Kornimate/medical-research-clean huggingface dataset:
optivol for precision medical management of heart failure

Conditions: Ischemic and Non-ischemic Cardiomyopathy

Summary: this clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in guideline directed medical therapy (gdmt) in the intervention group compared to the conventional group in patients with ischemic and non-ischemic cardiomyopathies.

subjects in this study will be randomized (2:1) to an intervention group whose medical care will be guided by data from a cardiac implantable electronic device (cied) including information on heart rate, activity, and fluid status derived from the optivol monitor versus a conventional management control group. subjects will followed for 12 months with follow up contact for 6 consecutive months and a chart review at 12 months. the study population will include patients with ischemic and non-ischemic cardiomyopathy who have had an icd implanted per standard of care guidelines.

Eligibility criteria:
inclusion criteria: * 18 to 85 years of age on the date of randomization * icd implantation per guidelines for primary prevention in patients with ischemic and non-ischemic cardiomyopathy ≥3 calendar months ago. * smart phone or tablet with bluetooth capability with internet access. * no other identifiable reversible cause explaining the left ventricular dysfunction exclusion criteria: * crt implanted * lvef\>45% in the last echocardiogram or other clinic imaging study performed. * medtronic device generator and/or device components not implanted * unstable clinical condition, life threatening arrhythmia * heart failure hospitalization within the preceding 3 calendar months * cognitive impairment * severe renal dysfunction (egfr \< 30 ml/min/m2) * serious known concomitant disease with a lift expectancy of \< 12 calendar months * non-ambulatory nyha class iv * pregnancy

Keywords: icd optivol-monitor cardiac compass garmin vivo smart guideline directed medical therapy
efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) treatment for hiv/hcv co-infected participants who switch to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (e/c/f/taf) or emtricitabine/rilpivirine/tenofovir alafenamide (f/r/taf) prior to ldv/sof hcv treatment

Conditions: HIV-1 Infection; HCV Infection

Summary: this study will evaluate efficacy of ledipasvir/sofosbuvir (ldv/sof) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (e/c/f/taf) or emtricitabine/rilpivirine/tenofovir alafenamide (f/r/taf) from the current antiretroviral (arv) therapy and in virologically-suppressed, hiv-1/hcv co-infected participants.


Eligibility criteria:
key inclusion criteria: * chronic genotype (gt) 1, hcv infected, male and non-pregnant/ non-lactating female individuals, without cirrhosis, treatment-naive or treatment-experienced with interferon (ifn) +/- ribavirin (rbv) +/- hcv protease inhibitor (pi). * compensated cirrhotic individuals must be hcv treatment-naive. * no prior treatments with ns5a and ns5b or any hcv direct acting antivirals, except boceprevir, telaprevir and simeprevir, in combination with ifn and rbv * currently on an arv regimen (2 nrti + a third agent) without change for 6 months prior to screening. * documented plasma hiv-1 rna levels \< 50 copies/ml (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is ≥ 50 copies/ml) for ≥ 6 months preceding the screening visit. after reaching hiv-1 rna \< 50 copies/ml, single values ("blips") of hiv-1 rna ≥ 50 copies/ml followed by resuppression is allowed. * for individuals with 3 or more prior arv regimens, a regimen history should be provided for approval by the sponsor. * note: individuals that changed from tdf to taf less than 6 months ago will be eligible as long as the tdf/ taf change was the only change to the regimen. * plasma hiv-1 rna level \< 50 copies/ml at the screening visit * have no documented resistance to any of the hiv study agents at time in the past, including but not limited to the reverse transcriptase resistance mutations k65r, k70e, k101e/p, e138a/g/k/r/q, v179l, y181c/i/v, m184v/i, y188l, h221y, f227c, m230i/l, the combination of k103n+l100i, or 3 or more thymidine analog associated mutations (tams) that include m41l or l210w (tams are m41l, d67n, k70r, l210w, t215y/f, k219q/e/n/r). if a historical genotype prior to first arv is not available or individual had 3 or more prior arv regimens, individual will have proviral genotype analysis for archived resistance prior to day 1. * no history of hiv virologic failure * no evidence of hepatitis b infection * estimated glomerular filtration rate (egfr) ≥ 30 ml/min as estimated by cockcroft-gault formula note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: hiv hcv antiretroviral therapy hcv direct acting antiviral(s) (daa)
comparing self monitored blood glucose (smbg) to continuous glucose monitoring (cgm) in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the use of smbg and cgm for clinical decisions related to the management of type 2 diabetes. the secondary objective is to determine the benefit of using cgm for clinical diabetes management decision-making.

this study involves the use of the following 2 glucose monitoring methods to measure your blood sugar (glucose) levels and help manage type 2 diabetes: 1. self monitoring blood glucose (smbg): blood glucose is measured 4-7 times each day using finger sticks and an blood glucose meter. 2. continuous glucose monitoring (cgm): blood glucose is measured continuously via the cgm device. this device has been approved for use by the u.s. food and drug administration (fda).

Eligibility criteria:
inclusion criteria: * male or female ≥18 and ≤75 years of age (upper range to assure dexterity for use of cgm) * clinical diagnosis of type 2 diabetes * hba1c ≥7.0% * diabetes can be treated with any of the following therapies within one month prior to study enrollment: (1) medical nutrition therapy alone or with metformin; (2) sulfonylurea with or without metformin; (3) dipeptidyl peptidase 4 (dpp-4) inhibitor or glucagon-like peptide-1 (glp-1) agonist with or without metformin; or insulin with or without metformin. exclusion criteria: * treated with thiazolidinediones (tzd) * administered prednisone or cortisone medications in the previous 30 days * currently pregnant or planning pregnancy during the study period * presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the subject's safety or successful participation in the study * hba1c \<7.0% * unable to follow the study protocol * unable to speak, read and write in english

Keywords: type 2 diabetes continuous glucose monitoring
exome sequencing study in cardiomyopathy to identify new risk variants

Conditions: Cardiomyopathy

Summary: genetic mutations has been proved to be associated wth the onset of cardiomyopathy. in the present study, we intend to identify new related variants or genes. from march, 2003 to november, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their sampled were drawn from peripheral blood. paired control group were also enrolled. the whole exome sequencing was used to find out the variants associated with the onset of cardiomyopathy and its prognosis.


Eligibility criteria:
inclusion criteria: · patients diagnosed as cardiomyopathy according to the definition of american heart association exclusion criteria: * uncontrolled hypertension significant valvular disease * mild ischemic heart disease * significant systemic infection * thyroid-induced cardiomyopathy * excessive alcohol consumption * precious cancer treatment including irradiation * refusal to participate in the study
clinical study on bihapro total hip system with different surface coatings

Conditions: Osteoarthritis

Summary: this post market study intends to evaluate the safety and the performance of bihapro total hip system with two types of coatings.

the efficacy of the prosthesis will be evaluated comparing the pain, the function and the range of motion measured preoperatively and postoperatively using recognized clinical outcomes harris hip score. the secondary efficacy measurement is based on x-rays to measure the mineral bony thickness in the areas of gruen zones of the proximal femur.

Eligibility criteria:
the patients who are selected for this study must fit the following criteria. * candidate for a total hip arthroplasty * less than 80 years of age. * a pre-operative level of pain and function the same as for conventional joint replacement. * a likelihood of obtaining relief of pain and improved function. * full skeletal maturity. * ability to follow instructions. * good general health for age. * willing to return for follow-up evaluations. * no bias to sex.

Keywords: total hip replacement
selenium and prostate cancer: clinical trial on availability to prostate tissue and effects on gene expression

Conditions: Prostatic Neoplasms; Prostate Cancer

Summary: the aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue.

rationale: prostate cancer is a frequently observed malignancy in men, especially in elderly men. besides diagnosis and treatment, also prevention of prostate cancer is an important point of interest to reduce the incidence and mortality of prostate cancer. selenium is considered to be a promising chemopreventive agent for prostate cancer. exact mechanisms of chemoprevention by selenium are not fully understood. however, it is expected that selenium (among other effects) directly affects gene expression in the prostate. objective: the aim of this study is to get insight into bioavailability of selenium in prostate tissue and changes of gene expression profiles that might be responsible for selenium-induced chemoprevention. to meet this objective, the relationship between dietary selenium intake and changes in gene expression profiles, tissue selenium levels and blood flow in prostate tissue will be examined. study design: the present study is designed as a double-blind, randomized and placebo-controlled intervention trial. blood samples, toenails, questionnaires, mr images and surgical specimens will be collected to examine effects of selenium supplementation. study population: the study population will consist of 60 men, diagnosed with prostate cancer and scheduled for radical prostatectomy. written informed consent will be obtained from each participant. intervention: participants will receive 300 ug selenium / day or a placebo during 5 weeks prior to radical prostatectomy. selenium will be supplemented in the form of selenized yeast tablets (selenoprecise, pharma nord). main study parameters: levels of selenium in prostate tissue and changes in prostate gene expression profiles of participants supplemented with selenium or placebo, compared before and after the short intervention period, will be considered as the main parameters of the present study. besides gene expression profiles in prostate tissue, also gene expression profiles of peripheral mononuclear cells (pbmc), levels of selenium in blood and toenails and blood flow and permeability of blood vessels of prostate tissue will be analyzed.

Eligibility criteria:
inclusion criteria: * male * biopsy proven prostate cancer * scheduled for radical prostatectomy exclusion criteria: * liver diseases (e.g. hepatitis) * kidney diseases * inflammatory bowel diseases * use of dietary supplements containing selenium * adjuvant therapy for prostate cancer (e.g. hormonal therapy, hifu) * previously or concurrent diagnosed with cancer, other than prostate cancer

Keywords: prostate cancer selenium chemoprevention gene expression
the efficacy of prolonged antibiotic therapy for the prevention of relapsing peritonitis in peritoneal dialysis patients with high dialysis effluent bacterial dna fragment levels

Conditions: Peritoneal Dialysis

Summary: peritoneal dialysis (pd) is the first-line treatment of end stage renal disease (esrd) in hong kong. despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. a recent study showed that an elevated bacterial dna fragment levels in pd effluent 5 days prior to the completion of antibiotics predicts the development of relapsing or recurrent peritonitis episodes. we hypothesize that prolonged antibiotic therapy in pd patients with peritonitis and high pd effluent bacterial dna fragment levels could prevent the development of relapsing and recurrent peritonitis. we plan to conduct a randomized control study of 360 patients with pd peritonitis. after inform consent, they will be randomized to receive one additional week of the effective antibiotic treatment (the preemptive treatment group) or no additional treatment (the control group). specimens of pd effluent will be collected 5 days prior to the completion of antibiotics for the measurement of bacterial dna fragments. all patients will be followed for 6 months after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. our study will determine the efficacy of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic treatment.


Eligibility criteria:
inclusion criteria: * patients with peritoneal dialysis-related peritonitis exclusion criteria: * patients with fungal peritonitis * patients with obvious surgical problems and require laparotomy
acid suppressing drug seizure epidemiology study

Conditions: Seizure

Summary: the purpose of this study is 1. to estimate the incidence of seizure in the general population and stratified by epilepsy status 2. to estimate the relative risk of seizure associated with use of proton pump inhibitors and histamine 2 receptor antagonist and stratified by epilepsy status

a cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using thin database in the uk

Eligibility criteria:
inclusion criteria: * primary care physician for at least 2 years. * computerized prescription history of at least 1 year. * patients will have to be free of acid-suppressing drugs (ppi or h2ra) for at least one year. * no diagnosis of cancer. * no alcohol abuse or alcohol-related disease- no drug abuse. exclusion criteria: * patients with at least 1 prescription of ppi or h2ra in the year prior to start date. * cancer before start date. * alcohol abuse or alcohol-related disease before start date. * drug abuse before start date.

Keywords: seizure acid-suppressing drugs epidemiology
implementing and evaluating an internet-based cognitive behavior therapy intervention in school settings

Conditions: Depression Anxiety and Co-occurring Rural Youth

Summary: this research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders.

in the united states, and rural montana, a substantial health disparity exists for rural youths' mental health and mental health care access. in 2017, nearly a third of all montana high school students reported being impacted by depression; 21% considered suicide compared to 17% nationally. over 30% of montana adolescents indicated drinking alcohol and 20% indicated using marijuana. rural montanans face enormous barriers to behavioral health care including low mental health care provider coverage, long distances to adequate care, and stigma. we have developed a culturally and developmentally appropriate internet-based cognitive behavior therapy (icbt) program designed to teach skills that address mental and behavioral health challenges common to adolescents. building on previous development and evaluation of an adult version of icbt (thrive), the investigators propose to pilot the newly developed youth version of thrive (y-t), a fully automated stand-alone program. y-t will deliver cbt skills through educational, real life adolescent scenarios, and tailored feedback videos to address symptoms of depression, anxiety and co-occurring (addiction) behaviors. the investigators intend to conduct feasibility analyses of pilot study implementation in school communities. the investigators will document and assess organization-level facilitators and barriers that impact the study processes at each study site. short-term goal for this research are to understand how to effectively conduct trials within school community settings and to obtain preliminary information on the acceptability and effectiveness of the y-t program to address depression and anxiety symptoms, and addictive behaviors. the investigators will conduct post-intervention focus groups to assess the program as experienced by participants and insight on the extent of program engagement and learning. the investigators hypothesize that those using y-t over an 8-week period will report markedly decreased scores on anxiety, depression, and addictive behaviors. the long-term goal is to conduct a larger trial of the program to determine the evidence of impact among youth. provided that this research demonstrates such programs to be evidence-based, the investigators will work on a broader dissemination plan with the ultimate aim of decreasing mental and behavioral health and respective health care disparities among rural youth.

Eligibility criteria:
inclusion criteria: * participants are youth enrolled in participating schools * ages 13 - 18 years old * have access to electronic device to access icbt intervention exclusion criteria: * none.
study of epidemiologic investigation and mechanism of brain network of otologic and cognitive function with post-covid-19

Conditions: COVID-19; Cognitive Decline; Otological Disease

Summary: the purpose of this study was to analysis the incidence of ear symptoms, cognitive function decline and emotional disorders in chinese people who were infected with covid-19, exploring the impact of covid-19 on the auditory system, cognitive function and emotional function, and analyzing the changes in functional connectivity of brain network after covid-19 infection.


Eligibility criteria:
inclusion criteria: * confirmed cases of covid-19 that test positive for nucleic acid or antigen * after infection with covid-19, the patient has experienced hearing loss, tinnitus, ear tightness, ear pain, vertigo and other ear symptoms, memory loss, depression and so on exclusion criteria: * diagnosed cognitive disability * patients with confirmed meniere's disease, auditory neuropathy, and heavy noise exposure * those with incomplete basic information or for other reasons are unable to complete questionnaires and other listening and cognitive assessments

Keywords: covid-19 epidemiologic investigation brain network otological symptoms cognitive function
mirror therapy integrated with electrical stimulation for cortical modulations

Conditions: Peripheral Nerve Injuries

Summary: peripheral nerve injury is common and can result in loss of sensation and motor function, reduced quality of life, and prolonged time to return to work. maladaptive cortical reorganization occurs after nerve injury or immobilization and can further impair the recovery process. to improve the sensorimotor prognosis of people with peripheral nerve injury, methods such as mirror therapy, motor imagery, and electrical stimulation have been used in addition to usual care. however, no studies have shown the effect of integrating mirror therapy, motor imagery, and electrical stimulation in these individuals. furthermore, the real-time effect of mirror therapy on cortical activation in this population remains unexplored. this study aims to determine the real-time cortical modulation effects of mirror therapy combined with electrical stimulation in individuals with peripheral nerve injury.

two groups of subjects (a group of peripheral nerve injury group and a group of healthy adults) will perform hand exercises in three randomized conditions: (1) mirror therapy with electrical stimulation and motor imagery, (2) electrical stimulation and motor imagery, and (3) motor imagery. each participant performs specific sets of two exercises based on the type of nerve injury: (1) median nerve injury: picking up and putting down a pen using the thumb and index finger, and picking up and putting down a marble using the thumb and little finger. (2) ulnar nerve injury: picking up and putting down a card using the thumb and index finger, and picking up and putting down a marble using the thumb and little finger.(3) brachial plexus injury: picking up and putting down an empty cup, and picking up and putting down a pair of pliers. for combined median nerve and ulnar nerve injuries and healthy adult groups, movements corresponding to median nerve injuries are performed. each experimental condition consists of 20 repetitions, lasting 60 seconds, followed by a 30-second rest between conditions. relative alpha and beta band power in the sensorimotor cortex will be recorded and analyzed.

Eligibility criteria:
inclusion criteria: * newly diagnosed median or ulnar nerve transection injury of the forearm in the past 6 months * sufficient communication in the chinese language * being able to follow instructions * muscle atrophy or lack of voluntary contraction over the injured hand, with maximum voluntary isometric contraction (mvic) recorded with surface electromyography (emg) less than 10% compared to the non-affected hand * achieve an average score of 2 or above in the kinesthetic and visual imagery questionnaire-10 (kviq-10) for kinesthetic imagery exclusion criteria: * had central nervous disease * had a recent (1 year) history of nerve entrapment syndrome * had a history of latent neuropathy, such as diabetes or dialysis

Keywords: mirror therapy electrical stimulation cortical modulation motor imagery