Kornimate/medical-research-clean huggingface dataset:
vaccine-based immunotherapy regimen for nsclc and tnbc

Conditions: Non-Small Cell Lung Cancer; Triple-negative Breast Cancer

Summary: part 1of the study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of increasing doses of a vaccine-based immunotherapy regimen (vbir-2) for patients with advanced or metastatic non-small cell lung cancer and metastatic triple-negative breast cancer. part 2 will evaluate the safety, pharmacokinetics and pharmacodynamics, immunogenicity and preliminary evidence of efficacy of the expansion dose of vbir-2 in participants with advanced or metastatic non-small cell lung cancer.

the study is divided into two parts, dose escalation (part 1) in participants with nsclc and tnbc without acceptable alternative treatment options, followed by dose expansion (part 2) in participants with nsclc who have progressed on or after treatment with platinum-based chemotherapy and treatment with 1 immune checkpoint inhibitor, given concurrently or sequentially with chemotherapy. part 1 has been completed.

Eligibility criteria:
inclusion criteria: part 1:histological or cytological diagnosis of non-small cell lung cancer or triple-negative breast cancer. adequate bone marrow, renal and liver function. part 2: histological or cytological diagnosis of metastatic non-small cell lung cancer previously treated with 1 or 2 regimens in metastatic setting including a cpi and platinum-based chemotherapy. adequate bone marrow, renal and liver function. exclusion criteria: * known symptomatic brain metastases * ecog performance status greater than or equal to 2 * concurrent immunotherapy * history of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus, erythematosus, scleroderma) and other conditions that disorganize or alter the immune system. * history of inflammatory bowel disease. * current use of any implanted electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators. * presence of any surgical or traumatic metal implants at the site of administration
internet-delivered cognitive behaviour therapy for students: duration preference trial

Conditions: Depression; Anxiety

Summary: there is growing evidence for the effectiveness of internet-delivered cognitive behaviour therapy (icbt) for post-secondary students with symptoms of depression and anxiety. in icbt, clients review structured online content over several weeks to learn strategies and skills to manage their symptoms. low treatment completion rates remain a concern for post-secondary students, so it is possible that existing treatment protocols do not offer enough flexibility for students' needs and preferences. this trial will examine students' preferences for different course options (fast-track, 5-week, and 8-week) and compare enrollment, adherence, and outcomes of students who pick each of the three options. in all three options, students will receive optional therapist support, in which the assigned therapist only contacts the student on weeks where the student sends the therapist a message. this trial will help inform the delivery of flexible treatment options for post-secondary students in a routine care setting.


Eligibility criteria:
inclusion criteria: * registered as a student at a post-secondary institution in saskatchewan; over the age of 18; endorse symptoms of depression (score of 5 or greater on the phq-9) and/or anxiety (score of 5 or greater on the gad-7); and be able to access computers and the internet and be comfortable using them exclusion criteria: * high risk of suicide or hospitalization for mental health in previous 12 months; unmanaged alcohol or drug use problems; severe psychiatric illness that is not managed (e.g. psychosis or mania); or receiving other psychological services more than twice per month

Keywords: anxiety depression post-secondary students internet-delivered cognitive behaviour therapy transdiagnostic preference trial
revascularization in patients undergoing transcatheter aortic valve implantation

Conditions: Coronary Artery Disease; Aortic Valve Stenosis; TAVI; PCI

Summary: the aim of this study is to evaluate the effect of routine ffr-guided complete revascularization with pci compared to conservative management in patients with concomitant coronary artery disease who are undergoing tavi.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. severe aortic valve stenosis and selected for tavi by a multi-disciplinary heart team 3. at least one stenosis with ffr ≤ 0.80 or diameter stenosis \> 90% in a coronary artery ≥ 2.5 mm in diameter exclusion criteria: 1. life expectancy \< 1 year due to other severe non-cardiac disease 2. severe renal failure with estimated glomerular filtration rate \< 20 ml/min 3. no pci-eligible coronary artery stenosis, but rotablation is allowed 4. admitted with a new acute coronary syndrome (st-elevation myocardial infarction (stemi) or non-stemi) within 14 days 5. significant stenosis in left main stenosis or ostial left anterior descending artery (lad) + ostial left circumflex artery (lcx)) 6. only stenoses with thrombolysis in myocardial infarction grad \< 3 7. potential pregnancy 8. known allergy towards p2y12 receptor antagonists, heparin or contrast medium 9. more than one chronic total occlusion (cto)
comparison of two dosing regimens of gw433908/ritonavir versus lopinavir/ritonavir for 48 weeks in hiv patients who have taken protease inhibitors and experienced virological failure

Conditions: HIV Infections

Summary: the purpose of this study is to test 2 different dosing regimens of gw433908/ritonavir (rtv) versus lopinavir (lpv)/rtv when each is given with 2 active reverse transcriptase inhibitors (rtis), in patients who have taken anti-hiv drugs without success.

patients will receive 2 dosing regimens of gw433908/rtv or lpv/rtv, in combination with 2 active rtis, after failing their first or second protease inhibitor-containing regimen. patients are required to be on therapy at time of screening and must remain on this therapy until day 1.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * have a viral load of 1,000 or more copies/ml. * have taken protease inhibitors (pis). * have taken pi drugs for at least 12 straight weeks and have had virologic failure on the pis. * are now taking antiretroviral therapy. * are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18. * are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control. exclusion criteria patients will not be eligible for this study if they: * have taken apv or lpv for more than 1 week. * have taken tenofovir disoproxil fumarate (tdf) or adefovir. * have taken more than 2 pis. * are unable to take 2 active rtis, as specified by the study. * have an active cdc category c disease. * have certain abnormal laboratory tests. * are pregnant or breast-feeding. * have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient. * have a history of significant kidney or bone disease. * are not able to take drugs by mouth and cannot absorb them. * have had pancreatitis or hepatitis within the previous 6 months. * have a drug allergy or other allergy which might cause a problem during the study. * have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study. * have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-hiv activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug. * have had any hiv vaccine within 3 months before taking the study drug. * have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study. * use alcohol or illicit drugs in a way that the doctor feels would interfere with the study. * are not able to take the study drugs. * have inadequate kidney function.

Keywords: hiv-1 hiv protease inhibitors ritonavir rna, viral anti-hiv agents viral load abt 378 vx-175
simplified tai chi for reducing fibromyalgia pain

Conditions: Fibromyalgia

Summary: data from two recent tai chi studies have found that tai chi yields symptomatic benefit in patients with fibromyalgia (fm). the purpose of this study is to confirm those findings in a larger randomized, controlled clinical trial in a community-based setting. we also sought to extend this line of inquiry by closely examining tai chi's effect on physical function, specifically postural stability. towards these ends, we conducted a single-blind, randomized controlled clinical trial of an fm modified 8-form yang-style tai chi program compared to standard education. subjects in both conditions meet in small groups two times weekly for 60 minutes over 12 weeks.

120 males and females with fibromyalgia were randomized to participate in a modified 8 form yang-style tai chi program or a standard group education program. both programs met in a small group format for twice weekly 60 minute sessions lasting for 12 weeks. 99 subjects completed the protocol. primary outcomes from the fibromyalgia impact questionnaire were assessed at baseline and 12 weeks. secondary measures included pain intensity and interference, sleep, coping, and fitness tests.

Eligibility criteria:
inclusion criteria: * subjects included adults over 40 years of age or older who met 1990 acr criteria for the classification of fm. those criteria include pain in three or more body quadrants (above the waist, below the waist, left of midline and right of midline) including axial pain by self-report for a minimum of three consecutive months. * additionally at least 11 of 18 muscle/tendon junction tender points were found to be painful via digital palpation of 4kg over 4 seconds by a trained examiner (wolfe 1990). exclusion criteria: * individuals were excluded if they practiced tai chi within the past 6 months; - were exercising more than 30 minutes, three times weekly for past 3 months; * could not independently ambulate without assistive devices; * were unable to attain md clearance for exercise within past 3 months; * were unwilling to undergo random assignment; had cognitive impairment based on score \>3 pfeiffer mental status; * had significant depressive symptoms based on a score of \>27 on beck depression inventory; * had bpi pain severity scores less than 3/10, had planned elective surgery during the study period; * were unwilling to keep all treatments/medications steady throughout the study period; * were currently enrolled in another study.
diabetes prevention program outcomes study

Conditions: Diabetes Mellitus; Cancer; CVD

Summary: the diabetes prevention program (dpp) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (igt, 2 hour glucose of 140-199 mg/dl). the dpp has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. dppos (2002-2013) is designed to take advantage of the scientifically and clinically valuable dpp participants. this group of participants is nearly 50% minority and represents the largest at risk population ever studied. clinically important research questions remain that focus on 1) durability of the prior dpp intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, cvd risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. the major aims of dppos-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the dppos cohort. the metformin exposure and high degree of study retention and adherence (\~85% of the dppos cohort continues to attend annual and mid-year visits) allows dppos-3 to examine the long-term effects of metformin on cardiovascular disease (cvd) and cancer outcomes, outcomes of great clinical interest and import.

the current dppos executive summary and protocol, as well as dppos protocol and lifestyle manuals and publications are available at: http://www.dppos.org

Eligibility criteria:
participation as a volunteer in the diabetes prevention program (dpp).

Keywords: dpp igt prediabetes type 2 diabetes macrovascular disease microvascular disease lifestyle metformin obesity
blood flow restriction with aerobic exercise in frail older adults

Conditions: Rehabilitation

Summary: background:frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. exercise intervention including aerobic exercise training has been proven to be effective in improving aerobic capacity and frail condition in elderly. recently a novel training method using blood flow restriction (bfr) combined with aerobic exercise has shown positive effects on muscles strength and physical function in healthy elderly. this training method only required lower exercise intensity compared with traditional aerobic exercise to observe improvement. however, it is still unclear whether aerobic exercise training combined with bfr could also improve aerobic capacity and physical function in frail older adults. therefore, the aim of this study will be to investigate the effect of aerobic exercise combined with bfr on cardiopulmonary function and functional activities in frail older adults. method: this study will be an assessor-blind randomized controlled trial.participants aged over 65 years old with more than one item positive of fried frailty phenotype assessment results will be recruited from the hospital and nearby communities. the participants will be randomly assigned to one of two training groups, aerobic exercise with bfr and only aerobic exercise. the exercise will be executed 30 minutes/session, three sessions/week for six weeks. cardiopulmonary function and performance of functional activities will be assessed at pre-training, 3 weeks after training, post-training, and 3- and 6-week follow-up.


Eligibility criteria:
inclusion criteria: * more than one positive item of fried frailty phenotype assessment * able to walk more than 8 meters independently * can understand and follow more than three-step order exclusion criteria: * severe hypertension (\>160/100 mmhg) * cardiovascular disease, such as myocardial infarction, new york heart association class iii or iv heart failure, pulmonary hypertension * deep vein thrombosis or peripheral vascular disease * peripheral neuropathy due to diabetes * neuromuscular diseases, such as stroke, parkinson's disease, etc.

Keywords: blood flow restriction aerobic exercise frailty elderly
validity and reliability of the six-minute peg board and ring test in chronic neck pain

Conditions: Chronic Neck Pain

Summary: the purpose of this study was to evaluate the validity and reliability of six-minute peg board and ring test (6-pbrt) in individuals with chronic neck pain and to determine the applicability of the test for this patient population.

neck pain is the fourth leading cause of disability worldwide and is a significant public health problem. chronic neck pain is defined as the presence of pain in the neck region of individuals for more than twelve weeks. chronic neck pain is a disorder that negatively affects the individual's daily life activities and causes labor force and economic losses by causing functional limitations, loss of work and disability. it is important to evaluate the physical fitness components in detail in individuals with chronic neck pain. it has been stated that neck pain reduces upper extremity performance. different measurement methods have been used to evaluate the upper extremity functions of individuals. standard measurement tools are needed to evaluate the upper extremity exercise capacity in patients with chronic neck pain. the 6-pbrt is a valid, reliable, useful, practical and easy-to-apply test that evaluates the endurance of the upper extremity without support in healthy individuals and those with chronic obstructive pulmonary disease. the validity and reliability of 6-pbrt, which is used to evaluate functional upper extremity exercise capacity in different diseases, has not been investigated in individuals with chronic neck pain. the aim of this study was to evaluate the validity and reliability of 6-pbrt in individuals with chronic neck pain and to determine the applicability of the test for this patient population.

Eligibility criteria:
inclusion criteria: * individuals with neck pain that has lasted at least 3 months due to problems such as cervical strain or sprain, cervical disc lesions, cervical spondylosis, facet joint dysfunction and myofascial pain syndrome, * those between the ages of 18-65, * individuals who volunteer to participate in the study will be included in the study. exclusion criteria: * neck pain severity under 3 point during activity according to visual analog scale * motor deficit in upper extremity neurological examination * undergone any surgery related to neck problem * presence of cervical radiculopathy * undergone any upper extremity surgery, * presence of rheumatic and/or neurological disease or any disease affecting the vestibular system * presence of carpal tunnel syndrome, rotator cuff syndrome, impingement syndrome, thoracic outlet syndrome, lateral and medial epicondylitis, hand osteoarthritis that will affect upper extremity and hand functions * individuals with cognitive dysfunction who will understand and apply the exercise test instructions will be excluded from the study.

Keywords: exercise capacity six-minute peg board and ring test chronic neck pain
the effects of laughter therapy on hemodialysis on depression

Conditions: End Stage Kidney Disease

Summary: end stage kidney disease is associated with increased depression. laughter is associated with improvement in depression in chronic disease. the study objective was to measure the effect of intradialytic group laughter therapy on anxiety and depression. pragmatic randomized controlled trial conducted in 10 hemodialysis centers in northern california. the intervention group received a once weekly 30-minute long group laughter therapy session for 8 weeks. primary outcome was depression score as measured using the patient health questionnaire.


Eligibility criteria:
inclusion criteria: * diagnosis of end stage kidney disease (eskd) and currently undergoing hemodialysis at a satellite healthcare hemodialysis center * ability to understand english exclusion criteria: * cognitive impairment

Keywords: laughter depression hemodialysis
study of tumor samples from patients with stage iii colon cancer who have undergone surgery and chemotherapy

Conditions: Colorectal Cancer

Summary: rationale: studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment. purpose: this research study is looking at tumor samples from patients with stage iii colon cancer who have undergone surgery and chemotherapy.

objectives: * identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage iii colon cancer. * investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified. outline: patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (tp), dihydropyrimidine dehydrogenase (dpd), vegf, egfr, mrna-expression levels of tp, dpd, thymidylate synthase (ts), and orotate phosphoribosyl transferase (oprt) by elisa, human duo set, and rt-pcr assays. patients' enzyme expression levels are compared with their clinical data.

Eligibility criteria:
\ * pathologically confirmed stage iii colon adenocarcinoma * curatively resected (r0) * patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy * provided written informed consent \ * synchronous or metachronous multiple cancers * contraindications for fluorouracil-based chemotherapy * patients who have initiated neo-adjuvant chemotherapy or radiotherapy prior to participating in this study * ineligible patients according to the investigator's judgement

Keywords: adenocarcinoma of the colon stage iii colon cancer
comparison of xience prime versus resolute integrity in diabetes or small vessel disease

Conditions: Angioplasty, Balloon, Coronary

Summary: the newer generation zes (medtronic, minneapolis, mn, resolute integrity) and ees (abbott vascular, abbott park, illinois, xience prime) were introduced to south korea. although these are thought to be superior in effect and stability compared to zes and ees of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. moreover, looking at the 8.3% of restenosis in resolute all comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. therefore, the aim of this study is to investigate the effectiveness and safety of resolute integrity or xience prime in diabetes or small vessels lesion patients.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. patients requiring stent procedure (visual diameter stenosis ≥ 50%) 3. stable angina with evidence of myocardial ischemia, acute coronary syndrome(st segment elevation, non-st segment elevation acute myocardial infarction, and unstable angina) 4. patients diagnosed of type 2 diabetes or small vessel disease 5. patients willing to participate in the study through written consent exclusion criteria: 1. those hypersensitive to or abstaining from heparin, aspirin, clopidogrel, contrast medium, zotarolimus, or everolimus. 2. pregnant women or those having future plans for pregnancy. 3. those having hemorrhagic disease or blood-clotting disorders (including heparin-induced thrombocytopenia), or those rejecting blood transfusion. 4. those having medical history of digestive and urinary system bleeding during the last 3 months, or who have received major surgery within 2 months. 5. those with thrombocytopenia (\< 100,000/mm3) or hemoglobin 10.0 g/dl or less. 6. those planning a surgery that requires the discontinuation of antiplatelet drugs within next 12 months (especially, thienopyridines type). 7. when the remaining survival period is expected to be less than 1 year. 8. restenosis lesion 9. left main coronary artery lesion 10. saphenous vein graft stenosis lesion 11. left ventricular ejection fraction \< 30% 12. cardiac shock 13. those with liver function failure: when liver enzyme level (alt) is 3 times the normal upper limit. 14. type i diabetes

Keywords: drug-eluting stent diabetes small vessel disease