Kornimate/medical-research-clean huggingface dataset:
resolution of liver fat in non-alcoholic fatty liver disease

Conditions: NAFLD

Summary: the major adverse health consequences of obesity occur only when non-alcoholic fatty liver disease (nafld) also develops. nafld is characterized by abnormal hepatic accumulation of triglycerides and other lipids. the first-line approach to nafld management is caloric restriction and weight loss, but these remain difficult to achieve. little attention has been given to dietary carbohydrate restriction, despite recent reports showing that hepatic de novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the postprandial state, accounts for approximately 25% of liver triglyceride content in hyperinsulinemic subjects with nafld. for comparison, only 15% of the liver triglycerides were derived from dietary fatty acids in patients with nafld who had consumed a standardized 30% fat diet for four days before being assessed.

to establish the time-course of hepatic fat loss in nafld subjects on a carbohydrate-restricted diet (\<20 g/day), a serial assessments of liver fat during two week diet will be performed. also, markers of lipid and insulin metabolism, liver function test and changes in gut microbiota during rapid metabolic improvement will be assessed. the overall aim is to exploit this unique set of human material to determine the specific cellular and molecular pathways that are modified in the early stages of metabolic improvement and fatty liver regression.

Eligibility criteria:
inclusion criteria: * increased liver fat above 5 % in magnetic resonance spectroscopy * body mass index 27-39.9 kg/m2 exclusion criteria: * liver cirrhosis * portal hypertension * chronic liver disease other than nafld * diabetes mellitus or other significant endocrine disease * any medication acting on nuclear hormone receptors or inducing liver enzymes or self-administration of supplements other than calcium or vitamins/trace elements * any significant cardiovascular co-morbidity * history of non-compliance * genotype (pnpla3-mm and tm6sf2-tt) promoting liver fat accumulation
effect of medical care on health status in acute kidney injury

Conditions: Acute Renal Insufficiency

Summary: various forms of organisation in the care of patients with akute kidney injury are investigated. in this prospective study the investigators compare the effect of usual care with the effect of intensive care. primary endpoint is the development of cardiovascular events ("major adverse cardiovascular events" "mace").

the investigators plan to investigate the use of various organisation forms in the care of patients with the diagnosis of acute kidney injury in the hospital. this prospective study compares the effect of usual care with the effect of intensive care in the hospital and outpatient health care center. primary endpoint is the development of cardiovascular events ("major adverse cardiovascular events" "mace"). patients with intensive care receive a nephrology consulting report and extensive information about acute kidney injury and the importance of ambulant follow-up care. the investigators hypothesise a better in-hospital treatment and an improvement of clinical course in the interventional group.

Eligibility criteria:
inclusion criteria: * men and women at the age of 18 or older * acute kidney injury according to kdigo-guidelines * the patient (or his/ her authorised representative) is in the position and willing to give informed consent. exclusion criteria: * patients, who received kidney transplantation * patients on chronic dialysis at the time of enrolment * patients who are placed in an institution by judicial or governmental order * pregnancy * infection with hi- or infektionen mit hi- oder hepatitis virus infektion * participation in a clinical study with testing on drugs or medical devices (according to german medicines law or medicinal devices act)

Keywords: nephrologists health services, outpatient patient care bundles
prevention of ectopic bone related pain and disability after hip replacement surgery with peri-operative ibuprofen

Conditions: Osteoarthritis, Hip; Arthroplasty, Replacement, Hip; Arthritis, Rheumatoid

Summary: the primary aim of this randomised trial is to determine the effects of a short peri-operative course of treatment with a non-steroidal anti-inflammatory drug (nsaid), ibuprofen, on the long-term consequences of ectopic bone formation in patients undergoing elective total hip replacement surgery. the specific hypotheses to be tested at that 6 to 12 months after surgery, patients assigned post-operative ibuprofen will have less self-reported pain and physical disability, greater health-related quality of life and reduced ectopic bone formation compared with those assigned placebo.

methodology: the study is a multicentre, randomised, double blind, placebo-controlled trial. 1000 patients undergoing elective total hip replacement surgery from 20 orthopaedic centres in australia and new zealand will be assigned to receive either ibuprofen (1200mg daily) or matching placebo in 3 divided doses for 14 days. study treatment will be started postoperatively on the day of surgery. patient should not receive any other nsaids, apart from low dose aspirin, during the 14-day treatment period, unless such treatment becomes definitely indicated, in which case the study treatment should be withdrawn and open label treatment provided. there will be no other changes to standard care. participants: all patient scheduled for elective total hip replacement surgery, or revision thereof, are potentially eligible unless there is a definite indication for or contraindication to treatment with a nsaid during the 14-day treatment period. randomisation: randomisation will be performed centrally using a computer-based system that can be accessed 24 hours a day by a toll-free telephone call. a minimisation program will stratify treatment allocation by centre. outcomes: the primary outcome are self-reported pain and physical function, 6 to 12 months after randomisation. secondary outcomes include health-related quality of life, patients' global assessment, radiographic evidence of ectopic bone.

Eligibility criteria:
inclusion criteria: patient undergoing elective total hip replacement surgery, or revision thereof - exclusion criteria: a definite indication or contra-indication for treatment with a nsaid during the 14-day study treatment period, in the opinion of the treating clinician. -

Keywords: osteoarthritis hip arthroplasty ectopic bone formation non-steroidal anti-inflammatory drugs disability
pharmacodynamic study of carvedilol versus metoprolol in heart failure

Conditions: Heart Failure

Summary: metoprolol succinate is a beta1-selective beta-blocker, becoming non-selective at higher doses, while carvedilol is non-selective. we examined whether metoprolol remained beta1-selective compared to carvedilol during dose up-titration in class c heart failure (hf) beta-blocker naïve patients. methods: twenty-five nyha fc ii-iii hf patients were randomized to carvedilol or metoprolol. patients were studied at baseline and after 2 weeks of up-titration (metoprolol at 25, 50, 100, and 200 mg daily; carvedilol ir at 3.125, 6.25, 12.5, 25 mg and 50mg twice daily). beta2- blockade was determined by an infusion of terbutaline at 6 mg/kg over 1 hour. glucose and potassium levels were serially measured at baseline, every 15 minutes for the 1st hour and 30 minutes for 2nd hour post-infusion. the median area under the curve (auc) for glucose and potassium changes were calculated.


Eligibility criteria:
inclusion criteria: * patients eligible for the study had objective evidence of systolic dysfunction (ejection fraction ≤40%), were \>18 years of age, and were on stable optimal medical heart failure therapy excluding the use of beta-blockers within the previous 30 days. exclusion criteria: * . patients were excluded for active viral myocarditis; hemodynamically significant valvular heart disease; hypertrophic cardiomyopathy, peripartum cardiomyopathy; contra-indications to beta-blockers (asthma or obstructive airway disease requiring scheduled bronchodilators or inhaled steroids), resting heart rate \ 2.5 mg/dl), liver disease (transaminase levels \> 3 fold above laboratory normal), or anemia.
medication review in chronic complex or polymedicated patients after hospital discharge.

Conditions: Medication Review; Polypharmacy; Disease, Chronic

Summary: the goal of this prospective multicentre clustered randomized controlled trial is to evaluate the effect on new hospitalization episodes of a multidisciplinary medication review in primary care patients with polypharmacy or chronic complex conditions after hospital discharge. the multidisciplinary team will be integrated by a family physician (fp), a primary care nurse (pcn) and a primary care pharmacist (pcp). patient will be adults aged 65 years and older. polypharmacy refers to the use of 10 or more drugs based on information in electronic prescription software. research questions are: in elderly patients with polypharmacy, which is the effect of an interdisciplinary medication review after hospital discharge in comparison with standard care, in terms of: * new hospitalization episodes? * number of drugs prescribed? * prescribed drugs adequacy?

centres will be randomized to medication review intervention or usual care group. eligible patients will be ask for informed consent. for patients in the intervention group, pcp will collect information about prescribed medication and diseases from the electronic health record and e-prescribing application. the medication review in primary care will be focus to reconcile the medications the patient was taking prior to admission and those initiated in hospital, with the medications they should be taking post-discharge to ensure all changes are intentional and that discrepancies are resolved as soon as possible. the review process will include detection of potential drugs interactions, wrong doses, lack of adherence (based on dispensing recorded data) and adequacy to explicit criteria for potentially inappropriate prescriptions included in different tools: a) stopp-star, stopp-pal, less-chron lists; b) guideline for medication review in primary care, a local publication and c) medication review in patients with polypharmacy. a list of drugs frequently associate with potentially inappropriate prescriptions. andalusian health service). pcp will write a report to communicate the results of medication review to primary care physician and nurse. the multidisciplinary team will define a personalized therapeutic plan to be implemented for every patient. patients in the control group will receive usual care.

Eligibility criteria:
inclusion criteria: - hospital discharge in the last 48 h and one of the following conditions: * polypharmacy: ten o more drugs prescribed in a chronic schedule or * complez chronic condition exclusion criteria: * patients in last days of life * major mental health disorder * patient on dialysis * organ transplant patients

Keywords: medication review polypharmacy
icbt for psychological symptoms related to the covid-19 pandemic remaining after societal opening

Conditions: Depression Symptoms; Anxiety Symptoms

Summary: this study aim to investigate the effects of internet-based cognitive behavioral therapy (icbt) addressing psychological symptoms related to the covid-19 pandemic and its consequences that remain after societal opening. the target group is adults (18 years or older) who still experience psychological symptoms related to the pandemic and the icbt consists of eight modules during eight week with weekly support by a therapist. icbt will be compared to a wait-list control condition. participants will be recruited in sweden with nationwide recruitment.

the study is a randomized controlled trial about the effects of icbt regarding psychological symptoms related to the covid-19 pandemic and its consequences remaining after societal opening. primary outcome measures are depression symptoms (measured with beck depression inventory-ii) and anxiety symptoms (measured with generalized anxiety disorder-7). other outcome measures used will for example be about stress symptoms, sleep problems, post traumatic stress symptoms and quality of life. because of uncertainties about the psychological effects of covid-19 pandemic, a transproblematic individually tailored treatment will be used that has been tested in several previous trials and adapted for addressing problems related to the pandemic and its consequences. the study (nor the recruitment within it) has not a focus on whether people have or have not been infected by the covid-19 virus.

Eligibility criteria:
inclusion criteria: * experience mental health problems related to the covid-19 pandemic and/or its consecuences, which are still experienced as a problem (when the pandemic is not considered as dangerous to the society) * 18 years or older * adequate ability to speak, read and write in swedish * having access to the internet and a smartphone, computer or other device exclusion criteria: * severe psychiatric or somatic issues that makes participation harder or impossible (which can include the diagnosis postcovid) * ongoing addiction * acute suicidality * other ongoing psychological treatment * recent (within the past 3 months) changes in the dose of psychotropic medication or planned change during the treatment weeks

Keywords: covid-19 corona postpandemic internet-based cognitive behavioral therapy (icbt) internet intervention depression anxiety
rehabilitation in subjects with moderate chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: 1. a diagnosis of moderate copd. 2. motivation for pulmonary rehabilitation. exclusion criteria: 1. comorbidity contraindicating rehabilitation. 2. participation in pulmonary rehabilitation within the last year. 3. cognitive disorders limiting the ability to participate in physical training and education sessions.

Keywords: effect of pulmonary rehabilitation. exercise capacity quality of life
insulin dosing practices in persons with diabetes on multiple daily injections

Conditions: Diabetes; Medication Adherence; Technology; Insulin

Summary: in this cross-sectional study the investigators will examine two populations: young adults with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on \> 2 insulin injections per day. the sample size for this observational study will be up to 125 patients. the investigators will issue a common sensing gocap bluetooth-enabled pen cap that fits on the end of solostar lantus and apidra insulin pens; this pen cap registers the position of the insulin pen plunger and automatically sends confirmation of dose delivery to a smartphone app.


Eligibility criteria:
inclusion criteria: * type 1 diabetes or insulin-requiring type 2 diabetes * \> 2 insulin injections * age 18-35 or older than 65 years * use of glargine insulin as basal insulin * stable insulin doses for past 3 months exclusion criteria: * previous tape/adhesive allergies with cgm sensors * visual or cognitive impairment with inability to self-administer insulin

Keywords: diabetes insulin medication adherence
effectiveness of the gumchucks® flossing system compared to string floss for interdental plaque removal in children

Conditions: Gingivitis; Plaque

Summary: this study evaluates the interdental plaque removal efficacy, flossing speed, and reduction in gingival inflammation of a new flossing system (gumchucks®) compared to string floss, and to assess preference between the two flossing products in children, parents, and dentists.


Eligibility criteria:
inclusion criteria: * healthy children aged 4-15 years, who were not on any type of medication * presence of at least 4 posterior interdental contacts * ability to follow verbal and/or written instruction * availability for a 4-week study period * one parent or legal guardian of each included child participant. exclusion criteria: * had antibiotics within the last 6 months * are pregnant.

Keywords: interdental plaque flossing aid children gingival inflammation
state-wide health approach to increase reach and effectiveness: study 2

Conditions: Obesity

Summary: behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. this project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and tests the efficacy of adding components designed to enhance accountability and increase motivation for weight loss.

this is a randomized trial. participants will be randomly assigned to 1 of 3 treatment arms: (1) shape up rhode island (a community-based weight loss campaign) plus and internet-based behavioral weight loss program (suri+ibwl), (2) suri + ibwl + optional group sessions (suri+ibwl+group), or (3) suri+ibwl + monetary incentives for submitting self-monitoring information and achieving clinically significant weight loss. the primary outcome is weight loss at 12 weeks.

Eligibility criteria:
inclusion criteria: 1. body mass index \>=25 kg/m2 2. english speaking exclusion criteria: 1. health problems that make weight loss or unsupervised exercise unsafe 2. current pregnancy or plan to become pregnant in the next 12 months 3. planned relocation 4. previous participation in shape up rhode island research studies
jailed-balloon technique in coronary bifurcation lesion pci

Conditions: Coronary Artery Disease

Summary: this study aims to test the hypothesis that jailed-balloon technique(jbt) is superior to jailed-wire technique(jwt) in non-left main coronary bifurcation percutaneous coronary intervention(pci) by lowering the risk of side branch(sb) loss and pci related myocardial infarction, as well as 1-year major adverse cardiovascular events(maces).

1. objective: to compare the protective effect between jbt and jwt during pci for non-left main coronary bifurcation lesions. 2. background: solid evidence is scant to compare the protective effect between jbt and jwt during pci for non-left main coronary bifurcation lesions. 3. study design: this is a multi-center, prospective, randomized study. 4. methods 4a. study populations: patients with non-left main coronary bifurcation lesions(medina 1,1,1 ), which sbs are less than 2.5mm and more than 1mm, are enrolled in this study. patients are randomized to jbt group and jwt group. 4b. procedure: for patients enrolled in jbt group, a monorail balloon is placed at the ostium of sb to protect the sb before the stent in main branch(mb) is deployed. only a ptca wire would be placed in the sb while stenting mb for patients randomized in jwt group. only drug-eluting stent should be implanted in the target vessel.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years and ≤75 years; 2. de novo medina 1,1,1 coronary bifurcation with a main branch(mb) \>2.5mm while side branch \ 1.5mm; 3. only one bifurcation lesion need to be treated in one vessel; 4. the target lesion in mb has stenosis more than 75% or fractional flow reserve(ffr) less than 0.75 and the stenosis in sb ostium is more than 50%; 5. signed consent is obtained. exclusion criteria: 1. left ventricular ejection fraction(lvef) less than 30%; 2. hemodynamic instability or cardiac shock; 3. myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dl; 4. tumor with expected survival less than 1 year; 5. autoimmune disease; 6. active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy; 7. acute coronary syndrome require emergency pci; 8. coronary bifurcation need to be treated with two-stent strategy; 9. not suitable for drug-eluting stent(des) implantation; 10. mental disorder or alcohol dependence; 11. pci or coronary artery bypass graft (cabg) within 6 months before enrollment; 12. target lesion is in-stent restenosis; 13. women in gestation period or lactation period or human chorionic gonadotropin (hcg) urine test positive.

Keywords: coronary artery disease percutaneous coronary intervention bifurcation jailed-balloon technique
team based equity conscious telemedicine approach to hypertension

Conditions: Hypertension

Summary: the purpose of study is to understand the different factors (patient, societal, provider, clinic, health system) relevant in recruitment and participation of patients in team based equity conscious telemedicine approach to improve hypertension clinical trial.

black patients suffer disproportionate hypertension (htn) burden with worse control, resulting in htn-related mortality rates twice those observed in non-hispanic white patients. contextually informed care approach is urgently needed in black patients for htn management. this study will evaluate multi-level barriers and facilitators for recruitment and participation of black patients in a team based equity conscious telemedicine approach to improve hypertension (tet-htn) clinical trial. this study will also evaluate the feasibility of tet-htn intervention in a randomized comparison with usual clinic-based hypertension care approach.

Eligibility criteria:
inclusion criteria: * african american or black * patients with last clinic systolic blood pressure \>140 mmhg or diastolic blood pressure \>90 mmhg or both exclusion criteria: * unable to read or speak english * diminished ability to measure home bp (dementia, or psychosis) * acute health changes in past 3 months increasing chance of bp instability (hospitalization); * terminal illness.

Keywords: high blood pressure telemedicine african-american
genetics of arteriovenous malformations

Conditions: Arteriovenous Malformation

Summary: the goal of this study is to identify genetic alterations resulting in the development of arteriovenous malformation (avm) in the central nervous system.

the study will include avm patients and members of their nuclear family. all patients will donate a sample of saliva (5 ml) or blood (10 ml). basic demographic and clinical parameters will be collected, including ethnicity, age at first presentation, symptoms at presentation, history of subsequent symptoms, treatment history, spetzler-martin avm grade, medication history, and other pertinent medical information. in patients undergoing avm resection, a small sample of the avm will be collected for concurrent genomic analysis. family members will donate saliva (5ml) and document their relationship to the patient (i.e., parent, sibling, child, etcl). nucleic acids will be isolated from the saliva/blood samples, and genetic sequencing will be carried out. when a surgical sample of the avm is available, nucleic acids will be obtained and transcriptome profiling will be performed. identification of genetic alterations common to patients with avm and not present in samples from parents and siblings will greatly aid in identification of pathways associated with avm formation. candidate sequences will be chosen by differential expression (p\<0.05) and fold-changes. once identified, mechanisms for the rapid detection of marker sequences will be developed and their predictive value tested in future collections.

Eligibility criteria:
inclusion criteria: * age between 6 and 60 years inclusive * diagnosis of avm or nuclear family member of a patient with avm * grants access to saliva, blood, and/or tissue exclusion criteria: * age less than 6 years or greater than 61 years * nuclear family members who do not share the same parents as the avm patient