Kornimate/medical-research-clean huggingface dataset:
evaluating the glycemic control with vildagliptin and metformin combination therapy.

Conditions: Diabetes Mellitus, Type 2

Summary: to evaluate the changes from baseline in random blood sugar (rbs) and fasting blood sugar (fbs) levels at week 12 in participants receiving vildagliptin combination with metformin.

galvecta plus is a combination of vildagliptin and metformin hydrochloride. combination drug with complementary mechanisms of action, provides efficacy and allows to reach glycemic targets compared to continuing metformin monotherapy and is used as an oral hypoglycemic in type ii diabetes mellitus that shows potential to achieve better blood glucose without increasing the risk of hypoglycemia, exposing to weight gain and altering common cardiovascular risk factors (hypertension and lipid profile). the fact that vildagliptin with metformin substantially enhances the incretin effect. vildagliptin belongs to dipeptidyl peptidase-4 (dpp-4) inhibitor. inhibition of dipeptidyl peptidase-4 (dpp-4) by vildagliptin prevents degradation of glucagon-like peptide-1 (glp-1) and reduces glycaemia in patients with type 2 diabetes mellitus, with low risk for hypoglycemia and no weight gain and metformin is a biguanides with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. it does not stimulate insulin secretion and therefore does not produce hypoglycemia.

Eligibility criteria:
inclusion criteria: * participants diagnosed with type 2 diabetes mellitus (dm). * patient with hba1c levels greater than 7.0% who were naïve or were receiving monotherapy with oral hypoglycemic agent were eligible to participate in the study. exclusion criteria: * patient with a history diabetic ketoacidosis, clinically significant liver or renal disease, congestive heart failure requiring pharmacological treatment, coronary artery percutaneous intervention or unstable angina within the past 6 month excluded from study * participants who are pregnant or with gestational dm * age over 80 years * hypersensitivity to any active ingredient.

Keywords: grip, dm
preventing postpartum depression with intranasal oxytocin

Conditions: Depression, Postpartum; Anxiety

Summary: the purpose of this study is to test a new treatment for preventing childbirth-related mental illness in postpartum mothers. the treatment is aimed at enhancing maternal bonding, reducing postpartum depression (ppd) and anxiety in mothers at risk, and promoting child development. to this end, the investigators will test the clinical utility of intranasal (in) oxytocin (oxt) administered to mothers during the first postpartum days.

postpartum depression (ppd) is a debilitating disorder which imposes a threat to mother and infant health. an estimated 600,000 american women suffer from ppd annually, making it one of the most frequent complications of pregnancy. available secondary preventive interventions are often ineffective, which calls for identifying novel means for prevention. impaired mother-infant bonding is a hallmark of ppd. depressed mothers may have difficulties developing maternal feelings and providing sensitive care. in turn, impaired bonding may worsen mother's depression. conventional pharmacotherapy does not help with bonding impairment. this study will attempt to fill in the current gap in effective preventive interventions for pregnant mothers at risk. evidence in postpartum mothers indicates that high peripartum oxt levels are associated with enhanced maternal behavior and low levels with depression. data also indicates that in depressed mothers, oxt levels may decrease during the first days following childbirth rather than increase as is the norm. therefore, the investigators will test the therapeutic effects of oxt in women at risk for ppd. it is hypothesized that administration of in-oxt (total daily dose 48 iu) over the course of four days from as early as day one postpartum in comparison to placebo will 1) enhance mother-infant bonding, 2) reduce depressive and anxiety symptoms at 5 days postpartum, and 3) facilitate child development.

Eligibility criteria:
inclusion criteria: * third-trimester pregnant women being followed at the massachusetts general hospital (mgh) obstetrics program * at risk of postpartum depression (ppd) exclusion criteria: * failure to participate in regular prenatal check-ups * current diagnosis diagnostic and statistical manual of mental disorders (dsm-5) mental disorder pertaining to psychosis or substance abuse * suicidality * obstetric complication (e.g., preeclampsia, excessive hemorrhaging) * use of potentially confounding or interacting medications * complicating pediatric medical condition in the newborn

Keywords: oxytocin, bonding child development
pelvic organ prolapse repair plus mini-sling versus pelvic organ prolapse repair alone

Conditions: Pelvic Organ Prolapse; Urinary Incontinence

Summary: the investigators have performed colposacropexy in women with uterovaginal prolapse for many years with satisfactory results. this study was designed to compare whether, in the treatment of patients with uro-genital prolapse and urinary incontinence, the addition of a contemporary anti-incontinence procedure such as mini-sling is associated with a reduction of post-operative urinary incontinence (correction of pre-existent urinary incontinence and prevention of masked urinary incontinence).


Eligibility criteria:
inclusion criteria: * patients affected by iii-iv grade urogenital urogenital prolapsed and urinary incontinence * candidates for pelvic organ prolapsed repair using sacropexy * prospectively randomized, using a predetermined computer-generated randomization code (4 blocks), to sacropexy plus anti-incontinence procedure (mini-sling) or sacropexy alone exclusion criteria: * fertile patients * contraindication to major surgery * uterine cancer

Keywords: pelvic organ prolapse urinary incontinence sacropexy sling
short-term results after minimally invasive chevron osteotomy for hallux valgus correction

Conditions: Hallux Valgus; Minimally Invasive Surgical Procedures

Summary: by means of clinical satisfaction and clinical scores comparison of an open to a minimally invasive distal chevron osteotomy for correction of a hallux valgus deformity is performed.

the aim of this study is to evaluate shortterm clinical outcome after a minimally invasive chevron osteotomy technique for correction of hallux valgus deformity in comparison to the open distal chevron technique. patients undergoing a distal chevron osteotomy for correction of a hallux valgus deformity are assigned to one of the two groups. survey is taken preoperatively, after 2, 4, 6 and 12 weeks postoperatively. assessment of the clinical outcome measures in terms of the range of motion (rom), visual analogue scores (vas) of pain, the american orthopaedic foot and ankle society (aofas) forefoot score and a patient satisfaction score and a life quality score (sf 12) as well as the evaluation of the charlson comorbidity score is performed. it is hypothesized, that clinical outcome with the minimally invasive distal chevron osteotomy is superior to the open technique.

Eligibility criteria:
inclusion criteria: * all patients undergoing hallux valgus correction by means of a distal chevron osteotomy exclusion criteria: * surgery on the lesser rays of the same foot * mental illness with impossibility to follow the postoperative protocol
dna changes in patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at changes in dna in patients and their brothers with prostate cancer.

objectives: * determine the frequency of single nucleotide polymorphism (snp) genotypes in patients with prostate cancer, their affected siblings, and an unaffected healthy population (control). * determine the age of onset of prostate cancer in affected probands and affected siblings. * determine the penetrance or likelihood that given snps will result in disease in affected siblings based upon mendelian genetics. * determine the odds ratio of developing prostate cancer in the presence of snps. * determine snp genotypes in patients enrolled on ecog-e3805, a prostate phase iii study enrolling men with d2 prostate cancer treated with androgen-ablation therapy alone or androgen-ablation therapy with chemotherapy, and correlate them with disease progression (i.e., androgen independence). outline: this is an open-label, multicenter study. patients are stratified according to ethnicity, age at diagnosis, and gleason score. patients, their affected siblings, and healthy participants (controls) undergo collection of blood samples. genomic dna is extracted from whole blood and sequenced for single nucleotide polymorphisms (snps) in akt and mdm-2 genes. snp data is correlated with clinical and biographical data. projected accrual: a total of 500 patients (250 probands and 250 siblings) and 146 healthy participants (controls) will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets one of the following criteria: * patient or sibling diagnosed with prostate cancer * cancer-free participant (healthy control) * whole blood sample available patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: recurrent prostate cancer stage iv prostate cancer stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer
efficacy and safety of repaglinide and metformin combined in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 3 months * no previous treatment for diabetes * hba1c between 7.0-12.0% * body mass index (bmi) between 19.0-40.0 kg/m2 exclusion criteria: * type 1 diabetes * known unstable/untreated proliferative retinopathy * uncontrolled treated/untreated hypertension * pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
the role of serum adipokines in predicting response to neoadjuvant therapy in patients with rectal cancer

Conditions: Rectal Cancer Stage III

Summary: it has been shown that adipokines (resistin, leptin, adiponectin) secreted from adipose tissue and proinflammatory cytokines such as il-6, tnf-a are associated with the risk of developing colorectal cancer. however, the role of these factors in predicting clinical response to neoadjuvant therapy in rectal cancers is unknown. in this study, the role of serum adipokine levels before neoadjuvant therapy in predicting clinical response in patients with rectal cancer is investigated. for this purpose, blood will be drawn from patients with rectal cancer who will receive neoadjuvant therapy, serum adipokines will be studied and clinical response to neoadjuvant therapy will be compared.


Eligibility criteria:
inclusion criteria: * all patients with locally advanced rectal cancer exclusion criteria: * below 18 years old * patients who did not received neoadjuvant therapyall

Keywords: rectal cancer neoadjuvant serum adipokines leptin adiponectin
peripheral endothelial function and coronary status in asymptomatic diabetic patients

Conditions: Myocardial Ischemia

Summary: silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary stenoses and endothelial dysfunction or both. we therefore hypothesized that peripheral endothelial dysfunction is a marker of silent myocardial ischemia. the aim of the study is, in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia endothelium-dependent brachial artery dilation.

coronary microcirculation, non invasively assessed with trans-thoracic echo-doppler (coronary blood flow before and after cold pressure testing), and biochemical markers of endothelial dysfunction will also be measured. correlations between peripheral and coronary endothelial functions will be checked. the measurements will be performed and validated in two other groups * 30 patients with overweight but free of diabetes, matched with the patients with diabetes for age, gender and body mass index * 30 control subjects.reproducibility of the methods will be assessed in 10 patients of the three groups of subjects.

Eligibility criteria:
inclusion criteria : for type 2 diabetic patients asymptomatic: * with normal resting ecg * coronary primary prevention * other cardiovascular risk factors justifying screening for silent myocardial ischemia and coronary stenoses in case of silent myocardial ischemia. for patients with overweight: * asymptomatic with normal resting ecg * coronary primary prevention * body mass index 25-40 kg/m² * without diabetes. controls asymptomatic: * coronary primary prevention * body mass index 18-25 kg/m² * without diabetes * without cardiovascular risk factors including dyslipidemia, hypertension, smoking habits, no treatment exclusion criteria : * pregnancy * renal failure * acrosyndrome

Keywords: type 2 diabetes silent myocardial ischemia endothelial function
clinical and basic study for pediatric liver transplantation

Conditions: Biliary Atresia; Metabolic Disorders; Fulminant Liver Failure; Hepatic Tumors

Summary: background: in mainland china, the development of pediatric liver transplantation (lt) has lagged behind that of adult lt during the past two decades, but it has been progressing immensely in recent years. renji hospital(shanghai) is currently the largest pediatric transplant center in mainland china. aim and method: this study is performed for establishment of key techniques for pediatric lt in mainland china, including the indications and timing for pediatric lt, the criteria for donor selections, living donor lt planning, prevention and treatment for posttransplant complications, long-term follow-up management et al.

outcome measures: * annual caseloads of pediatric liver transplantation * patient survival: 1-, 3- and 5-year patient survival after liver transplantation * graft survival: 1-, 3- and 5-year graft survival after liver transplantation * posttransplant complications, such as biliary complications, vascular complications, acute rejections, infections et al. * perioperative data, such as duration of operations, postoperative hospital stay et al. * clinical data for living donors.

Eligibility criteria:
inclusion criteria: * children with end-stage liver diseases * children with metabolic disorders for whom liver transplantation are required * children with fulminant liver failure * children with unresectable hepatic tumors * other miscellaneous conditions which need liver transplantation exclusion criteria: * recipient age ≥ 18 years * patients with metastatic liver tumors * severe systmatic infections * acquired immune deficiency syndrome
is monocyte/hdl ratio a predictor of mortality in aortic valve surgery

Conditions: Inflammation; Aortic Valve Stenosis; HDL

Summary: in this study, the investigators aimed to determine whether the preoperative monocyte/hdl ratio would be a predictor of postoperative mortality and morbidity in patients who underwent aortic valve replacement due to aortic stenosis.

inflammation is causally associated with both coronary artery disease and aortic stenosis. although aortic stenosis is considered a static degenerative and calcific process, recent evidence has shown the opposite. the role of inflammation in the pathogenesis of as it will be investigated that mortality may be associated with increased inflammation in patients treated with avr. adult patients (aged ≥18 years) with asa ii-iv who underwent elective aortic valve replacement under cardiopulmonary bypass (cpb) due to aortic stenosis in our clinic between january 1, 2010 and march 31, 2022, will be included in the study by retrospectively scanned from the computer system and patient cards. the exclusion criteria from the study are as follows; those with signs of acute infection, those with autoimmune disease, those with severe renal (serum creatinine \>2.0 mg/dl) disease, those with severe hepatic disease, those with suspected malignancy. demographic characteristics of patients (age, gender, body mass index, diabetes mellitus, hypertension, chronic kidney disease-failure, peripheral vascular disease, smoking history, hyperlipidemia, atrial fibrillation history, left ventricular ejection fraction, coronary artery disease history, cabg history) europe cardiac operative risk assessment system ii (euroscore), systemic immune-inflammatory index (sii), apache ii, sofa score, nyha iii/iv values, drugs used (asa, oral anticoagulants, beta blocker, statin, ace inh., arb) , preoperative glucose, hba1c, urea, creatinine, total cholesterol, ldl, hdl, triglyceride, hemoglobin, hematocrit, platelet, wbc, neutrophil, lymphocyte, monocytes, monocyte/hdl ratio, crp, preoperative and postoperative ef and pab values, icu admission duration, duration of invasive mechanical ventilation, type of discharge, amount of es replaced will be recorded. operation time, cardiopulmonary bypass (extracorporeal circulation) time, cross clamp time, inotropic and vasopressor requirements will be recorded)

Eligibility criteria:
inclusion criteria: be over the age of 18, asa ii-iv patients scheduled for cardiac surgery due to on-pomp aortic valve replacement exclusion criteria: emergency operations, off pump)pumpless surgery, revision (repetitive) operations, those with signs of acute infection, those with autoimmune disease, those with severe renal (serum creatinine \>2.0 mg/dl) disease, those with severe hepatic disease, those with suspected malignancy, patients where data variables cannot be saved due to technical problems.
the effects of physical activity on patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: physical activity (pa) is beneficial in the prevention and management of chronic disease. however, few data exist regarding the level of pa in inflammatory bowel disease (ibd) and whether or not vigorous pa may have beneficial effects on patients' health. to evaluate the level of pa and the effect of pa on disease activity of patients with ibd. to evaluate the effect of pa on quality of life of patients with ibd.


Eligibility criteria:
inclusion criteria: * age ≥ 19 * patients with inflammatory bowel disease (crohn's disease, ulcerative colitis, intestinal behcet's disease) exclusion criteria: * age \<19 * patient who denied to response the survey questions * patient who denied to enroll the survey research

Keywords: inflammatory bowel disease physical activity disease activity quality of life
the use of voice-based ai in 988 crisis counseling

Conditions: Suicide; Suicide and Self-harm

Summary: effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. this research study focuses on developing an ai-based, coding and feedback tool ("lyssncrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating lyssncrisis to improve services and client outcomes. this research study's goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities.


Eligibility criteria:
inclusion criteria: must be employed at protocall services, inc. exclusion criteria: call-takers who participated in stage 2 research will not be able to participate in stage 3 research.

Keywords: crisis counseling 988 artificial intelligence ai
national inferior vena cava (ivc) filter registry

Conditions: Venous Thrombo-embolism

Summary: inferior vena cava (ivc) filter is an important therapeutic device used in the management of venous thrombo-embolism (vte) in patients that are contra-indicated for anti-coagulation therapy. while there has been significant increase in the use of filters , unfortunately there are no standardized collection of data to track, compare outcomes, report safety and efficacy.

the registry is a multi-institutional bioinformatics database for the collection of data relevant to inferior vena cava filters. participating study centers may enroll patients and enter data in the web-based registry that include demographics, clinical features, management details and follow-up up to 48 months. the purpose of this study is to improve our understanding of the retrieval rate, long term safety and efficacy on ivc filters placed in north america.

Eligibility criteria:
inclusion criteria: * data obtained in line with good clinical practice,applicable laws and regulation

Keywords: vte inferior vena cava venous thrombo-embolism outcome data ivc filters
study with fascigel

Conditions: Back Pain

Summary: the product is a class iii medical device. structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution. the device intended use is to help treat back pain by lubricating fascia.


Eligibility criteria:
inclusion criteria: * back pain (vas above 4 cm) * limited range of motion * duration of pain for over 3 months * patient willing and able to provide the written consent * ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study exclusion criteria: * state after back surgery * bmi \> 35 * age \< 18 years * pregnant or lactating woman * patient in terminal stage of living * patient with known hypersensitivity or allergy to any of substances contained in medical device * patient participating in the intervention clinical study * alcohol or drug abuse * patient undergoing chronic coagulation therapy