Kornimate/medical-research-clean huggingface dataset:
performance comparison of the 25 gauge 20,000cpm hypervit dual blade vs. 10,000cpm ultravit vitrectomy cutter

Conditions: Vitrectomy; Epiretinal Membrane; Macular Hole; Vitreous Hemorrhage; Retinal Detachment

Summary: this prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. we plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.

in addition, we will measure the core vitrectomy duration by constellation vision system stopwatch. we will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. for our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age who are undergoing vitrectomy for the following conditions: * macular hole * epimacular membrane * vitreous hemorrhage * primary retinal detachment exclusion criteria: * patient who is * unable to give proper consent * previous vitrectomy or scleral buckle surgery * cases requiring silicone oil tamponed * undergoing repeated retinal detachment surgery * undergoing surgery for tractional diabetic retinopathy
dose titration of lisinopril in children aged 1 to 18 years with primary or secondary hypertension

Conditions: Primary Hypertension; Secondary Hypertension

Summary: this open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. this dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.


Eligibility criteria:
inclusion criteria: * parental consent must be granted * patient age: 1y - 18 y * documented diagnosis of hypertension as defined in the national heart, lung and blood institute (nhbli) 4th report, 2004 * no reversible cause found on diagnostic work-up for hypertension * children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension exclusion criteria: * pregnancy * sexually active girls can only be included in the trial if they use an adequate form of birth control; during and until 30 days after ending the trial * following abnormal laboratory values: hyperkaliemia (serum potassium \> 5.3mmol/l); anemia (hemoglobin \ 3 times the upper limit of reference range; total bilirubin \> 3 times the upper limit of reference range * abnormalities of the oral cavity that can influence intake of medication * known sensitivity to ace-inhibitors * known lactose intolerance * history of angioedema * unilateral or bilateral stenosis of the renal artery * diagnosis of heart failure (nyha class ii-iv) * history of coarctation of the aorta * current treatment with: other drugs influencing the renin-angiotensin-aldosterone system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs; aspirin; oral antidiabetic medication
evaluation of the efficacy of hifu treatment on rectal endometriosis symptoms.

Conditions: Endometriosis

Summary: rectal endometriosis (re) induces lesions associated with painful symptoms that can alter quality of life. high intensity focused ultrasound (hifu) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. focal one® is a transrectal hifu device, which is validated to treat prostatic cancer. in this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the hifu treatment of rectal endometriosis with focal one® hifu device on the acute pelvic pain 3 months after hifu treatment, in comparison to a sham group.


Eligibility criteria:
inclusion criteria: * patient 18 years of age or older, * rectal endometriosis on preoperative imaging with no other digestive location, * symptomatic patient (acute pelvic pain \> 3), in failure of drug treatment, * endometriotic lesion visible on ultrasound and confirmed on mri, * centralized mri, reviewed and validated by the mri review committee, * no current pregnancy and no pregnancy plan during the study period, * patient agreeing not to change her hormonal treatment throughout the study period, * patient accepting the constraints of follow-up defined in the framework of the study, * patient affiliated to french health insurance. exclusion criteria: * ongoing urogenital infection, * anorectal anatomy incompatible with hifu treatment, * overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible, * history of segmental rectal resection or discoid resection, * patient with an implant located less than 1 cm from the treatment area, * inflammatory disease of the colon, * allergy to latex, * no scheduled endometriosis procedures during study follow-up, * treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate * patient with contraindications to mri, * patient who has already received hifu treatment for a rectal endometriotic lesion, * patient who does not speak or read french, * patient deprived of liberty following a judicial or administrative decision, * patient in labor or nursing, * patient under guardianship or curatorship

Keywords: rectal endometriosis hifu focalone high intensity focused ultrasound
sars-cov-2 infection among healthcare workers

Conditions: COVID-19

Summary: at present, covid-19 vaccine is considered as the safest, economic and effective measure to prevent and control covid-19. adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. cellular immunity includes virus specific b cells and t cells, which can provide long-term memory immunity. for acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. however, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to covid-19 in peripheral blood and respiratory mucosa. this study will provide an important scientific basis for us to scientifically assess the risk of individual infection with covid-19.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. sars-cov-2 nucleic acid testing showed negative within 72 hours exclusion criteria: 1.do not consent to enroll in this study
the effect of combination therapy using li-eswt and pde-5 inhibitor in patients with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients

comparing the effect of combination therapy (li-eswt combined with pde5-inhibitor) vs single therapy (pde5-inhibitor) in mild to moderate erectile dysfunction patients. parameters used for comparation are ehs score, iief-5 score, vegf level and psv

Eligibility criteria:
inclusion criteria: * mild to moderate erectile dysfunction * married * sexually active * consenting to participate in the trial exclusion criteria: * psychological problems * spinal injury * history of malignancy * penile anatomy abnormalities * allergic and contraindications to tadalafil * on anti-mitotic drugs
cohort of chronic pain patients

Conditions: Chronic Pain

Summary: chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. the overall cost of chronic pain is estimated at around 300 billion euros in the eu. unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care. in order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-dol, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. the purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.

this first french e-cohort of chronic pain patients will allow real-life follow-up in order to generate big data including various information on chronic pain, associated-comorbidities, pain impacts on sleep, activity and psycho-emotional parameters, sociodemographic characteristics and pain treatments. these data will be collected with he edol tool (smartphone application for patients and web platform for caregivers in pain clinics), integrating numerous repeatable questionnaires, weekly barometers, a therapeutic education module and a conversational agent (chat bot). all of these data will also be linked with french health insurance care data in order to get an overview of comorbidities and patient care consumption in a medico-economic approach. the study will include 20 pain clinics and a minimum of 5000 patients followed for 24 months.

Eligibility criteria:
inclusion criteria: * all patients with chronic pain * patients equipped and regular users of a smartphone * non-opposition to participation in the study exclusion criteria: * patient unable to understand or answer questionnaires

Keywords: chronic pain e-health
intravenous thyroxine for heart-eligible organ donors

Conditions: Brain Death; Heart Failure

Summary: this randomized controlled trial will evaluate whether intravenous thyroxine infusion given to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more hearts transplanted than saline placebo

background: brain death frequently induces hemodynamic instability and cardiac stunning. impairments in cardiac performance are major contributors to hearts from otherwise eligible organ donors not being transplanted. deficiencies in pituitary hormones (including thyroid stimulating hormone) may contribute to hemodynamic instability and replacement of thyroid hormone has been proposed as a means of improving stability and increasing hearts available for transplantation. intravenous thyroxine is commonly used in donor management. however, small controlled trials have not been able to demonstrate efficacy. methods: this multicenter study will involve organ procurement organizations (opos) across the country. a total of 800 heart-eligible brain dead organ donors who require vasopressor support will be randomly assigned to intravenous thyroxine for at least 12-hours or saline placebo. the primary study hypothesis is that thyroxine treatment results in more hearts transplanted. additional outcome measures are time to achieve hemodynamic stability (weaning off vasopressors) and improvement in cardiac ejection fraction on echocardiography. discussion: this will be the largest randomized controlled study to evaluate the efficacy of thyroid hormone treatment for organ donor management. by collaborating across multiple opos, it will be able to enroll an adequate number of donors and be powered to definitively answer the critical question of whether treatment increases hearts transplanted and/or provides other hemodynamic benefits.

Eligibility criteria:
inclusion criteria: * declared dead by neurologic criteria (brain dead) * authorization for organ donation and research * on one or more vasopressors and/or inotropes exclusion criteria: * brain death declared more than 24 hours prior * only vasopressor is vasopressin * weight \< 45 kg (100 lbs) * known coronary artery disease or history of myocardial infarction * known valvular heart disease * prior sternotomy or cardiac surgery * donor at va hospital * received intravenous or oral thyroxine within past month * known hiv+ status * other reason donor is unable to receive study drug (determined by on-site personnel)

Keywords: organ donor
rehabilitation and quality of life assessment for soft tissue sarcoma treated with radiotherapy and surgery

Conditions: Soft Tissue Sarcoma

Summary: this is a pilot study with a feasibility lead-in evaluating the use of multimodal cancer rehabilitation in patients planning to undergo radiotherapy and surgical resection for extremity or superficial trunk soft tissue sarcoma (sts). at enrollment, patients will be assigned to either a pre-operative radiation or post-operative radiation cohort.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed soft tissue sarcoma of the extremity, or superficial trunk (abdomen or chest) * planning to receive radiotherapy and surgical resection * at least 16 years of age. * ecog performance status ≤ 3 * able to complete the cancer rehabilitation protocol safely, as determined by a treating physician. * ability to understand and willingness to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: * patients deemed ineligible for curative therapy by the treating medical oncologist, radiation oncologist, or surgeon. * patients with deep retroperitoneal or abdominal sts * patients who have received prior radiotherapy and, based on the treating radiation oncologist's opinion, may not safely be treated with protocol neoadjuvant radiotherapy. * currently receiving any investigational agents. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * pregnant and/or breastfeeding. women of childbearing potential must have a negative pregnancy test prior to starting radiotherapy. * hiv-positive patients whose cd4+ t-cell count is \< 350 cells/mcl. * receiving concurrent chemoradiation therapy
the health burden of primary biliary cirrhosis (pbc) in switzerland

Conditions: Primary Biliary Cirrhosis

Summary: pbc is a rare, autoimmune, cholestatic liver disease with genetic and environmental pathogenetic factors. data about epidemiology of pbc in switzerland are completely lacking. epidemiology can be a powerful tool in yielding important clues as to burden and etiology of diseases. in addition, the investigators study will be the first one carried out in the country on pbc, and therefore will raise disease awareness and create a network.


Eligibility criteria:
inclusion criteria: * pbc patients living in switzerland exclusion criteria: -
show me to help me

Conditions: Autism

Summary: this cohort observation, randomized controlled trial is intended to provide data that icons and non-verbal communication improve communication and cooperation with children with autism/communication delay and aid in the transition to an unfamiliar environment. it would lay the foundation for future studies and practices of using icons and pictures for the whole office visit to enhance communication between the patient and physician/nurse/medical staff and cooperation of the patient. 1. use icons during triage/check in process to decrease time and increase patient compliance. compare typical children to those with autism/communication delay. 2. use icons during blood draw to improve communication with patients, to help with patient understanding, and increase patient cooperation and decrease noise and length of procedure.


Eligibility criteria:
inclusion criteria: * established patients with a documented diagnosis * 4-18 years old * present to the neurodevelopmental center during the study period * lab study: given prescription for lab work that will be following the visit or the next day in the locust outpatient lab exclusion criteria: * \ 18 years old * new patient * diagnosis not documented * lab study: lab work will be drawn at another lab or more than 1 day later

Keywords: icons in clinic or office for patients with autism
investigating geographic atrophy insights (i-gain) natural history study

Conditions: Dry Age-related Macular Degeneration; Geographic Atrophy; Retinal Disease; Macular Degeneration; Macular Atrophy; Retinal Degeneration; Eye Diseases

Summary: an observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration

prospective, observational study to assess the relationships between circulating levels of complement proteins measured using the complement precision medicine (cpm) platform, genetic profile and lesion progression in subjects with geographic atrophy (ga) secondary to age-related macular degeneration (amd) up to a 24-month period

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of bilateral ga due to amd as confirmed by fundoscopy and imaging at screening 2. ga lesion sizes of ≥ 1.25 mm2 to ≤ 17 mm2 (approximately 1-7 disc diameters) in at least one eye as per central reading center 3. willing and able to provide written informed consent 4. male or female aged 65 years and over exclusion criteria: 1. history of neovascular (wet) amd or presence of neovascular (wet) amd in either eye confirmed by fundoscopy at screening and/or any pre-existing retinal imaging 2. history of intravitreal (ivt) injection in the study eye. note: intravitreal treatment with pegcetacoplan (syfovre®) and avacincaptad pegol (izervaytm) if approved within the participant's country of origin and if deemed necessary by the principal investigator (pi) is allowed in the fellow eye only. ivt injections in the study eye are prohibited. 3. history of uveitis or endophthalmitis 4. high myopia (more than 6 diopter) in the study eye 5. any ocular pathology which would impede clear imaging of the macula, e.g. intra-ocular opacities 6. macular changes from causes other than amd 7. diabetic retinopathy in either eye. note: presence of systemic diabetes with no retinopathy is not exclusionary 8. any other physical condition which would prevent the participant from undertaking imaging procedures 9. any cell or gene therapy in either eye

Keywords: dry age-related macular degeneration geographic atrophy retinal disease macular degeneration macular atrophy retinal degeneration eye diseases amd ga
high versus low bicarbonate bath in critically-ill patients receiving continuous renal replacement therapy

Conditions: Metabolic Acidosis; Acute Kidney Injury; Acute Kidney Failure

Summary: researchers are trying to determine which dialysis solution, low bicarbonate fluid (22 mmol/l) or high bicarbonate fluid (32 mmol/l), is better in subjects with acute kidney injury (acute kidney failure) and metabolic acidosis that are admitted to the intensive care unit and require continuous renal replacement therapy (also known as continuous dialysis).

this is a prospective randomized trial that will be conducted at mayo clinic in rochester minnesota. it will be based on good clinical practice standards and performed under irb supervision. this will be a pragmatic clinical trial due to the nature of the intervention and short interval for making a clinical decision. while dialysis in general is valid in cases of severe aki and metabolic acidosis, there remains uncertainty as to which replacement fluid to use. in one retrospective study, using high bicarbonate replacement fluid was associated with worse outcomes, even after accounting for several important confounders. while this intervention is valid in cases of severe metabolic acidosis (ph\<7), there has not been much data to support the use of either intervention in cases of any metabolic acidosis in general. while both interventions are equally valid, to our knowledge, there is no randomized clinical trial evaluating the difference of either intervention on outcomes. there is limited evidence in the literature on benefit or harm associated with either of the interventions on the outcomes thus generating a clinical equipoise. this pivotal study should help guide nephrologists and intensivists on the appropriate prescription of crrt.

Eligibility criteria:
inclusion criteria * adult patients (≥ 18 years of age) * ability to obtain informed consent, either from patient or legally authorized representative (lar) * diagnosis of aki according to kdigo definition \[an increase in serum creatinine concentration of greater than or equal to 0.3 mg/dl within the first 48 hours of injury, a relative increase in serum creatinine of greater than or equal to 50% (1.5-fold from baseline) within the first 7 days of injury, or a reduction in urine output (\<0.5 ml/kg/h for more than 6 hours)\] * crrt initiated for the first time during current icu admission. * bicarbonate ≤ 22 meq/l * arterial ph between 7.05 and 7.25(if an abg is not available, venous ph must be between 7.00 and 7.20) exclusion criteria * pregnancy (women of child-bearing potential must have a negative pregnancy test) * diagnosis of end-stage renal disease and receiving hemodialysis or peritoneal dialysis prior to icu admission (this information will be easily obtained by the nephrology team) * arterial ph \ 7.25 (if an abg is not available, venous ph \ 7.20) * potassium level \>6.0 mmol/l * severe acute liver failure meeting all the following criteria): * inr \>2 * ast/alt more than 500 u/l and * bilirubin more than 12 mg/dl) * previous enrollment in this study