Kornimate/medical-research-clean huggingface dataset:
clinical characteristics of severe childhood asthma

Conditions: Severe Asthma

Summary: asthma remains a serious health problem with increasing prevalence and incidence. there is limited information about severe asthma among chinese pediatric patients. in this context, we decided to explore the clinical characteristics and risk factors of severe asthma in children. this is a descriptive, observational, retrospective cohort study in children with asthma. the purpose of this retrospective study is: to determine the clinical characteristics of severe asthma of children; to identify the factors associated with severe childhood asthma.

asthma remains a serious health problem with increasing prevalence and incidence. there is limited information about severe asthma among chinese pediatric patients. in this context, we decided to explore the clinical characteristics and risk factors of severe asthma in children. this is a descriptive, observational, retrospective cohort study in children with asthma. the purpose of this retrospective study is: to determine the clinical characteristics of severe asthma of children; to identify the factors associated with severe childhood asthma. participants were consecutively recruited from asthma clinics between january 2021 and december 2021 at children's hospital of fudan university. patients fulfilling the following criteria were eligible for inclusion: (1) aged 6-17 years old; (2) diagnosed with asthma according to the global initiative for asthma (gina) 2020 guideline; (3) children and their caregivers are informed and voluntarily join the database and had follow up for at least 1 year. patients who had cystic fibrosis, mechanical airway obstruction, or any other pulmonary disease or whose parents or legal guardians were not able to fill in the questionnaires were not enrolled. at baseline, the asthma specialist questioned each of the patient in the presence of their caregivers to ensure that they supplied accurate disease information and were included according to the criteria. the patients and their caregivers are asked to complete the online questionnaires including the demographic; baseline asthma control, triggers, exacerbation, medication and adherence; environmental exposure, and diagnosis and control of comorbidities, etc. if a patient had poorly controlled comorbidities, multidisciplinary consultation would be recommended. clinical assessments were arranged at baseline, 3, 6, 9, and 12 months.

Eligibility criteria:
inclusion criteria: * (1) aged 6-17 years old; * (2) diagnosed with asthma according to the global initiative for asthma (gina) 2020 guideline; * (3) children and their caregivers are informed and voluntarily join the database and had follow up for at least 1 year. exclusion criteria: * (1) patients with cystic fibrosis; * (2) had mechanical airway obstruction, or any other pulmonary disease; * (3) whose parents or legal guardians were not able to fill in the questionnaires.
the effect of dexmedetomidine for emergence cough

Conditions: Cough

Summary: dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation period after general anesthesia. the purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence.

administration of dexmedetomidine before end of surgery could reduce airway reflexes and hemodynamic changes during tracheal extubation. compared with remifentanil alone, administration of dexmedetomidine in combination with remifentanil is effective in relieving cough and hemodynamic changes without inhibition of respiration. the purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence using the modified up-and-down method.

Eligibility criteria:
inclusion criteria: * asa physical status i or ii undergoing endoscopic sinus surgery or septoplasty under general anesthesia exclusion criteria: * predicted difficult airway * body mass index \> 35 kg/m2, * recent upper respiratory infection * asthma * current smoker * patients using angiotensin converting enzyme-inhibitors * uncontrolled hypertension

Keywords: dexmedetomidine remifentanil extubation
leveraging eeg for antidepressant prediction with sertraline and escitalopram

Conditions: Major Depressive Disorder

Summary: the leap-se study will be conducted to validate the utility of eeg biomarkers as an aid to antidepressant treatment selection in adults with mdd.

the leap-se study is an 8-week, multicenter, randomized, blinded study to evaluate the performance of eeg-based biomarkers in predicting treatment outcome. study participants will be randomized in a 1:1 ratio to receive either sertraline or escitalopram and followed for 8 weeks.

Eligibility criteria:
inclusion criteria: * male or female, aged 22 or older at the time of informed consent. * diagnosis of major depressive disorder (mdd) based on the structured clinical interview for dsm-5 for depression. * moderate or severe depression on dsm-5 depression criteria items, as assessed by a score of 10 or more on the patient health questionnaire (phq-9) * has not taken either study medications (sertraline, escitalopram) in the current episode * has not received electroconvulsive therapy (ect), transcranial magnetic stimulation (tms), or esketamine treatment in the current episode * provision of personally signed and dated written informed consent prior to any study procedures * agrees to, and is eligible for all biomarker assessments (eeg, neurocognitive testing, activity and sleep monitoring, genetic testing) * fluent in english * ability to complete all assessments independently * stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: * diagnosis of bipolar disorder or a psychotic disorder based on the structured clinical interview for dsm-5. * concurrent use of antidepressants, antipsychotics or mood stabilizers * use of hypnotics, anxiolytics or opiate pain medications greater than three days per week and unable to reduce use to three or fewer days per week on an as needed basis * pregnant or breastfeeding * severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks * active substance use that interferes with ability to consent and/or complete assessments * any contraindication to eeg (e.g. requiring high concentration oxygen) * employees/family of employees of clinic site * participation in another research study within 2 months prior to the first study visit

Keywords: major depressive disorder eeg biomarker antidepressant sertraline escitalopram
motivational interviewing to improve self-care in heart failure patients

Conditions: Heart Failure

Summary: the aims of this study will be to evaluate the effect of motivational interviewing (mi) to improve self-care in heart failure (hf) patients and caregiver contributions to hf self-care. also this study will evaluate the effect of mi on the following secondary outcomes: in hf patients: hf somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; in caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.


Eligibility criteria:
inclusion criteria: diagnosis of hf (for patient), new york heart association (nyha) functional class ii- iv (for patient), inadequate self-care assessed with the self-care heart failure index (for patient), being the informal caregiver of the patients (for caregiver). exclusion criteria: severe cognitive impairment evaluated with the six-item screener (for patient), acute coronary syndrome during the last three months (for patient), living in a residential settings (e.g., nursing home) (for patient), patients not willing to participate in the study (for caregiver).

Keywords: self-care motivational interviewing heart failure caregivers
sudden death counselling and its impact on family members of sudden death victims

Conditions: Sudden Death

Summary: assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.

family members are often shocked and devastated by the death of their loved one, especially when it is sudden and unexpected. on the scene, families often don't really believe it happened because they didn't have time to absorb the fact of their loss. they hear the words and explanation given by the prehospital emergency medical services (ems) team, but do not comprehend the full impact. emotions seem frozen. they feel disoriented, restless, stunned and unable to think. most often, after cardiac arrest resuscitation attempt, the prehospital ems team leaves the scene, letting the family without any further medical bond and support. families are left alone facing this tragedy. after a while, families need medical counseling trying to understand what happens and why but they don't know who to consult. instead, they remain without medical explanation or guidance with the fear regarding their own future, in particular, regarding the risk of dying from sudden death. this fear may be based on the knowledge of the eventuality of familial diseases increasing the risk of sudden death, or simply on a mechanism of identification with the deceased. one important factor credited by experts is to encourage first-degree family members to seek sudden death counselling. however, the literature concerning this problem lacks of reliable data. the aim of this clinical trial is to evaluate the psychological consequences of a sudden death counselling on family member after a relative's sudden death compared to the usual family management. this study will compare the percentage of depression in a group of family members after a relative's sudden death for whom a sudden death counselling has been proposed by the prehospital medical team versus a group for whom the medical team has not modified its usual strategy.

Eligibility criteria:
inclusion criteria: a first-degree relative of a: * patient aged 18-75 years * with an out-of-hospital sudden death\* * and cardiopulmonary resuscitation attempted relative aged ≥ 18 years given consent for the study. sudden death definition\*: an unexpected cardiac arrest without obvious extracardiac cause, leading to a collapse in front of a witness (or in the absence of witnesses, occurring within the hour after the onset of symptoms). exclusion criteria: relative under guardianship/curatorship relative unable to communicate relative not affiliated to a medical insurance

Keywords: family members sudden death sudden death counseling depression
longterm immunogenicity of the japanese encephalitis vaccine ic51

Conditions: Japanese Encephalitis

Summary: the study investigates the long term safety and immunogenicity of the japanese encephalitis vaccine ic51 up to month 60.


Eligibility criteria:
inclusion criteria: * healthy subjects at least 18 years of age * written informed consent obtained prior to study entry * subjects correctly included and having completed clinical studies ic51-301 (nct00604708) and ic51-302 (nct00605085) with at least one vaccination exclusion criteria: * inability or unwillingness to provide informed consent and to abide the requirements of the study
pharmacokinetics/pharmacodynamics (pk/pd) of fluconazole in children on extracorporeal membrane oxygenation (ecmo)

Conditions: Cardiopulmonary Arrest; Fungal Infection

Summary: extracorporeal membrane oxygenation (ecmo) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. while on ecmo, children are at increased risk of infection, including fungal infection. treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (iv) lines. since ecmo requires large iv lines, proper treatment of fungal infections would be difficult if not impossible. the investigators believe that giving prophylactic antifungal medication to all children on ecmo may prevent fungal infections from developing in the first place. fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. unfortunately, the ecmo machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of fluconazole to give children on ecmo. standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. the investigators have obtained fda approval to give this dose of fluconazole to children on ecmo who are enrolled in the study. blood samples will be collected at specific times around the first and second fluconazole doses to describe the pk and drug extraction by the ecmo circuit.


Eligibility criteria:
inclusion criteria: 1. \<= 17.5 years at the time of enrollment. 2. sufficient venous access to permit administration of study medication. 3. supported with either venoarterial (va) or venovenous (vv) ecmo. 4. availability and willingness of the parent/legal guardian to provide written informed consent. exclusion criteria: 1. subject with a history of anaphylaxis attributed to an azole. 2. any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study. 3. previous participation in this study. 4. subjects who are receiving or who have received cyclosporine, tacrolimus, or azithromycin in the 72 hours prior to first dose of study product require protocol chair notification prior to enrollment. 5. pregnancy

Keywords: extracorporeal membrane oxygenation ecmo extracorporeal life support fluconazole diflucan pharmacokinetics pharmacodynamics
aveir dr coverage with evidence development (ced) study

Conditions: Cardiac Pacemaker; Arrythmia; Bradycardia

Summary: the purpose of this coverage with evidence development (ced) study is to evaluate complications and long-term health outcomes of the dual chamber aveir leadless pacemaker device (aka aveir™ dr lp system).

this ced study utilizes a real-world evidence (rwe) method merging multiple real-world datasets from abbott and the center for medicare services to assess aveir dr lp health outcomes among medicare beneficiaries. the study will enroll all medicare patients with continuous claims data implanted with the aveir dr lp system or a dual-chamber transvenous pacemaker system from any manufacturer. due to the rwe data collection methods used in this study, a central institutional review board (irb) approved informed consent waiver has been granted. due to this waiver and the sponsor's use of the central irb, individual hospitals are not required to consent patients or complete local irb submissions for this rwe study.

Eligibility criteria:
inclusion criteria: * medicare beneficiaries implanted with an aveir dr leadless pacemaker on or after the study start date (i.e., the date of aveir dr market approval) will be included in the study. or medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date exclusion criteria: none

Keywords: dual chamber sick sinus rhythm pacemaker av block
intervention for persons leaving residential substance abuse treatment

Conditions: Substance Use Disorders

Summary: this research uses a multi-phase approach to adapt and implement an established intervention, critical time intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. the goals of the study are to: (phase 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (phase 2) adapt cti for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (phase 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted cti compared to enhanced usual discharge planning services.

this randomized pilot study will examine the feasibility, acceptability, and preliminary outcomes of the adapted cti compared to enhanced usual discharge planning services. more specifically, 60 participants will be randomized to either cti (n=30) or enhanced usual discharge planning services (n=30) at the time of discharge. participants will complete a baseline interview (prior to randomization) and 3-, 6-, 9- and 12-month follow-up assessments post-discharge.

Eligibility criteria:
inclusion criteria: * eligible participants will be enrolled in residential substance abuse treatment and who are at least 18 years of age, speak english, and expect to be discharged within 3 months. exclusion criteria: * individuals that do not meet the aforementioned inclusion criteria will be excluded from the study.more specifically, the following categories will be excluded: 1. anyone under the age of 18 2. non-english speaking individuals due to limited resources 3. individuals who are considered vulnerable/protected populations, including children, pregnant women, and prisoners. 4. individuals judged by clinical treatment staff to be in immediate crisis, i.e., suicide watch or inadequate decisional capacity to participate in the study.

Keywords: residential substance use treatment transition
observing pelvic organ prolapse symptoms and treatment outcomes

Conditions: Genital Prolapse

Summary: to prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.

patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. once informed consent is obtained, chart review will be conducted here at william beaumont hospital and at the physician's office to collect patient information related to their prolapse condition. prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death.

Eligibility criteria:
inclusion criteria: * female * pelvic organ prolapse * able to provide informed consent * able to complete study assessments, per clinician judgment exclusion criteria: * age \< 21 years * currently pregnant or \< 6 months post-partum

Keywords: prolapse pelvic organ prolapse
retrospective, observational chart review study conducted in poland to document the management and clinical outcome of cuvitru and hyqvia in pediatric participants (< 18 years) with primary immunodeficiency (pid)

Conditions: Primary Immunodeficiencies (PID)

Summary: the purpose of this observational, multi-center, retrospective cohort study is to assess treatment patterns of cuvitru (scig) 20 percent (%) and hyqvia (fscig) in polish pediatric participants with pid. the study will collect pediatric patient data. these data are gathered and collected during routine clinical care. as this is a non-interventional/observational study, no treatment/pharmacotherapy is provided as part of the study.

subcutaneous immune globulin (scig 20%) and facilitated subcutaneous immunoglobulin (fscig) treatment in polish paediatric patients with primary immunodeficiencies (pid) - retrospective medical chart review study

Eligibility criteria:
inclusion criteria: participant eligibility is determined according to the following criteria prior to entry into the study: * the participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. * male or female participants with pid, aged less than (\<)18 years treated with scig 20% or fscig.. * diagnosis of pid according to the criteria developed by the european society for immunodeficiencies (esid) https://esid.org/about-esid * treatment period for 20% scig ranges from november 1, 2017 until june 30, 2020, and for fscig from july 1, 2018 until june 30, 2020. exclusion criteria: * none
transvaginal ultrasound cervical length screening in singleton pregnancy without prior spontaneous preterm birth

Conditions: Preterm Birth

Summary: preterm birth (ptb) is a major cause of perinatal morbidity and mortality. worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. few prognostic tests are available to predict ptb. a short transvaginal ultrasound cervical length (tvu cl) has been shown to be a good predictor of ptb.different strategies have been adopted for prevention of ptb. the evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous ptb and tvu cl ≤25mm, and not in singletons without prior ptb, nor in multiple gestations. however, so far there are no level-1 data on the efficacy of tvu cl screening neither in low risk nor in high risk pregnancy thus, we aim to assess the efficacy of a policy of tvu cl screening in singleton pregnancy without prior spontaneous ptb


Eligibility criteria:
inclusion criteria: * 18-50 years of age * singleton pregnancy (limits the participants to female gender) * no prior spontaneous preterm delivery, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks exclusion criteria: * multiple gestation * prior spontaneous preterm birth 16-36 6/7 weeks * ruptured membranes at time of randomization * lethal fetal structural anomaly at time of randomization * fetal chromosomal abnormality at time of randomization * placenta previa and/or accreta at time of randomization * women who already underwent tvu cl measurement during the index pregnancy