Kornimate/medical-research-clean huggingface dataset:
changes to the retina following anti-vegf treatments for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: anti-vegf therapy is an established method to control leakage and abnormal growth of retinal blood vessels. questions on the long-term effect on the retina, intraocular pressure and on the overall retinal perfusion from these treatments remain to be answered. the purpose of the study was to evaluate changes in the retina following anti-vegf treatment over time, using structural and functional diagnostic tests.

diabetic retinopathy (dr) causes changes in the capillaries that nourish the retina. two treatments clinically used for dr are laser photocoagulation to reduce the angiogenic drive by knocking off metabolically active retina and anti-vegf drugs for diabetic macular edema (dme). dme affects approximately 2.5% of the nearly 2.4 million canadians with diabetes, or approximately 60,000 canadians, making it a major cause of adult-onset vision loss. dme occurs when blood vessels in the retina of diabetic patients become leaky resulting in unwanted fluid accumulation in the center of vision known as the macula. if not treated, this can lead to blindness. originally used in the treatment of age-related macular degeneration (amd), anti-vegf drugs are increasingly used to control leakage and abnormal growth of retinal blood vessels. numerous questions have emerged following the usage of anti-vegf medications in the eye such as their long-term effects of these drugs on intraocular pressure and on the overall retinal perfusion. by recruiting dr patients requiring anti-vegf treatment for dme, this study will answer whether long-term usage of anti-vegf will result in structural and functional changes to the retina.

Eligibility criteria:
inclusion criteria: * dme patients * require anti-vegf injections in at least one eye exclusion criteria: * advanced lens opacity or cataract that could affect diagnostic testing * prior retinal treatment (prp, focal laser or surgery within 6 months of participation)
measuring g protein-coupled receptor kinase-2 (grk2) in the blood to diagnose and treat patients with heart failure

Conditions: Heart Failure

Summary: the primary objective of this study is to determine the utility of grk2 to differentiate between normal patients and patient groups that differ by the presence/absence of hf symptoms, systolic or diastolic left ventricular dysfunction, and risk factors; and to evaluate if a new assay provides similar values as traditional methods for measuring grk2 levels.

this study seeks to define a beta-adrenergic receptor kinase molecule in the blood and its role as an improved biomarker to be used for the diagnosis, assessment and management of patients with heart failure. we will test blood cell samples for the levels of this molecule, called "g protein-coupled receptor kinase-2" (grk2) using both the existing method of grk2 quantification in the koch laboratory and using a prototype enzyme immunoassay (eia) method being developed by johnson \& johnson, ortho-clinical diagnostics (ocd).

Eligibility criteria:
inclusion criteria: * normal controls: individuals without hf, hypertension, diabetes, hyperlipidemia, coronary artery disease or obesity; * group i: symptomatic subjects with reduced lv function, hf symptoms, ef ≤ 40%. * group ii: asymptomatic patients with lv dysfunction, no hf symptoms (nyha class i and ats score 0 or 1, ef ≤ 40%. * group iii: symptomatic subjects with preserved lv function, hf symptoms, ef ≥ 50%, and diastolic dysfunction. * group iv: asymptomatic high risk subjects - individuals with normal heart function, no hf symptoms (nyha class i and ats score 0 or 1), preserved lv function (ef ≥ 50%), no diastolic dysfunction. also possess one or more cardiovascular high risk factors: diagnosis of diabetes; hyperlipidemia; coronary artery disease; renal insufficiency; hypertension; age \>70 years exclusion criteria * pregnancy * not providing consent * inability to provide consent * participation in a clinical study involving an experimental therapy.
efficacy of intra-articular injection of human amniotic suspension allograft and platelet-rich plasma in the treatment of knee osteoarthritis.

Conditions: Knee Osteoarthristis

Summary: a double-blind, randomized controlled trial designed to evaluate the symptomatic modulating efficacy of amniotic suspension allograft (asa) in comparison to platelet-rich plasma (prp), hyaluronic acid (ha) and normal saline (ns) in the injection treatment of knee osteoarthritis. the hypothesis is that asa would provide the greatest functional improvement.

at least 150 subjects with osteoarthritic knee will be recruited and computer randomized 1:1:1:1 to single injection of asa (40mg), asa (20mg), prp + ha, and ns groups. both subjects and evaluaters were blinded to allocations. functional and radiologic outcomes were measured at baseline, and 1 week, 1, 3, 6, 12 months postinjection.

Eligibility criteria:
inclusion criteria: * age between 20 and 80 years * ability to provide informed consent * unilateral or bilateral knee vas pain score ≥ 4 of 10 (worst possible pain) for more than 4 months * diagnosis of oa kellgren-lawrence i-iii by radiography (triple-film of bilateral lower limb, standard knee anterior-posterior view in full extension, lateral view in 30-degrees flexion, and 45°merchant views) * no prior prp injection of knee * no prior surgical procedure of the participating knee * bmi\<40 kg/m2 exclusion criteria: * lawrence stage iv * major axial deviation (varus\> 5°, valgus \> 5°) * any concomitant symptomatic knee disorder (i.e. ligamentous/ meniscal injury) * systemic inflammatory arthropathy * hematologic diseases * severe cardiovascular disease * neurological disorders * active infection * immuno-compromised * therapy with anticoagulants or antiaggregants * use of nsaids and/or chondroprotective supplements, such as glucosamines and chondroitin sulfates, within 7 days prior to trial * recent intra-articular injection of corticosteroids (within 30 days) * prior treatment with ha in past 6 monthshb\< 11 g/dl * platelet count \< 150,000/mm3
effect of dietary, lifestyle, and environmental factors on patients with early-stage bladder cancer

Conditions: Bladder Cancer

Summary: rationale: learning about the long-term effects of dietary, lifestyle, and environmental factors on the risk of cancer progression and recurrence may help the study of bladder cancer in the future. purpose: this clinical trial is studying how dietary, lifestyle, and environmental factors affect patients with early-stage bladder cancer.

objectives: * to examine if common and potentially modifiable dietary, lifestyle, and environmental exposures affect the risk of recurrence and progression in bladder cancer. outline: this is a multicenter study. detailed information will be collected about the patients' lifestyle and their exposure to risk factors associated with bladder cancer using semi-structured questionnaires. a baseline questionnaire will be administered at the time of diagnosis and will collect information about socio-demographics, environmental exposures, medical history, diet, health-related quality of life, and social support. further questionnaires will be administered at regular follow-up visits to capture information relating to changes in exposure. a postal questionnaire will be used to collect historical information that may require the patient to check records or consult family or friends. patients will also be asked to keep a 1-week food, fluid, and micturition diary. patients continue to complete questionnaires at 3 months and then annually for up to 5 years. peer reviewed and funded or endorsed by cancer research uk.

Eligibility criteria:
disease characteristics: inclusion criteria: * enrolled on parent protocol cruk-bcpp-2005-01 * bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma * histologically proven urothelial cancer meeting one of the following criteria: * stage ta (who grade 2/3, or grade 1 tumors that are either multifocal or \> 3 cm in size) * stage t1 (any grade) * stage tis exclusion criteria: * previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis patient characteristics: inclusion criteria: * fit for cystoscopy and surgical biopsy/resection exclusion criteria: * hiv infection * any condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives prior concurrent therapy: * not specified

Keywords: stage 0 bladder cancer stage i bladder cancer transitional cell carcinoma of the bladder
prprofile: a study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ion717

Conditions: Prion Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (it) delivery of ion717.

this is a first-in-human, randomized, multi-center study in participants with prion disease. eligible participants will receive ion717 and placebo. the study will consist of a screening period of up to 6 weeks, a 30-week double-blind treatment period, a 70-week open-label extension period and a 32-week post-treatment period. during the double-blind period, the order of ion717 and placebo doses will be randomized and blinded to participants, study sites and the sponsor. during the open-label extension period, all participants will receive ion717. multiple dose levels will be tested.

Eligibility criteria:
key inclusion criteria * a confirmed diagnosis of probable or definite prion disease. * early-stage prion disease at the time of screening. * willing to meet all study requirements, including travel to study center, procedures, measurements and visits. * patients must have a caregiver who is ≥ 18 years old and who is able and willing to facilitate the patient's involvement, to the best of their ability, for the duration of the trial; caregivers must also be able and willing to provide information about themselves and the patient for the duration of the trial. * aged ≥ 18 at the time of informed consent. key exclusion criteria * clinically significant abnormalities in medical history, laboratory tests or physical examination that would render a patient unsuitable for inclusion. * any contraindication or unwillingness to undergo an mri. * obstructive hydrocephalus, presence of a functional ventriculoperitoneal shunt for the drainage of cerebrospinal fluid (csf) or an implanted central nervous system (cns) catheter. * known brain or spinal disease that would interfere with the lp process, csf circulation or safety assessment. * have any other condition, which, in the opinion of the investigator would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study.
does additional use of preoperative azithromycin decrease posthysterectomy infections

Conditions: Infection Post Op; Hysterectomy; Antibiotics; Prophylactic

Summary: during hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. the risk for deep infection after hysterectomy is about 5%. by reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. this study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. in addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.


Eligibility criteria:
inclusion criteria: * women undergoing hysterectomy for benign indication in university hospitals (helsinki university hospital, turku university hospital, tampere university hospital, oulu university hospital and kuopio university hospital) who have not any contraindications for azithromycin or cefuroxime. exclusion criteria: * inability to understand the study protocol. * allergy for either cefuroxime or azithromycin. * congenital or acquired prolonged q-t-corrected interval. all the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family, * electrocardiogram will be checked for all the participants. * use of medicines that may prolong q-t-corrected interval (class ia arrhythmia medications, quinidine, procainamide, and class iii arrhythmia medications dofetilide, amiodarone and sotalol). * use of selective serotonin reuptake inhibitor medication and prolonged q-t-corrected interval.

Keywords: postoperative, infection, hysterectomy, antibiotics
a phase 1/1b study of zh9 treatment in patients with non-muscle invasive bladder cancer

Conditions: NMIBC; High Risk NMIBC; Non Muscle Invasive Bladder Cancer

Summary: this is a first-in-human, multicenter, phase 1/1b, 3-part, double-blind study of zh9 in patients with recurrent nmibc who are eligible for intravesical therapy. in part 1, the safety, tolerability, and pharmacology of zh9 ivi will be evaluated in a single ascending dose (sad) patient cohort. in part 2, the safety, tolerability, and pharmacology of zh9 oral prime followed by zh9 ivi will be evaluated in 2 patient cohorts at the doses and schedule established in part 1. in part 3, the safety, pharmacology, and clinical efficacy of zh9 will be further evaluated in 2 expansion cohorts of patients with recurrent intermediate- and high-risk nmibc.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histologically documented recurrence of nmibc * bcg unresponsive (bcg naïve patients may be enrolled if they have received at least 1 line of adequate intravesical standard of care (soc) treatment and are either not candidates for bcg or do not have access to bcg (e.g., bcg shortage)) * eastern cooperative oncology group performance status 0-1 * adequate organ and marrow function * highly effective contraception if risk of conception exists. * a female participant is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (wocbp) or is a wocbp that uses highly effective contraception. exclusion criteria: * received treatment with any local or systemic antineoplastic therapy within 3 weeks or 5× the plasma half-life prior to first dose of zh9 * major surgery or radiation within the 3 weeks prior to screening (turbt is not considered major surgery) * concurrent urinary tract infection or history of clinically significant polyuria * symptoms consistent with typhoid * evidence of infection within 2 weeks of the first dose of zh9 * significant 12-lead electrocardiogram abnormalities * history of malignancy within the previous 12 months * history of allogeneic tissue/solid organ transplant
the effects of smartphone addiction on physical activity, fatigue and sleep quality of university students

Conditions: Addictive Behavior

Summary: the increasing rate of usage of smartphones ushers in various health problems and smartphone addiction. in the literature, the research focused mainly on the relationship between smartphone addiction and depression, anxiety and musculoskeletal system problems; however, the number of studies on fatigue was limited. we believe that this paper will be of interest to the readers of your journal because it adds information about the effect of smartphone addiction on physical activity, on sleep quality and especially on fatigue.

this cross-sectional study was conducted with the participation of 322 students attending the faculty of health sciences at süleyman demirel university. the participants were given the socio-demographic characteristics form, developed by the researchers according to the literature review. they were also given the evaluation form, which surveys some variables related to smartphones, as well as the short version of the smartphone addiction scale short version (sas-sv), the international physical activity questionnaire-short form (ipaq-sf), the pittsburgh sleep quality index (psqi), and the piper fatigue scale (pfs).

Eligibility criteria:
inclusion criteria: * the students who volunteered to participate in the study after being informed about the aims and procedures of the study. exclusion criteria: * the students who didnot volunteered to participate in the study after being informed about the aims and procedures of the study.
prevention of postpartum haemorrhage

Conditions: Post Partum Hemorrhage

Summary: use of tranexamic acid for prevention of postpartum hemorrhage in high risk patients: randomized control trial

this study aims to assess the efficacy of administration of tranexamic acid in preventing postpartum haemorrhage \& reducing intraoperative and postoperative blood loss in high risk women for postpartum hemorrhage undergoing caesarean section. studying its benefit to transfusion-sparing and hysterectomy-sparing. \& reduction of hemorrhage-related mortality when postpartum hemorrhage is expected.

Eligibility criteria:
inclusion criteria: * women at high risk for postpartum hemorrhage after cesarean section exclusion criteria: * women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.

Keywords: tranexamic acid postpartum hemorrhage cesarean section
tuned app self-fitting vs. professional fitting

Conditions: Hearing Loss

Summary: the aim of the study is to compare the perceived outcome of the self-fitting performed by the participants using the tuned mobile application with the traditional professional fitting as performed by a licensed professional audiologist in subjects with mild to moderate sensorineural hearing loss.


Eligibility criteria:
inclusion criteria: * adult males and females, 18 years and older. * mild to moderate sensorineural hearing loss. * own and able to use a smart phone (android or ios). * able to read and understand hebrew. exclusion criteria: * conductive mixed hearing loss. * unilateral hearing loss. * any external or inner ear malformations. * symptoms of ear disease or excessive cerumen.

Keywords: self fitting
prevalence of deleterious oral habits among a group of school children in cairo, egypt: cross-sectional study

Conditions: Habits; Bruxism; Sucking Behavior; Nail Biting

Summary: this study aims to detect the prevalence of practicing oral habits among a group of school children in cairo, egypt.

an online questionnaire utilizing the third domain of nordic orofacial test screen will be distributed among school children (aged five to seven years) parents to measure the prevalence of oral habits.

Eligibility criteria:
inclusion criteria: * school children * accept to participate * children within the age group exclusion criteria: * special health care needs children
single pre-operative radiation therapy - with delayed or no surgery (sport-dns)

Conditions: Breast Cancer

Summary: eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year


Eligibility criteria:
inclusion criteria: 1. female aged 50 years or older. 2. postmenopausal status (defined as: age 60 or bilateral ovariectomy or amenorrhea \> 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65). 3. world health organization (who) performance status 0-2. 4. invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start. 5. unifocal disease on preoperative staging ultrasound or mri done ≤ 12 weeks from treatment start. 6. tumors less than or equal to 2cm clinically on physical exam, as well as on breast ultrasound. 7. no clinical evidence of nodal disease (i.e. cn0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound. 8. estrogen receptor status (er) positive on biopsy ≥ 80%. 9. progesterone receptor status (pr) positive on biopsy ≥ 20%. 10. her2 negative on biopsy. 11. no lymphovascular invasion on biopsy. 12. low oncotype dx recurrence score performed on biopsy specimen (rs ≤18). 13. planned surgery is a partial mastectomy with sentinel lymph node biopsy. exclusion criteria: 1. age less than 50 years. 2. premenopausal or uncertain menopausal status. 3. a known deleterious mutation in brca 1 and/or brca 2. 4. clinical tumor size \> 2.0 cm in greatest diameter on staging ultrasound. 5. tumor histology limited to lobular carcinoma only. 6. clinically positive axillary nodes (cn+). 7. lymphovascular invasion on biopsy. 8. pure ductal or lobular carcinoma in situ on biopsy. 9. extensive intraductal component on biopsy. 10. neoadjuvant hormonal manipulation or chemotherapy. 11. prior non basal cell or squamous cell skin cancers within 5 years. 12. more than one primary tumor in different quadrants of the same breast. 13. diffuse microcalcifications on mammography. 14. paget's disease of the nipple. 15. previous irradiation to the ipsilateral breast. 16. presence of an ipsilateral breast implant or pacemaker. 17. serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (sle), scleroderma) which would preclude definitive radiation treatment. 18. estrogen receptor status (er) not known. 19. currently pregnant or lactating. 20. psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol. 21. geographic inaccessibility for follow-up. 22. lack of preoperative staging with breast and axillary ultrasound. 23. inability to adequately plan the patient for the experimental technique. 24. prior breast cancer.

Keywords: ablative radiotherapy preoperative radiotherapy neoadjuvant radiotherapy
effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients

Conditions: Stroke, Ischemic; Balance; Distorted; Gait, Hemiplegic

Summary: to determine the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients

the aim of this study is to compare the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients. the randomized controlled trial will recruit the stroke patients will be selected and randomly divided into two groups: group a (unilateral training group (utg)) and group b (bilateral training group (btg)). patients in group a will undergo approach-oriented training using the motor relearning program (mrp) and proprioceptive neuromuscular facilitation (pnf) for the affected side, while those in group b underwent strength training for the lower-limb muscles using delorme's principle for the unaffected side and approach-oriented training using the mrp and pnf for the affected side for a period of six weeks, five days per week. a strengthening regimen will designed for the unaffected side, considering the frequency, intensity, time, and type (fitts) principle provided by the american college of sports medicine (acsm). the static and dynamic balance along with gait parameters will measure using the functional reach test (frt), one-leg stance test (olst), berg balance scale (bbs) dynamic gait index (dgi), gait parameters (stride length, gait velocity, and cadence), and brunnstrom recovery stages (brs) at the baseline and post rehabilitation.

Eligibility criteria:
inclusion criteria: * medically stable patients (the diagnosis was made by neurologist). * cognitive level is greater than 25 on mmse. * chronic stroke patients (ischemic and hemorrhagic) (6 months to 2 years). exclusion criteria: * transient ischemic attack. * patients with other neurological condition, orthopedic problems, and uncontrolled metabolic disease. * severe hearing and visual loss. * uncontrolled arterial hypertension. * recurrent stroke. * patient diagnosed with brainstem stroke and middle cerebral artery stroke. * patient with any cardiovascular unstable condition.

Keywords: stroke, ischemic balance; distorted gait, hemiplegic