Kornimate/medical-research-clean huggingface dataset:
ventrassisttm lvad as a bridge to cardiac transplantation - pivotal trial

Conditions: End-stage Heart Failure; Cardiomyopathies

Summary: the purpose of this study is to evaluate the safety and effectiveness of ventrassisttm lvad in individuals who are awaiting heart transplants.

lvads are efficacious in improving survival and functional status when used as a bridge to transplantation. the purpose of this study is to evaluate the safety and effectiveness of the ventrassist lvad in providing circulatory support in individuals who are awaiting heart transplants. the ventrassist lvad is a centrifugal flow pump. its small size and mechanical simplicity offers benefits not available with currently approved lvads, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.

Eligibility criteria:
inclusion criteria:(the following are general criteria; more specific criteria are included in the study protocol): * approved and listed for cardiac transplantation. * patient for whom lvad implantation is planned as a clinically indicated bridge to cardiac transplantation. exclusion criteria:(the following are general criteria; more specific criteria are included in the study protocol): * presence of heart conditions that would contraindicate lvad implantation by adversely affecting patient survival or lvad function. * primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents. * presence of any mechanical circulatory support other than intra-aortic balloon pump. * therapy with an investigational intervention at the time of screening.

Keywords: ventrassisttm lvad end-stage heart failure cardiomyopathy
comparison of the efficacy and safety of atorvastatin monotherapy vs. combination atorvastatin/fenofibric acid

Conditions: Mixed Hyperlipidemia

Summary: the purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals with atorvastatin 10mg monotherapy.

study conduct according to the standard operating procedure * the sponsor, the investigator, and all other persons involved in the study at the study center or other facilities should conduct the study in accordance with the study protocol, each standard operating procedure, and korea good clinical pratice. data quality control * in order to ensure the reliability of all study-related data and their appropriate processing, the sponsor will apply quality control to each step of data handling monitoring * in order to confirm that the study is being conducted, recorded and reported according to the study protocol and international conference on harmonization good clinical practice(ich-gcp), the sponsor or cro will perform monitoring of study procedure. in monitoring, the monitors will cross check the description in the case report form, etc. against study-related records such as source documents to confirm that the description is accurate. measures taken to cope with adverse events and reporting procedure * the investigator should notify the event to the sponsor or contract research organization(cro) immediately (within around 24 hours) after having noticed the occurence of a serioius adverse event by telephone, fax or e-mail. the investigator should complete and submit an serioius adverse event(sae) report form containing all information to the institutional review board (irb). data management * in this study, data will be collected in electronic case report form(crf) * data validation for missing data will be managed by computer programming and manual check.

Eligibility criteria:
inclusion criteria: * patients of the age of 20years or older * patients who have been taking atorvastatin 10mg 1 tab per day for more than 8 weeks before screening * patients who meet the following criteria 1. low density lipoproteins-cholesterol level \< 130mg/dl 2. 150mg/dl \< triglyceride level \< 500mg/dl 3. hdl-cholesterol level \< 45mg/dl * patients who consent for the consent before enrolling the study exclusion criteria: * allergic to hmg-coa reductase inhibitor and fibrates * uncontrolled hypertension * unstable angina, myocardial infarction, transient ischemic attack * uncontrolled diabetes * thyroid disease * myopathy, rhabdomyolysis history * alcoholic * chronic diarrhea, gastrointestinal disease * malignant tumor * patients who are pregnant * lactating woman

Keywords: hyperlipidemia atorvastatin fenofibric acid combination monotherapy
a study to evaluate the efficacy and safety of mizoribine in the treatment of refractory nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: to demonstrate that the treatment effect in refractory nephrotic syndrome of mzr is non-inferior to that of standard therapy ctx through analyzing overall remission rate after treatment.


Eligibility criteria:
inclusion criteria: * patients who have medical history with clear documentation of diagnosis of nephrotic syndrome * patient who received renal biopsy within 1 year prior to screening and confirmed the pathologic classification: minimal change disease (mcd), iga nephropathy, mesangioproliferative glomerulonephritis (mspgn), membranous nephropathy (mn), focal segmental glomerulosclerosis (fsgs) * patient with the above different pathologic classification who received adequate hormone therapy more than 8 weeks (including fsgs more than 12 weeks)prior to screening and have 24hr-urine protein≥2.0g/day at screening adequate hormone dose is defined as prednisone (prednisolone) equivalent dose of 0.8 to 1.0 mg/kg/day (inclusive) * male or female patient between 18 and 70 years (inclusive) at informed consent obtained date * patient with body weight between 40kg and 80kg (inclusive) at screening * patients who sign the informed consent form exclusion criteria: * other primary nephrotic syndrome, e.g. membrano-proliferative glomerulonephritis (mpgn) * secondary nephrotic syndrome (e.g. diabetic nephropathy, anaphylactic purpura nephritis, lupus nephritis, type b hepatitis-related nephritis, renal amyloidosis) * patient who had history of allergy to any investigational product (mzr, ctx) or hormone * patient who had received accumulated dosage of ctx \>3g within one year prior to screening * patient who had received immunosuppressant or chinese traditional medicine with immunosuppressive effect within 30 days prior to screening * patient who received other investigational drugs within 30 days prior to screening * patient who have received plasma exchange therapy or immunoadsorption therapy within 30 days prior to screening * patient who require pentostatin or live vaccine (not including flu vaccine) * patient who is undergoing renal replacement therapy * patient who received kidney transplantation * patient with malignancy * patient with severe hypertension (sbp \> 160mmhg or dbp \> 100mmhg) which has not been effectively controlled * patient with white blood cell count \<3×109/l /l(=3.0 gi/l) * patient with scr \> 176.8μmol/l * patient who has a value that is \> 3 times of the upper limit of normal range for ast or alt * patient with hepatitis b, hepatitis c or hiv infection * patient with other serious infections * patient who is unsuitable for participating in this study in the opinion of investigators ( e.g. uncontrolled diabetes, central nervous system lupus , lupus encephalopathy, active psychosis,osteonecrosis of the femoral head, fulminant hepatitis, peptic ulcer, etc.) * female patient who is pregnant, currently breast feeding or willing to become pregnant * patient with any other diseases that would affect the evaluation of efficacy or safety
safety and acceptability of using a rewetting drop with contact lens wear

Conditions: Ametropia

Summary: testing the safety and acceptability of using a rewetting drop with contact lenses


Eligibility criteria:
inclusion criteria: * adapted contact lens wearer exclusion criteria: * monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
vibrant study of vurolenatide in adult patients with short bowel syndrome.

Conditions: Short Bowel Syndrome

Summary: a study of vurolenatide in adult patients with short bowel syndrome.

a phase 2 study of vurolenatide in adult patients with sbs. patients were planned to be dosed in four treatment groups with placebo and/or active vurolenatide. the study is 13 weeks (3 weeks screening, 4 weeks sc study drug administration, and 6 weeks of follow up). safety and efficacy will be analyzed.

Eligibility criteria:
key inclusion criteria: criteria for patient inclusion in this study are as follows: 1. male and female adults with sbs secondary to surgical resection of small intestine 2. 18-75 years of age at the time of screening. 3. female patients must be postmenopausal (at least 2 years prior to dosing) or surgically sterile or agree to use an acceptable form of birth control from screening until 30 days after last dose. if oral contraceptives are used, patients must have been on a stable dose for ≥6 months. 4. male patients must agree to use an acceptable form of birth control during the study and for 30 days after the last dose. male patients should not donate sperm for 90 days after last dose. 5. at least 6 months since last surgical bowel resection. 6. patients may be on parenteral support \[ps\] (nutrition and/or fluid and electrolytes for at least some of their nutritional needs). 7. if on ps, stable administration of ps volume for 1 month (±20% vol) prior to enrollment \[stable administration of ps volume confirmed by medical monitor\]. 8. able to ingest solid or semi-solid foods and drink. key exclusion criteria: criteria for exclusion from participation in this study are presented below. 1. pregnancy or lactation 2. body mass index at screening \ 30 kg/m2 3. clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study 4. active crohn's disease or ibd (as evaluated by standard procedures employed by the investigator/institution). if in remission, must be ≥12 weeks of remission prior to screening 5. inflammatory bowel disease patients who have not been on a stable drug treatment regimen for at least the past 3 months prior to screening 6. visible blood in the stool within the last 3 months 7. known heart failure or active coronary disease 8. alcohol or drug abuse within the last 12 months by history, or a disqualifying positive urine drug test at screening. 9. inadequate renal function as defined by serum creatinine \ 1.3 mg/dl (in men) and \ 1.1 mg/dl in women. 10. personal or family history of medullary thyroid cancer. 11. history of pancreatitis 12. any use of growth hormone, or growth factors such as native glp-2 or glp-2 analog (teduglutide) within the last 3 months 13. use of antibiotics within the last 30 days 14. patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
silver foam dressing superior to porcine xenograft in pediatric scalds

Conditions: Burns Scald

Summary: prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years.

aim: the aim of this study was to compare two different treatment regimes for children with partial-thickness scald burns. burns were treated with either a porcine xenograft (ezderm®, mölnlycke health care, gothenburg, sweden) or a silver foam dressing (mepilex® ag, mölnlycke health care, gothenburg, sweden). methods: a prospective randomized clinical trial including 58 children admitted between may 2015 and may 2018 for partial-thickness scalds to the burn centre in linkoping, sweden. primary outcome was time to wound closure. secondary outcomes were pain, need of surgery, wound infection, length of hospital stay, required dressings changes, and labour time.

Eligibility criteria:
inclusion criteria: * partial-thickness scald burns admitted within 72 hours of injury and with burns suitable for porcine xenograft according to the burn surgeon on duty were eligible and enrolled after (guardians) consenting to participate. exclusion criteria: * children with other severe concomitant cutaneous trauma, skin disease, or children with a known hypersensitivity to silver.

Keywords: burns dressings healing
scintigraphy study in healthy volunteers to characterize the performance of alln-346 tablets

Conditions: Hyperuricemia; Gout

Summary: the purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when alln-346 formulations are given with light meal or in fasted or other fed states.

this study includes two parts. part one will evaluate two alln-346 formulations, a fast release and a slower sustained release. subjects will receive a single tablet of each formulation and a capsule of each formulation at separate assessment visits. subjects will attend a maximum of 4 assessment visits. the primary purpose of this part of the study is to understand the gastrointestinal transit time and disintegration behaviour of the formulations in vivo in normal healthy volunteers when alln-346 formulations are given with light meal. part two will involve a second cohort of subjects and will comprise further scintigraphic studies on one or both formulation(s) from part one in fasted and/or fed states. subjects will attend a maximum of 4 assessment visits, the number of treatment arms will be decided following completion of part one.

Eligibility criteria:
inclusion criteria: * bmi between 18 and 30 kg/m², inclusive. * body weight ≥50 kg * voluntary written informed consent * good general health with no clinically significant and/or relevant abnormalities of medical history or prior to dosing evaluations, including physical examination, vital signs and ecg and screening clinical laboratory results exclusion criteria: * current or recurrent disease that could affect the study conduct or laboratory assessments * history of current or relevant previous non-self-limiting gastrointestinal disorders * currently suffering from disease known to impact gastric emptying, e.g., migraine, type 1 or type 2 diabetes mellitus * untreated hypertension or has hypertension under treatment. * diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression. * as a result of a physical examination or screening investigations, and available prior to dosing evaluations, the pmi or medically qualified designee/physician responsible considers the volunteer unfit for the study * any contradictions to the gamma scintigraphy procedure * measured body temperature \>38°c at screening visit (covid-19 risk reduction procedure)
music intervention on golfers under mental fatigue

Conditions: Mental Fatigue

Summary: this study aims to evaluate the effects of music intervention on golf-specific skill performance under mental fatigue. it is a randomised, controlled, double-blind design. the study consists of three main phases: familiarisation with the experimental procedure, baseline testing, and the formal experiment. during the formal experiment, participants will be randomly assigned to one of the following three groups: (mf-mu group) participants undergo a mental fatigue induction task followed by a music intervention; (mf-nmu group) participants undergo a mental fatigue induction task but do not receive a music intervention; (con group) participants neither undergo a mental fatigue induction task nor receive a music intervention. the total intervention duration is 45 minutes, consisting of 30 minutes of mental fatigue induction and 15 minutes of music intervention. in conditions where mental fatigue induction or music intervention is not conducted, participants will remain in the same experimental environment and rest quietly for the same duration to control for external confounding factors and ensure experimental consistency. immediately after the intervention, participants will complete golf skill testing, with the testing site located within a 2 minutes walking distance from the intervention area. performance outcomes include driving performance, iron shot performance, chipping performance, and putting performance.


Eligibility criteria:
inclusion criteria: * athletes must be between 18 and 24 years old. * be registered golfers in the national colleges and universities golf championship. * have at least three years of specialised golf training. * engage in at least five weekly training sessions. exclusion criteria: * colour blindness. * hearing loss. * insomnia. * physical injuries. * ongoing mental health issues. * the use of any medication that might influence cognitive. * the use of any medication that might influence physical performance.

Keywords: lack of energy feelings of tiredness decreased attention impaired cognitive impaired behavioral performance
criteria for advanced prosthetic foot prescription

Conditions: Prosthesis User; Amputation; Traumatic, Limb, Lower

Summary: the purpose of this study is to develop criteria for prosthetic foot prescription for veterans and service members with transtibial limb loss. the objectives are to: 1) determine the appropriate functional outcome tests and measures to support the prescription of a type of energy storing and returning (esr) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a veteran or service member with transtibial limb loss. 2) correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) develop criteria for the appropriate prescription of non-articulating esr, articulating esr, and active plantar flexion esr ankle-foot units.


Eligibility criteria:
inclusion criteria: * deers eligible veteran or service member, or civilian with unilateral transtibial amputation * currently using an energy storing and returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis * achieved a "modified independence" score on the functional independence measure (fim) for the locomotion mobility items * has a minimum clearance of 8 ¾ inches to accommodate all feet exclusion criteria: * has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures * has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis), * weighs more than 275 pounds, the maximum product weight load * is unable or unwilling to comply with all research visits * has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study * women who are pregnant or plan to become pregnant during study activities. this will be determined by asking the participant if they are pregnant or if they believe that they may be pregnant. this question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study. * poorly fitting socket * vision loss that requires use of an assistive device for gait * upper limb amputation

Keywords: prosthetic limb design prosthesis fitting
cyber-human systems for personalized well-being and health

Conditions: Geriatric Health Services; Health Services for the Elderly

Summary: the purpose of the present study is to evaluate the effectiveness of using multi-parameter monitoring devices in the elderly to improve their quality of life not already understood as the absence of disease but in a logic that is intrinsically linked to the body-mind relationship, which is increasingly significant as biological age advances. the study will be conducted on a sample of volunteer elderly subjects who will wear devices capable of constantly monitoring vital parameters such as heart rate, physical activity, sleep quality, stress levels and higher level activities, linked sensory and cognitive aspects ecologically integrated with the elderly person's living environment, in the sense of an evaluative and qualitative focus on relationships within the person's area of action/interaction, possibly supported and stimulated by individualized and easily usable activities. the signals interpreted and returned by the technology to the elderly person who uses it can also act as a reassuring self-assessment of even normal body states, sometimes experienced as threatening and anxiogenic, thus stressful. the collection and management of these data may serve as a reference to the recognition of distress signals and complex experiences (e.g., depressive) that normally have significant effects on mental health, understood as intrinsically linked to the health of the body.


Eligibility criteria:
inclusion criteria: * healthy male and female aged 60 years and older * signing of informed consent exclusion criteria: * chronic diseases * cardiovascular disease * presence of dementia and/or depression * presence of confirmed paranoid or psychotic symptoms

Keywords: elderly wellbeing artificial intelligence quality of life ai
transcranial direct current stimulation (tdcs) as an add-on therapy for treatment of major depressive disorder. (deptdcs2014)

Conditions: Depression

Summary: the aim is to investigate the safety and effectiveness of transcranial direct current stimulation (tdcs) in patients with moderate to severe major depression compared to patients treated with conventional therapy. the tdcs will be used as add-on to conventional therapy. this is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.


Eligibility criteria:
inclusion criteria: * fulfils the icd-10 diagnostic criteria for moderate or severe major depressive episode (f32), or recurrent major depressive episode (f33) * able to understand the purpose and potential risks of the study * able to sign informed consent exclusion criteria: * intracranial metal implants or other foreign intracranial metal object * history of neurological conditions e.g. epilepsy, stroke (ischemic or haemorrhagic); brain tumor; increased intracranial pressure etc. * schizophrenia * bipolar disorder * psychotic disorder * substance abuse or dependency * contra-indications to tdcs * personality disorder that may prevent him/her to commit to the study * skin lesion in the area of stimulation * planned treatment of current depressive episode with ect or rtms