Kornimate/medical-research-clean huggingface dataset:
empower 3: improving palliative care health literacy and utilization

Conditions: Cancer; Neoplasm Malignant

Summary: through this award, michael hoerger, phd, mscr, a psychologist at the tulane cancer center in louisiana, will lead a study called empower 3 designed to test an educational intervention to help patients understand palliative care, use it, and feel better emotionally and physically. participants will be adults with serious cancer diagnoses. participants will be randomized into two groups. patients in the control group will get enhanced usual care, meaning standard cancer care and several additional healthcare-related brochures. patients in the intervention group will get enhanced usual care plus an educational video developed by the investigators and other materials designed to increase understanding and use of palliative care. family members of patients in the intervention group may also attend if desired. the investigators will track participants' understanding of palliative care, attitudes toward palliative care, symptoms over 6 months of follow-up, and palliative care utilization.


Eligibility criteria:
inclusion criteria: 1. adult, age 18 or older 2. meets criteria for 2a or 2b. 2a) the patient's doctor believes they may be appropriate for palliative cancer care or 2b) the patient has a new diagnosis, recurrence, or progression of cancer in the past 90 days and any of the following: * advanced cancer, such as: * lung cancer: stage iiib or iv non-small cell, or extensive stage small cell * breast cancer: stage iv * gastrointestinal (gi) cancers: unresectable stage iii or stage iv * genitourinary (gu) cancers: stage iv * melanoma: stage iv * hematologic malignancies * leukemia (e.g., acute myeloid leukemia \[aml\], acute lymphoblastic leukemia \[all\], chronic myeloid leukemia (cml), chronic lymphocytic leukemia \[cll\]): advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, older age * lymphoma: stage iv or treatment refractory hodgkin's disease or non-hodgkin's lymphoma multiple myeloma: elevated β2-microglobulin, albumin \ 1%, crp \>6µg/ml, elevated ldh, plasmablastic morphology, or abnormal chromosome 13 * advanced heart, lung, renal (kidney), or liver disease * two or more severe symptoms (≥7 on 0-10 scale): pain, tiredness, drowsiness, nausea, bad appetite, shortness of breath, depression, or anxiety 3. patient can understand spoken or written english 4. patient receives care in southeast louisiana exclusion criteria: * known history of receiving specialty palliative care or hospice * significant psychiatric or other co-morbid disease that would prohibit informed consent or participation in the study * unlikely to complete any follow-up surveys
humax-il8 (interleukin8) in patients with advanced malignant solid tumors

Conditions: Solid Tumor

Summary: a phase ib, dose escalation, multiple dose trial with humax-il8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.

all human subjects with a diagnosis of incurable solid tumors are eligible for the dose-escalation phase of this study. this study consists of two phases, the dose-escalation phase and the expansion phase. subjects will be treated with the study treatment until any off-treatment criteria are met. the safety and efficacy will be assessed until the end of treatment or for a maximum of 52 weeks. in addition, a separate visit will be performed at the time of disease progression if the patient has a progression between end of treatment and 52 weeks. the patients will be followed up for overall survival until the study closure. the study will be closed when all enrolled patients have been followed up for at least 52 weeks or have died.

Eligibility criteria:
inclusion criteria: * subjects must have metastatic or unresectable locally advanced malignant solid tumor. * patients may have measurable or non-measurable but evaluable disease. * patients with surgically resected metastatic disease at high risk of relapse are also eligible. * patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease. * patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy * age ≥ 18 years. . * ecog (eastern cooperative oncology group) performance status ≤ 1 (karnofsky ≥ 70%). * patients must have normal organ and hematologic function therapy * patients must have baseline pulse oximetry \> 90% on room air exclusion criteria: * pregnant women or women presently breast-feeding * concurrent treatment for cancer * chronic hepatitis b or c infection. * any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment. * significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. * active autoimmune diseases requiring treatment or a history of autoimmune disease. * concurrent use of systemic steroids * patients who are receiving any other investigational agents * patients with untreated central nervous system metastases or local treatment of brain metastases * history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study. * serious or uncontrolled intercurrent illness * hiv-positive patients are ineligible * patients unwilling to use adequate contraception other protocol defined inclusion/exclusion criteria could apply
elements vital to treat obesity study

Conditions: Obesity

Summary: the overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. the investigators will be comparing the previously developed and optimized behavioral weight loss intervention (app) to the diabetes prevention program (dpp), to evaluate program weight-loss success and cost-effectiveness.

the proposed study seeks to determine if the app program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the dpp program. during the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) app, wherein participants receive calorie, fat, and physical activity goals via a smartphone application for self-monitoring, online educational readings, and biweekly sessions with a health promotionist; or 2) dpp, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a health promotionist. assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.

Eligibility criteria:
inclusion criteria: * bmi 30-45 * weight stable * own a smartphone and be willing to install our smartphone app * willing to conduct video conference calls with study staff exclusion criteria: * enrolled in any formal weight loss program * taking anti-obesity medications * not taking medications that may cause weight gain * unstable medical conditions * diabetes requiring insulin supplementation * crohn's disease * diagnosis of obstructive sleep apnea requiring intervention (i.e., cpap) * assistive devices for mobility * hospitalizations for a psychiatric disorder within the past 5 years * cardiovascular disease symptoms while performing moderate intensity exercise * pregnancy, trying to get pregnant, or lactating. * bulimia or binge eating disorder * reports of active suicidal ideation * current substance abuse or dependence besides nicotine dependence

Keywords: weight loss diet physical activity self monitoring mobile health
bioavailability of pea protein in young and old volunteers

Conditions: Healthy Male Volunteers

Summary: the aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " nutralys ® s85 plus" or a reference protein brought in water either alone or at the end of a standardized meal.


Eligibility criteria:
inclusion criteria: * adult male volunteers, aged over 65 or under 30 * body mass index (weight in kg/ height² in m²) between 22 and 28 kg/m², * subjects considered to be healthy by the principal investigator doctor according to the interview, medical and clinical examination, * biological assessment considered compatible with participation in the study, * persons able to sign the informed consent, * persons affiliated to social security scheme. exclusion criteria: * pathologies or treatments not compatible with the study * food allergy or a contraindication to the consumption of the products tested * subject in a situation which, in the opinion of the investigator, could interfere with their optimal participation in the study or constitute a particular risk for the subject, * subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.), * subject weighing \< 55 kg,

Keywords: protein bioavailability pea protein amino acidemia
premenstrual hormonal and affective state evaluation (phase) project

Conditions: Premenstrual Dysphoric Disorder

Summary: phase is designed to evaluate neuroactive hormone trajectories across the menstrual cycle and endocrine, autonomic, and subjective responses to psychosocial stress in women suffering from severe pms (i.e., premenstrual dysphoric disorder).

female volunteers will be recruited from the community for participation in this 3-menstrual cycle study. in the first two menstrual cycles, study participants will chart their symptoms and and ovulation. study participants will continue to perform ovulation testing during their third menstrual cycle in which they will attend one individualized task session and provide 8 serum samples at different timepoints across the menstrual cycle. primary analyses will contrast neuroactive hormone trajectories across the menstrual cycle and stress reactivity according to study groups (pmdd vs healthy).

Eligibility criteria:
inclusion criteria: * female * aged 18-35 years, established by visual inspection of a government-issued id * average menstrual cycle 21-35 days exclusion criteria: * lifetime dsm-5 axis 1 disorder (except anxiety and depression), as documented in the mental health interview * current dsm-5 axis depressive or anxiety disorder, as documented in the mental health interview * positive urine drug screen test * breath alcohol concentration \>0.00% * self-reported smoker or carbon monoxide concentration ≥ 6 ppm * irregular menstrual cycle * current pregnancy (urine test-verified) or lactation, or a plan to become pregnant * moderate or high suicide risk * shipley iq (vocabulary standard score) \> 80 * any prescription medications (including hormonal forms of birth control)
efficacy and safety of ethanol lock solution in prevention of catheter related bloodstream infection for patients suffering acute renal failure, and hospitalized in intensive care unit. a multi-center, randomized, versus placebo, double blinded clinical trial

Conditions: Acute Renal Failure; Infection

Summary: the primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.

the primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients

Eligibility criteria:
inclusion criteria: * patients of both genders, over 18 years, * patients admitted in icu * dialysis catheter insertion for renal replacement therapy * at least two renal replacement therapy sessions * written informed consent * social security exclusion criteria: * pregnant or breastfeeding women * patient requiring dialysis on arteriovenous fistula or permanent catheter * known allergy to ethanol * dialysis catheter covered or impregnated with antimicrobial agent * dialysis catheter insertion before icu admission * single-lumen dialysis catheters * patient whose death is likely to occur within hours after admission to icu

Keywords: nosocomial infection catheterization central venous ethanol lock solution intensive care units renal replacement therapy in icu
efficacy of high power laser versus low level laser in ultrasonographic and functional outcomes in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study will be conducted to compare between high power laser and low-intensity laser on ultrasonographic and functional outcomes in patients with knee osteoarthritis

osteoarthritis (oa) is a major source of pain, disability, and socioeconomic cost worldwide. the epidemiology of the disorder is complex and multifactorial, with genetic, biological, and biomechanical components. it is estimated that 63 to 85 percent of americans over age 65 have radiographic signs of oa and that 35 to 50 percent have symptoms of pain, stiffness or limitation of motion. between 9 and 12 percent of elderly americans (approximately 3 million people) have enough impairment from oa that they cannot perform their major activities, and half of these individuals are totally disabled (confined to bed or a wheelchair). high power laser therapy (hpl) that involves higher-intensity laser radiation is a new, painless, and powerful modality that showed significant results in pain reduction. one of the modalities commonly used by clinicians was low level laser therapy introduced as an alternative, safe and non-invasive treatment for oa about 30 years ago.a more recent systemic review investigated the effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis and concluded that both lllt and hpl are beneficial as adjuncts to rehabilitation exercise in the management of knee oa. based on an indirect comparison, the hpl and exercise seems to have higher efficacy in reducing knee pain and stiffness, and in increasing function. to confirm this finding, a direct comparative investigation of the two types of laser therapy may be necessary. ninety patients with knee osteoarthritis will be assigned randomly to three groups; the first experimental will receive high power laser plus conventional physical therapy, second one will receive low-intensity laser and traditional physical therapy, finally, the third group will receive traditionally therapy only

Eligibility criteria:
inclusion criteria: * x-ray stages ii and iii osteoarthritis * age between 45 and 75 years. * bmi equal to or less than 35. exclusion criteria: * unwillingness to participate in the study. * uncompleted evaluation/treatment programs. * any damage to the knee joint during the study. * using any treatment other than prescribed therapeutic protocols.

Keywords: high power laser low level laser ultrasonographic changes knee osteoarthritis
study evaluating the efficacy and safety of ocs-01 eye drops in subjects following cataract surgery

Conditions: Inflammation Eye; Pain, Postoperative; Cataract

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of ocs-01 in treating inflammation and pain in subjects following cataract surgery.

this is a multi-center, randomized, double-masked, vehicle-controlled study, designed to evaluate the efficacy and safety of ocs-01 compared to vehicle in treating inflammation and pain following cataract surgery. subjects will be randomized 1:1 to receive ocs-01 or vehicle once daily.

Eligibility criteria:
inclusion criteria (selection): * provide written informed consent, approved by the appropriate ethics committee; * able to comply with the study requirements and visit schedule; * at least 18 years of age of either sex or any race; * will undergo unilateral cataract extraction via phacoemulsification and pciol implantation in the study eye; * have an anterior chamber cell score ≥ 2 at visit 2 (day 1 \[18 to 30 hours post- uncomplicated cataract surgery without vitreous loss\]); exclusion criteria: * have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components; * have only one functional eye (monocular); * have any intraocular inflammation (e.g., white blood cells or flare) present in either eye at the visit 1 (day -1 to day -28 \[prior to surgery\]) slit-lamp examination; * have a score \> 0 on the ocular pain assessment at visit 1 (day -1 to day -28 \[prior to surgery\]) in the study eye \*additional inclusion/exclusion criteria apply

Keywords: ophthalmology topical ophthalmic solution eye drop post-surgical
preferences of vaccination for covid-19 among university students and staff: a discrete choice experiment

Conditions: Preference, Patient

Summary: from march 2021, covid-19 vaccines have been made available to hong kong residents, first to priority groups including healthcare professionals and the elderly, and later to all adults and adolescents. vaccinated individuals are generally exempted from mandatory regular out-of-pocket antigen testing. vaccinated individuals of university halls and colleges of the university of hong kong (hku) will also be exempted from mandatory weekly antigen testing. freedom of choice is highly respected in the hku community and as such, we would like to better understand the decision-making process among members of the hku community. the anonymised results of this independent research study will help us understand preferences among the hku community and inform on future vaccination planning policies. objectives: to elicit hku staff and students' preferences and their willingness-to-pay (wtp) for covid-19 vaccination in hong kong design: an online cross-sectional internet-based questionnaire with a discrete choice experiment (dce) design distributed via email. all current students and staff from the university of hong kong are eligible to participate in the study main outcome measures: preferences for the efficacy of protecting against infection, against severe disease manifestations, duration of protection, risk of adverse events, incentives, and out-of-pocket costs


Eligibility criteria:
inclusion criteria: * at least 18 years old * fluent in english * students and staff of the university of hong kong exclusion criteria: * individuals who are younger than 18 years old * individuals who are unwilling to give consent
edoxaban treatment in routine clinical practice for patients with non-valvular atrial fibrillation (nvaf)

Conditions: Atrial Fibrillation

Summary: in order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the nvaf indication, daiichi-sankyo thailand proposed this non-interventional study (nis) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with nvaf.

edoxaban was recently approved by the thai food and drug administration (thai fda) (date: 2nd december 2016) for the prevention of stroke and systemic embolism in adult patients with nvaf with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (tia). treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and prevention of recurrent dvt and pe in adults. in order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the nvaf indication, daiichi-sankyo thailand proposed this non-interventional study (nis) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with nvaf. real world evidence data of routine clinical practice use of edoxaban up to 2 years will be collected and evaluated in approximately 300 patients, treated by specialized as well as non-specialized physicians in hospital centres.

Eligibility criteria:
inclusion criteria: * is a nvaf-patient whose physician has made the clinical decision to prescribe edoxaban therapy according to package information * has provided written informed consent to participate in the study exclusion criteria: * is participating in an interventional study

Keywords: non-valvular atrial fibrillation real world evidence observational safety
effects of telerehabilitation-based exercises in cystic fibrosis

Conditions: Cystic Fibrosis; Exercise; Telerehabilitation; Exercise Capacity

Summary: pulmonary rehabilitation programs are an important part of lifelong therapy in the treatment of patients with cystic fibrosis. although the possible benefits of exercise are known, physical activity levels and participation in exercise are low in patients with cystic fibrosis. there are barriers such as lack of time, demoralization, lack of motivation, and transportation problems. although group exercises are an approach that increases participation and motivation, it is not considered a very suitable method because it increases the risk of cross infection in patients with cystic fibrosis when performed face-to-face. telerehabilitation programs, which are increasingly used in chronic respiratory diseases, show similar results with clinical rehabilitation programs. telerehabilitation programs, the effects of which have been examined in different disease groups in recent years, on patients with cystic fibrosis are limited in the literature. group exercises that can be given with the telerehabilitation method may be a good approach for patients with cystic fibrosis, eliminating possible infection transmission. the goal of this interventional clinical trial is to compare of effects of telerehabilitation based individual and group exercises on functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic power, quality of life, and adherence in children with cystic fibrosis. the main question it aims to answer are: • is there a difference between functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic performance, quality of life and compliance with treatment between telerehabilitation based group exercises and telerehabilitation based individual exercises in patients with cystic fibrosis? participants will be randomized into three groups: group 1: they will be divided into groups of four and included in the exercise training for eight weeks with telerehabilitation. group 2: they will be individually included in exercise training with telerehabilitation for eight weeks. group 3 (control group): they will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).


Eligibility criteria:
inclusion criteria: * being diagnosed with cystic fibrosis * being between the ages of 8-18 * having a device for video calls (phone, computer, tablet, etc.) exclusion criteria: * severe airway obstruction (fev1 (%, predicted) \<40%) * pulmonary exacerbation/hospitalization in the last four weeks * history of lung transplant * orthopedic problems that limit exercise * those who had a change in their medical treatment during the study

Keywords: physiotherapy cystic fibrosis randomized controlled trial telerehabilitation