Kornimate/medical-research-clean huggingface dataset:
β-blockers withdrawal in patients with hfpef and chronotropic incompetence: effect on functional capacity (preserve-hr)

Conditions: Heart Failure With Normal Ejection Fraction; Chronotropic Incompetence

Summary: the pathophysiology of heart failure with preserved ejection fraction (hfpef) is complex and multifactorial. chronotropic incompetence has emerged as a crucial mechanism, particularly in elderly patients. betablockers, drugs with negative chronotropic effect, are commonly used in hfpef, despite current evidence does not support its routine use in these patients. the aim of this work is to evaluate the effect of betablockers withdrawal in patients with hfpef and chronotropic incompetence on functional capacity assessed by the peak oxygen consumption at maximal exercise (peakvo2) at 15 and 30 days after the intervention

this is a prospective, crossover, randomized (1:1) and single center study. after randomization, clinical and cardiac rhythm will be continuously registered during 30 days. the primary endpoint (peakvo2) will be assessed by cardiopulmonary exercise testing (cpet) at 15 and 30-day in both groups. patients with hfpef, functional class nyha ii-iii, chronic treatment with betablockers, and chronotropic incompetence will be enrolled. a sample size estimation \[alfa: 0.05, power: 90%, a 15% loss rate, and delta change of mean peakvo2: +1.2 ml/kg/min (sd±2.5)\] of 52 patients would be necessary to test our hypothesis. in conclusion, optimizing therapy that improve quality of life and autonomy has become a health care priority in hfpef. the investigators believe this study will add important knowledge for the treatment of a subgroup of hfpef.

Eligibility criteria:
inclusion criteria: * stable symptomatic patients with heart failure and preserved ejection fraction (nyha class ii-iii). * nt-probnp \>125 pg/ml in the last month * previous treatment with beta-blockers during the last 3 months * documented chronotropic incompetence, defined as: \[(heart rate at peak exercise- heart rate at baseline)\] / \[(220 - age) - (heart rate at baseline)\] \< 0.62 exclusion criteria: * moderate to severe valvulopathy or miocardiopathy associated * patient with heart failure with recovered ejection fraction * acute coronary syndrome in the previous 12 months * angina or signs of myocardial ischemia on cardiopulmonary exercise testing * baseline heart rate\>75 bpm. * uncontrolled hypertension, defined as \>140mmhg systolic blood pressure and/or \>90 mmhg diastolic blood pressure. * moderate to severe pulmonary disease associated * extracardiac comorbidity with a life expentancy less than 1 year. * unable to perform an adequate cardiopulmonary exersice test * previous treatment with digitalis or calcium channel blockers

Keywords: heart failure with preserved ejection fraction chronotropic incompetence functional capacity quality of life
card for community pharmacy vaccinations

Conditions: Vaccination Reaction; Vaccination Pain; Community Pharmacy

Summary: to integrate card in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.

it is estimated that 1 out of 5 children and adults are not vaccinated because of concerns about pain and fear. the card (comfort ask relax distract) system is a new vaccine delivery system proven to reduce pain, fear and immunization stress-related responses. improving the vaccination experiences of patients can improve attitudes about vaccination and increase vaccine acceptance. the objective of this cluster randomized trial is to evaluate scaling of card across community pharmacies on patients vaccination symptoms, beliefs and attitudes and pharmacy staff beliefs and attitudes.

Eligibility criteria:
inclusion criteria: * vaccine clients being vaccinated in community pharmacies participating in the project * pharmacy staff in community pharmacies participating in the project exclusion criteria: * unable to understand and read english

Keywords: vaccination reaction vaccination experience
comparison of laparoscopic total extraperitoneal hernia repair and lichtenstein hernia repair

Conditions: Inguinal Hernia

Summary: the superiority of laparoscopic inguinal hernia surgery over open surgery has been shown in many high patient-numbered studies with early return to work, less pain and good cosmetic results. the aim of this study is to determine the differences between two different methods in terms of sexual, sensory, quality of life and urinary results.

between july 2017 and january 2018, 42 sexually active male patients were randomized with laparoscopic total extraperitoneal (tep) method and lichtenstein (lch) method and repair of inguinal hernia. patients were evaluated preoperatively, at 1 month and 6 months postoperatively, international sexual function index (ifif), international prostatic symptom score, sf-36 quality of life scale, visual analog pain scale, beck depression scale, inguinal region discrimination test ( dt), dn4 neuropathic pain survey, uroflowmetry and fsh, lh, total testosterone levels were evaluated.

Eligibility criteria:
inclusion criteria: * unilateral inguinal hernia (diagnosed by physical examination or imaging) * sexual active * male gender * aged between 18 and 65 * asa 1-2 * ehs classification (primary, lateral or medial, 1 and 2) exclusion criteria: * patients with previous abdominal and inguinal hernia surgery * asa 3-4 * sexually inactive * emergency patients (etrangule inguinal hernia)

Keywords: quality of life inguinal hernia lichtenstein repair sexual function total extraperitoneal repair
residual disease driven strategy for carcik (cd19) in adults/pediatric bcp-all

Conditions: Acute Lymphoblastic Leukemia

Summary: this is a single arm, open-label, multi-center, phase ii study to determine the activity and the safety of a therapeutic strategy that allows a second carcik-cd19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r bcp- all.


Eligibility criteria:
inclusion criteria: children (1-17) and adults (18-75 years old); * relapsed or refractory adult and pediatric b- all as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if \<5%, with at least 1% of molecular disease at pcr; * evidence of cd19 tumor expression in bone marrow and/or peripheral blood by flow cytometry; * diagnosis of cd19 positive all in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of central nervous system (cns) if cns-3 disease. exclusion criteria: * gvhd grades ii-iv for patients who had previously been transplanted; 2. any cell therapy in the previous 30 days; * patient with concomitant life-threatening infectious disease; * lansky/karnofsky score \<60; * patients with hepatic or renal disease as specific above; * pregnant or breast-feeding females; * rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;

Keywords: all
an assessment of long term safety of the combination of aliskiren / amlodipine in patients with high blood pressure

Conditions: Hypertension

Summary: to assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (mean sitting diastolic blood pressure \[msdbp\] ≥ 90 mmhg and \< 110 mmhg).


Eligibility criteria:
inclusion criteria: * outpatients 18 years of age or older * male or female patients are eligible * for newly diagnosed/untreated patients with essential hypertension defined as msdbp ≥ 90 and \< 110 mmhg at visit 1 and visit 4 * for previously treated patients with essential hypertension defined as msdbp ≥ 90 and \< 110 mmhg after 2 to 4 weeks of washout (visit 4) exclusion criteria: * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, aliskiren, amlodipine, hctz, blood pressure
hospital orientation since samu regulation centre call

Conditions: Sepsis

Summary: specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the samu centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit

anonymous, descriptive, longitudinal, resting study searching an association between clinical criteria transmitted by non-medical emergency services to the regulation of the samu centre call for patients with suspected sepsis and their subsequent hospital orientation

Eligibility criteria:
inclusion criteria: * adults (age\>18years) * patients with suspected sepsis state at the regulation samu centre call exclusion criteria: minor (age\<18years)

Keywords: sepsis adults pre hospital settings triage hospital orientation outcome
efficacy and safety study of abp 215 compared with bevacizumab in patients with advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: the purpose of this research study is to compare the effectiveness and safety of abp 215 against bevacizumab in men and women with advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-squamous non-small cell lung cancer (nsclc) * subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy * eastern cooperative oncology group (ecog) performance status score 0 or 1 exclusion criteria: * small cell lung cancer (sclc) or mixed sclc and nsclc * central nervous system (cns) metastases * malignancy other than nsclc * palliative radiotherapy for bone lesions inside the thorax * prior radiotherapy of bone marrow * known to be positive for hepatitis b surface antigen (hbsag), hepatitis c virus (hcv), or human immunodeficiency virus (hiv) * life expectancy \< 6 months * woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment * man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment * subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products * other inclusion/exclusion criteria may apply
attention bias modification treatment for young adults with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: in this study, the investigators test whether a 4-week 12-session attention bias modification treatment (abmt) could reduce depressive symptoms relative to placebo controls in young adults with major depressive disorder at post-training and 3-month follow-ups. meanwhile, the investigators also test whether a 2-week 4-session abmt booster training for every three months could reduce residual depressive symptoms and recurrences relative to placebo controls for 1-year follow-up

attention bias modification training was a modified dot-probe task, in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. the placebo training procedure is a classic dot-probe task in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions. the investigators assess attention bias scores, depressive symptoms, trait anxiety, rumination and self-report attention control ability at 1-week, 2-week, 4-week,7-week,3-month,4-month, 5-month, 6-month and 12-month follow-ups after training.

Eligibility criteria:
inclusion criteria: * the presence of definite and probable mdd (i.e., at least 1 core symptom plus 3 further depressive symptoms present for at least 2 weeks) diagnoses exclusion criteria: * a diagnosis of bipolar disorder, schizophrenia, or mood disorder due to a general medical condition or substance-induced mood disorder; and any concurrent treatment (i.e., psychotherapy and/or pharmacotherapy).

Keywords: attenion bias modification, major depression, treatment
study of cm310 in patients with uncontrolled seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: allergic rhinitis (ar) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin e after exposure to allergens in atopic individuals. the typical symptoms of ar are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. bronchial asthma is associated with bronchial asthma in 40% of patients with ar, suggesting a comorbid feature of allergic disease.

ar is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. ar not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden. ar has a variety of classification methods. according to the type of allergen, it can be divided into seasonal (sar, common allergens are seasonal allergens such as pollen) and perennial (par, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. according to the course of the disease, it can be divided into intermittent (symptom onset \< 4 days/week, or \< 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). according to the severity of the disease, it can be divided into minor ar (mild symptoms, with no significant impact on quality of life) and moderate-severe ar (more severe or severe symptoms, with significant impact on quality of life). the results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of ar has become an urgent problem to be solved.

Eligibility criteria:
inclusion criteria: * voluntarily sign the informed consent form. exclusion criteria: * have any condition that are not suitable for participating in this study.
disability of musculoskeletal origin in community-dwelling elderly

Conditions: Musculoskeletal Diseases

Summary: objectives: to assess the efficacy of an intervention program targeted to the elderly with recent-onset disability of musculoskeletal origin (dims), and to perform its economic evaluation.

methodology: 1) controlled randomised intervention study (3 years). subjects: persons older than 65 in health district 7 of madrid with acute (\< 3 months) dims. intervention group patients will be attended by rheumatologists acording with clinical (diagnostic and therapeutical) protocols. control group will receive the routine attention from the health system. efficacy and costs variables will be collected through monthly structured telephone interviews performed by independent personnel blinded to the intervention group. efficacy will be measured by differences between groups regarding: 1) time to improvement in the baseline dims episode, 2) number of subsequent dims, and 3) total number of dims days. an economic evaluation will be performed from a societal perspective.

Eligibility criteria:
inclusion criteria: * diagnosis of musculoskeletal disorder * older than 64 years * to have disability measured with a) or b): 1. rosser clasification: at least 4. 2. m.gill questionnaire: to need help from other person to dress, to tidy up itself, to walk or to stand up. * disability of recent onset:less than three months.(patiens had a better functional situation before) exclusion criteria: * recent surgery * dementia with no family support * institutionalized

Keywords: elderly disability musculoskeletal diseases
imaging neuroinflammation in epilepsy with ferumoxytol mri

Conditions: Epilepsy

Summary: the investigators plan to study inflammation in the brain (neuroinflammation) in human patients with epilepsy using a novel, non-invasive technique that has been proven successful in humans with other neuroinflammatory diseases. this technique uses ferumoxytol, a drug with minimal side effects that is fda-approved for the treatment of iron deficiency anemia, as the contrast agent in magnetic resonance imaging (mri). the study will recruit epilepsy patients who are admitted to dartmouth-hitchcock medical center (dhmc) for video-electroencephalography (video-eeg) monitoring in order to evaluate their candidacy for curative brain surgery. during the hospital stay and after informed consent, the patient will receive a standard-dose intravenous injection of ferumoxytol, and undergo one session of mri at 24-48 hours after the injection. the patient will also undergo a separate "baseline" mri session (if not already done at dhmc) at admission or at more than four weeks after the injection but before any brain surgery. brain regions that preferentially uptake ferumoxytol are localized by subtracting the post-injection mri session from the "baseline" mri session. the investigators will investigate whether these regions overlap with the epileptogenic focus, namely the region that generates epilepsy and is localized by video-eeg and other diagnostic measures. lastly, for those patient participants who thereafter undergo brain surgery, dhmc neuropathologists will use special stains to detect and quantify neuroinflammation in brain tissue removed, and the results will serve as the reference for the investigators to measure the sensitivity and specificity of ferumoxytol-based mri in detecting neuroinflammation.


Eligibility criteria:
inclusion criteria: * patient has a plan of hospital stay at dartmouth-hitchcock medical center for video-eeg monitoring for standard presurgical evaluation for epilepsy. * between the ages of 18 and 70 years old. * patient or patient's legal guardian is able and willing to sign the informed consent prior to the ferumoxytol injection. * able to undergo routine mri. exclusion criteria: * absence of epileptic seizure event that is detected by video-eeg monitoring and/or by a board-certified epileptologist during the hospital stay * history of central nervous system conditions other than seizure, including but not limited to history of brain surgeries, cerebral vascular accidents, encephalitis or meningitis, or diagnosis of brain tumors, cerebral aneurysms, multiple sclerosis or alzheimer's disease. * history of medical conditions that may influence iron metabolism, including but not limited to diagnosis of hemochromatosis, hyperbilirubinemia, hepatitis, cirrhosis or liver tumors, physical exam finding of jaundice or hepatomegaly, history of abnormal liver function test (lft) results, or significant family history of hemochromatosis. * medical history of adverse reaction to ferumoxytol * pregnant or breast feeding
randomized controlled trial of escreen for problematic alcohol use

Conditions: Problematic AOD Use

Summary: objectives: this study compares the efficacy of escreen and alkoholhjalpen in a three-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. the escreen brief internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. progress over time is shown in diagrams detailing consumption levels. a more extensive internet intervention for problematic alcohol use, alkoholhjalpen,provides cbt- and mi-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum. method: participants with problematic alcohol use (audit \>7 for men and \>5 for women) are randomized into one of three groups: t1, escreen referral (n=211); t2, alkoholhjalpen referral (n=211); control group (n=211). outcomes on alcohol use as well as health-related symptoms are assessed after 3, 6 and 12 months. the first hypothesis is that all three groups will reduce their alcohol consumption and alcohol-related problems at follow-ups compared to the baseline level. the second hypothesis is that there will be no differences between participants in the escreen and the alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at follow-ups. the third hypothesis is that participants in the escreen and the alkoholhjalpen group will show a greater reduction in alcohol consumption and alcohol-related problems compared to the control group (no intervention) at follow-ups. for a greater understanding of the study results possible other interventions received by the study participants for their problematic alcohol use during these 12 months of study participation will be investigated.


Eligibility criteria:
inclusion criteria: * problematic alcohol use. audit\>7 for men and audit\>5 for women exclusion criteria: * drug use dudit\>0 * unproblematic alcohol use, audit\<8 for men and audit\<6 for women

Keywords: randomized controlled trial alcohol internet screening brief intervention personalized feedback
morning bright light to improve sleep quality in veterans

Conditions: Brain Injuries, Traumatic; Post-traumatic Stress Disorder

Summary: one of the principal complicating factors associated with traumatic brain injury (tbi) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). morning bright light therapy (mblt) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of mblt in improving sleep in veterans with tbi. this proposal aims to determine the effect of mblt on sleep quality in veterans with tbi. veterans with and without tbi will be recruited from the va portland health care system. baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of mblt daily for 4 weeks, during which actigraphy will also be collected continuously. post-mblt questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-mblt.


Eligibility criteria:
inclusion criteria: * veterans exclusion criteria: * history of bipolar disorder * history of macular degeneration * non-english speaking * decisionally impaired * currently using a light box

Keywords: sleep bright light