/or any other serious diseases; 6) unstable medical conditions; 7) patients who have received acupuncture treatment within one month, 8) alcoholism or drug abuse in past 1 year; 9) have needle phobia; 10) have known history of developing acupuncture related severe adverse reaction.

Keywords: olfactory dysfunction acupuncture covid-19 randomized sham controlled trial
sacral transcutaneous electrical stimulation efficacy in chronic pelvic pain: a randomized clinical trial

Conditions: Chronic Pelvic Pain Syndrome

Summary: the goal of this interventional study is to test of efficacy of sacral transcutaneous electrical stimulation (tens) in patients with chronic pelvic pain. the main questions it aims to answer are: 1. is sacral transcutaneous electrical stimulation (tens) effective to reduce/relief pain in patients with chronic pelvic pain? 2. is the effect of tens comparable to sham stimulation therapy in patients with chronic pelvic pain?

our study aiming to test the efficacy of sacral transcutaneous electrical stimulation (tens) intervention in patients with chronic pelvic pain. we aim to test the efficacy and compare it with sham stimulation therapy in chronic pelvic pain.

Eligibility criteria:
inclusion criteria: * female with chronic pelvic pain for ≥6 months * 18-65 years old * visual numeric scale of pain score ≥4/10 * voluntarily participate to the study exclusion criteria: * pregnancy * having severe medical and/or psychiatric disorder * malignancy * chronic infection * inflammatory musculoskeletal system disease * skin infection in sacral/pelvic area * having implanted neuromodulatory device (such as pacemaker or defibrillator) * refusing to participate the study

Keywords: transcutaneous electrical stimulation chronic pelvic pain sacral randomized clinical trial
cardiac autonomic modulation in older hypertensive individuals submitted to different types of physical training

Conditions: Autonomic Dysfunction

Summary: sixty-one sedentary older hypertensive individuals were randomized to four groups: continuous aerobic training (ca), interval aerobic training (ia), resistance training (r), and control (c) group. the protocol included 3 sessions of training by week for 12 weeks. c individuals were instructed to continue their usual activities. they were submitted to the passive tilt test before and after the research protocol, evaluating the heart rate (hr), low frequency (lf) and high frequency (hf) bands, detrended fluctuation analysis (dfaα1) and entropy

the individuals were randomized into four groups: continuous aerobic training (ca), interval aerobic training (ia), resistance training (r), and control (c), which performed physical exercises three times a week for twelve weeks, with a total of 36 sessions. the tilt test was performed before and after the research protocol. individuals in the control group were only encouraged to maintain their usual activities. for the analysis of hrv, the baseline conditions (resting in the supine position) were determined, followed by the passive postural maneuver, which characterizes the tilt test (table til tat 70 °) in order to determine the following variables: * hr: heart rate (sympathetic action) * lf: low frequency band (modulated predominantly by the sympathetic system) * hf: high frequency band (modulated predominantly by the parasympathetic system) * entropy: data complexity or irregularity index showing that, the higher the values, the better the hrv. * dfaα1 (short term detrended fluctuation analysis)

Eligibility criteria:
inclusion criteria:men and women 60-year-old or older, extensively using prescription antihypertensive drugs, and having no previous experience with physical training - exclusion criteria: * • positive treadmill test (tt) for ischemia * related left ventricular systolic dysfunction of any degree * presence of arrhythmias * use of β-blockers * use more than seven doses of ethyl alcohol per week * renal insufficiency * diabetes * hyper- or hypothyroidism * limiting lung disease * osteomioarticular impairment that would limit exercise performance * sbp ≥160 and/or dbp ≥ 100 mmhg on baseline

Keywords: older individuals heart rate variability physical training hypertension
the fourth generation cart-cell therapy for refractory-relapsed ovarian cancer

Conditions: Ovarian Cancer

Summary: the goal of this clinical trial is to study the safety and feasibility of anti- mesothelin chimeric antigen receptor t-cell (meso car-t cells) therapy for refractory-relapsed ovarian cancer

primary objectives: 1. to determine the safety and feasibility of anti- meso car-t cells therapy for refractory-relapsed ovarian cancer secondary objectives: 1. to access the efficacy of anti- meso car-t cells in patients with ovarian cancer. 2. to determine in vivo dynamics and persistency of anti- meso car-t cells 3. to assess the quality of life in patients with ovarian cancer after treatment with anti- meso car-t cells.

Eligibility criteria:
inclusion criteria: 1. histopathologically confirmed ovarian cancer; 2. 18-75 years old, female; 3. expected survival \> 12 weeks; 4. eastern cooperative oncology group (ecog) score 0-2; 5. patients who have previously been treated with second- line or above standard treatment are failed (progress in treatment or recurrence within 6 months after discontinuation of treatment); 6. according to the immune-modified response evaluation criteria in solid tumors (imrecist) , there should be at least one measurable tumor foci； 7. positive expression of mesothelin in tumor tissue； 8. creatinine ≤ 1.5×uln or creatinine clearance ≥ 60ml / min; 9. alanine aminotransferase and aspartate aminotransferase ≤ 2.5×uln , such as with liver metastasis, ≤ 5×uln; 10. total bilirubin ≤ 2×uln; 11. hemoglobin≥90g/l(no blood transfusion within 14 days); 12. absolute value of neutrophils ≥1.5×10\^9/l; 13. absolute counting of lymphocytes \>0.7×10\^9/l; 14. counting of platelet≥80×10\^9/l； 15. the venous access required for collection can be established without contraindications for leukocyte collection; 16. able to understand and sign the informed consent document. exclusion criteria: 1. accompanied by other uncontrolled malignant tumors; 2. active hepatitis b, hepatitis c, syphilis, hiv infection; 3. insufficient function of important organs (heart, lung); 4. any other uncontrolled active disease that impedes participation in the trial; 5. any affairs could affect the safety of the subjects or purpose this trial; 6. pregnant or lactating women, or patients who plan to be pregnancy during or after treatment; 7. there are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy within 14 days or 14 days prior to enrollment； 8. the investigator believes that it is not appropriate to participate in the trial; 9. received car-t treatment or other gene therapies before enrollment; subjects suffering disease affect the understanding of informed consent or unable to comply with study; unwilling or unable to comply with study requirements.

Keywords: meso car-t ovarian cancer refractory-relapsed
a study to evaluate effectiveness and safety of edoxaban in patients 80 years of age or older with nonvalvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: non-valvular atrial fibrillation (nvaf) increases the risk of stroke by three- to five-fold, especially in elderly patients, creating a huge burden on medical system as well as a negative impact on patients' lives. direct oral anticoagulants (doacs) are recommended for patients with nvaf to prevent strokes. real world data reveal the underuse of anticoagulation in the elderly, especially due to physicians' concern of bleeding, often neglecting the thromboembolic risk. this study is designed to evaluate the safety and effectiveness of edoxaban in korean elderly patients with atrial fibrillation.

the objective of this study will be to evaluate the safety and effectiveness of edoxaban in patients 80 years of age or older with nvaf. this observational, non-interventional study will prospectively follow korean patients who have been prescribed edoxaban at the discretion of the physician up to 12 months.

Eligibility criteria:
inclusion criteria: * nvaf participants aged ≥ 80 years old * participants who are determined to be prescribed with edoxaban at the discretion of the physician within 8 weeks prior to enrollment according to package information * participants who can return to the site in person for face-to-face visits * written informed consent for participation in the study (icf) exclusion criteria: * planning to participate or simultaneously participating in any interventional study * life expectancy \< 1 year no influence on prescribing behavior as participants will only be included in the study after the physicians have made the clinical decision to prescribe edoxaban.

Keywords: non-valvular atrial fibrillation elderly patients
polypropylene vs polyglactin in suturing of the lung

Conditions: Lung Injury; Bleb Lung; Lung Cancer

Summary: comparative study comparing polypropylene and polyglactin in suturing of the lung

lung tear or, pulmonary laceration is an injury in lung parenchyma, said injury can be caused by several reasons: blunt chest trauma penetrating trauma such as stab wounds or firearm wounds iatrogenic, such as faulty intercostal tube insertion

Eligibility criteria:
inclusion criteria: * patients admitted to assiut university hospital and will undergo surgery for lung tear repair. * patients admitted to assiut university hospital and will undergo surgery for bullectomy or lobectomy. exclusion criteria: * patients with lung injury repaired with a stapler
a pilot study of effect of dexmedetomidine on sleep and inflammation in critically ill patients

Conditions: Sleep; Critical Illness

Summary: the purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.

over 1 million patients receive mechanical ventilation every year in the united states. in mechanically ventilated patients, despite sedative infusions, sleep is severely disrupted. sleep disruption, in turn, can lead to activation of sympathetic nervous system and elevated inflammatory cytokines. both sympathetic hyperactivity and elevated cytokines have been associated with delirium, which, in turn, is associated with increased mortality and higher healthcare costs. currently, however, there is very little understanding of the inter-relationship between critical illness, sleep, and neuropsychological well-being. the purpose of this study is to collect preliminary data on the short-term effects of sedation with and without sympatholysis on sleep and inflammation in critically ill patients receiving mechanical ventilation. this pilot study will be accomplished by performing sleep studies and circulating cytokine measurements in critically ill patients randomized to receive two different sedation strategies: dexmedetomidine versus midazolam and fentanyl. the ultimate goal of this program of research is to identify sedation practices that are least associated with adverse short- and long-term consequences, and thereby ultimately help improve sleep quality and quality of life in patients surviving critical illness.

Eligibility criteria:
inclusion criteria: * patients requiring mechanical ventilation with a diagnosis of * acute respiratory distress syndrome * cardiogenic pulmonary edema * pneumonia * chronic obstructive pulmonary disease exclusion criteria: * patients who are considered too unstable to undergo this investigation by their primary physician * comatose patients, or patients with severe debilitating neurological disease * renal insufficiency (sr. creatinine \> 2 mg/dl) * heart block (second or third degree heart block) or sinus bradycardia (heart rate \< 60 beats per minute) * pregnancy

Keywords: sleep critical illness cytokine
insulin infusion in the hospital wards

Conditions: Hyperglycemia

Summary: increasing evidence from clinical studies in intensive care unit (icu) settings indicates that insulin infusion can improve outcome measures for patients with hyperglycemia (high blood sugar) independent of a previous diagnosis of diabetes mellitus. this improvement in health could also apply to patients that have high blood sugars in various other non-critical care areas of the hospital as well. however, the data that shows improvement in health outcomes has been collected from wards that have a lower patient to provider and patient to nurse ratio, resulting in the ability for a much tighter control of the insulin infusion. we hypothesize that tight blood glucose control will provide the same benefits for patients in non-intensive care units settings but that these protocols may lead to a higher incidence of hypoglycemia (low blood sugar) and potentially to adverse outcomes in patients. this study aims to determine the clinical outcome of patients treated with insulin infusion as well as the rate of hypoglycemic episodes in non-intensive areas. we will conduct a chart review of patients treated with insulin infusions in non-critical wards at emory university hospital during the period of 7/1/04 to 6/30/05. medical records of all patients treated with intravenous insulin infusion protocols will be analyzed. data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.


Eligibility criteria:
inclusion criteria: * all subjects over 18 years of age that received intravenous insulin treatment on general medical and surgical wards at emory university hospital during the period of 7/1/2004 to 6/30/2005

Keywords: hyperglycemia diabetes insulin drip hypoglycemia general wards
immunogenicity, safety and optimal dose finding study of recombinant influenza h5n1 vaccine in healthy young adults

Conditions: Influenza; Virus Diseases

Summary: umn-0501 is a purified recombinant influenza ha vaccine (a h5n1/vietnam/1203/2004). the purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of umn-0501 following two same-dose vaccinations of umn-0501 per patient with a 3 week interval between vaccination in healthy young adults. immunogenicity will be confirmed by both microneutralization (mn) antibody and hemagglutination inhibition (hai) titer levels in the serums of subjects after receiving different doses of umn-0501. there will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.


Eligibility criteria:
inclusion criteria: * healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator. * males and females aged 20-40 years. * provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures. exclusion criteria: * body mass index (bmi) 30 kg/m2 and above. * has a history of a a/h5n1 influenza virus infection and subjects had received other a/h5n1 influenza vaccine. * has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0c) within 2 days of vaccination. * has a history of guillain-barre syndrome or acute disseminated encephalomyelitis (adem). * has severe allergic diseases. * has asthma. * has a history of convulsions. * has a history of any serious disease. * known impairment of imune function. * known rheumatism and autoimmune disease. * receipt of medicines that would affect evaluation of immunogenicity. * receipt of any live virus vaccination or receipt of any inactivated vaccine/toxoid prior to enrollment. * blood donation prior to enrollment. * receipt of another investigation agent prior to enrollment. * history of alcohol or drug abuse. * females who are pregnant or potentially childbearing or are breastfeeding. * ineligible subject based on the judgement of the investigator.

Keywords: h5n1 vaccine influenza h5n1 avian influenza h5n1 pandemic
fmri study of tes in major depression

Conditions: Depression

Summary: this is a functional mri study that will examine the effects of noninvasive transcranial electrical stimulation (tes) on brain function in individuals with major depression.

the purpose of this research study is to understand how a kind of brain stimulation, called transcranial electrical stimulation (tes), affects brain function in people with major depression. tes delivers low electrical current to the head using electrodes applied to the skin, and is described as a "neuromodulation" or "neurostimulation" technique. this study uses a specific kind of tes called "transcranial direct current stimulation", or tdcs, where a constant (unchanging) electrical current is passed between two electrodes on the head. neuromodulation methods like tes have shown promise in changing brain function, as well as treating some brain disorders like major depression. yet, how tes brain function remains unclear. to better understand how tes works, the investigators will use mri (a type of brain scan) to measure brain function during tes in people with major depression.

Eligibility criteria:
inclusion criteria: * ages between 18 and 55 * diagnosis of major depressive disorder made by a physician, psychiatrist, or psychologist at least one year prior * mild-to-moderate symptoms of depression (hamilton depression rating scale 17-item, hdrs-17, score 8-23) * stable standard or no pharmacological antidepressant regimen (ssri, snri, maoi, or trycyclic/tca) with no change in treatment 6 weeks prior to study start exclusion criteria: * suicidal thoughts, ideation, or behavior within the past month (hdrs-17 item 3 score greater than 1) * greater than moderate symptoms of depression within the past month (hdrs-17 score \>23) * change in antidepressant medication within 6 weeks of study start * diagnosis of any medical condition potentially affecting brain function, including neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, anxiety, ptsd), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence * mri contraindications: metal or other implants that are not mr-safe, claustrophobia, pregnancy or suspected pregnancy * tes contraindications: skin conditions or injuries on the scalp, hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers * other major medical conditions (e.g., cancer, stroke) * current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics, or antidepressants * prisoners will not participate in this study