Kornimate/medical-research-clean huggingface dataset:
community-based hearts intervention (pilot)

Conditions: Hypertension

Summary: the goal of this pilot study is to assess the feasibility of health system change intervention with a focus on recruitment of patients with hypertension, initiation of antihypertensive medication, and retention of patients in care at the community clinics (cc) with a goal of finalizing the key features of a team- and community-based intervention in rural bangladesh. patients with uncomplicated hypertension will be enrolled, their medical treatment will be provided from cc by a community health care provider (chcp) according to the telemedicine-based instruction of medical officer from upazila health complex (uhc) with provision of referral to uhc for an in-person evaluation. participants will be followed up periodically and their medicine will be refilled accordingly.


Eligibility criteria:
inclusion criteria: * patients residing in the catchment area of the selected 4 community clinics under selected 2 upazila health complexes (uhcs) * aged 18 years and older * raised bp during screening \[systolic bp ≥140 mmhg and/or diastolic bp ≥90 mmhg (based on an average of minimum two measurements)\] * not currently taking antihypertensive medications * eligible for the hearts technical package, defined as not being treated for an acute illness or medical emergency and not having a terminal illness exclusion criteria: * patients with cardiovascular diseases, chronic kidney diseases (as evident by previous laboratory report of serum creatinine or urinary protein more than ++ on dipstick test prior to the enrollment), diabetes, or bp \>180/110 mmhg (based on the mean of last two bp measurements) at screening or after 14 days of recommended lifestyle modification will be excluded and referred directly to uhc for further management * pregnancy or intent to become pregnant * patients who otherwise meet inclusion criteria but decline to participate in the hypertension program evaluation or do not provide written informed consent
quetiapine xr versus sertraline in acute bipolar depression as add-on therapy

Conditions: Bipolar Disorder; Bipolar Depression

Summary: prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine xr) versus sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. this multicentric study will be featured in two sites in spain.


Eligibility criteria:
inclusion criteria: * adult ambulatory patients diagnosed of bipolar disorder i or ii, current depressive episode (dsm-iv-tr 4ª ed: 296.5x or 296.89 codes) * have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to randomization * hamilton depression rating scale (hdrs-17) total score ≥ 20 and young mania rating scale (ymrs) total score ≤ 14 at the screening and randomization visits - informed consent signed exclusion criteria: * patients with any axis i or ii diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) diagnoses different from bipolar disorder i or ii - length of current depressive episode less than 2 weeks or more than 12 months * having been treated with more than one mood stabilizer or any mood stabilizer other than lithium or valproate, any antidepressant, any antipsychotic or any cp450-3a inductor/inhibitor within the 7 days period prior to randomization

Keywords: bipolar disorder bipolar depression quetiapine sertraline
examine the feasibility of a standardized field test for marijuana impairment: laboratory evaluations

Conditions: Marijuana Impairment

Summary: marijuana is one of the most widely used substances. this study will characterize the persistence of cannabis' (cnb's) acute effects on cognitive test performance and simulated driving over a several hour time period. the data obtained from simulated driving, cognitive tests, and biological assays of thc will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk. eligible participants will undergo a full day screening visit, if still eligible they will come to hartford hospital in hartford, connecticut to take part in the full study. participation requires overnight stays between each of the five study visits. on each of the study days participants are dosed with either a low dose of thc marijuana, a high dose of thc marijuana or placebo marijuana, (the low and high doses are repeated once each, order in which the study drug is given is double blind and chosen at random.)

this responds to nhtsa's request with a proposal to increase our understanding of smoked cannabis' (cnb's) acute effects on cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with cnb on these effects. the project also will link an extensive literature on cnb's effects on laboratory cognitive tests to simulated driving performance for the first time, providing a crucial validation of cnb's neurofunctional effects identifying maximally relevant candidate measures for field sobriety tests. to this goal, the proposed study was based upon a careful and thorough review of the scientific literature describing cnb effects on cognitive test performance and driving, as well as current state-of-knowledge on the sensitivity of biological assays for identifying recent cnb use. the study will carefully characterize the persistence of cnb's acute effects on cognitive test performance and driving over a several-hour time span. this will allow us to identify the point at which any effects of cnb intoxication on cognitive tests and driving performance cannot be distinguished from normal, i.e., the first step towards establishing standards for legal and social policy. the data obtained from simulated driving, cognitive tests, and biological assays of thc will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk. participants

Eligibility criteria:
inclusion criteria: * must have a current driver's license * have used marijuana before * right handed exclusion criteria: * females who are pregnant or breast feeding * any serious medical, or neurological disorder * any psychiatric disorder * no major head traumas

Keywords: marijuana thc cannabis driving impairment intoxication
avacostar - (pass)

Conditions: ANCA-associated Vasculitis

Summary: the avacostar pass is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe aav, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe aav. the overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years.

the avacostar pass is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe aav, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe aav. the overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years. enrolled patients will be followed until the last patient last visit (lplv) milestone, which will be 4 years after the last participant is enrolled. germany and the united kingdom (uk) have been selected for the study. additional countries may be considered according to availability of avacopan and suitability for the study. patients will be enrolled prospectively, but up to 6 months of data may be collected retrospectively if necessary. baseline visit is defined as the day that induction treatment (avacopan or non-avacopan standard of care (soc) cyclophosphamide or rituximab) is started for active severe aav. patients who started avacopan/soc induction therapy for active severe aav within 6 months of the enrolment visit and fulfil eligibility criteria may be enrolled in the pass. individual participant follow-up data will be collected periodically at routine clinic visits until the lplv, which will be 4 years after the last participant is enrolled. the primary objective of the study is: to evaluate the incidence of defined medical events of special interest (mesis) in patients with aav commencing avacopan.

Eligibility criteria:
inclusion criteria: * diagnosis of aav (mpa or gpa), as determined by the investigator according to their usual practice. * active, severe aav at the time of commencing avacopan or non-avacopan soc induction therapy, in the opinion of the investigator. * age ≥18 years of either sex. * has provided written informed consent. * has commenced within the previous 6 months, or is planned to commence avacopan, cyclophosphamide or rituximab for the treatment of severe, active aav outside of an interventional clinical study. exclusion criteria: • concurrent participation in an interventional study, unless prospectively discussed and agreed with the medical monitor.

Keywords: anti-neutrophil cytoplasmic antibody (anca)-aav
comparing brief alcohol interventions for hiv-hcv co-infected persons

Conditions: HIV; Hepatitis C

Summary: two types of brief intervention, brief advice (ba) and motivational interviewing (mi), have been shown to be efficacious in reducing drinking in non-hiv samples. our goal is to determine whether offering counseling beyond brief advice, namely mi, has greater alcohol reduction effects. in the proposed randomized trial, all 300 hiv-hcv co-infected participants will receive ba delivered by their hiv pcp during a regular hiv visit and will then be randomized to either a 30-minute motivational interviewing intervention with a behavioral counselor (mi) or to hiv clinic treatment-as-usual. after this initial meeting, drinking "check-in" (mi or ba) sessions will then be provided telephonically every three months for 18 months, with a final assessment at 24 months. our primary outcome is drinks per week.

two types of brief intervention, brief advice (ba) and motivational interviewing (mi), have been shown to be efficacious in reducing drinking in non-hiv samples. our goal is to determine whether offering counseling beyond brief advice, namely mi, has greater alcohol reduction effects. in the proposed randomized trial, all 300 hiv-hcv co-infected participants will receive ba delivered by their hiv pcp during a regular hiv visit and will then be randomized to either a 30-minute motivational interviewing intervention with a behavioral counselor (mi) or to hiv clinic treatment-as-usual. after this initial meeting, drinking "check-in" (mi or ba) sessions will then be provided telephonically every three months for 18 months. research assessments will also be done every three months, with a final assessment at 24 months. our primary outcome is drinks per week.

Eligibility criteria:
inclusion criteria: * hiv+ * hcv rna positive * consuming on average at least 4 alcoholic drinks per week in the last month * 18 years or older exclusion criteria: * current, severe psychiatric symptoms requiring immediate clinical attention (e.g., suicidal ideation, current mania, psychosis) * inability to understand english * cognitive impairment severe enough to interfere with ability to actively participate * hepatocellular carcinoma or life expectancy less than 24 months * plan to move from providence area in the next 24 months

Keywords: alcohol
change in patient-reported outcomes in severe eosinophilic asthma patients treated with benralizumab under real-life conditions

Conditions: Asthma

Summary: the main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary care setting in germany. the study also aims to investigate quality-of-life (qol), the early treatment response, treatment effectiveness and the change in asthma control over time, following benralizumab therapy. this study will also describe the physician-chosen reasons for starting beralizumab therapy or switching to benralizumab therapy.


Eligibility criteria:
inclusion criteria: * male or female patients aged 18 years or older with confirmed diagnosis of severe asthma according to the ats/ers and local german guidelines * decision was made by the investigator (regardless of this nis) to start treating the patient with benralizumab according to severe eosinophilic asthma indication (nb: can include patients that are switched from another eu approved biologic treatment if required for a medical reason). * patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol * after full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study. exclusion criteria: * concomitant treatment with any other biologic for any indication * patients already treated with benralizumab * clinically important pulmonary disease other than asthma including: chronic obstructive pulmonary disease (as main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (nb: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis). * an acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results. * concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). acceptable wash-out periods for other asthma biologics: ≥30 days from last dose of previous biologic * pregnancy or lactation period * participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 3 months

Keywords: benralizumab
revision lr femoral stem for hip replacement

Conditions: Hip Arthropathy; Orthopedic Disorder

Summary: this is a post-market, monocentric retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of revision lr femoral stem


Eligibility criteria:
inclusion criteria: * males and females of any race * age ≥ 18 years old * a diagnosis or condition in the target hip of one or more of the following: primary tumors or metastasis and relative outcomes; advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;fracture or avascular necrosis; congenital or acquired deformity; failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty; epiphyseal region general trauma, willingness to comply with prescribed rehabilitation and study evaluation and ability to return for follow-up visits * signed study-specific informed consent form exclusion criteria: * acute or chronic infections, local or systemic infections, * septicaemia * persistent acute or chronic osteomyelitis * serious muscular, neurological or vascular diseases affecting the concerned limb * mass higher than 60 kg
holding, stress, and bonding during therapeutic hypothermia

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period. this is a safety study that will assess whether or not there is an increase in adverse event frequency in infants that are held during hypothermia. parents and nicu nurses will be given a questionnaire after holding is complete investigating their feelings on maternal-infant bonding and safety of the holding protocol.


Eligibility criteria:
inclusion criteria: * infant must have a gestational age of greater than or equal to 35 weeks * infant must be undergoing treatment with therapeutic hypothermia * infant must be without seizures in the first 24 hours of treatment based on eeg * infant must be clinically stable on bubble cpap, nasal cannula, or no respiratory support. * informed consent must be signed by the mother at maine medical center exclusion criteria: * infant is intubated * infant is being treated with inhaled nitric oxide * presence of persistent pulmonary hypertension of the newborn * presence of seizure on eeg * use of vasopressors or paralytic agents * presence of chest tubes, wound vacuums, or drains * neonatal abstinence syndrome
multiplex pcr -microarray-based assay in the detection of mycobacterium

Conditions: Tuberculosis; Non-Tuberculous Mycobacterial Pneumonia

Summary: the study will use the veremtb tool for rapid diagnosis of tb or non-tuberculous mycobacterium (ntm) pulmonary infections in hospitalised patients, with positive results in acid-fast bacilli smears, which are emerging in many regions of the world.

delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all around the world, and was associated with poorer outcomes, including respiratory failure and mortality. rapid and accurate tools for diagnosis of tb is of great importance in initial treatment and for better treatment outcomes. other than tb, non-tuberculous mycobacterium (ntm) pulmonary infections are emerging in many regions of the world. these bacterium are more common to be found in respiratory specimens than mtb. with similar clinical presentation of ntm pulmonary infections and pulmonary tb, misdiagnosis of ntm pulmonary infections to pulmonary tb would lead to unnecessary intake of anti-tb medications and delay of the initiation of corresponding treatment. this test aims to detect mtb as well differentiate the ntm species involved in pulmonary infections simultaneously using veremtb.

Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. one or more symptoms compatible with mycobacterial pulmonary infections, including fever, cough, sputum production,hemoptysis dyspnea, chest pain and weight loss 3. one or more sputum samples with positive afb smear exclusion criteria: 1. receiving anti-mycobacterial treatment for more than one week 2. refusal to consent
african youth in mind (y-mind) - pilot feasibility trial of a brief psychological intervention for older adolescents with depression delivered through senior high schools in navrongo, ghana

Conditions: Depression Disorders

Summary: the overarching aim of this pilot study is to assess the feasibility of implementing a psychological intervention (y-mind), delivered by school guidance and counselling coordinators, for the treatment of depression among adolescents in senior high schools in ghana. the study is a parallel arm cluster randomised controlled pilot trial. we will recruit adolescents aged 15 to 18 years in senior high schools. participants will be randomised to receive the y-mind psychological intervention or enhanced usual care.


Eligibility criteria:
inclusion criteria: * adolescents aged 15 to 18 years in senior high schools located within the kassena-nankana municipality and kassena-nankana west district * have scored 10 or more on the locally validated patient health questionnaire-9 (phq-9) * be willing and able to be followed up for 5 months and provide informed consent or assent * for adolescents 15-17 years participants must have 5) access to a caregiver to obtain informed consent * all participants must have the ability to read, write and communicate in english language. exclusion criteria: * are currently receiving any psychological treatment (talking therapy) for any common mental disorder through formal health care services * have active bipolar disorder or psychosis (assessed through a brief screening tool for bipolar disorder and psychosis) * have advanced or chronic physical illness (assessed through self-report) * have significant visual or hearing impairment which would interfere with their ability to take part in the study * are actively suicidal (assessed through the use of a four-item screening tool administered by a psychiatric nurse and reviewed by the trial clinical psychologist
prospective chart-review: impact of combination - digital breast tomosynthesis + digital mammography

Conditions: Breast Cancer

Summary: digital breast tomosynthesis (dbt) is a technology that has been developed to improve lesion detection in dense breasted women. even though dbt has been regarded as a study for dense breasted women, it may also improve lesion detection at an earlier stage and smaller size in women with less dense breast tissue. the overlapping of tissue on a standard of care 2d mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that mimic cancers. this leads to patients being asked to come back for additional imaging including mammogram and/or ultrasound images. dbt has shown to decrease call back rates by up to 43% in reader studies. even though these results are promising they were not done in a realistic clinical setting.the purpose of this study is to evaluate the fda-approved combination standard digital mammography (dm) and dbt technology and its impact on our clinical practice.

the investigators would like to prospectively measure the impact on recall rates, comparing dm (digital mammography) and dm+dbt, in our practice and the impact on cancer detection in our screening population. this is a two-site study in which all asymptomatic subjects undergoing the fda-approved combination standard of care digital mammogram and digital breast tomosynthesis (dm+dbt) exam will be eligible for the trial. each subject will be her own control.only radiologists who have gone through 8 hours of tomosynthesis training will interpret the dm and dbt images. these radiologists will categorize each case as either dense (bi-rads density score of 3 or 4) or fatty (bi-rads density score of 1 or 2). the radiologist will initially read the standard of care dm part of the study first and record their interpretation and final birads category. the same radiologist will then interpret the dm+dbt combination study and record their final interpretation and birads category. prior mammogram studies will be used for comparison when reading the dm and dm+dbt studies.

Eligibility criteria:
inclusion criteria: * female ages 30 and over * asymptomatic * any ethnic origin * no contraindication for routine bilateral mammogram exclusion criteria: * pregnancy * lactating patients * breast implants * unable to understand and execute written informed consent * patient unable to obtain a mammogram while standing without assistance

Keywords: breast cancer digital breast tomosynthesis (dbt) digital mammography (dm)