Kornimate/medical-research-clean huggingface dataset:
protocol 3: role of the renal nerves in the increase in egp in response to glucosuria

Conditions: Diabetes Mellitus, Type 2

Summary: purpose/objectives: examining the effect of sglt2 inhibition on egp and plasma glucose concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which mediates the changes in plasma glucagon and/or insulin concentration in response to glucosuria.

purpose/objectives: examining the effect of sglt2 inhibition on egp and plasma glucose concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which mediates the changes in plasma glucagon and/or insulin concentration in response to glucosuria. research design/plan: after screening, eligible subjects will receive 2 measurements of endogenous glucose production with a prime-continuous infusion of 3-3h-glucose. each measurement will be performed on a separate day in random order after a 10-12 hour overnight fast and will last 8 hours (from 6 am to 2 pm). after a 3-hour tracer equilibration period, each subject will receive one of the following medications in random order: (i) placebo and (ii) dapagliflozin 10 mg. following the test medication at 9 am, blood samples will be drawn every 20 minutes for an additional 5 hours and plasma glucose, insulin, c-peptide, glucagon, catecholamine concentrations and tritiated glucose sp act will be measured. methods: visit 1: screening visit 2: endogenous glucose production measurement (egp) visit 3: after completing the first egp measurement, subjects will return to the diabetes research unit for the second study.

Eligibility criteria:
inclusion criteria: * age = 18-70 years * bmi = 18.5-40 kg/m2 * hba1c ≥ 7.0% and ≤10.0% for type 2 diabetics * males or females * must be at least 3 months post renal transplantation and be on a stable dose of prednisone (≤5 mg/day), tacrolimus, and mycophenolate mofetil * not taking any antidiabetic medications or who are treated with metformin, sulfonylurea, dipeptidyl peptidase 4 (dpp4) inhibitor, thiazolidinedione or some combination * must be in good general health as determined by physical exam, medical history, blood chemistries, cbc, tsh, t4, ekg and urinanalysis exclusion criteria: * subjects who are taking insulin or sglt2 inhibitor are excluded * only subjects whose body weight has not been stable (± 3 lbs) over the preceding three months and/or who participate in an excessively heavy exercise program will be excluded. * individuals with evidence of proliferative diabetic retinopathy, plasma creatinine \>1.4 females or \>1.5 males (and egfr \ 300 mg will be excluded.
titanium-prepared platelet-rich fibrin in periodontal regeneration

Conditions: Platelet-Rich Fibrin

Summary: in this study, the possible effect of blood group distribution on the content of blood biomaterial was investigated. 64 volunteers were included in the study. various parameters were evaluated. as a result, it was concluded that blood group distribution does not affect blood biomaterial content.

the aim of this split-mouth, randomized, and controlled study was to compare open flap debridement (ofd) alone against ofd with autogenous titanium-prepared platelet-rich fibrin (ofd+ t-prf) combined in treating intrabony defects (ibd). subjects were 20 systemically healthy patients with chronic periodontitis according to 2017 world workshop. bilateral operation sites in patients (40 sites) were randomly selected for ofd alone or ofd+ t-prf combined. clinical parameters (probing depth (pd), relative attachment level (ral), and gingival marginal level(gml)), radiographic parameters (intrabone defects (ibds) and periodontal bone support (pbs)), and growth factors levels (gfl) in gingival crevicular fluid (gcf) (platelet-derived growth factors (pdgf-bb), fibroblast growth factors (fgf-2), relative ratio of receptor activator nuclear factor kappa-b (rankl)/osteoprotegerin (opg)) were analyzed. the wilcoxon signed-rank test, the student's t-test, the two way anova, and the tukey post hoc test were used for statistical analysis.

Eligibility criteria:
inclusion criteria: 1)patients with bilaterally similar periodontal intrabone defects (ibds) exclusion criteria: 1. who did not show the necessary oral hygiene during the non-surgical periodontal treatment process, 2. history of periodontal therapy in the preceding 1 year, 3. presence of devital tooth, grade ii, or higher mobility of the tooth, and less than 3 bone walls or a defect in the furcation at the site of the bone defect, 4. history of any systemic diseases that can alter the course of the periodontal disease, 5. smokers, 6. use of antibiotics, 7. pregnant/lactating women.

Keywords: chronic periodontitis growth factors guided tissue regeneration periodontal platelet-derived growth factor platelet-rich fibrin
the performance of the endurant endoprosthesis in an infrarenal aortic aneurysm with a wide or conical shaped infrarenal neck anatomy

Conditions: Abdominal Aortic Aneurysm

Summary: retrospective single centre observational cohort study of patients who underwent an elective infrarenal abdominal aortic aneurysm repair, from january 2011 to january 2020.

objective: to evaluate the performance of the endurant endoprothesis in patients with a wide or conical shaped neck anatomy after elective abdominal aortic aneurysm repair. inclusion: patients who underwent elective infrarenal abdominal aortic aneurysm repair with the endurant endograft between january 2011 until january 2020 in rijnstate, arnhem, the netherlands. primary endpoint: freedom from reinterventions at one year. secondary outcomes: * endoleaks * aneurysm sac growth * aneurysm rupture * stent migration * aaa-related mortality * all-cause mortality * procedural time * 30-day complications * renal dysfunction/renal occlusion * proximal fixation failure

Eligibility criteria:
inclusion criteria: all patients with an elective infrarenal endovascular abdominal aortic aneurysm repair with the endurant endoprothesis between january 2011 till january 2020 in the rijnstate hospital, arnhem, the netherlands. exclusion criteria: * emergency/rupture procedures * objection use of data for research * other prosthesis used for evar

Keywords: abdominal aortic aneurysm evar wide neck conical neck hostile neck
effects of α-linolenic acid supplementation on hemostasis in nondiabetic and hypercholesterolemic subjects

Conditions: Hypercholesterolemia

Summary: this study evaluates whether ala intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase a2 (lp-pla2) activity.

an 8-week, randomized, double-blind, placebo-controlled study was conducted with 86 nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dl ≤ serum cholesterol ≤ 300mg/dl) subjects, not taking any medications and supplements to affect lipid metabolism, platelet function and inflammation, divided into two groups: an α-linolenic acid (ala) group \[1.2 g (two capsules) of perilla oil daily; 497 mg ala\] and a placebo group (1.2 g of medium-chain triglyceride oil daily).

Eligibility criteria:
inclusion criteria: * voluntarily agree to participate and sign in informed consent form * adults aged 40-70 * nondiabetic and hypercholesterolemic subjects (serum cholesterol ≥ 200 mg/dl) exclusion criteria: * subjects taking any medication or supplements known to affect lipid metabolism or platelet function, n-3 fatty acid supplementation or n-3 fatty acid-rich fish more than two times per week * following diseases: dyslipidemia, hypertension, diabetes, liver disease, renal disease, pancreatitis, cardiovascular disease, gastrointestinal disease, cancer, or any other disease requiring treatment * participation in clinical trials of any drug or supplement within 30 days prior to the participation of the study * pregnant or lactating women, alcoholic, mental patient * judged to be inappropriate for the study by the investigator after reviewing other reasons

Keywords: α-linolenic acid perilla oil aptt collagen-epinephrine closure time lp-pla2
aqueous urea concentration may be related to cataract development

Conditions: Cataract Cortical

Summary: cataracts could be cured with eye drops. some studies reported that in chronic renal failure, the occurrence of cataract is rare and the mechanism is unknown. the aim of this research is to describe correlation between urea concentration in the serum and aqueous humor and development of age related cataract.

the study was conducted in the departments of ophthalmology and internal medicine, asyut university hospitals, egypt. three groups of subjects were included: patients with age related cortical cataracts who are otherwise healthy (cases) and two control groups; first systemically healthy subjects with ocular problems other than cataract and a second control group of patients with impaired renal functions and are not on dialysis treatment and thus have elevated serum urea levels. slit lamp examination was performed to evaluate crystalline lens for opacities. measurement of serum urea was done for all study subjects. aqueous humor urea concentration was done only for the group of patients who are planned to have intraocular surgery. for that purpose, 0.1 ml of aqueous humor will be aspirated at the start of routine intraocular surgery.

Eligibility criteria:
inclusion criteria: * senile cortical cataract. exclusion criteria: * senile nuclear cataract. * congenital cataract * traumatic cataract
optimizing tobacco treatment delivery for people living with hiv

Conditions: Hiv; Smoking, Cigarette

Summary: the purpose of this study is to conduct a randomized trial to evaluate a proactive, opt-out model of provider contact to deliver smoking cessation support for people living with hiv compared to standard care support delivered through traditional clinic pathways. investigators will also evaluate implementation outcomes to identify barriers and facilitators towards future implementation. investigators hope to define best practices and optimize the delivery of smoking cessation interventions for people living with hiv.

this hybrid effectiveness-implementation trial presents on opportunity to optimize tobacco treatment delivery for people living with hiv (plwh), and identify barriers and facilitators towards future implementation. we are proposing a comparison of treatment as usual (tau; reactive, opt-in tobacco treatment using standard clinical pathways) vs proactive outreach with medication opt-out for tobacco treatment engagement (promote). participants will be randomized in a 1:1 allocation. the primary aim is to compare rates of cessation and quit attempts at the week 12 follow-up between participants who received tau versus promote. as a secondary aim we will characterize key determinants of promote reach, implementation fidelity, adherence, and acceptability. we hypothesize that the promote intervention will increase cessation rates and number of quit attempts, and that it will result in greater reach and pharmacotherapy delivery compared to tau. key determinants of promote implementation outcomes will also be characterized. an exploratory assessment of cd4 cell count and hiv viral load, in addition to durability of smoking cessation outcomes, will also be assessed. by optimizing the delivery of effective tobacco treatments for plwh, we hope to increase the number of people receiving tobacco treatment, increase tobacco cessation rates, and reduce the risk of morbidity and mortality from smoking-related causes.

Eligibility criteria:
inclusion criteria: * age 21 and older * current diagnosis of hiv * current smoker (defined as self-report of current smoking) * willing to be randomized * english speaking exclusion criteria: * currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking nicotine replacement therapy or other cessation medications, enrolled in the quitline, or in another study) * currently imprisoned * pregnant women * non-english speaking persons

Keywords: smoking
struvite stones antibiotic study

Conditions: Kidney Stones

Summary: the aim of this research is to determine an effective antibiotic regimen following definitive surgical therapy of kidney stones caused by bacterial infection (struvite stones).

struvite stones or infection stones are a subset of kidney stones that are related to bacterial infection. they only make up 15% of all kidney stones, but account for a much higher percentage of mortality (up to 67%) compared to other stones-due to the infectious component. treatment is to ensure 100% eradication of the stone with surgery followed by antibiotics to eliminate the infection. failure to eliminate the bacteria results in the stone growing back quickly. it is unknown how long antibiotics should be administered immediately after surgery-some urologists give 2-4 weeks while others give 2-3 months. we seek to randomize patients to receive 2 weeks of antibiotics or 3 months of antibiotics after surgery to remove all the kidney stones. we will see patients at 3, 6, and 12 months with x-rays and to test their urine for bacterial infections. this is a multi-centre study with participating 12 sites across north america.

Eligibility criteria:
inclusion criteria: 1. male or female. 2. no age restriction. 3. diagnosed with an infection related stone. 4. medically fit for definitive surgical management of stone. 5. life expectancy greater than one year. 6. stone free after definitive surgical therapy defined as fragments less than 3mm. exclusion criteria: 1. patients with medical comorbidities preventing them from definitive surgical therapy. 2. patients with persistent stone burden following definitive surgical therapy.

Keywords: struvite infection stones calculi antibiotics
clinical outcomes of early-progressed follicular lymphoma in korea

Conditions: Follicular Lymphoma

Summary: this retrospective study was proposed by the investigators to analyze treatment status and outcome in patients with early relapsed follicular lymphoma. in patients with follicular lymphoma who experienced disease progression within 24 months after initiation of treatment, the second-line therapy, stem cell transplantation, tumor response, progression free survival, and overall survival will be analyzed.

follicular lymphoma is the second most common non-hodgkin's lymphoma in western countries, but it is relatively less frequent in asia. as a result, the prognosis and treatment status in korean patients with follicular lymphoma have been rarely studied. with the recent addition of monoclonal antibodies targeting cd20 into existing cytotoxic chemotherapy, the overall life expectancy of patients with follicular lymphoma has improved a lot. however, nearly 20% of these patients experience early worsening of disease within the first 24 months of treatment, followed by poor prognosis. since patients with early relapse within 24 months usually experience worsening of disease during treatment with rituximab combined with chemotherapy or during rituximab maintenance therapy, optimal treatment for such patients is unknown, but remission induction therapy followed by stem cell transplantation, bendamustine combined with obinutuzumab, pi3k inhibitors, and lenalidomide are possible options. however, most of these drugs are limited for use in korea, and there is little information with regard to treatment guidelines for patients with early relapsed follicular lymphoma or their treatment outcome in korea. this retrospective study was proposed by the investigators to analyze treatment status and outcome in patients with early relapsed follicular lymphoma. this study will provide basic data for follicular lymphoma study in korea and for future clinical trial design.

Eligibility criteria:
inclusion criteria: 1. patients histologically diagnosed with follicular lymphoma (icd-10 c82.0 to c82.9) 2. radiologically confirmed disease progression within 24 months from the start date of an induction chemotherapy 3. all of the following should be available for retrospective analysis. * pathologic findings report * medical records containing age, sex, date of diagnosis, clinical symptoms, laboratory findings, treatment methods, progression, survival, death, etc. exclusion criteria: 1. known histologic transformation to aggressive lymphoma 2. follicular lymphoma grade 3b 3. patients whose pathologic findings report and appropriate medical records are not available
misoprostol versus uterine striating by bladder filling for pain relief during office hysteroscopy

Conditions: Pain

Summary: the aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

several studies revealed that cervical ripening with misoprostol is effective in reducing pain especially in postmenopausal patients. a recent randomized controlled trial revealed that uterine striating by bladder filling prior to office hysteroscopy is associated with reduced pain perception and easier introduction of hysteroscope through the cervix. the aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Eligibility criteria:
inclusion criteria: * menopausal patients who have an indication for office hysteroscopy exclusion criteria: * nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.

Keywords: misoprostol, office hysteroscopy ,pain
biomarkers of efficacy and tolerability of sacituzumab-govitecan in the treatment of patients with triple-negative breast cancer in the metastatic phase: prospective multicenter real-world study

Conditions: Breast Cancer

Summary: observational, prospective, multicenter study. collection of data relating to the effectiveness of sacituzumab govitecan sg, in a real-world context and planned research of predictive biomarkers of efficacy/tolerability carried out on multiple platforms at the center coordinator.

identification and inclusion in the study of patients affected by metastatic triple-negative breast cancer mtnbc, treated with sacituzumab govitecan sg as indicated at the participating centers. histological and biomolecular characteristics will be evaluated both on the tumor at diagnosis and on tissue resulting from biopsy of the metastatic site, where available. otherwise, the analyzes will come anyway carried out on the most recent and available tumor tissue, whether deriving from primary tumor or site metastatic. the search for biomarkers predictive of efficacy/tolerability will be carried out on tumor tissue (where possible both primary and metastatic) and on circulating plasma collected at two separate time points (t0 and t1). biomolecular characterization on the biological material of the enrolled patients (tumor tissue and plasma) will be carried out at the end of the study. the feasibility of organoid development and single-cell sequencing will be evaluated on a small subgroup of patients, among those enrolled at the coordinating center, considering the need for tumor tissue prepared fresh for both methods.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * histological diagnosis of tnbc; * locally advanced unresectable or metastatic disease; * indication for treatment with sg in monotherapy according to clinical practice (patients pre-treated with at least two lines of systemic therapy, of which at least one in an advanced stage); * availability of at least one tumor tissue sample (from primary tumor or metastasis) to be sent to the coordinating center (ire); * written informed consent; * availability to comply with the procedures established by the protocol, according to the methods and times described. exclusion criteria: * patients with a history of other malignancies; * contraindications to the use of sacituzumab govitecan sg; * untreated and/or clinically unstable (symptomatic) brain metastases.
predicting premature treatment termination in inpatient psychotherapy: a machine learning approach

Conditions: Premature Treatment Termination; Dropout Prediction; Inpatient Psychotherapy; Machine Learning

Summary: the study aims to develop a prediction model of premature treatment termination in psychosomatic hospitals using a machine learning approach.

the aim of the study is to identify risk factors that lead to or predict premature treatment termination in psychosomatic hospitals. in the long-term, the study shall help to develop more precise prediction models that can enhance communication between therapists and patients about potential dropout and- if necessary- adaption of treatment in using a feedback loop. since it is still not clear which variables play a major role in predicting treatment termination in psychosomatic hospitals, the study design is exploratory and includes a broad range of intake patient characteristics. the purpose of this study is hereby, to develop a prediction model based on the information that are routinely assessed at intake. therefore, three kind of variables are planned to be included: (1) demographic and other clinical variables (e.g. age, gender, icd-10 diagnoses), (2) psychological questionnaire data (e.g. phq, sf-12, eb-45, iip-32, opd-sfk), and (3) physiological data (e.g. routine laboratory data, blood pressure). for the study, all patients that started inpatient psychotherapy at the medical centre heidelberg between 2015 and january 2022 will be included, resulting in a sample size of approximately n = 2000. as the average dropout rate based on meta analytical results is around 20%, one can assume that up to 400 patients prematurely dropped out of treatment. to calculate the prediction model, it is planned to use a machine learning approach which is highly functional in big data sets. using a random forest model for binary outcomes (regular treatment length vs. premature treatment termination) it is envisioned to identify variables that contribute to the prediction of premature treatment termination at intake. additionally, waiting list effects will be considered by taking into account the waiting duration between the initial intake interview and the moment of the hospital admission. therefore, the study will, for the first time, investigate a prediction model for premature treatment termination in inpatient psychotherapy including clinically relevant physiological data as well as waiting time effects in preparation of the psychosomatic treatment.

Eligibility criteria:
inclusion criteria: * patients of at least 18 years of age * included in inpatient psychotherapy treatment program in a hospital for psychosomatic medicine * provided information about admission and discharge date exclusion criteria: * bipolar, acute psychotic or substance abuse disorder