Kornimate/medical-research-clean huggingface dataset:
to explore the anti-oxidative effects and inflammation effects of soy protein to renal function of end stage diabetes nephropathy patients

Conditions: Diabetic Nephropathies

Summary: this study investigated the beneficial effects of soybean on the renal function, oxidative stress, and inflammatory responses in patients with end-stage diabetic nephropathy (dn).

dn outpatients were recruited from tung's taichung metroharbor hospital (taichung city, taiwan). they were randomly separated into two groups; one group was given soy protein drink and the other group was given casein drink for 4 months. the blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, egfr), inflammatory factor levels were analyzed at the baseline and at the end of the study.

Eligibility criteria:
inclusion criteria: * participants aged from 40 to 75 years and were at dn stage 4 or 5 were enrolled in this study. exclusion criteria: * the exclusion criteria were having hemodialysis, lactose intolerance, gastrointestinal (gi) tract dysfunction, liver disease, acute metabolic acidosis or ketoacidosis, in acute infection, severe dehydration, alcohol abuse, addictive drug abuse, cancer in recent 5 years, being involved in another trial in past 1 month, had operation in the past 4 months, or had compliance lower than 90% in the first month of study.
asthma in central texas project

Conditions: Asthma

Summary: asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor. few studies of childhood asthma have been conducted with children who live in rural areas or have included mexican american children in their samples. this study builds on the original r01nr007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care. in this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp. the tri-ethnic sample will be composed of 320 mexican-american, african-american, and white rural school-aged children (grades 2-5) who have asthma and their parents. in addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation. families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life. hypotheses (h): children in the camp-workshop group and the school-home group will demonstrate equivalent improvements, but greater improvements than the attention-control group in:(h1.1) their asthma severity and airway inflammation from the time 1 assessment when compared to time 4 assessment; (h1.2) office visits, ed visits, and hospitalizations for asthma, and absenteeism for the study year (time 4) when compared to the pre-study year (time 1); and (h1.4) parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (qol0 from the pre-study year (time 1) to the end of the study year (time 4) measurement, when compared to the attention-control group.

families are recruited at the beginning of the school year (time 1, october-november); parents consent and child assent obtained and baseline data collected in fall. the intervention is provided in december-january. follow-up data are collected at february (time 2), april (time 3), and august (time 4).

Eligibility criteria:
inclusion criteria: * parent reports the child has a diagnosis of asthma made by a medical provider; * has had asthma symptoms in the previous 12 months; * speaks either english or spanish. exclusion criteria: * has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)

Keywords: children asthma quality of life self-management
the shortcut™ continued access study protocol

Conditions: Valve-in-valve Procedures; Aortic Stenosis; Coronary; Obstruction

Summary: a prospective, multicenter, non-randomized, single-arm, open-label continued access study of the shortcut™ device (the shortcut™ cas). the continued access study will be used to collect additional safety and effectiveness data of the shortcut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for tavr-induced coronary artery ostium obstruction following a viv procedure.


Eligibility criteria:
inclusion criteria: 1. patient is planned to undergo a percutaneous valve-in-valve procedure for an approved viv indication due to a failed bioprosthetic valve. 2. patient is at risk for tavr-induced coronary artery ostium obstruction. 3. written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure. exclusion criteria: 1. an excessive aortic valve leaflet calcium morphology, such as diffuse massive calcification at the targeted leaflet for splitting or anatomy not suitable for the use of the shortcut™ device, as determined by the ct measurements. 2. carotid or vertebral artery disease that, in the opinion of the local heart team, should be treated; or treatment of carotid stenosis ≤ 1 month prior to index procedure. 3. cva or tia ≤ 6 months prior to index procedure. 4. history of a myocardial infarction (mi) ≤ 6 weeks prior to index procedure. 5. hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance. 6. lvef \< 30%. 7. ongoing severe infection or sepsis. 8. patient has renal insufficiency or is on chronic dialysis. 8. need for emergency surgery for any reason. 9. life expectancy is less than 1 year.

Keywords: tavi pi-cardia tavr viv continued access shortcut
noninvasive beat-to-beat clearsight blood pressure monitoring

Conditions: Hypotension

Summary: subjects will first have a blood pressure reading recorded on both arms using a non-invasive blood pressure monitoring (nibp) cuff in the preoperative area. then blood pressure will be recorded using the clearsight monitor on each hand over a one-minute period. if mean arterial pressure (map) as assessed by either the noninvasive blood pressure (nibp) monitoring cuff or the clearsight system differs by more than 10% from arm to arm, the subject will be excluded from the study. before induction of anesthesia, the subject will be randomized to either: clearsight group + usual clinical care: information from clearsight monitor will be available to the clinicians. according to asa guidelines, usual blood pressure monitoring includes non-invasive blood pressure measurements every 5 minutes during a surgical case. non-clearsight group (blinded) + usual clinical care: information from clearsight monitor will not be available to the clinicians. both patient groups will have continuous clearsight monitoring and non-invasive blood pressure monitoring every 5 minutes. the difference will be in the intervention group data from the monitor will be available to the clinicians in the operating room, but in the control group data from the clearsight monitor will not be available (blinded) to the clinicians. regardless of the study group assignment, second-by-second clearsight monitor continuous blood pressure data will be recorded for each study patient and will be used for analysis. the morning of post-operative day 3 the subject will be given the qor-15 questionnaire and will complete poms morbidity surveys.


Eligibility criteria:
inclusion criteria: * written informed consent * age \> 45 years * asa physical status 3 or 4 * moderate- or high-risk non-cardiac surgical procedures (i.e., orthopedic, spine, urology, and general surgery) in patients in whom invasive blood pressure monitoring is not planned * anticipated surgical duration \>2 hours exclusion criteria: * any contraindications to the proposed interventions * patient with invasive blood pressure monitoring * patients with contraindications to oscillometric blood pressure monitoring on one arm and clearsite monitoring on the other * preoperative discrepancy in mean arterial pressure \>10% between the arms
prospective, observational study of low-risk criteria for node metastasis in endometrial cancer

Conditions: Endometrial Cancer

Summary: the purpose of this study is to evaluate the efficacy of low risk criteria for lymph node metastasis, that was determined by kgog-2014 retrospective study, in women with endometrial cancer.

the korean gynecologic oncology group (kgog) undertook a multi-center retrospective study to develop a preoperative prediction model for lymph node metastasis in endometrial cancer (kgog-2014). this retrospective multi-center study showed that the accurate identification of a low-risk group for lymph node metastasis among the patients with endometrial cancer can be achieved with the new criteria using preoperative mri and serum ca-125 assay. in this study, serum ca125 levels and three mri parameters (deep myometrial invasion, lymph node enlargement, and extension beyond uterine corpus) were found to be independent risk factors for nodal metastasis. based on the success of kgog-2014, korean gynecologic oncology group initiated this prospective, multi-center observational study to validate our prior prediction model.

Eligibility criteria:
inclusion criteria: * patients with a histologic diagnosis of endometrial cancer before surgical staging. * patients with a preoperative magnetic resonance imaging (mri) and serum ca-125 within 4 weeks from surgical staging. * patients who underwent adequate systemic lymph node dissection during surgical staging. exclusion criteria: * patients with a histologic feature suggesting sarcoma or squamous cell carcinoma

Keywords: endometrial cancer lymph node metastasis lymphadenectomy risk criteria
study of bone mineral density and trabecular bone score in patients with ankylosing spondylitis

Conditions: AS

Summary: osteoporosis is a common complication of as even in the early stages of disease. yet, as is also characterized by new bone growth that leads to syndesmophytes formation and subsequent vertebral ankyloses.

accordingly, previously-published studies have demonstrated large discrepancies in the reported incidence of osteoporosis, based on measurement of bone mineral density (bmd), in patients with as ranging from 18.7% to 62%. measurement of trabecular bone score (tbs) is a novel tool used to evaluate bone microarchitecture. aim of the work: to compare bone quality using tbs between as patients and healthy controls and to evaluate factors associated with tbs in patients with as. patients and methods: a total of 40 male as patients recruited from outpatient clinic of rheumatology, mansoura university hospital. 40 age-matched healthy males as matched control. tbs was analyzed using dxa images over exactly the same region as the lumbar bmd assessment (l1-l4). lumbar spine dxa images were reanalyzed using tbs inight software version 2.1 (med-i maps, merignac, france). patients were divided in 3 tbs groups according to guidelines for fracture risk: any tbs \>1.31 was considered as normal; tbs values between 1.23 and 1.31 were consistent as partially degraded structure; and any tbs \<1.23 was considered as degraded structure

Eligibility criteria:
inclusion criteria: * a total of 40 consecutive male as patients were invited to participate in this study. patients were recruited from outpatient clinic of rheumatology, mansoura university hospital, between january and september 2019. as was diagnosed according to modified new york criteria. during the same period, 40 age-matched healthy males were invited to participate in the study as a control group. exclusion criteria: * patients or controls with thyroid or parathyroid disorders, presence of chronic renal or liver disease, and use of any medication that could potentially interfere with bone metabolism including bisphosphonates, teriparatide, anticonvulsants, anticoagulants, calcium and corticosteroids. none of the participants was using vitamin d supplements.
patient benefit from the new modular shoulder prosthesis promos

Conditions: Primary or Secondary Omarthrosis of the Shoulder Joint

Summary: overall study design: this study is a prospective, non-randomized, multicenter postmarket clinical follow-up study with two study arms using the two shoulder prosthesis promos™ standard (group a) and promos reverse™ (group b). the study will collect efficacy and safety data over 10 years.

primary objective of the study: the primary objective is to quantify patient benefit after primary total shoulder arthroplasty with the modular promos™ shoulder system in a multicenter cohort study (real world approach). patient benefit will be quantified using objective and validated subjective measures of function, activities of daily living (adl) and quality of life (qol). secondary objectives: * rate of implant related findings like radiological loosening of the glenoid and complications like intraoperative stem fissures * prosthesis survival at common time points, e.g. 5 and 10 years

Eligibility criteria:
eligibility: * ages eligible for study: minimal age of 18 years * genders eligible for study: both * accepts healthy volunteers: no inclusion criteria: * primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty * massive rotator cuff rupture * willing an able to give written informed consent to participate in the study including follow-ups exclusion criteria: * previous ipsilateral shoulder arthroplasty (group a and b) * late stage rotator cuff disease (only group a) * acute shoulder trauma (group a and b) * general medical contraindication to surgery (group a and b) * legal incompetence (group a and b) * tumour / malignoma (group a and b) * recent history of substance abuse (group a and b) * any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) (group a and b) * known hypersensitivity to the materials used (group a and b) * bacterial infection at the time point of operation (group a and b)

Keywords: omarthrosis shoulder joint
dose escalation study of simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer

Conditions: Locally Advanced Cervical Cancer

Summary: this will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with locally advanced cervical cancer. following screening to confirm eligibility patients will commence a six week treatment period. after this, patients will be followed up by visits to clinic every 3 months for a period of 24 months (2 years). end of study is defined as 24 months after treatment. patients will be followed up for a minimum of 5 years (as per local policy) after treatment.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed squamous cell carcinoma, adenocarcinoma or poorly differentiated carcinoma of the cervix 2. figo stage iib-iva (any pelvic nodal status) and figo stage 1b2 and iia with pelvic nodal involvement 3. measurable disease on mri 4. age \> 18 years (no upper limit) 5. who performance status 0,1 6. adequate renal function with edta clearance\> 55ml/min 7. adequate liver function, as defined by alt or ast less than 2.5 x uln, and bilirubin less than 1.25 x uln 8. adequate bone marrow function, defined by wcc \>3.0 x 109/litre, neutrophils \> 1.5 x 109/litre and platelets \> 100 x 109 /litre 9. able to understand and give written informed consent exclusion criteria: 1. evidence of common iliac or para-aortic nodal involvement, or distant metastases 2. previous history of cancer except skin tumour 3. previous pelvic radiotherapy or surgery other than toparoscopic node disection 4. previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus 5. females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy if required. acceptable contraception should be used such as barrier or hormonal methods. 6. females must not be pregnant or breastfeeding

Keywords: cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma stage ib cervical cancer stage iia cervical cancer stage iib cervical cancer stage iii cervical cancer stage iva cervical cancer
multi-component, kindergarten-based, family-involved intervention for the prevention of childhood obesity:the toybox-study

Conditions: Prevention of Childhood Obesity

Summary: the toybox proposal addresses knowledge-based bio-economy (kbbe)-2009-2-1-03 - behavioural models for prevention of obesity, with a particular focus on children. it will primary aim to influence children's behaviours and prevent obesity in early childhood. the proposal will identify key behaviours related to early childhood obesity and their determinants and evaluate behavioural models and educational strategies. based on the obtained insights at a local level, a multidisciplinary team will develop and implement a school based family involved intervention programme that could be applied on a european scale. process, impact, outcome and cost-effectiveness evaluation will be conducted to support decision making for european public health policy. the combined use of precede-proceed model and intervention mapping will provide the framework for the development, implementation and evaluation of the toybox intervention. to achieve this, the project will be subdivided into 10 work packages (wps). this carefully planned stepwise approach will include systematic reviews, secondary analyses of existing data sets, focus group research and school policies overview. the toybox project consortium spans the necessary multidisciplinary variety of experts such as public health experts, epidemiologists, nutritionists, physical activity experts, pedagogists, psychologists, behavioural scientists, nutritionists, paediatricians, early childhood psychologists, health economists, totalling 15 partners, from 10 countries. the consortium, consists of 11 universities, 1 research institute, 2 advocacy groups and a small to medium enterprise (sme) representing all regions of europe. the consortium has ample experience in conducting and coordinating multi-centre international research as well as undertaking dissemination activities to all relevant stakeholders.


Eligibility criteria:
inclusion criteria: * children aged between 3.5 and 5 years at the time of recruitment (i.e. born between january 2007 and december 2008) * signed consent form provided by parents/caregivers * not participating in any other clinical trial or other health-oriented project during the academic years 2012-2013 and 2013-2014
immunogenicity and safety of a live attenuated varicella vaccine in children aged 1-12 years

Conditions: Chickenpox Vaccines

Summary: immunogenicity and safety of a live attenuated varicella vaccine in children aged 1-12 years: a phase iii, randomized, double-blind, active-controlled study


Eligibility criteria:
inclusion criteria: * ages ranging from 1 to 12 years for the general healthy population ; * obtain informed consent from the volunteer and/or their legal guardian, and sign the informed consent form; * the volunteer and/or their legal guardian is able to comply with the requirements of the clinical trial protocol; * axillary body temperature ≤37.0℃. exclusion criteria: * those who have previously been vaccinated against varicella, have a history of varicella or herpes zoster infection; * allergy to known components of the study vaccine, or a history of severe allergic reactions to any vaccination; * a history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders; * individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or hiv-related immunocompromised individuals, or those with family members closely exposed to congenital immune diseases; * those with congenital malformations, developmental disorders, or severe chronic diseases (such as down syndrome, diabetes, sickle cell anemia, neurological disorders, guillain-barré syndrome); * known or suspected concurrent diseases, including respiratory diseases, acute infections, or active chronic diseases, cardiovascular diseases, skin diseases, severe hypertension, or during treatment for malignant tumors; * diagnosed with coagulation dysfunction (e.g., deficiency of coagulation factors, coagulation disorders, platelet abnormalities) or significant bruising or coagulation disorders; * receipt of blood products within the past 3 months; * receipt of attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days; * acute illnesses or acute exacerbations of chronic diseases in the past 7 days; * a history of high fever (axillary body temperature ≥38.0℃) within the past 3 days; * any other factors deemed by the investigator as unsuitable for participation in the clinical trial.
sarcopenia and orthostatic hypotension

Conditions: Orthostatic Hypotension; Sarcopenia

Summary: elderly patients generally have a tendency for having sarcopenia which refers to muscle loss that may be related to many factors. these patients also have a tendency to falls and injuries. whether elderly sarcopenic patients have abrupt blood pressure drops upon standing remains unknown. therefore, in this study, we sought to determine the incidence of orthostatic hypotension in sarcopenic elderly patients and compare it with elderly patients with no sarcopenia.


Eligibility criteria:
inclusion criteria: * patients 75 years or older exclusion criteria: * pace-maker * end stage renal insufficiency * end stage malignancy * dehydration * severe anemia ( hgb \< 8 gr/dl) * acute infection * marked edema * neurodegenerative disease

Keywords: blood pressure elderly sarcopenia fall
pain relief by intra-peritoneal ropivacaine during gynecological laparoscopy

Conditions: Laparoscopic Surgical Procedures

Summary: in our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy. * the patient is not participating in other medical study at present or in the last 30 days. * the patient signed on an informed consent. * age 18 years and above. * asa (american society of anesthesiologists) physical status grade 1- 2. exclusion criteria: * allergy to ropivacaine, other local anesthetics or other medications listed in the protocol. * the patient is participating in other medical experiment at present or in the last 30 days. * acute pelvic inflammatory disease. * coumadin or aspirin treatment. * asa physical status grade 3-4. * age \< 18 years. * significant arrythmias * analgesic treatment for chronic pain

Keywords: ropivacaine laparoscopy intraperitoneal nebulization pain local analgesic gynecology