Kornimate/medical-research-clean huggingface dataset:
trial of the impact of the electronic frailty integrated with social needs

Conditions: Aging

Summary: participants in electronic frailty integrated with social needs (efriend) will randomize to receive regularly scheduled in-person and telehealth contacts with a community health worker (chw) or continue to receive standard of care. the purpose of this research is to use chw to help older adults because there may be some resources that could benefit them that they are not aware of or for which they need help applying.

the study team will conduct a pragmatic randomized pilot trial of a chw-led hybrid in-person/telehealth program pathway (efriend) for frail older adults. using zelen's effectiveness design, the study team will identify eligible frail older adults via the electronic health record (ehr). eligible participants will be randomized to the efriend pathway or usual care. the study team will randomize 2050 older adults (1050 to efriend, 1000 to usual care), with the randomization stratified by primary care clinic. eligible participants randomized to the efriend pathway will be contacted by phone to discuss study procedures and obtain verbal informed consent. efriend comprises a 6-month intervention. all chw will be certified and have participated in the north carolina community health worker standardized core competency training. chw are trusted members of the community and are utilized as part of routine care to assist patients. at the first visit, the chw will assess if the participants have any unmet social and/or functional needs (baseline survey). the frequency and amount of time of each point of contact will be at the discretion of the chw.

Eligibility criteria:
inclusion criteria: * frail based on the electronic frailty index (efi\>0.21) * live in forsyth county, nc * linked to any accountable care organizations (aco) registry * have a primary care provider (pcp) in atrium health wake forest baptist (ahwfb) system, and have seen their pcp or someone else in the clinic of their pcp within the last 12 months exclusion criteria: * diagnosis code for dementia in the past 2 years * does not speak english

Keywords: community health care worker elderly assistance at home care
clinical outcomes in hiv with comorbidities

Conditions: Hiv

Summary: multi-arm, non-randomized, quality of life

this is a prospective, longitudinal, observational study, performed at a co-morbidities clinic for plwh. plwh with one or more co-morbidities receiving anti-retroviral therapy (art) will be analyzed for their prevalence and incidence of developing renal, metabolic, hepatic and bone diseases. all participants will be assessed at baseline and followed up for one year, or until change in art regimen, whichever earlier.

Eligibility criteria:
inclusion criteria: 1. hiv antibody positive 2. age above 18 years 3. diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases 4. receiving art regimen, which consists of b/f/taf, or 1-2 nrti(s), plus another anti-retroviral drug, including insti other than bictegravir, nnrti, or protease inhibitor exclusion criteria: 1. recent diagnosis of aids within 6 months 2. recent hospitalization for management of acute medical problems within 6 months 3. receiving art regimens other than the combinations listed in inclusion criteria
the effect of two different massages on migraine

Conditions: Headache, Migraine; Manuel Therapy

Summary: the study aims to compare the effects of connective tissue massage on pain severity, attack frequency and duration, migraine-related disability, and quality of life in patients diagnosed with migraine, by comparing them with the classical massage.


Eligibility criteria:
inclusion criteria: * volunteers with a migraine diagnosis * taking only analgesics for migraine treatment and continuing their routines * no problem in reading, writing and understanding turkish exclusion criteria: * having any other neurological problems * who had been injected with botulinum toxin in the last 3 months
complete™ acetabular hip system

Conditions: Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Post-traumatic Arthritis

Summary: the primary objective of this investigation is to evaluate survivorship at ten years. for this post approval study (pas), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.

this is a retrospective and prospective, non-randomized study of the ceramic on metal(com) device. this study will follow each subject through 10 years postoperatively. a total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new pas subjects and approximately 100 subjects recruited from the investigational device exemption study to the pas.

Eligibility criteria:
inclusion criteria: * 1. if the subject: 1. was previously enrolled in the com ide study with the ceramic-on- metal device, or 2. qualifies based on the approved labeling for the device; and * 2. is willing and able to provide informed patient consent for participation in the pas study; and * 3. is willing and able to return for follow-up as specified by the pas study protocol; and * 4. is willing and able to complete the hip outcomes questionnaire as specified by the pas study protocol. a patient will be considered a "valid study subject" when he/she has * consented to participate, * authorized release of personal health information (phi), * met all eligibility criteria through the operative stage, and * received the implant as noted in this protocol. exclusion criteria: * subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or subject inclusion criteria.

Keywords: non-inflammatory degenerative joint disease
helicobacter pylori eradication with berberine quadruple therapy versus clarithromycin quadruple therapy

Conditions: Gastritis; Peptic Ulcer; Dyspepsia

Summary: this study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in h. pylori eradication. it is hypothesized that berberine-containing quadruple therapy is non-inferior to clarithromycin-containing quadruple therapy. patients with confirmed h. pylori positive status will be randomized to one of the treatments described above. at week 2 and 6 follow-up visits, a urea breath test(ubt) will be performed to confirm eradication.

the study will include three phases: screening, treatment and follow-up. screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. endoscopy and urea breath test will be performed in addition to the baseline routine evaluations. treatment: subjects are randomly assigned to treatment and will be treated for 14 days. a randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 12 and 14. follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. eradication of h. pylori will be confirmed through urea breath test(ubt).

Eligibility criteria:
inclusion criteria: 1. age between 18\~70,both gender. 2. patients with upper gastrointestinal symptoms and with documented h.pylori infection. 3. patients are willing to receive eradication treatment. 4. women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter. exclusion criteria: 1. patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with h. pylori. 2. contraindications to study drugs. 3. substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. 4. constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(ppi) within 2 weeks before the \[13c\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening) 5. pregnant or lactating women. 6. underwent upper gastrointestinal surgery. 7. patients with barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia. 8. evidence of bleeding or iron efficiency anemia. 9. a history of malignancy. 10. drug or alcohol abuse history in the past 1 year. 11. systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 12. enrolled in other clinical trials in the past 3 months.

Keywords: helicobacter pylori berberine-containing quadruple therapy clarithromycin-containing quadruple therapy
peripheral artery disease and sepsis outcomes

Conditions: Peripheral Artery Disease; Peripheral Artery Occlusion; Sepsis; Diagnosis

Summary: the peripheral artery disease (pad) prevalence is high in the elderly, the diabetic patients, and the patients receiving hemodialysis. to date, there is no guideline recommendation on the screening of pad in patients admitted to the medical intensive care unit (micu) for sepsis. we conducted a prospective cohort study focusing on patients admitted to the micu with the main diagnosis of sepsis. the ankle-brachial indexes are performed within 24 hours after admission. invasive arterial line monitoring and standard non-invasive measurements are collected. after confirmation of pad, standard anti-platelet treatments (aspirin and cilostazol) are initiated. the survival before and after the conduction of this trial is compared to historical records. the outcomes including all-cause mortality, stroke, myocardial infarction, minor amputation, major amputation, and prolonged ventilator dependent are to be collected.

this is a prospective observational study focusing on peripheral artery disease (pad) in patients admitting to intensive care units with a diagnosis of sepsis. the sepsis is defined by the quick sofa score. the primary outcome is all-cause mortality. the secondary outcomes included stroke, myocardial infarction, amputation, and prolonged mechanical ventilation. we plan to enroll 150 patients. patients will be grouped into patients with pad and patients without pad. we then compare them in the following parameters: clinical data, laboratory data, survival and other outcome data. two-sample student's t-tests will be used for the comparisons of continuous variables. chi-square test will be used to detect the difference between categorical variables. the difference is considered statistically significant if p \< 0.05. all statistics works were analyzed using the spss 17.0 software (chicago, il, usa), r software (gimc packages).

Eligibility criteria:
inclusion criteria: * sepsis patients admitted to the micu meeting quick sofa score \>= 2 points exclusion criteria: * na

Keywords: peripheral artery disease sepsis
examining genetic factors that affect the severity of 22q11.2 deletion syndrome

Conditions: DiGeorge Syndrome; 22q11.2 Deletion Syndrome

Summary: 22q11.2 deletion syndrome is a genetic disorder that can cause heart defects, facial abnormalities, and developmental and learning disabilities. the severity of the disorder can vary widely among people. this study will analyze dna from people with 22q11.2 deletion syndrome to identify genetic variations that may affect the severity of the disorder.

22q11.2 deletion syndrome is a disorder caused by the deletion of a small piece of chromosome 22. most people with this disorder are missing a sequence of about 3 million dna building blocks on chromosome 22 within each cell. this disorder affects many areas of the body. people with 22q11.2 deletion syndrome may have heart defects, immune deficiency, kidney abnormalities, hearing loss, and cleft palate or other facial deformities. many children experience developmental delays and learning disabilities, and they have an increased risk of developing mental illnesses, including schizophrenia, depression, anxiety, and bipolar disorder. all people with 22q11.2 deletion syndrome are missing the same sequence of dna, but the severity of this disorder varies widely; some people are diagnosed with multiple health and developmental problems, while others experience very few symptoms. in some people, the symptoms may be so minimal that they are not even aware they have 22q11.2 deletion syndrome. this study will examine genetic material-either from blood or saliva-among people with 22q11.2 deletion syndrome. participants will attend one study visit and undergo either blood or saliva collection. by analyzing the dna sequences of participants, the study will aim to identify any genetic variations that may affect the severity of 22q11.2 deletion syndrome.

Eligibility criteria:
inclusion criteria: * has 22q11 deletion of 3 megabases (mb) exclusion criteria: * has 22q11 deletion smaller than 3 mb or no deletion

Keywords: congenital heart defects single nucleotide polymorphisms copy number variations whole genome association study
italian cardioneuroablation study for neurocardiogenic syncope patients

Conditions: Neurally Mediated Syncope

Summary: multicenter italian interventional "proof of efficacy" clinical trial that aims to evaluate the incidence of asystolic pauses and heart rate in patients with cns who performed severe cna identified through asystolic pauses identification by implantable loop recorder. the study is independent, "investigator-initiated," sponsored by a nonprofit scientific association called the italian multidisciplinary group for the study of syncope (gimsi).

the so called "cardioneuroablation (cna)" focused on the endocardial ablation of atrial ganglionated plexi has proven to be efficacy in patients affected by neuro-mediated cardioinhibitory syncope (ncs). no center currently has sufficient case series to establish long-term efficacy and safety results, for which a multicenter interventional study is therefore needed. the aim of the study will be to evaluate the efficacy and safety of cna focused in ncs patients. the ablation procedure, consists of radiofrequency delivering at right atrial anatomic sites where the underlying presence of gp clusters is regarded as highly probable: 1) the inferior-posterior area (first ablation site): inferior right gp placed between inferior vena cava, coronary sinus ostium and near the atrio-ventricular groove, 2) the superior-posterior area (second ablation site): superior right atrial gp, adjacent to the junction of the superior vena cava and the posterior surface of ra.

Eligibility criteria:
inclusion criteria: * age between 18 and 60 years * patients with a clinical diagnosis of neuromediated syncope according to class i criteria of the esc guidelines, table 1 * clinical history of recurrent syncope (≥2 in the last year or ≥3 in the last 2 years), severe, not tolerated by the patient * documentation of ≥2 asystolic pauses \>3 sec daytime on ecg monitoring by implantable loop recorder (ilr), with or without syncope * refusal by patient to perform pacemaker implantation tilt test is recommended but not mandatory. patients with negative tilt test are also enrollable. it can be either positive or negative. exclusion criteria: * absence of sinus dysfunction and atrioventricular node disease. * absence of structural heart disease * possible alternative diagnoses of syncope
impact of bilingual prescription medication labels among elderly singaporeans

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: the proposed study aims to provide preliminary data that will enable the conduct of a larger randomized controlled trial (rct) on the impact of bilingual prescription medication labels (pmls) on 3 medication-related outcomes - medication adherence, medication management self-efficacy, and pml understanding.

the investigators will randomize 40 patients to pilot trial a or pilot trial b. those in pilot trial a will be further randomized to bilingual pmls (intervention arm) or english pmls (usual care arm) at 2 weeks post-recruitment, after assessing baseline level of the 3 medication-related outcomes; trial outcomes: difference in change, from baseline to 2 weeks post-randomization, in the 3 medication-related outcomes between the 2 arms. those in pilot trial b will be further randomized to bilingual pmls or english pmls immediately post-recruitment; trial outcomes: difference, at 2 weeks post-randomization, in the 3 medication-related outcomes between the 2 arms. this formative study will (1) assess the feasibility of administering the intervention, (2) refine protocols for study participant recruitment, engagement and retention, and (3) gain experience with and refine measurement of the outcomes for evaluating the intervention. the conduct of 2 pilot trials will allow us to choose the optimal trial design and determine variability.

Eligibility criteria:
inclusion criteria: * singapore citizen/permanent resident * aged 50 years and above * just received a new (i.e., not received before) oral medication for a chronic disease * no moderate/severe cognitive impairment (5 or more correct responses on the abbreviated mental test, amt) * not deaf (self-reported) * no binocular presenting near vision impairment (near visual acuity, with routinely used spectacles/lenses: at least 6/15 (0.40 logmar) on the landolt's c chart) * able to speak at least 1 of the 4 official languages; * unable to read in english but able to read another official language (as they will benefit the most from bilingual pmls) * assessed as non-adherent exclusion criteria: - patients who received, from the prescribing physician, a set of instructions for their new oral medication that does not match standard instructions (as the bilingual instructions for non-standard instructions would not be prepared for beforehand)

Keywords: medication adherence prescription medication labels bilingual prescription medication labels anti-diabetic drugs older adults medication management self-efficacy health literacy literacy anti-hypertensives glucose-lowering agent
evaluation of the accuracy of zygomatico- maxillary complex (zmc) fractures reduction using patient specific guide (psg) versus conventional technique

Conditions: Zygomatic Fractures

Summary: evaluation of the accuracy of zygomatico- maxillary complex (zmc) fractures reduction using patient specific guide (psg) versus conventional technique


Eligibility criteria:
inclusion criteria: * • zygomatic fracture type iii, iv and v according to rowe and killey classification(13) * age (18-60 years) * recent fracture (less than 2 weeks) exclusion criteria: * • zygomatic fracture type i, ii and vi according to rowe and killey classification(13) * medical compromised patient * patient on radiotherapy * bone disease
residual pulmonary vascular obstruction index computed with ventilation/perfusion spect/ct imaging to predict the risk of venous thromboembolism recurrence in patients with pulmonary embolism (pronospect)

Conditions: Pulmonary Embolism; Venous Thromboembolism

Summary: major risk after pulmonary embolism (pe) is recurrence, fatal in 10% of patients. patients with pe can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or intermediate risk. little is known about this last group. anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence. identifying risk factors of recurrent pe remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation. in 30-40% of cases, pe patients develop residual pulmonary vascular obstruction (rpvo), which has been found to be associated with an increased recurrence risk. this last observation was mostly reported in patients with unprovoked pe (patients with high risk of recurrence) and rpvo was measured using conventional planar lung scan. in patients with an intermediate risk of recurrence, the impact of rpvo has been much less studied. in addition, the definition of rpvo was variable according to studies and correlation between rpvo burden and recurrence risk has not been clearly demonstrated. this might be explained by the inherent limitation of rpvo quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images. ventilation/perfusion single photon emission computed tomography (v/q spect/ct) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of rpvo. the main hypothesis of this study is that in patients with pe at intermediate risk of recurrence, rpvo computed with v/q spect/ct imaging may be an important predictor of recurrence.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years, * who experienced an objectively proven pe, * who have been treated initially with anticoagulant therapy for 3 to 6 uninterrupted months (180 - 210 days) and for whom anticoagulation will not be prolonged. exclusion criteria: * unwilling or unable to give written informed consent (protected adults, under tutorship or curatorship) * patients deprived of their liberty by a judicial or administrative decision, patients undergoing psychiatric care by virtue of articles l. 3212-1 and l. 3213-1 who are not covered by the provisions of article l. 1121-8 and patients admitted to a health or social establishment for purposes other than research * no social security affiliation * isolated dvt * pregnant women,parturients women * other indication for anticoagulant therapy (e.g. atrial fibrillation, mechanic valve) * life expectancy \< 6 months * any patients for whom there is a strong indication to treat longer than 6 months: pe provoked by a major persistent factor (e.g. cancer) or recurrent unprovoked pe * pe provoked by a major transient risk factor

Keywords: venous thromboembolism recurrence
medical treatment of "high-risk" neurofibromas

Conditions: Neurofibromatosis 1

Summary: patients with neurofibromatosis type 1 (nf1) commonly develop non-cancerous tumors called plexiform neurofibromas. these tumors can be defined as "high-risk" when they result in severe pain, physical disability, organ dysfunction and/or become life-threatening. presently, there is no effective medical therapy to offer patients with "high-risk" plexiform neurofibromas, and surgery does not provide lasting help. this study will evaluate the effectiveness of two treatment combinations in patients with "high-risk" plexiform neurofibromas.

the study's design involves treating eligible patients with a combination of celecoxib and pegylated interferon alpha-2b. if the patients have at least a partial response after six months, they may continue on the same treatment for up to two years. if the patient experiences less than a partial response, or has progressive disease after six months of therapy, then vincristine and temozolomide will be added to the celecoxib and interferon alpha-2b backbone. response to treatment will be assessed after a minimum of six months, presuming the patient has not experienced progressive disease. total duration of therapy on study is two years for any individual treatment plan.

Eligibility criteria:
inclusion criteria: * "high-risk" plexiform neurofibromas associated with a diagnosis of nf1 * 2-30 years old (minimum bodyweight of 10 kilograms) * adequate renal function exclusion criteria: * previously untreated active optic glioma * history of any previous allergy to study medications * history of ischemic vascular disease * pregnancy / breast feeding

Keywords: neurofibromas neurofibromatosis 1 celecoxib celebrex peg-interferon alpha-2b peg-intron temozolomide temodar vincristine sulfate oncovin