Kornimate/medical-research-clean huggingface dataset:
mobile health application for adolescents with asthma

Conditions: Adolescent; Nursing Care; Asthma in Children; Self Efficacy

Summary: mobile health applications (mhealth apps) are an opportunity offered by developing technology which in widely used among youths. the evidence regarding mhealth apps suggests that the apps can be safer and more feasible if are developed by healthcare team. healthcare professionals have a major role to play in developing mhealth apps of good interventions.

this study aims at developing the mhealth application (youngasthma) and evaluating the effectiveness of youngasthma app on the mean score of the asthma control test and self-efficacy scale in adolescents with asthma. this study is a self-efficacy theory-based, 4-week, randomized parallel group study. participants will be randomized to either the intervention or control group in a 1:1 ratio. adolescents will be randomly allocated to intervention (youngasthma which is a user-focused mhealth app) or control group (usual care). the study protocol is conducted in accord with the standard protocol items: recommendations for interventional trials (spirit 2013 statement) (chan et al., 2013), the rct is perform by the consolidated standards of reporting trials (consort) (moher et al., 2010) and the mhealth app is identified according to the mera guideline (agarwal et al., 2016).

Eligibility criteria:
inclusion criteria: * having ability to speak, read and write turkish at a sufficient level, * having a diagnosis of asthma for at least a year, * having an asthma control test score of 19 or below, * having ability to use mobile devices, * having a mobile device with an internet connection to login to the mhealth app. exclusion criteria: * having an internet access problem, * having a psychiatric medical diagnosis

Keywords: asthma control nursing care mobile health self-efficacy randomized controlled trial adolescent
galectin-3 binding protein in cardiovascular disease and chronic heart failure

Conditions: Heart Failure; Cardiomyopathies; Coronary Artery Disease

Summary: the purpose of this study is to determine whether galectin-3 binding protein plasma levels can predict adverse cardiovascular events in patients with coronary artery disease and/or heart failure.

chronic heart failure represents an important cause of disease burden in western countries. heart failure can be either caused by vascular disease (i.e. cardiomypathy (cmp) due to coronary artery disease ("ischemic/icmp")) or by myocardial conditions (i.e. dilated cardiomyopathies (dcmp) resulting from other causes like familial disposition, drug toxicity, etc.). gold standard for the diagnosis of cmps is the coronary angiography in conjunction with left ventricular angiography and myocardial biopsy, non-invasive markers include c-reactive protein (crp) for icmp and brain natriuretic protein (bnp) for dcmp. we have previously identified g3bp to be overexpressed in foam cells and plasma-derived microparticles, both potentially important in formation of atherosclerotic plaque. galectin-3 binding protein (g3bp) is a secreted protein that is involved in cell adhesion and immune activation. the purpose of the current study is to test, whether g3bp plasma levels (a) are able to non-invasively differentiate causes of cmp and (b) are a suitable means for future risk assessment in cmp patients.

Eligibility criteria:
inclusion criteria: * impaired ventricular function exclusion criteria: * neoplastic disease * infections with hepatitis c or hiv
effect of intranasal midazolam versus ketamine midazolam combination as a premedication on the occurrence of postoperative respiratory adverse events

Conditions: Tonsillectomy; Adenoidectomy; Drug-Related Side Effects and Adverse Reaction

Summary: the aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of praes

perioperative respiratory adverse events (praes) are the most common complication during pediatric anesthesia furthermore, most children presenting for at have sleep-disordered breathing and obstructive sleep apnea syndrome (osas) caused by tonsillar hypertrophy which could aggravate the praes specially with the use of the conventional sedatives as a premedication. a recent randomized controlled trial has shown that more than 50% of children premedicated with midazolam had experienced praes . midazolam and ketamine are commonly used as preoperative sedative drugs for pediatric populations. ketamine is a safe and widely used sedative and analgesic in the pediatric emergency department (ed) with less profound effects on the upper airway and respiratory muscles. intranasal ketamine administration is well tolerated and without serious adverse effects. the addition of ketamine to midazolam as a preoperative sedation to reduce the occurrence of praes was not investigated before in children undergoing at. the authors hypothesize that combination of ketamine to midazolam could offer optimum sedation condition while reducing the occurrence of praes in children undergoing at.

Eligibility criteria:
inclusion criteria: * children both sexes male and female. * age from 3 to 12 years old. * asa grade i, ii. * undergoing elective at procedures. exclusion criteria: * congenital heart diseases (cyanotic and a cyanotic). * congenital syndromes affecting airway anatomy such as pierre-robin syndrome and down syndrome. * severe lung diseases affecting either lung tissue such as pulmonary cystic fibrosis and idiopathic pulmonary fibrosis or affecting lung circulation such as pulmonary hypertension with marked limitation of physical activity or inability to carry out any physical activity according to nhya classification. * recent upper respiratory tract infection (less than two weeks). * neuromuscular diseases including cerebral palsy and epilepsy.

Keywords: midazolam ketamine tonsillectomy respiratory adverse events
an observational multicenter clinical study to assess the safety and effectiveness of the omni® surgical system in pseudophakic eyes with primary open angle glaucoma (orion 2.0)

Conditions: Glaucoma, Open-Angle

Summary: the purpose of this study is to evaluate the safety and effectiveness of the omni® surgical system in subjects who have undergone canaloplasty and trabeculotomy using omni® surgical system without any concomitant surgery in pseudophakic eyes with mild to moderate primary open angle glaucoma (poag) at least 150 days prior to enrollment.


Eligibility criteria:
inclusion criteria: * treated with omni® surgical system as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma at least 150 days prior to enrollment. exclusion criteria: * systemic disease that, in the opinion of the investigator, would put the subject's health at risk and/or prevent completion of required study visits. * ocular pathology which, in the investigator's judgment, would either place the subject at increased risk of complications or contraindicate washout, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits).
sequential versus simultaneous use of vinorelbine and capecitabine in patients with metastatic breast cancer (mbc)

Conditions: Breast Cancer; Metastasis, Neoplasm

Summary: the primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with mbc.

the administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. this study was designed to explore whether sequential and simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the sequential way has better tolerability.

Eligibility criteria:
inclusion criteria: * signed informed consent. * female, ≥ 18 and ≤ 70 years. * histologically confirmed invasive breast cancer. * metastatic breast cancer. * ecog performance status of 0 to 2. * life expectancy of more than 3 months. * subject must have adequate organ function. * normal laboratory values: hemoglobin \> 90g/dl, neutrophils \> 1.5×10\^9/l, platelets \> 80×10\^9/l, serum creatinine \< 1.5×upper limit of normal (uln), serum bilirubin \< 1.5×uln, alt and ast \< 2.5×uln. * negative serum pregnancy test for women with childbearing potential. * good conditions for infusion and willing to have phlebotomy throughout whole study. * have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days. * have at least one target lesion according to the response evaluation criteria in solid tumors (recist) criteria. exclusion criteria: * pregnant or lactating females * history of other malignancy. however, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible * concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety * active or uncontrolled infection * known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure * concomitant with brain metastases * have received chemotherapy after metastasis

Keywords: metastasis chemotherapy breast cancer vinorelbine capecitabine sequential chemotherapy ttf
comprehensive long-term follow up of adults with arterial switch operation

Conditions: Transposition of Great Vessels

Summary: background: long-term outcomes in adults with prior arterial switch operation (aso) have not yet been well defined. the aim of this study is to elucidate incidence and predictors of adverse cardiac outcomes in a prospectively followed cohort of adults after their aso. methods: the comprehensive long-term follow up of adults with aso is a project within the european collaboration for prospective outcome research in congenital heart disease (epoch). it is designed as a prospective, international multicenter cohort study. consecutive patients (aged 16 years or more) with prior aso will be included at 11 european tertiary care centers. participants will be followed according to a standardized protocol following international recommendations, including standardized protocols for imaging and for exercise testing. main outcome measures are all-cause and cardiac-related mortality, rate of cardiac re-intervention, neo-aortic dissection, myocardial infarction, stroke, infective endocarditis, sustained atrial and ventricular arrhythmias, new-onset or worsening pulmonary hypertension and new-onset heart failure. secondary endpoints are frequency and progression of right ventricular outflow tract stenosis, neo-aortic root dilatation, neo-aortic valve regurgitation and ventricular dysfunction. the impact of demographic, anatomic (e.g. coronary artery anatomy) and functional variables on the above-mentioned outcomes, as well as quality of life and incidence of pregnancy related complications will also be assessed. aim: the prospective, international, multicenter epoch-aso study will provide a better understanding of adverse outcomes and their predictors in adults after aso. the results of the epoch-aso study may help to optimize future care of this novel patient cohort in adult cardiology.


Eligibility criteria:
inclusion criteria: * adults (≥16 years) * with transposition of great arteries or a taussig-bing anomaly * who underwent repair by an aso, and who are actively followed at one of the participating centers will be enrolled. exclusion criteria: * incapability of giving informed consent and previous heart transplant.

Keywords: transposition of the great arteries arterial switch operation coronary artery anomaly outcome
optilene® suture material for dermal sutures

Conditions: Laceration; Incision

Summary: in this non-interventional study, optilene® suture will be evaluated for skin closure in adult patients.

the study is designed as a prospective, unicentric and single-arm observational study to evaluate optilene® suture material for skin closure. the product under investigation will be used in routine clinical practice and according to the instructions for use (ifu). after operation the investigator will examine the patients at discharge, at 10±5 days after surgery (removal of the suture) and 30±10 days postoperatively.

Eligibility criteria:
inclusion criteria: * adult patients undergoing skin closure using optilene® suture material. * small (0.5 cm - 10 cm) linear minimally contaminated incision/laceration in the trunk, neck or extremities (in the event that more than one incision is performed in the same patient, only one incision will be included). * written informed consent. exclusion criteria: * emergency surgery. * transplant surgery. * pregnancy. * facial laceration or incision. * visible dirt in the wound. * non-linear shape. * patient with limb ischemia. * patient taking medication that might affect wound healing (i.e. cytotoxic antineoplastic and immunosuppressive agents, corticosteroids, nonsteroidal anti-inflammatory drugs (nsaids), anticoagulants). * patient with hypersensitivity or allergy to the suture material.
the ohio state university asthma registry

Conditions: Asthma

Summary: the purpose of this study is to collect information in order to identify people who have asthma and who may be good candidates to participate in one of the future asthma studies to be conducted at the ohio state university asthma clinical research center.

patients from the ohio state university division of pulmonary and critical care medicine will be sent a letter explaining the registry and asking about their interest in participating in this registry. the registry and all procedures related to their inclusion will be explained, opportunity to ask questions will be given and a consent document signed prior to any registry activity. information about the registry will be shared with the community by newspaper ads, internet postings, word of mouth, flyers, and other pulmonologists in central ohio. those potential registrants may choose to make an appointment to complete lung function tests at the asthma clinical research center. the registry and all procedures related to their inclusion will be explained, opportunity to ask questions will be given and a consent document signed prior to any registry activity. each participant will be asked to provide appropriate (general medical history, asthma history, current medications, past asthma medications, demographic information, weight height, smoking history, allergies, and prior surgeries. participants will be asked to complete an asthma control questionnaire, which will be scored to determine how well their asthma is controlled. all consented registrants will be given the opportunity to visit the ohio state university asthma clinical research center where an extensive lung function test (spirometry) will be provided. at the asthma clinical research center each registrant will perform at least three lung function efforts, then given two puffs of albuterol (a fast acting medication that opens airways). after a standard waiting period that meets the standards of the american thoracic society, a second set of lung function test will be done. the results of the second set of tests will reflect any reversibility in lung function levels, and will serve as an indicator that treatment may improve lung function. all participants will be given copies of all lung function tests, and the results of the test will be explained to them. all study procedures are provided without cost to the registrant.

Eligibility criteria:
inclusion criteria: * asthma * must be able to provide medical history exclusion criteria: * unable to give consent

Keywords: asthma registry for future asthmatic studies questionnaires lung function tests
effect of dehydroepiandrosterone (dhea) on hot flashes in postmenopausal women

Conditions: Hot Flashes

Summary: the purpose of the study is to evaluate the effect of daily oral intake of dhea 50 mg for 4 months on reducing vasomotor symptoms (hot flashes) compared to placebo administration in postmenopausal women.

humans, along with the other primates, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (dhea) and especially its sulfate dhea-s. the marked reduction in the formation of dhea-s by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. much attention has been given to the benefits of dhea administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid. this study proposes to study the effect of 50 mg oral dhea capsules during a period of 4 months administered to postmenopausal women experiencing 50 or more moderate to severe hot flushes per week. participants will be stratified by the number of hot flushes experienced per week. the two strata are: 50-70 or more than 70 hot flushes per week. during the study several biological and clinical parameters will be evaluated, as well as the reduction of the number of hot flashes and improvement of overall quality of life. subjects will be evaluated at specific time intervals during the study for the above mentioned parameters as well as tolerability and adverse reactions.

Eligibility criteria:
inclusion criteria: * healthy postmenopausal women with 50 or more moderate to severe hot flushes. * women between 40 to 70 years of age. exclusion criteria: * body mass index (bmi) of 35 kg/m2 or more. * significant metabolic and endocrine diseases. * diagnosis of cancer. * use of steroids or drugs that interfere with the metabolism of estrogen. * use of any systemic estrogen, progestin, or dhea in the eight weeks prior to randomization. * use of alternative therapies or natural products to treat postmenopausal symptoms in the four weeks prior to randomization. * palpable fibroids or uterine prolapse: grade 2 or 3. * cigarette smoking

Keywords: hot flashes menopause quality of life hot flushes
a study of tooth erosion in people with esophagogastric cancer

Conditions: Esophagogastric Cancer

Summary: the researchers are doing this study to find out more about what may lead to the loss of tooth enamel (the thin outer covering of the tooth) and how often it happens in people with esophagogastric cancer, colorectal cancer, pancreatic cancer, breast cancer, head and neck cancer, or non-small cell lung cancer, or a healthy volunteer.


Eligibility criteria:
inclusion criteria: * subject is willing and able to provide written informed consent. * patients with a history of esophagogastric, hnscc, pdac, crc, or nsclc or healthy controls * patients must be able to fully comprehend and complete the survey and be willing to have pictures taken of their teeth with a camera or intra-oral camera. * patients must be able to understand english language or have access to adequate translation services. * age ≥ 18 years old. exclusion criteria: * subjects without evaluable molars or with significant molar dental work precluding dentists from assessing enamel status, note: evaluable is defined as having bilateral assessable mandibular molars, or erosions present in the remaining assessable quadrants. * for healthy controls only, patients cannot have a non-skin cancer history nor presenting for a procedure evaluating reflux symptoms.

Keywords: tooth erosion gerd loss of tooth enamel 22-370
prospective study on cesarean wound outcomes

Conditions: Surgical Site Infection; Cosmetic Appearance of Cesarean Scar; Post Operative Pain

Summary: this study will investigate whether the placement of silver impregnated dressings beginning in the or will improve wound healing in patients undergoing cesarean delivery compared to traditional telfa pads. this study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the telfa pads. the study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard telfa dressings. investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.

this is a randomized, prospective study involving 660 patients undergoing cesarean sections at tampa general hospital. the control group (n=330) will receive standard telfa pad dressing and the treatment group (n=330) will receive the silver impregnated dressing. the primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at the 1-week and 6-weeks post operative visits. the secondary objective is to assess the cosmetic outcome of the cesarean incision observed at the 1-week and 6-week post-operative visits. a plastic surgery investigator will also conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks.the tertiary objective is to evaluate the amount of narcotic and non narcotic medicine consumed during the hospitalization and query the patient with regards to pain involving the cesarean wound at 1 and 6 week post-operative visits

Eligibility criteria:
inclusion criteria: * age 18 or older * elective and emergent cesarean deliveries * primary and repeat cesarean sections * transverse skin incisions (pfannenstiel) * low transverse uterine incisions * patients with or without the diagnosis of chorioamnionitis with antibiotic treatment prior to or after the delivery of the baby * single and multiple gestations * able and willing to provide written informed consent exclusion criteria: * patients that did not receive routine prophylactic dose of antibiotics in the operating room. * skin incisions other than pfannenstiel * uterine incisions other than low transverse * patients with known or discovered allergy to silver or nylon

Keywords: cesarean section incisions silver c-section wound infection scar appearance post operative pain
prospective surveillance for breast cancer-related lymphedema

Conditions: Breast Cancer

Summary: this randomized trial will test the effect of a prospective surveillance program for early detection and subclinical management of breast cancer-related lymphedema on the prevalence of chronic lymphedema.

design and setting: this trial is a multi-center single-blind trial involving five hospitals in denmark. procedure: all women booked for surgery for breast cancer at one of the study sites will be invited to participate. women, who provide written informed consent, will have bis measurements, and perform self-measurements of arm circumference. further, participants will complete a sociodemographic questionnaire which will be used to ensure recruitment of a representable sample. this data will be collected at the hospital of surgery at pre-treatment. after surgery, women who had \>6 lymph nodes removed and have planned radiation therapy will be randomized 1:1 into intervention or control.

Eligibility criteria:
inclusion criteria: * female; * ≥18 years; * surgery for breast cancer (unilateral and bilateral) including aldn with \>6 lymph nodes removed; * can effectively communicate verbally in danish; exclusion criteria: * surgery for breast cancer with slnb or \< 6 nodes removed; * pre-existing lymphedema (primary or secondary); * previous treatment for breast cancer; * pace maker; * conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).

Keywords: lymphedema prospective surveillance