Kornimate/medical-research-clean huggingface dataset:
convalescent plasma in outpatients with covid-19

Conditions: Covid19

Summary: the overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical covid-19 illness and to understand the immunologic kinetics of anti-sars-cov-2 antibodies after passive immunization.the primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (cp) for preventing the progression from mild to severe covid-19 illness. the secondary objective is to characterize the immunologic response to cp administration. this study will enroll adults presenting to the emergency department (ed) with mild, symptomatic, laboratory-confirmed covid-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.


Eligibility criteria:
inclusion criteria: * one or more symptoms of covid-19 illness and laboratory-confirmed sars-cov-2 infection * has at least one study defined risk factor for severe covid-19 illness * clinical team deems stable for outpatient management without supplemental oxygen * cp available at the site at the time of enrollment * duration of symptoms ≤ 7 days at ed presentation * informed consent from subject exclusion criteria: * age less than 18 years * prisoner or ward of the state * presumed unable to complete follow-up assessments * prior adverse reaction(s) from blood product transfusion * receipt of any blood product within the past 120 days * treating clinical team unwilling to administer 300 ml fluid * enrollment in another interventional trial for covid-19 illness
body composition, growth, and maturation of triathletes

Conditions: Diet Habit; Body Weight Changes

Summary: the goal of this observational study is to determine if physical activity and the adherence to a mediterranean diet have a relationship with body composition, growth, and maturation status in youth triathletes. the main question it aims to answer is: • is body composition (fat and muscle) determined primarily by growth and biological maturation or by physical activity and the mediterranean diet in youth triathletes? participants already have been evaluated in body composition, mediterranean diet adherence and practical of physical activity during 3 years.

triathlon is an individual, multidisciplinary and resistance sport with three stages: swimming, cycling and running, linked by two transitions. the importance of knowing body composition, eating patterns, level of physical activity and maturational state, will allow influence on training, increasing sports performance. regarding body composition and its relationship with performance, it has been observed that the greater the body fat, the lower the physical performance of triathletes. in each sport, athletes have different composition somatotypes. for triathlon, it is difficult to establish a specific somatotype, since it is a modality that encompasses three sports, among which the anthropometric characteristics of the athletes who practice them are not similar. in addition, since it is a relatively new category, there are not enough bibliographical references regarding anthropometry and body composition. during biological maturation, there is an increase in the basal metabolic rate, so an optimal diet helps the growth process and improves the performance and recovery of athletes. therefore, in the early stages of childhood and adolescence, adherence to the diet plays an important role in the acquisition of healthy lifestyles to determine an optimal state of health. the mediterranean diet model is associated with healthy eating habits, high levels of quality of life and physical benefits.

Eligibility criteria:
inclusion criteria: * acceptation of informed consent by parents exclusion criteria: * no attendance to body composition evaluation * reporting less than 80% of assistance to physical activity sessions reported by trainer
clinical trial to evaluate the efficacy and safety of the use of ozone versus sunflower oil in treating diabetic foot

Conditions: Diabetes Mellitus

Summary: this is a open, phase iii, multicenter, prospective, comparative, controlled, randomized clinical trial to evaluate the efficacy and safety of the use of ozone released by philozon medplus device versus conventional therapy in treating patients with diabetic foot.

* clinical trial, open, phase iii, multicenter, prospective, comparative, controlled, randomized to evaluate the efficacy and safety of the use of ozone released by philozon medplus device versus conventional therapy in treating patients with diabetic foot. * primary objective: evaluate the efficacy and safety of ozone released by the device philozon medplus in the treatment of patients with diabetic foot. * secondary objective: evaluate ozone analyzer by environmental ozone philozon medplus released by the device in the clinical setting after using the device for rectal insufflation in a patient with diabetic foot. * study population: patients of both sexes, consisting of 100 patients over 18 years, patients with diabetic foot. * treatment: 50 patients receive ozone therapy (topical and rectal insufflation of ozone). 50 patients will receive conventional treatment (sunflower oil).

Eligibility criteria:
inclusion criteria: * consent form signed; * patients with diabetes mellitus type i or type ii trophic lesions presenting in the lower limbs; * injury whose largest diameter is less than 5 cm; * patients of both sexes, aged above 18 years; * heart rate 60 to 100 bpm. exclusion criteria: * presence of severe septic conditions; * imc \> 30; * presence of lymphedema; * presence of trophic lesions in the lower limbs: exudative, traumatic and parasitic; * trophic lesions caused by venous disease requiring treatment; * hepatic or renal dysfunction; * history of alcohol abuse and drugs in the last 6 months; * laboratory parameters: * hemoglobin \< 10 g/dl; * glycated hemoglobin \> 9%; * diagnosis of hyperthyroidism (tsh \ 1.80 ng/dl); * deficit of glucose 6 phosphate dehydrogenase (g6pd) \> 20%; * use of immunosuppressive drugs or anticonvulsants; * pregnant woman or lactating; * any significant medical condition which in the opinion of the investigator may bring risks to the patient; * known hypersensitivity to drugs and/or treatments to be used in the study; * inability to compliance with the protocol; * participation in another clinical trial for less than 30 days.

Keywords: ozone sunflower oil diabetes mellitus
dextenza versus topical steroid eye drops for postoperative management following corneal crosslinking

Conditions: Keratoconus

Summary: this study aims to compare the use of dextenza, an fda-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (predforte) eye drops starting from four times daily. following treatment, dextenza resorbs and exits the nasolacrimal system without the need for removal. three prior phase 3 clinical trials have demonstrated that dextenza is equally efficacious to a month-long topical pred forte taper in the treatment of postoperative inflammation following cataract surgery. this proposed study strives to demonstrate the non-inferiority of using dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. by demonstrating dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.


Eligibility criteria:
inclusion criteria: * the study will enroll patients age 13 and up with progressive keratoconus (kcn) who are scheduled for bilateral epithelial off corneal collagen cross-linking (cxl) with photrexa. a patient's study eye must meet the following criteria to be eligible for inclusion in the study: 1. progressive keratoconus as defined by increasing astigmatism and/or keratometry on corneal topography or tomography or increasing cylindrical error on refraction 2. patients requiring general anesthetic for the procedure 3. preoperative central corneal thickness of \>= 400 microns exclusion criteria: * history of acute hydrops in treated eye * history of pre-existing severe corneal scarring in the treated eye * history of pre-existing glaucoma in the treated eye * history of or pharmaceutical treatment of glaucoma or ocular hypertension and history or current spikes in intraocular pressure (iop) in either eye. * history of pre-existing ocular inflammation or infection (conjunctivitis, keratitis, uveitis, or retinitis) in treated eye * active infectious systemic disease * obstructed nasolacrimal duct in the study eye(s) * patients with a nasolacrimal duct smaller than 0.4 mm or greater than or equal to 1.0 mm. * patients with stenosis to the location where the insert will be placed should be excluded from the study, as the study team would not engage in surgical procedures to expand or surgically correct that region * hypersensitivity to dexamethasone * patients being treated with immunomodulating agents in the study eye(s) * patients being treated with immunosuppressants and/or oral steroids * patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
a randomized trial of cerclage versus 17 α-hydroxyprogesterone caproate for treatment of a short cervix

Conditions: Mid Trimester Cervical Shortening

Summary: we hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17p) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to cerclage therapy. the purpose of this study was to compare medical therapy with 17p to surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short cervix and funnel in the mid-trimester.


Eligibility criteria:
inclusion criteria: * ultrasonographic evidence of premature dilatation of the internal os * prolapse of the chorio-amniotic membranes into the endocervical canal * functional cervical length less than 25mm * exacerbation of these ultrasound findings with transfundal and/or suprapubic pressure exclusion criteria: * any fetal chromosomal or structural anomaly * multiple gestation * known allergy to progesterone * ruptured membranes * vaginal bleeding * intra-amniotic infection (diagnosed clinically or by amniocentesis) * prolapse of endocervical membranes beyond the external cervical os * persistent uterine activity accompanied by cervical change * obstetrically indicated delivery.

Keywords: short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone
a study of subcutaneous mircera for the maintenance treatment of anemia in participants with chronic kidney disease not on dialysis

Conditions: Anemia

Summary: this single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.


Eligibility criteria:
inclusion criteria: * chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis; * continuous stable subcutaneous maintenance erythropoietin-stimulating agent (esa) therapy during previous month. exclusion criteria: * transfusion of red blood cells during previous 2 months; * significant acute or chronic bleeding; * poorly controlled hypertension.
adenoma miss rate in tandem endocuff-assisted colonoscopy

Conditions: Colon Polyp; Endocuff

Summary: colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (crc). older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. in order to improve the diagnostic accuracy of colonoscopy and to improve the adenoma detection rate (adr) (a significant marker of quality), efforts have been made to improve endoscopic techniques, the bowel preparation, to keep slower withdrawal time, and to use new technologies and devices. since 2012, a new accessory device (endocuff; arc medical design, leeds, uk), which is mounted on the tip of the colonoscope has been introduced to the market. the endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. use of this device may achieve better visualization of the bowel lumen, especially behind folds, and improve stability of the instrument on withdrawal. the aim of this study is to conduct a back-to-back endoscopy study and to evaluate the contribution of endocuff-assisted colonoscopy to the detection of missed adenomas in a mixed population of colorectal cancer (crc) screening/surveillance and symptomatic patients.


Eligibility criteria:
inclusion criteria: * (i) crc screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years. exclusion criteria: * (i) age below 50 years; (ii) the presence of significant comorbidities (american society of anesthesiologists \[asa\] score iii or iv); (iv) recent abdominal surgery; (iv) inflammatory bowel disease; (v) colectomy; (vi) polyposis syndrome; (vii) the presence of acute, severe colitis or a known colonic stricture (viii) boston scale bowel preparation ≥6.

Keywords: endocuff tandem colonoscopy
improvement of cerebrovascular autoregulation in patients with septic shock due to cytokine elimination

Conditions: Septic Shock

Summary: the trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. patients with inclusion criteria were randomly assign in either use of cytosorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. cerebrovascular autoregulation will be measured with transcranial doppler ultrasound and correlation with arterial blood pressure.


Eligibility criteria:
inclusion criteria: * septic shock * acute renal failure with need for renal replacement therapy exclusion criteria: * pregnancy * nursing * impossibility to do transcranial doppler ultrasound

Keywords: cerebrovascular autoregulation septic shock cytokine
nut supplementation to mitigate post-stroke cognitive decline

Conditions: Stroke; Dementia

Summary: stroke is a strong risk factor for dementia, with up to 80% of individuals having lower cognitive function 5 years after a stroke event. however, having a stroke does not need to result in declining cognition if effective strategies to reduce the risk of post stroke dementia are identified. diets containing nuts can reduce the risk of both dementia and stroke but have not been tested in stroke survivors. therefore, this pilot study aims to determine whether eating nuts regularly reduces post-stroke cognitive decline and dementia. the nut-me pilot study will supplement the diet of stroke survivors with a mix of nuts containing walnuts, hazelnuts, almonds and brazil nuts for 3 months and assess the effects on cognition and health markers. the researchers predict that regular nut consumption will contribute to preserving post-stroke cognitive function in comparison to patients who do not consume nuts. the results of this novel pilot study will be used to guide a larger trial and provide a simple dietary strategy that stroke survivors can adopt to reduce post-stroke cognitive decline.

this study will investigate the efficacy and feasibility of supplementing the habitual diet of stroke survivors with a supply of mixed nuts containing brazil nut, walnuts, hazelnuts, and almonds to reduce post-stroke cognitive decline. the overall aim of this project will be achieved through the following objectives: * examine the feasibility through the assessment of compliance with the intervention and participants' perception of the study * investigate the efficacy of the intervention on cognitive decline, body composition and health outcomes (blood pressure, fasting glucose and insulin, and blood lipids) the investigators hypothesise that the inclusion of nuts is a simple dietary strategy that will slow post-stroke cognitive decline and that supplementation with nuts will improve body composition and health biomarkers of stroke survivors.

Eligibility criteria:
inclusion criteria: * ischaemic stroke (first or recurrent stroke) in the last 6 months * able to attend 4 study visits over 3 months * motivation and willingness to participate in the study protocol * no prior neurological or psychiatric disease, including dementia * can give informed consent and participate in cognitive testing exclusion criteria: * be \< 18 years; * have allergy to nuts * have premorbid modified rankin scale (mrs)≥4, denoting no severe disability * incapable of giving consent * have problems with mastication that preclude nut intake * have habitual consumption of tree nuts (\>2 servings/wk) in the previous 2 months * have habitual consumption of alpha-linolenic acid supplements (fish oil, flaxseed oil, and/or soy lecithin) * have dementia or psychiatric disease * do not speak english

Keywords: dementia cognitive decline nuts
study of abrocitinib compared with dupilumab in adults with moderate to severe atopic dermatitis on background topical therapy

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally qd compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe ad. the treatment duration is 26 weeks. a total of approximately 600 participants will be enrolled from approximately 220 sites globally. approximately 600 participants will be randomly assigned to study intervention. there are primary efficacy assessments at week 2 and week 4, and a key secondary efficacy assessment at week 16. efficacy and safety endpoints will be assessed throughout the entire study. exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosis of chronic atopic dermatitis (ad) for at least 6 months * moderate to severe ad (bsa at least 10%, iga at least 3, easi at least 16, and pp-nrs severity score at least 4) * recent history of inadequate response to treatment with medicated topical therapy for ad, or who have required systemic therapies for control of their disease exclusion criteria: * acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation * have increased risk of developing venous thromboembolism * unwilling to discontinue current ad medications prior to the study or require treatment with prohibited medications during the study * prior treatment with systemic jak inhibitors or il-4 or il-13 antagonists including dupilumab, lebrikizumab or tralokinumab * other active non-ad inflammatory skin diseases or conditions affecting skin * medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator * pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Keywords: atopic dermatitis atopic eczema eczema jak janus kinase
immunological responses of covid-19 vaccination

Conditions: Cancer; Chemotherapy

Summary: cancer patients with covid-19 have a 30% higher mortality rate compared to the general population and are considered a high-risk group by the american association for cancer research that should be given "high priority" during covid-19 vaccine administration. although studies have suggested that vaccination during active treatment with chemo and/or radiation therapy provides suboptimal antibody response, the studies were underpowered and heterogeneous thus putting this conclusion into question. we need data in cancer patients on immunosuppressive chemotherapy at the time of covid vaccination to understand how immune responses compare to healthy controls and cancer patients not on immunosuppressive therapy.


Eligibility criteria:
inclusion criteria: * participants must meet all of the following inclusion criteria to be eligible for enrollment: 1. willing and able to provide written informed consent for the trial. 2. male or female participants \>18 years of age on the day of signing informed consent. 3. a. participants (\>18 years) with gastrointestinal (gastroesophageal, pancreatic, small bowel, colon, anal) solid tumors, breast, or prostate cancers who received myelosuppressive chemotherapy within 60 days prior to initial or booster covid vaccination, or who started on chemotherapy within 60 days after the initial or booster covid vaccination; or b. adult participants (\>18 years) not receiving chemotherapy at the time of initial or booster covid vaccination, but who were on non-immunosuppressive treatments (endocrine therapy, treatment with tyrosine kinase inhibitor or antiher-2 therapy); or c. adult participants \> 18 years either: (i) with no history of cancer or (ii) prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and \>12 months from completion of chemotherapy or radiation. 4. a. participants in groups a and b who have a planned covid vaccination within the next 90 days of study enrollment with any fda approved vaccine, or previous covid vaccination within 90 days from study enrollment are eligible provided they meet all other above eligibility criteria; or b. participants in group c who have planned covid vaccination within the next 90 days of study enrollment with any fda approved vaccine; or previous covid vaccination within six months from study enrollment are eligible provided they meet all other above eligibility criteria exclusion criteria: * participants will be considered ineligible for enrollment with the following criteria: 1. participants currently on immunotherapy 2. participants with documented covid 19 infection within \< 6 months from study enrollment 3. prior history of autoimmune disorder and are currently on immunosuppressive therapy or have received immunosuppressive therapy within the last 6-12 months prior to enrollment 4. no planned and no prior covid vaccination