Kornimate/medical-research-clean huggingface dataset:
acceptability and efficacy of zemedy app versus education and relaxation training app for ibs

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this research is to assess if a new digital app version of a self-help intervention for irritable bowel syndrome (ibs), is an acceptable and effective treatment for improving the overall quality of life in patients with ibs.

the aim of the current study is to test the acceptability and efficacy of an updated digital app for ibs patients. the design of the study is experimental. there will be two experimental groups, an immediate treatment group and an active control group. once consented and enrolled, participants will be randomly assigned to either the immediate treatment group or the active control group by the coin toss feature of random.org. participants in the immediate treatment group will be able to download the app at no cost. participants in the control group will be given access to an education and relaxation training control app at no cost to them. at 8 weeks after enrollment, all participants in both groups will receive a battery of follow-up questionnaires (the same that they answered directly after consenting in the beginning of the study as baseline measures). upon receipt of the 8 week questionnaire data, participants in the control group will be given access to the zemedy app. after having had access to the app for 8 weeks, control participants will be asked to complete another set of questionnaires. all participants will receive 3 month post-treatment follow-up questionnaires. the research method is experimental, cross over (randomized controlled trial) with a control control. participation in the study will last approximately 4.5 months, depending on the subjects willingness to participate and rate of completion.

Eligibility criteria:
inclusion criteria: * self-report of physician diagnosis of ibs. * at least 18 years of age. exclusion criteria: * severe depression or suicidality * comorbid gi disorder such as inflammatory bowel disease or celiac disease. * pregnancy

Keywords: cognitive behavioral therapy
harnessing macrophage lysosomal lipid metabolism in obesity

Conditions: Obesity; Nonalcoholic Fatty Liver; Diabetes Type 2; Healthy

Summary: the goal of this study is to evaluate the role of transcription factor eb (tfeb) in adipose (fat) tissue macrophages (atm) in regulating adipose tissue and systemic metabolic function in obesity. the investigators will assess the differences in atm lipid metabolism in people with metabolically abnormal obesity and lean individuals. both groups will have: * screening visit * imaging (body composition testing - dual-energy x-ray absorptiometry (dexa) scans, magnetic resonance imaging \[mri\] and magnetic resonance spectroscopy \[mrs\] scans) * overnight visit with intravenous infusion (iv), muscle, and fat tissue biopsies participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss.


Eligibility criteria:
inclusion criteria : * age: ≥18 but ≤70 years * not pregnant or breastfeeding * weight stable and sedentary before enrollment * no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \[mao\]-type 2 diabetes group) * no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer) * participants must fulfil all of the following group-specific inclusion criteria below: lean group: * body mass index (bmi) ≥18.5 but \<25.0 kg/m2 * intrahepatic triglyceride (ihtg) content \<5% * fasting blood glucose concentration: \<100 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl * hemoglobin a1c (hba1c) \<5.7 % metabolically normal obesity (mno) group: * bmi ≥30.0 but \<45.0 kg/m2 * ihtg content \<5% * fasting blood glucose concentration: \<100 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl * hba1c \<5.7 % metabolically abnormal obesity (mao)-insulin resistance and non-alcoholic fatty liver disease (nafld) group: * bmi ≥30.0 but \<45.0 kg/m2 * ihtg content \>7.5% * fasting blood glucose concentration: ≥100 but \<126 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \<200 mg/dl * hba1c: ≥5.7 but \<6.4 % mao-type 2 diabetes group: * bmi ≥30.0 but \<45.0 kg/m2 * clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \>126 mg/dl or blood glucose concentration 2 h after a 75 g oral glucose challenge\>200 mg/dl or hba1c \>6.4 % without medication if not diagnosed and medically treated for diabetes exclusion criteria: - individuals that do not meet all inclusion criterion
novel peptide vaccination for patients with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the safety and clinical efficacy of novel peptide vaccination for advanced prostate cancer

cell division cycle associated gene 1(cdca1) has been identified using genome-wide expression profile analysis by the use of cdna microarray in our previous studies. we have determined the hla-a\*2402 restricted epitope peptides derived from cdca1, cdca1-a24-56. this epitope showed strong ifn-g production when stimulated with the appropriate targets expressed the appropriate protein and hla-a\*2402. furthermore, when vaccinated this peptide, specific ctl was determined after the vaccination. therefore we focused on the safety and efficacy of novel vaccination for the advanced prostate cancer patients who already showed resistance to standard hormonal therapy and chemotherapy.

Eligibility criteria:
inclusion criteria: disease characteristics advanced prostate cancer which already showed resistance to standard treatments patients characteristics 1. patients who showed resistance to hormonal therapy and chemotherapy 2. histological diagnosis is adenocarcinoma 3. hla-a\*2402 4. ecog performance status of 0 to 2 5. age ≥ 20 years, ≤85 years 6. wbc≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl platelet count ≥ 70000/mm³ ast, alt ≤100 iu/l total bilirubin ≤ 1.5 mg/dl creatinine ≤ 1.0 mg/dl pao2≥ 70mmhg 7. life expectancy ≥ 2months 8. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) 2. breastfeeding 3. patients willing to childbearing ( refusal or inability to use effective means of contraception) 4. serious infections requiring antibiotics 5. concomitant treatment with steroids or immunosuppressing agent 6. other malignancy difficult to control. 7. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: novel epitope peptide ctl advanced prostate cancer
phase 3 study of sitravatinib plus nivolumab vs docetaxel in patients with advanced non-squamous non-small cell lung cancer

Conditions: Metastatic Non-Squamous Non-Small Cell Lung Cancer

Summary: this study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous nsclc who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

sitravatinib (mgcd516) is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (rtks) including met, tam (tyro3, axl, mertk) family, vegfr family, pdgfr family, kit, flt3, trk family, ret, ddr2, and selected eph family members. nivolumab is a human igg monoclonal antibody that binds to the pd-1 receptor and selectively blocks the interaction with its ligands pd-l1 and pd-l2, thereby releasing pd-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. rtks have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. inhibition of these rtks by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

Eligibility criteria:
inclusion criteria: * diagnosis of non-squamous non-small cell lung cancer * receipt of at least one but not more than two prior treatment regimens in the advanced setting * prior treatment with pd-1/pd-l1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy) * most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment * candidate to receive docetaxel as second or third line therapy exclusion criteria: * uncontrolled brain metastases * tumors that have tested positive for egfr, ros1, alk mutations, or alk fusions * unacceptable toxicity with prior checkpoint inhibitor therapy * receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy * impaired heart function

Keywords: sitravatinib nivolumab docetaxel checkpoint inhibitor mgcd516 nsclc sapphire
rest study (compression therapy for rls)

Conditions: Restless Legs Syndrome

Summary: this study in patients with restless leg syndrome (rls) will evaluate the use of cirvo™ therapy for the treatment of this disorder when applied to both legs.


Eligibility criteria:
inclusion criteria: 1. male or female over the age of 18. 2. diagnosis of restless leg syndrome (rls) per the hopkins-hening diagnostic questionnaire 3. international rls study group (irlss) score ≥15. 4. rls symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months. exclusion criteria: 1. known or suspected deep vein thrombosis. 2. pregnancy 3. prior use with home intermittent pneumatic compression (ipc) device 4. currently using any other device to treat rls 5. active skin infections in the affected leg 6. vein ligation or skin graft of the leg within past 12 months 7. mental or physical limitations that would prevent the subject from reliably completing study questionnaires. 8. physical impairments that would prevent the use of the cirvotm device. 9. use of any medications typically used to treat rls, where dose has not been stable for at least 2 months. 10. if previously on medication to treat rls, patient must have been weened under medical supervision and off medication for at least 14 days at time of enrollment 11. history of pulmonary vascular disease (pvd) 12. history of pulmonary edema 13. history of decompensated congestive heart failure (chf) 14. open surgery or major trauma to the legs within the last six months 15. history of lower limb malignancy, primary or secondary 16. acute symptomatic lower extremity thrombophlebitis 17. any chronic back pain or lower extremity pain 18. other sleep problems that are felt to be currently affecting the quality of sleep 19. calf geometry on which cirvo™ device does not appropriately fit 20. known sensitivity to any of the materials used in the cirvo™ device 21. currently participating or plans to participate in in any other investigational clinical evaluation during the 56 day study period that may, in the opinion of the investigator, affect rls.
neurofeedback for treatment-resistant obsessive-compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder; OCD

Summary: the aim of this study is to teach participants with a ocd diagnosis and treatment-resistance how to decrease the response from a brain region involved in the disease by using a technique called neurofeedback. while using this technique, the participants visualize their own brain response in a screen during a mri exam. participants will learn strategies to decrease brain responses. the neurofeedback technique is non-invasive, without known risks to participants. with this study, it is expect that the neurofeedback training over 2 weeks (2 sessions) will reduce the ocd symptoms when compared to a control intervention based on neurofeedback's placebo effects.

ocd individuals will be recruited at hospital of braga, braga, portugal, in collaboration with the psychiatry unit (n = 30, nonrandom convenience sample based on effect size of 0.30, alpha = beta = 0.05, and anova repeated measures within-between interaction). some participants may quit the study but sample size was predetermined considering a putative 30 percent dropout rate. clinical history will be assessed (sociodemographic information, disease onset and severity, and previous/current treatments). the participants' neuropsychological state, the blood hormonal levels, and brain function and structure as baseline measures before and after the neurofeedback intervention will be assessed. two mri neurofeedback sessions will be performed during 2 weeks (2 distinct days; 36 min per session) in a 3 t mri scanner. data analysis will be performed with a repeated measures design (baseline and after neurofeedback) between the groups to measure brain, blood, and neuropsychological changes. patients will be supervised by a physician to track putative complications/adverse effects during the intervention. the participation will be immediately interrupted in case of adverse reactions or symptomatic worsening and a physician will follow the participants to provide the appropriated care.

Eligibility criteria:
inclusion criteria: * primary diagnosis of current ocd according to the fifth diagnostic and statistical manual of mental disorders; * treatment resistance (≥ 3 selective serotonin reuptake inhibitors in proper dose for ≥ 12 weeks). exclusion criteria: * concomitant psychiatric or neurological illness; * substance abuse/dependence in the past 6 months (except nicotine/caffeine); * acute suicidal ideation; * psychotropic medication (except selective serotonin reuptake inhibitors, anafranil, or low-dose hypnotic or anxiolytic taken occasionally); * mri contraindications (pregnancy, major head trauma, severe claustrophobia, severe back pain, ferromagnetic materials/prostheses/implants inside the body, or other).

Keywords: neurofeedback biofeedback ocd obsessive-compulsive disorder magnetic resonance imaging functional magnetic resonance imaging orbitofrontal cortex
aerobic exercise on improving sleep in systemic lupus erythematosus.

Conditions: Systemic Lupus Erythematosus; Sleep Disorders

Summary: the purpose of this study is to determine the effectiveness of exercise training on improving sleep in patients with systemic lupus erythematosus.

this study will test the effectiveness of aerobic exercise on improving sleep in patients with systemic lupus erythematosus. the subjects will do treadmill 2 times per week, from 15-20 min. with low to moderate(55-65% maxcf) intensity exercise, so 30 min. until 4ª week. from the 5ª to 8ª week they will be able to make greater efforts to 35-40 min. totalizing 16 weeks. the control group will not do exercise and will receive education class about disease, health, sleep, 1 time per month.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus (sle) according american college of rheumatology (acr) criteria revised in 1997; * pittsburgh sleep quality index (psqi) ≥ 5; * free and clarified consent term signature. exclusion criteria: * patients who have other rheumatologic diseases (rheumatoid arthritis, sjogren syndrome, fibromyalgia, ankylosis spondylitis), excerpt mild osteoarthritis; * systemic lupus erythematosus disease assessment index (sledai) \> 8; * untreated diseases: hypertension, diabetes mellitus (dm), dyslipidemia, thyroid dysfunction, cardiorespiratory diseases, malignancies; * patients who do not accept the study rules as time and/or follow-up exercise program time proposed; * suspected or pregnancy confirmation; \* patients who are taking sleeping medication; * patients who won´t sign the free and clarified consent term informed; * patients engaged in physical activity (defined as previously sedentary individuals, or that which do not perform any type of regular physical activity at least six months);

Keywords: systemic lupus erythematosus lupus sleep disorders sleep disturbed physical exercise aerobic exercise
horton & maizy pilot study for resistant to starch

Conditions: pH; Weight Gain

Summary: this is a pilot study and will be used to power an nih grant application on the effect of resistant starch on weight gain in children.

stool fatty acids and stool ph from the baseline and week 4 stool samples will be compared by paired-t test. the stool microflora changes will be reported using descriptive statistics for the percent changes in the different bacterial phyla.

Eligibility criteria:
inclusion criteria: * healthy male or female between the ages of 5 and 15 years exclusion criteria: * gastrointestinal disease * medication such as antibiotics that have the potential for altering the gut bacterial flora. * allergic to milk or corn products.

Keywords: stool fatty acid
dietary supplementation with omega-3 fatty acid in muscle response

Conditions: Elderly Women; Sarcopenia

Summary: both aging and other factors associated with it may contribute to the development of sarcopenia, such as lack of physical activity, inadequate food intake, hormonal changes and age-related increases in cytokine levels. what is a growing number of elderly people in brazil and the world, it is extremely important to conduct research in order to know the mechanisms of action of new strategies to combat sarcopenia. supplementation with omega-3 fatty acids is a promising intervention in sarcopenic rest. however, there is a practice of studies confirming the effects of omega-3 fatty acid supplementation on neuromuscular function in the elderly.

the aim of this study is to investigate the effect of omega 3 polyunsaturated fatty acid supplementation on the muscular adaptive response in sarcopenic elderly women submitted to resistance training. a total of 30 sarcopenic elderly women, aged 65 years or older, were divided into two groups of 15 volunteers: (1) exercise group and placebo (gep) and (2) exercise group and fish oil (geop). the two groups underwent a resisted exercise program over 12 weeks in three weekly sessions supervised by physicists and physicists at the school of physical education and sports of ribeirão preto (eeferp). all volunteers (both groups) are also instructed to ingest two food supplement capsules at each main meal, and the gep group will use capsules composed of sunflower oil as a placebo. the geop is directed to take two capsules of fish oil at each main meal, totaling 4 capsules per day, that is, four grams of fish oil. to check the quadriceps muscle volume before and after an intervention, as volunteers from both groups are submitted to mri. an extension power and isokinetic force of extension of the lower limb at a knee and hip extension and are measured by dynamometry (biodex 4 pro, biodex, usa) and a functional solution evaluated by the application of the 6-minute walk test. in addition, will be described the biochemicals for the quantification of the following cytokines: il1, il6, il8, il10 and tnf-α, such as to allow selection of the presence of inflammation.

Eligibility criteria:
inclusion criteria: * being sedentary (moderate to vigorous physical activity for at least 3 months) * bmi \<30.00 kg / m2; exclusion criteria: * any type of absolute and / or relative contraindication to moderate or intense physical activity. * any physical limitation that makes it impossible to practice physical activities and / or that impairs the performance of the tests. * also not included are those volunteers who do not go through pre-physical activity evaluation. (par q questionnaire) * miss more than 3 workouts consecutive

Keywords: elderly sarcopenia dietary supplementation omega-3 fatty acid
assessing the optics of the eye pre- and post-operatively in cataract

Conditions: Cataract

Summary: the purpose of the study is to investigate if a novel instrument called a binocular optical coherence tomographer (oct) may resolve many of the issues with the assessment of patients with cataract.

cataract is the second leading cause of blindness in western europe but the leading cause of blindness in the developing world and both central and eastern europe. the most common cause of cataract is age. a number of clinical assessments are required to assess the status and suitability of each patient for cataract surgery. currently, these procedures are performed in an inefficient manner with the patient having to move to different clinical areas to access often large instruments that are costly to both purchase and maintain. such an inefficient patient pathway has been identified as a factor that can markedly increase the cost of outpatient appointments, extend waiting times, and crucially lead to a reduction in patient satisfaction. a novel instrument that offers a solution to such problems is the recently developed binocular optical coherence tomographer. binocular-oct is capable of non-invasively imaging the whole-eye in a potentially small, inexpensive and portable device and is also capable of capturing images from both eyes in the same session without the need for assistance from a trained technician. the binocular-oct has the capability to perform the functions of many clinical tools in a single instrument. of particular relevance to the assessment of the patient with cataract is the ability to capture high resolution images of the anterior eye and crystalline lens with swept-source oct technology. in this study, the proposed advantages of binocular oct system will be assessed for the management of cataract. this research is important, to not only improve cataract assessment and optomise surgical outcomes, but it is also vital to establish sensitive measures of lens quality to determine tools to aid trails attempting to retard the progression of cataract.

Eligibility criteria:
inclusion criteria: * - presence of cataract * male or female, aged 18 years or older * ability to understand nature/purpose of the study and to provide informed consent * ability to undergo binocular oct imaging * ability to follow instructions and complete the study * ability to speak english exclusion criteria: * - hearing impairment sufficient to interfere with hearing instructions * any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct. * any cases where the globe has been affected by trauma, etc. * traumatic aetiologies of cataract