Kornimate/medical-research-clean huggingface dataset:
creation of a national multicenter platform for the study of inflammatory myocardial disease: pre-myo cohort

Conditions: Myocarditis Acute; Inflammatory Cardiomyopathy

Summary: the objectives of this project are: 1) to comprehensively characterize a large national cohort of patients with suspected myocarditis, their clinical phenotype, care management, blood and imaging biomarkers, epidemiological, environmental and genetic data; 2) to retrospectively validate the accuracy of the new hsa-rna-chr8:96 biomarker for the diagnosis of myocarditis compared to conventional diagnosis; 3) to identify acquired and inherited mutations, and their interaction with the environment, which explain the susceptibility to myocarditis, its severity and response to treatment; 4) to study the lower incidence in women and the influence of age, considering socio-health and genetic factors.

the primary endpoint of the study will be the characterization of a broad national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy. the secondary endpoints of the study will be (a) individual susceptibility to developing myocarditis or inflammatory cardiomyopathy, 1) identifying acquired and inherited genetic variants, and 2) from the persistence of gender, age, and socioenvironmental conditions; and (b) studying the correlation between the final diagnosis of myocarditis and the hsa-mir-chr8:96 marker.

Eligibility criteria:
inclusion criteria: • presence of at least one compatible symptom and at least one objective finding in diagnostic tests (figure 2), according to the consensus document of the european society of cardiology (1): a. clinical presentation: * acute chest pain: pericardial or pseudo-ischemic. * dyspnea on exertion or at rest for up to 3 months. * dyspnea on exertion or at rest for 3 months - 1 year. * unexplained palpitations / arrhythmias, sudden death recovered. * unexplained cardiogenic shock. b. findings in complementary tests: * ecg: new onset av block, new onset bundle branch block, st segment elevation/depression, t wave inversion * elevation of tni/tnt * segmental or global contractility alterations not explained by other causes * positive lake louise criteria in cardiac mri (13) (annex iii figure s1) • patients who have given their informed consent.
salivary transcriptome biomarkers for early diabetes detection

Conditions: Pre-diabetes; Type II Diabetes; Insulin Resistance

Summary: a probe design study will be used to obtain saliva from patients before undergoing blood study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes of type ii diabetes. pre-specified saliva biomarkers will be evaluated along with multi-marker models for their discriminatory value for distinguishing patients with normal glucose metabolism from those with disease. appropriate housekeeping genes will also be incorporated to allow for the measurement of relative gene expression.

prospective-specimen-collection, retrospective-blinded-evaluation (probe) methods will be employed to collect saliva and evaluate transcriptome markers for early pre-diabetes and type ii diabetes identification. at risk patients will have fasting blood glucose and insulin levels measured along with hemoglobin a1c and 2 hour post-prandial glucose levels. saliva samples will be stored and will be analyzed after pre-specifying a panel of mrnas and a multi marker model for validation. the pre-specified mrnas and multi-marker model will be determined after analysis of data from a currently ongoing case-control study. after analyzing the data from this prior trial a validation plan will be locked before analysis of the prospectively collected specimens. pre-diabetes will be defined based on abnormal glucose tolerance tests. insulin resistance will be calculated as homa ir. the diagnostic value of the salivary transcriptome for will be compared with that of hemoglobin a1c and fasting blood glucose for the detection of pre-diabetes, insulin resistance and type ii diabetes.

Eligibility criteria:
inclusion criteria: * adult patients with unknown glucose metabolism status and * requiring clinically driven screening for abnormal glucose metabolism and * outpatient status exclusion criteria: * patients on treatment for abnormal glucose metabolism including diet and drug therapy * patients with a prior diagnosis of abnormal glucose metabolism * patients on treatment with corticosteroids
clinical outcomes for patients with metastatic renal cell carcinoma (mrcc) who received sunitinib after 1st line immune-oncology (io) treatments

Conditions: Metastatic Renal Cell Carcinoma (mRCC)

Summary: the study aims to assess clinical outcomes in mrcc patients treated with sunitinib in second-line following io therapy in real world clinical practices.


Eligibility criteria:
inclusion criteria: * patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * diagnosed with mrcc * received io therapy as 1l therapy * received sunitinib as 2l therapy * age 18 years or over at the time of mrcc diagnosis * actively treated at an imdc clinical center (to avoid incomplete data) exclusion criteria: none
trial of outpatient intravenous interleukin-2 in malignant melanoma and metastatic kidney cancer

Conditions: Melanoma; Metastatic Kidney Cancer

Summary: the current study will test single agent il-2 in stage iv melanoma and kidney cancer.

the current study will test single agent il-2 given daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting in stage iv melanoma and kidney cancer to attempt to determine the response rate, how long the responses last, and median survival of this regimen in these two diseases. responding patients and those with absence of disease progression may receive additional cycles of therapy every 3 weeks.

Eligibility criteria:
inclusion criteria: 1. patients must have a histologic diagnosis of metastatic kidney cancer or malignant melanoma patients may be either newly diagnosed with metastatic disease or may have received prior treatment for metastatic kidney cancer. 2. patients must have measurable disease on physical exam or radiologic studies. 3. ecog performance status of 0 or 1 and estimated survival of at least 3 months. 4. white blood count of \> 3500/mm3, platelet count \> 100,000/mm3, hemoglobin \> 9.0 gm/dl; bilirubin, alt, ast \< 2 x upper limit of normal; serum creatinine \< 2.0 mg/dl. 5. patients must undergo a low-level cardiac stress test (or similar cardiac evaluation such as dobutamine stress echocardiogram or radionuclide-based stress test) for possible atherosclerotic heart disease. patients with a positive stress test would be excluded from this trial. 6. patients with elevated temperatures \> 100.5 f must have sources of occult infection excluded. 7. patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy. exclusion criteria: 1. medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate). 2. autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy. 3. prior history of psychiatric disorder, which could be exacerbated by interleukin-2. 4. lactation or pregnancy. 5. evidence of significant cardiovascular disease including history of recent (\< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional pvc's, angina, positive low-level stress test, or cerebrovascular accident. 6. current brain metastasis.
dietary nitrate on plasma nitrate levels for nasopharyngeal carcinoma patients

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to evaluate whether dietary nitrate supplementation could improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.

twenty patients diagnosed as nasopharyngeal carcinoma will be recruited. a 70 ml beetroot juice containing 0.45g nitrate or placebo will be provided to the patients for 7 days at the end of the radiotherapy . the plasma nitrate levels will be determined before radiotherapy, before intervention and after intervention.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed stages iii-ivb (uicc 2002) nasopharyngeal carcinomas, will be recruited. exclusion criteria: * patients with local invasion or metastatic foci in salivary glands, detected by mri and pet-ct prior to treatment, were excluded, as were patients suffering from diseases, such as sjogren's syndrome, or with a history of surgery to major salivary glands, or prior head and neck radiotherapy.

Keywords: dietary nitrate radiotherapy nasopharyngeal carcinoma
gb001 in adult participants with chronic rhinosinusitis

Conditions: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP); Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Summary: a phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (pk), and pharmacodynamics (pd) of gb001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (np).


Eligibility criteria:
inclusion criteria: * a diagnosis of chronic rhinosinusitis with nasal polyps (crswnp) or chronic rhinosinusitis without nasal polyps (crssnp) by a physician at least 12 weeks before screening visit * treated with stable intranasal corticosteroid (incs) for at least 2 months prior to screening visit * presence of at least 2 nasal symptoms: nasal blockage/ obstruction/congestion or nasal discharge or facial pain/pressure or reduction/loss of smell * women of childbearing potential must use an acceptable method of contraception exclusion criteria: * sino-nasal outcome test-22 (snot-22) score \< 20 at screening * asthma or chronic obstructive pulmonary disease (copd) patients that are current smokers * use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to screening visit * pregnant or breastfeeding * pre-existing clinically important co-morbidities * regular use of systemic corticosteroids or immunosuppressive treatments other protocol-defined inclusion/exclusion criteria will apply.

Keywords: gb001 gossamer bio gossamer nasal polyposis crswnp crssnp
the safety and efficacy of double-target cart-19 and 20 cells in non-hodgkin's lymphoma (nhl)

Conditions: Non-hodgkin Lymphoma,B Cell

Summary: this is a study for patients who have been previously treated for nhl. the purpose of this study is to determine the safety and feasibility of double-target cart-19 and 20 cells to the patients with relapsed and refractory cd19+/cd20+ nhl.


Eligibility criteria:
inclusion criteria: 1. age between 18 to 75 years old (including 18 and 75) 2. diagnosed as r/r nhl 3. cd19/cd20 positive confirmed by cell flow cytometry or immunohistochemistry 4. having at least one measurable lesions 5. world health organization-eastern cooperative oncology group performance status (ecog) 0-2 6. life expectancy no less than 3 months 7. enough main organ function 8. pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and 12 months after this study 9. agreeing to sign the written informed consents exclusion criteria: 1. congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 12 months 2. active gvhd 3. history of severe pulmonary dysfunction 4. active malignant tumor need be treated at the same time 5. uncontrolled active acute/chronic infection 6. severe autoimmune diseases or congenital immunodeficiency 7. untreated active hepatitis 8. hiv-positive, aids patients and syphilis infection 9. history of severe allergies to biological products 10. patients with a history of mental illness 11. pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test) 12. researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results

Keywords: non-hodgkin's lymphoma cart
intervening to reduce suicide risk in veterans with substance use disorders

Conditions: Suicide; Suicidal Ideation; Substance-Related Disorders

Summary: the purpose of this study is to evaluate the impact of a cognitive behavioral therapy (cbt) intervention compared to a supportive psycho-educational control (spc) condition in reducing the frequency and intensity of suicidal thoughts and behaviors in veterans with substance use disorders (suds) over a two-year follow-up period.

the project is a multi-site randomized controlled trial of the cbt intervention versus the spc condition for 300 suicidal veterans seen in veterans health administration (vha) intensive outpatient substance treatment programs (sud iop). participants will be screened for current suicidal ideation and other conditions by completing a self-report survey questionnaire. eligible participants will complete a baseline assessment which will include a self-report survey questionnaire, a research staff administered interview, and a voluntary urine drug screen. participants will be randomized to either a cognitive behavior therapy (cbt) or supportive psycho-education control (spc) condition. both conditions will involve receipt of 8 one-on-one sessions lasting approximately one hour over a period of approximately 3-4 weeks in addition to their standard sud iop treatment of care they may be receiving at the vamc. the intervention is designed to augment their current treatment, not to take the place of current treatment. participants will be re-assessed immediately after receiving the study interventions (at 1-month) and then again at 3-, 6- 12-, 18-, and 24-month post-intervention follow-ups by completing a series of self-report surveys, researcher administered interviews, and a voluntary urine drug screen. to ensure adequate monitoring of suicidal ideation, additional telephone follow-up assessments will occur 2-, 4-, and 5-months post-intervention.

Eligibility criteria:
inclusion criteria: * must be 18 years of age or older * must be a united states military veteran * report current suicidal ideation * enrolled in outpatient substance abuse treatment within the past month * must live within 75 miles of treatment site at time of recruitment exclusion criteria: * inability to give informed, voluntary, written consent * inability to speak and understand english * receipt of methadone treatment for substance use currently or within the past 6 months * evidence of active, severe psychotic symptoms * women who are currently pregnant

Keywords: veterans cognitive behavioral therapy
influence of foam rolling on elbow proprioception, strength, and functional motor performance

Conditions: Proprioceptive Disorders

Summary: the purpose of this study is to investigate the long-term effects of foam rolling on elbow proprioception, strength and functional motor performance with healthy participants . study group will receive foam rolling exercise. control group will receive no foam rolling exercise. control group will be given a brochure including information about proprioception and foam rolling.

there is no information in literature about the effects of foam rolling on elbow proprioception, strength and functional motor performance. the purpose of this study is to investigate long-term effects of foam rolling with healthy participants. study group will receive foam rolling exercise actively by themselves on elbow. foam rolling exercise will be applied 10 times each for 1 minute. these exercises will be performed as 2 sets. after each set will be a resting period for 30 seconds.a total of 12 sessions of exercise will be performed three times a week. second evaluation will be performed after 4 weeks. then the follow up evaluation (third evaluation) will be performed 4 weeks later. control group will receive no foam rolling exercise. they will be handed a brochure about the proprioception and its role in injury prevention and foam rolling. control group will be evaluated for the first time. afterwards, second evaluation will be performed after 4 weeks and follow up after 4 more weeks.

Eligibility criteria:
inclusion criteria: * 18 years and above healthy participants * no pain in elbow area within 6 months and at the time of measurement * to be able to complete all evaluations and applications to be carried out exclusion criteria: * having previous foam rolling and self-myofascial relaxation applications on the target area * having acne and similar skin problems, open wounds * having upper extremity injury, history of fracture or surgery * having any systemic musculoskeletal disease * having diagnosis of diabetic mellitus or peripheral neuropathy * having osteoporosis diagnosis * having any cardiovascular disease * having vertigo * being pregnant

Keywords: elbow foam rolling proprioception motor performance strength
effect of propranolol on preventing posttraumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: this study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress disorder in acutely traumatized individuals.

posttraumatic stress disorder (ptsd) is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. ptsd is marked by clear biological changes as well as psychological symptoms. many people with ptsd repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. this study will assess the effect of post-trauma propranolol on reducing the incidence and severity of ptsd. the study will also evaluate propranolol's effectiveness as a preventive measure against subsequent ptsd symptoms. participants in this double-blind study will be recruited upon admission to the massachusetts general hospital emergency department after exposure to a psychologically traumatic event. baseline psychometric and psychobiologic measurements will be collected. within 6 hours following the traumatic event, participants will be randomly assigned to receive either 40 mg of short-acting propranolol or placebo and 60 mg of either long-acting propranolol or placebo. for the next 10 days, participants will receive 120 mg of either long-acting propranolol or placebo twice daily. a 9-day medication tapering will follow. participants will undergo psychophysiologic, psychodiagnostic, and psychometric testing for ptsd 1 and 3 months following the traumatic event.

Eligibility criteria:
inclusion criteria: * experienced an acute psychological traumatic event * heart rate of 80 beats per minute (bpm) or greater * understands english exclusion criteria: * traumatic event that occurred more than four hours before arrival to emergency department * physical injury that may affect safe participation (e.g., head injury) * systolic blood pressure less than 100 mm hg * medical or surgical condition that poses a risk of shock * medical condition that may affect the safe administration of propranolol * previous adverse reaction to, or non-compliance with, a beta-blocker * current use of medication that may react badly with propranolol * elevated saliva alcohol level * presence of salivary opiates, marijuana, cocaine, or amphetamines * pregnant or breastfeeding * traumatic event reflecting ongoing victimization * psychiatric condition that may affect safe participation * unwilling or unable to commute to boston for research visits * attending physician in emergency department does not advise participation

Keywords: post-traumatic stress disorder prevention propranolol psychophysiology
home based intervention led by nurse in brazil

Conditions: Heart Failure

Summary: home visits (hv) are one of the multidisciplinary approaches that has already shown to benefit the follow-up of heart failure (hf) patients. it is considered to be one of the most effective and humane approaches as it educates and takes care of the patient in his/her routine environment. in this study, the follow-up of hf patients in a home setting after being discharged from hospital will include the reinforcement, monitoring and re-evaluation of guidelines previously provided about the disease and self-care, compliance to prescribed medicines and, specially, the early recognition of decompensation signs and symptoms by patients and their caregivers.

the epidemiological overview of cardiovascular diseases in which hf turns out to be the main cause of re-hospitalizations in the unified health system, which has not changed over the years, impairs the management of the limited resources of the public health system. additionally, hf leads to substantial damage to the quality of life of patients, many of them at a socially productive age, resulting in early retirements and absences. in this study, the objective is to evaluate the impact of the follow-up of heart failure patients at home, interspersed with telephone contacts, by the nursing team, after hospital discharge, regarding knowledge of the disease, self-care skills and quality of life improvement, compared with the conventional follow-up of patients in a 6-month period without this intervention, as well as to build a mobile-technology computer structure to make the use of cardiology nursing evaluation forms viable; correlate sociodemographic and clinical characteristics with treatment compliance and re-hospitalization rates in both; and ascertain home follow-up costs. with this purpose, a two-center randomized clinical trial, blinded for the endpoints re-hospitalization and costs, was designed.

Eligibility criteria:
inclusion criteria: * patients of both sexes * age equal to or above 18 years * diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%) * hospitalized for heart failure decompensation and who agree to participate in the study by signing a free informed consent form. exclusion criteria: * patients presenting with communication barriers and suffering from degenerative neurological diseases. * patients who had acute coronary syndrome (acs) in the past 6 months before randomization * patients with renal/hepatic/pulmonary or systemic disease who may confuse the interpretation of findings or result in limited life expectancy * surgical or therapeutic treatment that may influence the follow-up * pregnancy * diagnosis of heart failure secondary to: * sepsis * myocarditis * acute myocardial infarction * peripartum cardiomyopathy and other acute cause * no interest in receiving home visits * living more than 10 km away for the original hospital * no possibility of telephone contact.

Keywords: home based education knowledge of disease self-care skills quality of life heart failure randomized clinical trial