Kornimate/medical-research-clean huggingface dataset:
holo cto proctoring study

Conditions: Percutaneous Coronary Intervention; Chronic Total Occlusion of Coronary Artery

Summary: assess microsoft hololens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex cto procedures

proctoring in medicine is related to better outcomes. specifically, in cto pci systematic proctoring has demonstrated improved success rates, and an increased ability to treat lesions that are more complex. most likely, proctoring together with operator volume is one of the foundations to the introduction and execution of cto procedures. proctoring traditionally involves an expert operator (proctor), visiting the institution, performing the procedure together with the local operator. this involves increased cost, and current travel restrictions makes traditional one-on-one proctoring challenging. this study aims to evaluate the microsoft hololens as a potential platform in proctoring and effective real time communication between pci operators located at different geographical locations. the proctor and the local operator interact using a head mounted mixed reality (mr) display, enabling the proctor to see the same image as the operator, from any distanced location.

Eligibility criteria:
inclusion criteria: clinical inclusion criteria: * stable angina pectoris, or dyspnoea as an angina equivalent * age ≥18 yrs. * able to provide written informed consent angiographic inclusion criteria: * one or more completely occluded coronary arteries with thrombolysis in myocardial infarction (timi) flow 0. an estimated occlusion duration of at least 3 months * absence of q-wave in ecg leads corresponding to the occluded vessel, or documented viability of the main territory by mri or echocardiography procedural inclusion criteria: * clinical indication for cto pci regardless of operative technique exclusion criteria: * stemi within 72 hours * cardiogenic shock * active bleeding or coagulopathy * life expectancy \< 2 years * relevant allergies (aspirin, clopidrogrel, ticagrelol, contrast compounds) * severe peripheral artery disease * clinical unstable angina
association between early childhood caries, low birth weight and nutritional risk factors: (cohort study)

Conditions: ECC; LBW Children

Summary: the aim of this study is to assess the ecc experience in children aged from 12 to 36 month with low birth weight children in comparison to normal birth weight.

dental caries is on the top list of most widespread chronic diseases in addition to be a major public health issue. dental caries is the single most common chronic childhood disease; it is 5 times more common than asthma, 7 times more common than hay fever and 14 times more common than chronic bronchitis. deciduous tooth decay was ranked as the 12th most prevalent condition, affecting 560 million children in the 2015 global burden of disease study. low birth weight and premature birth are highly related to infant mortality, perinatal infections and the poor growth and development of children. some risk groups have been identified, and attention should be focused on them so that preventive and health promotion measures are taken in an attempt to reverse this situation. one of these risk groups is composed of children born prematurely. prematurity may be a predisposing factor for the development of caries. there is a strong relationship between birth weight and infant mortality and morbidity and chronic diseases later in life. many studies discussed the association between birth weight and dental caries however the results were conflicting. knowledge of the association between low birth weight and the risk factors of ecc and the associated nutritional risk factors will improve the preventive and health promotion measures for this population.

Eligibility criteria:
inclusion criteria: * healthy children. * children aged from 12 to 36 month. exclusion criteria: * refusal of participation from the parents. * medically compromised children * major illness * child with special needs * any systemic disease that may affect caries experience. * any congenital deformity that may affect caries experience.

Keywords: ecc premature birth
support activities for the reduction of distress and pain in children during venipuncture

Conditions: Venipuncture

Summary: to evaluate the efficacy of health support activities (animal assisted intervention, clows, musicians) in the reduction of pain and distress in children undergoing venipuncture. hypothesis: the investigators expect a reduction in in pain and distress.

venipuncture is one of the most unpleasant procedures for children. previous studies demonstrated the effectiveness of distraction techniques in reducing anxiety and pain but no one compares the specific activities of animals assisted intervention (aai), clowns and musicians for this procedure. in the hospital involved in the present study, venipuncture service has a week schedule for health support activities. in specific days children can benefit of health support activities as part of routine care. aims of the present study are: evaluate efficacy of aai, clowns and musicians in the reduction of childrens' distress and pain during venipuncture with respect of a control group undergoing venipuncture in the days where health support activities are not scheduled; compare distress and pain levels between groups; evaluate caregiver's anxiety and its influence on child pain and distress; explore parents' and staff opinion.

Eligibility criteria:
inclusion criteria: * outpatients * scheduled to venipuncture * italian speaking exclusion criteria: * cognitive and/or developmental impairment

Keywords: pain, procedural child anxiety
mechanism of hypersensitivity reactions to iron nanomedicines

Conditions: Iron-deficiency

Summary: iron deficiency is common and when oral treatment is not sufficient intravenous application is indicated. hypersensitivity to intravenous iron nanomedicines is rare but does occur and little is known about the underlying mechanism but complement activation has been suggested. this is a purely exploratory study as it is not yet known whether in vitro complement activation can be stimulated by titration with iron preparations. these data will provide first empirical evidence of whether and to what extent complement activation occurs in this population.


Eligibility criteria:
inclusion criteria:group 1) * adult participants from 18-65 years of age * previous hypersensitivity reaction grades i-iv to intravenous ferric carboxymaltose (ferinject) group 2) * adult participants from 18-65 years of age * previous intravenous ferric carboxymaltose (ferinject) and no hypersensitivity reaction group 3) * adult participants from 18-65 years of age * previous hypersensitivity reaction grades i-iv to iron sucrose (venofer) group 4) * adult participants from 18-65 years of age * previous intravenous iron sucrose (venofer) and no hypersensitivity reaction exclusion criteria: * group 1)-4) • autoimmune disorder or immune deficiency

Keywords: hypersensitivity
incidence of non receptive endometrium in obese women

Conditions: Infertility

Summary: this study evaluates the incidence of non receptive endometrium in obese infertile women compared to infertile normal weight women using endometrial receptivity array (era) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's window of implantation, regardless of the histological appearance of the sample. an endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (hrt) cycle and the test is performed.


Eligibility criteria:
inclusion criteria: * infertile women: \> 1 year of regular unprotected intercourse without evidence of pregnancy. * normal uterus by 2d/3d ultrasound scan and/or hysteroscopy * no endometriosis * presence of both ovaries * \< 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies). exclusion criteria: * hydrosalpinx * stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy. * implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy) * recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)
share - symbicort and health economics in a real life evaluation

Conditions: Asthma

Summary: the purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for symbicort® given as a low maintenance dose plus as needed compared to a free combination of pulmicortâ and oxis® plus bricanyl® as needed, and symbicort fixed dosing plus bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.


Eligibility criteria:
inclusion criteria: * signed informed consent, * asthma, * previously treated with glucocorticosteroids and b2-agonist exclusion criteria: * history of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation
effect of iodine-containing multiple micronutrient during lactation on infant neurodevelopment

Conditions: Iodine Deficiency; Nutrition Poor; Development, Infant; Breastfeeding

Summary: the goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency. the main questions it aims to answer are: 1. what are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials? 2. what are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status? 3. how do iodine and iron interact with each other to affect thyroid function in the mother during lactation? participants will be randomized to receive a daily multiple micronutrient tablet containing iodine (unimapp) for 6 months postpartum, or routine postnatal care per ethiopia ministry of health. mothers will provide a breast milk sample and drop of blood at 3 and 6 months postpartum. infants will provide a urine sample and drop of blood, and have a neurodevelopmental assessment at 3 and 6 months. researchers will compare the groups that received the iodine-containing micronutrient supplement with the group that received routine care (ifa) and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.


Eligibility criteria:
inclusion criteria: * intention to breast feed at least 3 months * birth weight \>2000g exclusion criteria: * intention to primarily feed by alternative sources (formula, animal milk) * multiple pregnancy * infant with major congenital anomalies * infants with severe morbidity or developmental disorder * mother with hiv or chronic renal disease * plan to move out of study catchment area * does not agree to follow up or eeg/vep
remote monitoring in parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of this observational study is to learn about the usefulness of physical activity measures and tremor detection using wearable devices and smartphone video to detect and evaluate disease burden in people with parkinson's disease. participants will wear an activity tracker at home and complete a short research visit where they will make a video using a smartphone of themselves performing a fine motor task. they will wear the activity tracker for two weeks at home.

for all groups (there is no control group): at enrollment, the participants will complete a baseline survey that records participant sex, years since the diagnosis of parkinson's disease, current use of levodopa medication, and whether levodopa was taken today. next, a research nurse from neurology will complete the unified parkinson's disease rating scale (updrs) assessment. as part of this assessment, the researchers will make a video recording of part 3 (the motor assessment) as a gold standard for comparison with the participant-recorded videos. next, the participant will complete the pdq-39 (parkinson's disease questionnaire), a 39 item questionnaire about the quality of life. after completing the pdq-39, the researchers will provide the participant with a camera, small tripod, and a set of written directions about how to perform the updrs motor assessment. the goal with this task is to simulate a home recording session to uncover any issues and create preliminary data for validation of the home recording compared to the gold standard collected by the study team. the recordings will then be converted to x, y, z landmarks using mediapipe, running on uiowa hardware. after completing the video, the participant will complete a short survey about ease of making the video recording. after completing the baseline assessments, the research team will provide the participant with a fitbit inspire 3 activity tracker watch, configure the tracker to sync with their phone, and provide an overview of use. the participant will wear the activity tracker for 24 hours a day for the next 14 days except for if the device needs charging and when bathing. at 14 days, the research team will send participants a link to complete a web-based exit survey about their experience with the activity tracker during the study.

Eligibility criteria:
inclusion criteria * diagnosis of pd * current patient at uihc movement disorders clinic * owns a smartphone that is compatible with a activity tracker. exclusion criteria * non-english speaking * bedridden or uses a wheelchair the majority of the time * prisoner status * inability to provide own informed consent
a study of safety, reactogenicity and immunogenicity of hrv vaccine in hiv infected infants in south africa

Conditions: Infections, Rotavirus

Summary: the aim of this study is to evaluate the reactogenicity, safety and immunogenicity of gsk biologicals' human rotavirus (hrv) vaccine given concomitantly with routine vaccines including opv in hiv positive infants. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

hiv infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (who stages i and ii) of disease will be enrolled. the study will have two groups: group hrv and group placebo. three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. routine epi (expanded program on immunisation) vaccinations will be administered concomitantly with the study vaccines. at the time of first dose, subjects will be aged 6 to 10 weeks. this study will evaluate safety, reactogenicity and immunogenicity of the hrv vaccine relative to the placebo.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including 6 and 10 weeks of age at the time of the first vaccination. * written informed consent obtained from the parents or guardians of the subject * documented hiv status of the subject as confirmed by pcr. * hiv asymptomatic and hiv mildly symptomatic; stages i and ii disease according to who's most recent classification for hiv stages in infants and children. * born after a gestation period of 36 to 42 weeks. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * previous routine vaccination except opv, bcg and hbv vaccination at birth * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gi tract or other serious medical condition as determined by the investigator. * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine. * acute disease at time of enrolment. * gastroenteritis within 7 days preceding the study vaccine administration. * previous confirmed occurrence of rv gastroenteritis. * other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. * hiv moderately and severely symptomatic: stages iii and iv according to who's recent classification. * administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
parent-reported symptom assessments in children taking multiple medications

Conditions: Neurologic Disorder; Chronic Disease; Pediatric Disorder

Summary: this study plans to learn about how to measure symptoms (like tiredness or rash) in children with special healthcare needs who take 5 or more medications. sometimes symptoms change in severity over time or new symptoms develop. this can happen after a new medication is started. this can also happen after the dose of an existing medication is changed. the investigators believe that parents will be able to provide the best assessment of any symptoms that their child might be experiencing. this study asks parents to report any symptoms their child is currently experiencing.

an increasing number of children with complex chronic conditions (cccs) who have intractable illnesses or multi-organ dysfunction are exposed to daily polypharmacy. parents of children with polypharmacy often administer 5 or more medications each day, sometimes for months, including high-risk medications prescribed by many different specialists in multiple settings of care. while medications can be life-saving, polypharmacy increases the risk of additive adverse effects, drug-drug interactions, and can lead to serious adverse drug events (ades). pediatric ades result in over 4.3 million estimated ambulatory visits annually, including \>150,000 pediatric emergency room visits. despite the risks associated with polypharmacy, little is known about how polypharmacy escalates and how polypharmacy should be managed. to enable children to thrive at home using medications while minimizing unwanted symptoms, this proposal aims to implement a prospective, parent-reported symptom assessment system to guide and monitor pharmaceutical care for high-risk children. strategies to improve recognition of problematic symptoms will have a substantial impact on the health of children.

Eligibility criteria:
inclusion criteria: * neurological impairment * 5 or more scheduled medications * english- or spanish-speaking exclusion criteria: * receives primary care outside outside of the children's hospital colorado network of care

Keywords: neurological impairment pediatric complex chronic condition children with medical complexity pediatric polypharmacy
a prospective danish national registry of ptra in patients with renovascular hypertension

Conditions: Renal Artery Obstruction; Hypertension, Renovascular; Cardiovascular Diseases; Kidney Diseases

Summary: a prospective danish national registry of percutaneous transluminal renal angioplasty (ptra) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three danish centres offering ptra


Eligibility criteria:
eligibility criteria 1. true resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) and uncontrolled blood pressure confirmed by 24-hour ambulatory blood pressure monitoring. the 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. if the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmhg the patient can be evaluated for renal artery stenosis. 2. hypertension and intolerance or side effects of the antihypertensive treatment. hypertension is confirmed by 24-hour ambulatory blood pressure monitoring. the 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. if the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmhg the patient can be evaluated for renal artery stenosis. 3. progressive renal insufficiency (a reduction in egfr \> 5 ml/min/1,73 m2 per year) in patients with bilateral renal artery stenosis or in patients with renal artery stenosis and only one kidney. 4. recurrent heart failure/pulmonary edema and resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) that may not be attributed to non-compliance, reduced left heart ventricular ejection fraction/heart valve disease or other obvious explanations (atrial fibrillation, fever, hyperthyroidism etc.). if the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmhg after nurse-administered medication the patient can be evaluated for renal artery stenosis. 5. younger patients (\< 40 years) with hypertension (24-hour ambulatory blood pressure monitoring ≥ 130/80 mmhg after nurse-administered medication ) inclusion criteria: all of the following: 1. at least one of the above eligibility criteria 2. duplex doppler ultrasonography or renography investigations consistent with hemodynamically significant renal artery stenosis 3. ct angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection exclusion criteria: 1. if angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with ptra 2. ptra of a renal artery supplying a kidney which pre-ptra handles ≤ 10% of the total kidney function (with no blockage of the renin-angiotensin system) and has a kidney size \< 7 cm (length)
comparative effects of focused and unfocused (radial) eswt in the treatment of patellar tendinopathy.

Conditions: Patellar Tendinitis

Summary: there is no scientific study in the literature regarding the use of different extracorporeal shock wave therapies (eswt) in the treatment of patellar tendinopathy. in this study, we aim to investigate both the effectiveness of eswt and which type of eswt can be more effective in the treatment of patellar tendinopathy.


Eligibility criteria:
inclusion criteria: * engaging in active sports, being 18 years or older, history of activity-related knee pain in the patellar tendon or patellar insertion, symptoms lasting longer than 8 weeks (non-acute), visa-p score less than 80 before treatment, pain during knee loading on tendon or tendon it remains isolated in the limited part of the bone junction and does not spread to the entire patellar region (to differentiate patellar tendinopathy and patellofemoral pain). exclusion criteria: * being under the age of 18, acute knee or acute patellar tendon injury, chronic inflammatory joint diseases (rheumatoid arthritis, etc.), using immunosuppressive or corticosteroid medication in the last 6 months, previous knee surgery (in the anterior cruciate ligament or patellar tendon), knee in the last 1 month local (corticosteroid) injection, contraindications for eswt treatment (eg pregnancy, malignancy, coagulopathy), previous eswt treatment