Kornimate/medical-research-clean huggingface dataset:
efficacy of a new symbiotic formulation in children with familial hypercholesterolemia

Conditions: Dyslipidemia; Familial Hypercholesterolemia

Summary: probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (fh).

fh subjects, aged 6-12 years, consecutively observed a tertiary center for pediatric nutrition were randomly allocated to two groups of intervention for 6 months: active group, received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control group, received low saturated fats diet alone. all children received written indications for low saturated fats diet. the plasmatic lipid profile was assessed by peripheral blood sampling at t0 and t1.

Eligibility criteria:
inclusion criteria: * aged ≥ 6 and ≤ 12 years. * diagnosis of hypercholesterolemia (ldl cholesterol\> 140 mg / dl) * each patient must have shown resistance to dietary therapy lasting at least 6-12 months. exclusion criteria: * age \ 12 years. * patients undergoing drug treatment for hypercholesterolemia. * any medical condition that may interfere with participation in this study * participation in clinical trials still in progress. * taking pre / probiotics for more than 7 days in the 6 months prior to enrollment
cognitive effects of theta-burst stimulation (tbs) in suspected non-alzheimer disease pathophysiology (snap)

Conditions: Suspected Non-Alzheimer Disease Pathophysiology (SNAP)

Summary: this is a pilot study to identify a homogeneous cohort of pathologically specific dementia with snap for clinical trial of brain stimulation.

the investigators apply the nia-aa criteria to identify the individuals of biomarker-defined snap endophenotype. this is a prospective, randomized controlled clinical trial for the first two weeks, followed by an open-label trial for the next two weeks, and combined functional neuroimaging study of 18f-fdg-pet to further explore the potential mechanisms. a total of 20 snap dementia patients will be recruited for consecutive two years, and be subjected to itbs for 5 daily interventions per week for four consecutive weeks. cognitive evaluation will be performed before and immediately after tbs intervention, and 8 weeks after tbs. data on functional neuroimaging will be also collected before and after tbs protocol.

Eligibility criteria:
inclusion criteria: 1. subjects aged 50-90 year. 2. patients meet nia-aa research criteria for suspected non-alzheimer disease pathophysiology (snap) (petersen, smith et al. 1999; jack, bennett et al. 2018), and dsm-5 criteria for major neurocognitive disorder of dementia (regier, narrow et al. 2013). 3. amyloid pet should ever be performed. 4. the cdr of subjects can be 0.5-2. exclusion criteria: 1. any subject has a definite diagnosis of epilepsy or history of seizure attack. 2. current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor. (cerebrovascular disorders, hydrocephalus and intra-cranial mass, documented by mri; a history of traumatic brain injury or another neurological disease). 3. any subject has clinically significant or unstable medical diseases including metabolic, renal, liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders. 4. any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia, bipolar disorder, and previously prolonged substances abuse. 5. any females who is pregnant or lactating. 6. general mri, tms and/or pet exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not mr compatible in the body. withdrawal criteria 1. complications onset after intervention that affect efficacy and safety judgments. 2. new onset or progression of disease that may affect outcomes. 3. use of other therapies or drugs during the intervention period to change cognitive functions. 4. any subjects who are recognized as high risk of adverse effects by principle investigator.

Keywords: suspected non-alzheimer disease pathophysiology (snap) theta-burst stimulation repetitive transcranial magnetic stimulation (rtms)
a glp-1 receptor pet imaging substudy within the ver-a-t1d trial investigating the effects on beta cell mass

Conditions: Diabetes Mellitus

Summary: the goal of the trial is to measure pancreatic uptake of 68ga-nodaga-exendin by pet/ct for detection of intra-individual differences in beta cell mass before and after treatment with verapamil.

the ver-a-t1d (verapamil sr in adults with type 1 diabetes) study is an intervention study within the innodia project (an innovative medicines initiative consortium (imi-2), established through horizon 2020 initiative of the european union, involving academic, industry and charitable partners). in the ver-a-t1d study, the effects of treatment of newly diagnosed patients with t1d with verapamil will be evaluated. verapamil appears to protect beta cell function, an effect that could in part be caused by protection against beta cell apoptosis. glp-1 receptors are expressed in high densities in beta cells. exendin, a glp-1 receptor agonist, can be labeled with radionuclides and thus be utilized for visualization of beta cells in vivo by positron emission tomography (pet). this technology has been demonstrated to deliver quantitative information of the radiotracer uptake in the pancreas demonstrating a linear correlation with beta cell mass. in ver-a-t1d, we propose to measure beta cell mass at the time points of inclusion and at evaluation after 12 months. if verapamil protects beta cells against apoptosis, we expect that the uptake of the radiotracer will be higher at 12 months in comparison to the first measurement in the treatment group. the study will be a substudy to ver-a-t1d.

Eligibility criteria:
inclusion criteria: * • have given written informed consent * • age ≥18 and \<45 at consent * • must have a diagnosis of t1d of within 6 weeks duration at screening (date of the first insulin * injection) * • must have at least one or more diabetes-related autoantibodies present at screening * • must have random c-peptide levels ≥200 pmol/l measured at screening * • be willing to comply with intensive diabetes management exclusion criteria: * treatment with synthetic exendin (exenatide, byetta®) or dipeptidyl-peptidase iv inhibitors (to exclude interferences with imaging, specifically mentioned although in principle part of exclusion criteria of ver-a-t1d) * renal disease defined as mdrd \<40 ml/min/1.73 m2 * pregnancy or the wish to become pregnant within 2 months after the second pet/ct scan.

Keywords: verapamil type 1 diabetes mellitus exendin beta cell mass pet imaging
cbt for spanish speakers

Conditions: Substance Use

Summary: the investigators are conducting a randomized clinical trial of our new web-based version of the cbt4cbt (computer based training for cognitive behavioral therapy) in spanish. this program specifically designed for spanish-speaking substance users to evaluate its effectiveness relative to standard outpatient counseling at the hispanic clinic. the computer-based training program (cbt4cbt) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance use treatment.

100 spanish-speaking substance using individuals seeking treatment at the hispanic clinic of the connecticut mental health center will be randomized to (1) standard outpatient counseling at the hispanic clinic (typically consisting of weekly group counseling), or (2) cbt4cbt plus standard outpatient counseling. treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. the primary outcome measures will be reduction in substance use (frequency of substance use by time, confirmed by urine toxicology screens and breathalyzers). secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based cbt4cbt retains key characteristics of traditional clinician-administered cbt (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Eligibility criteria:
inclusion criteria: * are 18 years of age or older. * are applying for outpatient, non-agonist substance abuse treatment at the hispanic clinic. * meet current dsm-iv criteria for cocaine, marijuana, opioid, alcohol or other stimulant abuse or dependence. * are sufficiently stable for 8 weeks of outpatient treatment. * can commit to 8 weeks of treatment and are willing to be randomized to treatment * are willing to provide locator information for follow-up. * speak spanish as their preferred or principal (most commonly spoken)language exclusion criteria: * have an untreated bipolar or schizophrenic disorder. * who have a current legal case pending such that incarceration during 8-week protocol is likely. * are physically dependent on alcohol, opioids or benzodiazepines

Keywords: substance use, spanish speaking, cbt4cbt
a decision aid on end-of-life care for patients with advanced copd and their family

Conditions: Chronic Obstructive Pulmonary Disease Severe

Summary: this study aims to support eol decision-making in patients with advanced copd and their family members. a parallel two-arm single-blinded randomised controlled trial will be conducted to evaluate the effects of a specific decision support intervention. a total of 226 patients with advanced copd and their designated family members will be recruited from hospital wards and outpatient clinics.

chronic obstructive pulmonary disease (copd) is a progressive life-limiting condition. however, patients with advanced copd and their family members generally are unprepared for end-of-life (eol) situations. the ottawa decision support framework model is adopted to address the patients' decisional needs for the difficult decisions in eol care. the participants will be randomly allocated to either the intervention group to receive the decision support intervention or the control group to receive general health coaching. outcomes will be measured at baseline and 1- and 6-month post-allocation. subsequently, a descriptive qualitative study will be conducted with a subsample of 30 dyads to explore how the intervention influenced the study outcomes.

Eligibility criteria:
inclusion criteria of patients: * are aged 50 years or over * have been diagnosed with copd * are cognitively sound (scored \> 5 on the validated abbreviated mental test (hong kong version) \[amt-hk\]) * meet at least two of the six specific clinical indicators related to advanced copd in the gold standards framework (gsf) proactive identification guidance, 6th edition * can nominate a family member who would take part in their healthcare decision- making. inclusion criteria of patients' family members: * are aged 18 years or over, * can communicate in cantonese, * have at least one personal contact per week with the patient in the past 6 months and * are willing to join the study. family members will be excluded if they score \< 6 on the amt-hk or are expecting to leave hong kong within the next 6 months. exclusion criteria: * non-communicable due to a severe hearing impairment, dysphasia or a language barrier; * are receiving palliative care services or * have already completed acp or an advance directive.

Keywords: advance care planning decision making end-of-life care
trial of valproic acid in patients with progressive supranuclear palsy (depakine)

Conditions: Progressive Supranuclear Palsy

Summary: progressive supranuclear palsy (psp) is a relentlessly progressive neurodegenerative disorder, clinically characterized by parkinsonism with prominent axial involvement and postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive dysfunction. abnormal neuronal and glial tau aggregations affecting the basal ganglia and selective brainstem structures result in dysfunction of the five frontosubcortical circuits and brainstem functions. there is no effective treatment for psp. one of the key feature in the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b (gsk3b). recent reports have shown that valproic acid was able to inhibit the activity of gsk3b and could exert a neuroprotective effect through this inhibition. the investigators thus decided to conduct this controlled study to assess the putative neuroprotective effects in patients with psp.


Eligibility criteria:
inclusion criteria: * patients with possible or probable psp * from 45 to 75 year of age

Keywords: progressive supranuclear palsy (psp)
multimedia-based hormonal therapy information program for patients with prostate cancer

Conditions: Prostatic Neoplasms

Summary: this study takes place in the divisions of urology. patients who have only received hormonal therapy will be enrolled. patients will be randomly sorted into an experimental group and a control group after completing a pretest questionnaire. the experimental group will receive the the multimedia hormone therapy information program once per week for 6 consecutive weeks, while the control group will receive routine care. the follow-up data collections will be completed at 8 and 12 weeks after the pretest. for quantitative measurement, the main variables will be social support, self-efficacy, quality of life, and positive thinking.

this study takes place in the divisions of urology at chang gung memorial hospitals. patients who have only received hormonal therapy will be enrolled. with reference to past research findings, self-efficacy theory, and experts' advice, a multimedia hormone therapy information program was developed. the multimedia hormone therapy information program covered 6 topics, namely the recognition of hormone therapy and multimedia information programs, mindfulness, exercise, stress relief, positive thinking, and prevention or reduction of fatigue. a pilot study will be conducted to check the feasibility of intervention study design and the effectiveness of the program will be tested. patients will be randomly sorted into an experimental group (multimedia information group, n = 36 to 40) and a control group (routine care group, n = 36 to 40) after completing a pretest questionnaire. the experimental group will receive the multimedia information intervention once per week for 6 consecutive weeks, while the control group will receive routine care. the follow-up data collections will be completed at 8 and 12 weeks after the pretest. for quantitative measurement, the main variables will be social support, self-efficacy, quality of life, positive thinking, and satisfaction with program. generalized estimating equations (gees) will be used to o analyze data.

Eligibility criteria:
inclusion criteria: 1. patients with prostate cancer who were receiving hormonal therapy 2. patients were at least 20 years old 3. patients were ability to communicate in chinese or taiwanese 4. the married partner agrees to study together, or the single patient has a cohabitation partner who agrees to study together. 5. patients or family have a smart phone or tablet and can connect to the internet. exclusion criteria: 1. having a history of other cancers 2. unknown diagnosis of prostate cancer or unknown disease status 3. patients who received chemotherapy, radiotherapy, radical prostatectomy or other treatments for prostate cancer in the past 4. having history of mental disorder, e.g., phobia, obsessive-compulsive disorder, generalized anxiety, , major depression, mania, manic-depressive psychosis, or dementia 5. the score of eastern cooperative oncology group performance is ≧ 2

Keywords: prostate cancer hormonal therapy multimedia self-efficacy positive thinking
proof-of-concept trial of apraglutide in gvhd

Conditions: GVHD

Summary: the aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal acute graft versus host disease (agvhd).

this is an international, multicenter, randomized proof-of-concept trial to evaluate safety, tolerability, efficacy, durability of response, and clinical outcomes of apraglutide administration to subjects with steroid-refractory (sr) agvhd of the lower gi tract being treated with systemic steroids (ss) and ruxolitinib (rux).

Eligibility criteria:
inclusion criteria: * able to give informed consent and agree to follow the details of participation as outlined in the protocol * male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg. only subjects aged 18 years and above will be included in germany. * clinically confirmed steroid refractory lower gi-agvhd (magic stage 1-4) prior to randomization * have undergone allosct from any donor source, any conditioning regimen * treated with ss plus rux (rux starts concomitantly to apraglutide or a maximum of 72 hours before apraglutide initiation) * women of childbearing potential (wocbp): highly effective method of contraception and refrain from donating eggs during the trial and for 4 weeks after the end of trial (eot) visit * male subjects with partner wocbp: contraception and abstention from sperm donation during the trial and for 2 weeks after the eot visit exclusion criteria: * treatment with any systemic gvhd therapy other than ss and rux including methotrexate and mycophenolate mofetil at the time of randomization / day 0 * concomitant treatment with janus kinase inhibitor other than rux at the time of randomization * failed allosct due to relapse of underlying malignant disease * presence of sr gi-agvhd occurring after donor lymphocyte infusion for pre-emptive treatment of malignancy recurrence * any use of enteral glutamine or glp analogs or known ada, within 6 months prior to randomization / day 0 * significant organ system failures (respiratory renal hepatic and cardiac) * presence of relapsed primary malignancy or treatment for relapse after allohsct * presence or history of gi tumors (including the hepatobiliary system and pancreas) within the last five years before randomization * presence of colonic polyps not removed * active clinically uncontrolled infection or active tuberculosis * known chronic gvhd * known active gi inflammation not related to gi-agvhd * major abdominal surgery in the last 6-months prior to randomization or history of clinically significant intestinal adhesions * abnormal liver function tests

Keywords: graft versus host disease gvhd gvhd, acute steroid-refractory agvhd gastrointestinal-gvhd gi-gvhd
emergency department-based palliative care for advanced cancer patients

Conditions: Advanced Cancer; Metastatic Cancer

Summary: the purpose of this study is to: 1) identify the palliative care needs of emergency department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ed; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.

as the population ages, the number of individual living with cancer will continue to rise, and the number of emergency department (ed) visits for this population will continue to increase. cancer patients visit eds because symptoms, such as pain or vomiting, can't be controlled at home, in an assisted living facility, or in their provider's office. the ed is often the only place that can provide the necessary treatments as well as immediate access to technologically advanced testing for those with cancer. however, palliative care (pc) services, such as relief of burdensome symptoms), attention to spiritual or social concerns, and establishing goals of care, is not standard care in the ed outside of a few medical centers. most patients do not have well-defined goals of care, and are often subjected to painful and marginally effective tests and procedures, not because they are consistent with their goals but because it is less time-consuming than discussing other options and has less perceived legal risk. until recently little emphasis has been placed on education, research, or guidelines for the delivery of pc services in this important setting. while emergency providers could provide some of these services themselves, knowledge and skills regarding pc as well as staffing are currently inadequate to provide comprehensive services. in addition to further decreasing days spent in the hospital and health care costs, consultation by a pc team for ed cancer patients might also reduce pain and other symptoms, aid in complex medical decision-making regarding testing and treatments, and facilitate transfer to hospice or home with visiting nurse services. to enable pc consultation for ed cancer patients, the investigators will first determine who could benefit from emergent consultation, what services they need, and what characteristics of emergency providers and hospitals are preventing them from being offered. to determine what affect pc consultation for patients with advanced cancer has on symptoms, discussions with patients and families about goals of care, and how long patients spend in the ed, the investigators will then randomly assign 200 ed cancer patients to targeted pc consultation versus usual or standard care.

Eligibility criteria:
inclusion criteria: * ≥ 18 years age * speak english or spanish * ed patient with an advanced solid malignancy exclusion criteria: * have already been seen by palliative care team * cognitive deficits * children or adolescents * no confirmed history of active cancer * do not speak english or spanish * reside outside the us

Keywords: palliative care cancer emergency medicine end- of- life care
peripheral nerve stimulation to reduce hypoxic events

Conditions: Apnea; Hypoventilation; Hypoxemia

Summary: this study is designed to determine if using peripheral nerve stimulation in conjunction with pulse oximetry as an adjunct to traditional monitoring in the pacu reduces the frequency and severity of sedation related apnea and hypoxic events.

the primary effectiveness objective is to determine if transcutaneous stimulation will generate a respiratory response capable of reducing the extent and duration of oxygen desaturations in patients with presumed risk of obstructive sleep apnea (osa) who have received some form of anesthesia or sedation. the primary safety objective is the demonstration that the peripheral nerve stimulation is safe for the use of preventing or reducing the sedation related hypoxemic events.

Eligibility criteria:
inclusion criteria * males and females \> 18 yrs old * flemon's score \> 15 * able to provide written informed consent * having gynecological, colorectal, orthopedic surgery, and urologic surgeries * baseline oxygen saturation on room air \> 96% exclusion criteria: * peripheral neuropathy involving the upper extremities * procedures requiring direct admission to the icu or any site other than the post-anesthesia care unit from the or * diagnosed obstructive sleep apnea (osa) and / or use of continuous positive airway pressure (cpap) or biphasic positive airway pressure (bipap) in the pacu. * presence of any implantable electric devices, including internal defibrillators, pacemakers, or left ventricular assist device (lvad) * post-procedure temperature \< 35.5 celsius or evidence of vasoconstriction * presence of metal hardware in either arm or in either shoulder * patients lacking access to the bare skin on an arm after surgery. * history of atrial fibrillation * history of bundle branch block * females from menarche to menopause that do not have a current negative pregnancy test or surgical history preventing pregnancy.