Kornimate/medical-research-clean huggingface dataset:
telemedicine's utility for augmenting clinical trials and informed consent tactic

Conditions: Stroke

Summary: this is a 6 year, phase i, clinical research protocol to study the feasibility of using a telemedicine system for performing research in a remote hospital system.

the ucsd telemedicine system is a digital video camera system, which can transfer video and audio images from a clinic or emergency room to a remote place where a physician can review images in real time (as they happen). the system uses site independent software to access the camera system from multiple locations. this research study will determine if it is feasible to obtain informed consent for various types of research trials (hypothetical, non-invasive, invasive trails) via telemedicine. inpatient assessments on participants to complete clinical research case report forms by telemedicine will also by performed.

Eligibility criteria:
inclusion criteria: * male/female, age 18 years or older * clinical neurological focal deficits consistent with stroke * time of onset 3-24 hours and with stable neurological deficit * signed informed consent exclusion criteria: * deficits known to be due to non-stroke etiology * time of onset less than 3 hours * patients unable to give consent

Keywords: telemedicine
role of endothelial function, muscular fitness and metabolism in functional activity in patients with chronic heart failure (chf)

Conditions: Chronic Heart Failure; Coronary Disease; Dilated Cardiomyopathy

Summary: shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart failure (chf). recent studies suggested that peripheral impairment was the major cause of clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular smooth muscle dysfunction. it results in increased peripheral resistance that may influence limb blood flow, muscle fitness and activities of daily.the purposes of this study are 1. to compare muscular strength, endurance, and perfusion of quadriceps between chf patients and healthy controls by isokinetic test and near-infrared spectroscopy (nirs) and difference in activities of daily living 2. to compare endothelium function between chf patients and healthy control subjects 3. the relationship between endothelium function, muscular strength, endurance, perfusion, and metabolism of quadriceps.


Eligibility criteria:
inclusion criteria: * age 40-75 years * chronic heart failure: ejection fraction\<40% and at stable condition * coronary disease and dilated cardiomyopathy without heart failure * control group without diagnosis of any heart disease exclusion criteria: * clinical diagnosis of neuromusculoskeletal , pulmonary, or other systemic diseases that may affect the testing of the study

Keywords: chronic heart failure isokinetic test near-infrared spectroscopy laser doppler flowmetry endothelial function
natriuretic peptides - predictors of in-hospital and long-term major adverse cardiac events after emergency surgery?

Conditions: Surgery

Summary: the investigators hypothesize that the level of perioperative natriuretic peptides is associated with in-hospital and long term major adverse cardiac events.

the purpose of the study is to measure levels of brain natriuretic peptides before and after urgent non-cardiac surgery and to evaluate their predictive value for adverse long-term outcome.

Eligibility criteria:
inclusion criteria: * emergency surgery: 1. vascular 2. intra-abdominal 3. orthopedic exclusion criteria: * patients unable to provide informed consent * thoracic surgery * trauma surgery

Keywords: natriuretic peptides emergency non-cardiac surgery
metabolic syndrome as modifiable risk factor for breast cancer

Conditions: Metabolic Syndrome as Breast Cancer Risk Factor

Summary: healthy women and women with breast cancer have been enrolled in our nested case-control study between 2008 and 2009 in order to evaluate the association between metabolic syndrome and breast cancer, analyzing anthropometric parameters blood pressure, assessing serum hdl-c, triglyceride, fasting plasma glucose, insulin, testosterone and uric acid levels and administering a questionnaire about physical activity, food intake, tobacco use, alcohol abuse, personal and familial history of disease. our data support the hypothesis that metabolic syndrome may be an indicator of breast cancer risk in postmenopausal women. the change of the hormonal arrangement in postmenopausal, along with an increase in visceral adiposity, probably favour the hormone dependent cell proliferation, which drives tumorigenesis. adjustments in lifestyle with physical activity intensification and healthy diet may represent modifiable factors on which sporadic breast cancer primary prevention may work on.

a total of 777 patients have been enrolled in our nested case-control study. 293 of them operated for breast cancer (cases) and 484 healthy women (controls) have been recruited between 2008 and 2009 to take part to our study for evaluating the association between ms and breast cancer. liver or renal disease, thyroid pathology and coronary artery disease were considered exclusion criteria. after obtaining informed consent, signing the authorization to be enrolled in the study, for each woman anthropometric features were measured, including weight in kilograms, height in meters, waist and hip circumference, arterial blood pressure was taken and venous blood was collected \[15\]. bmi (kg/m²) was calculated from weight and height values according to world health organization classification (\ 1.20 ng/ml were considered indicative of hyperandrogenic status. women were asked to answer a questionnaire about chronic diseases, tobacco use, alcohol abuse, food intake, physical activity grade, parity, age of menarche, menopausal status, oral contraceptive use, hormonal therapy use, personal and familial history of cancer. according to the ncep atp iii \[10\], women presenting three disorders were diagnosed with low grade ms \[5\], whereas women presenting more than three disorders (four or five) were diagnosed with high grade ms. chi-squared test and logistic regression analyses (or and 95% ci) were used to confirm the association between ms and breast cancer and to calculate the risk. statistical significance was considered at p \< 0.05.

Eligibility criteria:
inclusion criteria: * healthy women * women operated for breast cancer exclusion criteria: * liver or renal disease, * thyroid pathology * coronary artery disease

Keywords: metabolic syndrome obesity visceral adiposity breast cancer
development of a nursing care bundle to prevent pressure injuries and its impact on rates and costs

Conditions: Pressure Injury; Hospital Acquired Pressure Ulcer

Summary: pressure injuries (pis) represent a significant clinical complication for patients worldwide and pose financial and quality challenges for healthcare systems. these wounds, which are highly challenging to treat and care for both patients and caregivers, lead to physical and psychological trauma, negatively affect daily life activities, reduce quality of life, and increase care costs (padula et al., 2019; yilmazer \& tüzer, 2022). moreover, the expenses associated with treatment are 2.5 times higher than those for prevention (lyder \& ayello, 2007). additionally, they often prolong hospital stays and increase the time nurses spend on care (yilmazer \& tüzer, 2022). according to the national pressure injury advisory panel (npiap, 2019), providing high-quality care for patients with pis requires adopting a multidisciplinary, standardized care approach tailored to the specific needs of patients (heasler, 2019). past and current literature supports the use of evidence-based care bundles to reduce pis (coyer et al., 2015; chaboyer et al., 2015; amr et al., 2017; deakin et al., 2020; yilmazer \& tüzer, 2022; wang et al., 2023). a care bundle is a critical element for standardizing and enhancing the quality of nursing care through the utilization of evidence-based clinical practice guidelines by healthcare professionals. therefore, adopting these evidence-based approaches will improve the consistency and quality of nursing care, enhance patient outcomes, and reduce institutional costs. moreover, the use of care bundles during interventions promotes teamwork and collaboration while supporting the development of a common language (anderson et al., 2015; institute for healthcare improvement, 2021). this study aims to reduce pis, enhance the quality of patient care, lower healthcare costs, and improve overall patient outcomes through the development and implementation of a nursing care bundle based on evidence in the literature. the widespread use of the care bundle, grounded in achieved outcomes, will contribute to the prevention of pis. additionally, it will serve as a supportive tool for nurses to improve the quality of care.


Eligibility criteria:
inclusion criteria: * being 18 years of age or older * patients who fall into all risk categories assessed by the braden scale * not having developed a pressure injury anywhere on their body * expectation of a minimum of 24 hours or more in the intensive care unit exclusion criteria: * being 18 years of age or younger * having and developing a pressure injury anywhere on their body * expectation of a less than 24-hour stay in the intensive care unit

Keywords: care bundles cost
trial of mesenchymal stem cell transplantation in decompensated liver cirrhosis

Conditions: Liver Cirrhosis

Summary: there has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. mesenchymal stem cells (msc) has been shown to be safe and effective for liver diseases in some studies. randomization controlled studies are needed to confirm the long term effect of msc treatment for liver cirrhosis. this study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis b and c related liver cirrhosis patients. this study is an open-label multicenter randomized control study. patients with with decompensated cirrhosis will be randomly assigned to receive msc treatment plus standard medical care(treatment）or standard medical care (control). three times of msc infusion (1x10e6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). the primary outcome is absolute change in liver function indexes and and scores. secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.


Eligibility criteria:
inclusion criteria: 1. aged 18-65 years 2. hbv -related liver cirrhosis 3. child-pugh score ≥7 4. with presentations of decompensation 5. written consent exclusion criteria: 1. hepatocellular carcinoma or other malignancies 2. severe problems in other vital organs(e.g.the heart,renal or lungs) 3. pregnant or lactating women 4. severe bacteria infection 5. anticipated with difficulty of follow-up observation 6. coinfection with hiv or other viral hepatitis. 7. drug abuse or alcohol abuse 8. history of severe allergy to biological products 9. other candidates who are judged to be not applicable to this study by doctors -

Keywords: liver cirrhosis mesenchymal sem cells
effects of danggui buxue tang on blood biochemical parameters in male recreational runners

Conditions: Sports Anemia; Inflammation; Oxidative Stress; Iron Deficiency; Hemolysis; Fatigue

Summary: the aim of this study is to examine the beneficial effects of danggui buxue tang on blood biochemical parameters in male recreational runners.

1. male recreational runners would be recruited by community websites or email. after completely introducing the study, the participants would be requested to sign informed consent. 2. the participants would perform maximal oxygen consumption test prior to the supplementation. the participants would be supplemented with either danggui buxue tang or placebo for a week before performing the 13-km run. a total of 4 times blood collection (before supplementation, immediate after running, 1 day and 3 days after running) would be performed for evaluating the effect of danggui buxue tang on blood biochemical parameters.

Eligibility criteria:
inclusion criteria: * the participants should have the experience finishing 10-km run but without the experience of attending a marathon run. exclusion criteria: * participants suffering from anemia (hb \<13 g/dl), taking usual supplements, medication, alcohol or not feeling comfortable.
clinical application of pd-1 inhibitor in colorectal cancer for improving survival

Conditions: Rectal Cancer; Colon Cancer

Summary: this trial is a single-center retrospective study. eligible patients receiving pd-1 inhibitor treatment will enrolled.

in patients with colorectal cancer (crc), curative surgery combined with chemotherapy ( folfox or capox regimens) has become the standard treatment. however, 20 to 30% of these patients will develop distant metastasis, which ultimately results in death. oxaliplatin- and fluoropyrimidine-based doublet chemotherapy does not adequately meet the clinical need for tumor shrinkage and downstaging. there is an urgent need to explore drugs with different mechanisms of action in combination with chemotherapy to improve efficacy. relatively few trials of preoperative therapy have been reported, in recent years, the emergence of immune checkpoint inhibitors has revolutionized cancer treatment. given the limitations of current treatment strategies in achieving optimal clinical outcomes, this retrospective study aims to research the disease-free survival rates and overall survival (os) in crc patients using pd-1 inhibitors.

Eligibility criteria:
: inclusion criteria: willing and able to provide written informed consent. histological or cytological documentation of adenocarcinoma of the colorectal. eastern cooperative oncology group's (ecog) performance status of 0 or 1. ct or mri scans (done within 30 days of registration) of the chest, abdomen, and pelvis all without clear evidence of distant metastatic (m1) disease. no clinically significant obstruction, perforation, or bleeding related to the primary tumor. no previous systemic anticancer therapy for colon cancer disease. adequate bone marrow, hepatic, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment exclusion criteria: previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years before randomization. significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. heart failure grade iii/iv (nyha classification). unresolved toxicity higher than ctcae v.5.0 grade 1 attributed to any prior therapy/procedure. subjects with known allergy to the study drugs or any of its excipients. current or recent (within 4 weeks before starting study treatment) treatment of another investigational drug or participation in another investigational study. breast-feeding or pregnant women lack of effective contraception.

Keywords: pd1
efficacy of pectoral nerve block for breast reduction surgery

Conditions: Nerve Blocks; Breast Surgery; Postoperative Pain

Summary: the purpose of the study is to evaluate the efficacy of pecs block applied to patients undergoing bilateral breast reduction surgery on postoperative analgesia compared to local infiltration anesthesia.

pectoral nerve block (pecs block) has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. it is frequently applied for postoperative analgesia especially in breast cancer surgery and subpectoral breast prosthesis.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology (asa) i-ii * body mass index (bmi) ≤40 kg/m2 * elective bilateral breast reduction surgery exclusion criteria: * declining to give written informed consent * asa iii and above * under 18 years of age or over 65 years of age * history of allergy against to the local anesthetics, * controendication of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc.) * history of breast surgery * treatment due to psychiatric disorder * history of treatment for a chronic pain * history of nerve blocks in order to treat postoperative pain

Keywords: pectoral nerve block (pecs block) breast reduction surgery ultrasonography postoperative pain vas score
observational study to compare outcomes of different psychiatric treatment of suicidal adolescents

Conditions: Suicidal Ideation

Summary: to address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate the effectiveness and safety of telehealth services compared to inpatient and ocic for suicidal adolescents in target population. to achieve this goal, the investigators propose a multi- site study to compare telehealth, ocic, and inpatient care, and see which can lead to a lower risk of a suicidal event (primary outcome) as well as higher treatment satisfaction (ts) and satisfaction with life (sl) (secondary outcomes) of both the legal guardians/parents and patients.

the investigators have proposed an observational design. eligible individuals will be identified during a crisis assessment, either in the emergency department or during an emergency phone or telehealth assessment. once the individual has been assessed and assigned to the clinician for treatment, study staff will assess if the patient is appropriate for the study using the study eligibility criteria. individuals who receive treatment in one of the following treatment arms will be eligible for this observation study: inpatient, in-person ocic or telehealth crisis intervention service. eligible individuals will be contacted by study staff to introduce and offer the study. if patient and guardian agree, they will complete surveys at baseline and every 2 weeks for 6 months to evaluate outcomes.

Eligibility criteria:
inclusion criteria: * adolescents that are 12 through 18 years old. * adolescents that are brought to the emergency department for crisis evaluation due to suicidal thoughts or behaviors. * require a higher level of care. * the presence of a legal guardian for consent. * capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * adolescents with suicidal thoughts who had prior ocic treatment in the past 12 months. * adolescents without the ability to answer survey questions. * adolescents that are non-english speaking due to the scales and surveys that are used for this study only being available in english.
living memory home-4-dementia care pairs

Conditions: Dyadic Family Caregiver-person With Dementia Online Intervention

Summary: the purpose of this study is to evaluate an online platform -- the living memory home for dementia care pairs (lmh-4-dcp) for persons with dementia and their family caregivers to engage in reminiscence activities together and record meaningful memories. the main aims of this study are: * to evaluate the feasibility and acceptability of the lmh-4-dcp platform. * to explore the potential for lmh-4-dcp to reduce feelings of pre-loss grief and enhancing relationship quality in dementia family caregivers and their care-recipients ('care-pairs') care pair participants will be asked to log-in to lmh-4-dcp and complete study activities three times per week for two weeks. researchers will compare the intervention group to an attention control condition to see if lmh-4-dcp's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.

the goal of this randomized controlled trial is to evaluate the living memory home for dementia care pairs (lmh-4-dcp) web application, a dyadic online psychosocial reminiscence platform, to reduce feelings of pre-loss grief and improve relationship quality in individuals with dementia and their family caregivers ('care pairs'). the main aims of this study are: * to evaluate the feasibility and acceptability of the lmh-4-dcp platform. * to explore the influence of the lmh-4-dcp intervention on reducing feelings of pre-loss grief and enhancing relationship quality in the care pair caregiver participants randomized to the intervention condition will be asked to log-in to lmh-4-dcp and complete reminiscence activities three times per week for two weeks. researchers will compare the intervention group to an attention control condition, which includes lmh-4-dcp use without reminiscence-specific features, to see if lmh-4-dcp's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.

Eligibility criteria:
inclusion criteria: family caregivers: * be a primary source of care for a family member in the early to moderate stages of dementia * 18 years of age or older * english-speaking * able to use the internet and has internet access * residing in the united states exclusion criteria: caregiver exclusion criteria: * is not the primary family caregiver of the pwd * under the age of 18-years-old * exhibits cognitive impairment (by scoring 3 or more on the spmsq) * does not speak english as a primary language. pwd exclusion criteria: * severe cognitive impairment detected by the clinical or study staff using validated, brief screening tools (e.g., a score of 8 errors or more on the spmsq) * does not demonstrate capacity to consent (e.g., a score of 9 or fewer errors on the university of california-san diego brief assessment of capacity to consent * pwd is living in a long-term care facility * does not speak english as a primary language * is under the age of 18 years old.
mariner trial: multiparametric cardiac pet for cav surveillance after heart transplantation

Conditions: Cardiac Allograft Vasculopathy

Summary: cardiac allograft vasculopathy (cav) is a common complication affecting heart transplant patients. this condition causes narrowing of the heart arteries leading to graft dysfunction. surveillance for cav is vital; however an ideal approach has not been established. the goal of this study is to assess whether noninvasive positron emission tomography (pet) based surveillance is non-inferior to invasive coronary angiography (ica) surveillance.

mariner is a canadian multicentre prospective, randomized clinical outcomes-based trial evaluating noninferiority of a noninvasive pet strategy compared to ica for cav surveillance. patients are randomized to annual pet or ica for cav surveillance. non-inferiority is assessed according to a clinical composite of death, retransplant, allograft dysfunction not related to acute rejection, and angiographic cav associated with myocardial infarction or heart failure. secondary outcomes include the rate of new or progressive cav, number of ica performed, number of ica and pet procedural related complications, euroqol-5 dimension assessed patient health-related quality of life and health care resource use.

Eligibility criteria:
inclusion criteria: 1. post heart transplant 2-10 years. 2. age ≥18 years. 3. able to provide informed consent. exclusion criteria: 1. contraindication to dipyridamole due to severe aortic stenosis. 2. contraindication to dipyridamole due to 2:1 or greater av block without pacemaker. 3. contraindication to dipyridamole due to severe bronchospasm. 4. unable to undergo coronary angiography due to allergy to iodinated contrast. 5. unable to undergo coronary angiography due to glomerular filtration rate ≤30 ml/min/1.73 m2. for non-dialysis patients as determined by local laboratory analysis. 6. unable to undergo coronary angiography due to unsuitable vascular access. 7. treated rejection ≤1-month. 8. unstable angina or mi ≤7 days.

Keywords: heart transplant