Kornimate/medical-research-clean huggingface dataset:
absolute coronary flow in patients with heart failure with reduced ejection fraction and left bundle branch block with cardiac resynchronization therapy

Conditions: Left Bundle-Branch Block; Heart Failure; Cardiac Resynchronization Therapy; Dilated Cardiomyopathy

Summary: cardiac resynchronization therapy (crt) is an effective therapeutic strategy in patients with symptomatic heart failure (hf) patients with lvef of ≤35% and left bundle branch block (lbbb). however, approximately one-third of crt-recipients do not improve after therapy (non-responders), despite meeting the required criteria. previous studies have documented that the positive respons to crt is related to the delayed electrical activation of the left ventricle in patients with lbbb. it has also been illustrated that non-ischemic crt-candidates with lbbb demonstrate lower regional myocardial blood flow and metabolism in the septum. additionally, it has been suggested that lbbb can lead to impaired coronary blood flow in the left anterior descending artery (lad). this observation is based on an echocardiography-based study, that showed that the percentage of diastolic flow duration (%dd) in lad was shorter in patients with lbbb compared to the control-group and patients with right-ventricular pacing. it has been demonstrated that crt has positive effects on septal myocardial perfusion in patients with hf and lbbb. the dominant hypothesis explaining this phenomenon is built on improved septal myocardial work after crt-implantation, which leads to increased myocardial energy and therefore increased myocardial perfusion. in contrast, it has been suggested that due to re-established synchronous left ventricular electrical activation, crt reduces the septal intramyocardial pressure in early diastole, leading to a relatively longer antegrade flow duration in lad. therefore, the aim of the study is to evaluate the effect of crt on coronary blood flow in lad in patients with non-ischemic hf and lbbb. the investigators hypothesize that increased lv-function after crt not only is due to resynchronized lv ejection and filling, but also improved coronary flow. the study aims to enroll 60 patients with heart failure due to non-ischemic dilated cardiomyopathy, lbbb, with or without crt. all patients meeting the criteria will be recruited from the outpatient clinic at the department of cardiology, aalborg university hospital. invasive flow measurements in the lad, including fractional flow reserve (ffr), absolute coronary flow and -reserve will be conducted with the crt on and off, respectively.


Eligibility criteria:
inclusion criteria: * age \> 18 * qrs ≥ 150 ms before implantation * heart failure because of dilated cardiomypathy * sinus rhythm * stable medical therapy * lbbb * crt device exclusion criteria: * egfr \< 30 ml/min * severe valvular heart disease * permanent atrial fibrillation or atrial flutter * prior pci or cabg * prior myocardial infarction * heart failure due to ischemic heart disease * other type of device (pacemaker, icd) * not able to give informed consent * does not understand danish

Keywords: absolute coronary flow fractional flow reserve
improving screening and therapy for hispanic/latinx at risk for ckd

Conditions: Type 2 Diabetes; Chronic Kidney Diseases

Summary: in this study, the investigators will utilize community organizations to screen hispanics/latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a pcp. additionally, the investigators will implement an intervention in local health clinics to assist pcps with screening and treating patients with diabetes. completion of the project will hopefully slow progression of kidney disease among hispanic/latino(a) patients in durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.

the goals of this study are to (1) increase rates of screening and monitoring of ckd and ckd risk factors for hispanic/latinx community members in durham by utilizing existing community resources and screening events and (2) pilot test a pcp-facing intervention to promote guideline concordant testing and evidence-based therapy provision for hispanics/latinx with t2d at community health centers, utilizing clinical champions and pharmacists. the investigators anticipate the study will identify patients with ckd or ckd risk factors and establish feasibility of the pilot intervention, which the investigators plan to ultimately apply on a large scale to reduce inequities and improve clinical outcomes among hispanics/latinx.

Eligibility criteria:
aim 1: inclusion criteria: * age 18 or older at time of screening * self-identifying as hispanic/latinx ethnicity. exclusion criteria: * unable to be reached by telephone
the effects of aronia melanocarpa extract on obese individuals with impaired fasting blood glucose

Conditions: Obesity

Summary: obesity is closely related to many chronic diseases such as hypertension, coronary heart disease, hyperlipidemia, type 2 diabetes, fatty liver, certain types of tumors, etc, which are associated with adverse health outcomes. limiting energy intake is one of the most important treatment measures for weight loss. the fruits of aronia melanocarpa (aronia berries) have been found to show multiple bioactivities potentially beneficial to human health, including antidiabetic, anti-infective, antineoplastic, antiobesity, antioxidant and gut microbiota-regulating activities. thus, it is worth investigating whether consumption of aronia melanocarpa extract have additional benefits in improving anthropometric indicators, glucose and lipid metabolism, inflammatory status, adipocyte cytokines, and intestinal microbiota in obese individuals on the basis of an energy-restricted diet. obese individuals will be divided into intervention group and control group in this 8-week trial. both groups will be given an energy-restricted diet, with an additional dose of aronia melanocarpa extract in capsules in intervention group and an additional dose of maltodextrin in capsules in control group. fecal and blood samples from participants before and after the intervention will be collected for the analysis of gut microbiota, glucose and lipid metabolism, inflammatory status, and adipocyte cytokines


Eligibility criteria:
inclusion criteria: * aged 18-40 years * simple obese individuals with stable body weight in the last three months before enrollment (28.0kg/m2 ≤ bmi \<35.0kg/m2) * impaired fasting blood glucose: within the last three months before enrollment, the venous fasting blood glucose was between 6.1 and 7.0 mmol/l, and the 2-hour postprandial blood glucose was\<7.8 mmol/l and the glycated hemoglobin (hba1c) was \< 6.5% exclusion criteria: * diagnosed patients with diabetes or those who use hypoglycemic drugs * patients with concomitant hyperthyroidism or hypothyroidism, or those taking thyroxine tablets * those who apply glucocorticoids within 12 weeks * individuals with suspected renal dysfunction (female: serum creatinine ≥ 84 µ mol/l; male: serum creatinine ≥ 104 µ mol/l) or suspected liver dysfunction (elevated transaminase \>3 times normal or cirrhosis) * secondary obesity (such as thalamic diseases, pituitary diseases, cushing's syndrome, etc.) * previous weight loss surgeries * pregnant or lactating individuals * individuals with confirmed mental illness or eating disorders * women with polycystic ovary syndrome * individuals who are allergic or intolerant to experimental products * lactose intolerant individuals * those who have taken probiotics and/or probiotic drugs or supplements within one month before enrollment * those who fail to use intervention agents according to the study protocol or have severely incomplete visit records
open-label extension study for the long-term efficacy and safety of roxadustat in participants with dialysis and non-dialysis chronic kidney disease

Conditions: Chronic Kidney Disease; End Stage Renal Disease; Anemia

Summary: the purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (hb) in participants with dialysis and non-dialysis chronic kidney disease (ckd) who have completed the treatment period of a roxadustat fibrogen-sponsored anemia study.

this is an open-label, long-term maintenance study of roxadustat anemia therapy in participants with dialysis and non-dialysis ckd who have completed the treatment period of a roxadustat fibrogen-sponsored anemia study. participants assigned to roxadustat in the previous study will continue to receive the same roxadustat dose and dosing frequency, unless a dose adjustment is required.

Eligibility criteria:
inclusion criteria: 1. minimum age 18 years 2. completed the treatment period of an ongoing roxadustat fibrogen-sponsored anemia study in the united states. exclusion criteria 1. participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study 2. pregnant or breastfeeding females 3. females of childbearing potential, unless using adequate contraception; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use adequate contraception 4. participants who received roxadustat in a previous study that did not demonstrate adequate hemoglobin response per the investigator's clinical judgment 5. any medical condition that in the opinion of the investigator may pose a safety risk to a participant in this study or which may interfere with study participation

Keywords: kidney esrd end stage renal disease anemia oral anemia treatment hemoglobin levels hemodialysis ckd chronic kidney disease peritoneal hd pd hb erythropoietin blood count
clinical performance of dual- and light-cure bulk-fill resin composites

Conditions: Dental Caries Class II

Summary: this study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in class ӏӏ restorations. the null hypothesis tested in this study was that, there would be no difference in the 2-year clinical performance of all tested bulk-fill resin composites in class ii restorations. forty patients were enrolled in the study. each patient received three bulk-fill resin composites class ӏӏ restorations. one dual-cure and two light-cure bulk-fill resin composites were used for class ӏӏ restorations following manufacturer's instructions. a universal adhesive was used with all restorations. all restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the fdi world dental federation criteria.


Eligibility criteria:
inclusion criteria: * each participant should have at least three permanent molars and premolars that need to be treated with class ii restorations due to primary carious lesions. * all participants required to have a full and normal occlusion and to maintain adequate oral hygiene. exclusion criteria: general exclusion criteria: * heavy bruxism. * poor oral hygiene. * chronic or severe periodontitis. * a history of allergies to any of the materials utilized in this study. * pregnant or nursing females. specific exclusion criteria: * fractured or visibly cracked teeth. * rampant caries. * faulty restoration opposite or adjacent to the tooth to be restored. * atypical extrinsic staining.

Keywords: bulk-fill resin composite dual-cure light-cure class ӏӏ restorations clinical performance randomized clinical trial
increasing oral medication adherence for metastatic breast cancer patients

Conditions: Breast Cancer

Summary: aim of this study is to optimize an adherence increasing intervention designed for metastatic breast cancer (bc) patients by applying a full factorial design in order to evaluate the optimal combination of three different intervention components.

today different types of oral anticancer agents (oaa) are commonly prescribed to breast cancer (bc) patients. patients are reported to prefer the oral modality of administration over the intravenous one for its convenience, flexibility, and easier assumption; nonetheless, the phenomenon of medication non-adherence is well-documented. although several interventions have been designed and tested in order to foster medication adherence among bc patients, the great majority of them were focused on adherence to endocrine therapy for early-stage bc patients, with only few exceptions involving metastatic bc patients or considering adherence to other types of oaa. the aim of this work is to optimize an adherence increasing intervention designed for metastatic bc patients. this will be achieved by applying a full factorial design in order to evaluate the optimal combination of three different intervention components (informative documentation, personalized reminders and feedback).

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of metastatic bc * patients with a prescription for any oaa (i.e. oral chemotherapy, endocrine therapy, and cyclin-dependent kinase 4/6 inhibitors) * age \>18 years old * patients with a personal smart phone with internet access * willingness and ability to comply with scheduled visits and other trial procedures * understanding and speaking italian language * written informed consent exclusion criteria: * psychiatric disorders or conditions that might impair the ability to give informed consent * comorbidity that may impact on compliance to study procedures

Keywords: metastatic breast cancer oral anticancer agents oral medication adherence
a study to evaluate the safety, tolerability and plasma concentration profiles of mk0633 in asthmatic children aged 12 to less than 16 years (0633-019)

Conditions: Asthma

Summary: to evaluate the safety, tolerability and pharmacokinetics (pk) of mk0633 in adolescent mild-to-moderate asthma patients to permit further clinical investigation.


Eligibility criteria:
inclusion criteria: * patient is judged to be in good health, other than having mild to moderate asthma, based on medical history, physical examination, vital signs, and laboratory safety tests * patient has no clinically significant abnormality on electrocardiogram (ecg) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug * patient has at least 1 year of mild-to-moderate asthma * patient has been a nonsmoker for at least 6 months * patients of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug * patients must be able to swallow tablets exclusion criteria: * patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, other than asthma, or genitourinary abnormalities or diseases * patient has required a visit to a hospital or emergency room due to an asthma exacerbation within 3 months of the prestudy visit * patient has unresolved signs and symptoms of an upper respiratory tract infection (uri) or has had had an upper respiratory tract infection within 3 weeks prior to the prestudy visit * patient has a history of stroke, chronic seizures, or major neurological disorder * patient has a history of neoplastic disease * use of theophylline, singulair (montelukast), xolair (omalizumab), zyflo amd zyflo cr (zileuton), oral corticosteroids and oral beta agonists are excluded approximately 2 weeks prior to administration of study drug and throughout the study * patient consumes alcoholic beverages
technology-based distractions during minor procedures

Conditions: Pain; Anxiety; Procedural Anxiety

Summary: the purpose of this study is to determine if non-invasive distracting devices (virtual reality headset, augmented reality headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). the anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.


Eligibility criteria:
inclusion criteria: * age 17 and under * able to consent or have parental consent * undergoing minor procedures (i.e lumbar punctures, cardiac catheterization) at lucile packard children's hospital (lpch) or stanford hospital facilities exclusion criteria: * people who do not consent * significant cognitive impairment * history of severe motion sickness * current nausea * seizures * visual problems * non-english speaking * patients who clinically unstable or requires urgent/emergent intervention * (asa) physical status classification class 4 or higher * patient or parental preference for general anesthesia
virtual intervention stroke initiative

Conditions: Ischemic Stroke; Acute Ischemic Stroke

Summary: the goal of this clinical trial is to determine if patients admitted to a primary stroke centre, such as the general internal medicine service of the ottawa hospitals general campus, for acute ischemic stroke would benefit from a scheduled virtual assessment with a stroke neurologist to review investigations, results, and evaluations to identify stroke etiology, propose appropriate therapy, and guide decision-making and multidisciplinary assessment, similar to services provided to patients admitted to comprehensive stroke centres, such as the civic campus of the ottawa hospital.

patients admitted to primary stroke centres do not have access to the same level of stroke expertise on site as do patients admitted to comprehensive stroke centres, resulting in increased length of stay with implications for access to stroke rehabilitation. virtual access to stroke experts has been used in hyperacute stroke care through programs such as ontario telestroke, but this has not been routinely used for acute inpatient management. the investigators propose a system to provide virtual access to the stroke neurology team to patients admitted with stroke in a primary stroke centre. patients at the general campus of the ottawa hospital are currently admitted to internal medicine; this includes scheduled virtual assessment with a stroke neurologist and advanced practice nurse/interdisciplinary support to review investigations, results, and evaluations to identify stroke etiology, propose appropriate therapy, and guide decision-making and multidisciplinary assessment, similar to services provided to patients admitted to the civic campus. this will be developed with the assistance of internal medicine and will utilize technologies and assessment tools and strategies already being used for provision of virtual care in other settings. the goal of this project will be to prove that patients in primary stroke centres, with the assistance of virtual care, can benefit from the expertise available at comprehensive centers throughout their stay, and that this will result in an improved quality of care with benefits for patients, hospitals, and the community.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * admitted to the general internal medicine service of the ottawa hospital general campus for acute ischemic stroke * able to participate in video assessments with necessary accommodation/facilitation for participation (particularly if stroke results in physical or communication deficits) exclusion criteria: * patients who are unable, in the judgement of the study team or treating team, to participate in video assessments

Keywords: telemedicine virtual care
optimizing postoperative recovery after breast reconstruction with autologous tissue (bestdiep)

Conditions: Breast Reconstruction; Breast Cancer

Summary: women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. however, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than some other methods, such as implant-based techniques. the main objectives of the present study are to investigate if pre- peri- and postoperative protocols can be safely modified, so the operation demands less resources, while maintaining a low complication rate and a high patient satisfaction.


Eligibility criteria:
inclusion criteria: * operated or will be operated with a diep flap in the department * \>18 years of age exclusion criteria: * inability to leave informed consent * inability to understand and speak swedish (for the questionnaire)

Keywords: breast reconstruction plastic surgery microsurgery free flap
proleukin and rapamune in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: this is a phase i trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. the study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes progression.

at the time of diagnosis with type 1 diabetes, 15-40% of beta cells may remain active and healthy in the pancreas, capable of producing insulin the body needs to regulate blood glucose levels. because even small amounts of natural insulin production can decrease the long term effects of diabetes, it is essential that these cells are preserved. this trial will test whether a combination of the drugs proleukin (il-2) and rapamune (sirolimus) may be safely administered to recently diagnosed type 1 diabetes patients and whether it causes changes to the immune system that can halt the autoimmune destruction of the remaining beta cells. this drug combination has been found to be effective for long-term diabetes prevention in mouse models of type 1 diabetes. this study is a phase i study for individuals 18-45 years of age who have been diagnosed with type 1 diabetes in the past 3-48 months. all participants will be treated with proleukin (administered subcutaneously 3x per week) for 28 days and rapamune (taken orally, daily) for 12 weeks. the study will last for 12 months, with additional follow-up of 24 months. the majority of study visits occur within the first 6 months. mixed meal tolerance tests, in which participants take a milkshake-like drink and have blood sampled over a 2 or 4-hour period, will take place during an initial screening visit and three additional times during the first year. all participants will also receive intensive diabetes management designed to maintain stable blood glucose levels.

Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes (per ada criteria) more than 3 but less than 48 months prior to enrollment; * 18 to 45 years of age;and * positive for at least one islet cell autoantibody (gad65-antibody, ca512-antibody and/or ica). exclusion criteria: * chronic use of glucocorticoids or other immunosuppressive ages 4 weeks before enrollment; * history of recurrent infections, other autoimmune diseases, cardiac disease, cataracts or other chronic medical conditions that investigators believe could compromise participant safety; * females who are pregnant, lactating intend to get pregnant, or are unwilling to undergo pregnancy testing during the study; * males who intend to father a pregnancy during the first 6 months of the study; or * participation in another clinical study within the last 30 days.

Keywords: diabetes juvenile diabetes type 1 diabetes diabetes mellitus recent onset new onset