Kornimate/medical-research-clean huggingface dataset:
effect of slt location on treatment outcomes

Conditions: Glaucoma

Summary: selective laser trabeculoplasty (slt) is a glaucoma treatment that has been shown to effectively lower intraocular pressure by increasing aqueous outflow through macrophage recruitment. there is evidence of increased drainage in the nasal quadrants of the eye. this study aims to compare whether there is a difference in the reduction of eye pressure when slt is performed nasally and temporally.

this study aims to evaluate if there is a difference between 180 degree nasal and temporal selective laser trabeculoplasty (slt) in treatment outcomes. it is known that there is increased aqueous collectors and veins and thus aqueous drainage in the nasal quadrants of the eye. if slt works by the hypothesized biologic mechanism in which macrophages remodel the aqueous drainage system to increase outflow, performing slt in an area concentrated with aqueous veins may increase outflow more. as a result, we hypothesize that nasal 180 degree slt may have better outcomes compared to the temporal counterpart. the results of this study may help inform decisions when performing 180 degree slt and provide insight to slt's mechanism of action. the primary objective of this study is to determine if there is a difference in treatment efficacy between nasal and temporal 180 degree slt by measuring differences in baseline and post-operative intraocular pressures. we hypothesize that nasal slt will have superior outcomes compared to temporal slt due to increased number of aqueous veins.

Eligibility criteria:
inclusion criteria: * diagnosis of open angle glaucoma, ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome * participant must be over 18 years of age * iop \> 16mmhg on at least two consecutive occasions separated by one month * two sighted eyes with visual acuity of 20/200 or better * informed consent from patient exclusion criteria: * diagnosis of secondary oag (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma * previous incisional glaucoma surgery * incisional glaucoma surgery scheduled within 1 year of intervention * corneal disease affecting visualization of anterior chamber of the eye * treatment or plan to treat with topical or systemic steroids * previous selective laser trabeculoplasty treatment

Keywords: selective laser trabeculoplasty practice treatment intraocular pressure
breathing performance of healthy young adult

Conditions: COPD; COPD-like

Summary: the study will recruit subject of healthy adult, copd-like patient and patient with copd to investigate the difference of respiratory performance. we will measure the body composition, respiratory muscle force, pulmonary function and performance of voluntary cough. the muscle thickness of abdominal muscle and diaphragm, assessment of diaphragm during different breathing pattern and the muscle activation during voluntary cough will also being determined. we hypothesized that there will be a significantly different between three group on the performance of voluntary cough, and the correlation between each variable will be further investigated.

the specific aims of the study are: 1. difference of respiratory muscle performance between three groups 2. the correlation between respiratory symptom and pulmonary functional test 3. difference of functional respiratory performance (peak cough flow of voluntary cough) between three groups 4. muscle activation of abdominal muscle and diaphragm during performing voluntary force 5. performance of diaphragm under different breathing load

Eligibility criteria:
1. health subject inclusion criteria: * aged 20 years or above * currently not being diagnosis as copd * less than 4 times/week of aerobic exercise 2. copd-like subject inclusion criteria: * aged 20 years or above * currently not being diagnosis as copd * presented of copd symptoms (coughing, sputum production and dyspnea), last for 3 months and more than 2 years * score more than 1 on modified medical research council (mmrc) or copd assessment test (cat) 3. copd subject inclusion criteria: * aged 20 years or above * currently being diagnosis as copd * haven't participated in any pulmonary rehabilitation program in the past three months exclusion criteria: * untreated comorbidities for copd * postural asymmetries (scoliosis, length discrepancy of the lower limbs or other previous surgical history of spine) * chronic nonspecific lumbopelvic pain * gynecological or abdominal surgery in the previous year * pregnancy or post-delivery in the previous 6 months * neurological or inflammatory disorders * any conditions that may interfere with the data collection

Keywords: copd diaphragm voluntary cough abdominal muscle activation
investigate the efficacy and safety of farudodstat compared with its placebo in adult alopecia areata participants

Conditions: Alopecia Areata

Summary: the main purpose of this study is to measure the efficacy of farudodstat compared to placebo at week 12 from the treatment start, in adult participants with alopecia areata (aa) with 30% or greater scalp hair loss.


Eligibility criteria:
inclusion criteria: * adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informed consent) * moderate, severe, or very severe alopecia areata (aa), as determined by meeting the following criteria: 1. clinical diagnosis of aa with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.) 2. at least 30% scalp hair loss, as defined by a salt score ≥30 3. current episode of hair loss lasting at least 6 months and not exceeding 7 years at the time of screening. participants who have aa for longer than 7 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 7 years 4. no appreciable change (i.e., change exceeding 20 points on salt score) in terminal hair regrowth within 6 months exclusion criteria: * known history of androgenic alopecia or female pattern hair loss prior to aa * other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium, diffuse type of aa) * history or presence of hair transplants * other scalp disease that may impact aa assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)

Keywords: farudodstat alopecia areata dhodh inhibitor aslan003
brain-heart interactions in tako-tsubo cardiomyopathy and cardiac syndrome x:

Conditions: Takotsubo Cardiomyopathy; Cardiac X Syndrome; Acute Myocardial Infarction

Summary: the tako-tsubo cardiomyopathy (ttc) and the cardiac syndrome x (csx) are respectively acute and chronic heart diseases, which mimic myocardial infarction and stable angina pectoris without alterations of large coronary vessels. the causes and the most appropriate and best treatment for these diseases have not been yet clarified, but there are indications, that mental and psychosocial aspects may also contribute to these two diseases. so far, there is no study, which has comprehensively evaluated the interactions between mind and heart in these two conditions. the purpose of this study is to search for possible differences in mental activity, response to stressful events and function of specific areas of the brain deeply involved in relation between mind and heart. 45 subjects will be recruited and divided equally into: patients with csx, patients with ttc (at least 6 months ago) and patients with previous acute myocardial infarction (at least 6 months ago). all participants will undergo a clinical interview and several questionnaires that assess various mental functions, the stress response and the quality of life. in addition, in a separate visit the participants will undergo a magnetic resonance imaging without contrast medium that helps to assess function of specific areas of the brain.


Eligibility criteria:
inclusion criteria: * group a. 15 patients with cardiac x syndrome (csx), according to the diagnostic criteria previously proposed by lanza et al. * group b. 15 patients with tako-tsubo cardiomyopathy (ttc), according to mayo diagnostic criteria at least 6 months after being hospitalized or diagnosed with ttc. * group c (control group). 15 prospectively enrolled patients with previous type 1, 4a, 4b myocardial infarction (st-segment elevation acute myocardial infarction \[stemi\] and non st-segment elevation acute myocardial infarction \[nstemi\] acute coronary syndrome \[acs\] with significant ≥70% coronary stenosis) at least six months after the event. acute myocardial infarction will be defined according to the third universal definition of myocardial infarction. exclusion criteria: * refused consent * unable to participate or provide written informed consent * short-term survival (\<1 year) * acute or decompensated medical conditions * acute neurological or psychiatric diseases * absence of sinus rhythm or frequent ectopic beats * history of severe lung, liver, kidney or autoimmune diseases * any contraindication to mri
the study estimates the longitudinal impact of a gamified health education app on students' health and learning outcomes

Conditions: Infectious Disease; COVID-19; Physical Inactivity; Health Behavior; Nutrition, Healthy; Habit, Diet

Summary: the primary aim of this study is to assess and quantify the longitudinal impact of a mobile app-based module - fya-003 - which is a gamified health education module for children promoting nutrition, physical activity, health hygiene, and infectious disease risk reduction within the clinically proven app fooya!, on the dietary and physical activity habits, hygiene practices, clinical outcome measures, and related knowledge of children and their caregivers. the app will be delivered in the classroom setting through school-based health education.

a 2-arm cluster randomized controlled trial with pre-, during- and post-treatment measurements will be conducted in a school in chennai (india) - panchayat union middle school (pums), katchipedu - to assess and quantify the longitudinal impact of a proposed digital vaccine candidate, called fya-003®, on students' knowledge, behaviors and outcomes related to diet, physical activity and health hygiene. after following the protocol for recruitment and informed consent, the investigators will pair up grades in the school (site) in consecutive order, such as grades 1-2, 3-4, 5-6, and 7-8, and randomly assign one grade in the pair to group 1 and the other to group 2. these pairs are assumed to be close to each other in age, maturity levels, health related knowledge, and exposure to mobile apps, hence appropriate for pairing up for the study. a team of research staff located in chennai will coordinate the execution of the experiment. after following the protocol for participation by the school administrator and staff, and the protocol for student recruitment and informed consent, the investigators will adopt a cluster-randomized trial design, where treatment assignment will be done at the grade level. actual food choice, clinical measurements, survey data, and food logs will be collected by the site pi with support from a research project coordinator during weekly visits to the school. game play data will be collected automatically whenever the mobile device is connected to the internet and will be downloaded to a secure server after the school visits. the research team will coordinate the gameplay timing with the school officials.

Eligibility criteria:
inclusion criteria: * age 5-14 * parents willing to participate (fill out parent surveys) exclusion criteria: * children physically unable to use a device * children with special needs

Keywords: digital vaccine mobile games physical activity lifestyle habit formation infectious diseases nutrition
a liquid biopsy diagnostic techniques for endometriosis

Conditions: Liquid Biopsy; Endometriosis

Summary: to evaluate the diagnostic efficiency of circulating endometrial cell detection method using microfluidic chip as an non-invasive method for diagnosis in endometriosis.

endometriosis is a chronic condition, characterized by the presence of functional endometrial glands and interstitium in extrauterine ectopia. ectopic endometrial tissue responds to estradiol and other hormones similar to normal endometrium. endometriosis is one of the most common benign gynaecological conditions, affecting up to 5 to 10 percent of women of reproductive age. in addition to severe dysmenorrhea or pelvic pain, decreased fertility is a common clinical manifestation of internal heterogeneity, with up to 40 percent of patients associated with infertility . currently, laparoscopy is the gold standard for diagnosis. however, the actual time to diagnosis in patients with internal dysmorphia is delayed by an average of 4 to 11 years, resulting in a large number of patients with moderate to severe (stage iii to iv) at diagnosis. recently, the exploration of efficient and cost-effective non-invasive diagnostic solutions has been a hot button issue.

Eligibility criteria:
inclusion criteria: • surgically and pathologically verified patients with or without endometriosis exclusion criteria: * suspicion of malignancy * pregnancy * acute infection * lack of ability to sign informed consent forms on their own
roflumilast safety administered once a day on alternate days for two weeks compared to the usual dosage once daily

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: it is a phase iv clinical trial: longitudinal, prospective, evaluator-blind, randomized into 2 groups of patients with chronic obstructive pulmonary disease (copd). the intervention group was based on the administration of roflumilast 500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks (phasing). in the control group assigned to undertake the treatment according to the standard dosage (roflumilast 500μg od). the patient monitoring will be done by one of the sub-investigators fully independent team that started the medication keeping the pattern masking by single blind, and since it aims to assess the frequency of adverse events (aes) in both groups were collected systematically different aes and their characteristics at 15 days (v1), and from that moment a month (v2) and 2 months (v3). likewise, other data collected (functional demographic, comorbidities, home treatment, anxiety and depression and quality of life). the purpose of this study is to assess whether the administration of roflumilast by a gradual pattern varies the incidence of discontinuations due to adverse events when compared with the usual dosage.


Eligibility criteria:
inclusion criteria: * diagnosis of copd in severe degree gold criteria, assessed by post-bronchodilator spirometry (fev1 \<50%, fev1/forced vital capacity (fvc) \<70% of theory). * age over 18 years. * productive cough recurrently most days for at least three months a year and at least 2 consecutive years. * history from smoking prior\> 15 to 20 packs / year. * an exacerbation in the previous year. * stability clinic in the last 30 days. exclusion criteria: * pregnancy / breastfeeding. * acute infections. * patients with severe mental disorder or uncontrolled, in the opinion of the investigator, would make the patient has a higher risk due to their participation in the study, could be a confounding factor in the study's results or is likely to prevent that the patient meets the requirements of the study or to complete the study. * patients cachectic or the risk of cachexia. * hiv infection. * severe immune infections (systemic lupus erythematosus, multiple sclerosis, etc.). * gastroesophageal reflux symptoms and diagnosis established. * hiatal hernia. * peptic ulcer disease. * inflammatory bowel pathology. * neoplastic pathology: current diagnosis of cancer other than basal cell or squamous cell carcinoma of the skin. * moderate to severe hepatic impairment (child-pugh bc). * inability to understand / perform the techniques. * home treatment with theophylline, methotrexate, azathioprine, infliximab, etanercept, inducers of cytochrome p450 (eg, rifampicin, phenobarbital, carbamazepine, phenytoin),cytochrome p450 3a4 (cyp3a4) inhibitors (erythromycin and ketoconazole), oral contraceptives (gestodene and ethinyl estradiol), making prolonged oral corticosteroids, or a drug that contains fluvoxamine, enoxacin and cimetidine.

Keywords: copd
reducing distress and improving self-care in diabetes

Conditions: Diabetes Type 2

Summary: to date, there have been few practical, evidenced based interventions that are directed at patients with type ii diabetes who are experiencing depressed and/or emotional distress in primary care settings. this study will (1) combine two existing, evidenced-based, interventions (a computer automated, diabetes specific self-management program (casm) vs. a self-care program plus a live problem solving distress-reduction program (caps) vs. a lifestyle and activities education program (leap-ahead)) into a practical, 3-arm clinical trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention using the re-aim framework, sharing the results through a comprehensive dissemination package. hypothesis 1: the combined casm and caps arms will be superior to the leap-ahead group on the primary outcomes at follow-up. hypothesis 2: the caps arm will be superior to the casm arm on primary outcomes at follow-up.


Eligibility criteria:
inclusion criteria: * have a diagnosis of type 2 diabetes (confirmed using the wellborn criteria for a minimum of 12 months) * be between 21 and 75 years of age * speak and read spanish or english fluently * in addition, based on the telephone screening, patients will have to display a high level of diabetes distress and a deficit in at least one of three self-management areas (diet, physical activity, medication adherence). this is defined as having an average item score \> 3.0 on 2 items from the regimen distress and emotional burden sub scale of the dds and indication of problems in management on at least one scale of the sdsca (i.e., endorsing having a healthy eating plan on less than 5 days/week, 30 minutes physical activity less than 5 days/week, or forget to take medicines more than 1 day/week). * have access to the internet exclusion criteria: * have major disabilities or severe disorders (mi in the last 12 months, psychosis, on end-stage dialysis, dementia) * have current mdd (based on the phq8).

Keywords: diabetes type 2 distress problem solving therapy computer automated self-management (casm)
a shedding study of adenovirus serotype 26 based respiratory syncytial virus pre-fusion f protein (ad26.rsv.pref) vaccine in adults

Conditions: Healthy

Summary: the purpose of this study is to assess the shedding and kinetics of the adenovirus serotype 26 based respiratory syncytial virus pre-fusion f protein (ad26.rsv.pref) vaccine after one intramuscular injection of ad26.rsv.pref in adults.


Eligibility criteria:
inclusion criteria: * in the investigator's clinical judgment, participant must be in good or stable health. participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. if they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. participants will be included on the basis of physical examination, medical history, vital signs measurement and 12-lead electrocardiogram (ecg; for participants greater than \[\>\] 65 years of age only) performed at screening * contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants in clinical studies * all women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hcg) pregnancy test at screening and a negative urine beta-hcg pregnancy test immediately prior to study vaccine administration * from the time of vaccination through 3 months after vaccination, participant agrees not to donate blood * participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study exclusion criteria: * participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments * per medical history, participant has chronic active hepatitis b or hepatitis c infection * participant has received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study * participant has received treatment with immunoglobulin in the 2 months, or blood products in the 4 months before the planned administration of study vaccine or has any plans to receive such treatment during the study * participant has received any rsv vaccine in any previous rsv vaccine study at any time prior to randomization
viveye ocular magnetic neurostimulation system (omns) for the management of severe dry eye disease

Conditions: Dry Eye Syndromes; ATD; Sjogren's Syndrome

Summary: the objective of this study is to evaluate the safety and effectiveness of viveye omns non-invasive treatment for management of the signs and symptoms of severe dry eye disease.


Eligibility criteria:
inclusion criteria: 1. males and females, 18-80 years old 2. subjects with severe aqueous deficient dry eye disease (concomitant meibomian gland disease is permitted): 1. speed questionnaire score ≥ 10 and 2. fluorescein corneal staining score (fcss) ≥ 5 nei score in at least in one eye and 3. schirmer score ≤ 10 mm in at least one eye (at screening or treatment day pre-treatment) 3. no contact lens wear for at least seven days prior to the screening visit and willingness to forego contact lens wear for the duration of the study; 4. literacy, able to speak english or hebrew, and able to complete questionnaires independently; 5. willing and able to sign the informed consent form and deemed capable of complying with the requirements of the study protocol (tests and follow-up visits). exclusion criteria: 1. significant anterior blepharitis including signs of demodex eyelid infection; 2. if the subject is using prescription dry eye ophthalmic drug such as restasis (cyclosporine a 0.05% ophthalmic emulsion), xiidra (lifitegrast), cequa (cyclosporine 0.09% ophthalmic solution), and the medication has not been used regularly for the past 3 months prior to screening visit; 3. change in eye lubricant type usage in the last 1 month prior enrollment. use of any device to manage ded within 1 month of screening visit; 4. punctal plugs are present at screening that were inserted in the last 30 days prior enrollment, or intracanalicular plug that were inserted in the last 6 months in any eyelid; 5. corneal transplant in either or both eyes;