Kornimate/medical-research-clean huggingface dataset:
empa pass on urinary tract malignancies

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating a dipeptidyl peptidase-4 (dpp-4) inhibitor.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * age over 18 years at index date * at least 1 year of membership in the medication database prior to index date exclusion criteria: * patients with any cancer (excluding non-melanoma skin cancer) recorded at any time prior to the index date (i.e. during the available look-back time) * diagnosis of type 1 diabetes or other specific non-type 2 diabetes * use of any sglt-2 inhibitor or any dpp-4 inhibitor (including free and fixed-dose combinations) recorded at any time prior to index date (i.e. during the available look-back time). * use of fixed-dose combinations of sglt-2 inhibitors with dpp-4 inhibitors * diagnosis of end stage renal disease or receipt of renal dialysis recorded at any time prior to index date (i.e. during the available look-back time)
study of anemia in chronic kidney disease (ckd) among high-risk hypertensive and diabetic patients in pakistan

Conditions: Anemia, Diabetes, Kidney Disease, Chronic, Hypertension

Summary: the purpose of this study is to evaluate the prevalence of ckd-related anemia at an early stage through screening of high-risk patients in pakistan at the level of physicians, cardiologists, and diabetologists. the information gathered may serve as a foundation in formulating national guidelines for better early diagnosis and management of patients with ckd.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 40 years * known hypertension and/or diabetes for at least 3 years * positive dipstick test result for proteinuria exclusion criteria: * known ckd * receiving erythropoietin * blood transfusion within 8 weeks * history of acute or chronic bleeding, hemolysis, or hemoglobinopathy
covid-19 pneumonia and gut inflammation

Conditions: Inflammation

Summary: the primary objective of our study was to evaluate the efficacy of a mix of three probiotic strains (bifidobacterium lactis la 304, lactobacillus salivarius la 302, and lactobacillus acidophilus la 201; lactibiane iki®) in the reduction in fecal calprotectin in patients with covid-19 pneumonia, compared to a control group. the secondary aim was to evaluate the reduction in oxygen support and length of hospital stay in patients taking the probiotic mix.


Eligibility criteria:
inclusion criteria: * patients admitted to our hospital for sars-cov-2 infection with respiratory and/or gastrointestinal symptomsandradiological imaging (chest x-ray/ct with/without contrast) of interstitial pneumonia. patients with mild covid-19 disease (requiring oxygen support with 2l or 4l nasal cannula or ventimask 28-35-40% to reach a spo2-target of 95%) exclusion criteria: * patients on antibiotic therapy or patients who had taken antibiotics in the previous month; patients with ibd,ibs,or infectious colitis of non-covid-19 bacterial and/or viral etiology; patients with colonic neoplasia (first to last stage); patients who had undergone colon surgery; patients with severe hepatopathy, nephropathy, heart disease or terminal oncological disease; pregnant women; and patients in circulatory shock and under positive pressure support on admission to hospital.
a randomized phase iii study comparing maintenance treatment with fluoropyrimidine + bevacizumab versus fluoropyrimidine after induction chemotherapy for a metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the aim of bevamaint is to improve benefic effect of maintenance therapy after a first line of induction chemotherapy for patients with colorectal cancer


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic colorectal adenocarcinoma before induction treatment * measurable or non-measurable lesion before the induction treatment according to the response evaluation criteria in solid tumors (recist 1.1) * metastatic, unresectable disease according local practice after induction treatment * ecog performance status ≤ 2 * disease control (complete response, partial response or stable disease) after 4-6 months of frontline induction chemotherapy with doublet (fluoropyrimidine + irinotecan or oxaliplatin) or triplet (fluoropyrimidine + irinotecan + oxaliplatin) +/- (cetuximab, panitumumab, bevacizumab) or iah chemotherapy * life expectancy \> 3 months * age ≥ 18 years * patient is at least 4 weeks from any major surgery * total bilirubin \ 60% , pal\ 1500/mm3, platelets \> 100 000/mm3, haemoglobin ≥ 9 g/dl * creatinin clearance \> 30 ml/min (mdrd) - if creatinin clearance comprised between 30 and 50 ml/min, see smpcs for dose adjustments * proteinuria ≤ 2+ (dipstick urinalysis) (if more than 2+, so proteinuria at or ≤1g/24hour must be ≤1g) * patient is able to understand, sign, and date the written informed consent * evidence of post-menopausal status or negative urinary or serum pregnancy test for premenopausal female patients * male and female patients of childbearing potential agree to use a highly effective contraceptive measure * patient affiliated to a social security system exclusion criteria: * myocardial infarction, severe coronaropathy or severe cardiac dysfunction less than 6 months prior randomization * follow-up impossible * patients with all metastases resected (r0/r1) after induction chemotherapy * patient with a hand-foot syndrome \> 1 before maintenance treatment * known brain or leptomeningeal metastases * other concomitant or previous malignancy, except: adequately treated in situ carcinoma in complete remission for \> 5 years * uncontrolled hypertension (defined as systolic blood pressure \>140 mmhg and/or diastolic blood pressure \>90 mmhg), or history of hypertensive crisis, or hypertensive encephalopathy * pregnancy or breast feeding * treatment with sorivudine or analogs (brivudine) * treatment with phenytoin or analogs * partial or complete dpd deficiency (uracilemia ≥ 16 ng/ml) * peptic ulcer not healed after treatment * any contraindication to bevacizumab or fluoropyrimidine treatments according to the updated smpc * intestinal perforation or intestinal fistula * previous or active gastrointestinal bleeding * thromboembolic event and/or history of thromboembolic event * severe hepatic insufficiency
the effect of exercise on mood after traumatic brain injury

Conditions: Traumatic Brain Injury; Depression

Summary: we proposed to examine the effect of an aerobic exercise intervention on depression in persons with traumatic brain injury (tbi). we will compare persons with chronic brain injury who are assigned to receive the exercise intervention with those in the control group to determine the effect of exercise on levels of depression and specific symptoms related to depression including anxiety, pain, sleep, and cognition. in addition, the effect of exercise on activity, participation level, and quality of life will be examined. hypotheses: 1. participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic tbi. 2. participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning. 3. participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with tbi. 4. participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.


Eligibility criteria:
inclusion criteria: * traumatic brain injury 1-5 years prior to enrollment * current depression as measured by a score of 5 or greater on the depression portion of the physician health questionnaire (phq). * sufficient cognitive ability to maintain participation in the study * sufficient english language ability to allow participation without an interpreter exclusion criteria: * current suicidal ideation with intent or plan * currently pregnant * history of significant cardiovascular or respiratory disease * history of significant cardiovascular or respiratory disease * physical barriers to the use of standard aerobic exercise equipment

Keywords: traumatic brain injury depression exercise
ethanol consumption in the heat

Conditions: Alcohol Consumption; Heat Stress; Age

Summary: climate change has significantly increased the earth's average surface temperature and heat waves have been predicted to increase in frequency, intensity and duration. extreme heat events have increased the susceptibility to heat-related illnesses, such as heat exhaustion, heat stroke or death. heat health action plans have been designed to advertise cooling behaviours to mitigate physiological strain. heat health action plans suggest avoiding alcohol consumption during extreme heat as it may increase dehydration and impair behavioural or physiological temperature regulation and thermal perception. regardless of these messages, alcohol sales continue to remain high during the summer months year after year, and 1/5 of adults identify alcohol as a hydration strategy during extreme heat events. a recent scoping review investigating the effects of alcohol and heat has demonstrated that acute alcohol consumption does not negatively influence thermoregulation, hydration, or hormone markers of fluid balance in the heat compared to a control fluid (https://doi.org/10.1186/s12940-024-01113-y). further, alcohol consumption may elicit sex- and age-specific alterations in physiological and perceptual responses, neither of which have been explored. therefore, this study aims to comprehensively evaluate how alcohol consumption systematically alters physiological responses and perceptions during conditions similar to those experienced indoors during extreme heat events in younger and older adults.


Eligibility criteria:
inclusion criteria: * male or female above the age of 19 * able to provide informed consent exclusion criteria: * history of cardiovascular disease, cancer, type 1 or 2 diabetes, chronic obstructive pulmonary disorder, cystic fibrosis, or alcohol addiction or dependence * been hospitalized due to covid-19 * pregnant/breastfeeding * scoring an eight or above on the alcohol use disorders identification test (audit)

Keywords: alcohol heat stress heat wave sweating core temperature micturition perception behaviour
comparison of iv fluid loading and ondansetron in reduction of ponv after lc

Conditions: Postoperative Nausea; Postoperative Vomiting; Postoperative Nausea and Vomiting

Summary: this study is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group f), ondansetron (group o) and receiving neither fluid nor ondansetron or control group (group c).

this study is a prospective randomized control trial. it is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group f), ondansetron (group o) and receiving neither fluid nor ondansetron or control group (group c). this study is hypothesized that the incidence of ponv in patients receiving preoperative intravenous fluid loading (group f) and patients receiving ondansetron (group o) will be similarly reduced from the control group (receiving neither fluid nor ondansetron).

Eligibility criteria:
inclusion criteria: * patients with aged 18 to 70 years with an asa physical status 1-3 exclusion criteria including patients * with pregnant or breast-feeding patients * having history of taking antiemetic drugs within 24 hours before surgery * with hypersensitivity or allergy to ondansetron * with ckd stage 4, 5 * with congestive heart failure, lvef \<40 * with cirrhosis child c * refusal or cannot communicate or understand the purpose of this study
myvoice:rheum decision aid for women with rheumatic diseases

Conditions: Rheumatic Diseases; Physician-Patient Relations; Contraception

Summary: this is a pilot trial to assess feasibility and acceptability of myvoice:rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care. • hypothesis: myvoice:rheum will be feasible and acceptable to patients who receive rheumatology care.

the pilot will demonstrate if the myvoice:rheum decision aid can be feasibly and acceptably implemented into the rheumatology context and inform operational procedures for a future hybrid effectiveness-implementation trial. women in the intervention arm will receive the myvoice:rheum decision aid (n=30). women in the control arm (n=9) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to myvoice:rheum, targets women with a broad range of rheumatic diseases.

Eligibility criteria:
inclusion criteria: patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (ra), systemic sclerosis (ssc), myositis, sjogren's syndrome, vasculitis, spondyloarthritis, and systemic lupus erythematosus (sle). patients must read and speak in english as a spanish-language version of the tool has not yet been developed access to a smart phone, personal computer, or tablet. exclusion criteria: * women who have had prior hysterectomy or sterilization, or are pregnant.

Keywords: rheumatic diseases shared decision-making sexual and reproductive health decision aids
comparison of virtual training to in-person training of helping babies breathe in ethiopia

Conditions: Neonatal Death; Birth Asphyxia

Summary: helping babies breathe (hbb) is a program that teaches providers in low- and middle-income countries about neonatal resuscitation. historically, hbb training was delivered in person. during the covid-19 pandemic, many subject matter experts were unable to travel to conduct hbb courses. innovative methods for teaching hbb are needed to promote the acquisition and retention of resuscitation skills and knowledge.

in this non-inferiority randomized controlled trial, medical students, nursing students, and midwifery students will be randomized to receive either standard in-person hbb training (control) or virtual telesimulation training (intervention). the hypothesis is that virtual delivery is as effective as in-person training of hbb content when teaching neonatal resuscitation skills and knowledge to medical, nursing, and midwifery students.

Eligibility criteria:
inclusion criteria: * adults * year iv through year vi medical students, year ii to iv nursing students, year ii and iii midwifery students at jimma university in jimma, ethiopia. exclusion criteria: * minors * individuals who are not medical students, nursing students, or midwifery students at jimma university. * individuals who attended a neonatal resuscitation training course in the preceding year. * individuals who would be unavailable or unwilling to participate in follow-up study activities throughout the 2-month post-initial training period.

Keywords: helping babies breathe (hbb) training
androgens and subclinical atherosclerosis in young women - ancillary to cardia

Conditions: Cardiovascular Diseases; Coronary Arteriosclerosis; Heart Diseases; Polycystic Ovary Syndrome

Summary: to examine whether serum androgens, measured earlier in life, and variation in genes related to androgen synthesis, metabolism, and signaling are associated with early-onset subclinical coronary atherosclerosis in young adult women from the community.

background: polycystic ovary syndrome (pcos) is denoted by hyperandrogenism and symptoms of ovulation dysfunction (e.g., infertility, oligomenorrhea). women who are diagnosed with pcos represent the more extreme end of abnormal ovarian function. while pcos is rare, approximately 20 percent of women are expected to have subclinical polycystic ovaries, identified by sonogram. factors that are associated with pcos, insulin resistance and dyslipidemia, are also risk factors for coronary artery disease and there is evidence to suggest that women with pcos are more likely to experience coronary artery disease. this raises the question: are subclinical cases of polycystic ovaries at increased risk of coronary artery disease? the study is ancillary to the the coronary artery risk development in young adults (cardia) study, a large cohort study supported by the nhlbi. the cardia population provides a unique opportunity to explore these associations because there is a 15-year period of risk factor ascertainment in this population including stored blood + dna specimens from which serum androgens and relevant genetic markers can be ascertained. in addition, all participants will have coronary artery calcium (cac) determinations at the year 15 exam. in the ancillary study an additional year 16 visit will occur for the purpose of obtaining a trans vaginal ultrasound determination (tvus) so as to obtain clinical evidence of hyperandrogenism and look at the joint effects of the clinical evidence and serum markers as predictors of cac. the study is in response to an initiative on ancillary studies in heart, lung, and blood disease trials released in june, 2000. design narrative: the ancillary study in year 16 of cardia will recall 1,200 women who received a coronary artery calcification (cac) determination in year 15. these women will have an additional blood draw three to 10 days after their last menstrual period, will have a questionnaire administered to them regarding clinical symptoms of pcos (polycystic ovarian syndrome) and other aspects of hyperandrogenism. two principal analyses will be performed. the first is a longitudinal analysis using year 2 and year 10 data to use serum markers of hyperandrogenism and genetic markers from dna samples as predictors of cac which is defined as present (absent) and is determined at the year 15 examination. the principal method of analysis will be logistic regression. an additional analysis will relate androgen levels at year 2 to lipid levels and other coronary risk factors ascertained at year 2, 7, 10 and 15.

Eligibility criteria:
no eligibility criteria
chromoendoscopy of the colon after oral administration of indigo carmine

Conditions: Inflammatory Bowel Diseases

Summary: the purpose of this study is to examine whether oral administration of indigo carmine together with polyethylene glycol (peg), the usual colon preparatory solution, can be used instead of staining during the examination itself.


Eligibility criteria:
inclusion criteria: * patients suffering from inflammatory bowel disease * patients under surveillance for disease-associated lesions and masses (dalm) exclusion criteria: * all others
study of sim0508 alone and in combination in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and pk/pd characteristics of sim0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and signature of informed consent form. 2. participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer. 3. ecog score of 0 or 1. 4. expected survival ≥ 12 weeks. exclusion criteria: 1. active hepatitis b (hbsag or hbcab positive and hbv dna≥1×104 copies/ml or≥2000 international unit \[iu\]/ml) or hepatitis c (hcv antibody positive and hcv rna≥uln) infection; participant with hbsag positive or detective hbv-dna at screening should receive antiviral treatment as per local practice during the study. 2. known human immunodeficiency virus (hiv) infection or acquired immunodeficiency syndrome (aids). 3. participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug. 4. toxicities from previous anticancer therapies have not resolved (e.g to ≤ grade 1). 5. pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of sim0508 or olaparib, whichever comes later. 6. male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of sim0508 and 90 days after the last dose of olaparib, whichever comes later.
efficacy study of mindfulness-based exercise for posttraumatic stress disorder (ptsd)

Conditions: Stress Disorders, Post-Traumatic

Summary: this study will explore the relationship between changes in plasma cortisol and symptom reduction resulting from individuals with posttraumatic stress disorder (ptsd) participating in an 8-week program of mindfulness-based stretching and breathing exercise. the investigators hypothesize that at the completion of participation in the 8-week program, exercise-induced symptom reduction will be associated with changes in cortisol levels.

this study will employ an intent-to-treat design to evaluate the relationship between exercise-induced posttraumatic stress disorder (ptsd) symptom reduction and exercise-induced changes in cortisol level. the participants consist of nurses and the intervention will be conducted at the clinical and translational science center of the university of new mexico. the study was approved by the human research protections office of the university. nurses who are screened positively for ptsd will be randomly assigned to either control or exercise group. at baseline and in weeks 4, 8, 12 and 16, immediately after the phlebotomy for serum cortisol, the investigators will ask the participants to rate the severity of their ptsd symptoms using the ptsd checklist (pcl).

Eligibility criteria:
inclusion criteria: * employed as a nurse * pcl-c score of at least 28 with at least a score of 3 on one or more items for inclusion in the ptsd symptomatic groups (ex and con) * pcl-c score of 27 or lower for inclusion in the non-ptsd symptomatic group (base). exclusion criteria: * the inability to complete the exercise program * a positive answer to any of the seven screening questions on the physical activity readiness questionnaire (par-q) * current use of prednisone or other forms of cortisone medication excluding cortisone in inhaled form

Keywords: exercise stress ptsd mindfulness breathing cortisol