Kornimate/medical-research-clean huggingface dataset:
study to evaluate the effect of the smart care-diabetes management system on subjects with diabetes

Conditions: Diabetes Mellitus

Summary: smartcare-diabetes management system' to evaluate the long-term effects on patients with diabetes.

primary outcome measure: to see if there's any change in hba1c at visit 6 (12m) compared visit 2 (baseline) within each group and between the two groups. all statistical analysis will progress through the sas (version 9.1). statistical test's significance level is 0.05. the principle is two-sided test. secondary outcome measures : to see if there's any change in hba1c at each visit (visit 3 - visit 6) compared visit 2 (baseline) within each group and between the two groups. add a secondary outcome measure: treatment satisfaction (dtsq, diabetes treatment satisfaction questionnaire): to see if there's any change in treatment satisfaction scores compared visit 2 (baseline) within each group and between the two groups.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. at least 1 year after being diagnosed with type 2 diabetes 3. 7.0% ≤ hba1c ≤ 10.0% 4. agreed to participate voluntarily in the study exclusion criteria: 1. severe chronic disease 2. diabetes mellitus complications 3. severe renal disease; serum creatinin \> 1.5(men), \> 1.4 (women) 4. severe liver disease or ast, alt ≥ 2.5 x uln 5. known not to be taking medication reliably 3 months before the screening visit 6. insulin pump user 7. being registered for other clinical research or are planning to participate in other clinical researches during this study 8. pregnant woman 9. illiterate 10. being assessed irrelevant by the investigator

Keywords: diabetes mellitus smart-care u-health care
rhtpo combining rituximab versus low-dose rituximab in management of itp

Conditions: Purpura; Idiopathic Thrombocytopenic Purpura

Summary: the project was undertaking by qilu hospital of shandong university and other 13 well-known hospitals in china. in order to report the efficacy and safety of recombinant human thrombopoietin combining with rituximab for the treatment of adults with refractory immune thrombocytopenia (itp), compared to conventional rituximab therapy.

the investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 refractory itp adult patients from 14 medical centers in china. one part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 units/kg for 14 consecutive days,following with a flexible dosage depending on platelet count until the 29th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. day 1, 8, 15, 22; the others are selected to receive low-dose of rituximab treatment (given intravenously at a dose of 100 mg weekly, i.e. day 1, 8, 15, 22). platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study. in order to report the efficacy and safety of the combination therapy compared to conventional rituximab therapy for the treatment of adults with refractory itp.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years. 3. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 4. eastern cooperative oncology group（ecog）performance status ≤ 2. 5. willing and able to sign written informed consent exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(ivig)in the 3 weeks prior to the start of the study. 3. current hiv infection or hepatitis b virus or hepatitis c virus infections. severe medical condition (lung, hepatic or renal disorder) other than itp. 4.unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5.female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6.have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 7.patients who are deemed unsuitable for the study by the investigator.

Keywords: purpura idiopathic thrombocytopenic purpura
effects of atorvastatin on adiponectin levels and insulin sensitivity in hypercholesterolemic patients

Conditions: Hypercholesterolemia

Summary: high dose atorvastatin may worsen insulin sensitivity.


Eligibility criteria:
inclusion criteria: * hypercholesterolemia exclusion criteria: * chronic renal disease

Keywords: insulin sensitivity
effect of vsl#3 on intestinal permeability in pediatric crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine the effect of a probiotic formulation, vsl#3, on intestinal permeability in pediatric patients with crohn's disease.

children with crohn's disease have altered intestinal permeability. a pilot study in children showed that probiotics may decrease intestinal permeability. in this double blind, randomized controlled trial, we will observe the effect of vsl#3 on small bowel permeability using a double sugar absorption test. pcdai was monitored, but not analyzed.

Eligibility criteria:
inclusion criteria: * current diagnosis of small bowel or colonic crohn's disease as defined by histological and endoscopic criteria. * males or females ages 11-17 years. * crohn's disease in remission as defined by a pediatric crohn's disease activity index (pcdai) \< 10 * patients on maintenance doses of aminosalicylates, 6-mp and/or azathioprine for at least 2 months. * procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent. exclusion criteria: * patients with documented intestinal stricture. * patients with signs of symptoms of systemic or intestinal infection. * antibiotic use the previous 1 month. * probiotic use in the previous 2 months (excluding yogurt). * use of the following medications; methotrexate, cyclosporine, tacrolimus and infliximab. * patients with diagnosis of other co-morbid diseases such as heart disease, renal disease, immunodeficiency, diabetes, or thyroid disease. * patients with indwelling catheters. * patients with short bowel syndrome * positive urine pregnancy test for female subjects

Keywords: crohn's disease pediatric vsl#3 permeability probiotic zonulin
spinal cord stimulation to treat hypertension

Conditions: Hypertension

Summary: to investigate the exercise blood pressure response during a lower-extremity dynamic exercise in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord stimulation reduces blood pressure during exercise in postmenopausal women and men with hypertension.

this is a single center study conducted at the university of minnesota, enrolling up to forty subjects (30 men and 30 post-menopausal women). subjects will be a assigned to one of the two study arms, (dynamic exercise or spinal cord stimulation) and then crossover to the other arm after the initial assignment is complete. however is the screening mri determines the subject is not a candidate for spinal cord stimulation, then they will be assigned to the dynamic exercise arm only.

Eligibility criteria:
inclusion criteria: 1. men and post-menopausal women between the ages of 40-90 years old 2. hypertension (defined as bp ≥ 140/90), diagnosed by a physician 3. ability of the patient to provide consent exclusion criteria: 1. history of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire. 2. history of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision) 3. currently taking specific anti-hypertensive medications that may affect the exercise pressor response or influence the effect of spinal cord stimulation. please contact study staff for information regarding your eligibility. 4. history of spinal fusion or laminectomy at l3 or above 5. current prescription opioid usage 6. contraindication to mri 7. at physician discretion which will be documented on the case report form.

Keywords: hypertension high blood pressure
the mysterious on/off itch and erythema during whole body vibration exercise

Conditions: Itch; Athlete

Summary: intense itch on the legs sometimes associated with redness can be adverse effects of whole body vibration (wbv) according to own observations and numerous posts in non-professional online-blogs. to the investigators' knowledge, the appearance of itch and/or a rash during wbv exercise has not yet been described. the research objectives are: 1. to determine the effect of wbv on itch rating and its unpleasantness and on skin changes. 2. to determine the effect of wbv on immunoglobulin e (ige) and serum tryptase

objectives intense itch on the legs sometimes associated with redness can be adverse effects of wbv according to the investigators observations and numerous posts in non-professional online-blogs. to the investigators knowledge, the appearance of itch and/or a rash during wbv exercise has not yet been described. the objectives of this study are: 1. to determine the effect of wbv on itch rating and its unpleasantness and on skin changes. 2. to determine the effect of wbv on serum tryptase. hypothesis the working hypothesis is that repeated wbv leads to an increase of itching and erythema. further investigators hypothesize that repeated wbv does not lead to an increase in serum tryptase. inclusion and exclusion criteria will be evaluated. subjects will be instructed to not shave their legs one week before the intervention day and to shave only the left leg from the ankle to the knee on the day prior to the intervention day. on the intervention day, subjects will be informed in detail about the study protocol and written informed consent will be collected. if a pregnancy cannot be excluded (days from last menstruation) subjects are instructed to do a pregnancy test. then, a blood sample will be taken. subsequently, subjects will be instructed to stand on the vibration plate (galileo 900) in a slightly crouched position with their hands loosely resting on the rail. subjects will complete ten 1-minute wbv repetitions interspaced by 1-minute breaks in seated position. during each break, subjects will rate the itch intensity, and skin changes will be captured. sixty minutes after the last wbv repetition, another blood sample will be taken. subjects will rest until itch and erythema return to baseline. during resting phase subjects will fill in the eppendorf itch questionnaire and the erlanger atopy score.

Eligibility criteria:
inclusion criteria: * age 18-35 years * female * informed consent as documented by signature (appendix informed consent form) exclusion criteria: * itchy skin diseases * hay fever * asthma * chronic venous insufficiency * peripheral artery disease * musculoskeletal diseases or injuries affecting the legs, hips and pelvis * bmi \ 35 kg/m2 * pregnancy

Keywords: whole body vibration, erythema, tryptase, unpleasantness
long-term recurrence and other complications requiring surgery following primary ventral hernia repair

Conditions: Umbilical Hernia; Epigastric Hernia

Summary: nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair

cohort based on patients registered in the danish ventral hernia database. through cross-linking at an individual level, all subsequent operations will be identified in the danish national patient registry. for all potentially related reoperations, patient charts will be retrieved and manually reviewed. furthermore cross-linkage with the danish civil registration system to retrieve information on civil status. follow up from time of operation for primary ventral hernia repair (index operation) until reoperation, death, emigration or end of follow up (december 31, 2023), whichever comes first.

Eligibility criteria:
inclusion criteria: * operation for primary ventral hernia repair registered in danish ventral hernia database * known body mass index and smoking status at time of surgery, as registered in the danish ventral hernia database exclusion criteria: * hernia type misclassification (based on manual medical file review)
olfactory outcomes of dupilumab treatment for nasal polyposis

Conditions: Chronic Rhinosinusitis With Nasal Polyps; Olfactory Disorder

Summary: the study aims to investigate the olfactory tdi score (threshold, discrimination, identification) using the sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (crswnp) on dupilumab. twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the otolaryngology clinic (baseline, 3 months and 6 months). the primary endpoint will be the tdi score. nasal polyp score, quality of olfactory disorders - negative symptoms (qod-ns symptom scores), snot-22 will be secondary endpoints.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old * chronic rhinosinusitis with nasal polyps * olfactory loss * clinical indication for treatment with dupilumab exclusion criteria: patients with olfactory loss from other causes such as: * sinonasal malignancies * trauma * idiopathic olfactory loss * use of cocaine * covid-19 related olfactory loss * pregnancy
determinants of cognitive impairment among geriatrics

Conditions: Cognitive Impairment; Dementia; Hearing Impairment; Vision Impairment and Blindness; Diabetes; Dyslipidemias; Obesity; Central Obesity; Mobility Limitation; Osteoarthritis; Hypertension; Depression

Summary: this study aims to explore the determinants of cognitive impairment among indonesian geriatrics in an old age home.

elderly patients (≥ 60 years of age) are enrolled in this study. the inclusion criteria are patients which have consented to take part in the study. data such as age, ethnic, education, bmi, waist and hip circumference, blood pressure, hearing impairment, vision impairment, depression, sleep disorder, mobility, hemoglobin levels, glycemic and lipid profile, as well as comorbidities and drugs used were collected from the patients' medical records, laboratory tests and through examination by trained examiners. cognition was determined through a combination of several psychiatric examinations using validated instruments namely - minicog, clock drawing test, three word recall, alzheimer's disease-8 indonesia (ad-8 ina) questionnaire and short portable mental status questionnaire (spmsq).

Eligibility criteria:
inclusion criteria: * must be classified as geriatric according to indonesian laws (≥ 60 years of age). * consented to participate in this study. exclusion criteria: * uncooperative. * incomplete records.

Keywords: cognitive impairment dementia geriatrics
tailored implementation intervention for managing depressed elderly patients in primary care

Conditions: Depression

Summary: background the prevalence of depression is high and the elderly have an increased risk of developing a chronic course. international data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer, and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. although recommendations for the treatment of elderly patients with depression exist, health care professionals adhere to these recommendations to a limited degree only. investigators conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. investigators identified and prioritised determinants of practice related to implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. the objective of this study is to evaluate the effectiveness of these tailored implementation interventions to implement six recommendations for the management of elderly patients with depression in primary care. methods/design investigators will conduct a pragmatic cluster randomised trial comparing implementation of the six recommendations using tailored interventions with usual care. investigators will randomize 80 municipalities into one of two groups: an intervention group, to which investigators will deliver tailored interventions to implement the six recommendations, and a control group, to which investigators will not deliver any intervention. investigators will randomise municipalities rather than patients, individual clinicians or practices because we will deliver the intervention for the first three recommendations at the municipal level and investigators want to minimise the risk of contamination across practices for the other three recommendations. the primary outcome is the proportion of general practitioners' behaviours which are consistent with the recommendations. discussion this trial will investigate whether a tailored implementation approach is an effective strategy to improve collaborative care in the municipalities and health care professionals' practice towards elderly patients with depression in primary care. the effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.


Eligibility criteria:
inclusion criteria: home-dwelling patients aged 65 or higher, who have a diagnosis of depression, according to international statistical classification of diseases and related health problems, tenth revision exclusion criteria: patients will be excluded if they have a diagnosis of dementia, bipolar disorder or reside in nursing homes or is assessed by their practitioner to have low life expectancy.

Keywords: tailored implementation interventions primary care depression in the elderly
effect of tiotropium on inflammation and exacerbations in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: patients with copd experience exacerbations that are a major cause of morbidity. exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. the study will compare airway inflammation and exacerbation frequency in patients with copd on tiotropium or placebo.

patients with copd will be randomised to tiotropium or placebo in addition to their usual medication. they will be followed prospectively over 1 year and provide sputum for quantification of il-6 and il-8 at baseline and at 3 monthly intervals.serum il-6 will also be quantified at baseline and over the year. changes in inflammatory markers will be assessed by analysis of area under the curve of log transformed data. exacerbation frequency will be calculated from patient diary cards using a previously validated symptom-based exacerbation definition.

Eligibility criteria:
inclusion criteria: * diagnosis of copd, * fev1 \< 80% predicted, * minimum 10 pack year smoking history exclusion criteria: * asthma, * atopic disease, * eosinophilia, * history of malignancy, * history of clinically significant pulmonary disease

Keywords: inflammation exacerbations
covid-19 vaccination detoxification in ldl-c

Conditions: COVID-19 Stress Syndrome; COVID-19 Vaccine Adverse Reaction; COVID-19-Associated Thromboembolism; COVID-19 Post-Intensive Care Syndrome; COVID-19-Associated Stroke; COVID-19 Respiratory Infection

Summary: the study hypothesizes that sars-cov-2 vaccination poisoning hibernates in human host in low density lipoprotein cholesterol (ldl-c). the clinical trial is a follow-up from the intervention trial with nct number nct05711810. it tests the use of atorvastatin calcium tablets for detoxification and prevention of blood acidification, and the use of the chinese herb compounded anti-viral granules for the detoxification in the endocrine system.


Eligibility criteria:
inclusion criteria: * people who received covid-19 vaccinations, or experiencing long-covid. exclusion criteria: * people with moderate and severe liver dysfunctions.

Keywords: covid-19 sars-cov-2 low density lipoprotein cholesterol sebum immune reflex immunology immune deficiency immune regulation detoxification
comparative effectiveness of telemedicine in primary care

Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure; Diabetes; Hypertension

Summary: leveraging a natural experiment approach, the investigators will examine rapidly changing telemedicine and in-person models of care during and after the covid-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedicine-supplemented care, rather than return to in-person care.

during the covid-19 pandemic, telemedicine has quickly emerged as the primary method of providing outpatient care in many regions with shelter-in-place and social distancing policies. it is critical to understand the impact of this rapid and widespread transition from in-person to remote visits on disparities in access to primary care, especially in chronic disease where ongoing communication between providers and patients is essential. also, these newly developed or expanded telemedicine programs vary widely, raising important questions about the effect of these differences on uptake of telemedicine among different patient populations and on patient-centered outcomes. leveraging a natural experiment approach, the investigators will examine rapidly changing telemedicine and in-person models of care during and after the covid-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedicine-supplemented care, rather than return to in-person care. the overarching goals of this study are to describe the features of telemedicine programs in primary care during the covid-19 pandemic and to use natural experiment methods to provide rigorous evidence on the effects of these programs. pcori has granted an extension for the final research report to october 1, 2023.

Eligibility criteria:
inclusion criteria: * patients that are attributed to primary care clinics across four health systems in the insight (mount sinai health system and weill cornell medicine), oneflorida (university of florida health), and star (university of north carolina health) crns. * patients received two or more outpatient visits at a participating practice during a one-year period before the covid-19 pandemic, * patients had one or more of five chronic illnesses (asthma, chronic obstructive pulmonary disease (copd), congestive heart failure (chf), diabetes, hypertension) as defined by the medicare chronic conditions warehouse algorithm exclusion criteria: * patients who tested covid-positive * patients from hospice and palliative care practices * patients from osteopathic medicine practices * patients from pediatric practices * patients that did not reside in states where the four health systems were located: the new york-tri state area (connecticut, new york, and new jersey), florida, and north carolina. * patients that moved out of state (or out of the new york-tri state area) or who died during the study period were also excluded. * patients who were not continuously enrolled over the entire study period (2019-2021).

Keywords: telemedicine primary care