Kornimate/medical-research-clean huggingface dataset:
correlation of pupillary diameter changewith age and anterior chamber depth after cataract surgery

Conditions: Pupillary Disorders

Summary: purpose: to assess the correlation between the change in pupil diameter, age and depth of the anterior chamber after 3 months of cataract surgery both in photopic and mesopic conditions. and study the changes of the pupillary diameter at 3 months after surgery in the two light conditions

healthy patients who are going to be operated on for cataracts are expected to take part in the study. if during the clinical study the minimum number of patients established in the protocol is exceeded, new samples will continue to be registered until the end of the established period. the sample selection mechanism is by consecutive recruitment during the study period (in order of arrival at the medical office). patients are operated bilaterally in a period not exceeding 15 days and it will get the variables of both eyes. a simple random sampling will be used for the choice of single eye data per patient.

Eligibility criteria:
inclusion criteria: * both sexes with age equal to or greater than 45 years * diagnosed cataract n1, c1, p1 or worse in some eye. * patients who will be operated on both eyes. * patients who have not been diagnosed with diabetes mellitus. * patients who have given their informed consent to take part in the study. exclusion criteria: * age under 45 years. * patients with anisocoria, neurological disorders, diagnosed with diabetes mellitus, glaucoma or another eye disease. * patients with complications during and after cataract surgery.

Keywords: cataract pupillary changes age anterior chamber depth
clinical trials in organ transplantation extension study

Conditions: Lung Transplant Failure and Rejection

Summary: the purpose of the study is to continue to follow subjects who were enrolled in the ctot-20 clad phenotypes study. subjects will provide clinical data and complete quality of life questionnaires that will be used to determine the clinical factors associated with the development of chronic lung allograft dysfunction (clad) after lung transplant.

there are no mandated study visits, rather the study will be conducted using real world data collected as part of usual clinical care according to the standard of care transplant protocols at each site. specimens and study data will be collected during standard of care visits and study coordinators will review medical records and extract available clinical data every 6 months. study coordinators will collect pulmonary function test data that will be transferred to the data coordinating center as in ctot-20. subjects will be asked to complete quality of life questionnaires on an annual basis. the majority of times, blood samples will be collected during clinical care routine venipuncture based on clinic visit scheduling. in the rare circumstances in which research blood is missed during a standard of care venipuncture or one is not scheduled, a participant may be asked to undergo venipuncture for study purposes. standard of care (soc) bronchoscopies with collection of bronchoalveolar lavage (bal) lung fluid will be performed at each center according to clinical management protocols. during soc bronchoscopies, research participants will undergo additional fluid instillation for research bal sampling as in ctot-20.

Eligibility criteria:
inclusion criteria: * current ctot-20 participants exclusion criteria: * non-ctot-20 participants * withdrawn ctot-20 participants

Keywords: lung transplantation chronic lung allograft dysfunction
bk virus in salivary gland disease: treating the potential etiologic agent

Conditions: HIV; Salivary Gland Disease; Benign Lymphoepithelial Lesion

Summary: the purpose of this study is to analyze bk viral infection in salivary gland diseases; specifically, to determine a definitive relationship between bk virus and hiv associated salivary gland disease (hivsgd). participants are adults hiv+sgd+ who will be randomized 1:1 to receive bk virus antiviral (ciprofloxacin) or placebo for 28 days. salivary function/protein secretion will be correlated with bk polyomavirus titers. it is expected that patients with hiv+sgd+ will have elevated oral bk polyomavirus viral loads and will benefit from ciprofloxacin.

the study duration is 12 weeks with a baseline visit, a visit at 4 weeks and a visit at 12 weeks. at baseline participants are randomized to ciprofloxacin or placebo and take the drug or placebo for 28 days. at subsequent visits bk polyomavirus presence and salivary gland function will be assessed.

Eligibility criteria:
inclusion criteria: * hiv positive with salivary gland disease * ability to read and understand english exclusion criteria: * allergy to the family of fluoroquinolones (including ciprofloxacin) * currently taking tizanidine * concurrently taking antiacids containing magnesium hydroxide or aluminum hydroxide * current use of theophylline * previous tendon disorder such as rheumatoid arthritis * history of seizures * current use of phenytoin * current use of glyburide * current use of methotrexate * severe renal impairment (known creatinine clearance \< 30 or on dialysis)

Keywords: hiv salivary gland disease benign lymphoepithelial lesion bk polyomavirus
circulating microvesicles regulating metabolic homeostasis in obesity after caloric restriction programs

Conditions: Obesity

Summary: the main aim of the present study is to evaluate the effectiveness of two dietary protocols: daily caloric restriction (dcr) and early time-restricted feeding + dcr (etre) on metabolic homeostasis and the influence of circulating extracellular vesicles (evs) as inter-organ communication elements in obese patients.

the specific objectives are: 1. to assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects. 2. influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones. 3. define the "digital footprint" of evs as inter-organ communication elements influencing metabolic status in obese subjects. the study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy mediterranean diet under daily caloric restriction (dcr) (n=20) or an etre protocol (n=20) for 12 weeks. clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. glucagon-like peptide 1 (glp1) and gastric inhibitory polypeptide (gip) dynamics after a standard meal test. metagenomics. bioenergetic analysis of pbmc by seahorse. total ev mirna profile. isolation of host and bacterial evs. characterization of the protein cargo of host and bacterial evs.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 70 years old. 2. bmi ranges between 27 and 40 kg/ m2. 3. absence of underlying pathology in medical and physical examination, except for those related to excess weight. 4. signature of the informed consent for participation in the study. exclusion criteria: 1. serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease. 2. systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma). 3. pregnancy and lactation. 4. vegetarians or subjects subjected to an irregular diet. 5. patients with severe eating disorders. 6. patients with clinical symptoms and signs of infection in the previous month. 7. patients with chronic anti-inflammatory steroid treatments and/or nonsteroidal anti-inflammatory drugs. 8. recent antibiotic treatment. 9. uncontrolled alcoholism or drug abuse. 10. rotating or nocturnal shift workers.

Keywords: obesity extracellular vesicles incretins bile acids short-chain fatty acids time-restricted feeding caloric restriction brown fat
immunogenicity and safety study of zostavax administered by intramuscular or subcutaneous route to participants aged from 50 years old (v211-045)

Conditions: Herpes Zoster

Summary: primary objectives two co-primary objectives are: * to demonstrate that the immunogenicity of zostavax administered by intramuscular route (im) is non-inferior to zostavax administered by subcutaneous route (sc) * to demonstrate that zostavax administered by im route induces an acceptable fold-rise of varicella zoster virus (vzv) antibody titre from pre to 4-week post-vaccination secondary objectives immunogenicity objectives * to evaluate the immunogenicity as measured by vzv antibody titre at 4 weeks following zostavax administered by im or sc route * to evaluate the immune response as measured by a second assay, the vzv interferon gamma enzyme-linked immunospot (elispot) at 4 weeks following zostavax administered by im or sc route safety objective - to describe the safety profile of zostavax administered by im or sc route


Eligibility criteria:
inclusion criteria: * adults aged \>=50 years * varicella history-positive or residence for \>30 years in a country with endemic vzv infection exclusion criteria: * febrile illness * history of hypersensitivity or anaphylactoid reaction to any of the vaccine components * prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination * prior receipt of varicella or zoster vaccine * active untreated tuberculosis * thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection * receipt of medication / vaccine that may interfere with study assessments * known or suspected immune dysfunction * user of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year * any condition that might interfere with the interpretation of the study,
prophylactic treatment of skin rash associated with egfr inhibitor therapy

Conditions: EGFR Inhibitor-Induced Skin Rash

Summary: epidermal growth factor receptor inhibitor (egfri) therapy for cancer is associated with potentially severe face and trunk skin acneiform rash. severe or persistent side effects may lead to decreased dose, interruption or discontinuation of egfri treatment. inflammation is believed to play an important role in egfri-induced skin toxicity as a number of proinflammatory cytokines induced by egfri are released from epidermal cells, resulting in activation and recruitment of immune cells such as neutrophils and lymphocytes, and subsequent development of skin reaction associated with keratinocyte apoptosis. ac-701 has been reported its antibiotic and anti-inflammatory activities in literature, and further demonstrated in vitro effect to prevent the secretion of inflammatory cytokines associated with egfr inhibition. this study is to evaluate the prophylactic efficacy of topical ac-701 in subjects with skin rash associated with egfri therapy.


Eligibility criteria:
inclusion criteria: 1. is between 20 and 80 years of age, inclusive. 2. patients who are within ±3 days of initiating egfr inhibitor therapy using afatinib or erlotinib, and have no prior history of using afatinib or erlotinib within 6 months. 3. has a life expectancy of at least three months. exclusion criteria: 1. has any active dermatological conditions of the face that may interfere with the diagnosis, assessment, or treatment of face skin rash associated with targeted cancer therapy. 2. has been treated with steroids (systemic or topical on face) to the face within 7 days prior to day 1. 3. patients who have been treated with oral antibiotics that known to exert anti-inflammatory effect (such as doxycycline or minocycline) within 7 days prior to day 1. 4. is currently treated with target therapy other than afatinib or erlotinib. 5. receive prior treatment with any investigational product within 28 days prior to day 1. 6. has hypersensitivity or allergy to the study medication. 7. has any other significant diseases, conditions, or laboratory values which, in the opinion of the investigator, might make participation not in the subject's best interest or confound the interpretation of study results.
analysis of the potential savings of rivaroxaban events versus vitamin k antagonists events

Conditions: Atrial Fibrillation

Summary: the main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin k antagonists (vkas) in routine clinical practice using data from three cohorts of patients receiving vkas or rivaroxaban in spain, including the time in therapeutic range (ttr) values of the same and the incidence of events in the first year following diagnosis.


Eligibility criteria:
inclusion criteria: * older than 18 years * diagnosis of non-valvular af (icd code 427.31) * pharmacological treatment with vkas or rivaroxaban following diagnosis exclusion criteria: -

Keywords: atrial fibrillation vka stroke
the effect of daily intakes of dairy products on blood pressure in human beings

Conditions: Hypertension

Summary: the purpose of the project is to elucidate the effect on blood pressure by daily intake of dairy products. previous studies have demonstrated a beneficial effect on blood pressure. in total 90 subjects will be enrolled. for eight weeks, the participants will ingest one of two different dairy produces. before, during and after the study period, the blood pressure is measured.


Eligibility criteria:
inclusion criteria: * borderline hypertension exclusion criteria: * cvd, diabetes, any kind of antihypertensive therapy.
cancer screening; access; awareness; navigation

Conditions: Colorectal Cancer Screening

Summary: to assess the feasibility and efficacy of community-based colorectal cancer (crc) screening intervention in increasing crc screening rates to evaluate individual-level knowledge related to crc screening and risk factors to characterize individual -level facilitators and barriers to engaging in crc screening and related diagnostic tests and treatment when applicable.

to address the multiple determinants of health that impact crc screening in the south shore community in the university of illinois cancer center's catchment area by conducting an experimental intervention to test the effectiveness of fecal immunochemical test (fit) tests dispensed by community stakeholders (community-dispensed) versus fit tests dispensed using standard of care procedures by a clinic dispensed fit test return rates. this study will follow american cancer society (acs) guidelines for fit testing, with the south shore community area assigned to the intervention group (community-dispensed). crc screening within the mile square englewood health center, using standard of care, will serve as our control group to use for comparison (clinic-dispensed). the intervention will include a multifaceted approach to health education and community engagement focused on crc led by a team of trusted health champions (community leaders, a barber, a hair salon, and community health workers) in the south shore community area.

Eligibility criteria:
inclusion criteria: * male or female ages 45-74 * speaks english and resides in or near the south shore community area or utilizes the mile square englewood heath center * have not had crc screening in the previous 12 months exclusion criteria: * adults ages \ 75 * does not speak english * does not reside in or near the south shore community area and do not utilize mile square englewood heath center * have had crc screening in the previous 12 months
sensorimotor training for adults with diabetic peripheral neuropathy

Conditions: Peripheral Neuropathy; Somatosensory Disorders; Sensorimotor Gait Disorder

Summary: adults with diabetic peripheral neuropathy tend to fall more frequently than healthy population as a consequence of multiple sensorimotor and cognitive damages. in this protocol study, a randomized controlled trial is proposed using a sensorimotor intervention based on feldenkrais method to improve somatosensory aspects and, therefore, postural control of participants.

among all the systems suffering damage due to hyperglucemia toxicity in diabetes, somatosensory system, composed by proprioception and skin sensory receptors has a key role since it is in charge of the faster body reaction when a postural control response is needed. despite of it, few studies have focused on this issue. this randomized controlled trial proposed a safe and easy training adapted to adults and old people with diabetic peripheral neuropathy. pressure, touch, proprioception and graphesthesia sensibility were measured, as well as functionality in daily basis, quality of life and fear of falling.

Eligibility criteria:
inclusion criteria: having peripheral neuropathy and history of falls or risk factors for it. current ulcer - exclusion criteria: amputation and cognitive or mental issues -

Keywords: gait diabetes sensorimotor training peripheral neuropathy somatosensory system postural control quality of life fear of falling feldenkrais method
remote ischemic conditioning in adult moyamoya disease patients

Conditions: Moyamoya Disease; Remote Ischemic Conditioning

Summary: remote ischemic conditioning (ric) is a non-invasive therapeutic approach for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. many protective factors produced by the stimulus of ric could protect remote target organs and tissues through inhibiting oxidation and inflammation. the phenomenon of this protect effect was first found in myocardium ischemia-reperfusion injury and then ric was used in children cardiac surgery to provide myocardial protection during operation. then ric was gradually applied to brain protection and a series of clinical researches have confirmed that it could improve the cerebral perfusion status, increase cerebral tolerance to ischemic injury, reduce perihematomal edema and promote clearance. recently, a randomized controlled study reported that daily ric could improve cerebral perfusion and slow arterial progression of adult mmd. meanwhile, a single-arm open-label study also indicated that ric was a promising noninvasive method for ischemic mmd control by relieving symptoms and reducing stroke recurrence. in addition, the effects of ric on reducing neurological complications in mmd patients treated with revascularization surgery has also been reported. however, the mechanism of ric in reducing peri-operative complications for mmd patients is still unknown. thus, we conducted a randomized controlled study to explore the safety and efficacy of ric in adult mmd patients undergoing revascularization therapy


Eligibility criteria:
inclusion criteria: 1. patients aged from 18 to 65 years old; 2. subjects all performed digital subtraction angiography (dsa) and diagnosed with mmd accroding to the criteria recommended by the research committee on mmd (spontaneous occlusion of the circle of wills) of the ministry of health and welfare of japan in 201211. 3. modified rankin scale (mrs) score\<4; 4. informed consent obtained from the patient or legally authorized representative. exclusion criteria: 1. subjects suffered from acute ischemic or hemorrhagic stroke within 3 months; 2. severe hepatic or renal dysfunction; 3. severe cardiac disease; 4. severe hemostatic disorder or severe coagulation dysfunction; 5. serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year; 6. patients with moyamoya syndrome caused by autoimmune disease, down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy;
high-dose vitamin d supplementation for adt-induced side effects

Conditions: Prostatic Neoplasms; Bone Mineral Density Quantitative Trait Locus 3

Summary: the purpose of this study is to test the efficacy of a high-dose vitamin d supplementation regimen in reducing androgen deprivation therapy (adt)-related side effects in older prostate cancer patients on adt. the proposed study is a randomized, double-blind, 2-arm, controlled clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60 and older, beginning adt, and scheduled to receive at least 6 months more of adt. participants will be randomized to: 1) weekly high-dose vitamin d3 (50,000 iu) or 2) vitamin d placebo only for a period of 24 weeks. both groups will also receive a daily multivitamin and calcium supplement.

the investigators hypothesize high-dose vitamin d supplementation will reduce androgen deprivation therapy (adt)-related side effects including adt-induced bone loss, decreased muscle mass, falls, reduced muscle strength, and diminished physical performance in older prostate cancer patients. the vitamin d supplementation is aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. both vitamin d and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on prostate cancer patients and survivors. vitamin d could reduce fracture risk among prostate cancer survivors.

Eligibility criteria:
inclusion criteria: * have a confirmed diagnosis of stage i-iiia prostate cancer * within 6 months of starting adt with an additional 6 more months planned. * participants must have sub-optimal vitamin d levels of \<32 ng/ml. * participants must agree not to take calcium and/or vitamin d supplements for the duration of the intervention other than those provided. * participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/l) and a total corrected serum calcium of ≤10.5 mg/dl. * no contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician. * able to read english (since the assessment materials are in printed format). * able to swallow medication and provide written informed consent. * 60 years of age or older. exclusion criteria: * previously verified diagnosis of osteoporosis (any t-score ≤ -2.5). * patients on antiresorptive drugs (i.e. bisphosphonates) within the past year. * patients with hypercalcemia (corrected serum ca \> 10.5 mg/dl) or a history of hypercalcemia or vitamin d toxicity/sensitivity. * patients with impaired renal function (crcl \< 60 ml/min) or who had kidney stones (calcium salt) within the past 5 years. * myocardial infarction within the past year.

Keywords: prostate cancer bone density vitamin d micronutrients pharmacologic actions
investigating the safety profile of liraglutide under normal conditions of use in korean subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this study is to investigate the safety profile of liraglutide (victoza®) under normal conditions of use in korean subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subjects with t2dm (type 2 diabetes mellitus), including newly-diagnosed subjects, who require treatment with victoza® according to the clinical judgment of their treating physician * subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information exclusion criteria: * subjects with a hypersensitivity to victoza® or to any of the excipients * subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods * subjects with personal or family history of medullary thyroid carcinoma (mtc) * subjects with multiple endocrine neoplasia syndrome type 2 (men2)