Kornimate/medical-research-clean huggingface dataset:
scibase international melanoma pivotal study

Conditions: Malignant Melanoma

Summary: the purpose of this clinical investigation was to determine the safety and effectiveness of the scibase iii device (test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (eis) relative to the histological gold standard (reference). the purpose of the study is to collect data to support a pre-market application(pma) to obtain food and drug administration(fda) approval to market the scibase iii electrical impedance spectrometer.


Eligibility criteria:
inclusion criteria for inclusion in the study, all subjects had to fulfill all of the following criteria: * men or women of any ethnic group aged ≥18 years * primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise. * lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter * in subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. note: a subject may only be entered into the study once. * the subject is willing and able to read, understand and sign the study specific informed consent form. exclusion criteria: subjects were excluded from the study if they fulfilled any of the following criteria: * skin surface not measurable, e.g. lesion on a stalk * skin surface not accessible, e.g. inside ears, under nails * lesion located on acral skin, e.g. sole or palms. * lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions. * lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers. * lesion located on genitalia. * lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized. * lesion located on mucosal surfaces. * skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration. * lesion with foreign matter, e.g. tattoo, splinter * lesion and/or reference located on acute sunburn.
the early prediction of sepsis in icu

Conditions: Prediction of Sepsis in Critical Patients

Summary: sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. we aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the icu.


Eligibility criteria:
inclusion criteria: patients who met all of the following criteria were included in the case group: 1. at least 14 years old. 2. sepsis onset at least 5 hours after icu admission. 3. sepsis onset is the first instance since admission to the hospital. exclusion criteria: patients meeting all of the following criteria were included in the control group: 1. at least 14 years old. 2. patients staying in icu for at least 5 hours and have not had sepsis in this time. 3. patients without icd-9 codes for sepsis (785·52, 995·91, 995·92). 4. sofa score change is not more than 1 point in an arbitrary continuous 72 hours in the icu stay.
effects of multimodal training of combined cognitive and/or physical training on cognition and fitness of older adults

Conditions: Cognitive Decline; Cognitive Impairment, Mild

Summary: the elderly population worldwide is expected to increase exponentially. there will be a higher percentage of older adults suffering cognitive decline in the coming decades. cognitive impairment, being the most common health problem associated with ageing, contributes to possible loss of functional independence and disability. the purpose of this study is to determine the effectiveness of four mixed modalities of three training programs (combined cognitive and physical training \[ccpt\], cognitive or physical training only) on cognition and fitness of community-dwelling older adults in hong kong. the study hypotheses will be set as the integrated format of all three training will have higher cognition and fitness scores than other combinations of two training modes and all these mixed modalities will have greater positive outcomes than the active control subjects.

the study design is a cluster randomized controlled trial. twenty-four elderly centers as clusters will be randomly selected and assigned to be intervention (n=20) or control groups (n=4) in two study phases. a total of 8-10 older adults (age ≥ 60) from each cluster (total subjects = 228) will be invited to be study participants. each intervention cluster will receive either an integrated training format or one out of three combinations of two training modes. each intervention training mode will last for 2-month of 16 sessions in total, 2 sessions per week and 60 min per session, hence, the total intervention will last for 4 months for two training modes or an integrated training format. assessments will be conducted at pre-test, two post-training tests, and a 2-month follow-up test after completion of all training.

Eligibility criteria:
inclusion criteria: 1. age 60 or above 2. both gender 3. willingness and capability to participate in this study and training 4. willingness and capability to give informed consent to participate in this study 5. pass the cutting-point of referenced screening tests (cognitive and emotional) screening tools: * moca score above 19 (satisfactory basic function) * positive and negative syndrome scale (panss) with scores \< 19 in positive scale, \< 22 in negative scale, and \< 38 in general psychopathology scale exclusion criteria: 1. a history of systematic cardiovascular diseases, poorly controlled hypertension, stroke, parkinson's disease 2. early stages of alzheimer's disease, or the use of psychoactive drugs 3. complicated conditions that preclude regular attendance of the training 4. currently receiving regular physical (perform aerobic, flexibility and stretching exercises for 3 days per week, 45 minutes per session, for 1 year or longer) and cognitive exercises (such as playing mahjong, chess, bridge and reading for more than 30 minutes per session and 3 times per week, for 1 year or longer ).

Keywords: intervention programs older adults cognitive & physical training cluster rct multimodal
universal screening for vocal fold motion impairment in children undergoing congenital cardiac surgery

Conditions: Vocal Fold Palsy; Dysphagia; Congenital Heart Disease in Children

Summary: the purpose of this study is to determine how often heart or chest surgery in children leads to problems with the movement of the vocal folds.

pediatric vocal fold motion impairment (vfmi) is a well-known cause of dysphonia and dysphagia. previous studies have demonstrated the most common etiology for pediatric vfmi is cardiothoracic surgery which is possibly due to a variety of mechanisms.the investigators hypothesize that universal screening of neonates for vmfi following congenital cardiac surgery (ccs) will lead to a more accurate incidence and earlier diagnosis of vfmi. they believe that earlier identification will lead to changes in feeding regimens that may decrease length of stay (los), decrease time to oral feeding, earlier otolaryngologic intervention if indicated, and decreased rates of readmission for pulmonary or feeding complications. the investigators will also use this information to design a refined algorithm for targeted screening of patients who are more likely to have vfmi based on patient and surgery characteristics.

Eligibility criteria:
inclusion criteria: * children 18 and younger with congenital cardiac disease necessitating surgery * children 18 and younger whose parents have given and signed an informed consent and hipaa authorization as well as the assent of the patient exclusion criteria: * history of prior cardiac surgery * known history of vfmi prior to evaluation * children 18 and younger who do not survive the immediate postoperative course will be excluded. * further exclusion may be determined at the discretion of the principal investigator.
pre-conception interventions to reduce blood pressure before pregnancy

Conditions: Blood Pressure

Summary: the study proposes to evaluate the feasibility of a preconception intervention comprising two proven interventions for reducing blood pressure; beetroot juice; a source of dietary nitrate which reduces bp by 8/4mmhg after 4 weeks(6); personalised resistance and endurance exercise programme (as per cmo recommendations) which reduces bp by \~10/5mm hg over 8-12 weeks (7).

a feasibility study will be conducted for a randomised, controlled trial of preconception interventions. the study will advertise using posters, social media and on departmental emails at imperial college healthcare nhs trust or imperial college for women aged 18-45 planning a pregnancy at any time in the future. the study will randomise women to 1 of 4 arms arm 1: exercise intervention for weeks 1-12 arm 2: beetroot juice for weeks 1-12 arm 3. exercise and beetroot juice for weeks 1-12 arm 4: control group women will be provided with daily beetroot juice shots (as per study arm), membership to an everybody active centre close to their home, personal training sessions to tailor an exercise program to them (2 initial sessions then monthly), a wearable to track their physical activity and a home bp monitor.

Eligibility criteria:
inclusion criteria: * aged 18-45 * considering pregnancy at some time in the future * no health contra-indications to moderate-vigorous exercise * employed by icht nhs trust or imperial college. exclusion criteria: * currently pregnant * planning pregnancy during the study period, or becoming pregnant during the study period.

Keywords: blood pressure pre-conception hypertension exercise beetroot wearable
continuous glucose monitoring and diabetes

Conditions: Diabetes

Summary: the study is a longitudinal single-arm prospective study design. adult patients who are african american or hispanic with type 2 diabetes mellitus will be recruited to participate in this study. the goal of the study is to determine if the use of a continuous glucose monitoring system will improve diabetes management in persons from health disparity background. the subjects will be closely monitored for the first 3 months as they utilize the continuous glucose monitor and engage in diabetes education classes. they will then be followed for an additional 3 months to determine if they are able to maintain the same glucose control as experienced for the initial 3 months.


Eligibility criteria:
inclusion criteria: * adult subjects with type 2 diabetes mellitus ≥18 years * african-american or hispanic * with a1c ≥8% to ≤12% exclusion criteria: * patients with type 1 diabetes, * pregnant, * end-stage renal disease, * recent use of any cgm within the last 12 months, * on steroid therapy and history of adhesive allergy.

Keywords: glucose control type 2 diabetes continuous glucose monitoring educational support
antiviral therapy in hepatitis b virus (hbv)-related advanced liver disease patients

Conditions: Hepatitis B, Chronic

Summary: this is a randomized, open label, phase iv, multicenter study for efficacy and safety of lamivudine versus entecarvir therapy in hbv-related advanced liver disease patients with high viral load and normal or slightly elevated transaminase.

currently, treatment guidelines for the management of chronic hepatitis b (chb) recommend that patients with serum hbv dna \> 105 copies/ml and elevated alt levels greater than two times the upper limit of normal (uln) are obvious candidates for antiviral therapy. guidelines also suggest that antiviral therapy be considered in chb patients with high viral load, if a biopsy shows significant liver disease despite alt ≤ 2× uln. data from recent trials in hepatitis b patients who present with normal to minimally elevated alt (≤ 2× uln) indicate that significant hepatic pathology could still be found. serum alt level may not accurately predict activity of liver damage. alt is a poor predictor of outcome and therefore is not a suitable criterion for antiviral therapy in chronic hepatitis b infection. also, a recent large randomized controlled clinical trial comparing lamivudine maintenance and placebo in advanced fibrosis (ishak fibrosis score ≥ 4) suggests that sustained viral suppression with antiviral therapy is linked to reduced risk for disease progression. (liaw yf et al. nejm 2004;351:1521-1531)

Eligibility criteria:
inclusion criteria * male and female, 18 years of age or older * hbsag positive for more than 6 months * serum hbv dna \> 2,000 iu/ml * serum alt \< 2 x uln on two consecutive occasions at least 3 months apart * naïve to nucleoside or nucleotide therapy * on liver biopsy, fibrosis score ≥ 3 according to metavir scoring system (within 2 years of day 0) * if liver biopsy is not available, subjects must have two of the following items * overt findings of cirrhosis by radiologic evidence (mri, ct, us) * gastrointestinal varices * platelet count \< 100,000,splenomegaly (spleen size - 12cm) * the patient who is willing and able to provide written informed consent to participate in this study exclusion criteria * a history of sbp, variceal bleeding, hep, hcc * decompensated liver disease (child-pugh score \> 10) * co-infected with hcv or hiv * history of any other forms of liver disease. * patient who is pregnant or breastfeeding * treatment with immunosuppressive, immunomodulatory agents or antiviral agents within 6 months prior to study entry * a history of liver transplantation or planned for liver transplantation * a history of any other medical disease or condition that would make the patients unsuitable for the study. * patient is currently abusing alcohol or illicit drugs or has a history of alcohol abuse or illicit substance abuse within the preceding 2 years. * patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.

Keywords: chronic hepatitis b advanced fibrosis lamivudine entecavir
to assess the efficacy and safety of hd-6277 in adult patients with inadequate control of type 2 diabetes mellitus by diet and exercise

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: a multi-center, double-blind, randomized, placebo-controlled, parallel-group, dose-finding, phase 2 study to assess the efficacy and safety of hd-6277 in adult patients with inadequate control of type 2 diabetes mellitus by diet and exercise

this trial is a phase 2 study to evaluate the efficacy and safety of hd-6277 in adult patients with inadequate control of type 2 diabetes mellitus by diet and exercise. this is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.

Eligibility criteria:
inclusion criteria: * diagnosis of t2dm with hba1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 8 weeks prior to screening. exclusion criteria: * type 1 diabetes or another immune-mediated diabetes syndrome * bmi: \> 40 kg/m2 * c-peptide: \< 0.5ng/ml
effective treatment of jak1/3 inhibitor in blau syndrome

Conditions: Blau Syndrome

Summary: to investigate the effectiveness of the jak 1/3 inhibitor tofacitinib in treating blau syndrome and explore the association between various clinical and genetic features and therapeutic responses within the cohort.

blau syndrome (bs) is a monogenic systemic autoinflammatory disease characterized by dominantly inherited granulomatous inflammation due to mutations in nucleotide-binding oligomerization domain 2 gene (nod2). traditionally associated with a clinical trial of arthritis, dermatitis, and uveitis, recent observations have expanded its recognized manifestations to include systemic inflammatory features, skin or cutaneous vasculitis, and multi-organ involvement. despite the rarity of bs, significant advances have been made through multi-center collaborations. current studies, primarily retrospective, highlight the clinical diversity of bs, including cases with disease-causing nod2 mutations but lacking the typical clinical trial . in response to gaps in understanding of bs's pathogenic mechanisms, the investigators initiated a retrospective observational study to collect detailed clinical data and perform whole exome sequencing, specifically targeting nod2 mutations and stat3 rs2293152 phenotypic variations to explore their relationships with therapeutic responses.

Eligibility criteria:
inclusion criteria: 1. the patient must conform to the characteristic triad of granulomatous arthritis, uveitis, and dermatitis, or the characteristic non-caseous granuloma of bs indicated by skin or synovial biopsy; 2. whole exon detection indicated characteristic mutations of nod2 gene exclusion criteria: 1. patients with autoimmune diseases, including but not limited to lupus erythematosus, sjogren's syndrome, vasculitis, ankylosing spondylitis, myositis, dermatomyositis, rheumatoid arthritis, etc.; 2. combined with other neoplastic diseases, such as lymphoma, leukemia, etc.

Keywords: blau syndrome retrospective janus kinase inhibitors
study to investigate the ability of [11c]donepezil pet to image the parasympathetic nervous system

Conditions: Parkinson's Disease

Summary: aim: to validate the tracer \[11c\]donepezil for use in the parasympathetic nervous system. materials and methods: the investigators will include 7 healthy males aged 45-75 in our study. the participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. the subjects also have an mri scan of the brain. pet/ct scans with \[11c\]donepezil are conducted. six subjects will receive two pet/ct scans - once for the upper abdominal region and once for the head region two evaluate dynamic binding characteristics of the tracer in internal organ. additionally, one single subject will receive 5 consecutive whole body pet scans to estimate radioactive dosimetry of this tracer. perspectives: the study will potentially result in the development of a pet ligand for imaging the parasympathetic nervous system. this will have applications for research in parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved

please see the published paper wherein all details are listed: in vivo imaging of human acetylcholinesterase density in peripheral organs using 11c-donepezil: dosimetry, biodistribution, and kinetic analyses. gjerløff t, jakobsen s, nahimi a, munk ol, bender d, alstrup ak, vase kh, hansen sb, brooks dj, borghammer p. j nucl med. 2014 nov;55(11):1818-24.

Eligibility criteria:
inclusion criteria: * male * 45-75 years exclusion criteria: * dementia, * psychiatric diseases, * serious medical illness including any type of previous cancer, any drug with known interaction with the autonomic nervous system
a multicenter, randomized, open-label, parallel-group trial to compare the efficacy and safety of the sufentanil nanotab pca system/15 mcg (zalviso™)to intravenous patient-controlled analgesia with morphine for the treatment of acute post-operative pain

Conditions: Post-Operative Pain

Summary: the study is intended to show that the sufentanil nanotab pca system is as effective as morphine intravenous patient-controlled analgesia (iv pca) for treating pain after surgery. each patient will use either the sufentanil nanotab pca system or morphine iv pca to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.


Eligibility criteria:
inclusion criteria: * male or female patients who are 18 years or older * patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. * post-surgical patients who have been admitted to the pacu and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery. exclusion criteria: * patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of vicodin®, norco®, lortab® with 5 mg hydrocodone per tablet). * patients with an allergy or hypersensitivity to opioids * female patients who are pregnant or breast-feeding

Keywords: adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery or hip/knee replacement surgery
evaluation of volume status in peritoneal dialysis patients

Conditions: Cardiovascular Diseases; Inflammation; Peritoneal Dialysis

Summary: patients with kidney failure on dialysis have a much higher risk of developing cardiovascular disease as compared to the general population. recently, two large studies have shown that increasing the amount of dialysis does not decrease cardiovascular disease. it is known that retaining too much fluid leads to high blood pressure and thickening of the heart wall. peritoneal dialysis is a method of home dialysis which allows dialysis patients autonomy and independence. this study will measure blood levels of a protein called n-bnp and measure the extent of body fluid by a machine called a bioimpedance analyzer. this device administers an undetectible electric current which distributes throughout total body water. the relationship between these tests and the clinical presence of volume expansion will be assessed. in addition, the extent of total body fluid and it's impact on heart attacks, heart failure and stroke will be determined.

patients with end-stage renal disease (esrd) have a higher risk than the general population of developing premature cardiovascular disease; the reasons for this are complex. two recent randomized controlled trials in peritoneal dialysis patients have demonstrated that targeting patients to higher dialysis clearance values is not associated with a reduction in mortality. it is known that patients on peritoneal dialysis are more likely to be volume expanded, develop left ventricular hypertrophy, and have inadequate blood pressure relative to patients on hemodialysis. as a result there has been increased attention on the role of fluid management in reducing the risk of developing congestive heart failure and other adverse cardiovascular events in peritoneal dialysis patients. extracellular fluid volume and total body water can be accurately assessed with multi-frequency bioimpedance analysis (bia). estimation of volume expansion by measuring the natriuretic peptide n-bnp produced by cardiac tissue in response to ventricular wall stretch can also be used. the purpose of this study is to determine whether volume status, as measured by bia and n-bnp levels, correlates with clinical volume assessment, cardiovascular outcomes, peritoneal membrane transport properties and markers of inflammation such as serum albumin and c-reactive protein.

Eligibility criteria:
inclusion criteria: * adult patients, * 18 years of age or older, * with end stage renal disease on peritoneal dialysis for a minimum of 3 months exclusion criteria: * peritonitis in previous 3 months; * history of bilateral lower limb amputation; * inability to provide informed consent; * presence of a pacemaker or defibrillator; * anticipated death or transplant within 6 months of recruitment

Keywords: cardiovascular outcomes congestive heart failure peritoneal membrane transport properties arterial stiffening inflammatory markers