Kornimate/medical-research-clean huggingface dataset:
intermittent oral-esophageal tube feeding in delayed dysphagia after radiotherapy for nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma; Dysphagia

Summary: this is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for npc. patients enrolled are randomly divided equally into the observation group and the control group. all patients receive conventional care, and the observation group received ioe while the control group received ngt for enteral nutrition support. baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (qol) after treatment as well as adverse events are compared.

palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (npc) continues to be a challenge. although nasogastric tube feeding (ngt) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. this study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (ioe) in the treatment of delayed dysphagia after radiotherapy for (npc). this is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for npc. patients enrolled are randomly divided equally into the observation group and the control group. all patients receive conventional care, and the observation group received ioe while the control group received ngt for enteral nutrition support. baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (qol) after treatment as well as adverse events are compared.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * with the history of npc and radiation therapy. * with dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support. * conscious and with stable vital signs; * willing to participate and sign the written informed consent form either personally or by a family member. exclusion criteria: * presence of other diseases that might cause dysphagia. * with distant metastasis of tumors, or complicated with severe systemic disorders or malignancies. * concurrent participation in other treatments that could interfere with the trial. * inability to cooperate with treatment due to aphasia, mental health issues, etc. * received tube feeding for enteral nutrition support within the past three years.
a registry study of biomarkers in ischemic heart disease ( bioms-ihd )

Conditions: Cardiovascular Diseases

Summary: the registry study aims to discover biomarkers for accurate classification and risk assessment of ischemic heart disease.

the purpose of this study is to discover biomarkers for early identification, diagnosis, molecular classification, and intervention based on the mechanism of ischemic heart disease（ihd）. using mass spectrometry-based metabolomics and multimodal imaging technology, the study aims to further construct a new system for early risk stratification of ihd based on abnormal metabolites.

Eligibility criteria:
inclusion criteria : * aged 18 years or older. * previous ischemic symptoms/signs or electrocardiographic ischemic changes and. * \>70% stenosis of at least one epicardial coronary artery on angiography or a history of myocardial infarction or coronary revascularization. exclusion criteria: * current known inability to follow instructions or comply with follow-up procedures. * eligible patients without informed consent form

Keywords: ischemic heart disease
validation of datscan for detection of parkinson disease related disorders

Conditions: Parkinson Disease; Movement Disorders

Summary: this investigator initiated trial is designed to measure the accuracy of diagnosis of parkinson disease through the use of datscan. currently, datscan is fda approved to measure dopamine transporter densities in human tissue. this measurement can assist in distinguishing between essential tremor and parkinsonian syndromes (idiopathic parkinson disease, progressive supranuclear palsy, multi systems atrophy, etc). this study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. patients will be registered in the parkinson research institute's brain donation program, receive a clinical diagnosis of parkinson disease, have their brain scanned using datscan, and donate their tissue for research and autopsy purposes. the hypothesis of the study is that datscan will diagnosis idiopathic parkinson disease as accurately as a clinician.


Eligibility criteria:
inclusion criteria: * aged 75 or older * sporadic late onset parkinson disease or one of its variants * registered in tissue donation program exclusion criteria: * aged less than 75 years old * mental status preventing neuroimaging or transportation to site * inability to remain "relatively steady" during the scanning procedure

Keywords: dat-spect scan parkinson's diagnostic
role of eicosapentaenoic acid (epa) and docosahexaenoic acid (dha) on inflammation and lipids

Conditions: Metabolic Syndrome

Summary: the objective of this study is to provide critical information regarding both common and distinctive roles of epa and dha in systemic inflammation and lipid metabolism.

this is a randomized, placebo-controlled, double-blind, crossover study of the effects of epa and dha on inflammation and lipid metabolism in 24 men and women with metabolic syndrome. the study will characterize the effects of epa alone and dha alone, relative to each other and to placebo, on plasma biomarkers of inflammation, inflammatory cell activation and gene expression, and plasma lipid and lipoprotein levels.

Eligibility criteria:
inclusion criteria: * fasting plasma tg levels between 150 and 500 mg/dl * c-reactive protein (crp) levels ≥2 µg/ml * at least one of the following criteria for the definition of metabolic syndrome: * abdominal obesity (waist circumference \>40 inches in men and \>35 inches in women), * hypertension (blood pressure ≥130/≥85 mmhg or use of anti-hypertensive medications), and * fasting glucose ≥110 mg/dl. exclusion criteria: * high-fish diets (\>2 fish meals/week) * taking fish oil supplements or supplements containing epa or dha * allergy to sardines * allergy to sunflower oil * regular use of anti-inflammatory medications (nsaid, cox inhibitors, corticosteroids) * anticoagulant therapy * alcohol consumption \>7 drinks/week * uncontrolled thyroid dysfunction * insulin-dependent type 2 diabetes mellitus * kidney or liver disease * smoking * alterations in coagulation * use of lipid altering medications
the impact of a mhealth application on outpatient physical therapy hep adherence and outcomes: a rct

Conditions: Orthopedic Disorder; Musculoskeletal Injury

Summary: the purpose of this study is to determine the impact a mobile health application has on adherence to a physical therapy home exercise program and its effect on functional outcomes.

outpatient physical therapy is an integral aspect in combating the impairment and dysfunction associated with musculoskeletal injuries. healthcare and insurance restrictions are leading to reduced clinic visits, encouraging efficient and effective treatments and focusing a greater demand on education, proactive wellness and home exercise maintenance. home exercise prescription has long been a fundamental aspect to a physical therapy routine or regimen. it is well established that exercise protocols can positively impact pain, fitness levels, physical function and measures of life quality (forkan, pumper, smyth, wirkkala, a ciol, \& shumway-cook, 2006). it is also recognized that treatment outcomes may be negatively impacted by non-adherence to the prescribed exercise recommendation in rehabilitation (holden, haywood, portia, gee, \& mclean, 2014). research historically suggests that levels of non-adherence to exercise prescription range from 50-70% (bassett, 2003; sluijs, kok, \& van der zee, 1993), and likely increase as time passes. investigating non-adherence demonstrates a myriad of influencing factors. these factors can be characterized as motivators and barriers. with the explosion of mobile communications access and increasing number of active device users, healthcare is embarking on the concept of mobile health management. mobile health interventions have been found to have a positive impact in the arenas of medication compliance, weight loss, chronic disease management and postoperative complication (lee, 2016; ronghua, li, (2015).the implementation of a mobile health application in physical therapy outpatient management has not been well established. it is time to investigate the impact of using a mobile health application on a prescribed physical therapy treatment regimen for the enhancement of hep adherence and functional outcome assessment.

Eligibility criteria:
inclusion criteria: 1. any musculoskeletal pathology: spine, ue, le 2. age18 or older 3. primary language is english. ability to read, write and understand the english language 4. ownership of mobile smart phone 5. functional and cognitive ability to operate/manipulate a mobile media application 6. willingness to use their data package for support/use of mobile application exclusion criteria: following the initial screening criteria, the study population will be scrutinized for exclusion. exclusion criteria: 1. history of neurological pathology with neurological impairments 2. impaired cognition 3. difficulty with operation and manipulation of mobile application 4. difficulty with directions as set forth by the intake the exclusion criteria will be screened by written intake and a traditional medical history by the primary researcher. subject enrollment will commence after eligibility is met and informed consent received.
erector spinae plane block versus quadratus lumborum block for postoperative analgesia in children

Conditions: Postoperative Pain

Summary: postoperative pain management in children is still standing as a problem to solve. effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.


Eligibility criteria:
inclusion criteria: * 1-7 years of age * asa i-ii * undergoing elective low abdominal surgery exclusion criteria: * infection of the skin at the site of needle puncture area * patients with known allergies to any of the study drugs * coagulopathy * asa iii-iv * patients with neurological disorders

Keywords: pediatric surgery postoperative pain erector spinae plane block quadratus lumborum block
evaluating simplified layered consent for clinical trials

Conditions: Staphylococcus Aureus Bacteremia

Summary: the goal of this clinical trial (the simply-snap trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of staphylococcus aureus bloodstream infection (the snap trial). the main questions it aims to answer are: * does use of a simplified layered consent form lead to an increased recruitment rate to the snap trial? * does use of a simplified layer consent form lead to increased participant understanding of the snap trial and increased participant satisfaction with the informed consent process? participants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. research staff will use the assigned form to explain the snap trial to participants. after consent, participants will be evaluated on their understanding of the snap trial and satisfaction with the consent process using a questionnaire.


Eligibility criteria:
inclusion criteria: * all inclusion criteria from the larger snap trial: 1. s. aureus complex grown from ≥1 blood culture 2. admitted to a participating hospital at the time of eligibility assessment * specific additional inclusion criteria for simply-snap: 1. admitted to participating hospital of simply-snap 2. self-reported proficiency in english or french adequate to be able to participate in consent process carried out solely in english or french (as the supplementary consent materials required in the simplified consent process are currently only available in these two languages) exclusion criteria: * all exclusion criteria from larger snap trial: 1. time of anticipated platform entry is greater than 72 hours post collection of the index blood culture 2. polymicrobial bacteremia, defined as more than one organism in the index blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician 3. patient currently being treated with a systemic antibacterial agent that cannot be ceased 4. known previous participation in snap 5. known positive blood culture for s. aureus between 72 hours and 180 days prior to the time of eligibility assessment 6. treating team deems enrolment in the study is not in the best interest of the patient 7. treating team believes that death is imminent and inevitable 8. patient is for end-of-life care and antibiotic treatment is considered inappropriate 9. patient \<18 years of age and paediatric recruitment not approved at recruiting site * specific additional exclusion criteria for simply-snap: none

Keywords: informed consent research ethics clinical trials staphylococcus aureus bacteremia equity, diversity and inclusion
randomized, placebo-controlled trial of an ampakine in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to test a candidate drug, org 24448,in a phase ii clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder.

major depressive disorder (mdd) is a common, severe, chronic and often life-threatening illness. major depression contributes to significant morbidity and mortality. available pharmacotherapies for major depression are suboptimal in terms of speed of onset, efficacy, and tolerability. current medications for severe, chronic mood disorders are not based on pathophysiological models of illness, but rather are variation of monoaminergic-based therapies. org 24448 represents a new treatment approach for depression, by potentiating the ampa receptor subfamily of ionotropic glutamate receptors. this drug has been shown to have antidepressant features in preclinical models, as well as cognitive-enhancing qualities.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mdd * have not responded to an adequate trial of one antidepressant in the current episode or have not completed antidepressant trials due to intolerance to ≤3 antidepressant medications in the current or a previous episode exclusion criteria: * presence of psychotic features, ocd, drug or alcohol dependency with the preceding 3 months
observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab in the framework of use in special situations prior to commercialisation in spain

Conditions: Severe Asthma

Summary: the aim of this study is to provide the first results on the use of tezepelumab under clinical practice conditions in severe asthma patients who participated in the "foreign medication supply" program in spain.


Eligibility criteria:
inclusion criteria: * subjects 12 years and older with severe asthma who were inadequately controlled with high dose inhaled corticosteroids plus another medicinal product * received at least one dose of tezepelumab under the fms program, established according to royal decree 1015 / 2009 (prior to commercialization) exclusion criteria: * subjects having received tezepelumab or any other biologic for the treatment of asthma in the context of a clinical trial at any time during the 12 months prior to the index date.
current treatment outcomes in japanese rcc patients treated with avelumab plus axitinib as first-line therapy: retrospective study (j-dart)

Conditions: Renal Cell Carcinoma

Summary: this study is a multicenter, non-interventional, retrospective, medical chart review of patients with metastatic renal cell cancer(mrcc) treated with avelumab plus axitinib as a first-line therapy in japan between 20 december 2019 and 20 december 2020. all decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. data will be collected if available per study site.


Eligibility criteria:
inclusion criteria: 1. diagnosed with metastatic renal cell cancer(mrcc) based on the general rule for clinical and pathological studies on renal cell carcinoma (4th edition) before receiving avelumab plus axitinib as a first-line therapy. 2. over 20 years of age at the time of metastatic renal cell cancer(mrcc) diagnosis. 3. start treatment with avelumab plus axitinib as a first-line therapy for metastatic renal cell cancer(mrcc) from 20 december 2019 to 20 december 2020. 4. for patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. for patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained. 5. deceased patients are also included for inclusion criteria 1-3. exclusion criteria: there are no exclusion criteria for this study.

Keywords: retrospective multicenter non-interventional medical chart review japan metastatic renal cell cancer(mrcc) avelumab axitinib first-line therapy standard care in real-world clinical setting
act-hf: attention, cognition and self-management in heart failure

Conditions: Heart Failure

Summary: this study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure.

eligible participants are those 75 years of age or less, with left ventricular ejection fractions of 40% or less, english speaking and no known cognitive deficits. participants will be administered the repeatable battery for the assessment of neuropsychological status and the controlled oral word association test at the study visit. they will also be asked to complete the self-care in heart failure index and the anosognosia questionnaire for dementia at their convenience and mail back to investigator. participants will be contacted in 90 days to determine if they have been hospitalized, and if so, for how many days.

Eligibility criteria:
inclusion criteria: * 75 years of age or less * ejection fraction 40% or less * heart failure 6 months or more * english speaking * no known dementia * no active substance abuse * presence of caregiver/support exclusion criteria: * neurologic disorders potentially causing cognitive dysfunction

Keywords: heart failure self management cognitive dysfunction self management of heart failure
behavioral treatment for weight loss

Conditions: Overweight and Obesity

Summary: this project compares gold standard cognitive-behavioral therapy (based on learn, diabetes prevention program, look ahead) used in both research and clinical settings, with acceptance-based behavioral therapy for weight loss. standard behavior treatment (sbt) focuses on modifying eating, thinking, and activity levels. participants limit their daily caloric intake, keep food records, increase physical activity, and practice weight control behaviors, such as stimulus control, cognitive restructuring, alternative coping skills, and distinguishing hunger from cravings. the acceptance-based approach (abt) incorporates the behavioral and nutritional components, but replaced the cognitive and motivational components with components that are consistent with an acceptance-based approach, such as acceptance and willingness to experience cravings, cognitive defusion, mindfulness training to interrupt automatic eating, and values work. these components are drawn from acceptance and commitment therapy (act; hayes, strosahl, \& wilson, 1999), a cognitive-behavioral therapy that has been gaining increasing attention and empirical support (bach \& hayes, 2002; bond \& bunce, 2000; hayes et al. 2004). though relatively new, acceptance-based strategies have demonstrated effectiveness in helping individuals to respond to unwanted thoughts and feelings (hayes, rissett, korn, zettle, rosenfarb, cooper, \& grundt, 1999, keogh, bond, hanmer, \& tilston, 2005) and offer a novel alternative to control-based strategies (such as distraction and confrontation). participants in this study will be randomly assigned to either the traditional behavioral therapy condition (sbt) or the acceptance-based behavioral therapy condition (abt). both conditions are delivered in group format. a total of 30, 75 minute sessions will take place over the course of 40 weeks. specific aims 1. to evaluate the feasibility and acceptability of the treatment, and its short and moderate-term effectiveness relative to the current gold standard behavioral treatment (sbt). 2. to evaluate the effectiveness of abt with novice clinicians and with weight control experts. 3. to evaluate the effectiveness of abt would be moderated by mood disturbance, emotional eating, disinhibition or susceptibility to food stimuli.


Eligibility criteria:
inclusion criteria: * ages 18 to 65 * fluent in english * body mass index (bmi) of 25 kg/m2 higher * agrees to not join another weight loss program for 9 months exclusion criteria: * lactating, pregnant, or planning to become pregnant in the next two years * currently taking a medication or having medical/psychiatric problem known to cause weight loss or weight gain (unless medication is long-term and dosage is unchanging - e.g., synthroid) * a medical or psychiatric condition that limits ability to comply with the program's behavioral recommendations (including physical activity) * current or history in the past ten years of an eating disorder * plans to leave the philadelphia areas within the next nine months.

Keywords: behavioral interventions for weight loss