Kornimate/medical-research-clean huggingface dataset:
progression of renal amyloidosis of fmf and relation to serum saa level

Conditions: Observational

Summary: purpose of this study is to determine whether keeping saa on normal or near normal level will delay progression of renal failure in patients with amyloidosis secondary to fmf.

fmf is an inherited inflammatory disorder typically presented in most causes as recurrent episodes of fever and serositis. phenotype ii, another kind of this disorder, has atypical courses, when the inflammation proceeds without any clinical sign. each fmf attack is accompanied by sharp elevation of inflammatory markers in the serum, and serum amyloid a (saa) one of them. the level of these inflammatory markers returns to normal with termination of the attack. the saa is the main component of amyloids fibrils and constantly high level of saa after the attack (as occurs in undiagnosed or undertreated disease) is the significant risk factor responsible for development of amyloidosis. on the other hand, in patients with phenotype ii the amyloidosis occurs despite absolute absence of the attacks. the kidney is one of the first organ suffers from amyloid deposits. the spectrum of kidney damage spread wildly from mild proteinuria to obvious nephrotic syndrome with disturbance in renal function and progression to end stage renal failure. it is well known that deterioration of renal disease in aa amyloidosis links to level of saa in serum. the permanently high saa level is a major factor responsible to progression of renal disease. occasionally, however, decline in the renal function occurred despite normal or near normal levels of saa. renal impairment in these cases may be explained by mechanisms existing in other kidney diseases when uncontrolled proteinuria aggravates renal dysfunction. the purpose of the study is to find whether a cohort of patients followed in our clinic and receiving colchicine for fmf- amyloidosis according to the saa levels, monitored periodically, have better prognosis than an historical cohort receiving colchicine according to the attack status

Eligibility criteria:
inclusion criteria: * fmf patients with amyloidosis aa * 18 year and older exclusion criteria: * patients with aa amyloidosis not related to fmf * evidence of other primary renal disease or renovascular pathology * evidence of renal disease secondary to any systemic illness * presence of inflammatory, autoimmune conditions or chronic infection that could lead to high saa level * pregnancy * inability to provide legal consent

Keywords: familial mediterranean fever amyloidosis aa serum amyloid a renal failure nephrotic syndrome
dd t2 daily disposable registration trial

Conditions: Myopia; Refractive Errors

Summary: the purpose of this study is to evaluate the performance of the investigational verofilcon a contact lens compared to the commercially available delefilcon a contact lens, by assessing visual acuity as the primary variable.

enrolled participants will be randomized (2:1) to receive either verofilcon a (test) contact lenses or delefilcon a (control) contact lenses for wear in both eyes and attend 7 office visits: baseline, dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/exit.

Eligibility criteria:
inclusion criteria: * successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. * best corrected va 20/25 or better in each eye. * other protocol-specified inclusion criteria may apply. exclusion criteria * any current or prior wear experience with dt1 lenses. * wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * other protocol-specified exclusion criteria may apply.

Keywords: soft contact lenses vision eyesight
build a decision aid tool to help emergency intensive care specialists in the context of hypoxic ischemic encephalopathy

Conditions: Encephalopathy

Summary: the project aims at designing a machine learning solution able to recognize characteristics signals patterns of brain damages in full term babies born within a context of hypoxic ischemic encephalopathy (hie)

retrospective study based on a digital eeg signal library intending to design, train and test an efficient ai solution for hypothermia protocol start indications. the output of the project is to make available to pediatric resuscitation units an adequate tool to guide them in the decision of hypothermia protocol start in a general context of neurophysiologist competence scarcity. eeg signal that would allow the algorithm design will be based on several parameters of the conventional eeg and not only on signal amplitude

Eligibility criteria:
inclusion criteria: * full term (\> 36 weeks) * hie context * eeg recording before 6 hours of life exclusion criteria: -opposition of parental authority holders of a patient born after 2015

Keywords: full term newborn eeg hie
single or combined protocols for nv-amd

Conditions: Age-Related Macular Degeneration

Summary: the present interventional study represents a research program for the clinical governance supported by supported by the healthcare fund of the emilia-romagna region. it aims to evaluate, after 12 months of monitoring, clinical safety, therapeutic efficacy, number of intra-vitreous injections of bevacizumab (ivib), compliance and quality of life correlated to the vision by comparing the data obtained in two groups of patients (group a and group b), affected by neovascular age-related macular degeneration (nv-amd) never previously treated or already undergoing pro-re-nata (prn) treatments with biological drugs inhibiting vascular endothelial growth factor (vascular endothelial growth factor, vegf), i.e. anti-vegf drugs. participating patients are randomized to the following therapeutic regimens: i. group a, a single intra-vitreous injection of bevacizumab prn repeated after monthly periodic monitoring of the patient (ivibx1 regimen); ii. group b, two combined intra-vitreous injections of bevacizumab, spaced 30 ± 10 days apart and repeated as-needed after periodic monitoring of the patient (ivibx2 regimen). within the aforementioned regimens, the re-treatment (single or combined in patients undergoing ivibx1 or ivibx2, respectively) is performed when signs of persistent neovascular activity is present. the present trial consists of a randomized controlled open-label study with parallel arms to evaluate the non-inferiority of clinical safety and therapeutic efficacy of the ivibx1 regimen compared to the ivibx2 regimen (1: 1 allocation) administered in patients with nv-amd. the number and type of tests, as well as the number of intra-vitreous injections of anti-vegf drug performed in patients treated with the prn regimens ivibx1 or ivibx2 do not differ from those performed during normal clinical practice at the eye clinic of the university hospital of ferrara. the intra-vitreous administration of bevacizumab is performed in accordance with the guidelines of the italian ophthalmology society.


Eligibility criteria:
inclusion criteria: * age \> 50 years * ability to comply with study procedures * active nv-amd in either treatment-naïve or previously treated patients * bcva \> 20/200 in the study eye exclusion criteria: * any other possible cause of choroidal neovascularization other than amd * ocular media opacities or other causes counteracting data collection * presence or onset of contraindications to the use of bevacizumab

Keywords: neovascular age-related macular degeneration bevacizumab pro-re-nata regimens clinical governance
an adaptive algorithm-based approach to treatment for adolescent depression

Conditions: Depressive Disorder

Summary: the purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (atss) for adolescent depression. the atss include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, ipt-a), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment ipt-a. two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. adolescents will be randomized to the ipt-a ats condition or the community clinic's usual care (uc). adolescents in the ipt-a ats condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (ssri) or more intensive ipt-a (delivered twice per week). research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.


Eligibility criteria:
inclusion criteria: * meet dsm-v criteria for a primary diagnosis of major depressive disorder, persistent depressive disorder, or depressive disorder nec * current significant depressive symptoms (based on children's depression rating scale - revised \[cdrs-r\] \& beck depression inventory-ii \[bdi-ii\]) * current impairment in psychosocial functioning (based on children's global assessment scale \[cgas\]) exclusion criteria: * non english-speaking * meet dsm-v criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder. * adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study. * currently taking medication for a psychiatric diagnosis other than adhd * females who are pregnant, breastfeeding, or having unprotected sexual intercourse, due to the possibility of randomization to treatment with an ssri.
a clinical study of tranilast in the treatment of sarcoidosis

Conditions: Sarcoidosis

Summary: 56 patients with sarcoidosis will be selected to receive treatment of tranilast.the investigators can analyse the changes in the thickness and area of skin lesions before and after treatment as well as other involved organs nodule size changes to determine the efficacy and safety of drugs.

56 patients with sarcoidosis will be selected. after the signing of the informed consent ,participants will be collected the initial lesions photos, the size of the lump by ultrasound, the forced vital capacity(fvc), and chemical examinations including blood routine examination, routine urine test, liver function, renal function. during tranilast treatment (0.1g each time, three times a day) , participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, every three months to retest ultrasound and the forced vital capacity(fvc). with 3 month as a time point, participants were observed for four points(one point if only skin invasion ).after the experiment, the experimental data will be arranged and the data will be statistically processed (t test) to determine whether it is meaningful.

Eligibility criteria:
inclusion criteria: * (1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic granuloma and negative staining of fungi and atypical mycobacterium; (2)no corticosteroids and immunosuppressants were used for nearly 1 months. exclusion criteria: * 1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)with mental disease.

Keywords: sarcoidosis tranilast skin lung
lower leg edema evaluation after total knee arthroplasty using bioimpedance

Conditions: Edema

Summary: the purpose of this study is to evaluate the applicability and measurement properties of bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty

current measurement techniques of edema are not adapted or not convenient for assessment in the post surgical environment. developement of a convenient, quick and reliable method could be useful to facilitate edema evaluation in this context.

Eligibility criteria:
inclusion criteria: * knee replacement surgery exclusion criteria: * pacemaker * cardiac defibrillator * other metallic implant than knee arthroplasty

Keywords: physical therapy - therapeutics - edema arthroplasty replacement knee treatment outcome
virtual reality after pediatric scoliosis surgery

Conditions: Scoliosis Idiopathic; Pain, Postoperative

Summary: the purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.

purpose: to evaluate postoperative pain scores and postoperative opioid use in pediatric idiopathic scoliosis surgical patients using virtual reality (vr) as a method of immersive distraction compared with standard electronic use postoperatively. participants: patients age 11-17 undergoing idiopathic scoliosis surgery on enhanced recovery after surgery (eras) spine protocol at our institution. procedures (methods): participants will be randomized to intervention arm (vr) or control arm (ipad). baseline pain and anxiety scores will be assessed. on postoperative day 1, each patient will receive a visit by the research assistant who will assess pain scores, pca use, etc. the intervention group will be offered a vr device for up to 30 minutes. the control group will be offered an ipad for up to 30 minutes. this visit will be performed twice on postoperative day 1. follow up survey will be conducted at 48-72 hours and 7-10 days postoperatively.

Eligibility criteria:
inclusion criteria: * subjects age 11 - 17 years of age * patients undergoing idiopathic scoliosis surgery on enhanced recovery after surgery (eras) spine protocol (which includes postoperative pca) exclusion criteria: * patient/caregiver refusal * patients with developmental delay * patients with seizure disorder * non-english-speaking patients * patients with daily opioid use \>/= two weeks * patients with uncorrected visual or hearing impairment * patients admitted to pediatric intensive care unit on postoperative day #1

Keywords: virtual reality distraction methods idiopathic scoliosis postoperative pain pediatric surgery
impedance cardiography to decrease the risk of preeclampsia

Conditions: Chronic Hypertension Complicating Pregnancy (Diagnosis); Preeclampsia

Summary: to determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia.

impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output is occurring. the test is easy to perform and non invasive. the treatment for an elevated cardiac output in pregnancy is a beta-blocker while a vasodilator is used for vasoconstriction. if a beta-blocker is given to someone that vasoconstricted, this might make the cardiovascular parameters worse, leading to no improvement in future pregnancy issues. likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it could potentially make the cardiovascular parameters worse. all centers in the united states that choose to prescribe an antihypertensive medication for use in pregnancy do so by trial and error, whereas impedance cardiography can help the clinician choose the best medication from the start. many pregnant patient patients have chronic hypertension and this population is at increased risk for superimposed preeclampsia and other pregnancy complications. the current recommendation for pregnancy is to not treat mild hypertension because studies have not shown any benefit. these studies, have also not shown any harm. prior studies that have shown no benefit to treatment of mild hypertension in pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not improving the rate of superimposed preeclampsia and other pregnancy related complications.

Eligibility criteria:
inclusion criteria: pregnant patients 18-51 years old less than 20 weeks gestation with mild chronic hypertension - not on antihypertensive medications exclusion criteria: patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy patients who have a blood pressure 140/90 or greater -
influenza vaccine in lung transplant patients

Conditions: Influenza

Summary: this 5-year study was designed to investigate how antibody and t cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.

\[note: there are 6 clinicaltrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see nct04533061, nct04533139, nct04531787, nct04530786, and nct04531657 for related data\] although pre-transplant immunization is routinely recommended, this recommendation is based on little data. the primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant. this prospective cohort study is to include immunization events performed over five years to measure h1n1, h3n2, and b antibody responses to the influenza vaccine in pre- and post-lung transplant patients. the pre-transplant patients will move to the post-transplant group as the study progressed. similarly, participants are allowed to move to the next time-since-transplant group as time elapsed. serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season. geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.

Eligibility criteria:
inclusion criteria: * receiving care pre- or post-lung transplant at university of wisconsin hospital * healthy adult exclusion criteria: * allergy to eggs * moderate to severe febrile illness * active treatment for acute rejection * received season's influenza vaccine prior to enrollment

Keywords: pre or post-lung transplant healthy
a study of oral methylnaltrexone (mntx) for the treatment of opioid-induced constipation (oic) in participants with chronic, non-malignant pain

Conditions: Opioid-Induced Constipation

Summary: mntx 3201 is a phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral mntx for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.


Eligibility criteria:
key inclusion criteria: 1. history of chronic non-malignant pain (originating from a non-malignant source) with condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months' duration before the screening visit. 2. taking oral, transdermal, intravenous (iv), or subcutaneous (sc) opioids for chronic non-malignant pain for ≥1 month. 3. no known history of chronic constipation prior to the initiation of opioid therapy. 4. currently taking laxative therapy for ≥30 days and willing to discontinue all laxative therapy at the start of screening period and use only study-permitted rescue laxatives throughout the screening and double-blind treatment periods.. key exclusion criteria: 1. prior treatment with oral mntx. 2. prior treatment with sc mntx within 30 days of screening. 3. women who are pregnant, breastfeeding, or plan to become pregnant during the study. 4. fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant gastrointestinal disorders such as inflammatory bowel disease or clinically significant irritable bowel syndrome that would have made bowel movement assessment inaccurate. 5. current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists.

Keywords: treatment of opioid-induced constipation in participants with chronic, non-malignant pain
cheese intake and hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: in this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in alpha-lipoic acid (ala), conjugated linoleic acid (cla) and vaccenic acid (va), would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects.


Eligibility criteria:
inclusion criteria: * 42 adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dl), * 30-60 years of age exclusion criteria: * pregnant (or those planning to become pregnant during the study period) and lactating women were excluded; * also individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit. * in addition, those with a history of cancer (except non-melanoma skin cancer) in the 2 years before screening, or of any major trauma or surgical event within 3 months before screening, were not enrolled. * volunteers with the following characteristics were also excluded: * total cholesterol ≥ 300 mg/dl, * serum triglycerides ≥ 250 mg/dl or ≤ 200 mg/dl, * hdl ≥ 70mg/dl, * bmi ≥ 30, or * uncontrolled hypertension (systolic blood pressure ≥ 160 mm hg or * diastolic blood pressure ≥ 100 mm hg) at screening.

Keywords: hypercholesterolemia endocannabinoids
evaluation of aerosolized drugs deposition during mechanical ventilation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. the objective of this study was to evaluate inhaled bronchodilator and mucolytic agents delivered through a ventilator system.

aerosolized medication is used widely to patients with respiratory illness and admitted in the intensive care unit, and includes bronchodilators, steroids, mucolytics, and antibiotics. aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. only few clinical trials on aerosol delivery deposition were published in the last decades. in addition, inhaled bronchodilators, mucolytics, antibiotics, and steroids are often administered to ventilated patients in the intensive care units in taiwan, but they are never studied. therefore, the aim of this study was to evaluate inhaled bronchodilator and mucolytics (acetylcystine) delivered by a jet nebulizer through a ventilator system to intubated patients.

Eligibility criteria:
inclusion criteria: * mechanical ventilated patients with an endotracheal tube intubated * receiving aerosol therapy with salbutamol or acetylcystine * on relatively stable medical condition exclusion criteria: * pregnant * unstable hemodynamic status (e.g. blood pressure \<100/60 mmhg, under intra-aortic balloon pump) * infected with airborne pathogens (e.g. tuberculosis or influenza virus) * poor oxygenation (fraction of inspiratory oxygen \>0.8, under high frequency oscillatory ventilation, or extracorporeal membrane oxygenation)