Kornimate/medical-research-clean huggingface dataset:
genetics of interstitial cystitis

Conditions: Interstitial Cystitis; Painful Bladder Syndrome

Summary: the cause of interstitial cystitis is unknown. however, it tends to run in some families suggesting that there may be a genetic susceptibility to the disease. for instance, the disease is found 17 times more commonly in first-degree relatives (parent, sibling, or child) of patients with interstitial cystitis than in the general population. furthermore, if one twin has interstitial cystitis, the disease is much more common in identical co-twins than fraternal co-twins. this evidence suggests that, in some families, genes that make a person susceptible to interstitial cystitis are being passed from one generation to the next. the university of maryland school of medicine and the national institutes of health are performing a study to identify these genes for susceptibility for interstitial cystitis. this study is entitled the maryland genetics of interstitial cystitis (magic) study. the magic study will investigate several hundred families with two or more blood relatives with interstitial cystitis. the study will seek to find changes in genes that are found far more commonly in family members who have interstitial cystitis than in those who do not have the disease.identifying these genes should lead to a better understanding of the cause of interstitial cystitis. finding the cause is the first step to finding the cure. this is a national study which is conducted by telephone and mail, and in which you can participate entirely from your home.


Eligibility criteria:
inclusion criteria: * have interstitial cystitis, or painful bladder syndrome. * have at least one blood relative with interstitial cystitis, painful bladder syndrome, or urinary symptoms similar to yours. * are 13 years of age or older. * are available for a telephone, mail, or website interview. * live in the usa or canada. exclusion criteria: * are less than 13 years of age. * have parkinson's disease, multiple sclerosis, spina bifida, or another neurologic disease that preceeded your interstitial cystitis symptoms

Keywords: interstitial cystitis painful bladder syndrome genetics risk factors family history
a study of the efficacy of genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering (gensci048-202)

Conditions: Gout; Gout Initiating Urate-loweringUrate-lowering Therapy

Summary: to evaluate the safety and efficacy of genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering

a randomized, open-lable, multi-center, active-controlled phase 2 study. patients are randomized to genakumab 100mg single injection group, genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.

Eligibility criteria:
1. signed written informed consent before any study procedure is performed. 2. male or female, 18 years ≤ age ≤ 75 years. 3. bmi ≤ 40kg/m2. 4. confirmed diagnosis of gout meeting the american college of rheumatology (acr) 2015 preliminary criteria for the classification of arthritis of primary gout. 5. history of ≥2 gout flare within 12 months prior to screening. 6. willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening

Keywords: gout urate-loweringurate-lowering therapy
daily disposable toric comparative trial in europe

Conditions: Myopia; Astigmatism

Summary: the purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.


Eligibility criteria:
inclusion criteria: * current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters. * achieve 0.5 or better distance visual acuity in each eye at time of dispense. * achieve acceptable or optimal fit in each eye at time of dispense. * other protocol-defined inclusion criteria may apply. exclusion criteria: * habitual daily disposable contact lens wearer. * sleeps in contact lenses overnight. * currently enrolled in an ophthalmic clinical trial. * other protocol-defined exclusion criteria may apply.
web based investigation of natural history of keloid disorder, an online survey

Conditions: Keloid

Summary: this trial intends to gather very basic clinical information about keloid, its patterns of presentation, family history, ethnic background and correlation with the type of keloid, as well as prior treatment results that patients have had received.

this will be a web based study, whereby patients will have to read and acknowledge the consent form online. once patients agree and acknowledge the terms of the consent form, they will gain access to the questionnaire pages. for those who are under age of 18, a parent or a legal guardian must sign the consent form and answer the online questions on behalf of the patient.

Eligibility criteria:
inclusion criteria: 1. patients must have clinically confirmed diagnosis of keloid 2. adults, age over 18 3. parent or legal guardian may participate if patient is under the age of 18 4. able and willing to complete a web based survey exclusion criteria: * no one will be excluded from this study as long as the inclusion criteria are met.

Keywords: keloid scar hypertrophic scar familial keloid
amiodarone compared to dronedarone , post cardioversion maintenance of sinus rhythm

Conditions: Atrial Fibrillation

Summary: persistent atrial fibrillation (af) is a common and distressing cardiac arrhythmia and accounts for 1% of the healthcare budget in the uk and it's prevalence is rising. symptoms of atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue, with quality of life measures reduced for patients with persistent af, increased stroke risk and increased all cause mortality rates. dc cardioversion is used to restore normal sinus rhythm in patients with persistent af. it has a high success rate but reoccurence of af is common. the use of anti arrhythmic drugs (aads) can augment the number of patients remaining in sinus rhythm at one year, with amiodarone currently the most superior. unfortunately it can have serious side affects. dronedarone is a related drug designed specifically to minimise the most serious side affects and is no approved and used prominently in the management of non permanent af. however it has not yet been studied in a post dc cardioversion population. patients in persistent af who are referred for elective dc cardioversionwill be randomised to receive either amiodarone or dronedarone to compare the ability to help maintain sinu rhythm post cardioverion in one nhs hospital. patients will be followed up for a year post cardioversion to see if they stay in sinus rhythm. ho: there will be no difference in maintenance of sinus rhythm with the use of amiodarone or dronedarone


Eligibility criteria:
inclusion criteria: * • patients with persaf requiring dc cardioversion. * patients must be over 18 years old. * patients give informed consent form prior to participating in this study. * patients must be on warfarin for at least 4 weeks or a transoesphageal echo must be performed at the time of dc cardioversion. exclusion criteria: * • patient is suffering with unstable angina in last 1 week. * patient has had a myocardial infarction within last 2 months. * patient is expecting or has had major cardiac surgery within last 2 months. * patient is participating in a conflicting study. * patient is mentally incapacitated and cannot consent or comply with follow-up. * patient has nyha class iii/ iv heart failure. * pregnancy. * patient suffers with other cardiac rhythm disorders. * recent coronary artery intervention or other factors suggesting clinical instability (ecg, clinical or laboratory findings). * gfr\<30mls/min. * patients has a contraindication to amiodarone or dronedarone
precision dosing of metformin in youth with t2d

Conditions: Type 2 Diabetes

Summary: the purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).

based on the investigators previous studies of young people who take metformin, the study team found that young people's bodies process metformin faster than older people and young people may need higher doses of metformin for the best treatment outcomes. the purpose of this study is to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).

Eligibility criteria:
inclusion criteria: * age 10-21 years * provider diagnosis of t2d * stable medication regimen for 2 weeks before screening visit (no addition or removal of medications and no more than 20% change in insulin dose) * ≥ 1 month from t2d diagnosis * taking regular metformin (not extended-release formula) * ability to wear cgm for a total of 6 weeks while in the study. * english or spanish speakers. * willing to abide by recommendations and study procedures. * willing and able to sign the informed consent form (icf) and/or has a parent or guardian willing and able to sign the icf. * participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. exclusion criteria: * pancreatic autoantibody positivity (gad-65, insulin, ia-2, ica 512, zn-t8). * known history of ongoing renal or hepatic disease. * known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.

Keywords: type 2 diabetes metformin pediatric
long-term safety study of bhv-7000 in participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of bhv-7000, in participants with major depressive disorder (mdd).


Eligibility criteria:
key inclusion criteria: 1. eligible subjects should have successfully completed the treatment/randomization phase of parent studies. 2. wocbp must have a negative urine pregnancy test at baseline visit. 3. wocbp must not be breastfeeding or lactating at baseline visit or at any point during the study. key exclusion criteria: 1. any medical condition, based on the judgement of the investigator, that would confound the ability to adequately assess safety and efficacy outcome measures. 2. participant non-compliance with study procedures, study drug or visit attendance in the parent study that the investigator deems as clinically significant or unacceptable risk potential for this study. 3. investigator deems participant at imminent risk of danger to others.

Keywords: depression major depression antidepressant major depressive disorder mdd
schizophrenia treatment adherence investigation (stai)

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of australian patients diagnosed with schizophrenia.

the primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of australian patients diagnosed with schizophrenia. observational study - no study drug administered

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia or schizoaffective disorder according to dsm-iv * currently treated in an outpatient clinic * able to provide informed consent * concurrent enrolment in clinical trials is acceptable * have completed all questions on the drug attitude inventory (dai-10) and medication adherence rating scale (mars) survey exclusion criteria: * n/a

Keywords: treatment review schizophrenia observational prospective studies australia
a study of insulin glargine (ly2963016) in adult participants with type 2 diabetes in india

Conditions: Type 2 Diabetes Mellitus

Summary: the reason for this study is to see if insulin glargine is safe in participants with type 2 diabetes mellitus (t2dm) in india.


Eligibility criteria:
inclusion criteria: * have t2dm based on the disease diagnostic criteria from the world health organization (who) classification for at least 6 months before screening. * have been receiving glucagon-like peptide-1 receptor agonist (glp-1 ra) or ≥2 oral antihyperglycemic medication (oams) at stable doses for 90 days prior to screening. * have an hba1c level ≥7.0% and \<11.0%. * have never been treated with insulins except for short term treatment of acute conditions up to a maximum of 14 days. exclusion criteria: * have any form of diabetes other than t2dm. * have hypersensitivity to the active substance of ly2963016 or to any of the excipients. * have any clinically significant disorder, other than t2dm, that in the investigator's opinion, would preclude participation in the trial. * are receiving systemic glucocorticosteroids therapy or have excessive insulin resistance (total insulin dose \>2 units per kilogram). * have a history or diagnosis of human immunodeficiency virus infection, hepatitis b and c. * have comorbidities of unstable angina, cardiac failure (stage iii or iv as per new york heart association guidelines) or renal failure (estimated glomerular filtration rate \<30 milliliters/minute/meter squared). * are pregnant or intend to become pregnant during the course of the study; or are sexually active women of child-bearing potential not actively practicing birth control by a medically acceptable method as determined by the investigator. * is a woman who is breastfeeding. * have participated within the last 30 days in a clinical trial involving an investigational product other than the ly2963016. if the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed. * have previously completed or withdrawn from this study or any other study investigating ly2963016. this exclusion criterion does not apply to participants who are rescreened prior to baseline visit. * are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * are unwilling or unable to comply with the use of a glucometer.
outcomes of sleep disorders in older men

Conditions: Cardiovascular Diseases; Heart Diseases; Sleep; Sleep Apnea Syndromes; Neurologic Manifestations; Osteoporosis; Bone Diseases

Summary: to determine the effects of sleep disorders on cardiovascular function and disease in older men.

background: it is estimated that over 50 percent of adults aged 65 and older report some sleep disruption, while about 20 percent suffer from chronic insomnia. obstructive sleep apnea, a major cause of daytime drowsiness, occurs in an estimated 20-60 percent of older people, depending on the definition used and the specific population being studied. despite the high prevalence of sleep disorders in the elderly, there have been relatively few studies focused on the consequences. most studies have been limited by cross-sectional design, small sample size, or lack of comprehensive and objective assessment of sleep. the study, outcomes of sleep disorders in older men, will take advantage of the established cohort that has been recruited for the osteoporotic fractures in men (mros) study (5u01ar045647-dr. eric orwoll, pi). mros, a 7-year study that began in july 1999, is a multi-center prospective study of approximately 6,000 men aged 65 and older. during the mros baseline visit, a broad variety of measurements were collected, including body composition and body fat distribution by dual energy x-ray absorptiometry (dexa) and quantitative computed tomography, bone density, anthropometry, performance-based tests of strength and balance, medical history, medication use, smoking and alcohol use, and other parameters. blood, urine, and dna specimens have been archived for use in future studies of importance to the health of older men. design narrative: in a subcohort of 3,000 mros participants, comprehensive and accurate assessments of sleep will be added using in-home polysomnography, wrist actigraphy, questionnaires and other measures; and prospective adjudication of cardiovascular disease (cvd) events, to the extensive measures that have already been performed or planned in the mros cohort study. these new measures will enable testing of several important hypotheses: 1) to characterize the associations between sleep disruption and subsequent cvd events during 3.5 years of follow-up, 2) to determine if sleep disturbances are associated with an increased risk of total and cause-specific mortality in older men, 3) to test whether sleep disturbances are associated with increased risk of falls and decreased physical function, 4) to test whether sleep disturbances are associated with impaired cognitive function in older men, and 5) to test whether sleep disorders are associated with bone density and fracture risk in older men. the bank of mros specimens will be supplemented to allow for testing of future hypotheses concerning the role of sleep in the development of age-related diseases and conditions.

Eligibility criteria:
no eligibility criteria
comparison of bi-level erector spine plane block and combined pectoral i-ii block in breast surgery

Conditions: Postoperative Pain; Analgesia

Summary: in this study, we compared ultrasound-guided modified pectoral nerve (pecs) block and bi level erector spinae plane (esp) block on postoperative analgesic effect in breast surgery.

after being informed about the study and potential risks, written consent was obtained from all patients. patients who meet eligibility requirements will be randomized in a 1:1 ratio to bi- level erector spinae plane block and modified pectoral block.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classification (asa) i-ii patients * 18-70 aged patients * patients who scheuled elective breast cancer surgery exclusion criteria: * american society of anesthesiologists classification (asa) iii-iv patients * patients with coagulopathy * patients with infection at the injection site

Keywords: regional anaesthesia erector spinae plane block pecs blocks breast cancer surgery
study of home-embedded palliative care for hemodialysis- (and peritoneal-) dependent end-stage renal disease

Conditions: End-Stage Renal Disease

Summary: home palliative care needs are often under-recognized in patients with end-stage renal disease (esrd). this pilot study is designed to evaluate the effectiveness of referrals to home palliative care services in improving patient outcomes compared with usual care among patients with esrd admitted to a penn hospital. evaluating the effectiveness of home palliative care services is critical to determine whether increasing access to these services would improve patient-centered outcomes for these high-need patients


Eligibility criteria:
inclusion criteria: * be an adult (18 years of age or older) hospitalized at a penn study hospital * and digital signature of esrd (n18.6) within the last 12 months * and resides in the five-county area surrounding philadelphia which is served by penn palliative care nurse practitioner program * and have one or more of the following markers of potentially unmet needs: (i) existing home care eligibility or referral for home care (but not already receiving pc); (ii) non-ambulatory status determined via nursing assessment; (iii) severe protein-calorie malnutrition; (iv) 2 or more hospitalizations within the prior year exclusion criteria: * patients with functional kidney transplants * patients discharged to skilled nursing facilities and ltc facilities

Keywords: palliative esrd
treatment with mepolizumab on patients with severe refractory eosinophilic asthma with or without crswnp.

Conditions: Asthma; Nasal Polyps; Sinusitis Chronic

Summary: patients with severe or difficult-to-treat asthma represent a small amount of total asthmatic patients, but weight on the national health system for the costs of disease management. chronic rhinosinusitis with nasal polyposis, which the italian severe/uncontrolled asthma registry reported with a prevalence of 30%, represents a comorbidity that significantly impact lung function and asthma control in severe asthma. recent evidence indicates that there is a consistent heterogeneity regarding mucosal alterations present in subjects with nasal polyposis involving different pathways: inflammatory cells, remodeling, t cell activation, local ige production, alteration induced by interactions between microorganisms and epithelial cells.

nasal, bronchial and systemic inflammation can differ among patients with severe refractory eosinophilic asthma with or without crswnp. treatment with mepolizumab could modify nasal, bronchial and systemic inflammation of patients with severe refractory eosinophilic asthma and nasal polyposis acting on disease control.

Eligibility criteria:
inclusion criteria:age \>18 years * diagnosis of severe refractory asthma according to the ers/ats criteria ats * blood eosinophils \>150 cells/mcl at the screening visit and at least one value of 300 or more eosinophils/mcl during the previous year; * at least two exacerbations despite maximal therapy with long-acting bronchodilators and high dose inhaled corticosteroids in the previous year or the need for continued therapy with oral corticosteroids in addition to maximal inhaled therapy for at least 6 months in the previous year * written informed consent. * for crswnp diagnosis, the epos 2020 guidelines will be considered as reference. all the above-mentioned inclusion criteria must be met. exclusion criteria:pregnancy * eosinophilic granulomatosis with polyangiitis (egpa); * serious life threatening cardiopulmonary disorders; * systemic immunologic disorder in the last 12 months; * positive history for malignant tumors ever in patient's life; * immunodeficiency.