Kornimate/medical-research-clean huggingface dataset:
multicomponent strategy to implement a clinical practice guideline and improve health outcomes in people with sle

Conditions: Systemic Lupus Erythematosus

Summary: principal objective: to produce scientific knowledge on the effectiveness and cost-effectiveness of a multicomponent intervention for knowledge transfer and implementing a clinical practice guideline (cpg) for systemic lupus erythematosus (sle), formed by an educative intervention, an computerized clinical decision support system (sadc), complemented by an automated feedback built into the electronic clinical record. secondary objectives will be previously developed: 1) the analysis of medical practice variations along the care of sle patients in the canary islands health service (scs); 2) the best available scientific evidence to support the optimal development of the sadc; 3) the context and the barriers to innovation implementation in the scs; and 4) the development of the contents for the implementation strategy, including the sadc and the automated feedback. methods for the main objective: the main objective will be assessed under an open, multicentric and randomized (by clusters) clinical trial, in the scs. the multicomponent intervention will be compared to the usual procedures for cpg dissemination. the main measure will be the self-perceived activity of sle rated by the slaq scale. self-perceived health related quality of life (hrqol) data will be obtained by means of the questionnaire eq-5d-5l , to estimate a cost-effectiveness ratio. methods for secondary objectives: the rest of the objectives will be developed by a mix of quantitative and qualitative research methods to allow adapting the design, development and execution of the intervention to the characteristics of the context.


Eligibility criteria:
inclusion criteria: * patients: adults (older than 18 years) diagnosed with sle of any seriousness and situation (active, remission or clinically quiescent and serologically active), who agree to participate and sign informed consent. * health professionals: physicians specialized in rheumatology or internal medicine that include in their quotas a minimum of 30 patients with eligible sle. exclusion criteria: * patients: sle limited to the skin, advanced chronic kidney disease (dialysis or renal transplant); mental illnesses and / or sensory or cognitive deficits; or participating in extension or follow-up studies of another rct (possible change in follow-up guidelines). participants in observational studies may be included as they do not change usual practice.

Keywords: lupus quality of life multicomponent intervention clinical practice guideline computerized clinical decision support system activity
safety and efficacy study of insulin lispro versus insulin aspart in participants with type 2 diabetes on insulin pump therapy

Conditions: Type 2 Diabetes Mellitus

Summary: this study will provide information on the use of insulin lispro and insulin aspart in insulin pumps in participants with type 2 diabetes.

this study will provide clinical information on the use of insulin lispro in continuous subcutaneous insulin infusion (csii) in participants with type 2 diabetes. this study is designed to allow comparison of the 2 rapid-acting insulin analogs, with regard to their efficacy and safety, when used as a pump insulin therapy in this participant population. each participant will be randomized to 1 of the 2 sequence groups in a 1:1 ratio and randomization will be stratified according to screening a1c (less than or equal to 8.0% or greater than 8.0%) and thiazolidinedione (tzd) use (yes or no). the study design includes the following periods: screening/randomization, treatment period 1 (16 weeks), and treatment period 2 (16 weeks).

Eligibility criteria:
inclusion criteria: * have type 2 diabetes (per world health organization \[who\] classification of diabetes) * have been treated with csii therapy using a rapid-acting analog for the previous 6 months * have a screening a1c less than or equal to 9.0% (no lower limit for a1c) * have a body mass index (bmi) less than 45 kilograms/square meter (kg/m²) at screening * have a history of stable body weight (not varying by greater than 10% for at least 3 months prior to screening) * for participants on oral anti-diabetes medications (oams): must have been on a stable dose of oams, labeled for use with insulin, for at least 3 months prior to study entry exclusion criteria: * have severe insulin resistance \[require greater than 2 units/kilogram/day (u/kg/day) of insulin\] * are taking or have taken within the last 3 months, antihyperglycemic medication not approved for use with insulin, injectable non-insulin antihyperglycemic medications, or have a contraindication to current antihyperglycemic medication * have a serum creatinine greater than or equal to 2 milligrams/deciliter (mg/dl) if not on metformin; known metabolic or lactic acidosis; any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis; and/or a radiologic contrast study within 48 hours prior to study entry * are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intraarticular, and inhaled preparations) or have received such therapy within 2 weeks immediately before screening * have had more than 1 episode of hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study

Keywords: diabetes type 2 diabetes insulin pump continuous subcutaneous insulin infusion csii a1c
clinical trial to evaluate methylprednisolone pulses and tacrolimus in patients with covid-19 lung injury

Conditions: COVID-19; Lung Injury

Summary: the primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe covid-19 lung injury.

unfortunately, the treatment of covid-19 disease is still based on life support therapies. nowadays, there is no scientific evidence from clinical trials regarding the efficacy or safety of different drugs to treat covid-19 patients, despite some of them evolving to fatal severe lung injury due to important inflammatory process secondary to pro-inflammatory cytokines. interestingly, tacrolimus has been shown to inhibit both pro-inflammatory cytokines and, also, human coronavirus sars-cov replication, but it has not specifically been tested in covid-19 patients. our working hypothesis is that severe sars-cov-2 (covid-19) pneumonia is secondary to a deleterious inflammatory process; so, the use of methylprednisolone pulses and tacrolimus in hospitalized severe covid-19 lung injury patients might have a positive clinical effect. given the covid-19 current health emergency, this study could provide useful evidence to treat some covid-19 patients with methylprednisolona and tacrolimus, which might represent a new therapeutic option for them. tacrolimus is a drug with more than 20 years of experience, and therefore, its side effects are well known and usually reversible. in addition, since tacrolimus is a low-cost and easy to produce at large-scale drug, it could be used to treat a large number of patients. the administration of this drugs could not only decrease mortality secondary to lung involvement by covid-19, but also decrease the excessive burden of care that intensive care units are bearing.

Eligibility criteria:
inclusion criteria: * covid-19 infection confirmed by pcr * new onset radiological infiltrates * respiratory failure (pao2 / fio2 \<300 or sato2 / fio2 \<220) * pcr\>100 mg/l and/or d-dimer\>1000 µg/l and/or ferritin\>1000 ug/l * informed consent. exclusion criteria: * life expectancy ≤ 24h * glomerular filtration ≤ 30 ml / min / 1.73 m2 * leukopenia ≤ 4000 cells / µl * concomitant potentially serious infections. * contraindication for the use of tacrolimus according to the specifications of the product * known adverse reactions to treatment * have participated in a clinical trial in the last 3 months
black men evolving behavioral hiv prevention intervention for black msm

Conditions: HIV CDC Category A1

Summary: b-me is a research intervention study designed to address the needs of african american men who have sex with men (aamsm) who are at high risk for hiv. the intent of the intervention is to decrease hiv risk behaviors among african american msm using an intervention developed by and for african american msm. the hypothesis guiding this study is: that participants who complete b-me intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group.

the specific aims of this study are 1) to further explicate and develop the intervention, 2) to evaluate its efficacy in reducing hiv risk behaviors and 3) to expand the limited body of research on hiv prevention/risk reduction practices for african american men who have sex with men(aamsm). the study will use a randomized-controlled trial design to compare receiving b-me intervention to receiving basic men's health and wellness messaging (standard of care), hypothesizing: hypothesizing: that participants who complete b-me intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group. the study will utilize a pre-test/post-test design with participants randomized to intervention and comparison groups; have a strategy to retain at least 80% of participants through study completion; collect data at baseline, at 3 months post-intervention, and at 6 months post-intervention; and rigorously measure outcomes that directly impact hiv risk. data will be collected at each assessment point to assess b-me's ability to improve behavioral outcomes that directly impact black msm hiv risk: (1) number of unprotected anal and vaginal sex events; (2) number of unprotected sex events with persons of unknown hiv status; (3) frequency of hiv testing, and (4) increased communication between partners about sex and strategies for reducing the risk of hiv infection.

Eligibility criteria:
inclusion criteria: * a) be 18 to 55 years old b) self identify as african american (black national) c) self identify as a male (because this is a study of an intervention to impact change among black msm, only self identified males will be included, therefore no females or transgendered identified persons will be included). d) report being sexually active in the past 30 days (ie., one or more instances of vaginal or anal sex with a male or female) e) report at least one instance of unprotected anal or oral sex with a male identified partner in the past year f) have not previously participated in the ctca intervention. g) have not received an evidence-based hiv prevention intervention in the past 180 days exclusion criteria: * men are ineligible to participate in the trial if they: 1. identify as a transgender woman; or 2. plan to move before the end of the study; or 3. have participated in any hiv or substance use prevention studies in the last 180 days.

Keywords: black msm hiv prevention
autoimmune diabetes: markers of the disease and treatment of latent autoimmune diabetes in adults (lada)

Conditions: Autoimmune Diabetes

Summary: autoimmunity is the main cause of diabetes type 1 and an important factor as cause of latent autoimmune diabetes in adults (lada). recently, research has found that being deficient of t-reg cells is an important cause of autoimmunity. the study hypothesis are: 1. patients with newly found diabetes type 1 have less t-reg than healthy. 2. patients with newly found diabetes type 1 have less t-reg than patients with long duration of the illness. 3. the number of t-reg is negative associated with hla-risk-haplotype. 4. the number of t-reg is negative associated with lada. 5. differences relating to inflammatory cytokines will be seen among patients with newly found diabetes type 1, but not among others.

research has worked out that b-cells are being destroyed by cytokines released from inflammatory cells. one hypothesis in that t-reg is a cause of autoimmunity, and that t-reg concentrations are low in patients with newly diagnosed diabetes type 1. blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes, latent autoimmune diabetes in adults (lada) and type 1 diabetes older than 10 years and the same amount of samples from healthy, age- and sex-matched blood donors. markers of autoimmune diabetes will be analyzed.

Eligibility criteria:
inclusion criteria: * newly diagnosed diabetes type 1 * lada * diabetes type 1 older than 10 years exclusion criteria: * none

Keywords: autoimmune diabetes lada t-reg cytokine
chinese psoriasis real world evidence research

Conditions: Psoriasis

Summary: this research is a multicenter,observational study under real world settings in patients diagnosed as psoriasis by dermatologist in the clinic. as patient's choice of medication should be fully respected, all the patients can choose the treatments they prefer, like phototherapy, traditional systemic therapy or biologics. and the study was conducted to compare the effectiveness among different choices of medication in chinese psoriasis patients.

psoriasis is a chronic, recurrent inflammatory disease which is caused by heredity, environment and other factors. the typical clinical manifestation are erythematosquamous lesions, and the disease can progress to involve several organs. in view of its complex pathogenesis, there exists various of treatment of psoriasis like traditional systemic drugs and biologics. this study is an observational, multi-centre study based on real-world evidence. inclusion criteria is the patients who visit the clinic diagnosed psoriasis by the dermatologist. there existed no exclusion criteria. information were most collected by a phone application called "psoriasis new world". primary outcome measure is the percentage of patients who achieved a pasi reduction of 100% (pasi 100). and psoriasis area and severity index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher pasi scores indicating worse condition. also, static physician global assessment (spga), static investigator global assessment (siga), body surface area (bsa) and dermatology life quality index (dlqi) are measured to assess the severity of psoriasis and the change of the disease condition. it is important to monitor all the adverse events (aes) over the whole study. in addition, the laboratory examinations of patients such as liver function are also collected.

Eligibility criteria:
inclusion criteria: * all the patients diagnosed as psoriasis by dermatologist in clinic. exclusion criteria: * none
a phase iii study of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (day 169) of treatment in korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate


Eligibility criteria:
key inclusion criteria: * rheumatoid arthritis (ra) for longer than 1 year from the time of the initial diagnosis of ra * patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (day 1) * methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses key exclusion criteria: * evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment

Keywords: rheumatoid arthritis, with inadequate response to methotrexate
to explore the effectiveness of jing-si herbal tea against non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the aim of this study is to explore the effectiveness of jing-si herbal tea on improving the non-alcoholic fatty liver disease patients

this study adopted a randomized double-blind design, 2-arm trial study. all eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of taichung tzu chi general hospital (rec110-74). patients were recruited from the gastroenterology department of taichung tzu chi hospital. after random assignment to 2 groups, patients will receive jing-si herbal tea or placebo twice a day for 24 weeks. we will evaluate the blood test results, abdominal ultrasound and physical examination every 12 weeks.

Eligibility criteria:
inclusion criteria: * sign the informed consent * age between 20-70 * diagnosis for moderated nafld * liver disease without hepatic decompensation * hba1c \< = 8.0 % exclusion criteria: * do not sign the informed consent * other related liver diseases will affect the study which evaluated by physicians * women of potential pregnancy or pregnant women

Keywords: jing-si herbal tea
descriptive and risk factors analysis of all-cause postoperative death in patients undergoing emergency surgery

Conditions: Postoperative Death

Summary: the investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after emergency surgery. the investigators identify all patients treated with emergency surgery, between 2000 and 2020, within the wuhan union hospital and all collaborators. the surgical patient cohort will be matched with the national death database to determine the patient's postoperative death data. 60% patients were randomly selected to the development cohort. logistic regression analysis for prediction of postoperative death adjusted for different covariates. the model was externally validated in the remaining 40% patients.


Eligibility criteria:
inclusion criteria: * patients undergoing emergency surgery exclusion criteria: * patients with incomplete electronic medical record information

Keywords: postoperative death emergency surgery prediction model
objective results of anterior cruciate ligament reconstruction with and without internal suture augmentation technique

Conditions: Anterior Cruciate Ligament Injuries

Summary: the purpose of this study is (1) to report, compare and corelate the patient reported outcomes (pro) (ikdc score, lysholm score) and range of motion (rom) among patients following hamstring autograft aclr with and without independent suture tape reinforcement against objective laxity test using lachmeter. (2) rate of complications and reoperation.

investigators performed a randomized control trial in two groups utilizing all- inside aclr. group i was augmented by suture tape and group 2 without suture tape augmentation. from october 2018 to june 2020, 20 patients underwent all-inside acl reconstruction with internal suture augmentation technique (group i, brace group) and the other 18 patients underwent all- inside acl reconstruction without internal suture augmentation technique (group ii, non-brace group). demographic data (age, sex, side of injury, time since injury), manual assessment (lachman test, pivot shift test, rom), pros (ikdc score, lysholm score) and lachmeter examination were collected and analyzed at fixed time points during follow-up period as mean duration of follow up in our series was 18 months ± 3.4 (range, 12-24 months).

Eligibility criteria:
inclusion criteria: * age 20-35 years old. * patients will be diagnosed as acl tear by the following: i. history of knee traumatic event. ii. clinical examination (ant. drawer test, lachman test and pivot shift test). iii. radiological evidence of acl tear by mri. exclusion criteria: * other intra or extra articular knee injuries. * previous acl surgery on the affected knee. * bilateral acl injuries. * significant articular surface injury. * medical comorbidities * patients with malalignment (genu varum. genu valgum and genu recurvatum) * neuromuscular disorders

Keywords: rolimeter aclr internal suture augmentation ikdc score lysholm score
quality control of ce-labelled phonak hearing systems (study part: sonova2015-00)

Conditions: Hearing Loss

Summary: the purpose of this study, which contains a series of successive study parts, is to methodically evaluate phonak hearing systems on hard of hearing participants to grant quality control prior to each product launch.


Eligibility criteria:
inclusion criteria: * hearing impaired persons with and without (experience with) hearing aids * good written and spoken (swiss) german language skills * healthy outer ear (without previous surgical procedures) * ability to fill in a questionnaire conscientiously * informed consent as documented by signature exclusion criteria: * contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * central hearing disorders
io vs iv vancomycin in tourniquetless tka

Conditions: Infection, Surgical Site

Summary: purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.

primary objective: comparable levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, as well as in systemic levels, between the intravenous and intraosseous administration groups. secondary objective: compare 30- and 90-day post-operative complication rates (infection) between the control (standard iv administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). the research team hypothesizes that there will be no difference in complication (infection) rates between groups

Eligibility criteria:
inclusion criteria: * patient is undergoing a primary total knee arthroplasty. * patient is able to understand the study design and intervention and gives informed consent to participate in the study. no lar consents will be utilized for this study. * age \>18 years. * total knee arthroplasty performed without the use of a tourniquet. exclusion criteria: * previous surgery on the knee (including arthroscopic knee surgery) * bmi above 35 * contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc). * inability to locate the tibial tubercle or administer the io infusion * refusal to participate * uncontrolled diabetes mellitus type 1 or 2, defined as hemoglobin a1c \>7.5. * immunocompromised or immunosuppressed patients (hiv, hep c, end-stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)

Keywords: vancomycin total knee arthroplasty tourniquetless