Kornimate/medical-research-clean huggingface dataset:
evaluating a community-led covid-19 testing intervention to address mistrust

Conditions: COVID-19; Trust

Summary: the goal of this study is to assess how community-led group discussions about health-related topics may alter beliefs and intentions regarding healthcare recommendations, such as covid-19 testing and vaccination.

eligible participants will be randomized to intervention or control group. intervention group participants will meet virtually with other community member participants in small discussion groups once a week for one hour over the course of 12 weeks. the online discussion groups will be led by peer mentor facilitators and supported by a research team member. discussion topics will include current events, covid-19, and other health related topics. control group participants will not meet in weekly discussion groups. at approximately the 0 month, 3 month, and 6 month time points, all participants will answer online surveys about health related topics. at the 3 month and 6 month time points, all participants will also be asked to self-administer a covid-19 test that investigators provide. finally, around the fourth month, intervention group participants will be invited to an online feedback session with the research team about participants' experiences in the study.

Eligibility criteria:
inclusion criteria: * 18 years or older * resident of one of the 9 housing authority agencies * willing to participate in zoom meetings and complete online assessments at baseline, 3-month, and 6-month timepoints * ability to read, speak, and understand english exclusion criteria: * none

Keywords: community-led covid-19 trust vaccine hesitancy peer mentor community advisory board
strong for surgery & strong for life - intensive prehabilitation for risk reduction in ventral hernia repair

Conditions: Ventral Hernia; Surgery; Risk Reduction; Lifestyle; Postoperative Complications; Prehabilitation

Summary: the five risky lifestyles smoking, nutrition (obesity and malnutrition), risky alcohol intake, and physical inactivity (snap) are common in surgical patients and associated with worse postoperative outcomes. mono-factor interventions targeting and improving these risky lifestyles have been shown to reduce the risk at surgery, but there is a lack of systematic assessment of all five lifestyles of the patient before surgery and related optimization. this study aims to evaluate the effect of intensive combined lifestyle interventions (the strong programme) compared with treatment as usual in patients undergoing ventral hernia repair on postoperative complications, health, and costs on short and longer term. the hypothesis is that the strong programme will halve the complication rates within 30 days.

this study is a multicentre randomised controlled trial. a total of 400 participants with one or more of the five risky snap lifestyles will be randomised to either the strong programme (a prehabilitation intervention) or treatment as usual preoperatively (control). the strong programme is individually tailored to the needs of the participants. the program contains education, motivational, and pharmaceutical support. all participants will be followed up at the end of the intervention/at surgery, one, three, and six months after surgery. long-term outcomes are followed up from national registers two years after surgery. interim analysis will be employed.

Eligibility criteria:
inclusion criteria: * participants ≥18 years scheduled for ventral hernia repair (defect smaller than 8cm) * enough time for at least 4 weeks of prehabilitation * screened positive for at least 1 risky snap factor * signed informed consent exclusion criteria: * ventral hernia repairs with defect larger than 8 cm * pregnancy/breastfeeding * allergy/other contradiction to pharmaceutical and/or nutritional support * contradiction to exercise * previous complicated alcohol withdrawal symptoms (delirium or seizures) * not able to participate in intervention due to psychiatric ilness

Keywords: ventral hernia surgery risk reduction postoperative complications prehabilitation smoking alcohol drinking obesity malnutrition physical inactivity
carotid atherosclerosis in predicting coronary artery disease

Conditions: Carotid Atherosclerosis; Coronary Atheroscleroses

Summary: carotid plaque burden and composition features, particularly lipid necrotic core, are significantly associated with severity of cad stenosis. this study aims to explore the relationship between various phenotypic patterns of carotid atherosclerosis with the prevalence, phenotype, and severity of coronary atherosclerosis. the patients with chest tightness or chest pain will receive carotid artery ultrasonography before coronary angiography so as to explore the relationship between them.


Eligibility criteria:
inclusion criteria: * patients receive carotid ultrasound and coronary angiography exclusion criteria: * none
randomized, double-blind, placebo controlled, multi-center and tolerability of rbp-7000 in schizophrenia patients

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the efficacy and safety of rbp-7000 compared with placebo in the treatment of patients with schizophrenia. this will be a double-blind, placebo-controlled, phase iii study with 90 mg and 120 mg doses of rbp-7000 compared with placebo over an 8-week treatment period.


Eligibility criteria:
inclusion criteria: * males and females between the ages of 18 to 55 years, inclusive * diagnosis of schizophrenia as defined by diagnostic and statistical manual, edition 4, text revision (dsm-iv-tr) criteria * subjects who are deemed "valid" by the state, assessability, face, ecological, and rule (safer) interview * subjects who are otherwise healthy on the basis of their physical examination exclusion criteria: * subjects who have an improvement in their total positive and negative syndrome scale (panss) score of 20% or greater between the initial screening visit and the first day of treatment. * subjects taking daily oral risperidone at a dose ≥ 6 mg/day * subjects who have received a depot antipsychotic within 120 days of screen * subjects with treatment resistant schizophrenia, as judged by the investigator, who have been treated with antipsychotics for adequate durations and with adequate dosages.

Keywords: schizophrenia schizophrenic schizophrenias risperidone
effectiveness, immunogenicity and safety of meningococcal abcwy vaccine administered to healthy adolescents

Conditions: Meningococcal Disease

Summary: evaluate the effectiveness of 2 doses of menabcwy vaccine in adolescents compared to a single dose of menacwy vaccine.


Eligibility criteria:
inclusion criteria: * adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment. * female subjects of childbearing potential must have a negative urine pregnancy test. exclusion criteria: * serious, acute, or chronic illnesses. previous or suspected disease caused by n. meningitidis. previous immunization with any meningococcal vaccine. * exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.

Keywords: meningitis abcwy adolescents vaccination meningococcal disease
mobility opportunities via education/experience (move): healthcare impact assessment

Conditions: Quality of Life; Health Care Utilization

Summary: the purpose of this study is to determine whether participation in the mobility opportunities via education (move) program is associated with reduced use of healthcare for individuals with developmental disabilities.

the purpose of this study is to determine whether participation in the mobility opportunities via education (move) program is associated with reduced use of healthcare for individuals with developmental disabilities. the investigators will compare healthcare "events" and healthcare expenditures for children and adults during intervals of at least one year when the subjects were participating in the move program versus intervals of at least one year when the same individuals were not participating in the move program based on health insurance records (i.e. medicaid). healthcare events are those which required professional medical services (associated with international classification of disease (icd-xx) codes) or prescription medications. healthcare events and healthcare expenditures will be reviewed from healthcare records obtained by medicaid, medicare, or private insurers and data will be compared between intervals.

Eligibility criteria:
children: inclusion criteria * males and females 5-21 years old. * participated in the move program pre-covid and post-covid. * did not participate for at least 4 months in the move program during covid. * has a healthcare payor(s) who makes healthcare records available upon request. * subjects whose legal guardians are willing to give informed consent to obtain and review healthcare records from the subject's primary (and secondary, if applicable) payors. children: exclusion criteria * subjects who did not participate in the move program through the duration of interval #1 and interval #3. * subjects whose legal guardians are unwilling to cooperate with the requests to obtain and review healthcare records and expenditures from the subject's primary (and secondary, if applicable) payors. adults: inclusion criteria * males and females 22-65 years old. * participated in the move program during interval #1 and interval #3. * did not participate for at least 4 months in the move program during interval #2. * has a healthcare payor(s) who makes healthcare records available upon request. * subjects who are willing to give informed consent and/or subjects' legal guardians who are willing to give informed assent to obtain and review healthcare records from the subject's primary (and secondary, if applicable) payors. adults: exclusion criteria * subjects who did not participate in the move program through the duration of interval #1 and interval #3. * subjects who are unwilling to give informed consent and/or subjects' legal guardians who are unwilling to give informed assent to cooperate with the requests to obtain and review healthcare records and expenditures from the subject's primary (and secondary, if applicable) payors.
behavioral health evaluation and intervention program for patients undergoing craniotomy

Conditions: Brain Tumor

Summary: this is a single center non-randomized, single-arm feasibility trial of the implementation of virtual behavioral health counseling sessions alongside standard-of-care treatment.

primary objective: i. determine the feasibility of implementing behavioral health counseling sessions alongside standard of care treatment for brain tumor participants scheduled to undergo craniotomy for treatment. secondary objective: i. to assess the acceptance of virtual behavioral health counseling sessions during the initial management of a newly diagnosed brain tumor. ii. to explore the rates of pre- and post-surgical mental health disorders in participants newly diagnosed with a brain tumor. iii. to explore pre- and post-surgical quality of life with virtual behavioral health counseling sessions during the initial management of a newly diagnosed brain tumor. outline: participants will be given the opportunity to participate in virtual behavioral health counseling sessions at three time points relative to the scheduled tumor resection operation. all participants will receive questionnaires related to mental health, quality of life, and satisfaction with the study intervention. participants who do not want to participate in the counseling sessions will be provided the option to complete the assessment tools related to mental health and quality of life only. participants will be assessed over the course of 9 months related to standard-of-care treatment at the following time points: before the operation (baseline), 4 to 6 weeks following the operation, and 6 to 9 months following the operation. at each time point, the participants will fill out the questionnaires and engage in the virtual counseling sessions.

Eligibility criteria:
inclusion criteria: 1. age 18 years of age or older. 2. able to understand study procedures and to comply with them for the entire length of the study. 3. ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it. 4. documented diagnosis of a brain tumor. 5. phq-9 screening score of \>= 5. 6. no prior surgical intervention, other than biopsy, for brain tumor. 7. scheduled for craniotomy for brain tumor resection. exclusion criteria: 1. contraindication to any study-related procedure or assessment. 2. phq-9 scores of: 1. \< 5 2. \>= 20 3. \>= 1 point on question number 9 - thoughts of self-harm or suicidality. 3. require urgent or emergent surgical intervention or admission to the hospital prior to the scheduled surgery. 4. prior surgical intervention for brain tumor. 5. prior suicide attempt. 6. prior hospitalization for psychiatric treatment. 7. currently undergoing mental or behavioral health-related counseling or psychotherapy, other than currently taking an anti-depressant medication.

Keywords: health technologies virtual health counseling quality of life
pressure supporting ventilation and eeg-guided emergence for free of unwanted complications

Conditions: Thyroid Surgery

Summary: this study aims to assess whether pressure supporting ventilation and electroencephalogram (eeg)-guided emergence can reduce airway complications after thyroid surgery compared with conventional emergence. patients will be randomly assigned to either pressure supporting ventilation and eeg-guided emergence group (intervention group) or conventional emergence group (control group). co-primary outcomes are the incidence of emergence coughing and lowest percutaneous oxygen saturation (spo2) after emergence. secondary outcomes included severity of emergence cough, emergence time, blood pressure and heart rate during emergence, richmond agitation-sedation scale (rass) immediately after extubation and upon post-anesthesia care unit (pacu) arrival, incidence of desaturation during pacu stay, hoarseness, sore throat during pacu stay, duration of pacu stay, surgeon satisfaction regarding emergence process, postoperative pain score, and patient satisfaction score regarding emergence process.

adult patients aged \< 40 years scheduled to undergo thyroid surgery will be screened for eligibility. patients will be randomly allocate to either the intervention group or control group. * in the intervention group, pressure support ventilation will be applied from the start of subcutaneous suture until extubation. at the end of surgery, sevoflurane will be discontinued, and the attending anesthesiologist will perform tracheal extubation after observing the 'zipper opening' pattern on the eeg spectrogram, indicating the patient's recovery of consciousness. for safety reason, extubation will also be guided by the following processed eeg indices thresholds: 1. 95% spectral edge frequency (sef) ≥ 23 2. patient state index (psi) ≥ 64 * in the control group, conventional full-awake extubation will be performed based on the routine practice of our institution. at the end of surgery, sevoflurane will be stopped, and the attending anesthesiologist will lead the emergence process, allowing the patient to breathe spontaneously and providing intermittent manual assistance if necessary. extubation will be performed when the patient meets the following criteria: obeys commands such as eye-opening or hand-grip, tidal volume \> 5 ml/kg, end-tidal carbon dioxide \< 45 mmhg, spontaneous respiratory rate 10 to 20 breaths/min. in both groups, the oxygen reserve index (ori) will be monitored. blinded investigator will assess the incidence of emergence coughing and the lowest spo2 after emergence.

Eligibility criteria:
inclusion criteria: * adult patients aged under 40 years who are scheduled to undergo thyroid surgery. exclusion criteria: * patients scheduled for radical neck dissection * patients scheduled for lymph node biopsy * patients with an anticipated difficult airway * patients experiencing difficulty during intubation * patients with a fasting time not meeting institutional policy * patients with a body mass index (bmi) greater than 30 kg/m² * patients with sleep apnea * pregnant or breastfeeding women * patients unable to communicate
age-related macular degeneration of atrophic type treated with umbilical cord blood enriched with platelet plasma.

Conditions: Dry Age-related Macular Degeneration

Summary: the objective of the study will be to evaluate the efficacy of intravitreal injections of umbilical cord blood platelet-rich plasma (cb-prp) in order to reduce or stabilize the atrophic progression in dry age-related macular degeneration (amd).

patients will undergo intravitreal injections of cb-prp (cord blood platelet-rich plasma) according to three different treatment regimens, and the efficacy and safety of cb-prp in an in vitro model of lipopolysaccharide (lps)-induced degeneration in htert rpe-1 and arpe-19 model cell lines derived from retinal pigmented epithelium (rpe) will be evaluated. the purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of cb-prp and the response of photoreceptors in the macular region in dry-amd. microanatomical changes in the retina induced by intravitreal cb-prp therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy.

Eligibility criteria:
inclusion criteria: * age ≥65 years * bilateral dry-amd * etdrs-corrected visual acuity between (or equal to) 1/10 and 4/10 * no concomitant ocular pathology (e.g., glaucoma, amblyopia) or systemic pathology that would result in a bias for primary goal assessment * signature of informed consent exclusion criteria: * age \< 65 years * pregnancy * previous inflammatory/infectious events involving the eyes * eye trauma, diabetes, or disease potentially damaging to the visual system, even in the absence of impairment at the time of intake * previous intravitreal treatments. * refusal to sign informed consent.
evaluation of education for gestational diabetes

Conditions: Gestational Diabetes

Summary: prospective observational cohort study of women with gestational diabetes (gdm) based on the 'international association of pregnancy study groups' (iadpsg) criteria. the overall aim is to evaluate the knowledge regarding gdm of women with gdm and to evaluate the satisfaction of women with gdm about the education they receive (given in group or individually). normal routine care is followed and evaluated.


Eligibility criteria:
inclusion criteria: * women ≥ 18 years diagnosed with gdm in the university hospital leuven. exclusion criteria: * women who received bariatric surgery. * women with pregestational diabetes or diagnosed with diabetes during early pregnancy.

Keywords: gestational diabetes education
a pilot mri study of osteopathic manipulative treatment of acute low back pain

Conditions: Low Back Pain

Summary: this is a pilot project intended to determine the feasibility of detecting soft tissue changes in response to osteopathic manipulative treatment (omt). mris of the lumbar and pelvic regions of low back pain (lbp) patients will be taken once before and at two different time points after omt. images obtained will be quantitatively analyzed for changes in the volumes of back muscles and for changes (t2 signals) indicative of activity levels or pathological conditions. electromyography (emg) will be used as an independent measure of back muscle activity for comparison with mri results.


Eligibility criteria:
inclusion criteria: * adult patients (18-55) * patients with lbp with acute symptoms (within last 3 weeks) * test positive for lumbar somatic dysfunction exclusion criteria: * history of any spinal injuries/surgeries * positive findings of frank neurological signs during physical exam * any other orthopedic or neurological impairment * unsuitable for mri imaging: * cardiac pacemaker or defibrillator * severe claustrophobia * injured by a metallic object that was not removed * cochlear (ear) implants * surgery involving a metallic implant (e.g. knee replacement) * weight more than 300 lbs/136 kg (weight limit for scanner bed)
effect of the electronic cigarette on withdrawal symptoms

Conditions: Mental and Behavioral Disorders; Withdrawal State

Summary: study rationale: sensory/behavioural elements of smoking play a role in smoking behaviour and may have a potential to assist smoking cessation. among current treatments for smokers, only the nicotine inhalator is attempting to address such factors. the inhalator's efficacy does not exceed that of the other nicotine replacement therapy (nrt) products, but it mimics the relevant sensory input to only a limited extent, and its nicotine delivery is dependent on intensive puffing. recently a new product, the electronic cigarette (e-c) has become available, which provides a more realistic behaviour and sensory replacement for smoking and can provide good nicotine levels with less effort. primary objective: to compare e-c and nicotine inhalator in their effects on tobacco withdrawal symptoms over 24hr abstinence. hypotheses: e-c will be more effective than the inhalator in reducing withdrawal symptoms and craving and elicit more favorable user ratings. it will also provide higher nicotine levels. study design: in a cross-over study, participants will be randomized to the sequence of conditions and provide baseline measures and samples for salivary cotinine analysis. they will be asked to abstain from smoking their usual cigarettes and use the allocated product over 24 hours. they will return to the study centre the following day, and complete measures of craving and withdrawal, ratings of subjective and sensory effects of the products, product satisfaction, and adverse effects. they will also provide saliva samples for cotinine analysis. abstinence from smoking will be verified with co readings.

there is considerable interest in e-cs at the moment and the study would provide information on whether the e-c surpasses the tried and tested nicotine inhalator. if so, it would open a possibility of its utilization in smoking cessation, and provide encouragement for further examination of the role of sensorimotor replacements in the treatment of tobacco dependence.

Eligibility criteria:
inclusion criteria: * volunteers smoking at least 12 cigarettes per day * first cigarette smoked within 60 minutes of waking up * willing to abstain from smoking for one day in 2 consecutive weeks. exclusion criteria: * under 18 years of age * current psychiatric illness * pregnant or breastfeeding * enrollment in other research projects * used electronic cigarette and/or nicotine inhalator before

Keywords: nicotine inhalator electronic cigarette tobacco