Kornimate/medical-research-clean huggingface dataset:
remote monitoring of ibd

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: crohn's disease (cd) and ulcerative colitis (uc) are chronic inflammatory bowel diseases (ibd) with a heterogeneous disease course. recurrent mucosal inflammation or chronic subclinical inflammation results in damage to the bowel and complications like stenosis, fistula and colorectal cancer. therefore, tight control of mucosal inflammation is important to prevent complications. the goal of this multicenter observational cohort study is to determine the best remote monitoring tool for predicting mucosal inflammation in adult patients with inflammatory bowel disease, relative to the gold standard endoscopy. participants will be asked to fill out questionnaires regarding disease activity (miah, mhi, ibd-control, manitoba ibd index, p-hbi/p-sccai), perform a fc home test and collect one stool sample for routine laboratory calprotectin measurement, before the start of the bowel preparation for the ileocolonoscopy. during this ileocolonoscopy, endoscopic disease activity will be determined. .


Eligibility criteria:
inclusion criteria: * established diagnosis of cd or uc according to ecco guidelines * cd or uc patients scheduled for an ileocolonoscopy, or uc patients scheduled for an sigmoidoscopy at the endoscopy ward of one of the participating centers (regardless of indication) * aged 18 years or older * smartphone with internet access (for use fc home test) exclusion criteria: * unclassified ibd * ileostomy, colostomy, ileoanal pouch anastomosis or ileorectal anastomosis * isolated upper gastro-intestinal cd, or isolated peri-anal disease * insufficient knowledge of dutch language

Keywords: fecal calprotectin patient reported outcome measures mucosal inflammation
amniotic membrane for recurrent macular hole

Conditions: Macula Hole; Retinal Detachment; Myopic Macular Degeneration

Summary: macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. in this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.

it is an interventional study of using amniotic membrane graft for closure of macular hole associated retinal detachment in patient who had a previous failed macular surgery.

Eligibility criteria:
inclusion criteria: * patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ilm) peeling for treatment of myopic macular hole were included. * opened holes after 1 month of the surgery. * myopic macular holes only were included (refraction of more than _6 d and/or axial length of more than 26 mm). exclusion criteria: * all other causes of macular hole (traumatic and idiopathic) * patients with diseases that can affect visual outcome (diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.

Keywords: amniotic membrane retinal detachment myopic macular hole internal limiting membrane
a study of tarceva (erlotinib) and avastin (bevacizumab) in patients with advanced or metastatic liver cancer.

Conditions: Liver Cancer

Summary: this single arm study evaluated the efficacy and safety of a combination of tarceva and avastin in patients with advanced or metastatic liver cancer. patients were treated with tarceva 150 mg po daily plus avastin 5 mg/kg intravenous (iv) every 2 weeks. the anticipated time on study treatment was until disease progression, and the target sample size was \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age; * advanced or metastatic liver cancer; * ≥ 1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment. exclusion criteria: * prior or concomitant systemic anti-cancer treatment for advanced disease; * patients at high risk of variceal bleeding; * clinically significant cardiovascular disease; * major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.
study evaluating efficiency and tolerance of high-dose fluconazole associated with flucytosine as induction therapy for cryptococcal meningitis associated with hiv in sub-saharan africa

Conditions: Cryptococcal Meningitis; HIV

Summary: the aim of the trial is to demonstrate that in a sub-saharan african setting, the association of: 1. oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100 mg/kg/j) as induction therapy 2. lumbar punctures to control intracranial pressure can decrease mortality rate below 35% at 10 weeks. this is a non-randomized open label pilot study, with standardized management of cryptococcoses meningitis and follow-up in burundi and ivory coast. a total of 41 patients will be enrolled.


Eligibility criteria:
inclusion criteria: * \> 18 years * hiv infection * first episode of cryptococcal meningitis on basis csf india ink and/or csf cryptococcal antigen. * glasgow \> 9 after lumbar punctures * absence of peripheral focal deficit in the limbs * informed consent signed exclusion criteria: * hemoglobin \<7.5 g / dl; * neutrophils count \<500/mm3; * platelets count \<50 000/mm3; * transaminases \> 5 times upper limit of normal; * troubles with severe mental alertness glasgow \<9 after the initial lumbar puncture; * focal neurological deficit in the limbs; * pregnancy or lactation on going; * ongoing systemic antifungal treatment; * history of cryptococcal meningitis; * ongoing rifampicin and ritonavir treatment; * subject participating in another study with a risk of mutual interference on the interpretation of results.

Keywords: cryptococcal meningitis hiv infections oral treatment high dose of fluconazole flucytosine burundi ivory coast
impact of analytic-integrative cognitive behavioural therapy on acute insomnia disorder (stress)

Conditions: Acute Insomnia Disorder

Summary: the main objective of this study, conducted in a population with acute insomnia disorder (stress), was to investigate the efficacy of analytic-integrative cognitive behavioural therapy in the treatment of acute insomnia disorder (stress).

acute insomnia disorder, also known as short-term insomnia disorder, is basically characterised by difficulties with short-term sleep onset and maintenance and results in feelings of sleep dissatisfaction. when insomnia arises in response to a stressful life event (painful loss of a loved one, major illness, or divorce), associated features may include anxiety, worry, sadness, or depression related to the specific stressor. medications are a common form of treatment for acute insomnia disorders, and while they may improve the patient's clinical symptoms, the overall results are not very satisfactory. cognitive behavioural therapy, as a non-pharmacological treatment, has become the first-line recommended solution in the insomnia treatment guidelines of china and the united states, which can correct patients' wrong sleep cognition and bad sleep habits, establish correct sleep-wake cognition, and also improve mental health. compared with sedative-hypnotic medications, it has no adverse reactions and does not affect daytime function, making it a green and safe treatment method. based on the exact efficacy of cognitive behavioural therapy in improving insomnia, and also considering the diverse causes of acute insomnia disorder (stress), we analyse-integrate the analysis of the patient's specific situation, and we propose to treat acute insomnia disorder through analytical-integrative cognitive behavioural therapy, formulate an individualized treatment plan to improve the therapeutic effect, and prevent the patient from developing in the direction of chronic insomnia.

Eligibility criteria:
inclusion criteria: 1. meeting the dsm-5 diagnostic criteria for insomnia disorder; 2. a total score of \>5 on the pittsburgh sleep quality index (psqi); 3. age ≥18 years old, with junior high school education or above; 4. voluntarily participating in this study and signing an informed consent form; 5. the diagnostic criteria for acute insomnia disorder (duration of the disease less than 3 months). exclusion criteria: 1. people with comorbid serious physical or severe mental illnesses, suicide risk; 2. clinically diagnosed or suspected sleep breathing disorder, restless legs syndrome and sleep-wake rhythm disorder, shift workers; 3. pregnant and breastfeeding women; 4. people who are currently undergoing any psychological treatment.

Keywords: acute insomnia disorder analytic-integrative cognitive behavioural therapy stress
a non-interventional, post marketing surveillance (pms) study of tresiba® (insulin degludec) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in india

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of the study is to evaluate long term safety and efficacy of tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in india.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities (study related activities are any procedure related to recording of data according to the protocol). the historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (hba1c), fasting plasma glucose (fpg), severe hypoglycaemia before the start of tresiba® therapy) can be used for baseline data * patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with tresiba® based on the clinical judgment of their treating physician exclusion criteria: * known or suspected allergy to tresiba®, the active substance or any of the excipients * previous participation in this study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * patients who are or have previously been on tresiba® therapy * patients who are participating in other studies or clinical trials * patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
sglt-i use in diabetic foot ulcer disease

Conditions: Diabetic Foot Ulcer

Summary: background: people with diabetes and either current or previous diabetic foot ulcer disease (dfud) are at very high risk for adverse cardiovascular events including heart attacks and strokes. sodium-glucose co-transporter 2 (sglt2) inhibitors are a class of medications that have shown to be very effective in reducing heart disease and event risk. however, one recent study found that sglt2i's may increase minor amputation risk in those with dfud, though this finding has not been replicated in other similar studies. however, as a result, there has been limited further investigation into this issue and as such the use of sglt2i's in those with dfud remains a contentious issue, despite their potential for significantly reducing cardiovascular disease risk in this population. in the absence of further randomised controlled trials investigating the use of sglt2is in these populations, there is a need for clinical guidelines advising on their use based on expert clinical consensus, including specific criteria or scenarios in which they should or should not be used. the delphi methodology is an iterative survey technique that uses expert opinion from various relevant backgrounds and experiences to generate a consensus based upon various statements and/or scenarios. aim: the aim of this study is to use the delphi technique to generate expert consensus-based clinical guidelines on the use of sglt2i's in those with diabetes and dfud. methods: this is a delphi technique-based study using a purposive sample of convenience. consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of sglt2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines. the consensus group will consist of n=20 healthcare practitioners, including gps, secondary care diabetologists, foot care specialists, cardiologists and pharmacists in order to ensure a breadth of expertise and input. two rounds of the delphi consensus process will take place, in order to iteratively develop the consensus-based clinical guidelines. this process is expected to take 4-6 months. the analysis will be on-going throughout the study and completed within 3 months of the last questionnaire round of the delphi process.


Eligibility criteria:
inclusion criteria: * participants who are trained healthcare practitioners involved in the care of patients with current or previous diabetic foot ulcer disease exclusion criteria: * potential participants who do not give informed consent. potential participants who will not be able to participate in both rounds of the delphi process.
a clinical diagnostic system for intrinsic acute kidney disease

Conditions: Acute Kidney Disease

Summary: the goal of this observational cross-sectional study is to develop a clinical diagnostic system for intrinsic acute kidney disease (akd) to help clincians make non-invasive diagnosis when a kidney biopsy is not available. the main questions it aims to answer are: 1. can a clinical model comprised of common clinical indexes help diagnose akd ? 2. can a combinition of several urinary biomarkers help diagnose akd ? the study will be conducted in retrospective cohorts of patients with akd undergoing kidney biopsy. the gold standard of the study is histological diagnosis of akd. the model will be developed in a derivation cohort from one center, and will be further externally validated in a multicent cohort. the urinary biomarkers will only be tested in the derivation cohort.

acute kidney disease is a frequent syndrome characterized by a sudden loss of kidney function. akd caused by intrinsic kidney diseases are usually more severe than other causes. the treatment of intrinsic akd mostly depends on a definite pathological diagnosis, requiring invasive kidney biopsy which is not available in all akd cases. the goal of this study is to develop a clinical diagnostic system comprised of clinical model and urinary biomarkers for intrinsic akd to help clincians make non-invasive diagnosis.

Eligibility criteria:
inclusion criteria: * adult patients with akd undergoing kidney biopsy between jan. 1, 2020 and dec. 31, 2024. exclusion criteria: * patients were excluede if they 1. underwent a biopsy to evaluate renal allograft rejection; 2. had a history of hematopoietic stem cell transplantation; 3. were diagnosed with hematological malignancy or end-stage tumor with kidney metastasis; 4. were tested antineutrophil cytoplasmic autoantibody (anca) or double-strand dna (dsdna) or anti-glomerular basement membrane (gbm) antibody positive before biopsy.

Keywords: acute kidney disease kidney biopsy diagnostic model urinary biomarkers
integrated recovery program for critical illness

Conditions: ICU Survivors

Summary: this study aims to investigate the effects of the integrated critical illness aftercare and recovery enhancement (i-care) program on reducing healthcare burden and improving functional outcomes in icu survivors. the i-care program combines remote support via line bot care with in-person post-icu recovery clinic visits. the study will assess whether this integrated care model reduces unplanned hospital readmissions and emergency department visits within six months after discharge, and improves physical and cognitive outcomes at 3 and 6 months post-discharge. additionally, the study will evaluate the impact of a built-in patient-nurse interaction feature on icu nurses' burnout and intention to leave, measured every six months over a two-year period.

this randomized clinical trial is designed to evaluate the effectiveness of the integrated critical illness aftercare and recovery enhancement (i-care) program for survivors of critical illness discharged from the intensive care unit (icu). the i-care program integrates a line bot-based remote monitoring and support system with structured, in-person post-icu recovery clinic visits. the primary objective is to determine whether this comprehensive care model can reduce the incidence of unplanned hospital readmissions and emergency department visits within six months after hospital discharge. secondary outcomes focus on functional recovery and include assessments of physical mobility (e.g., ability to transition from sit to stand), inspiratory muscle strength, body weight changes, presence of dysphagia, and cognitive function at 3 and 6 months post-discharge. in addition, the line bot care system incorporates an interactive feature titled "thanks to nurses," which enables icu survivors to share personal reflections, such as short messages, photos, diary entries, stickers, and audio clips, with their icu care team. this bidirectional communication channel is intended to enhance emotional support and foster a sense of connection between patients and healthcare providers. the study will evaluate the impact of this feature on icu nurses' professional well-being, specifically measuring levels of burnout and intention to leave the profession at 6, 12, 18, and 24 months after implementation, using a pre-post intervention design.

Eligibility criteria:
inclusion criteria: * icu survivors who had experienced endotracheal intubation and mechanical ventilation treatment. exclusion criteria: * icu survivors who are unable to walk independently before admission * icu survivors who are unable to receive assessment (e.g., dementia or mental retardation) * icu survivors who don't have a smartphone. * icu survivors were discharged to institutional care facilities

Keywords: icu survivors physical function cognitive weight loss
influence of obstructive sleep apnea on the severity of coronary artery disease

Conditions: Coronary Artery Disease

Summary: it is widely accepted that coronary artery disease (cad) is related to a high mortality. it is predicted that an increase of approximately 21.3 million cardiovascular events and 7.7 million cardiovascular deaths over 2010 to 2030 in china.1 male sex, diabetes mellitus, hypertension, hypercholesterolemia, obesity and smoking are all traditionally considered as risk factors for cad. in recent decades, tremendous progress toward the prevention and treatment of traditional cardiovascular risk factors have helped decrease the morbidity and mortality from cad, but the condition remains a major public health challenge worldwide. looking into the other potential risk factors (osa) for cad, it may help to develop additional preventative strategies and further reduce the incidence and mortality of cad.

before initiating the study, all potential subjects were invited to attend an educational program that explained the purpose and methodology of this study. after getting informed consent from patients, demographic data including age, sex, medical history (including comorbidities and risk factors), current medicine, lifestyle habits, height (cm), and weight (kg) were recorded, and body mass index (bmi) was calculated as weight divided by height squared (kilograms per square meter, kg/m2). the included subjects need to perform transthoracic echocardiography or provide an echocardiographic examination within one month. cad diagnosis was determined based on the results of the coronary angiography, using stenosis 50% cutoffs considered have coronary diseases or not. consecutive patients of both sexes with coronary angiography from outpatient or inpatient departments of fuwai hospital were recruited into the study. the inclusion criteria were chinese, aged 35 to 75 years with cad verified by coronary angiography, and able to give informed written consent. the subjects were excluded if they had new york heart association class iii-iv degree with ejection fraction \< 45%, severe pulmonary disease, significant psychiatric disease, or history of pharyngeal surgery for osa or current use of cpap treatment for osa. they were also excluded if they declined to participate or were unable to provide informed consent.

Eligibility criteria:
inclusion criteria: * aged 35 to 75 years with cad * cad was verified by coronary angiography exclusion criteria: * patients had new york heart association class iii-iv degree with ejection fraction \< 45% * severe pulmonary disease * significant psychiatric disease * history of pharyngeal surgery for osa or current use of cpap treatment for osa * subjects declined to participate or were unable to provide informed consent.
evaluation of left ventricular autothreshold, phase two

Conditions: Heart Failure

Summary: this study will collect data, from an implanted cardiac resynchronization therapy-defibrillator (crt-d) device, to further evaluate a new feature for future heart failure devices.

elevate 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the left ventricular auto threshold (lvat) feature.

Eligibility criteria:
inclusion criteria: * patients who have a cognis crt-d device implanted for at least 24 hours, with or without a right atrial lead * patients who have an active lv bipolar lead * patients who have an active right ventricular (rv) defibrillation lead * patients who are willing and capable of participating in all testing associated with this clinical investigation * patients who are age 18 or above, or of legal age to give informed consent specific to state and national law exclusion criteria: * patients who have a cognis crt-d that has less than or equal to one year of battery life remaining * patients who are pacemaker-dependent * patients who will not tolerate a pacing pause of up to 6 seconds * patients who have a unipolar lv pace/sense lead, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads) * patients with pre-existing leads other than those specified in this investigational plan * patients with a pre-existing unipolar pacemaker * patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes * patients enrolled in any concurrent study, without boston scientific written approval * women who are pregnant

Keywords: heart failure auto threshold pacing crt-d recipients left ventricular (lv) evoked response signals