Kornimate/medical-research-clean huggingface dataset:
assessing athrough radiofrequency transseptal puncture system for left atrial access

Conditions: Heart Diseases; Atrial Fibrillation

Summary: this study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. participants are patients scheduled for atrial septal puncture. after signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). all participants will undergo immediate postoperative and discharge clinical follow-ups.


Eligibility criteria:
inclusion criteria: 1. patient age ≥ 18 years; 2. subjects scheduled to undergo cardiology interventional treatment via the transseptal puncture route; 3. subjects have been informed about the nature of the study, understand the purpose of the clinical trial, and voluntarily participate and sign the informed consent form. exclusion criteria: 1. echocardiogram indicates the presence of intracardiac masses, thrombi, or vegetations; left atrial myxoma; 2. subjects with an atrial septal defect occluder or atrial septal patch implant; 3. hemorrhagic disease or coagulopathy; or contraindications to antithrombotic medication treatment; 4. acute myocardial infarction occurred within the last 4 weeks; 5. end-stage heart failure (acc/aha stage d); post-heart transplant; or awaiting heart transplant; 6. pregnant or breastfeeding women; 7. acute systemic infection or sepsis; 8. participation in any drug and/or medical device clinical trial within the last month; 9. researchers judge the patient's compliance to be poor, unable to complete the study as required; or other situations deemed by the researchers as making the subject unsuitable for participation in the study.
assessment of optimal egg intake in a healthy population

Conditions: Cardiovascular Disease

Summary: recently, the united states department of agriculture (usda) has recommended removal of the 300mg/day limit on dietary cholesterol intake due to a lack of evidence supporting a connection between cholesterol intake and increased risk for cardiovascular disease (cvd). previous work has shown that daily intake of eggs actually favorably alters many parameters associated with cvd risk. conversely, emerging research suggests that choline, a nutrient in eggs, may be converted into trimethylamine oxide (tmao) by the intestinal microbiota. tmao is thought to increase the risk for cvd. therefore, the purpose of this study is to determine a threshold of daily egg intake at which the risk for cvd is not negatively impacted in a young, healthy population.

the purpose of this study is to establish a threshold of egg intake at which cvd risk is not negatively altered in young, healthy individuals. participants (age 18-30, healthy lipid profile) will undergo a 2-week washout period followed by daily intake of 1, 2, and 3 eggs per day for 4 weeks each. blood samples will be collected at baseline and following each 4-week dietary period. samples will be analyzed to determine the impact of daily intake of increasing numbers of eggs on blood lipids, tmao, biomarkers of oxidative stress and inflammation, and expression of cholesterol-related genes.

Eligibility criteria:
inclusion criteria: * bmi 18.5-29.9 kg/m2 * proficient in english * cholesterol ≤ 240 mg/dl * willing to consume 1, 2, and 3 eggs per day for 4 weeks each exclusion criteria: * diabetes mellitus, cardiovascular disease, history of stroke, renal disease, liver disease, cancer, or eating disorder * taking glucose-lowering supplements or medications * taking triglyceride-lowering medications, bile acid sequestrants, or high-dose chromium or cinnamon supplements * plasma glucose \ 500 mg/dl, or blood pressure \> 140/90 mmhg (average of 3 readings) * allergy to eggs
implementation of the caregivers-patients support coping with advanced-cancer (casa) intervention.

Conditions: Advanced Cancer; Caregivers; Patients; Stage III Cancer; Stage IV Cancer

Summary: this pre-pilot aims to prepare the pi to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. the catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. the pi's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the pi to focus on this critical gap in equal healthcare. the research goal of this proposal is to refine and pre-pilot an intervention titled caregivers patients support to cope with advanced cancer (casa), a five-session, 60-minute telehealth series for patient-caregiver dyads. the rationale for this project is that it will lay the groundwork for a randomized control trial (rct) testing the efficacy of casa. it will also assess the implementation of an innovative method to deliver the casa intervention. this study aims to use the collaborative intervention planning framework and orbit model to modify and assess the feasibility and preliminary effect of the casa intervention. the overall impact of this study is to improve access to psychosocial, culturally adapted interventions in the proposed catchment area.


Eligibility criteria:
inclusion criteria: * cancer patients must be stage iii and iv solid tumor patients who report distress \>4 on the distress thermometer * caregivers. identified caregivers by distressed patients. exclusion criteria: * (1) diagnosed with a major disabling medical or psychiatric condition, (2) unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.
management of albuminuria in hypertensive diabetics

Conditions: Microalbuminuria; Hypertension; Type 2 Diabetes

Summary: multicenter stepped wedge cluster randomized trial of family practice clinics in quebec and ontario comparing the effect of introducing a point of care testing (poct) for urine albumin to usual practice on quality of care in hypertensive patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or female 18 years and older and able to visit the study sites every 3 months * t2d patients with ongoing anti-diabetic therapy for at least 5 years * uncontrolled hypertension according to 2012 chep recommendations for management of hypertension in diabetic patients ( i.e. bp\> 130/80 mmhg) * able and agreeing to provide informed consent. exclusion criteria: * type 1 diabetes patients * ongoing therapy with perindopril, * known hypersensitivity or allergies to acei or sulfonamide derivatives, * a history of angioedema related or not to previous treatment with acei, * impaired renal function defined as serum creatinine levels \> 177 µmol/l, egfr \<30 ml/min, * hyperkalemia or hypokalemia, * severe hepatic impairment, * use of non-antiarrhythmic agents causing torsade de pointes, * pregnant or lactating women, or who are planning to become pregnant, * any conditions which may impact on participation according to treating physician.

Keywords: microalbuminuria hypertensive diabetics urine albumin
probiotic toothpaste to assess microbial colonization

Conditions: Microbial Colonization

Summary: the aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults

this is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium streptococcus salivarius m18. participants will be randomly assigned to one of 2 groups for brushing teeth with a probiotic toothpaste containing two different doses of streptococcus salivarius m18 over a seven day period. saliva samples will be collected at predetermined time points pre and post intervention. colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility criteria:
inclusion criteria: * in general good health * practise good oral hygiene exclusion criteria:- * have a history of autoimmune disease or are immunocompromised. * are on concurrent antibiotic therapy or regular antibiotic use within last 1 week * history of allergy (e.g. dairy).

Keywords: probiotic toothpaste streptococcus salivarius m18 microbial colonization oral probiotic toothpaste
cgm use in children with type 2 diabetes

Conditions: Type 2 Diabetes; Hyperglycemia Due to Type 2 Diabetes Mellitus

Summary: the purpose of this prospective study is to determine if trial use of a dexcom g6 cgm system for a 10 day wear period in pediatric type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.

the purpose of this prospective study is to determine if trial use of a dexcom g6 cgm system for 10 days has an impact on short and long term glycemic control and behavior in youth onset type 2 diabetes.

Eligibility criteria:
inclusion criteria: * type 2 diabetes, diabetes duration \>3 months exclusion criteria: * prior use of cgm

Keywords: continuous glucose monitoring (cgm) hemoglobin a1c
a study of the safety and efficacy of pf-04191834 in patients with osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: pf-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. the purpose of this study is to test how effective, safe and tolerated pf-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

this study has been terminated in response to a reported serious adverse event (sae). the sponsor's assessment of the limited data available at the time of the initial sae report was that the sae may alter the potential benefit - risk profile of the study medication.

Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of osteoarthritis based on the american college of rheumatology criteria confirmed by an x-ray * subjects must be willing and able to stop all current pain therapy for the duration of the study * subjects must be willing and able to complete a daily diary exclusion criteria: * bmi of \>39 kg/m2 * known allergy or hypersensitivity to naproxen * any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments

Keywords: cross-over safety efficacy tolerability osteoarthritis knee pain
health effect of canola oil consumption in shift workers

Conditions: Shift-Work Related Sleep Disturbance; Metabolic Syndrome; Diet Modification; Work-Related Condition

Summary: shift work is associated with a higher risk of the development of cardiometabolic syndrome (cmts) than in people working only during the day. one of the factors predisposing to the development of the cmts in shift workers is an inappropriate composition of their diet. it was observed that the shift workers diet is characterized by a higher intake of saturated fatty acids (sfa) and a lower consumption of unsaturated fatty acids. one potential way to reduce the risk of cmts in this study group seems to be a modification of their everyday diet by excluding the products of animal origin (e.g. butter) with simultaneously including vegetable oils (i.e. canola oil). the aim of the study is to evaluate the effect of replacement in the everyday diet of saturated fats (butter) with unsaturated fats (canola oil-based spread and canola oil added to main meals) in centrally obese shift workers on changes in body weight and body composition parameters as well as on changes in cmts markers.

the study was designed as a randomized clinical trial to investigate the effects of the dietary intervention with moderate in fat content (\~35% energy as fat) for 12 weeks on the improvement of cardiometabolic risk factors in centrally obese shift workers. forty centrally obese shift workers (waist circumference ≥94 cm) were randomized (1:1) to the experimental group (n = 20) or the control group (n = 20). eligibility criteria included: aged between 30-60 years, working rotating shifts for at least 5 years and working night shifts minimum five times a month. excluded criteria was described in the point "eligibility". written informed consent was obtained from all of the participants, and the local ethic committee approved the study. the dietary intervention was mainly based on the simple rearrangement of shift workers' diets by replacing food items including sfa (e.g. butter) with those being sources of unsaturated fatty acids (ufa), mainly canola oil (given to the diet as spread or this oil was added separately to main meals)

Eligibility criteria:
inclusion criteria: * centrally obese (≥ 94cm) male * aged between 30-60 years, * working rotating shifts for at least 5 years and working night shifts minimum five times a month, exclusion criteria: * diabetes, familial hypercholesterolemia, thyroid and parathyroid diseases, non-specific intestinal diseases, celiac disease, phenylketonuria, * taking medication for lowering blood lipids such as statins, * weight loss therapy for 3 months before the intervention, * allergies and intolerances * consuming high-proof alcoholic beverages (\>2 portions/week)

Keywords: shift work night work rotating shift work metabolic syndrome diet therapy canola oil fatty acids cardiometabolic parameters
devitalized non-valved pulmonary artery allograft implant for the repair of congenital cardiac abnormalities

Conditions: NA-Study Withdrawn

Summary: study no longer required


Eligibility criteria:
safety and immunogenicity study of the tetravalent rotavirus vaccine

Conditions: Rotavirus Gastroenteritis

Summary: a double blind placebo controlled phase i/ii study to evaluate the safety and immunogenicity of the live attenuated tetravalent (g1-g4) bovine-human reassortant rotavirus vaccine \[brv-tv\]in indian infants. the study would be carried out in 90 healthy infants. three doses of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12 and 14-16 weeks of age. the rotavirus vaccine would be administered at one of the two planned virus concentrations (10e5.5 or 10e6.25 ffu of each constituent serotype per 0.5 ml). each administration of the vaccine/placebo would be preceded by oral administration of 2.0 ml of antacid.


Eligibility criteria:
inclusion criteria: * healthy infants 6-8 weeks of age at time of enrollment of either sex; * born after a gestational period of 36-42 weeks with birth weight ≥2 kg; * father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (icf). in case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having had the icf explained to them in the presence of a study independent witness and the witness having signed the icf; * parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up. exclusion criteria: * history of congenital abdominal disorders, intussusception, or abdominal surgery; * known or suspected impairment of immunological function; * known hypersensitivity to any component of the rotavirus vaccine; * prior receipt of any rotavirus vaccine; * fever, with axillary temperature ≥38.1oc (≥100.5of); measured by study staff. * history of known rotavirus disease, chronic diarrhea, or failure to thrive; * baseline level of alt or ast \>2.5 times the upper limit of normal; * clinical evidence of active gastrointestinal illness (infants with gerd can participate in the study so long as this condition is well controlled with or without medication); * receipt of any im, oral, or iv corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study); * infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, hiv infection, leukemia, lymphoma, hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids); * infants suspected to be hiv, hbv or hcv positive from the available clinical history or born to mothers known to be hiv, hbv or hcv positive. * prior receipt of a blood transfusion or blood products, including immunoglobulins; * any infants who cannot be adequately followed for safety by a home visit; * any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. * parent/s or guardian of subject unable to maintain diary card
cohort of hiv-infected children

Conditions: Children Infected by HIV

Summary: the purpose of this study is to describe the conditions of access to early treatment of children infected with hiv, their management on the long-term, and impact on growth, clinical and immunovirological prognosis, adherence to treatment, living conditions

the co10 epf paediatric cohort includes therapeutic, clinical and biological detailed questionnaires. the data are collected by the doctors every three months to 2 years and then every 6 months until to 18 years or every year by a simplified questionnaire if medical follow up continues outside of a participating site. after 18 years of age, the patients are eligibile for the anrs co19-coverte cohort.

Eligibility criteria:
inclusion criteria: * hiv-infected children born to mothers included in anrs-co1 epf or children under the age of 13 newly entered in care management with no prior antiretroviral therapy, whose mother was or not included in anrs-co1 epf exclusion criteria: * \>= 13 years * refusal of legal representative of the child * antiretroviral therapy started before the entry in care management * care management for over 6 months before inclusion

Keywords: hiv infection adolescent
cancer treatment related cardiovascular toxicity: comprehensive myocardial and vascular phenotyping

Conditions: Cardiovascular Diseases; Cardiotoxicity; Fluorouracil Adverse Reaction; Malignancy; Colorectal Cancer; Oesophagus Cancer; Gastric Cancer; Pancreatic Cancer

Summary: observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity.

fluoropyrimidine (5-fu and capecitabine) based chemotherapy regimens form the cornerstone of treatments for gastrointestinal (gi) cancers. fluoropyrimidines however, are associated with the development of cardiovascular toxicity which can take on different forms including chest pain, myocardial infarction, arrhythmias, heart failure and sudden death. the underlying mechanisms of cardiovascular toxicity are not fully understood. the investigators will use quantitative cardiovascular magnetic resonance perfusion imaging, ct coronary angiography, extra-cardiac vascular assessments and serum cardiac biomarkers to improve insights into the pathophysiology of fluoropyrimidine cardiotoxicity. all enrolled participants in this two centre study will have gi cancers requiring treatment with fluoropyrimidine chemotherapy.

Eligibility criteria:
inclusion criteria: * age \>18 years * gastrointestinal malignancy * receiving fluoropyrimidine chemotherapy exclusion criteria: * participants unable or unwilling to provide consent * participants that have a conventional contraindication for magnetic resonance imaging (mri) including permanent implantable cardiac devices, ferromagnetic implants, pregnancy, large body size not fitting into the scanner bore and severe claustrophobia will be excluded * participants that have a conventional contraindication for adenosine stress perfusion including a history of trifascicular block or of second-degree heart block or higher on ecg, or uncontrolled asthma. * participants with significant renal impairment (egfr\<30ml/min) * history of allergy to adenosine, gadolinium or iodinated contrast * patients with terminal illness (life expectancy \<6 months) will be excluded.

Keywords: cardio-oncology cardiotoxicity fluoropyrimidine cardiotoxicity
black cohosh as alternative therapy for treating menopause-related anxiety

Conditions: Generalized Anxiety Disorder; Menopause

Summary: this study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women. study hypotheses: 1) black cohosh will have a superior anti-anxiety effect compared to placebo. 2) black cohosh will have a comparable safety profile to that of placebo.

during menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. concern over the safety and effectiveness of hormone replacement therapy for relieving these symptoms has caused many women to seek alternative medical treatments. data suggest that black cohosh has a direct effect on the neurotransmitters and receptors involved in anxiety. this study will determine whether black cohosh can effectively treat anxiety symptoms in menopausal women. this study will last 12 weeks. participants will be randomly assigned to receive either black cohosh or placebo daily for the duration of the study. self-report scales will be used to assess participants' anxiety symptoms and quality of life at the beginning and end of the study.

Eligibility criteria:
inclusion criteria: * currently experiencing menopause or postmenopausal * have symptoms of menopause-related anxiety exclusion criteria: * any form of generalized anxiety disorder (gad) unrelated to menopause * onset of gad at least 3 years prior to menopause or at least 5 years after menstruation has stopped * alcohol or drug dependence within 3 months prior to study entry * allergy to black cohosh * history of hormone replacement therapy * current use of vaginal estrogen cream or phytoestrogens * current use of tranquilizers, antidepressants, or antianxiety therapies * abnormal uterine bleeding * history of estrogen-dependent cancer * history of endometrial hyperplasia (abnormal increase in cells) or endometrial cancer * rapidly growing uterine fibroids * abnormal finding upon gynecological examination that would interfere with the study * abnormal breast examination or mammogram * any unstable medical condition

Keywords: black cohosh cimicifuga anxiety women complementary and alternative medicine