Kornimate/medical-research-clean huggingface dataset:
doze sleep app for youth with sleep disturbance

Conditions: Insomnia

Summary: insomnia is a highly prevalent problem among adolescents and young adults (ayas) with mental health issues. although evidence-based treatments to quickly address insomnia exist, access to such treatments is limited and there is very little research in ayas. furthermore, some of the sleep problems of aya are unique (e.g., voluntary sleep restriction, circadian phase delay, very poor sleep hygiene), so pediatric and adult programs are not suitable for this age group. this study will test an innovative program that consists of an integrated smart phone application (app) and web self-management system ("doze") to help adolescents and young adults sleep better. the first phase of this project, now completed, involved interviewing primary stakeholders of the app (ayas) to evaluate a low-fidelity prototype of the app and to gather information regarding their opinion about what tools participants would use to improve their health and/or sleep. using the data from phase i, the investigators have created an app that is acceptable, useful and easy to use while meeting the needs of ayas experiencing sleep problems. in this study, the investigators will conduct an open trial of the app with 145 ayas to evaluate usability, acceptability, and sleep and corollary outcomes using a mixed methods design. the investigators hypothesize: 1. that participants (ayas) will find the app satisfactory and credible; 2. doze will effect sleep-related behaviour change; 3. doze will contribute to improvements in energy, mood, and perceived quality of life. exploratory analyses will also be conducted to evaluate which aspects of doze participants (ayas) found most helpful.


Eligibility criteria:
inclusion criteria: * age between 15 and 24 years * experiencing sleep disturbance exclusion criteria: * none

Keywords: insomnia adolescents young adults
pattern and short term outcomes of renal affection in patients with liver cirrhosis in al-rajhi liver hospital

Conditions: Liver Cirrhosis

Summary: * to characterize the pattern and the prevalence of renal affection among liver cirrhosis patients. * to evaluate the short-term outcomes of those patients.

liver cirrhosis is a chronic liver disease characterized by significant scarring and dysfunction. one of its common complications is renal affection , which can significantly impact patient outcomes . aetiology of aki can be categorized into three main types. these are prerenal (results from decreased renal perfusion), intrinsic renal (acute tubular necrosis), and postrenal aki. in patients on admission, acute tubular necrosis is a common type of intrinsic aki . the development of portal hypertension in patients with liver cirrhosis leading to a reduction in systemic vascular resistance as a result of primary arterial vasodilation in the splanchnic circulation is the primary cause of aki in cirrhotics. this mechanism primarily leads to hepatorenal syndrome. in addition, the underlying causes of liver cirrhosis can be the cause of intrinsic renal disease . early identification and management of aki may improve outcomes. aki in patients with liver cirrhosis in egypt and their impact on inpatient mortality are largely unknown. this study was aimed at determining the prevalence, precipitating factors, predictors, and in-hospital mortality of aki in patients with liver cirrhosis admitted at al-rajhi liver hospital at egypt .

Eligibility criteria:
inclusion criteria: * patients with liver cirrhosis admitted to the department . exclusion criteria: 1. patients with known preexisting chronic kidney disease according to kdigo and easl 2018 definitions ( defined as functional gfr \<60 ml/min per 1.73 m 2 for ≥3 months or structural kidney damage for ≥3 months ). 2. patient refusal to give informed consent ( or his first degree relatives in case of disturbed conscious level).

Keywords: renal affection in patients with liver cirrhosis
immediate effect of ankle mobilization on active range of motion and gait in subacute stroke

Conditions: Hemiparesis;Poststroke/CVA

Summary: the goal of this observational study is to determine the effect of ankle joint mobilization on active range of motion and gait in subacute first-time stroke. the main questions it aims to answer are: * what is the effect of ankle joint mobilization on active range of motion in the ankle and gait qualities? * what is the effect of ankle joint mobilization on self-perceived gait ability? participants will receive physical therapy interventions of: * grade iii ankle joint mobilization * stretching of ankle plantarflexor muscles * ankle muscle activation training * assisted gait as part of assessment study design is to measure conditions before and after the intervention to determine effect(s) of one treatment dose, completed within one session of 90 minutes.

initial passive and active ankle range of motion measured by goniometer. initial gait quality will be measured by walking with splinting for frontal plane ankle stability if indicated, assistive device for body weight support if needed, and manual assistance from an experienced physical therapist, on a zeno walkway pressure-sensitive mat for five complete stride cycles, taking 3 to 5 minutes. data collected from the mat will be electronically captured using protokinetics software. participant initial self-rated perception of ability to walk will be marked on a 0-10 scale, on paper. treatment intervention follows. with participant lying on the back, paretic ankle moderate-force grade iii anterior to posterior-directed manual joint mobilizations will be performed by therapist; three sets of fifteen oscillations. ankle plantarflexor muscles will be stretched for 75 seconds in supported standing. ankle dorsiflexion muscle activation training will be performed for three minutes while in a seated position. post-intervention measurements will proceed in the same sequence as initial measurements listed above: ankle passive and active range of motion and walking ability will be reassessed, and self-perceived ability to walk will be rated again.

Eligibility criteria:
inclusion criteria: * first stroke * subacute phase after stroke * able to follow one-step commands * paretic passive ankle dorsiflexion less than 5 degrees exclusion criteria: referring to paretic ankle; * ankle pain of undetermined cause at rest * fracture in paretic lower extremity * muscle or ligament tear * recent ankle sprain * skin tear or wound * joint fusion or implanted hardware

Keywords: subacute stroke, gait, dorsiflexion, joint mobilization
screening diabetes patients for nafld with controlled attenuation parameter and liver stiffness measurements

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the purpose of this study is to compare the severity of nafld in diabetic patients to that in non-diabetic patients.

1. patient recruitment: eligible patients in the department of endocrinology and department of gastroenterology are encouraged to participate in this study. 2. non-diabetic patients admitted to the department of gastroenterology for other gastroenterological diseases. if available, these patients' data will be collected as control groups. each diabetic patient is matched with a non-diabetic patient by factors of age, gender and bmi. 3. hepatic steatosis and fibrosis are diagnosed via controlled attenuation parameter (cap) and liver stiffness measurement by fibroscan ®, respectively. according to the meta-analysis of individual patient data published recently, the cap in db/m will be adjusted by deducting 10db/m from the cap value for nafld/nash patients, 10db/m for diabetes patients and deducting/adding 4.4db/m for each unit of bmi above/below 25kg/m2 over the range of 20-30kg/m2. 4. regular laboratory tests are performed, including complete blood counts, liver function, renal function, coagulation function, glycosylated hemoglobin, lipid metabolism, urine albumin/creatinine ratio, 24-hour urine albumin. 5. anthropometric data consists of height, weight, body mass index (the weight in kilograms divided by the square of the height in meters) and waist circumference. 6. the diabetic duration, diabetic complications, the grading of hypertension, and the history of anti-diabetic drugs are gathered from medical records. 7. the data are collected via epidata software. they are input into computer twice by a single researcher to avoid typing errors. 8. site monitoring and auditing: as a project for postgraduate thesis, this study is monitored and audited by the school of postgraduate. the research records will be checked in december, 2016, as a mid-term inspection 9. statistical analysis plan: data are summarized and presented using appropriate descriptive statistics. the normality of continuous variables is assessed by skewness statistic and graphically by normal probability plot. patients characteristics between those with and without diabetes, and in diabetes group, between those with and without elevated cap are compared using independent t test, chi-square, or fisher's exact tests as appropriate.

Eligibility criteria:
inclusion criteria: * ≥18 years * type 2 diabetics exclusion criteria: * malignancy; * severe cardiovascular complications; * any history of chronic hepatitis (hepatitis b or c virus infection, autoimmune hepatitis, wilson's disease, hemachromatosis); * secondary causes of fatty liver ( glucocorticoids, amiodarone, tamoxifen); * alcohol consuming (20grams per day for male, and 10 grams per day for female); * any hints of type 1 diabetes ( ketoacidosis, ketonuria, using insulin within 1 year after diagnosis)

Keywords: non-alcoholic fatty liver disease diabetes mellitus, type 2
efficacy and safety study of binodenoson in assessing cardiac ischemia

Conditions: Coronary Artery Disease

Summary: binodenoson (an experimental drug) and adenosine (an fda-approved drug that is currently used by doctors) are used to increase blood flow to the heart just like when a person exercises on a treadmill. using imaging techniques, this increased blood flow can help determine if areas of the heart are not getting enough blood and oxygen during exercise. the purpose of the study is to determine if binodenoson is as good as adenosine in determining if there are areas of the heart not getting enough oxygen when blood flow to the heart is increased.


Eligibility criteria:
inclusion criteria: * able to understand and sign an informed consent form. exclusion criteria: * women who are of childbearing potential. * very low likelihood of coronary artery disease (by american heart association and american college of cardiology standards). * documented history of acute myocardial infarction within 30 days. * percutaneous coronary intervention or coronary bypass graft surgery within 3 years, unless typical or atypical anginal symptoms are present. * reactive airway disease or other contraindication that preclude a patient from receiving adenosine. * previous heart transplant or listed to receive a heart transplant. * cardiomyopathy (idiopathic dilated, restrictive, hypertrophic). * history of hemodynamically significant supraventricular tachycardia or sustained ventricular tachycardia. * presence of second- or third-degree av block (in the absence of permanent pacemaker). * left ventricular ejection fraction greater than 35%, known prior to the first imaging procedure. * presence of advanced heart failure, new york heart association class iv. * history of vasospastic/prinzmetal angina. * active (under treatment) cancer (except skin cancers). * inability to discontinue antianginal medications, aggrenox®, dipyridamole, and xanthine-containing drugs and foods (including caffeine) as required prior to each imaging procedure. * previous participation in a study of binodenoson. * any physical or psychosocial condition that, based on the investigator's judgment, would prevent the patient from completing the study.

Keywords: coronary artery disease angina anginal symptoms ischemic heart disease ischemia single photon emission computed tomography pharmacologic stress myocardial perfusion imaging typical or atypical anginal symptoms suspected coronary artery disease known coronary artery disease
dexamethasone and pregnancy: maternal effects

Conditions: Dexamethasone During Pregnancy

Summary: this study will analyze obstetric, endocrine and metabolic follow-up data in women treated with dex. it will reveal the prevalence and importance of weight gain, insomnia, edema, stretch marks, arterial hypertension and gestational diabetes, describe pregnancy outcome, and analyze the corticotropic axis during and up to 3 months after pregnancy, with the aim of improving the management of these women and preventing comorbidities. a few studies suggest problems in women treated with dex during pregnancy. however, all these studies are retrospective, based on self-questionnaires, and have not evaluated all pregnancy outcomes. moreover, it would appear that a third of women treated with dex no longer wish to resume the treatment (8). compliance with treatment is strongly linked to its efficacy. it is therefore important to start investigating the pregnancy outcomes of women treated with dex. this project is relevant because it has the potential to improve current clinical practice and recommendations related to this treatment, and thus have a direct impact on future patient care. the results of this study will guide us in the management of women presenting an indication for prenatal dex treatment, and will help to inform the order of november 15, 2022.

main objective: the main aim of this study was to assess the incidence of metabolic complications (hypertension and diabetes) in mothers treated with dex during pregnancy. secondary objectives: 1. to assess the prevalence and importance of adverse effects of dex: weight gain, stretch marks, insomnia in mothers treated with dex. 2. describe pregnancy outcomes and compare them with a reference population (data from the 2010 french perinatal survey (15)). 3. analyze the corticotropic axis of dex-treated mothers during and after pregnancy.

Eligibility criteria:
inclusion criteria: 1. femme majeure (âge ≥ 18 ans) 2. grossesse avec indication de traitement anténatal par dexaméthasone (dex) en accord avec le pnds : * mutation sévère du gène cyp21a2 chez chacun des parents * fœtus féminin 3. grossesse unique 4. ayant commencé un traitement anténatal par dex depuis au moins 24h exclusion criteria: 1. contraindication to dexamethasone treatment 2. objection to use of data 3. persons under legal protection (curatorship, guardianship), court-appointed guardians

Keywords: congenital adrenal hyperplasia 21 hydroxylase pregnancy
dexmedetomidine added to propofol for drug induced sleep endoscopy

Conditions: Obstructive Sleep Apnea of Adult

Summary: this study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.

propofol is a commonly used intravenous anesthetic drug used for procedural sedation. dexmedetomidine is an alpha 2 adrenergic receptor agonist which has a sedative and analgesic effects.in the current study the success of the sedation during drug induced sleep endoscopy will be assessed.

Eligibility criteria:
inclusion criteria: * age more than 18 years * patients with obstructive sleep apnea * asa 1and2 exclusion criteria: * patient refusal * age less than 18 years * morbid obesity * known or suspected allergy to the studied drugs

Keywords: dexmedetomidine sleep endoscopy propofol
soliris® (eculizumab) treatment of participants with covid-19

Conditions: COVID-19; Pneumonia, Viral; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Summary: this protocol provides access to eculizumab treatment for participants with severe covid-19.

this is an open label, multicenter, expanded access program (eap) to allow participants with a confirmed diagnosis of sars-cov-2 infection, and a clinical presentation consistent with covid-19 severe pneumonia, acute lung injury, or ards to be treated with eculizumab. participants admitted to a designated hospital facility who qualify for emergency treatment will be administered eculizumab up to 7 times during their treatment course (5 mandatory doses and up to 2 optional doses, per investigator assessment). the eap consists of a screening period of up to 7 days, a 4-week treatment period, a final in-hospital assessment on day 29 or day of discharge, whichever occurs first, and 3 monthly safety follow up visits (to be conducted as a telephone call if the participant has been discharged from the hospital or an in-person visit if the participant is still hospitalized). for each participant, the total duration of the program is anticipated to be 4.5 months.

Eligibility criteria:
inclusion criteria: 1. males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent. 2. confirmed diagnosis of sars-cov-2 infection presenting as severe covid-19 requiring hospitalization 3. symptomatic, bilateral pulmonary infiltrates confirmed by ct or x-ray at screening or within the 7 days prior to screening 4. severe pneumonia, acute lung injury, or ards requiring oxygen supplementation exclusion criteria: 1. confirmed diagnosis of sars-cov-2 infection presenting as mild to moderate covid-19, even if the participant is hospitalized 2. participant is not expected to survive more than 24 hours 3. participant has an unresolved neisseria meningitidis infection 4. hypersensitivity to murine proteins or to one of the excipients of soliris

Keywords: acute lung injury acute respiratory distress syndrome antibodies, monoclonal, humanized complement inhibition covid-19 eculizumab emergency treatment expanded access program hospitalization pneumonia severe acute respiratory syndrome severe acute respiratory syndrome coronavirus 2 severe pneumonia soliris viral
ultrasound for detection of prostate cancer

Conditions: Prostate Cancer

Summary: clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.

prospectively recruited patients before prostatectomy and/or definitive radiotherapy will be included in the study. dual-frequency ultrasound imaging will be compared to standard transrectal ultrasound and mri. imaging of primary tumor with dual-frequency ultrasound technology including the use of microbubble contrast-media. a prostate biopsy and blood sample will be taken from each patient, for histopathology and explorative biomarkers.

Eligibility criteria:
inclusion criteria: * age 18 years onwards * signed written informed consent to perform rectal and transperineal ultrasound exclusion criteria: * n/a
interscalene block with liposomal bupivacaine vs. interscalene block with bupivacaine and adjuvants

Conditions: Shoulder Arthroplasty

Summary: the purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (isb) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for isb, in patients undergoing total shoulder arthroplasty.

the primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (isb) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. principal investigators hypothesize that isb using plain bupivacaine with adjuvants will provide similar pain relief as isb using liposomal bupivacaine.

Eligibility criteria:
inclusion criteria: * all patients undergoing total shoulder arthroplasty (not a reverse) * age ≥ 18 years * ability to understand and the willingness to sign an irb-approved informed consent document. * asa patient status i-iii patients * weight greater than or equal to 50 kg exclusion criteria: * contraindications to an interscalene block or phrenic blockade * infection at injection site * pre-existing neurological dysfunction affecting the operative extremity * chronic pain diagnosis or opioid use \>40mg oxycodone daily equivalents or use of long-acting opioids * bmi \>40 * uncontrolled diabetes (a1c \>8.0) * concurrent painful physical condition requiring analgesic treatment (eg, nsaid or opioid) in the postsurgical period for pain not strictly related to the surgery * contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.) * patients who are wards of the state * history of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine. * patients with moderate-severe hepatic or renal impairment

Keywords: shoulder replacement surgery interscalene nerve block liposomal bupivacaine shoulder pain regional anesthesia brachial plexus blockade
emergency department safety assessment and follow-up evaluation (ed-safe)

Conditions: Suicide

Summary: the nimh s rfa-suicide prevention in emergency medicine departments recognizes the emergency department (ed) as an important setting to increase suicide detection and prevention efforts but observes that evidence-based practice guidelines do not exist. in response, we have designed the emergency department safety assessment and follow-up evaluation (ed-safe) trial. the ed-safe study will be conducted using a quasi-experimental design appropriate for studying systems-based change. the study consists of two components (screening outcome \& intervention evaluation) and three phases of data collection: treatment as usual, screening alone, and intervention. during each phase, 480 suicidal patients (1,440 total) will be enrolled and followed using multiple methods for 12 months. the screening outcome component the screening outcome component will use data collected during the treatment as usual and screening alone phases. consistent with systems-change principles, when universal screening is incorporated during the screening alone phase, it will be completed by the primary nurse as part of routine care. primarily, it will focus on testing a practical approach to screen ed patients for suicidal ideation and behavior and will assess its impact on suicide detection, process outcomes, and suicide behaviors. intervention evaluation component the intervention evaluation component will use data from the treatment as usual, screening alone, and intervention phases. during the intervention phase, each ed will implement a multi-component, systems-based intervention called the safety assessment and follow-up telephone intervention (safti). the safti will combine elements of: (a) safety planning administered by nursing staff in the ed, and (b) coping long term with active suicide program (clasp)-ed, a series of up to 7 semi-structured telephone advising calls to the patient and 4 to the significant other over the 12 months after the ed visit. safety planning will be implemented universally to all suicidal patients, regardless of whether they are ultimately enrolled into the trial, as part of a comprehensive suicide management protocol (e.g., it is a systems-based change). however, for practical and budgetary considerations, the clasp-ed telephone advising calls will be administered only to participants enrolled into the study. our overarching hypotheses will be tested using a combination of the screening outcome component and the intervention evaluation component. we predict that screening will improve detection of suicidal ideation, and the intervention will enhance the quality of care and reduce suicide outcomes.

see summary above

Eligibility criteria:
inclusion criteria: * over 18, * entering care at a hospital ed, * documented thoughts or behaviors related to self-harm. exclusion criteria: * no phone or permanent address, * does not speak english or spanish.

Keywords: suicide screening among ed patients