Kornimate/medical-research-clean huggingface dataset:
talent aortic cuff stent graft system compassionate use registry

Conditions: Abdominal Aortic Aneurysms

Summary: an evaluation of the talent aortic cuff in patients with existing aneurx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an aneurx aortic cuff.

the primary purpose of this registry is to provide an endovascular means of treatment for those patients experiencing a sub-optimal outcome related to the implanted aneurx bifurcated stent graft and who are not deemed suitable candidates for treatment with an aneurx aortic cuff. a sub-optimal outcome is defined as either a type i or type iii endoleak and/or an inadequate seal zone (\< 1 cm). for registry purposes, a type iii endoleak will be defined as a proximal modular endoleak.

Eligibility criteria:
inclusion criteria: * patient \>= 18 years of age * patient has a serious disease or condition * no generally acceptable alternative for treating patient is available * patient has had the aneurx stent graft system implanted \>= 30 days * patient has suboptimal outcome with the aneurx stent graft system as evidenced by one or more of the following: * type i endoleak * type iii endoleak (proximal, modular) * loss of seal zone * proximal aortic neck diameter \>= 14mm and \<= 30mm * angle between axis of the suprarenal aorta and aneurysm neck is \<= 60 degrees * patient is able and willing to be available for 12,24,26,48 and 60 months post-procedure exclusion criteria: * patient is pregnant of lactating * arterial access cannot be crossed with a delivery system * excessive vessel tortuosity * excessive aortic calcification * aneurx stent graft system implanted within the last 30 days

Keywords: abdominal aneurysm endovascular aortic repair (evar) endovascular stent graft endograft
deep learning in retinoblastoma detection and monitoring.

Conditions: Retinoblastoma

Summary: retinoblastoma is the most common eye cancer of childhood. eye-preserving therapies require routine monitoring of retinoblastoma regression and recurrence to guide corresponding treatment. in the current study, we develop a deep learning algorism that can simultaneously identify retinoblastoma tumours on retcam images and distinguish between active and inactive retinoblastoma tumours. this algorism will be validated through a prospectively collected dataset.

retinoblastoma, the most common eye cancer of childhood, affects 1 in 15 000 to 1 in 18 000 live births. china has the second-largest number of patients with retinoblastoma in the world. eye-preserving therapies have been used widely in china for approximately 15 years. eye-preserving therapies require routine monitoring of retinoblastoma regression and recurrence to guide corresponding treatment. however, the major amount of qualified ophthalmologists are concentrated in several medical centres. deep learning based on retcam examination that can identify retinoblastoma will reduce screening accuracy of the local hospitals and reduce monitoring wordload. in the current study, a deep learning algorism was developed that can simultaneously identify retinoblastoma tumours on retcam images and distinguish between active and inactive retinoblastoma tumours. this algorism will be validated through a prospectively collected dataset.

Eligibility criteria:
inclusion criteria: * retinoblastoma patients undergo standard medical management. exclusion criteria: * the operators identified images non-assessable for a correct diagnosis, due to reasons such as blur and defocus, and excluded them from further analysis.
intra-arterial chemotherapy(chemosurgery) for retinoblastoma

Conditions: Retinoblastoma

Summary: conventional treatments of retinoblastoma involves laser photocoagulation, cryotherapy (freezing of the tumor), plaque radiotherapy,external beam radiotherapy, and intravenous chemotherapy. enucleation (removing of the eye)is the last option when the tumor cannot be controlled otherwise. however,many children with retinoblastoma present with advanced intraocular disease for which enucleation is the only option. intra-arterial chemotherapy (chemosurgery)delivers anti-tumor drug directly into the ophthalmic artery (the artery feeding the eye) in order to increase the dose of drug reaching the tumor while minimizing toxicity to the rest of the body.

present treatments for intraocular retinoblastoma cure 99% of children but have significant toxicity. enucleation of the eye is effective but blinds the eye and leaves a lifelong cosmetic deformity. radiation is associated with the subsequent development of fatal cancers. systemic (intravenous)chemotherapy is used worldwide but experience with it has shown that the majority of eyes initially treated with chemotherapy still require additional treatments, such as radiation, laser, cryotherapy or even enucleation. in addition blood transfusions, secondary infections, insertion of ports and permanent hearing loss are now well reported. three years ago we developed this technique of chemosurgery for significantly increasing the dose of drug to the cancer while decreasing the dose of drug administered to children. this approach has decreased the need for enucleation in advanced eyes scheduled for enucleation with minimal systemic toxicity. we now offer treatment of both eyes simultaneously (in bilateral cases) and to eyes with less advanced disease and normal vision as an alternative to toxic systemic chemotherapy. in cases of very advanced ocular disease we will be using multiple drugs infused at the same session to increase tumor kill. chemosurgery interventions are performed under general anesthesia. the femoral artery (artery at the groin) is punctured and a catheter (a small plastic tube)is advanced into the opthalmic artery (the artery of the eye)using fluoroscopic (x-ray) guidance. the drugs are injected directly into the opthalmic artery over a period of 30-45 min.the catheter is then removed, manual compression exerted to the femoral artery, the child is awaken and goes to recovery for 6 hours. the procedure is repeated every 3-4 weeks for a total of 2 to 6 sessions according to tumor response. since april 2006, our center has treated by chemosurgery 60 eyes in 52 patients with advanced intra-ocular retinoblastoma for which enucleation was considered.

Eligibility criteria:
inclusion criteria: * advanced retinoblastoma in one or both eyes * recurrent retinoblastoma after failure of conventional methods exclusion criteria: * retinoblastoma judged curable by conventional methods * patient judged unable to undergo the procedure

Keywords: retinoblastoma intra-arterial chemotherapy chemosurgery melphalan topotecan
nitrate - clopidogrel - acute coronary syndrome

Conditions: Acute Coronary Syndromes

Summary: this study aims to investigate whether intravenous nitrate given during non-st-elevation myocardial infarction (non-stemi) affects the platelet inhibition of clopidogrel.


Eligibility criteria:
inclusion criteria: * diagnosed with non-stemi * patients aged 18 to 75 years * positive troponin levels, * blood pressure above 120/70 mmhg exclusion criteria: * hemodynamically unstable and requiring urgent intervention, * st elevation on electrocardiography, atrial fibrillation, * recurrent angina, * use of narcotic analgesics (e.g., morphine), nitrates and glycoprotein iib/iiia inhibitors during hospitalization, * history of coronary artery bypass graft (cabg) surgery, * active infection, * uncontrolled hypertension, * diabetes, cerebrovascular accident, use p2y12 inhibitor, proton pump inhibitor, oral anticoagulant, statin, cyp enzyme-inducing or inhibiting drugs at the time of admission, * active systemic disease (e.g., malignancy, thyroid disorders chronic inflammatory diseases, liver dysfunction), * left ventricular systolic dysfunction (ejection fraction \<50%), * glomerular filtration rate \<60 ml/min/1.73m2, * allergy to asa or clopidogrel, coagulopathy, * platelet counts below 100,000/μl and hematocrit levels below 29%, or exceeding 52%.

Keywords: intravenous nitrate clopidogrel acute coronary syndrome
triggered palliative care for advanced dementia

Conditions: Alzheimer Disease; Dementia

Summary: the objective of this study is to generate preliminary data for a large multi-site randomized clinical trial of a model of palliative care consultation for patients with advanced dementia, and for their family caregivers.

alzheimer's disease and related dementias affect 5 million americans at an annual cost of $215 billion. dementia is a contributing cause for 1 in 3 deaths, and is the only major cause of death with no effective prevention or treatment. dementia-specific palliative care is needed to address the unique symptoms and treatment decisions relevant to this disease. investigators therefore propose to develop and pilot test a model of palliative care consultation for advanced dementia patients, triggered by hospitalization for a serious acute illness. after systematic refinement of operational protocols and tools with stakeholders, they will enroll persons with advanced dementia plus an acute illness associated with high risk of death in the coming year. patients will be enrolled with their family decision-makers (n=60 dyads) in a randomized feasibility trial. intervention dyads will receive specialty palliative care consultation during hospital admission, plus post-discharge collaborative care by their outpatient primary care provider and a palliative care nurse practitioner. control dyads will receive usual care. the research objective is to generate preliminary data for a large multi-site randomized controlled trial of a model of palliative care consultation for advanced dementia. specific aims are: aim 1: to develop a best-practice model of palliative care consultation for advanced dementia triggered by hospital admission for serious acute illness. aim 2: to conduct a pilot randomized trial of triggered palliative care consultation for advanced dementia (versus usual care) to demonstrate the feasibility of conducting a larger randomized trial.

Eligibility criteria:
inclusion criteria: * diagnosis of dementia from alzheimer's or other underlying cause * global deterioration scale (gds) stage 5, 6 or 7 * acute illness hospitalization exclusion criteria: * no english-speaking family decision-maker * primary physician expects study to be too stressful for family caregiver
cruz hbr registry - post-market registry to evaluate the safety and efficacy of the supraflex cruz stent

Conditions: Coronary Artery Disease

Summary: this is a prospective, multicenter, open-label, single-arm registry. the primary objective of this registry is to confirm the results of the supraflex cruz stent in real life all-comer patients (800 patients as in the supraflex arm of the talent trial) and demonstrate that the supraflex cruz stent is not inferior to the biofreedom stent in high bleeding risk (hbr) patients (400 patients) with respect to device oriented composite endpoint (doce) at 12 months. all patients will be followed up to 12 months after the index procedure.


Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years old 2. de novo or re-stenotic significant stenosis in at least one native coronary artery 3. patients with silent ischemia, stable angina, unstable angina or non-stemi eligible for pci (no limitation of the number of treated lesions and vessels, except higher tercile of syntax score assessed by the site) 4. target lesions suitable for pci with drug-eluting stent (des) diameter between 2.00 and 4.50 mm 5. total lesion length should be from 15 to 120 mm 6. patient is willing and capable to sign the written informed consent and comply with all requirements of the registry 7. planned staged procedures are allowed within 3 months using supraflex cruz stent only exclusion criteria: 1. syntax score \> 32 2. hemodynamic instability or cardiogenic shock 3. known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (dapt) medication required by current practice 4. subject is pregnant, nursing or is a woman with child-bearing potential 5. any co-morbid condition with life expectancy \< 1 year or that may result in protocol non-compliance 6. patients who are participating in another drug or device investigational study, which has not reached its primary endpoint 7. patients under judicial protection, tutorship or curatorship

Keywords: supraflex cruz sirolimus-eluting stent high bleeding risk coronary artery disease arteriosclerosis myocardial ischemia vascular diseases coronary intervention observational registry ultra-thin strut biodegradable polymer
survey of current management of orthopaedic complications in cmt patients

Conditions: Charcot-Marie-Tooth Disease

Summary: charcot-marie-tooth (cmt) disease is the most common inherited peripheral neuropathy. foot deformities are frequent complications in cmt patients and orthopaedic surgery is often required. as yet there are no systematic studies on the management of orthopaedic complications in cmt patients and the current approach varies between centres. this study is a survey with the aim of understanding the current surgical approach to orthopaedic complications in cmt. the target population includes orthopaedic surgeons who perform surgical procedures for foot deformities in cmt patients attending centres participating in the inherited neuropathies consortium (inc).

the study protocol consists of a survey addressed to orthopaedic surgeons. the survey will be completed once and it includes two different scenarios of typical cmt patients (one adult and one child). the orthopaedic surgeons will be asked which surgical procedures they would apply to each scenario: * forefoot cavus, * clawtoes and * hindfoot varus no medications or therapeutic agents are a component of this project.

Eligibility criteria:
inclusion criteria: * orthopaedic surgeons who perform surgical procedures for foot deformities in cmt patients attending centres participating in the inherited neuropatheis consortium (inc) * willing to complete survey exclusion criteria: * does not read or speak english * inability to provide informed consent
to examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.

Conditions: Diabetes Mellitus, Type 2

Summary: to examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * normal lung function exclusion criteria: * smokers
next generation sequencing versus traditional cultures for clinically infected penile implants: impact of culture identification on outcomes

Conditions: Penile Implantation; Infections

Summary: randomized prospective study to evaluate next generation sequencing (ngs) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes.

randomized prospective study to evaluate next generation sequencing (ngs) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes. eligible subjects will undergo a baseline/screening visit at which time the following will be collected: demographics/history/known allergies to antibiotics, symptom scoring questionnaire. drainage swabs or needle aspiration will be collected for standard culture and pcr/ngs and empiric antibiotics will start. subjects will be randomized into the culture arm or the ngs arm. if randomized to ngs: central id reviews result according to arm and offers recommendations. physician will treat based on antibiotic recommendations (based on positive pcr/ngs or positive culture, if negative then empiric treatment will be continued) adjusted for patients contraindications and co-morbidities if randomized to the traditional culture arm: physician will follow routine local standard of care. a follow-up visit will occur within 10 days of starting empiric antibiotic therapy to collect symptoms scoring questionnaire. a 2nd and final visit will occur 6 months after baseline to collect similar data to the 1st follow up visit.

Eligibility criteria:
inclusion criteria: * male penile prosthesis patients * age range: 18-80 * within 6 months of penile prosthesis surgery * at least 1 of the following: device part stuck to thinning skin, any drainage from the wound site, massive red and swollen genitalia parts, exposed penile prosthesis parts, draining open tract, draining hematoma exclusion criteria: * transgender / neophallus * not able to communicate or follow up well, or non-compliant * less than 18 or more than 80 years old * active addiction * main issue is implant pain

Keywords: next generation sequencing penile prosthesis infections
indicators of neuronal insult in newborns of covid-19 positive mothers.

Conditions: COVID-19 Pandemic

Summary: the coronavirus disease (covid- 19) is now a global pandemic that was first reported in china (wuhan) in december of 2019. multiple placental abnormalities including fetal and maternal vascular malperfusion have been described in pregnant women infected with (covid- 19). to date, there are far fewer reports about the specific effects of (covid- 19) in the newborns delivered for (covid- 19) positive mothers.

covid-19 in pregnant women has important impacts on perinatal and neonatal outcomes. authors reported positive covid infection in neonates born to covid-19 positive mother. the finding of a recent study suggested that intrauterine or intrapartum transmission is possible and recommended for further investigation. furthermore, reports showed newborns of covid-19 positive mother that suffered from catastrophic sequelae of hypoxic ischemic encephalopathy (hie). these events could be attributed to covid-19 positive status of the mother. neuron specific enolase is a biomarker for neuronal injury and synaptic dysfunction and have been correlated with tissue damage in different experimental models. the increased serum levels of neuron specific enolase are associated with the clinical outcome in patients with anoxic encephalopathy. neuron specific enolase can be a candidate for a diagnostic/prognostic biomarker for neuroinflammation in covid-19. additionally, the cytokines are candidate biomarkers after hypoxic-ischemic injury. macrophage migration inhibitory factor (mif) is a multifunctional protein that has been identified as proinflammatory cytokine and activates the production of inflammatory cytokines such as tumor necrosis factor-α, interleukin-1β, interleukin-6, and interferon. macrophage migration inhibitory factor plays a central role in controlling the inflammatory and immune response, which may be of particular importance during the development of organ dysfunction in covid-19 patients. furthermore, it carries out the apoptosis of the cells. significant increase of neuronal apoptosis and caspase-3 expression was demonstrated in the brain of neonatal mice exposed to hypoxic injury. there are a limited number of studies investigating the effect of the pandemic period on the brain of the newborns. with this study, we aim to determine the impact of the covid-19 outbreak on the neuronal functions in the neonates. the current study searches for a diagnostic/prognostic biomarker for neuroinflammation in neonate born to covid-19 positive mothers.

Eligibility criteria:
inclusion criteria: * the following inclusion criteria will be used (all necessary): covid-19 positive mothers, term newborn (\>37 completed gestational weeks), free from severe malformations. all infants will be examined generally, systemically and neurologically at birth for clinical assessment of hie if present and for detection of outcome of these neonates. exclusion criteria: * free from severe malformations
dietary sources of lysophospholipids

Conditions: Obesity; Cardiovascular Risk Factor; Hyperlipidemia

Summary: this study aims to test the hypothesis that dietary intake of phosphatidylcholine (pc) and lysophosphatidylcholine (lpc) acutely alters plasma lysophosphatidic acid (lpa) levels and autotaxin activity in normal weight and obese subjects.

lysophosphatidic acid (lpa) is a simple glycerophospholipid that is found at biologically-relevant levels in plasma and has important effects on isolated or cultured blood, vascular and fat cells. the main enzyme responsible for generation of plasma lpa is the secreted lysophospholipase d, autotaxin (atx). adipocytes contribute substantially to plasma atx levels. the investigators have demonstrated rapid production and metabolism of plasma lpa in animals. more recently, the investigators have observed that plasma lpa levels increase in mice fed a high fat ("western") diet in comparison to levels found in mice fed normal chow. the investigators have also found that diet-induced obesity increased circulating atx levels in mice. the investigators hypothesize that diet, and in particular dietary phosphatidylcholine (pc), may regulate the autotaxin substrate lysophosphatidylcholine (lpc), from which lpa is derived. obesity may amplify the response by increasing plasma atx levels and/or activity. the current study will test whether dietary pc in normal weight and obese subjects acutely alters lpa levels and autotaxin activity.

Eligibility criteria:
inclusion criteria: * age 18 to 60 years old * body mass index of 20 and above * must be able to consume a low fat meal, unlimited fruits and vegetables and not eating after midnight the night before the lipid tolerance test * report to the clinical research unit fasting (no food since the meal the night before) * able to consume a liquid meal consisting of a commercial nutritional product supplemented with fat * able to have an indwelling catheter placed on one arm and have hourly blood draws for 8 hours exclusion criteria: * unstable medical condition (recent or unstable cardiovascular disease) * active cancer * renal insufficiency glomerular filtration rate \<30 * use of steroids * chronic inflammatory conditions * use of anticoagulants, anti-inflammatory, or lipid-lowering medications * lipodystrophy * gi conditions that result in lipid intolerance * pregnant women have a tendency to be anemic and therefore will be excluded.

Keywords: lipids lysophosphatidic acid lysophospholipids phosphatidylcholine lysophosphatidylcholine autotaxin dietary
effects of skeletally anchored maxillary expander via two approaches of microosteoperforations

Conditions: Posterior Crossbite

Summary: study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion

dento-skeletal effects of skeletally anchored maxillary expander assisted with two approaches of microosteoperforations.

Eligibility criteria:
inclusion criteria: * all patients should satisfy the following criteria:- 1. an age range from 18-22. 2. transverse maxillary deficiency. 3. crossbite (unilateral or bilateral) 4. no previous orthodontic treatment. 5. good oral and general health. 6. no systemic disease/ medication that could interfere with otm. exclusion criteria: 1. history of systemic and medical illness. 2. history of extraction of permanent teeth. 3. previos orthodontic treatment. 4. poor oral hygiene or periodontally compromised patient. 5. patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.