Kornimate/medical-research-clean huggingface dataset:
education program for care home staff

Conditions: Dementia

Summary: the competence of care home staff in dementia care is highly influential to the quality of care that adversely affects both people living with dementia and staff and in mainland china where knowledge on dementia among care home staff was generally poor and this area is under-researched. this study aims at developing a competency-based culturally-sensitive education program on dementia care for care home staff through literature review, qualitative study. and then a quasi-experiment design without random assignment will be conducted to evaluate the effects of this program on care home staff's sense of competence, knowledge, attitudes, and care approach related to dementia care and staff satisfaction with the intervention. focus group interviews will be conducted to understand participants' experience about the education program after the intervention. this study is expected to provide an effective way to improve care homes staff's competence in dementia care thereby improve the quality of care.


Eligibility criteria:
inclusion criteria: care homes: * having at least 10 people with dementia living in; * with at least 10 care staff working for people with dementia; * which do not have any educational activities for staff in dementia three months before the study and staff training plan during the whole study period; * whose management level agrees to participate. care staff: * working for people with dementia; * speaking and reading chinese; * being willing to participate in the study. exclusion criteria: * having any educational activities in dementia three months before the study; * having a training plan during the whole study period.

Keywords: dementia long-term care competency education staff
effect of tomato paste consumption on the microbiota-gut-brain axis in healthy adults

Conditions: Microbiota; Cognitive Function; Healthy Lifestyle

Summary: tomatoes and tomato-based products could play an important role in modulating microbiota-gut-brain axis (mgba) interactions due to their high content of fiber and phytochemicals. phytochemical metabolites derived from the consumption of tomato-based products can act directly as neurotransmitters in the central nervous system, crossing the blood-brain barrier, or indirectly by modulating the mgba. these metabolites can thus alter gut bacterial composition and brain biochemistry. therefore, researchers propose a new interventional study to assess the impact of daily tomato consumption in the organism, and to evaluate the effect on the mgba. the final aim of this study is to spread a message of the health benefits of tomato consumption for the general population.

to evaluate the possible changes in microbiota and cognitive skills after consumption of tomato paste in a crossover randomized controlled study. fifty healthy adults subjects (aged 40-55 years and consisting of 50% males and 50% females to assess possible sex-based responses) will be included. participants will sign the informed consent and carry out a washout period without consuming any tomatoes or tomato-based products during 1 week. participants will consume a daily amount of 0.5 g of tomato paste / kg of body weight following the regular diet plus consumption of low to moderate tomato or tomato-based products and other sources of lycopene (experimental intervention), and the normal diet plus consumption of low to moderate tomato or tomato-based products and other sources of lycopene (control intervention) during 3 months. biological samples (plasma, peripheral blood mononuclear cells, serum, 24-hours urine, feces, and saliva) will be obtained at baseline and the end of each arm of the trial.

Eligibility criteria:
inclusion criteria: * healthy adult subjects with bmi \< 30 kg/m2 * signed informed consent exclusion criteria: * participants with tomato allergy or intolerance * cardiovascular disease (cancer or diabetes) * mental disorders (e.g. depression, dementia, autism, etc.) * cardiovascular alterations in triglycerides or glucose * participants with body mass index (bmi) \> 30 kg/m2 * current smokers * frequent use of corticoids, nonsteroidal anti-inflammatory drugs * volunteers with extreme eating habits (i.e. atkins diet, very high protein diets, etc.) * excessive alcohol consumption (\>30 g/d for males and \>20 g/d for females), * pregnant or lactating women

Keywords: carotenoid inflammation mediators preventive medicine polyphenols tomato clinical trial
prostate cancer plasma integrative multi-modal evaluation

Conditions: Metastatic Prostate Cancer

Summary: the study aims to develop prime (prostate cancer plasma integrative multi-modal evaluation) liquid biopsy test and to implement its use to query prospectively collected samples in advanced prostate cancer (pca) clinical trials and/or clinical settings. in order to maximise the utility of liquid biopsies for advanced pca, prime is focused on the development of novel computational and sequencing approaches that integrate multiple information from plasma circulating elements: i) cell free dna (cfdna) gene mutation data with accurate quantitation of cfdna structural genomic changes, ii) cfdna genomic profiling with cfdna methylation status, and iii) the information provided by extracellular vesicles (evs) and ev-associated cargo (including dna, rna and proteins).


Eligibility criteria:
inclusion criteria: * diagnosis of prostate cancer * eligible for prostate cancer pharmacological treatment * given consent to study participation exclusion criteria: - histological diagnosis other than prostate cancer

Keywords: liquid biopsy cell free dna (cfdna) extracellular vesicles (evs) biomarkers
study of akcea-angptl3-lrx (isis 703802) in patients with homozygous familial hypercholesterolemia (hofh)

Conditions: Homozygous Familial Hypercholesterolemia

Summary: this is a single center, open-label study to evaluate the efficacy of akcea-angptl3- lrx for reduction of low density lipoprotein cholesterol (ldl-c) levels in patients with homozygous familial hypercholesterolemia (hofh).


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≤ 35 kg/m2, * genetic confirmation of two mutant alleles at the ldlr, apob, pcsk9, or ldlrap1 gene locus or an untreated ldl-c \> 500 mg/dl (13 mmol/l) or treated ldl-c ≥ 300 mg/dl (2.59 mmol/l) together with either cutaneous or tendon xanthoma before age 10 years or familial medical history of genetically confirmed heterozygous fh in both parents or untreated elevated ldl-c and tc \> 250 mg/dl consistent with the disease, * patients must be on stable ldl-c lowering agents or on regular apheresis exclusion criteria: * myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to screening, or cerebrovascular accident within 24 weeks prior to screening. * diabetes mellitus if newly diagnosed or if hba1c ≥ 9.0%
immune-pineal axis function in chronic tension-type headache

Conditions: Chronic Tension-Type Headache

Summary: the purpose of this study is to determine whether electroacupuncture is effective in the treatment of chronic tension-type headache, measured by headache impact test, visual analogue scale and biomarkers.

tension-type headache can be defined as a constant sensation of pressure or heaviness, and is a highly-prevalent condition in the health services. the objective of the present study is to investigate the function of the immuno-pineal axis in chronic tension headache, focussed on the neuro-immune regulatory dysfunction. in addition, the effect of neuro-stimulation (electroacupuncture) on the function of this axis will also be studied. this is a clinical trial study, randomised, in parallel, cross-over with a blinded assessor, and with a sham placebo control. the study will be carried out in the clinical research outpatient clinic of the hospital de clínicas de porto alegre (hcpa), with women aged between 18 and 60 years old. the participants will respond to questionnaires at the beginning and end of each therapeutic intervention, with 24-hour urine, blood and saliva collection. the therapeutic intervention will include: 10 electroacupuncture sessions and 10 sham placebo sessions. the measurements taken will be: quality of life, depression, impact of headache on daily life, sleep quality, chronotropic types, immuno-inflammatory mediators, levels of 6-sulfatoxymelatonin, and salivary cortisol. through these interventions it is hoped that patients will present an improvement in their pain presentation, quality of life and sleep, as well as central autonomic regulation. evidence for these hypotheses will support a minimally-invasive treatment, with few side-effects and a low cost.

Eligibility criteria:
inclusion criteria: * women, * aged between 18 and 60 years old, * providing informed consent to participate in the study, * literate, * clinical diagnosis of chronic tension-type headache according to the international headache society. exclusion criteria: * psychiatric or neurologic disorder that unable patient to consent and follow study protocol, * de-compensated systemic disease, * chronic inflammatory disease (e.g. systemic lupus erythematous, rheumatoid arthritis), * hiv.

Keywords: chronic tension-type headache electroacupuncture headache impact bdnf tnf
study of regn3500 and dupilumab in patients with asthma

Conditions: Asthma, Allergic

Summary: to assess the effects of regn3500, dupilumab, and regn3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (bac) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.


Eligibility criteria:
key inclusion criteria: 1. male or female aged between 18 and 60 years 2. has a body mass index {bmi) of 17 to 33 kg/m2 at pre-study screening 3. has a history of mild allergic asthma for at least 6 months 4. is a non-smoker or ex-smoker for at least 12 months key exclusion criteria: 1. has a history of life-threatening asthma 2. has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening 3. has a history of severe allergies or history of an anaphylactic reaction 4. has a history of drug or alcohol abuse within a year prior to the screening visit note: other protocol defined inclusion/exclusion criteria apply
impact of a pharmaceutical care model in the management of chronic myeloid leukemia patients

Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Medication Adherence

Summary: owing to effective treatment with tyrosine kinase inhibitors (tkis), chronic myeloid leukemia (cml) has become a chronic disease with a rising prevalence globally. although the possibility of stopping tki therapy in cml patients who have achieved deep molecular responses is a topic of active debate and investigation, life-long treatment remains the current standard of care. it has been estimated that 3% to 56% of cml patients are not adherent to their prescribed tki therapy. poor adherence to tkis could compromise the control of cml, and contributes to poorer survival. cml patients on long-term tki therapy are prone to developing certain medication-related issues such as adverse reactions and drug interactions.occurrence of adverse reactions even at low grades, has been shown to impact cml patient's health-related quality of life (hrqol) and adherence to treatment. however, there is no prospective high quality evidence showing adherence to tkis and the associated clinical outcomes can be improved in cml patients. therefore, the investigators hypothesize that medication management intervention by pharmacist might improve adherence to tkis, and translate into better disease response and hrqol in cml patients, when compared to control arm who receive standard pharmacy service.


Eligibility criteria:
inclusion criteria: * has a confirmed diagnosis of philadelphia chromosome positive cml * has a detectable bcr-abl1 mrna * has been taking tki for at least 3 months * able to speak and read english, malay or mandarin exclusion criteria: * with cognitive deficit or psychiatric disorders * in advanced phase of cml where tki is transitory to hematologic stem cell transplant * history of hematologic stem cell transplant * pregnant or plan to conceive in the next 1 year
three-dimensional assessment of intraventricular dyssynchrony using fast dobutamine gated spect

Conditions: Heart Failure

Summary: the prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. however, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (crt). this is a major issue since about a third of implanted patients will not be improved by crt. czt spect allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony. using low-dose dobutamine gated spect and czt camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for crt.


Eligibility criteria:
inclusion criteria: * patient with heart failure on optimal medical therapy and targeted for cardiac resynchronization therapy according to current recommendations; * age over 18 years * clinically stable (without hospitalization for heart failure in the last month) * sinus rhythm * social security insurance * signed consent form exclusion criteria: * recent history (less than 21 days) of acute coronary syndrome or unstable angina; * recent history (less than 1 month) of acute heart failure; * right bundle branch block; * irregular heart rate; * double-chamber cardiac pacemaker * patients previously implanted with a single-chamber cardioverter-defibrillator must have at least 99 percent of unstimulated qrs. * countraindication to dobutamine therapy; * valvular heart disease, congenital heart disease, hypertrophic cardiomyopathy; * significant ventricular arrhythmias; * hypertension (upper than 160/100 mmhg); * pregnant, breastfeeding or guardianship
the slim study: sling and botox® injection for mixed urinary incontinence

Conditions: Mixed Urinary Incontinence; Stress Urinary Incontinence; Urgency Incontinence

Summary: this double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). the primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxina (botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.


Eligibility criteria:
inclusion criteria: * undergoing mid-urethral sling surgery * have symptoms of both stress and urgency urinary incontinence * able to consent, fill out study documents, and complete all study procedures and follow-up visits * at least 18 years of age * english speaking * be able and willing to learn clean intermittent self catheterization technique exclusion criteria: * history of recurrent uti (defined as three culture proven utis within last 12 months) * systemic neuromuscular disease known to affect the lower urinary tract * undergoing concomitant prolapse surgery * previous incontinence surgery * treatment with anticholinergic medication in the last 2 months * previous bladder injection with onabotulinumtoxina * prisoner status * pregnancy
full anticoagulation versus prophylaxis in covid-19: coalizao action trial

Conditions: Coronavirus Infection

Summary: pragmatic randomized clinical trial of patients admitted to the hospital with confirmed covid-19 infection and elevated d-dimer. randomization 1:1 - group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation

patients admitted to hospital with confirmed covid-19, and who meet the eligibility criteria will be invited to participate in the proposed study. following the application of the informed consent form, they will collect the d-dimer (if they have not yet collected it routinely from the hospital) and confirm the value over the normal limit in patients with confirmed covid-19, will be randomized to 2 groups in the 1:1 ratio. group 1 will follow the strategy of routine use of full anticoagulation therapy (oral or parenteral when indicated); and group 2 will follow the usual standard care with in-hospital prophylactic anticoagulation (without routine full anticoagulation).

Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of covid-19 admitted to hospital; * duration of symptoms related to hospitalization ≤ 14 days; * patients ≥ 18 year old; * d-dimer above the upper limit of normal (collected until 72 hours before the randomization); * agreement to participate by providing the informed consent form (icf). exclusion criteria: * patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis); * platelets \< 50,000 /mm3 * need for asa therapy \> 100 mg; * need for p2y12 inhibitor therapy (clopidogrel, ticagrelor or prasugrel); * chronic use of non-hormonal anti-inflammatory drugs; * sustained uncontrolled systolic blood pressure (bp) of ≥180 mmhg or diastolic bp of ≥100 mmhg; * inr \> 1,5; * patients contraindicated to full anticoagulation (active bleeding, liver failure, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator); * criteria for disseminated intravascular coagulation (dic); * a history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (av) malformation, or aneurysm; * active cancer (excluding non-melanoma skin cancer) defined as cancer not in remission or requiring active chemotherapy or adjunctive therapies such as immunotherapy or radiotherapy; * hypersensitivity to rivaroxaban; * use of strong inhibitors of cytochrome p450 (cyp) 3a4 and/or p-glycoprotein (p-gp) (e.g. protease inhibitors, ketoconazole, itraconazole) and/or use of p-gp and strong cyp3a4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or st. john's wort); * known hiv infection; * creatinine clearance \< 30 ml/min according to the cockcroft-gault formula; * pregnancy or breastfeeding.

Keywords: sars-cov2 anticoagulation coronavirus infection covid-19
yield of cryoprobe vs flexible forceps pleural biopsy

Conditions: Pleural Effusion; Pleurisy; Tuberculosis; Metastatic Malignancy

Summary: this is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. they will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups: group a: four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps or group b: the above two procedures will be performed in the reverse order the biopsies will be performed from different areas of the involved pleura with the two techniques. thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Eligibility criteria:
inclusion criteria: * age ≥12 years * semirigid thoracoscopy being performed for diagnosis of the pleural effusion exclusion criteria: * age ≥80 years * spo2 \<88% on room air * hemodynamic instability * myocardial infarction or unstable angina in the last 6 wk * lack of pleural space due to adhesions * uncorrected coagulopathy * failure to provide informed consent

Keywords: thoracoscopy pleuroscopy semirigid thoracoscopy flexible cryoprobe cryobiopsy pleural biopsy
intravenous ascorbic acid in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer

Conditions: Fatigue

Summary: this is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status score ≤2; * diagnosed early stage breast cancer and scheduled to receive either adjuvant or neo-adjuvant chemotherapy; * willing to receive either intravenous ascorbic acid or normal saline; * willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug; * negative urine or serum pregnancy test within 2 weeks prior to receipt of study drug; * willing to complete all evaluation tools; * able to give informed consent to participate in the study; and * agree to avoid any additional supplemental ascorbic acid throughout the study. exclusion criteria: * diagnosed glucose-6-phosphate dehydrogenase deficiency; * renal insufficiency (blood urea nitrogen \>30 mg/dl, or creatinine \>1.5 mg/dl); * unwillingness or mental incapacity to complete self-reported questionnaires; * active smoker; and * male sex

Keywords: ascorbic acid breast neoplasms fatigue
smartquit program for smoking cessation

Conditions: Cigarette Smoking-Related Carcinoma; Tobacco-Related Carcinoma

Summary: this trial investigates how well a smartphone-based smoking cessation program called smartquit works to help patients stop smoking. smartquit is an smartphone application-based smoking cessation program that includes a defined program consisting of interactive evidence-based exercises for dealing more effectively with urges to smoke, a place to track desired behaviors, personalized plans for quitting, and a certificate of completion once the recommended program components are completed. smartquit may help patients quit smoking, lower healthcare costs and reduce premature tobacco-related deaths.

outline: patients use the smartquit program to learn and practice skill modules as often as they wish over 6 months.

Eligibility criteria:
inclusion criteria: * smokes at least five cigarettes daily for at least past 12 months * wants to quit in the next 30 days * interested in learning skills to quit smoking * resides in united states (us) * has at least daily access to their own smartphone * knows how to login and download a smartphone application from their smartphone * willing and able to read in english * not participating in other smoking cessation interventions (including our other intervention studies) * must be an employee of a company who is participating in recruitment * willing to complete one follow-up survey * provide email, phone, and mailing address