Kornimate/medical-research-clean huggingface dataset:
study to evaluate the performance of the therma covid-19 rapid antigen test for detection of sars-cov-2

Conditions: Covid19

Summary: the therma covid-19 rapid antigen test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of sars-cov-2 nucleocapsid protein antigens in human saliva specimens. this test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of covid-19. the therma covid-19 rapid antigen test will be compared to a health canada approved rt-pcr covid-19 test. nasopharyngeal (for rt-pcr) samples will be collected at a covid-19 testing centre and saliva (for the rapid antigen test) samples will be collected and compared. the prospective, observational, feasibility study will test 300 participants to establish the performance characteristics of the test on saliva specimens.


Eligibility criteria:
inclusion criteria: 1. participant is willing to sign verbal informed consent form 2. age 12 or older and parents or legal guardians must consent for children as required by law. 3. participant is attending covid-19 testing centre for a nasopharyngeal swab sample 4. participant is willing to provide a self-collected saliva sample exclusion criteria: 1. participant has previously tested positive for covid-19 within the past 90 days

Keywords: saliva antigen rapid saliva test
ehra-paths: clinical and health economic evaluation of new care pathways

Conditions: Atrial Fibrillation

Summary: in elderly atrial fibrillation (af) patients, af is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. especially in elderly often more than two comorbidities are present. the presence of comorbidities also affects outcomes in af patients. current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid af patients and to reduce costs. the ehra-paths consortium set out to address this need for change in management for multimorbid, elderly af patients in europe through the development of new care pathways. the aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly af patients, compared to current standard care.


Eligibility criteria:
inclusion criteria: * newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent) * ≥65 years of age * willing and able to participate and to attend the scheduled follow-up visits. exclusion criteria: * atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.) * life expectancy of less than 1 year * participation in another clinical study (registry studies not included) * severe cognitive impairment / dementia (defined based on mmse and cdr scoring systems)
thermal imaging of the lung on a smartphone to differentiate bacterial from non bacterial causes of pneumonia

Conditions: Pneumonia, Bacterial; Infections, Bacterial

Summary: this is a study of up to 275 participants from birth to 12 months who are having a chest x-ray while a patient at the queen elizabeth central hospital in blantyre, malawi. participants will have thermal pictures of their chest taken by trained study staff using a smartphone and a flir one attachment. thermal images will be read by trained study staff to determine if bacterial pneumonia is present. results of the thermal images will then be compared to the results of the chest x-ray. if additional images of the chest are available, additional thermal images will be taken of the same location within 24 hours of the other image.


Eligibility criteria:
inclusion criteria: * patient at queen elizabeth central hospital in blantyre, malawi * having chest x-ray done to rule out pneumonia * thermal image can be taken within 24 hours of chest x-ray * parent/guardian provides written informed consent exclusion criteria: * none

Keywords: bacterial pneumonia children diagnosing pneumonia thermal imaging
improving physical activity and cardiac rehabilitation attendance using technology and behavioral economics

Conditions: Cardiovascular Diseases

Summary: the objective of this study is to test the feasibility of using behavioral economic interventions (gamification with and without loss-framed financial incentives) targeting daily steps counts to improve cardiac rehabilitation attendance.

cardiovascular disease (cvd) is the leading cause of morbidity and mortality in the united states. cardiac rehabilitation is a multifaceted physical activity program that incorporates medication adherence, smoking cessation, nutrition, and psychological counseling. implementation of cardiac rehabilitation among those with cardiovascular disease (including ischemic heart disease, heart failure, and valvular heart disease) has been shown to increase physical activity and reduce cardiovascular mortality, morbidity, and hospital readmission rates. cardiac rehabilitation carries a class i indication (standard of care) for post-acute coronary syndrome, post-percutaneous coronary intervention, in patients undergoing coronary artery bypass grafting/valve surgery, in patients with stable angina, and in patients with chronic heart failure per american college of cardiology guidelines. patient attendance and completion rates of a full regimen of cardiac rehabilitation therapy have been shown to be \< 40% of those referred, depriving many eligible patients of the benefits of cardiac rehabilitation. the objective of this study is to test the feasibility of using behavioral economic interventions targeting daily step goals using wearable activity monitors to improve cardiac rehabilitation attendance among patients already referred for cardiac rehabilitation. we will compare three groups of 30 patients each as follows: 1) behaviorally designed gamification with social support; 2) loss-framed financial incentives; and 3) behaviorally designed gamification with social support and loss-framed financial incentives.

Eligibility criteria:
inclusion criteria: * age greater than 18; * ability to consent; * patients with diagnosis of stable angina, chronic systolic heart failure, post- percutaneous coronary intervention, post-coronary artery bypass grafting surgery, post-acute myocardial infarction, and post-valvular repair who were discharged after an inpatient admission within the last 12 months; * smartphone or tablet compatible with application for the wearable activity tracking device; * independence blue cross health insurance coverage. exclusion criteria: * conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write english; * already enrolled in another study targeting physical activity; * medical condition preventing participation in a physical activity program; * prior or ongoing enrollment in cardiac rehabilitation; * baseline step count \> 7,500 steps per day

Keywords: cardiac rehabilitation physical activity wearable devices
web intervention for parents of youth with genetic syndromes (wings)

Conditions: Telomeric 22Q13 Monosomy Syndrome; Tuberous Sclerosis; Hamartoma Syndrome, Multiple; Fragile X Syndrome; Angelman Syndrome; Rett Syndrome; Chromosome 15Q, Partial Deletion; Creatine Deficiency, X-linked

Summary: the purpose of this study is to evaluate the effectiveness of an adapted, telehealth functional behavioral therapy (fbtsidd) specifically focused on promoting appropriate communication and behavioral strategies in individuals with syndromic intellectual and developmental disorders. participants will be asked to complete virtual study assessments at intake and then on a monthly basis for the duration of 3-6 months. in addition, participants will attend weekly or biweekly virtual intervention visits with a study therapist.


Eligibility criteria:
inclusion criteria: * age(s) 2-12 years old at time of enrollment * existing genetic syndrome based on clinical or genetic diagnosis and confirmed by medical records * documented diagnosis of global developmental delay (gdd) or intellectual disability (id) * estimated id in all ranges * disruptive behavior challenges determined to be clinically appropriate for remote, parent-implemented coaching based on clinician determination of acuity of problem behaviors * caregiver who is able to consent in english. * parent/caregiver available for weekly intervention sessions * stable psychosocial and psychiatric treatments 3 months prior to baseline visit. exclusion criteria: * high levels of aggression that mitigate remote or outpatient treatment as defined by clinician judgement and/or abc irritability scores above 20 (i.e., higher level of care needed than provided by study procedures) * medical or psychiatric instability that may limit study participation * meaningful change in medication or psychosocial interventions 3 months prior to baseline visit * limitations in technology access that may hinder participation in remote trial (e.g., declining support provided by study participation)
perinatal interpersonal psychotherapy group for distressed women

Conditions: Depression, Postpartum; Social Adjustment

Summary: this is the first perinatal interpersonal psychotherapy group (p-iptg) implemented for distressed women from pregnancy to postpartum. the feasibility and effects of p-iptg are explored.

this is the first perinatal interpersonal psychotherapy group (p-iptg) implemented for distressed women from pregnancy to postpartum. the feasibility and effects of p-iptg are explored. the third-trimester women were recruited as intervention and control group participants by a quasi-experimental design.

Eligibility criteria:
inclusion criteria: * women in the third trimester of pregnancy, at least 20 years old, able to read and write in chinese, and "depressed, anxious, or wishing to improve family relationships." exclusion criteria: * women with schizophrenia, substance use, or suicide risk.

Keywords: feasibility group psychotherapy interpersonal psychotherapy maternal depression perinatal adjustment
comparing uscom and echocardiographic hemodynamic measurements in children (cue study)

Conditions: Hemodynamically Stable; Critical Illness

Summary: the primary objective of this study is to evaluate the agreement between hemodynamic measurements obtained using the ultrasound cardiac output monitor (uscom®; uscom ltd., sydney, australia), and reference standards as determined by 2 dimensional echocardiography (2d-echo) measurements in a group of hemodynamically stable and unstable pediatric patients.

2d-echo is the standard-of-care tool for non-invasive hemodynamic assessments in children. the use of 2d-echo requires highly trained personnel, and assessments may take anywhere between 30-45 minutes. the feasibility of real time hemodynamic assessments is therefore limited with 2d-echo. uscom has been introduced as a non-invasive bedside hemodynamic monitoring tool that utilizes continuous-wave doppler ultrasound. as uscom is easily portable, and measurements take only several minutes and can be conducted by trained physicians or nurses, it has become an attractive method of real time hemodynamic monitoring of unstable patients. while uscom validation studies have been conducted in adult, neonatal and pediatric populations, the following concerns have been raised: a) pediatric data on the agreement between uscom and other standard methods of co measurement (i.e. 2d-echo, pulmonary artery catheterization) are conflicting with some studies reporting acceptable agreement, while others report poor agreement ; b) uscom validation and agreement studies were previously conducted in primarily hemodynamically stable populations. its performance in hemodynamically unstable and mechanically ventilated patients has not been studied to date in the pediatric population.uscom is currently being promoted as a real-time tool for assessing hemodynamic status, and directing the care of unstable children without adequate evidence. therefore, this study is essential to inform the validity of uscom and whether it can or should be used when 2d-echo for real time hemodynamic monitoring in children is not feasible or available.

Eligibility criteria:
inclusion criteria: * age under 18 years * patient fulfills clinical criteria for either study cohort * most responsible physician has ordered an echo study on the patient * written informed consent by parents/legal guardian/substitute decision maker, and assent where appropriate * patients with normal cardiac structure, no pre-existing primary cardiovascular disease or hemodynamically insignificant shunt lesions (i.e. hemodynamically insignificant atrial septal defect/patent foramen oval and ventricular septal defect exclusion criteria: * age ≥ 18 years * premature infants (born \<37 weeks gestation) admitted to the neonatal intensive care unit * known co-existing primary cardiac anomalies (i.e. aortic or pulmonary valve stenosis or regurgitation, aortic valve regurgitation, shunt lesions save for those mentioned above, and pericardial effusion) * prior enrollment in study

Keywords: uscom (ultrasound cardiac output monitor) 2d echocardiography agreement pediatrics
efficacy of an app for monitoring physical activity and weight of obese pregnant women (pas&pes)

Conditions: Obese Pregnant Women

Summary: this study evaluate the efficacy of an app for monitoring the physical activity and weight with a smart watch and the provision of virtual advice through messages with a mobile phone in obese pregnant women in the second trimester. half of the women will be randomized at the intervention group (app + smart watch) and the other half, to the control group who will receive the usual prenatal care.

randomized controlled trial among obese women. these women will be randomized in two groups in order to evaluate an improvement in several outcomes thanks to different strategies: intervention group (ig). an app for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care. control group. pregnant women will receive the usual prenatal care. main hypothesis: in the intervention group pregnant women will improve the weight gain adjusted to the preconception bmi, during pregnanacy, with respect to the pregnant women of the control group. secondary hypothesis. in the intervention group pregnant women will improve the physical activity.

Eligibility criteria:
inclusion criteria: * pregnant women with bmi ≥ 30 kg / m2 preconceptional * speak spanish fluently * viable singleton non-malformed fetus * 12-18 weeks of gestation * users of android or iphone smart mobile phone with internet connection exclusion criteria: * pregnant women users of a physical activity and weight monitoring app * pregnant women with type i or ii diabetes mellitus * pregnant women with psychiatric disorders * pregnant women with thyroid disorders * women with chronic hypertension * pregnant women who for some reason have contraindicated the performance of exercise or mobility problems that make it impossible to walk in a moderate way. * pregnant women who do not accept to participate in the study.

Keywords: pregnant women obesity mobile applications weight gain physical activity
the financial navigator program

Conditions: Financial Hardship

Summary: over one third of caregivers with a child admitted to the hospital for sick children (sickkids) reported having difficulty making ends meet. the sickkids medical-financial partnership (mfp) working group conducted in-depth interviews exploring financial needs and supports with selected caregivers in the neonatal neurodevelopmental follow-up program (nnfu). results identified financial stress (including difficulties with employment, high cost of living, poverty, food insecurity, inaccessible supports, benefit time lines, costs of therapy) as a major theme. caregivers generally supported the idea of hospital-based financial services. in this feasibility study we will trial a financial navigator program in the nnfu.

the objective of the current proposal will be to evaluate the feasibility of the financial navigator program in the nnfu. research question: what is the feasibility of a financial navigator program in the nnfu? setting: the nnfu program follows infants who had a neonatal intensive care admission. follow-up appointments are scheduled for when the infant is 4, 8, 12, 18 and 36 months of age. we will invite all families at their first appointment in the nnfu to participate in our study. study procedure: caregivers will be informed about the study at their child's first nnfu visit at 4 months. the clinical team will introduce the study and if interested, they will be approached by a research assistant (ra) to provide more details of the study. this can be in person at the clinic visit or in a follow-up phone call depended on families preference. if the caregiver provides consent, an appointment with the financial navigator will be arranged. intervention: "access to a financial navigator" we anticipate the financial navigator will meet at least 2 times and up to 2 additional visits, at a time convenient for the family. examples of financial services that will likely be offered by the financial navigator are tax filing, applying for benefits and financial counseling. the program will be flexible and family centered. families can choose if they would like to meet the financial navigator in person at the nnfu appointment, during another medical appointment, or at another time during a virtual visit. the financial navigator will be integrated into the existing sickkids resource navigation service. at the 18-month nnfu visit the study will be completed.

Eligibility criteria:
inclusion criteria: * caregivers with a child followed in the nnfu in sickkids will be invited to participate in our study. * caregiver needs to attend 4-month nnfu appointment. exclusion criteria: * there are no exclusion criteria.

Keywords: financial services neonatal neurodevelopment follow-up clinic
epirubicin cisplatin and fluorouracil (fu) combined with endostar in patients with advanced or metastatic gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the efficacy and tolerability of the ecf regimen (epirubicin, cisplatin and fu) combined with endostar-- a inhibitor of angiogenesis, in patients with advanced or metastatic gastric cancer (a/mgc).

although there is no standard regimen in the treatment of metastatic gastric cancer, ecf regimen (epirubicin, cisplatin and fu) is often considered as a reference regimen. and ecf regimen has been suggested as the first line therapy for a/mgc by fda. according to the result of a chinese phase iii clinical trial in metastatic lung cancer, endostar-- a new angiogenesis inhibitor prolonged the overall survival, time to progression and improved response rate. so we designed this clinical trial to evaluate whether endostar can bring survival benefits to patients with advanced and metastatic gastric cancer patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ecog performance scale ≤ 2 * at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan) * adequate hepatic, renal, heart, and hematologic functions (platelets\>80×109/l, neutrophil\> 2.0 × 109/l, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(uln), and serum transaminase ≤ 2.5×the uln) exclusion criteria: * pregnant or lactating women * concurrent cancer * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * neuropathy, brain, or leptomeningeal involvement * clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia * uncontrolled significant comorbid conditions and previous radiotherapy

Keywords: time to progression overall survival response rate quality of live toxicities
the reliability, validity, and responsiveness of the static balance test in patients with multiple sclerosis.

Conditions: Multiple Sclerosis

Summary: the aim of the study is to investigate reliability, validity, and responsiveness of the static balance test in patients with multiple sclerosis.

at baseline, the static balance test, berg balance scale, timed up and go test, functional reach test, four square step test, and one-legged stance test is applied to the multiple sclerosis group. the static balance test is repeated after seven days from the first application in patients with multiple sclerosis. healthy controls are going to perform only the static balance test.

Eligibility criteria:
inclusion criteria: * at least 18 years, * neurologist-diagnosed multiple sclerosis, * expanded disability status scale (edss) score \< 7, * able to walk 10 m with or without aids, * no ms exacerbation within the last 2 months, * use of stable medication in the last 2 months, exclusion criteria: * other neurologic disorder, * pregnancy, * orhopedic problems iaffecting gait and stance, * visual, auditory, orientational problems that could affect study results, * cardiovascular, pulmonary, and humoral disease.

Keywords: multiple sclerosis static balance test balance reliability validity
improving quality of care for hip-fracture patients: studies on fast-track surgery

Conditions: Hip Fractures

Summary: the aims of the studies are to examine the impact of delayed time to surgery for hip-fracture patients with regard to in-hospital complication rate and one-year mortality and to evaluate two different fast-track systems for hip-fracture patients with regard to patient outcome, complication rate and patient satisfaction.

the aims of the studies are to examine the impact of delayed time to surgery for hip-fracture patients with regard to in-hospital complication rate and one-year mortality and to evaluate two different fast-track systems, the hip process pathway and the ambulance process pathway, for hip-fracture patients with regard to patient outcome, complication rate and patient satisfaction.

Eligibility criteria:
inclusion criteria: * hip fracture exclusion criteria: * periprosthetic fractures * pathological fractures