Kornimate/medical-research-clean huggingface dataset:
the added value of telephone follow up and home visits in helping children to grow up healthy

Conditions: Obesity

Summary: leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. brief interventions with simple behavior change messages are needed to reach high-risk children, particularly latino and black children who are disproportionately affected by obesity and related comorbidities. steps to growing up healthy (added value) is a randomized controlled trial testing the efficacy of brief motivational counseling (bmc) delivered by primary care clinicians and the added value of supplementing bmc with monthly contact by community health workers (chw) in the prevention/reversal of obesity in latino and black children ages 2-4 years old. mother-child dyads (targeted n=150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) bmc delivered by clinicians and nurses at well, sick, and wic visits with the goal of reducing obesogenic behaviors (bmc); 2) bmc plus monthly phone calls by a chw (bmc+phone); or 3) bmc plus monthly home visits by a chw (bmc+home). during bmc, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. monthly contacts with chws are designed to identify and overcome barriers to goal progress. dyads are assessed at baseline and 12 months and the primary outcome is change in the child's bmi percentile. we hypothesize that bmc+phone and bmc+home will produce greater reductions in bmi percentiles than bmc alone and that bmc+home will produce greater reductions in bmi percentiles than bmc+phone.


Eligibility criteria:
inclusion criteria: * child is 2-4 years old * latino or black descent by maternal report * receiving services through the special supplemental nutrition program for women, infants, and children (wic) exclusion criteria: * mother is younger than 18 years old * dad does not live in the greater hartford area or if they have plans to move out of the area in the next 12 months * child or mother has special needs (dietary, physical, and/or emotional) that would make the intervention inappropriate (e.g. failure to thrive, type 1 diabetes, cystic fibrosis)

Keywords: obesity prevention weight management motivational interviewing
low dose estriol with lactobacilli treatment for preventing recurrent urinary tract infection in postmenopausal women

Conditions: Urinary Tract Infections

Summary: recurrent urinary tract infections (uti) are a problem for postmenopausal women. the aim of this trial is to evaluate the effectiveness of lactobacilli in combination with low dose estriol for preventing recurrent urinary tract infections in postmenopausal women.


Eligibility criteria:
inclusion criteria: * postmenopausal woman * history of urinary tract infection * agree to abstain from self-medication with antibiotics for uti symptoms * agree to abstain from the use of any other intra-vaginal product * capable of providing informed consent exclusion criteria: * ovarian cancer, cervical cancer, breast cancer * estrogen treatment within last 2 years * vaginal bleeding * antibiotic therapy fewer than three days prior to randomization visit * known congenital urologic or gynecologic abnormalities * indwelling urinary catheter * thromboembolic disease * uncompensated liver disease * immunosuppressive drug within 60 days

Keywords: urinary tract infections postmenopause lactobacillus estriol
tinidazole versus cefazolin antibiotic prophylaxis of vaginal and abdominal hysterectomy

Conditions: Hysterectomy

Summary: purpose: to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. methods: a randomized clinical trial carried out at the women's integrated healthcare center (caism)/unicamp, campinas, brazil. women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

a randomized clinical trial carried out at the women's integrated healthcare center (caism)/unicamp, campinas, brazil, to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Eligibility criteria:
inclusion criteria: * women undergoing to hysterectomy due to non-oncologic causes exclusion criteria: * previous pelvic infection * antibiotic use within 7 days before surgery * study drugs allergy * immuno-incompetence * urinary tract infection

Keywords: hysterectomy antibiotic prophylaxis bacterial vaginosis tinidazole cefazolin
gut microbiota and color-rectal cancer.

Conditions: Cancer; Colo-rectal Cancer; Diagnoses Disease; Microbiota-related Disease; Intestinal Disease

Summary: this clinical trial is focused in the development of a screening test for the people at risk of colo-rectal cancer (aged more than 50 years old), valid and safe, improving the screening prognosis increasing the sensitivity and sensitive as compared with the current method, fecal occult blood.

colo-rectal cancer (ccr) is one of the most prevalent cancers in developed countries. several studies suggest that the ccr may be related with changes in the gut microbiota. this clinical trial is focused in the development of a screening test for the people at risk of ccr (aged more than 50 years old), valid and safe, improving the screening prognosis. the main potential improvement lies in the fact that the proposed method is more specific and sensitive than the current method, fecal occult blood. it aims to distinguish whether the positive results for fecal occult blood test is due to fissures, not related with ccr (which are positive for fecal occult blood, false positive) or was caused by a cancer-related lesion. the methodology derived will also improve the sensitive as sometimes the polyps do not leak blood. based in the previous differences found in the gut microbiota composition related with ccr for several research groups, the gut microbiota composition will be used as diagnosis tool.

Eligibility criteria:
inclusion criteria: -patients with positive results in the fecal occult blood test in the program for early detection of colon and rectal cancer, undergone by the consejeria de salud de la junta de andalucia (spain). exclusion criteria: -the consumption of antibiotic within the previous month to inclusion in the study.

Keywords: diagnosis improvement early diagnosis mathematical modelling gut microbiota colonoscopy
behavioral science and hepatitis c screening outreach

Conditions: Hepatitis C

Summary: this project aims to evaluate different approaches to increase hepatitis c screening among primary care patients at penn medicine through a centralized screening outreach program. in a pragmatic trial, we will evaluate different approaches to increase completion of screening among eligible patients, including changing the default from opt-in to opt-out and incorporating behavioral science principles into the outreach communication.

the hepatitis c virus (hcv) is the leading cause of liver transplant and hepatocellular carcinoma in the us. new direct-acting antivirals are available that can eradicate the disease in over 95% of those that are treated, with minimal side effects. as a result of new therapies and a five-fold higher risk among baby boomers, the us preventive services task force and cdc now recommend hcv screening for all patients born between 1945 and 1965. of the estimated 3.2 million people chronically infected with hcv, about 75% were born during this time frame. despite this, national rates of screening among this group remain low at less than 30%. if more people could get screened, we could potentially identify more undiagnosed disease and help navigate to treatment. at penn medicine primary care practices, hcv screening rates have risen from 37% in 2014 to 61% in 2017, likely from a combination of provider educational efforts and ehr alerts. there is also significant practice variation ranging from 4% to 99% screening rates. while ehr alerts have been shown to increase hcv screening rates, there is potential to complement this with direct outreach to patients homes, as has been incorporated into cancer screening initiatives. additionally, there is a mandate from the state of pennsylvania requiring health care providers to offer hcv testing to all primary care patients. there is an opportunity to provide direct outreach to all eligible primary care patients at penn medicine, while also evaluating different approaches to increasing hcv screening rates. insights from behavioral science have been shown to increase participation in health promoting behaviors in a variety of ways. switching from opt-in to opt-out framing has been shown to triple patient participation in remote monitoring and crc screening. additionally, messaging that incorporates social norms, reciprocity, and precommitment have also been shown to increase participation. however, it is not clear how these approaches would translate to hcv screening.

Eligibility criteria:
inclusion criteria: * at least 2 visits to primary care provider within 2 years * born between 1945 and 1965 exclusion criteria: * have had 1 hcv antibody test, viral load test or are considered up-to-date on hcv screening by health maintenance

Keywords: behavioral economics screening outreach
effects of consuming sugar-sweetened beverages with meals for 10 weeks

Conditions: Metabolic Syndrome; Insulin Resistance; Dyslipidemia

Summary: the purpose of this study is compare the effects of consuming glucose- and fructose-sweetened beverages on appetite, body weight, body fat, and the amount of energy the body burns as well as effects on blood pressure, hormones, blood triglycerides and cholesterol, and the body's sensitivity to the insulin.

the study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or glucose-sweetened beverages (25% of energy) with meals. experimental procedures, including 24-hour serial blood sampling, 26-h stable isotoped infusions, post-heparin blood collection, gluteal biopsies, metabolic rate monitoring, computed tomography scans of the abdomen, and oral glucose tolerance and disposal tests, are performed during baseline and at the end of a 10-week intervention period at the uc davis school of medicine/sacramento veterans affairs medical center clinical research center (ccrc). during the 2-week inpatient baseline period, subjects are served energy balanced diets containing 15% of energy as protein, 30% as fat, and 55% as complex carbohydrate. following the baseline period, the subjects reside at home for 8 weeks and consume their usual ad libitum diet along with 25% of energy requirements as fructose- or glucose-sweetened beverages. subjects then return to the ccrc for the 2-week inpatient intervention period at the end of the study and are served energy-balanced diets containing 15% of energy as protein, 30% as fat, 30% as complex carbohydrate and 25% of energy as fructose- or glucose-sweetened beverage.

Eligibility criteria:
inclusion criteria: * self-report of stable body weight * women were post-menopausal based on a self-report of no menstruation for at least one year exclusion criteria: * evidence of diabetes * renal or hepatic disease * fasting serum tg concentrations \>400 mg/dl * hypertension (\>140/90 mg hg) * surgery for weight loss * individuals who smoked * reported exercise of more than 3.5 hours/week at a level more vigorous than walking * having used thyroid, lipid-lowering, glucose-lowering, anti-hypertensive, anti-depressant, or weight loss medications * habitual ingestion of more than one sugar-sweetened beverage/day or more than two alcoholic beverages/day
efficacy and safety of low-molecular weight heparin for thromboprophylaxis in acutely ill medical patients

Conditions: Embolism

Summary: acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. unfractionated heparin (ufh) and low molecular weight heparins (lmwh) are thought to be effective in preventing thromboembolic events. this study is designed to provide efficacy and safety data for thromboprophylaxis with the lmwh certoparin in comparison to thromboprophylaxis with ufh in acutely ill non-surgical patients.


Eligibility criteria:
inclusion criteria: * hospitalization due to an acute non-surgical disease * significant decrease in mobility exclusion criteria: * indication for anticoagulant or thrombolytic therapy * major surgical or invasive procedure within the 4 weeks that precede randomization * expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization * immobilization due to cast or fracture of lower extremity * immobilization lasting longer than 3 days in the period prior to randomization * heparin administration longer than 36 hours in the period prior to randomization * acute ischemic stroke other protocol-defined inclusion/exclusion criteria may apply

Keywords: heparin, thromboprophylaxis, medical patients, acutely ill acutely ill non surgical patients immobilization
interpretability of the quantra® viscoelastic test in patients with haematological malignancies with profound thrombocytopenia below 50x10 g/l.

Conditions: Hematologic Malignancies; Thrombopenia

Summary: the goal of this single-center, non-controlled, non-randomized exploratory clinical trial is to evaluate the interpretability of viscoelastic tests (quantra® and rotem® type) in relation to platelet levels measured in standard biology in patients with haematological malignancies, hospitalized in day hospitals or full hematology wards, presenting thrombocytopenia strictly below 50 g/l. participants will undergo an additional blood sample to standard care. the total volume of blood drawn will be 12.1 ml. the following analyses will be performed: quantra®, rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, international normalized ratio, fibrinogen.


Eligibility criteria:
inclusion criteria: * patient age \> 18 years old ; * patients who have been informed of the study and have freely given their informed consent to participate in the study; * patients with hematologic malignancies, treated or untreated, at any stage of treatment; * patient with thrombocytopenia strictly below 50 g/l on a blood sample taken less than 72 hours ago; * patient hospitalized in day hospitalization or in full hematology hospitalization; * patient covered by a french social security scheme. exclusion criteria: * patients treated with antiplatelet agents or anticoagulants in preventive or curative doses; * patient with a history of thrombopathy; * patient with a history of haemostasis pathology at risk of haemorrhage or thrombosis; * pregnant or breast-feeding patients; * patients under guardianship; * patients who do not understand french; * patients under court protection.
pan-cardio-genetics clot assessment in acute coronary syndromes

Conditions: STEMI - ST Elevation Myocardial Infarction; Thrombi; MicroRNA

Summary: acute myocardial infarction with st elevation (stemi) is one of the leading causes of mortality. although the presence of thrombus in stemi patients has been linked to adverse outcomes, routine thrombus aspiration has not been proven effective. a potential explanation could be that patients with stemi should be risk-stratified. thus, a more personalized approach in treating these patients is stressfully required. this proposal aims to establish the required interdisciplinary infrastructure for developing a risk-stratification model by implementing clinical, laboratory and angiographic data with molecular knowledge obtained by using innovative technologies, such as data from nano/micro-computed tomography and circulating micrornas. two hundred consecutive patients with stemi undergoing thrombus aspiration will be enrolled in the study and will be followed-up for one year for major adverse cardiac and cerebrovascular events (macce). the proposed approach will shed light on the pathophysiological mechanisms and broaden the investigator's understanding of the complex cellular and molecular interactions in the stemi setting that, along with clinical parameters, affect patient outcomes. furthermore, it will enable the identification of certain circulating micro-rnas as cardiovascular disease biomarkers and it will help clinicians to better stratify the cardiovascular and cerebrovascular risk of patients with stemi. as part of the work, important characteristics of aspirated thrombi will be assessed for the first time (such as volume, density and shape) and will be linked to patient outcomes. all this information will be incorporated into one in-vitro model, which will be developed using bioprinting and microfluidics methodologies. the in-vitro model will facilitate: (i) the in-depth exploration of the pathophysiological mechanisms in patients with stemi; and (ii) the therapeutic optimization of innovative nanocarriers/nanomedicines with thrombolytic efficacy. clearly, the study improves personalized cardiovascular medicine approaches, by considering individual patient clinical assessment in a way that empowers the precision in diagnosis and therapy.


Eligibility criteria:
inclusion criteria: * patients with symptoms of myocardial ischemia lasting for more than 30 minutes * definite ecg changes indicating stemi * patients undergoing primary pci within 12 hours from symptom onset * possibility to perform thrombus aspiration * written informed consent exclusion criteria: * treatment with fibrinolytic therapy for qualifying index stemi event * patients with known intolerance to aspirin, ticagrelor or heparin * patients with active internal bleeding * patients with a recent history of intracranial hemorrhage

Keywords: bioprinting thrombus aspiration micro-ct
early detection of coronary artery disease by polygenic and metabolic risk scoring

Conditions: Coronary Artery Disease

Summary: the overall goal of this study is to develop a combined polygenic risk score (prs) and metabolic risk score (mrs) and determine its impact on selecting community members for ccs. the trial component of this study will compare the use of these scores to motivate people to adhere to therapy, an ongoing challenge for clinicians, by providing feedback in a meaningful form to both the clinicians and the patients.

patients undergoing a polygenic risk score (prs), metabolic risk score (mrs) and coronary calcium score (ccs) will be randomized to receive prs and ccs information and followed for the reduction of risk over 12 months. this information will provide information about how to motivate people to adhere to therapy, by providing feedback in a meaningful form to both the clinicians and the patients.

Eligibility criteria:
inclusion criteria: 1. asymptomatic subjects age 40-70y 2. statin naïve 3. tc ≤ 6.5 mmol/l and ldlc \<5 mmol/l, and 4. 5 year australian risk ≥2%. exclusion criteria: 1. symptomatic coronary, cerebrovascular, or peripheral vascular disease 2. intolerance of statins or currently on statins for any length of time 3. pre-existing muscle disease (eg polymyositis, fibromyalgia) - this may be confused with myalgia from statins 4. patients on drugs that increase the risk of myopathy/rhabdomyolysis such as cyclosporine and strong cyp3a4 inhibitors (e.g., clarithromycin, itraconazole, and hiv/hepatitis c protease inhibitors) 5. atrial fibrillation (interferes with ctca) 6. chronic kidney disease on haemodialysis (because of vascular calcification) or gfr \<50ml/min per 1.73m2 using the modification of diet in renal disease (mdrd) formula 7. inability to provide informed consent 8. major systemic illness eg. malignancy; rheumatoid arthritis 9. women of child bearing potential (due to performance of ct) 10. poorly controlled hypertension: sbp\> 200 and or dbp \> 100 11. severe psychiatric disorder (eg bipolar depression; psychosis) 12. patients eligible for treatment based on current australian guidelines (5 year risk \>15%) 13. patients eligible for treatment based on current pbs thresholds tc \>7.5 mmol/l and other criteria (see below).
study of late fetal loss in poitou-charentes. gyne-covid

Conditions: Identification of the Mother or Fetus Contamination by SARS Cov-2; Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father; The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes; Analysis Laboratories of the Poitiers CHU

Summary: maternal-fetal transmission in the second or third trimester of pregnancy of the sars-cov-2 virus could explain some late fetal losses. finding a cause in the context of fetal loss is essential for parents and caregivers. it helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies. if the maternal-fetal transmission of covid 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination. the investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.


Eligibility criteria:
inclusion criteria: * major patient * patient with late spontaneous abortion (≥15 weeks of gestation) * benefiting from a social security scheme * patient who consented to participate in the study * free subject, without tutorship, curatorship or subordination exclusion criteria: * persons not benefiting from a social security scheme or not benefiting from it through a third party. * concurrent participation in another clinical research study.