Kornimate/medical-research-clean huggingface dataset:
seed-lvpei myopia study

Conditions: Myopia

Summary: this randomized clinical trial study aims to investigate the efficacy of novel seed's edof based mid-lens design in controlling the myopia progression in indian children with these specific objectives: 1. to investigate the efficacy of seed's 1-day pure extended depth of focus lenses controlling myopia progression in indian children through a one-year randomized clinical study. 2. to investigate the role of seed's 1-day pure extended depth of focus lenses in altering peripheral refraction of the eye to control myopia progression. 3. to determine if there is any specific cohort that shows better efficacy in myopia control with 1-day pure extended depth of focus lenses based on central and peripheral optics (degree of myopia and optical parameters). 4. to investigate the qualitative assessment of comfort and visual experience with the seed's edof contact lenses through the questionnaire method.

this prospective randomized controlled clinical trial will be conducted in myopia research lab, l v prasad eye institute, hyderabad and the study protocol will adhere to the tenets of the declaration of helsinki. participants will be recruited through advertisements in local print media (newspaper), approaching schools, through clinical referrals. children will be assigned to either the control group or intervention group randomly based on computer-generated random numbers operated by the investigator. all participants will undergo a cycloplegic refractive error assessment after the instillation of tropicamide 1% eye drops (or cyclopentolate 1% eye drops in case of varying refractive error between objective and subjective values). axial length and cycloplegic refractive measurements will be taken with using lenstar ls900 biometer and shin- nippon autorefractor respectively for scheduled follow up and will be compared with the baseline parameters.

Eligibility criteria:
inclusion criteria: * myopia (se) between -0.50d to -10.00d * astigmatism less than 0.75d * anisometropia less than 1.00d * age of the participant from 7 to 15 years * neophyte or existing soft contact lens wearer * best-corrected visual acuity (bcva); ≤ 20/20 * participants who are willing to wear the contact lens constantly exclusion criteria: * participants who had any ocular or systemic conditions that could influence the refractive error * poor compliance of contact lenses from existing wearer * prior use of orthokeratology lenses/bifocal lenses/anti-myopia strategies * participants who had any medications that could influence the refractive error

Keywords: myopia contact lens peripheral defocus multi-focal india extended depth of focus
the effect of oral administration of 9-cis β carotene rich powder of the alga dunaliella bardawil

Conditions: Retinitis Pigmentosa

Summary: retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration starting in the rods. its prevalence is 1:4000 people and is the fourth most common blinding disease in israel in 2004 \[7% of all blindness\]. the investigators treated a non-progressive form of the disease \[fundus albipunctatus\] by oral therapy of the food supplement made from alga dunaliella bardawil composed of approximately 50% 9-cis β-carotene. the alga dunaliella bardawil accumulates high concentration of β -carotene when grown under appropriate conditions. the β -carotene of the alga is composed of approximately 50% of all-trans - β carotene and 50% 9-cis β -carotene. the 9-cis β -carotene has been shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. the night vision, as measured objectively by electroretinography (erg) more than doubled in six patients tested following treatment. the visual field was also improved significantly. in a more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis b carotene algae dunaliella bardawil in a double masked placebo control cross over trial. significant improvement in retinal function was recorded in 34% of the patients.


Eligibility criteria:
inclusion criteria: * written informed consent to participate in the study. * men or women aged 18 years or older. * electroretinogram (erg) responses compatible with the diagnosis of retinitis pigmentosa exclusion criteria: * current smokers. * current use of vitamin a/ beta carotene supplements. * active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (tia), stroke, and coronary artery bypass graft (cabg) surgery. * history of malignancy, except basal or squamous cell skin carcinoma. * pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception. * uncontrolled hypertension defined as either resting diastolic blood pressure of \>95mmhg (taken from the mean of 3 readings) or resting systolic blood pressure of \> 180 mmhg. * history of alcohol abuse or drug abuse, or both. * patient plans to engage in vigorous exercise or an aggressive diet regimen. * uncontrolled endocrine or metabolic disease. * participation in another investigational drug study within 4 weeks of entry into this study. * serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. * subject whose hormone replacement therapy (hrt) or oral contraceptive therapy (oct) was initiated within the 3 month prior to enrollment.
pelvic floor and sexual dysfunction in women with sjogren's syndrome

Conditions: Sexual Dysfunction; Pelvic Floor Disorders; Pelvic Organ Prolapse; Urinary Incontinence; Constipation

Summary: sjogren's syndrome (ss) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.

sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal imbalance in rheumatological disorders. vaginal dryness and dyspepsia negatively affect participation in sexual activity. the aim of the study is to examine the pelvic floor problems of women with ss with a self-report, to compare them with healthy individuals, and finally to examine the relationship between pelvic floor problems and sexual dysfunction.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * being a woman, * having sex partner, * no smoking, no alcohol exclusion criteria: * physical, psychological, cognitive impairment, * having a non-sjögren additional disease, * malignancy, * pregnancy, * no urogenital disease, * sarcoidosis, * aids, * anticholinergic drug use, * had a gynecological or urological operation other than cesarean

Keywords: pelvic pain sexual dysfunction unirary incontinence constipation pelvic floor dysfunction
impact at one year of a secondary prevention educational program on cardiovascular risk factors

Conditions: Myocardial Infarction; Acute Coronary Syndrome

Summary: in secondary prevention, the beneficial role of cardiac rehabilitation programs after myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now well established. the large majority of patients don't benefit from cardiac rehabilitation but for those who do, they usually follow an inhospital short health educational program with a sensibilisation to different coronary risk factors like smoking, overweight and inactivity. the impact of these inhospital short health educational programs combined to cardiac rehabilitation has never been totally evaluated, especially the impact on smoking cessation, weight loss and daily physical activity. therefore, the present study aims to evaluate the impact at one year on 400 consecutive patients' coronary risk profile of: * an inhospital short health educational program alone * an inhospital short health educational program combined to cardiac rehabilitation * a cardiac rehabilitation program alone

classical cv risk factors, quality of life, daily physical activity and energy expenditure, smoking dependency and a daily quantification of fat intake are assessed with previously validated self-administrated questionnaires. further factors like the lipid profile and glycaemia (with hba1c in case of diabetes) will also be assessed. these evaluation will take place once at the of the hospitalization for acute coronary events in all patients, once at the end of any of the three rehabilitation programs for the concerned patients and, finally, one year after the hospitalization or the end of the rehabilitation program (mailed questionnaires and biological check-up). at this time, smoking dependency, medication, body mass index, any coronary event or need of coronary revascularization along with the professional ongoing situation (return to work) will be investigated. as this study aims to evaluate the efficiency of france's clinical practice in spotting most relevant risk factors, the results of the present study could help us to focus the medical and paramedical resources on the modification of specific relevant risk factors.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome or myocardial infarcts exclusion criteria: * misunderstand the questionnaires * living in institution * severe morbidity

Keywords: health education myocardial infarction acute coronary syndrome quality of life
hyaluronan in the treatment of painful tendinopathy

Conditions: Tendinopathy

Summary: the primary objective of this study is to evaluate the efficacy and safety of tchy106 (2% hyaluronan) in the treatment of painful tendinopathy.


Eligibility criteria:
inclusion criteria: * male and female patients between 18 and 75 years of age and good general health condition. * signed written informed consent. * painful tendinopathy since ≥ 6 weeks. * pain according to visual analogue scale (vas; 100 millimetres (mm)) ≥ 40 mm. * ensured compliance of subjects for study period. exclusion criteria: * treatment with any investigational product within 4 weeks prior to study entry. * patients with known hypersensitivity to the products (that is active compound and excipients) or any component or procedure used in the study. * severe intercurrent illness (for example: uncontrolled diabetes mellitus, peripheral neuropathy), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study. * concomitant disease at study relevant site influencing study evaluation. * list of diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation. * list of concomitant medications not allowed. * patients treated with: systemic and/or local steroids within the last 4 weeks, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (nsaids) within the last week or occasional use within 24 hours. * recent history of drug and/or alcohol abuse (within the last 6 months). * list of contra-indications to the treatment. * pregnant or lactating females. * fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intrauterine devices (iuds), sexual abstinence or vasectomised partner during the treatment period and the first 4 weeks follow-up period. * subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and or non completion of the study according to investigator's judgement.

Keywords: tendinopathy hyaluronan tendon hyaluronic acid
indonesian study of vonoprazan vs esomeprazole in erosive esophagitis

Conditions: Erosive Esophagitis

Summary: the goal of this clinical trial is to compare drug vonoprazan vs esomeprazole effectiveness to relieve early symptoms in erosive esophagitis patients. it will also learn about the safety of both modalities. the main questions it aims to answer are: how does the effectiveness of vonoprazan compare with esomeprazole in improving early symptoms of erosive esophagitis patients in the indonesian population? researchers will compare drug vonoprazan to a esomeprazole with a look-alike packaging to see their effect to reduce early symptoms of erosive esophagitis. participants will: * take drug vonoprazan 20mg or esomeprazole 40mg one time every day for 2 weeks * visit the clinic once every weeks for followup (gastro esophageal reflux disease-quetionnaire measurement) * keep a diary of their adverse effect occurence and every variable data based on gastro esophageal reflux disease-questionnaire.

based on the calculation using the formula for comparing two population proportions, the minimum estimated sample size is 97 samples for each group. considering a potential 10% drop-out rate, the estimated sample size increases to 108 samples per group. therefore, the total minimum sample required for this study is 216 samples for both groups. all the patients will screened using the gastro esophageal reflux disease-quetionnaire (6 questions, 4 answer options, covering the last 7 days) and collected through redcap. after that all eligible patients will undergo endoscopic examination that performed by gastroenterology specialists or trained internists. included patients who consume any proton pump inhibiotr or potassium-competitive acid blockers within 2 weeks prior to this study will undergo wash-out period for 2 weeks. patients are monitored weekly during the wash-out period. medication reminders are sent via instant messaging at least twice per week. adverse event will be monitored by research assistants in coordination with the patient's primary physician. all the data will analyzed blindly with chi-square or fisher's exact test for categorical data and logistic regression for confounding factors. at the end of the study, the pharmacy team will reveal the group allocation.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years with a gerd-q score of 8. * diagnosed with erosive esophagitis by endoscopy. (los angeles classification a-d) * patients are willing to undergo a series of therapeutic management. exclusion criteria: * patients with a history of allergy to pcab or ppi groups. * patients with gastric and/or duodenal ulcers. * patients with helicobacter pylori infection. * patients with a history of significant systemic disease disorders affecting the esophagus and stomach. * patients with a history of malignant disease related to the esophagus and/or stomach. * patients with a history of esophageal and/or gastric surgery. * pregnant patients

Keywords: erosive esophagitis vonoprazan esomeprazole gerd-q
telitacicept followed with rituximab therapy on aps secondary to sle

Conditions: Antiphospholipid Syndrome

Summary: the aim of this study was to observe the clinical efficacy and safety of rituximab (rtx) combination with telitacicept (ta) in patients of systemic lupus erythematosus secondary antiphospholipid syndrome (aps).

in this multicenter, prospective, observational study, 80 patients with sle secondary aps patients were enrolled. rtx alone or its continuation with ta was observed for 24weeks，and extended for another 24 weeks. at week 12, the rtx group could be converted to the combination group. the primary end point was the response rate of total antiphospholipid antibody (apl) at week 12. the secondary end points included the decline rate and value of apl antibody, agapss score, remission degree of specific clinical indicators, changes in sle disease activity in saps group, and drug safety at week 12 and week 24.

Eligibility criteria:
inclusion criteria: * 1.patients who meet 2006 sapporo classification criteria of aps or 2020 nonstandard aps performance； 2.patients who meet 1997 or 2019 sle classification criteria ; 3.positive la /acl/ aβ2gpi ,on two or more occasions, at least 12 weeks apart; 4.with at least one extra-criteria manifestations of aps, including thrombocytopenia, hemolytic anemia, nephropathy, valve heart disease ,skin ulcer and arterial or deep vein thrombosis; 5.maintain a stable base treatment regimen for at least 4 weeks before screening; basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, and hydroxychloroquine; 6.no response, intolerance or dependence on glucocorticoids and immunosuppressants; 7.patients who had previously used beliumab or telitacicept could be enrolled in the study after 12 weeks of discontinuation; 8.age ≥18 years; 9.signed informed consent. exclusion criteria: * 1.patients with other causes of thrombocytopenia, hemolytic anemia, valvular heart disease, kidney disease and skin ulcer symptoms were excluded, such as drugs, infections, blood system diseases, genetic metabolic diseases, etc; 2.severe cardiovascular diseases, kidney, liver and other important organ injuries, serious blood and endocrine system lesions (aplastic anemia, hyperthyroidism crisis, etc.) were excluded; a history of active malignancy (within 5 years) was excluded and chemoradiotherapy was performed; patients with organ or bone marrow transplantation in the past year were excluded. exclusion of mentally ill persons; 3.a history of allergy to the relevant test drug; 4.patients had recently received a live vaccine or planned to use any live vaccine during the study; 5.ongoing pregnancy; 6.patients who were participants in clinical trials of other immunosuppressive agents/biologics within 24 weeks; 7.other conditions that the investigator considers would make the candidate unsuitable for the study;

Keywords: telitacicept rituximab
metabolic and appetite responses to altered timing of whey protein ingestion

Conditions: Obesity, Abdominal

Summary: the proposed study aims to determine the metabolic and appetite responses to standard breakfast and lunch meals whilst altering the timing of whey protein supplementation. currently, the designs implemented in many studies mean that it is unclear whether an optimum time for whey protein consumption exists in order to promote the greatest acute health benefits. a number of studies have investigated the effects of whey protein when consumed as a preload to a subsequent meal, whilst benefits have also been shown when whey protein is ingested with a meal. the proposed study will therefore investigate strategies of whey protein supplementation that vary in their practical applicability, using meals that reflect regular eating behaviours throughout the population in a sample of overweight/obese individuals. findings from this study may provide important information regarding the efficacy of whey protein supplementation before, during and after a composite meal, and its effect on the handling of a subsequent mixed-macronutrient meal.

a randomised crossover design shall be implemented, whereby all participants complete 4 trials separated by a minimum of 3 days. on all visits participants shall consume a standardised mixed-macronutrient breakfast meal, followed 180 minutes later by consumption of a standard lunch meal. the timing of additional protein supplementation shall vary by trial, with participants consuming a shake containing 20g whey protein isolate either as a preload (15 minutes prior to breakfast), alongside the breakfast meal, or 15 minutes following breakfast consumption. a control trial shall also be completed without additional protein supplementation. at all supplementation time points participants shall consume either a flavoured whey protein shake or a flavoured water isovolumetric beverage ensuring that they remain blinded to the condition. venous and capillary blood samples and visual analogue scales (for determination of subjective appetite sensations) shall be taken at regular intervals following both meals while the participant is rested.

Eligibility criteria:
criteria for inclusion are as follows: * male * aged 18-55 years * abdominal obesity (waist circumference \> 102 cm) * sedentary (not currently participating in structured physical activity) criteria for exclusion are as follows: * metabolic disease or current illness * regular breakfast skipper * food allergies/intolerances * eating disorders * smoking

Keywords: postprandial glycemia metabolic health measures
relative bioavailability study of bicalutamide 50 mg tablet and casodex following a 50 mg dose in healthy subjects under fed conditions

Conditions: Prostate Cancer; Hirsutism

Summary: the purpose of this study is to demonstrate the relative bioavailability of bicalutamide 50 mg tablet and casodex following a 50 mg dose in healthy subjects under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: treatment
analysis and improvising working practices in the er

Conditions: EMERGENCY MEDICINE

Summary: analysis of electronic files of patients presenting to the emergency department to improve current practice

overcrowding in the emergency department (ed) is a pressing healthcare issue globally and has been shown to negatively affect the quality of treatment, clinical outcomes and patient satisfaction. in recent years, an increasing number of studies have tried to implement changes in the ed to increase efficiency and thereby reduce the length of stay (los). examples to these efforts include physician triage, expanding the nursing scope of practice and patient-flow design (e.g., creating fast track units) in the ed. importantly, not all intuitive changes in the ed resulted in the reduction of los therefore, implementing changes in the ed must be done with caution and preceded with a cost-benefit analysis of the effects of the intervention using available retrospective data. this research was conducted in the ed of sheba medical center (smc), a tertiary government-owned hospital in israel with 1400 beds. this study is a retrospective medical record review of patients admitted to the adult primary smc ed. the study sample comprises all the walk-in patients that visited the ed between january 2013 and december 2017. the data here does not include other eds located elsewhere in smc, (e.g., pediatric ed, gynecology ed, ophthalmology ed, and psychiatric ed). all admissions files in smc ed are recorded in a computerized system with negligible exceptions (such as power outage and connection or server maintenance). the time and date of every change in the electronic files are also recorded in the system. therefore, it is possible to track the waiting times as well as the full content of the admission file. the aim of this study is to identify and analyze potential modifications in current ed practice which may improve outcomes such as los, missed diagnosis, leaving without being seen, patient satisfaction, etc.

Eligibility criteria:
inclusion criteria: * all the patients that visited the smc - ed between august 2014 and december 2017 exclusion criteria: * patients in which the electronic file is absent