Kornimate/medical-research-clean huggingface dataset:
wound bed preparation for diabetic foot ulcers

Conditions: Diabetic Foot

Summary: the study objective was to compare the efficacy of npwt versus alginates dressings on the wound bed preparation prior to stsg surgery, as well as investigating the underlying mechanisms.

the diabetic foot ulcers (dfus) are major complications of patients with diabetes mellitus. split thickness skin graft (stsg) surgery is a cost-effective method for the rapid healing of dfus. the aim of this study was to compare the efficacy of negative pressure wound therapy (npwt) using vacuum-assisted closure (vac) device versus conventional moist dressings (alginates) on the wound bed preparation prior to stsg surgery for patients with chronic dfus. this ia a prospective, randomized controlled trial. all the patients were randomly divided into two groups: the npwt group or the control group. once the dfus wound was filled with healthy granulation tissues, stsg surgery was performed. the primary endpoint included the time to stsg surgery (the duration from first surgical debridement to stsg surgery). the secondary endpoints included the survival rates of skin graft, the wound blood perfusion, the wound neutrophil extracellular traps (nets) formation, and polarization of m1 or m2 macrophages in the dfus wounds of the two groups.

Eligibility criteria:
inclusion criteria: 1. patients with dfus aged 20-80 years. 2. wagner grade 2 to 3. 3. chronic dfus wounds (duration of disease ≥ 2 weeks). 4. ankle brachial ratio (abi) 0.5～0.9, wound area 8\~20 cm2. exclusion criteria: 1. patients who were unable to complete the follow-up were not included, 2. pregnant or nursing mothers were not included. 3. patients with foot ulcers other than diabetes, peripheral vascular disease, organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included. 4. patients who received growth factors or hyperbaric oxygen therapies for the dfus wounds within one month were not included. 5. patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.

Keywords: diabetic foot ulcers negative pressure wound therapy wound blood perfusion neutrophil extracellular traps
effects of isolated lbbb on maximal functional capacity

Conditions: Left Bundle-Branch Block

Summary: left bundle branch block (lbbb) has been commonly associated with adverse cardiovascular (cv) events, but the effect of an isolated lbbb on maximal functional capacity is not well characterized. the study's main objective is to evaluate the effect of lbbb on maximum functional capacity.

left bundle branch block (lbbb) has been commonly associated with adverse cardiovascular (cv) events, but the effect of an isolated lbbb on maximal functional capacity is not well characterized. the main objective of the study is to evaluate the effect of lbbb on maximum functional capacity (objectively evaluated by the maximum oxygen consumption -vo2max- at peak exercise in a cardiopulmonary stress test -cpet-) in subjects with lbbb without known cardiovascular disease and compare these data with controls without lbbb. this is a prospective study that will be carried out in a single centre. all patients with a diagnosis of lbbb and without evidence of structural heart disease in imaging tests will be enrolled. for each candidate with lbbb, one control without lbbb and matched for age, sex, body surface area, and daily physical activity will be selected. all included subjects will undergo a cpet and echocardiography. a sample size estimation \[alpha: 0.05, power: 80%, and a clinically significant vo2max difference between groups of at least 10%\] of 148 subjects (74 subjects with lbbb + 74 controls) would be necessary to test our hypothesis.

Eligibility criteria:
inclusion criteria: * adult \>18 years old * ecg criteria of left bundle branch block (for controls without left bundle branch block ) * provide informed consent exclusion criteria: * inability to perform a maximal baseline exercise test; * structural heart disease, valve heart disease or diastolic dysfunction estimated by two-dimensional echocardiography; * previous ischemic heart disease, heart failure, myocardiopathy or myocarditis * effort angina during cardiopulmonary exercise testing (cpet); * any moderate pulmonary disease; * anaemia * left ventricular ejection fraction \< 55%.

Keywords: functional capacity cardiac dyssynchrony myocardial deformation
study of brimonidine and timolol ophthalmic solution with latanoprost compared with latanoprost in glaucoma patients

Conditions: Glaucoma, Angle-Closure

Summary: this study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with combigan® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.


Eligibility criteria:
inclusion criteria: * patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study * patient must have at least partially responded to latanoprost and requiring further iop lowering eye drops * diagnosis of chronic angle-closure glaucoma * patients using combigan® in the past must not have been discontinued due to adverse events or lack of efficacy. exclusion criteria: * known allergy or hypersensitivity to combigan® * corneal abnormalities that would preclude accurate iop readings * any other active ocular disease other than glaucoma or ocular hypertension * ocular surgery within the past 3 months.
efficacy of different low level laser therapy sessions

Conditions: Myofascial Pain Syndrome

Summary: myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. it accounts for 40-60% of the adult population. different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function.

low-level laser therapy has been a research focus in past few years as it provides effective and conservative treatment modality with minimal patient discomfort. lllt promotes the release of endogenous opioids, enhance tissue repair and cellular respiration, increase vasodilatation and pain relief recent systematic review and meta-analysis had reported that the available evidence didn't allow clinicians to draw firm conclusions on effective dosage. this study aimed to investigate the effect of different lllt sessions' number on pain, maximum mouth opening and quality of life in patients with masseter muscle trigger points.

Eligibility criteria:
inclusion criteria: 1. definite diagnosis of myofascial pain based on the dc/tmd criteria with a referral 2. presence of one or more trigger points in the masseter muscle 3. no history of any invasive procedures of the related masseter muscle. exclusion criteria: 1. any painful conditions affecting the orofacial region 2. any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy) 3. pregnancy and lactation.

Keywords: trigger point pain, myofascial, laser therapy
postoperative tolvaptan use in left ventricular assist device implantation patients

Conditions: Heart Failure; Heart Assist Device; Hyponatremic

Summary: this research study will compare two standard of care approaches for managing low sodium levels in heart failure patients with left ventricular assist device (lvad). the study will compare the outcomes of lvad patients with low sodium levels who take tolvaptan to those who do not take tolvaptan. tolvaptan is fda approved for use in the study population and is commonly used to treat low sodium levels in heart failure and lvad patients. it is not known if taking tolvaptan or not taking tolvaptan is better at improving outcomes in newly implanted lvad patients with low sodium levels. by doing this study, the principal investigator (pi) hopes to learn which is better at improving outcomes.


Eligibility criteria:
inclusion criteria: * hospitalized patients with american college of cardiology (acc) and the american heart association (aha) stage d heart failure and plan to undergo lvad implantation * age greater than or equal to 18 years old exclusion criteria: * no plan for lvad implantation * age less than 18 years old

Keywords: tolvaptan
tympanic thermometers accuracy

Conditions: Fever

Summary: the aim of the present study is to evaluate the measurement precision and accuracy of the third-generation tympanic thermometer in relation to the measurement modalities considered gold standard. the evaluation of the instrument will be conducted in relation to the different calibration times of the tympanic thermometer, the level of re-training of healthcare personnel in the use of the instrument and the adult and paediatric population subjected to the measurement. finally, the diagnostic capacity of the instrument in correctly identifying states of hypothermia and febrile elevations will be assessed.

the temperature measurement will be taken on each patient enrolled at a single time by the caregiver for that patient. as the measurements do not depend on which side they are taken, the most convenient side will be chosen. each patient will only be included once the research nurse will record the core temperature from the monitor on the crf and, within the next 5 minutes, take the peripheral temperature with the tympanic thermometer three times in a row, recording all three values on the crf. subsequently a second operator will always take the temperature 3 times within 5 minutes of the gold standard measurement. the gold standard (reference tests), as indicated in the literature, can be either the thermometer inserted in the probe placed in the pulmonary artery, or the thermometer inserted in the bladder catheter or oesophageal probe, or directly a rectal thermometer. only the first tympanic measurement will then be used to assess accuracy against the gold standard. the other measurements above will only be evaluated for inter and intra reliability. the unit under study is therefore the individual patient at a precise point in time

Eligibility criteria:
inclusion criteria: * paediatric patients over the age of 4 months * adults admitted to intensive care and resuscitation * undergoing surgery who by current practice undergo invasive core temperature measurement exclusion criteria: * patients with bilateral auricular inflammatory problems, * patients who will not use the gold standard for clinical reasons, * patients or legal guardians who do not consent to participate in the study.

Keywords: thermometers sensitivity and specificity hypothermia hyperthermia
diabetes care transformation: diabetes data registry and intensive remote monitoring

Conditions: Type 1 Diabetes Mellitus

Summary: with emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for frequent and timely monitoring is now feasible. the investigators propose to leverage this new technology to provide children and families with appropriate interventions to help manage their diabetes.

the investigators will collect insulin dosing via pump records, blood glucose meter, continuous glucose sensor, activity, heart rate, and sleep data on a weekly basis from 100 children with diabetes. the investigators hypothesize that with the collection and analysis of insulin, blood glucose, sensor, activity, heart rate and sleep data in children with diabetes the investigators can identify glucose patterns and predictors of acute events. the 100 children will be randomized to either conventional therapy (data upload group) or intensive remote therapy (weekly review group). conventional therapy will consist of routine quarterly visits to the clinic and as-needed communication with the diabetes staff, initiated by the family, between study visits. intensive remote therapy will consist of routine quarterly visits to the clinic along with weekly remote review of insulin and blood glucose data by the research staff, and additional communication with the family, initiated by the diabetes staff as needed, between visits. the investigators hypothesize that with weekly, manual review of real-time insulin, glucose, and activity data in children with diabetes, and recommended regimen changes based on the data, the investigators will be able to lower hba1c values in children in the weekly review group as compared to children in the data upload group.

Eligibility criteria:
inclusion criteria: 1. type 1 diabetes, using an insulin pump (medtronic, omnipod, animas) 2. duration of diabetes \>1 year 3. age: 8-17 years of age, inclusive. 4. hemoglobin a1c 8.0-10.0% at baseline visit, inclusive. 5. seen in the mcneely diabetes clinic within the past 6 months. 6. the family/child is testing blood glucose at least 4 times a day. 7. the family has a smart phone and service. exclusion criteria: 1. the child is not using insulin for management of diabetes. 2. the child uses multiple daily injections of insulin. 3. the child is unwilling to use the wearable device, or the family is unwilling or unable to upload glucose and insulin data on a routine basis 4. the family is unwilling or unable to upload data from devices such as meter, pump, sensor, wearable device. 5. diagnosis of a mental health disorder. 6. parent/child does not speak english as the device software is only available in english.
gene analysis and treatment optimization in chinese homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia

Summary: identify new or novel genes which may impact on cholesterol level, and establish the relationship between those gene mutations with atherosclerosis, as well as responses to lipid-lowering drugs.

to better understand the genetics basis for ldl-c elevation and develop an optimized lipid-lowering strategy, we propose to do the following studies: 1. to establish a china hofh registry, and collect dna and blood samples from all available family members of each proband (pedigrees); 2. to detect gene mutations known to cause fh and identify family suitable for future whole genome sequencing aimed to identify novel genes controlling cholesterol levels. 3.to establish the relationship between types of gene mutations and lipid and atherosclerosis profile, as well as responses to lipid-lowering agents.

Eligibility criteria:
inclusion criteria: patients of any age and sex who meet clinical or genetic criteria for hofh as follows: * cutaneous xanthomata before the age of ten years * ldlc \> 13 mmol/l before treatment or \> 7.76 mmol/l despite treatment * phenotypic features in keeping with hefh in both parents exclusion criteria: inability of patient, or, if less than 18, a parent, to sign informed consent.
phase ii study of florbetaben (bay94-9172) pet imaging for detection/exclusion of cerebral β-amyloid.

Conditions: Down Syndrome; Amyloid Beta-protein

Summary: to determine the sensitivity of the visual assessment of bay94-9172 pet images in detecting cerebral β-amyloid in individuals with down syndrome (ds) and specificity in individuals without ds. given that individuals with down syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of down syndrome will serve as the standard of truth.


Eligibility criteria:
inclusion criteria: study participants were individuals with ds and healthy volunteers (hvs). * main inclusion criteria for individuals without ds * \>=21 and \<= 40 years of age * mini-mental state examination (mmse) \>= 28 * clinical dementia rating (cdr) of 0 * main inclusion criteria for individuals with ds * \>= 40 years of age exclusion criteria: * main exclusion criteria for both groups * unstable medical or psychiatric condition, study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time

Keywords: amyloid beta-protein down syndrome
sonothrombolysis in patients with an st-segment elevation myocardial infarction with fibrinolysis (sonostemi-lysis) trial

Conditions: ST Elevation Myocardial Infarction

Summary: this study will assess the safety and feasibility of sonothrombolysis in the acute management of stemi undergoing reperfusion therapy with systemic fibrinolysis as part of a pharmacoinvasive approach

this study is an open label, single-centre, randomized investigation of sonothrombolysis in 60 adult patients presenting with stemi within 6 hours of the onset of clinical symptoms and receiving perfusion therapy with fibrinolysis as part of a pharmacoinvasive strategy. patients will be randomized 2:1 to either adjunct treatment with sonothrombolysis or standard therapy alone according to the current american college of cardiology/american heart association (acc/aha) or european society of cardiology (esc) stemi and pci guidelines. all patients will receive serial echocardiography assessments during and after reperfusion with the final echo assessment at 90 days (+/- 7d) post reperfusion. patient outcomes (medical records review) will be followed for 1 year after reperfusion.

Eligibility criteria:
inclusion criteria: * patients presenting with stemi within 6 hours of symptom onset and: 1. are expected to receive reperfusion therapy with fibrinolysis 2. have a high-risk stemi ecg as defined as: * \>2mm st-segment elevation in 2 anterior or lateral leads; or * \>2mm st-segment elevation in 2 inferior leads coupled with st-segment depression in 2 contiguous anterior leads for a total st-segment deviation of \>4mm 3. age \>30 years 4. adequate apical and/or parasternal images by echocardiography exclusion criteria: * 1. isolated inferior stemi without anterior st-segment depression 2. previous coronary bypass surgery 3. cardiogenic shock 4. known or suspected hypersensitivity to ultrasound contrast agent used for the study 5. life expectancy of less than two months or terminally ill 6. known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin 7. known large right to left intracardiac shunts 8. patient received another investigational medication or treatment within 30 days prior to presentation with stemi
phase ii study of dcvac/pca added after radical primary prostatectomy for patients with localized prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether dcvac/pca added after radical primary prostatectomy can improve psa doubling times for patients with localized prostate cancer.


Eligibility criteria:
inclusion criteria: * male 18 years and older * histologically confirmed pt2 prostate cancer * post radical prostatectomy * psa values measured after the value greater than 0.020 ng/ml resulted in psa doubling time (psadt) equal or less than 12 months * salvage radiotherapy naïve with psa increase within 2 years or after salvage radiotherapy with psa not higher than 1 ng/ml * eastern cooperative oncology group (ecog) 0-2 exclusion criteria: * confirmed brain and/or leptomeningeal metastases * prior androgen deprivation therapy or orchiectomy for prostate cancer * peripheral neuropathy of common toxicity criteria (ctc) grade 2 or greater * other uncontrolled intercurrent illness * treatment with immunotherapy against prostate cancer * clinically significant cardiovascular disease * active autoimmune disease requiring treatment

Keywords: immunotherapy prostate cancer biological vaccine
study to assess the efficacy and safety of act-541468 (daridorexant) in adult and elderly subjects suffering from difficulties to sleep

Conditions: Insomnia Disorder

Summary: the main purpose of this study is to assess efficacy and safety of act-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. efficacy will be evaluated on objective and subjective sleep parameters.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure; * male or female aged ≥ 18 years; * insomnia disorder according to dsm-5 criteria; * insomnia severity index score ≥ 15; * insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography; * women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake. exclusion criteria: * body mass index below 18.5 or above 40.0 kg/m2; * any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (rem) behavior disorder, narcolepsy, or apnea/hypopnea; * cognitive behavioral therapy (cbt) only allowed if, the treatment started at least 1 month prior to visit 3 and the subject agrees to continue this cbt throughout the study; * self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week; * acute or unstable psychiatric conditions diagnosed by the mini international neuropsychiatric interview; * mini mental state examination (mmse) score \< 25 in subjects ≥ 50 years; * for female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study; * history or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments. * any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
pharmacokinetics, pharmacodynamics, and safety profile of understudied drugs administered to children per standard of care (pops)

Conditions: Coronavirus Infection (COVID-19); Pulmonary Arterial Hypertension; Urinary Tract Infections in Children; Hypertension; Pain; Hyperphosphatemia; Primary Hyperaldosteronism; Edema; Hypokalemia; Heart Failure; Hemophilia; Menorrhagia; Insomnia; Pneumonia; Skin Infection; Arrythmia; Asthma in Children; Bronchopulmonary Dysplasia; Adrenal Insufficiency; Fibrinolysis; Hemorrhage; Attention Deficit Hyperactivity Disorder; Multisystem Inflammatory Syndrome in Children (MIS-C); Kawasaki Disease; Coagulation Disorder; Down Syndrome

Summary: the study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. the primary objective of this study is to evaluate the pk of understudied drugs currently being administered to children per soc as prescribed by their treating provider.


Eligibility criteria:
inclusion criteria: 1. participant is \< 21 years of age 2. parent/ legal guardian/ adult participant can understand the consent process and is willing to provide informed consent/hipaa: 3. (a) participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) participant is not receiving one or more of the study drugs of interest but is sars-cov-2 positive within 60 days prior to enrollment exclusion criteria: 1. participant has a known pregnancy below exclusion criteria apply only to: participants receiving one or more of the study drugs of interest at the time of enrollment, doi administration or pk sampling: (refer to doi specific appendices for details on enrollment cohort specifications and additional eligibility criteria) 2. has had intermittent dialysis within previous 24 hours 3. has had a kidney transplant within previous 30 days 4. has had a liver transplant within previous 1 year 5. has had a stem cell transplant within previous 1 year 6. has had therapeutic hypothermia within previous 24 hours 7. has had plasmapheresis within the previous 24 hours 8. has a ventricular assist device 9. has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study