Kornimate/medical-research-clean huggingface dataset:
caregiver outlook: an intervention to improve caregiving in serious illness

Conditions: Heart Failure; Pulmonary Disease; Cancer

Summary: informal caregivers provide a majority of care for patients during serious illness. lack of preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care. this study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use.

the investigators propose a randomized control trial to evaluate an intervention of preparation and completion with veterans and their caregivers during serious illness. specific aims are to 1) evaluate the impact of the caregiver outlook intervention on caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) evaluate the impact of the home versus in hospital, emergency department, or nursing facility; 3) evaluate the impact of the intervention session's qualitative content, examining variation associated with selected demographic variables, quality of family communication, and stage of illness on change. caregivers in the first group ("treatment", or "preparation and life completion") will meet with a facilitator three times for a period of forty-five minutes each. in the first session, subjects will be asked to discuss issues related to relationship life review. in session two, participants will be asked to speak in more depth about issues such as regret and forgiveness. in the final session, subjects will focus on legacy and celebration. caregivers in the second group ("attention control" or "relaxation meditation") will meet with a facilitator three times for a period of forty-five minutes each and be asked to listen to a non-guided relaxation compact disk (cd) or participate in a guided relaxation exercise. participants in both groups will receive pre and post-test measures administered by a blinded interviewer. outcome measures will be measures by the functional assessment of cancer therapy - general (fact-g), quality of life scale, facit-sp sub-scale, anticipatory grief scale, caregiver reaction assessment, the qual-e completion and preparation sub-scales, and patient days at home.

Eligibility criteria:
inclusion criteria: * patients with advanced cancer/congestive heart failure/copd/end stage renal disease who have a primary caregiver. caregivers of durham vamc patients with advanced disease. exclusion criteria: * no caregiver present. * caregiver with cognitive impairment/inability to speak on phone/non-english speaking

Keywords: caregiver end of life self-disclosure
adult subjects suffering from lower limb spasticity following stroke

Conditions: Spasticity

Summary: the purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the goal attainment scale following one botulinum toxin type-a (bont-a) injection cycle in accordance with routine practices.


Eligibility criteria:
inclusion criteria: * suffering from lower limb spasticity following stroke * with at least a 12-week interval between the last bont-a injection and inclusion * decision already been agreed to inject bont-a exclusion criteria: * documented positive antigenicity to botulinum toxin * any neuromuscular junction indication * severe muscle atrophy in any muscle to be injected * any other indication that might interfere with rehabilitation or the evaluation of results

Keywords: lower limb spasticity
phase iib safety and efficacy study of bay94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease alone

Conditions: Heart Failure

Summary: this study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (dm) with or without chronic kidney disease (ckd) or moderate ckd alone treated with evidence-based therapy for heart failure (hf) for at least 3 months prior to emergency presentation to hospital using a multi-center, randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design. primary objective of the study is to investigate efficacy \[percentage of subjects with a relative decrease in n-terminal prohormone b-type natriuretic peptide (nt-probnp) of more than 30% from baseline to visit 10 (day 90)\] and safety of different oral doses of bay94-8862 given once daily.


Eligibility criteria:
inclusion criteria: * subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous (iv) diuretics at hospital * subjects with either type 2 dm or moderate ckd exclusion criteria: * acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis * acute coronary syndrome (acs) (elevated cardiac troponins which are not caused by an acs are not an exclusion criterion) in the last 30 days prior to the screening visit * cardiogenic shock * valvular heart disease requiring surgical intervention during the course of the study * subjects with left ventricular assistance device or waiting for heart transplantation * stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit * addison's disease

Keywords: bay94-8862 mr antagonist heart failure japanese patients
continuous wound infusion in lumbar or thoracic surgery

Conditions: Lumbar Spine Surgery; Thoracic Spine Surgery

Summary: introduction : spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (iv analgesic infusion and local anesthesia). continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery. methods : after written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. patients are randomised in two groups : the "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (ml) followed by 8 ml/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). in addition, all patients receive patient-controlled intra-venous morphine analgesia. the investigators hypothesize that the "treated group" will consume morphine less than the "control group".


Eligibility criteria:
inclusion criteria: * adults * \> 18 years * physical status score i, ii or iii (american society of anesthesiologists) * lumbar or thoracic spine surgery with arthrodesis through posterior only approach * signed informed consent * beneficiary of social security exclusion criteria: * vulnerable persons according to law * scoliosis surgery * local anesthetic allergia * contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol * long term anti platelet aggregants * inability to comply to protocol requirements * psychiatric disorders or cognitive disabilities * chronic pain or long term opioids consumption * diabetes * obesity (bmi \> 30) * pregnancy or lactation
effect of glossopharyngeal nerve block on pharyngeal dysphagia induced by gastroesophageal reflux disease

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore clinical effect of glossopharyngeal nerve block on pharyngeal dysphagia induced by gastroesophageal reflux disease. the main question it aims to answer is: • can glossopharyngeal nerve block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given glossopharyngeal nerve block once a day additionally. the study lasts 20 days for each participant. researchers will compare the rosenbek penetration-aspiration scale, gastroesophageal reflux disease questionnaire, pressure pain threshold, to see if the glossopharyngeal nerve block can help improve the symptom.

gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus. the goal of this clinical trial is to explore clinical effect of glossopharyngeal nerve block on pharyngeal dysphagia induced by gastroesophageal reflux disease. the main question it aims to answer is: • can glossopharyngeal nerve block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given glossopharyngeal nerve block once a day additionally. the study lasts 20 days for each participant. researchers will compare the rosenbek penetration-aspiration scale, gastroesophageal reflux disease questionnaire, pressure pain threshold, to see if the glossopharyngeal nerve block can help improve the symptom.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for gastroesophageal reflux disease. * age between 18 and 65 years. * confirmed tongue-pharyngeal nerve injury by electromyography. * esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia. * normal higher brain function, able to cooperate with treatment. exclusion criteria: * brain vascular disease diagnosed. * clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders. * concurrent presence of other neurological disorders such as alzheimer's disease, traumatic brain injury, parkinson's disease. * esophageal obstruction and severe liver or kidney dysfunction * subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc.
midazolam whole body physiologically based pharmacokinetic model

Conditions: Respiratory Failure; Coma

Summary: this study investigates what independent variables may influence midazolam pharmacokinetics in critically ill patients.

this study has three specific aims: 1. to create a midazolam pbpk model based on anthropometric and physiopathological data from enrolled patients; 2. to estimate cerebral and systemic midazolam concentrations; 3. to assess independent variables about midazolam pharmacokinetic in critically ill patients.

Eligibility criteria:
inclusion criteria: * icu admittance * caucasian * clinical indication of least 72h of continuous sedation with midazolam * map between 60 - 150 mmhg, even if obtained with amine support * informed consent obtained exclusion criteria: * any endocranial lesion, spontaneous or induced * paco2 \> 60 mmhg or \< 30 mmhg * pao2 \< 50 mmhg * pregnancy * anuria * any transplantation * severe hepatic failure (child c) * life expectancy \< 72h * ketoconazole and antiretrovirals in therapy

Keywords: pbpk midazolam pharmacokinetics critically ill patients
the effects of a home-based occupational therapy tele-rehabilitation for outpatients after hip fracture surgery

Conditions: Telerehabilitation

Summary: the investigators will investigate the effects of a home-based occupational therapy telerehabilitation (tr) via smartphones in enhancing functional and motor performances, and fall efficacy, for outpatients receiving day hospital rehabilitation after hip fracture surgery. this is a feasibility randomized controlled trial with two groups - experimental and comparison groups, involving older adults after hip fracture surgery within 12 weeks attending the geriatric day hospital. patients will be assessed at baseline, immediately post 3-weeks intervention, and follow-up after 3-weeks for motor performances, daily activities functioning and fall efficacy. the experimental group will receive home program using the use of caspar health e-system and a mobile app in smartphones, while the comparison group will receive paper-and-pencil instructions for the home program on weekly basis, for 3 weeks.


Eligibility criteria:
inclusion criteria: * primary diagnosis of hip fracture * post-hip surgery within 12 weeks * aged 60 years old or above * medically stable * with abbreviated mental test scored 6 or above * having at least one functional limitation in the basic activities of daily living assessments exclusion criteria: * the hip fracture is the result of malignancy * there is risk of falls due to postural hypotension * either patients or caregiver do not understand cantonese, english or mandarin instructions * they do not use a smartphone * they are unable to read the instructions on the screen of the smartphone because of visual difficulty
endostar in combination with chemoradiotherapy in patient with advanced non-small cell lung cancer

Conditions: Quality of Life

Summary: to investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(nsclc).


Eligibility criteria:
inclusion criteria: * 1. male or female patients, age: 18-70 years of age * 2. pathology was diagnosed as non-small cell lung cancer. according to the tumor node metastasis（tnm）stage of the 8th edition of the international association for the study of lung cancer in 2017, and the pathological stage was identified as stage iiia-b. * 3. no previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy. * 4. eastern cooperative oncology group (ecog) test scored 0-1. * 5. serum hemoglobin ≥ 100g/l, platelet ≥ 100 × 109/l, absolute number of neutrophils ≥ 1.5 × 109/l. * 6. serum creatinine ≤ 1.25 times the upper limit of normal(unl) or creatinine clearance ≥ 60 ml/min. * 7. serum bilirubin ≤ 1.5 times unl, aspartate aminotransferase (ast) and adenosine triphosphate (alt) ≤ 2.5 times unl, alkaline phosphatase ≤ 5 times unl. * 8. forced vital capacity rate of one second（fev1）\>0.8 litre. * 9. coagulation function is normal * 10. lesions are measurable according to the response evaluation criteria in solid tumors version 1.1(recist1.1)standard * 11. sign the inform consent form with good compliance exclusion criteria: * 1. carcinoid or small cell lung cancer * 2. patients with any distant metastasis * 3. patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix * 4. any other disease or condition is a contraindication to chemoradiation (eg, active infection, 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy). * 5. pregnancy or breastfeeding women * 6. women who may be pregnant but are unwilling to take appropriate contraception * 7. hereditary bleeding or coagulopathy

Keywords: recombinant human endostatin nsclc chemoradiotherapy
study of innate host immune response to c. glabrata clinical isolates resistant to echinocandins: impact on the management of candidemia in high-risk patients

Conditions: Candidemia of C. Glabrata

Summary: in the context of candida yeast infections, a large number of studies have been published over the past two decades specifying the molecular mechanisms of antifungal resistance in different candida species. however, few of these studies have explored how these mechanisms influence host immune response to this opportunistic pathogen. recent advances in understanding how the host's immune system responds to candida have initiated the emergence of a new research theme aimed at better understanding candida's intrinsic and adaptive resistance mechanisms to antifungals can modulate "escape to" or "recognition by" the host's immune system. this knowledge could lead to (i) a better understanding of the predominance of certain candida species with antifungal resistance in certain patient populations, (ii) a better understanding of why high levels of in vitro resistance are not necessarily correlated with in vivo therapeutic failure, and (iii) effective immunotherapeutic strategies to control candida resistance to antifungals. it is therefore crucial to investigate the impact of candida's resistance to antifungals on the host's innate immune response. indeed, most antifungal resistance mechanisms have a direct or indirect structural modification of the fungal wall. however, it is the composition of this wall that is involved in the recognition of candida by the host cell via the pattern recognition receptors (prrs). we therefore put forward the very probable hypothesis that changes in the fungal wall, induced by the appearance of resistance, could alter the recognition of candida by prrs and thus trigger a different immune response, either qualitatively (type of cytokines secreted) or quantitatively (amplitude and duration of the immune response). however, even if initial experimental data support the hypothesis of a possible link between resistance and a modulation of the innate immune response in digestive mucosa (the most frequent starting point for disseminated candidiasis), many questions remain regarding (i) the proteins and mechanisms of the modulated immune cascade, (ii) the modification of the immune response according to the candida species in question and (iii) the modification of the immune response according to the resistance phenotype in question.


Eligibility criteria:
inclusion criteria: * 10 clinical isolates sensitive to all antifungal agents * 10 echinocandin-resistant clinical isolates (eucast, caspofungin \> 8µg/ml) clinical strains of c. glabrata susceptible or resistant to echinocandins will be selected on selected criteria: * patient's immune status * therapeutic management * clinical developments exclusion criteria: * not applicable
atrial flow regulator in heart failure

Conditions: Congestive Heart Failure

Summary: the aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of occlutech® atrial flow regulator (afr) device.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * symptomatic heart failure (hf) in nyha class iii or iv ambulatory * optimal medical therapy of hf according to european society of cardiology (esc) guidelines for last 6 months * hospitalization because of hf decompensation in last 12 months * absence of significant valvular disease requiring cardiac surgery * life expectancy ≥ 1 year * written informed consent obtained from the patient * left ventricle ejection fraction (lvef) ≥ 15% * elevated left heart filling pressures: 1. pulmonary artery wedge pressure (pawp) at rest \> 15 mmhg or 2. pawp \> 25 mmhg during hand grip test exclusion criteria: * participation in another clinical trial in last 30 days * acute infection or sepsis * severe coagulation disorder * allergy to nickel or titanium * severe peripheral artery disease disabling 6 minutes walk test * allergy to antiplatelet drugs, oral anticoagulants or heparin * contraindication to trans-oesophageal echocardiography (tee) * pregnancy * atrial septal defect (asd) or presence of atrial septal occluder * severe patent foramen ovale (pfo) with significant left to right shunt in rest * intracardiac thrombus * acute coronary syndrome or percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg) in last 6 months * severe pulmonary hypertension: 1. right atrial pressure ≥ pawp (measured in right heart catheterization) 2. right atrial pressure \> 20 mmhg (measured in right heart catheterization) * planned heart transplantation * transient ischemic attack or stroke within last 6 months * cardiac resynchronisation therapy (crt) within last 6 months

Keywords: atrial flow regulator; heart failure; interatrial shunting
adjust-unlikely pe

Conditions: Pulmonary Embolism (Diagnosis)

Summary: the aim of this pilot study is to assess the feasibility of a larger study to determine the adjust-unlikely algorithm safety and efficiency for diagnosing pe. the pilot study objectives are to: 1. determine study recruitment rate, per site, per month 2. determine study 90-day loss to follow up rate 3. estimate of the proportion of enrolled patients who test negative for pe at initial assessment using the adjust-unlikely rule 4. estimate of the adjust-unlikely algorithm efficiency 5. compare excluded and missed-eligible patients to study participants: age, sex and prevalence of pe diagnoses at initial testing. the pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.


Eligibility criteria:
inclusion criteria: * emergency physician decides to test for pe exclusion criteria: * tested for pe without using the adjust-unlikely algorithm * d-dimer level is known before adjust-unlikely assessment * a new indication for anticoagulation on emergency department assessment (other than pulmonary embolism) in a patient not previously prescribed an anticoagulant * declines participation * is inaccessible for follow-up * has previously participated in this study

Keywords: emergency medicine standardization of practice diagnostics evaluation
neuropsycatric disorders among children with systemic lupus erythematosus in sohag university hospital

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a chronic autoimmune disease involving multiple organs, characterized by the production of autoantibodies and the development of tissue injury. the etiology of sle is partially known, involving multiple genetic and environmental factors. as many as 50% of patients with sle have neurological involvement during the course of their disease. approximately 40% of neuropsychiatric sle (npsle) cases are a consequence of the disease itself; other causes of npsle are infections, metabolic disorders, and side effects of drugs. the american college of rheumatology identified 19 neuropsychiatric syndromes in sle patients that can be divided into central and peripheral nervous system manifestations. although this classification includes syndromes with no clear pathophysiological mechanism and is not specific for neuropsychiatric events caused exclusively by sle, it helps the physician to recognize any neurological involvement . the most common clinical manifestations of juvenile neuropsychiatric sle (npsle) are headache, cognitive dysfunction, mood disturbances and seizures. the pathophysiology of juvenile npsle is not yet fully known, but immunological and inflammatory factors, such as autoantibodies, cytokine and prothrombotic states are widely described . the of autoantibodies in the onset of specific clinical manifestations has also been recognized. juvenile npsle manifestations are often difficult to diagnose (. nineteen neuropsychiatric syndromes have been identified associated with sle, can be divided into central and peripheral manifestations.


Eligibility criteria:
inclusion criteria: * the study aims to include all children fulfilling the diagnostic criteria of sle (the european league against rheumatism and the american college of rheumatology (9)) attending to pediatric rheumatology and immunology clinic at sohag university hospitals during the study period. exclusion criteria: * children with other rheumatological disorders.; neonates (infants \> 1 month) children with other neuropsychiatric disorders not attributed to sle ( e.g. infection, metabolic disorders or side effects of drugs).
evaluation of safety of zycomb® in patients with common cold - zip 3000 (xy-005-im)

Conditions: Common Cold

Summary: the objectives of the study are to obtain knowledge about the safety in use, the patients' general impression of the treatment and the pattern of use of zycomb® in an over-the-counter (otc) setting.


Eligibility criteria:
inclusion criteria: * for inclusion the patient must buy zycomb® nasal spray with the intention to start using it either the same or the next day.