Kornimate/medical-research-clean huggingface dataset:
health coaching, continuous glucose monitoring and ai mobile app in diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and tertiary care management of diabetes. this parallel-group randomised controlled trial (rct) aims to investigate the effectiveness of a novel multi-component model of care comprising interventions including the mobile app empower and smartwatch, health coaching, and continuous glucose monitoring (cgm).


Eligibility criteria:
inclusion criteria: * aged 21 years and above * have diagnosis of type 2 diabetes mellitus * provided informed consent * have near-field communication (nfc) compatible phones * able to engage in light physical activity (e.g., walking) exclusion criteria: * significant cognitive impairment * other conditions that may preclude participants from wearing cgm devices
optimal duration of post-operative activity restriction after midurethral sling procedures

Conditions: Urinary Stress Incontinence

Summary: the purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.

this is a blinded, randomized controlled trial. patients undergoing midurethral sling placement for stress urinary incontinence will be asked to participate in the study. if eligible and willing to participate, patients will be randomized to a "3 weeks post-operative restriction" or "6-week post-operative restriction" of activities group. currently, pelvic surgeons' recommendations for activity and lifting restrictions during post-operative period vary widely from 1 to 50 pounds (10). given variation in literature and reasonable expectations for lifting restrictions, 20-pound lifting restriction was considered to be a reasonable and attainable expectation from patients. both groups will be given an identical set of postoperative instructions which include refrainment from lifting anything over 20 pounds, avoid strenuous exercise, running, or perform high-impact aerobic activities during the restricted activity period. depending on their random allocation, patients will follow these instructions either for 3 or 6 postoperative weeks. the activities which all patients will be allowed to do during their postoperative recovery include walking, using stairs and showering in both groups. all patient will be asked to refrain from sexual intercourse for 6 weeks consistent with current routine post op recommendations (6). other than the time of activity restriction post op (heavy lifting, strenuous exercise, running, high impact exercise), patients will receive identical postoperative instructions otherwise.

Eligibility criteria:
inclusion criteria: * at least 18 years of age, * patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence exclusion criteria: * • patients who are unable to read, understand, or complete study documents in english or spanish * patient undergoing concomitant surgery for pelvic organ prolapse other than midurethral sling * patients who are unable to commit to 6 weeks of no heavy lifting (20 lbs)

Keywords: post-operative physical restrictions
endovascular treatment key technique and emergency work flow improvement of acute ischemic stroke

Conditions: Intracranial Artery Occlusion With Infarction (Disorder)

Summary: endovascular thrombectomy (evt) is effective and safe for acute ischemic stroke (ais) caused by large vessel occlusion (lvo) in major clinical trials. whether the benefit of evt in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. the prospective chinese angel-act registry (endovascular treatment key technique and emergency work flow improvement of acute ischemic stroke) was established to evaluate the utilization, and subsequent outcomes of evt treated ais patients. this study is a multi-center, prospective registry study initiated by researchers, funded by national key r\&d program of china. a total of 2,000 patients with acute ischemic stroke will undergo endovascular treatment. the hypothesis was that favorable outcomes from clinical trials could be achieved in clinical practice in china.


Eligibility criteria:
inclusion criteria 1. age ≥ 18 years old; 2. diagnosis of acute ischemic stroke; 3. imaging confirmed intracranial large artery occlusion (lvo): intracranial internal carotid artery (ica t/l), middle cerebral artery (mca m1/m2), anterior cerebral artery (aca a1/a2), basilar artery (ba), vertebral artery (va v4), and posterior cerebral artery (pca p1); 4. initiation of any type of endovascular treatment (evt), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting; 5. the patient or the patient's legal representative is able and willing to sign the informed consent. exclusion criteria 1. isolated cervical ica or va occlusion; 2. no evidence of lvo on dsa.

Keywords: ischemic stroke endovascular treatment registry
tranexamic acid for blood loss minimization in endoscopic pituitary surgery

Conditions: Pituitary Tumor; Blood Loss; Surgery

Summary: this trial is to determine the effect of tranexamic acid (txa) on blood loss during endoscopic pituitary surgery. the hypothesis of this study is that txa will reduce blood loss during surgery compared to a placebo. to answer this hypothesis, the investigators are conducting a randomized controlled trial in which half of participants will receive txa and half will receive placebo (saline) in a double blind fashion.


Eligibility criteria:
inclusion criteria: * undergoing endoscopic pituitary surgery at unc exclusion criteria: * clival invasion * giant pituitary tumor (\>4 cm) * revision pituitary surgery * prior sinus surgery * lund mckay score \> 3 * active thromboembolic disease * coagulopathy * concomitant pro-thrombotic medications * concomitant use of anti-coagulants or anti-platelet agents * subarachnoid hemorrhage * history of severe hypersensitivity to tranexamic acid
efficacy and safety of acupuncture for dizziness and vertigo in emergency department: a clinical control trial

Conditions: Dizziness; Vertigo

Summary: dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department (ed). pharmacological therapy is often solicited for these symptoms, such as vestibular suppressants, anti-emetics and benzodiazepines. however, every medication is accompanied with unavoidable side-effects. to the best of the investigators knowledge, no papers surveyed assess the feasibility of applying acupuncture as an emergent intervention means to the treatment of dizziness and vertigo. the investigators study targeted on filling in this gap by performing a clinical control trial to evaluate the efficacy and safety of traditional chinese medicine - acupuncture - in treating patients with dizziness and vertigo in ed.


Eligibility criteria:
inclusion criteria: * visit emergency department and stay in observation unit. * consult otolaryngologist and neurologist to rule in dizziness and giddiness, auditory vertigo, vertebrobasilar artery syndrome, and peripheral vestibular disorders - ménière's disease, benign paroxymal peripheral vertigo, and vestibular neuritis. exclusion criteria: 1. serious comorbid conditions (for example, life-threatening condition or progressive central disorder). 2. patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.

Keywords: dizziness and vertigo emergency department (ed) clinical trial acupuncture
two doses mesalazine granules versus placebo for the prevention of recurrence of diverticulitis

Conditions: Diverticulitis

Summary: the purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.

the primary purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the two primary efficacy variables 'proportion of recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within 96 weeks'.

Eligibility criteria:
inclusion criteria: * diagnosis of left-sided uncomplicated diverticular disease confirmed by computed tomography * presence of at least one diverticulum of the left colon * most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months * c-reactive protein (crp) \> upper limit of normal (uln) or leucocytosis at the start of the most recent attack exclusion criteria: * complicated diverticular disease * right-sided diverticulitis * previous colonic surgery * presence of symptomatic organic disease of the gastrointestinal tract * active colorectal cancer or a history of colorectal cancer * hemorrhagic diathesis * active peptic ulcer disease, local intestinal infection * asthma if careful medical monitoring is not ensured * abnormal hepatic function or liver cirrhosis * abnormal renal function
brain health virtual reality study

Conditions: Aging; Aging Problems; Memory Loss; Memory Impairment; Memory Disorders in Old Age; Memory Disorder, Spatial; Memory Disorders; Mild Cognitive Impairment; Cognitive Decline; Cognitive Change; Cognition Disorders in Old Age

Summary: the interventions for brain health virtual reality study is a nih-funded clinical research trial at the university of california san diego (ucsd) health under the supervision of the study principal investigator dr. judy pa. the overarching goal of this trial is to use a novel virtual reality (vr) based intervention that simultaneously engages physical and cognitive activity aimed at improving brain health and cognition in older adults. the investigators will compare 3 types of interventions: physical activity, vr cognitive activity, and combined vr physical and cognitive activity over 16 weeks to evaluate physical and brain health changes.


Eligibility criteria:
inclusion criteria: 1. 50-85 years of age 2. fluent in english 3. can safely ride a stationary bike exclusion criteria: 1. dementia 2. history of a neurological disorder 3. severe sensory deficits 4. inability to perform intervention (e.g., inability to cycle safely) 5. contraindications to mri scan (e.g., pacemaker) 6. fear of needles/ blood 7. prior history of fainting due to sight of needles of blood

Keywords: virtual reality technology intervention exercise cycling memory brain health aging
study of the prognosis of patients with heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: study of the prognosis of patients with heart failure with preserved ejection fraction

obesity is an independent risk factor for heart failure with preserved ejection fraction (hfpef), however, the impact of visceral fat area (vfa) in patients with hfpef is unclear. according to established process of patients' selection, a total of 172 patients whose mean age was 72 years were included in this study, and the median follow-up duration was 395.5 days(interquartile range: 207.5 to 535.5 days). all patients were divided into two groups based on the best cut-off value of vfa, and the primary outcome of this study was all-cause death in patients with hfpef. the aim of this study was to clarify whether vfa has prognostic value in patients with hfpef by kaplan-meier analysis and cox analysis.

Eligibility criteria:
inclusion criteria: 1. adult aged \>=18years old; 2. diagnosed with hfpef.diagnostic criteria including: 1）left ventricular ejection fraction ≥50%； 2）with the symptoms and/or signs of heart failure； 3）bnp≥35 pg/ml and/or ntprobnp≥125 pg/ml； 4）at least one additional criterion: relevant structural heart disease(lvh and/or lae) or diastolic dysfunction exclusion criteria: 1. age \<18 years old； 2. lvef less than 45% at any time; 3. cancer diagnosis.

Keywords: visceral fat area
gore® excluder® endoprosthesis french mandatory registry

Conditions: Abdominal Aortic Aneurysm

Summary: this is a french registry mandated by the french national health authority assessing long-term (5-years) safety of the gore® excluder® endoprosthesis in the treatment of infra-renal abdominal aortic aneurysms (aaa).

the use of abdominal aortic endoprostheses makes the treatment of infra-renal abdominal aortic aneurysms possible, with implantation via the femoral artery, thus avoiding a very invasive surgical procedure. the french national authority for health requires a 5-year follow-up as part of the renewal for reimbursement for these endoprostheses.

Eligibility criteria:
inclusion criteria: * any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm. exclusion criteria: * patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).

Keywords: aneurysm aorta abdominal
effect of pravastatin in the subjects with prediabetes or early diabetes

Conditions: Diabetes Mellitus; Prediabetic State

Summary: an increased risk of incident diabetes with statin therapy have been reported in several studies. however, it is not recommended to limit the use of statin for this reason since the absolute risk increase was small, and the cardiovascular event rate reduction with statins overweighed the risk of new diabetes (scatter n et al. lancet, 2010). moreover, each statin may have different effect on the development of incident diabetes. in the west of scotland coronary prevention study, pravastatin therapy reduced the hazard of becoming diabetic by 30%. also, with pravastatin use, an increase in adiponectin level, which is related to the improvement in insulin sensitivity, has been reported. in this clinical trial, the investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin secretion, glycemic control, and adiponectin level in participants with prediabetes or early diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.


Eligibility criteria:
inclusion criteria: * subjects have early diabetes mellitus or prediabetes. early diabetes mellitus or prediabetes are defined according to the following criteria; subjects have two or more of the following three, or they have one of them at the initial test and the repeat test. 1. hemoglobin a1c 5.7-9.0% 2. fasting plasma glucose level 100mg/dl or more 3. plasma glucose level 140mg/dl or more at 2 hours after 75g oral glucose tolerance test * subjects have one of the following three; 1. low-density lipoprotein cholesterol (ldl-cholesterol) 130mg/dl or more, and body mass index (bmi) \> 23 kg/m2, 2. 10 year atherosclerotic cardiovascular disease (ascvd) risk of 7.5% or more, which is assessed by the ascvd-risk-estimator (circulation.2014;129:s1-s45) 3. in diabetic patients, ldl-cholesterol 100mg/dl or more exclusion criteria: * hemoglobin a1c \> 9.0% * history of statin use in three months * use of oral antidiabetic drugs except for metformin in three months * history of malignant diseases (cancers) * history of coronary artery diseases, heart failure, arrhythmia, valvular heart diseases, or cerebrovascular diseases * pregnant * serum creatinine level \> 1.5 mg/dl * aspartate aminotransferase (ast) or alanine aminotransferase (alt) levels higher than 80 u/l * taking weight loss medications, corticosteroids, angiotensin converting enzyme (ace) inhibitors, or estrogen replacement therapy * chronic hepatitis b or chronic hepatitis c

Keywords: pravastatin insulin resistance
indian transforming alzheimer's care training (intact)

Conditions: Alzheimer Disease

Summary: intact will utilize a group-randomized trial, to test the effectiveness of a culturally informed provider training and "dementia friendly clinic" intervention for detection and appropriate management of ai/an patients with adrd and mci in 28 urban and rural clinics serving ai/ans.

the intact team will conduct a group-randomized trial (grt) to test the effectiveness of the intact program, a culturally informed primary care provider training and clinic level workflow intervention for detection and appropriate management of ai/an patients with mild cognitive impairment (mci) and adrd in 28 urban and rural clinics serving ai/ans. the clinics are the primary unit of randomization. within each participating clinic, pcps who are routinely seeing ai/an patients ages 55 years and older will be recruited for data collection at baseline and 1-year follow-up. each clinic will be randomized either to the immediate intervention or to a wait-list control arm. data will be collected from pcp questionnaires, electronic health records (ehr) data extraction and manual medical chart reviews. at the clinic level, we will rely on ehrs to document intact's effect on new adrd diagnoses. at the pcp level, we will test whether intact increases knowledge and confidence in dementia assessment, adrd care, and caregiver support. patient-level data will be collected from the ehr and by manual chart review. once enrolled, clinics will complete a clinic profile interview and clinic and patient population information form, pcps will be consented and complete a baseline survey. next the clinics will be randomized into the immediate intervention or the wait-list control arms. data collection will be conducted at baseline and 1-year follow-up. after completing the 1-year study period, clinics in the wait-list arm will have the opportunity to receive the intact intervention.

Eligibility criteria:
clinic eligibility criteria to be eligible to participate in intact a clinic must be: 1. a primary care clinic 2. have at least 20 ai/an active patients 55 years or older 3. have an ehr system 4. not intending to change ehr systems in the next year 5. willing to conduct a total of 40 limited patient chart reviews to assess quality of care metrics for ai/an patients with mci and adrd, staff permitting pcp eligibility criteria: to be eligible to participate in the baseline and follow-up surveys a primary care provider must be: 1. have a title of md, do, nurse practitioner, or pa, and 2. regularly provides care to ai/ans aged 65 and older. patients we will only collect patient ehr data from eligible patients who: 1. recorded as ai/an in the ehr system 2. active clinic patient with prevalent adrd as of the first day of the time period each data extraction will cover 3. age 55 or older at the start of the surveillance interval 4. at least one primary care clinic visit during the time period each data extraction will cover. there are no exclusion criteria for the clinic, pcps and patients.

Keywords: adrd, mci
coronavirus: ventilator outcomes using artificial intelligence chest radiographs & other evidence-based co-variates

Conditions: Covid19; Pneumonia

Summary: we will determine ventilator outcomes to coronavirus infectious disease 2019 (covid-19) using artificial intelligence with inputs of chest radiographs and other evidence-based co-variates.

the chest radiograph (chest x-ray) has emerged as the united kingdom's national health service (nhs) frontline diagnostic imaging test for covid-19, in conjunction with clinical history and key blood markers: c-reactive protein (crp) and lymphopenia. typically, every suspected covid-19 patient presenting to the emergency department is undergoing blood tests and a chest radiograph. therefore, it has become critical for radiologists to review and "hot" report the chest x-ray urgently. primary objective: use chest radiographs and clinical data to determine whether patient can survive with a ventilator

Eligibility criteria:
inclusion criteria: admitted to intensive care unit (itu) or equivalent covid-19 polymerase chain reaction (pcr) positive exclusion criteria: no imaging prior to itu admission
a phase 2 hae prophylaxis study with recombinant human c1 inhibitor

Conditions: Hereditary Angioedema

Summary: primary objective: to evaluate the efficacy of recombinant human c1 inhibitor (rhc1inh) in the prophylaxis of angioedema attacks in patients with hae secondary objective: to evaluate the safety and immunogenicity of recombinant human c1 inhibitor (rhc1inh) in the prophylaxis of angioedema attacks in patients with hae

study design: this is a multi-center, randomized, double-blind, placebo-controlled, 3-period crossover study of rhc1inh in prophylaxis of angioedema attacks in patients with hae. medical screening (clinical and laboratory parameters) will be performed and patient medical history specific to hae attacks will be collected to assess eligibility. each patient will receive three 4 week periods of treatment twice weekly.

Eligibility criteria:
inclusion criteria: patients fulfilling the following criteria at screening are eligible for participation in the study: 1. age 13 years or older 2. laboratory confirmed diagnosis of hae 3. a history of frequent hae attacks (at least 4 attacks per month across a minimum of 3 consecutive months). 4. female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. 5. provided written informed consent (and written assent for minors) 6. willingness and ability to comply with all protocol procedures exclusion criteria: patients who meet any of the following criteria at screening are to be excluded from study participation: 1. patients with medical history of allergy to rabbits or rabbit-derived products (including rhc1inh) 2. diagnosis of acquired angioedema (aae) 3. patients who are pregnant, or breastfeeding, or are currently intending to become pregnant 4. treatment with any investigational drug in the past 30 days 5. patients with any condition or treatment that, in the opinion of the investigator, might interfere with the evaluation of study objectives 6. patients currently treated with angiotensin-converting enzyme (ace) inhibitors

Keywords: hae hereditary angioedema prophylaxis
value of montelukast as a potential treatment of post covid-19 persistent cough

Conditions: Post COVID-19

Summary: as of september 2020, the covid-19 pandemic has affected millions of people in 196 countries and left hundreds of thousands dead. after recovery it was found that up to 32% of cases had 1 or 2 symptoms, 55% had 3 or more post-covid-19 symptoms, and persistent post covid-19 cough was recorded in 29.3% of cases in one study. a recent study identified montelukast, among the top-scoring clinically-oriented drugs likely to inhibit sars-cov-2 main protease. besides its known effect that is reported to improve cough and prevent exercise-induced bronchoconstriction in asthma, many trials assessed montelukast in the treatment of post-infectious cough and found variable effects. despite that the exact mechanism is not yet identified, barré and colleagues proposed several properties of cyst lt1 receptor antagonists that are potentially beneficial in covid-19.


Eligibility criteria:
inclusion criteria: * patients with post covid-19 persistent cough after 4 weeks of acute attack exclusion criteria: * any contraindication to montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.

Keywords: montelukast cough cough severity