Kornimate/medical-research-clean huggingface dataset:
rct of follow up following cataract extraction

Conditions: Cataract

Summary: purpose: to examine the safety of omitting the routine postoperative eye clinic review following phacoemulsification cataract surgery. background: approximately 300000 cataract extractions are performed annually in the nhs in england, requiring a similar number of post-operative visits, the majority of which result in no change in management. a conservative estimate of 70% of visits being unnecessary suggests a potential saving to the nhs of approximately £10m annually. what's involved: the study involves some questionnaires during the duration of the study. these include questionnaires relating to the quality of life of the patient (conducted before the operation, and at the 3 month research clinic) and a patient satisfaction questionnaire. there is also a research clinic 3 months following the operation. what are the risks/benefits: there are no real personal benefits to patients on the trial. the trial aims to provide very important information regarding the safety of discharging patients immediately after surgery. however the trial could potentially save many thousands of unnecessary hospital visits each year.

method: the method presented is based on the method employed successfully by one of the applicants in an earlier stuy of the first day postoperative review following cataract surgery which has been peer-reviewed and published in the scientific literature. an earlier draft has been presented to a patient panel and has the benefit of external review by a potential steering group. patients undergoing routine elective phacoemulsification cataract surgery will be randomly assigned to either a routine review at 4-6 weeks post-operatively (routine care) or to be discharged from the cataract service immediately post-operatively. all patients will be advised to see their own optometrist at 4-6 weeks for new spectacles if appropriate and will then be reviewed in a research clinic at 3 months post operatively.

Eligibility criteria:
inclusion criteria: * adults aged \>= 40 years * scheduled for day-case cataract surgery * able to give informed consent exclusion criteria: * unable to provide written informed consent * unable to visit their optometrist post operatively * patients with ocular comorbidity that may be affected by cataract surgery or who require monitoring within three months of their operation (including significant diabetic retinopathy, wet age-related macular degeneration (amd) on treatment, severe/end-stage glaucoma, previous retinal detachment or vitrectomy) * patients undergoing another simultaneous ophthalmic procedure * patients who suffer from an intra-operative complication requiring early postoperative evaluation (identified at surgery).

Keywords: follow-up no follow-up removal randomised controlled trial 6 weeks
improving diagnosis and clinical management of familial hypercholesterolemia through integrated machine learning, implementation science, and behavioral economics

Conditions: Familial Hypercholesterolemia

Summary: the goal of this study is to identify individuals at high risk of fh, and to encourage the appropriate diagnosis and treatment of individuals at high risk of fh through the use of implementation science and behavioral economics principles. phase 1: applying the find fh tool to the health system ehr and gathering data for pilot development; phase 2: pilot development and implementation; phase 3: conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in phase 2

phase 1: aim 1: adjusting and refining the application of the find fh tool to the uphs ehr database aim 2: identifying the barriers and facilitators to making a diagnosis of fh and initiating or intensifying therapy for individuals with fh through qualitative interviews with clinicians and patients and creating a behavioral roadmap to inform the implementation approaches to test in the pilots phase 2: aim 1: co-design implementation strategies using behavioral economics in partnership with the family heart foundation aim 2: pilot implementation strategies with an enrollment goal of 80 patients total (40 per pilot) who have been flagged by the find fh tool as having probable fh to ascertain feasibility, acceptability, and appropriateness phase 3: conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in phase 2

Eligibility criteria:
inclusion criteria: * must be a patient at penn medicine * must have been flagged by the find fh tool as having a high probability of fh * first language is english * resides in pa or nj exclusion criteria: * already have been clinically diagnosed with fh using the proper icd-10 code * currently see a lipid specialist at penn medicine * pass study clinician's study validity check

Keywords: machine learning find fh
prospective russian evaluation of lp(a) role in cardiovascular disease

Conditions: Coronary Disease; Cardiovascular Diseases

Summary: the purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a) phenotype in fatal and non-fatal cardiovascular disease (cvd) events risk in coronary disease patients divided on the basis of management strategy - medical, endovascular or open cardiac surgery.

between january 1993 and september 2006, we enrolled 1400 consecutive patients from the atherosclerosis department with known lp(a) levels and coronary heart disease (chd) verified by angiography. in accordance with clinical condition and angiography data were assigned them into three parallel treatment arms and followed up to 15 years. this study was conducted according to the principles of the declaration of helsinki and the institutional ethics committee.

Eligibility criteria:
inclusion criteria: * stable coronary heart disease verified by angiography exclusion criteria: * acute coronary syndromes, * acute infections, * inflammatory disease within 3 months prior to inclusion, * familial hypercholesterolemia, * triglycerides\>4.5 mmol/l, * missing lp(a) measurements

Keywords: lipoprotein(a) coronary artery bypass grafting (cabg) apo(a) prognosis myocardial infarction cardiovascular death percutaneous coronary intervention (pci)
clinical trial to evaluate the efficacy and safety of stem cells

Conditions: Anal Fistula

Summary: efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

study of efficacy of adipose derived mesenchimals stem cells and surgery to treat complex perianal fistula

Eligibility criteria:
inclusion criteria: 1. signature of informed consent. 2. complex perianal fistula cryptoglandular. understood as a fistula in which at least one of the following circumstances is present: * some degree of fecal incontinence associated * extrasphinterics fistulas, * fistulas supraresfinterianas * high transsphincteric fistulas. 3. patients of both genders, with more that 18 years. 4. good overall health, according to data from the clinical history and physical examination. exclusion criteria: 1. patient diagnosed with inflammatory bowel disease. 2. subjects with abscess, except if a complete cleaning of the drainage area of collections is performed and the absence of abscess and other collections larger than 2 cm in maximum diameter before treatment is started is confirmed. 3. history of alcohol or substance abuse in the 6 months prior to inclusion. 4. malignancy, except in the case of basal cell carcinoma or squamous cell skin or a history of malignancy, unless they have been found in remission during the previous 5 years. 5. medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study. 6. subjects with congenital or acquired immunodeficiencies. treponema, hepatitis b and / or c or tuberculosis diagnosed at the time of inclusion. 7. major surgery or severe trauma of the subject in the previous semester. 8. pregnant or lactating women. 9. adult women of childbearing potential not using effective contraception during the trial. 10. administration of any investigational drug at present to three months prior to enrollment for this trial.

Keywords: phase iii adipose derived stem cells anal fistula cell therapy stem cell therapy
lactobacillus johnsonii supplementation in adults with t1d

Conditions: Type 1 Diabetes (T1D)

Summary: while genetics demonstrated a major risk factor for the development of type 1 diabetes (t1d), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. the probiotic lactobacillus johnsonii n6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the t1d population thereby preserving beta cell function.


Eligibility criteria:
inclusion criteria: * have confirmed t1d by physician diagnosis * have normal values at screening for cbc and complete metabolic profiles (with the exception of fasting glucose and hba1c). * are able to swallow a capsule. * are willing to complete weekly online questionnaires.\* * are willing to consume a probiotic or placebo capsule daily for 24 weeks. * are willing to provide stool samples throughout the study. * are willing to provide blood samples throughout the study. * are willing to take three 2-hour mixed-meal tolerance tests (mmtts). * are able to access a computer with internet throughout the study.\* * note: going into the study, we want the participants to have daily internet access. however, if this changes once they are in the study, we will provide paper copies of the questionnaires. exclusion criteria: * have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, crohn's, ulcerative colitis, etc.). * have chronic disease kidney disease. * have had or are currently being treated for other immune-compromising diseases or conditions (hiv, aids, hepatitis, cancer, leukemia, transplant patient, lupus, digeorge syndrome, selective deficiency of iga, bruton's disease etc.). * have an underlying structural heart disease. * currently live with an immunocompromised person. * are currently taking medications for constipation and/or diarrhea. * have taken antibiotics within the past 2 weeks prior to randomization. * are currently taking a probiotic supplement and are unwilling to discontinue it a minimum of 2 weeks prior to the study start. * are a current smoker. * are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months. * have a known allergy to milk or milk protein.

Keywords: probiotics genetics
impact of environmental factors on disease activity in spondyloarthritis (spa): results of the prospective co-env cohort

Conditions: Spondylarthritis; Primary Systemic Vasculitis

Summary: susceptibility to spa has been shown to be largely genetically determined. the objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.

susceptibility to spa has been shown to be largely genetically determined but the contribution of environmental factors to disease evolution has not yet been elucidated. the objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.

Eligibility criteria:
inclusion criteria: * 18 years spondilarthritis: modified new york criteria systemic vasculitis: acr criteria exclusion criteria: no internet access

Keywords: environment spondylarthritis vasculitis stress life event vaccine
consumer responses to alcohol warnings

Conditions: Alcohol Drinking

Summary: the primary objective is to evaluate whether alcohol warnings about different topics elicit higher perceived message effectiveness than control messages. the secondary objective is to evaluate whether alcohol warnings about different topics elicit higher reactance than control messages.

participants will complete a within-subjects online randomized experiment in which they will view and rate messages on the risk of alcohol consumption. participants will view and rate 12 messages total: 10 warning messages and 2 control messages. they will rate each message on perceived message effectiveness (primary outcome) and message reactance (secondary outcome). the 10 warning messages will be about 5 different warning topics (i.e., 2 messages per topic) and the 2 control messages will be about 1 control topic (2 messages per topic). in this within-subjects experiment, the survey will present the topics in random order and the messages within each topic in random order.

Eligibility criteria:
inclusion criteria: * age 21 and older * reside in the united states * able to complete a survey in english exclusion criteria: * under 21 years of age * reside outside the united states * unable to complete a survey in english
a study of at2101 (afegostat tartrate) in adult patients with type 1 gaucher disease currently receiving enzyme replacement therapy

Conditions: Gaucher Disease, Type 1; Type 1 Gaucher Disease; Gaucher Disease

Summary: this study was conducted to test the safety and tolerability of afegostat tartrate in participants with type 1 gaucher disease already receiving enzyme replacement therapy.

this was a phase 2, open-label study in participants with gaucher disease, a lysosomal storage disorder. afegostat tartrate (also known as at2101 or isofagomine tartrate) is designed to act as a pharmacological chaperone by selectively binding to misfolded β-glucocerebrosidase (gcase) and helping it fold correctly, intended to restore gcase activity. the study consisted of a 14-day screening period, a 28-day treatment period, and a 7-day wash-out period. participants received 1 of 4 dosing regimens for afegostat tartrate.

Eligibility criteria:
inclusion criteria: * had a confirmed diagnosis of type 1 gaucher disease with a known documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase alleles * clinically stable * male or female participants, 18 to 74 years old inclusive * all participants of childbearing potential used adequate birth control * provided written informed consent to participate in the study exclusion criteria: * clinically significant disease, severe complications from gaucher disease, or serious illness that precluded participation in the study in the opinion of the investigator that compromised the safety of the participant or precluded the participant from completing the study * during the screening period, any clinically significant findings, as deemed by the investigator * partial or total splenectomy (removal of spleen) within the 2 years prior to study entry * history of pulmonary hypertension or gaucher related lung disease * history of allergy or sensitivity to the study drug or any excipients, including any prior serious adverse reaction to iminosugars (for example, n-butyldeoxynojirimycin or miglustat) * pregnant or breast-feeding * current/recent drug or alcohol abuse * treatment with any investigational product in the 90 days before study entry * treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ * presence or symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs

Keywords: afegostat tartrate isofagomine tartrate at2101 amicus therapeutics
age-related macular degeneration (amd) - beta study telemedicine assessment

Conditions: Age-Related Macular Degeneration

Summary: the purpose of this study is to evaluate the compliance of the foresee home device in intermediate amd patients.

this is a non-randomized cohort, multi-center study. the eligible subjects will be asked to use the foresee home device daily and the tests results will be automatically transmitted to the data monitor center for analysis.

Eligibility criteria:
inclusion criteria: * subjects who successfully completed participation in foreseehome-us2 study * patients with ability to comprehend and sign the informed consent/authorization exclusion criteria: * subjects who failed to complete participation in foreseehome-us2 study

Keywords: intermediate amd
evaluation of a physical activity referral scheme

Conditions: Cardiovascular Risk Factor; Diabetes Mellitus, Type 2; Anxiety; Depression; Musculoskeletal Injury; Cardiovascular Diseases; Cancer; Obesity; Metabolic Syndrome; Physical Activity

Summary: the study will evaluate the effectiveness of a co-developed exercise referral scheme. participants will be recruited to one of three groups 1. co-developed exercise referral scheme, 2. usual care exercise referral scheme, 3. no treatment control (no intervention). the study will measure effectiveness by observing change in cardiorespiratory fitness at 12 weeks. intervention cost-effectiveness will also be evaluated at 3 months follow-up using objective physical activity data.

evidence of effectiveness for uk exercise referral is unclear. this representation has been deemed an unfair assessment of its potential to impact public health. this is due to systematic review evidence that reports evaluations of exercise referral interventions that are not evidence-based or underpinned by behaviour change theory. this evaluation is the third phase of a project that aims to co-develop (phase 1), pilot (phase 2) and evaluate (phase 3) an evidence-based exercise referral scheme. this approach is underpinned by the medical research council guidance for complex interventions. through co-development work with a multidisciplinary group of researchers and local stakeholders and subsequent pilot work, it is hypothesised that the co-developed, evidence-based intervention will have improved chances of implementation success, and therefore, clinical effectiveness.

Eligibility criteria:
inclusion criteria: • 18 years or older and have a health-related risk factor (e.g. high blood pressure, hyperglycaemia, obesity etc.) or a health condition (diabetes, cardiovascular disease, anxiety, depression etc.) that may be alleviated by increasing current pa levels. exclusion criteria: * uncontrolled health-conditions (cardiac, metabolic, respiratory etc.) and/or any recent traumatic events (e.g. myocardial infarction). * unstable angina or aortic stenosis. * severe psychological or neurological conditions. * participation in an ers at any location other than the research centres (at the time of recruitment).

Keywords: physical activity pragmatic evaluation exercise referral mixed-methods behaviour change intervention
efficacy and tolerability of an aliskiren-based treatment algorithm in patients with mild to moderate hypertension

Conditions: Essential Hypertension ( Mild to Moderate)

Summary: this study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (bp) target in patients with mild to moderate hypertension. (defined as mean sitting systolic blood pressure \[mssbp\] ≥ 140 mmhg and \< 180 mmhg and/or mean sitting diastolic blood pressure \[msdbp\] ≥ 90 and \<110 mmhg).


Eligibility criteria:
inclusion criteria: * outpatients ≥ 18 years of age * patients with a diagnosis of mild to moderate hypertension at visit 1 * all patients must have a mssbp ≥ 140 mmhg and \< 180 mmhg and/or msdbp ≥ 90 mmhg and \< 110 mmhg mmhg at visit 3 exclusion criteria: * severe hypertension defined as mssbp ≥ 180 mmhg and/or msdbp ≥ 110 mmhg * secondary form of hypertension * current diagnosis of heart failure (nyha class ii-iv) * current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates) * second or third degree heart block without a pacemaker * concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to visit 1 other protocol-defined inclusion/exclusion criteria may apply.

Keywords: essential hypertension ( mild to moderate)
vesair clinical trial

Conditions: Stress Urinary Incontinence

Summary: single-blind, multicenter, randomized clinical trial of the vesair balloon in the treatment of stress urinary incontinence in post-menopausal women


Eligibility criteria:
inclusion criteria: * post-menopausal women with sui for at least 12 months * average of at least one leak per day * failed non-invasive treatment * willing to undergo cystoscopy and a minimum of 5 visits over one year exclusion criteria: * bmi \> 40.0 * last menstrual period within 12 months of enrollment * on birth control and/or oral hormone replacement therapy * urge-predominant mixed incontinence * sui due to intrinsic sphincter deficiency * prior treatment with the vesair balloon * prior medical, surgical or non-surgical treatment for sui within 6 months of enrollment * recurrent or recent (within the past 5 years) kidney stones * recurrent or recent (within the past 3 months) urinary tract infection * stage 3 or higher cystocele (pop-q) * interstitial or follicular cystitis / painful bladder syndrome * local genital infection * artificial sphincter * anatomic abnormalities which would interfere with device placement. * visible blood in the urine * uncontrolled bladder contractions / discomfort with bladder filling up to 300cc * history of cancer of the urinary tract * history of any cancer within the past two years (excluding non-melanoma skin cancers) * history of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers) * immunologically suppressed or immunocompromised * undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation * non ambulatory / unable to do simple pad weight testing exercises * on anticoagulation therapy with the exception of aspirin * history of mental illness requiring inpatient treatment * neurological disease such as parkinson's or multiple sclerosis * uncontrolled diabetes (a1c \> 9%) * recent alcohol or drug abuse requiring treatment in the past year * autoimmune or connective tissue disorders such as marfan syndrome, ehlers-danlos or myasthenia gravis * allergy to polyurethane or perfluorocarbons

Keywords: sui women incontinence