Kornimate/medical-research-clean huggingface dataset:
prostate immobilization device used during radiation treatments to decrease rectal bleeding

Conditions: Prostate Cancer

Summary: during 3d-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. the purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.

* mri using an endorectal coil done prior to treatment for staging. * baseline quality of life (qol) assessment will be completed prior to treatment. * total androgen suppression is initiated and will continue for at least 6 months. * prostate immobilization device (pid) placed during the planning session. * pid will be placed daily for the first 15 3d external beam radiation treatments. * qol assessment and follow-up will take place every 6 months for 3 years.

Eligibility criteria:
inclusion criteria: * biopsy proven prostate cancer * clinical stage t1 - t4 * negative bone scan * psa and routine blood work * \>30 years of age * ecog performance 0,1, or 2 * no prior pelvic radiation * no pacemaker exclusion criteria: * inflammatory bowel disease (crohns, or ulcerative colitis) * prostatic rectal fistula * stricture of anal canal

Keywords: total androgen suppression simulation 3-d conformal external beam radiation therapy intra-rectal immobilization device quality of life assessment questionnaire rectal bleeding late effects
treatment of acute pericarditis with anakinra

Conditions: Acute Pericarditis

Summary: the goal of this study is to determine the safety and efficacy of anakinra for the treatment of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7 days. 1. to determine the efficacy of anakinra with respect to chest pain resolution 2. to determine the safety of anakinra with respect to adverse drug events

acute pericarditis is a clinical syndrome characterized by a profound inflammation of the membrane tissue that surrounds, supports and protects the heart. acute pericarditis can be caused by a variety of infectious and non-infectious agents, but it most commonly either follows a viral infection of the upper respiratory tract or has no apparent cause. acute pericarditis occurs rather abruptly in previously healthy individuals, generally a child or young adult. most cases of acute pericarditis resolve within a few days with non-steroidal anti-inflammatory drugs. however, patients experience severe chest pain and are at high risk for life-threatening complications involving the pericardium, such as pericardial tamponade. acute pericarditis is diagnosed in 1 in 20 (5%) ed visits for chest pain. anakinra (kineret) has been shown to treat and cure refractory and recurrent pericarditis. this study is aimed at determining whether anakinra is also effective as first line treatment in acute pericarditis.

Eligibility criteria:
inclusion criteria: * age ≥12 years in presence of a parent able to provide consent or age \>18 years * first or recurrent episode of acute pericarditis, defined as the presence of at least 2 of the following: * chest pain (suggestive of pericarditis and not explained by another condition) * pericardial friction rub on physical exam * st-segment elevation and/or pr depression on ecg * new or worsening pericardial effusion * pain of moderate-to-severe intensity (pain score ≥6 on a scale of 0-10 where 0 is no pain at all and 10 is the worst pain ever experienced) at time on enrollment * ability to provide written informed consent if 18 years or older or to provide assent in presence of parental consent if 12-17 years of age exclusion criteria: * pericarditis due to known bacterial or fungal infection * pericarditis due to known malignancy * pericarditis after cardiac surgery * tamponade or need for pericardiocentesis for diagnostic/therapeutic purposes * pregnancy or breastfeeding * hypersensitivity to anakinra, latex or products derived from escherichia coli * chronic pain syndrome or chronic use of analgesic drugs

Keywords: anakinra kineret pericarditis
case notes review on patients with hereditary haemorrhagic telangiectasia

Conditions: Telangiectasia, Hereditary Hemorrhagic

Summary: this observational study is for individuals with hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations that are reviewed at the hammersmith hospital, london.

the hammersmith hospital provides a clinical service for patients with hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations that is unique in the united kingdom. measurements obtained as part of standard clinical practice that has evolved since 1985 allow us to assess whether particular groups of individuals that we see are more prone to recognised complications such as strokes, brain abscesses, pregnancy related complications or pulmonary hypertension. we hypothesise that certain clinical characteristics will predict the susceptibility of individuals to particular complications.

Eligibility criteria:
inclusion criteria: * patients attending hammersmith hospital exclusion criteria: * none

Keywords: pulmonary arteriovenous malformations
non-interventional long term follow-up study of participants previously enrolled in the starlight study

Conditions: Stargardt Disease

Summary: the current study is a non-interventional long-term safety follow-up of the subjects who completed starlight, in accordance with fda guidance on recipients of human gene therapy products.

this study is designed to follow subjects with stargardt disease (sd) previously enrolled in study ntxmco-004 (starlight, nct05417126). in that study, all 6 enrolled subjects received mco-010, an ambient light-activated, multi-characteristic opsin (mco) transgene in an adeno-associated virus serotype 2 (aav2) vector via intravitreal injection (ivt). mco-010 has the potential to restore vision irrespective of the underlying gene mutation, and because it is directed at bipolar retinal cells, intact photoreceptors are not required. further details on mco-010 and the underlying disease under investigation are included in the protocol for starlight and are not repeated herein

Eligibility criteria:
inclusion criteria: * subjects are eligible to be included in the study only if all of the following criteria apply: 1. previously enrolled in study ntxmco-004 study 2. able to comprehend and give informed consent. 3. able to comply with testing and all protocol tests. 4. agree to participate for the full 4-year study duration to the best of their ability and barring any unforeseen circumstances. exclusion criteria: * not applicable. subjects will be included in this study and will be consented after completion of all assessments at the week 48 visit for the starlight study

Keywords: eye diseases retinal degeneration retinal dystrophy eye diseases, hereditary
enhancing epilepsy management with precision deep brain stimulation

Conditions: Epilepsy, Drug Resistant

Summary: the goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (dbs) programming for drug-resistant epilepsy in a prospective observational cohort study.

aim 1: to objectively monitor epilepsy burden with the provided sensing capabilities of the dbs leads by quantifying the association between neuronal activity and seizure frequency aim 2: to use the neuronal activity to inform programming of dbs for patients with epilepsy, and assess the impact on patient and caregiver quality of life and hospital costs. epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures that affects millions of individuals worldwide and poses a significant burden on their quality of life. despite considerable advancements in treatment strategies, approximately one-third of patients are considered to have drug-resistant epilepsy. patients with drug-resistant epilepsy frequently visit the emergency room, are hospitalized regularly, and have many seizure-related injuries. deep brain stimulation (dbs) offers a unique treatment option by delivering precise electrical pulses with surgically implanted electrodes to the specific brain regions responsible for seizures, disrupting the seizure pathways. long-term favorable findings showing significant seizure reduction at five-year post-implantation for patients who otherwise have no treatment options have convinced many centers to incorporate dbs into their healthcare practise. for assessing the treatment response in epilepsy, healthcare providers are dependent on patient-reported seizure diaries. recent research in dbs has focused on the biological implications of neuronal recordings through the implanted electrodes. these signals offer objective insight into brain activity, specifically epileptic burden, and offers potentially predictive capabilities. current research focuses on whether the sensing capabilities of dbs can provide reliable seizure burden detection, and whether this can be achieved with less demand on the patient. in this prospective observational cohort study, the researchers aim to improve the impact of dbs treatment on the seizure burden and quality of life of patients diagnosed with drug-resistant epilepsy in atlantic canada. this will be done by investigating the neural activity underlying epileptic events as a representation of epileptic burden, affording the opportunity to tailor dbs interventions with more precision and efficiency.

Eligibility criteria:
inclusion criteria: * patients qualifying for deep brain stimulation on the basis of drug-resistant epilepsy * informed consent exclusion criteria: * lack of consent * electrical or other devices that preclude the performance of an mri for pre-operative imaging

Keywords: deep brain stimulation dbs programming
a novel device for the management of adhd

Conditions: ADHD

Summary: this is a 2-months study, where eligible adhd adult participants will be provided with personalized vizo glasses.

this study was designed as a pilot single-center, open-label study of 2 months treatment. following the enrollment, the participants will go through an adjustment process where they will be fitted with a personalized pair of vizo glasses. the participants will be instructed to wear the glasses throughout the day for two months. a follow-up visit at the end of the 2-month treatment will be conducted to assess the efficacy of vizo glasses on managing adhd symptoms, using the conners continuous performance test-3, the adult adhd self-report scale (asrs), behavior rating inventory of executive function adults (brief-a), and clinical global impression-improvement (cgi-i) .

Eligibility criteria:
inclusion criteria: * documented history of primary adhd diagnosis by certified clinicians * age 18-40 y * written informed consent * able and willing to complete all required ratings and assessments exclusion criteria: * any current psychiatric / neurological comorbidity (e.g., epilepsy, autism, depression, tbi, etc), other than adhd * adhd medications (stimulants, non-stimulants, other) * neurofeedback, cognitive training

Keywords: adhd peripheral retinal stimulation non-pharmacological
vitamin d during in vitro fertilisation (ivf) - a prospective randomized trial

Conditions: Pregnancy Complication

Summary: during ivf treatment women will be randomized into supplementation with a high or a low dose of vitamin d main outcome laboratory pregnancy, live pregnancy at 12 weeks, baby take home rate, ohss secondary outcome: 1. pregnancy complications (pregnancy hypertension, sga, diabetes) 2.thrombin generation


Eligibility criteria:
inclusion criteria: * all women initiating ivf treatment exclusion criteria: * women that have entered the study before

Keywords: pregnancy rate (pos test, live fetus at 12 weeks, baby home) pregnancy complication (pregnancy hypertension, sga, diab) thrombin generation
is the current threshold for diagnosis of "abnormality", including non st elevation myocardial infarction, using raised highly sensitive troponin appropriate for a hospital population? the chariot study

Conditions: Myocardial Infarction

Summary: currently when defining the upper limit of normal (uln) or 99th percentile of a troponin assay manufacturer's use a healthy population traditionally aged 18-40. the 99th percentile value is the recommended value to use when diagnosing patients with an acute myocardial infarction. with the advent of the new highly sensitive troponin assays it has become clear that many patients have a troponin level above the 99th percentile when they have not suffered a myocardial infarction. we believe part of the problem with interpreting the the troponin values for patients is that the 99th percentile value which determines the uln has been derived from population that is very different to the hospital population of patients. this study aims to demonstrate what the 99th percentile is for the population of people who use the hospital services who are traditionally older and have more comorbidities when compared to the population traditionally used to define the 99th percentile of a troponin assay. an amendment was approved to follow-up patients' clinical outcomes at 1 year using nhs digital data.


Eligibility criteria:
inclusion criteria: * adult patients (aged 18 years or older). * biochemistry blood sample already taken as part of routine clinical care. exclusion criteria: * individuals aged less than 18 years old. * no biochemistry blood sample taken as part of routine clinical care. * biochemistry samples requested by general practitioner

Keywords: myocardial infarction highly sensitive troponin hospital population 99th percentile upper limit of normal
interrupting sitting with high intensity exercise on vascular function in adolescents before and after a mixed meal

Conditions: Cardiovascular Risk Factor; Endothelial Dysfunction

Summary: this study aims to investigate the effect of interrupting a three hour bout of prolonged sitting with high intensity interval exercise on lower limb blood vessel function in adolescents before and after a mixed meal challenge.

participants will be required to visit the laboratory on three separate occasions. the first of which will be a preliminary visit to collect anthropometric data (e.g. stature and body weight) and participants will complete a combined ramp-incremental and supra-maximal test to exhaustion on a cycle ergometer to determine the work rate for the exercise in the subsequent experimental visits. for the two experimental visits, participants will arrive to the laboratory after an overnight fast and an activpal accelerometer will be attached to the midline of the participants' thigh for the duration of the visit to quantity sitting time. lower limb macro and micro-vascular function will be assessed using a single protocol through flow mediated dilation of the popliteal artery and post-occlusive reactive hyperaemia in the capillaries of the calf. participants will then either sit for three hours or have this three hour sitting period interrupted with high intensity interval cycling exercise at 30, 90 and 150 minutes. vascular function will then be reassessed before participants will be given a mixed meal challenge (58.4 g fat and 53.4 g sugar) with a three hour postprandial period where the participants will remain seated for the duration. at the end of the postprandial period, vascular function will be reassessed. blood pressure, heart rate and calf circumference will be assessed hourly throughout the experimental day. in addition, capillary blood samples will be collected at baseline, pre meal and each hour during the postprandial period and assessed for changes in plasma glucose, triglyceride, cholesterol and insulin concentrations. participants will be transported to the toilet by wheelchair to limit the amount of walking undertaken during the sitting period and this activity will be quantified by the activpal accelerometers.

Eligibility criteria:
inclusion criteria: * male and female adolescents * 12-15 years exclusion criteria: * medications known to affect blood pressure, carbohydrate or fat metabolism * allergies to the test meal e.g. dairy or gluten * contraindications to exercise * individuals with special educational needs that mean they are unable to fully comprehend the demands of the study procedures

Keywords: flow mediated dilation reactive hyperaemia endothelial function paediatrics physical inactivity
the mcgill raas-covid-19 trial

Conditions: COVID-19; Cardiovascular Diseases

Summary: coronavirus disease (covid-19) related pneumonia significantly impact patients with underlying cardiovascular (cv) conditions. animal studies suggest that drugs commonly used to treated cv diseases may increase the ability of covid-19 to infect cells. the raas-covid-19 trial aims to assess whether temporarily holding these cv drugs in patients who are admitted with covid-19, versus continuing them, in patients admitted with covid-19 can impact short term outcomes.

open-label, pragmatic, randomized, study of approximately 40 adults. the following groups of participants will be considered: i) within 48 hours of diagnosis of covid-19; ii) who have received a diagnosis of covid-19 from another facility and are within 48 hours of transfer to a study recruitment site (royal victoria hospital, montreal general hospital, and jewish general hospital \[all in montreal, quebec, canada\]). participants will be randomized 1:1 to an upfront temporary discontinuation) of raas inhibition for the duration of the hospitalization (and to consider re-initiate after day 7 of admission or on discharge) versus a strategy continuation of raas inhibition. re-initiation of held raas inhibition will be based on treating team's clinical judgement. the raas-covid-19 rct will evaluate whether an upfront strategy of temporary discontinuation of raas inhibition compared to the continuation of raas inhibition among patients admitted with established covid-19 infection and on chronic raas inhibition therapy impacts short term clinical outcomes and biomarkers.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * hospitalization with a covid-19 infection * chronically treated with raas blockers (ace inhibitors or arbs on the last prescription prior to admission with a treatment duration ≥ 1 month * diagnosis of covid-19 confirmed by the presence of sars-cov-2 on any biological sample * participants are within 48 hours of diagnosis of covid-19 or have received a diagnosis of covid-19 from another facility and are within 48 hours of transfer to a study recruitment site exclusion criteria: * shock requiring vasoactive agents. * requiring invasive mechanical ventilation. * history of malignant hypertension * use of five or more antihypertensive drugs. * history of heart failure with reduced ejection fraction * history of hospitalization for acute heart failure in past 3 months * history of hospitalization for hemorrhagic stroke in the past 3 months. * history of ckd with an egfr \<45 ml/min/1.73m2 * history of copd gold iii/iv * history of end-stage dementia * history of active liver cirrhosis * raas blockers therapy previously stopped \> 48h. * anticipated discharge in less than 24 hours. * history of current active cancer receiving chemotherapy * inability to obtain informed consent.

Keywords: renin angiotensin aldosterone coronavirus cardiovascular diseases covid-19
txa in the ems on the helicopter and the ambulance

Conditions: Bleeding

Summary: coagulopathy in trauma increases mortality and morbidity. early administration of tranexamic acid (txa) seems to improve survival and outcome. thus this study evaluates the administration of txa on scene by the emergency medical services (ems) or by the crew of a rescue helicopter in multiple trauma patients or isolated traumatic brain injury (tbi). coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry.

coagulopathy in trauma increases mortality and morbidity. early administration of tranexamic acid (txa) seems to improve survival and outcome; this was shown partially by the crash2 study, where patients received txa in the emergency room. thus this study evaluates the administration of txa on scene by the ems or by the crew of a rescue helicopter in multiple trauma patients or isolated tbi. coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry in 50 patients. the results will be compared to a study published by theusinger et al. (changes in coagulation in standard laboratory tests and rotem in trauma patients between on-scene and arrival in the emergency department.theusinger om et al. anesth analg. 2014 dec 24. \[epub ahead of print\] pmid: 25545751) where no txa was administered on scene and only changes in coagulation between on scene and in the emergency department were assessed.

Eligibility criteria:
inclusion criteria: * multiple trauma * traumatic brain injury exclusion criteria: * pregnant * \< 18 years * no txa * not speaking the german language
effectiveness and safety of bulevirtide (blv) therapy in patients with chronic hepatitis delta (chd) in italy (d-shield)

Conditions: Hepatitis D

Summary: multicenter pharmacological observational prospective, no-profit, study. this study was designed to get a "real-life" snapshot across several italian hepatology centers. all hdv patients are followed up according to easl 2017 guidelines. this allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. no off-label medications are used. all data are retrievable from the patient's medical record. in addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally. the primary objective of the study is to describe the virological response to blv in all patients starting blv therapy for chd, defined as a \>2 log decline in hdv-rna or undetectable hdv-rna (using the robogene 2.0 quantitative kit, llq \<6 iu/ml) at month 12 of therapy. hdv patients who will start therapy with blv 2 mg/day from may 2023, according to aifa guidelines, will be consecutively enrolled.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * chronic hepatitis delta * compensated cirrhosis hdv related * patients who will start therapy with blv 2 mg/day from may 2023 exclusion criteria: * hdv-related decompensated cirrhosis (cpt ≥7)
detection and analysis of mbc with heterogeneous er expression

Conditions: Breast Cancer

Summary: to investigate the treatment pattern and efficacy of mbc patients with er heterogeneity using a novel convenient way of 18f-fluoroestradiol positron emission tomography/computed tomography (18f-fes pet/ct).


Eligibility criteria:
inclusion criteria: * patients received 18f-fes pet/ct in fudan university shanghai cancer center from 2017-2021. * patients had both fes positive (fes+) and negative (fes-) lesions in fes exam. * patients received further treatment. exclusion criteria: * incomplete medical records.