bioihbjkbjnl/mcl2 huggingface dataset:
Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to work with primary care physicians and their staff, and with
      community health workers (CHWs) to improve diabetes and hypertension management, health
      behaviors and improve blood pressure for South Asian patients with uncontrolled diabetes and
      hypertension in primary care clinics in Atlanta, Georgia. The CHWs are community members who
      are trained to work with patients to address health needs holistically by providing
      information on wellness, nutrition, stress relief, and blood pressure management in a
      culturally-appropriate and language-appropriate manner.
    

Detailed description: 
      The study will provide research training, technical assistance, and capacity-building to
      community and clinical sites in Georgia for implementation of culturally tailored,
      evidenced-based CHW programs to improve HTN and diabetes management for South Asians. In
      addition, the use a multi-theoretical framework to test the effectiveness of a CHW-led
      intervention compared to usual care among South Asian individuals with diabetes and
      uncontrolled HTN in Atlanta. The primary outcome is blood pressure control, defined as 130/80
      mmHg. It is hypothesized that, compared to usual care, individuals receiving the CHW
      intervention will be 20% more likely to achieve blood pressure control at 6 months.

      And to apply RE-AIM and CFIR frameworks to delineate factors influencing appropriateness,
      fidelity, adoption, and maintenance of the intervention within clinical and community
      settings to optimize intervention replication.

      In addition, this study will serve as a national information and dissemination resource in
      the adaptation of evidence-based strategies to reduce geographic disparities in HTN and
      diabetes across Asian American groups.
    

Intervention name(s): CHW
Intervention type(s): Behavioral
Intervention description(s): Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BlueWind Reprieve System for the Treatment of PNP
Condition: Peripheral Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external
      components.

      The system is intended for home care use. The chronic pain treatment is achieved by an
      electrical stimulation of peripheral nerve fibers. The stimulation is set so that it
      generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and
      improving the quality of life for the patient.
    


Intervention name(s): The Reprieve system
Intervention type(s): Device
Intervention description(s): BlueWind Medical neurostimulator for the treatment of neuropathic pain
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Neuropathic Pain; PNP
Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease
Condition: Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a
      randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was
      safe and effective to prevent catheter-related bloodstream infection in patients with
      haemato-oncological disease.

      The aim of this prospective randomised controlled trial is to compare the incidence of
      catheter-related bloodstream infection in 2 groups of patients with haemato-oncological
      disease:

        -  Group A: heparin impregnated catheters

        -  Group B: low-dose unfractionated heparin (100 IU/kg/daily)
    

Detailed description: 
      Studies have shown that catheter-related infection may be due to fibrin deposition associated
      with catheters. Interventions designed to decrease fibrin deposition and thrombus formation
      have the potential to reduce catheter-related infections. Seven randomised studies have been
      performed to assess the safety and efficacy of heparin (either as an infusion or bonded to
      central venous catheter) on central venous catheter-related bloodstream infections. Although
      a meta-analysis of 4 studies looking at heparin either as an infusion or bonded to central
      venous catheter showed a strong trend for a reduction in catheter-related bloodstream
      infection with the use of heparin, these studies used variable definitions of
      catheter-related infections.

      We have shown in a randomised study (in press), that low dose of unfractionated heparin (100
      IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in
      patients with haemato-oncological disease. The aim of this prospective randomised controlled
      trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of
      patients with haemato-oncological disease:

        -  Group A: heparin impregnated catheters

        -  Group B: low-dose unfractionated heparin (100 IU/kg/daily)
    

Intervention name(s): heparin impregnated central venous catheters
Intervention type(s): Device
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: central venous catheter; catheter related bloodstream infection; heparin
Chest X-ray in Diagnosis of Heart Failure
Condition: Chest X-ray ; Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The objective of this study is to compare the performance of x-chest ray in the diagnosis of
      acute cardiac insuficiency through the interpretation of a senior and a non-senior.
    

Detailed description: 
      Acute cardiac insufficiency (ICA) is a leading cause of acute dyspnea in the emergency
      department (SU) and is associated with a higher risk of morbidity and mortality.

      An increasing number of tools for better ICA diagnosis are available in the SUs. However,
      there is likely room to improve the ICA diagnostic approach using widely available routine
      tools, including chest x-ray .

      Chest x-ray is a rapid and inexpensive method that is routinely performed in an emergency in
      patients with acute dyspnea. This is the first-line diagnostic imaging modality recommended
      in the guidelines.

      The objective of this study is to compare the performance of x-chest ray in the diagnosis of
      acute cardiac insuficiency through the interpretation of a senior and a non-senior.

      A senior emergency physician or resident and an intern, perform a reading of chest x-ray in
      any included patient by answering to following questions:

      Is there cardiomegaly? Calculation of the cardio-thoracic index Is there a vascular
      distribution towards the vertices, if so is it uni or bilateral? Is there pleurisy, if so is
      it uni or bilateral? Is there an interstitial syndrome, if so is it uni or bilateral? Is
      there an alveolar syndrome, if so if so is it single or bilateral? Is the diagnosis of heart
      failure very likely, likely or unlikely? Then there will be a comparison of the two answers.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        alla patients admitted to th ED with acurte dyspnea who have recieved chest x- ray .
      
Keywords: chest x-ray; heart failure; diagnosis; senior; non-senior
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The objective of this clinical investigation is to assess the safety and clinical performance
      of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary
      artery lesions.
    


Intervention name(s): Percutaneous Coronary Intervention Biotronik Orsiro DES
Intervention type(s): Device
Intervention description(s): Stenting
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy Subjects
Condition: Scleroderma, Systemic
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2330811 is a humanised monoclonal antibody, that blocks Oncostatin M (OSM), which is being
      developed for the treatment of inflammatory and fibrotic diseases. This first time in human
      study will evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and
      immunogenicity profile of single ascending subcutaneous (s.c.) doses of GSK2330811, in
      healthy subjects.

      This study will be a randomised, double-blind (sponsor open), placebo-controlled, single
      centre, single dose escalation study of s.c. administrations of GSK2330811 in healthy
      subjects. Approximately 40 subjects will be enrolled in the study, across 5 cohorts. Each
      cohort is planned to consist of 8 subjects, randomised such that 6 subjects will receive
      GSK2330811 and 2 subjects will receive placebo.

      The starting dose for the study will be 0.1 milligram (mg)/kilogram (kg) s.c. single dose and
      the highest dose will be 6 mg/kg s.c. single dose. Subjects will be admitted to the clinical
      unit on the day prior to dosing (Day -1). On Day 1, each subject will receive a s.c. dose of
      GSK2330811 or placebo. Subjects will then remain as an in-patient until discharged on Day 8,
      after assessments have been performed. The duration of the study, including screening, is
      approximately 19 weeks for Cohorts 1 to 4 and 23 weeks for Cohort 5.
    


Intervention name(s): GSK2330811; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2330811 will be supplied as clear or opalescent, colourless, yellow to brown liquid administered as single dose s.c.; Placebo will be supplied as Normal Saline (0.9% weight by volume [w/v] Sodium Chloride) administered as single dose s.c.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2330811; Dose Escalation; Safety; First Time in Human; Pharmacodynamics; Pharmacokinetics
Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
Condition: Asthma; Acute Asthma
MeSH terms: Asthma; Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if adding nebulized budesonide to the systemic
      steroid for treatment of acute wheezing has any additive benefit in children who have
      hospitalized for acute wheezing.
    

Detailed description: 
      Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is
      unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic
      corticosteroids. There is insufficient evidence that inhaled corticosteroids result in
      clinically important changes in pulmonary function or clinical scores when used in acute
      asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that
      further research is needed to clarify if there is a benefit of inhaled corticosteroids when
      used in addition to systemic steroids.

      Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment
      of acute wheezing in hospitalized children has any benefit on, symptom score, duration of
      hospitalization and time to discharge from hospital.

      Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized
      budesonide versus placebo for children 6 months to 6 years of age who have admitted to the
      hospital for acute wheezing.

      Intervention: Participants will receive standard therapy including SCS, albuterol, and
      ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or
      saline.

      Study Measures: Differences in asthma scores, vital signs, duration of hospitalization and
      time to discharge from hospital will be compared between treatment groups.
    

Intervention name(s): Budesonide 0.5 mg/ml nebules; % 0.9 Saline solution
Intervention type(s): Drug; Drug
Intervention description(s): Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days; Children will receive 2 ml of nebulized saline 2 times a day up to 5 days
Other intervention name(s): Pulmicort 0.5 mg/ml nebules
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wheezing; Acute asthma; Children
Targeting Inflammation Using Salsalate in CardioVascular Disease
Condition: Coronary Artery Disease; Overweight
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Overweight; Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The hypothesis is that western lifestyle, with sedentary behaviors and caloric excess promote
      a chronic, subacute inflammatory state that participates in the development and progression
      of atherosclerosis. We will evaluate the effects of targeting inflammation using the
      anti-inflammatory drug salsalate, compared to placebo, on coronary artery plaque volume
      assessed by multi-detector computed tomographic angiography (MDCTA). The TINSAL-CVD study is
      a randomized, double-masked, placebo-controlled, 2 arm, clinical trial.

      The purpose of the study is to compare the effect of salsalate or placebo on sub-acute
      inflammation and coronary plaque, in people with cardiovascular disease. Participants are
      randomized to active intervention (salsalate) or placebo interventions for a period of 30
      months. The primary endpoint is change in plaque volume in the coronary arteries assessed by
      MDCTA from baseline to 30 months.
    

Detailed description: 
      OBJECTIVE:

      To determine whether targeting inflammation using salsalate compared with placebo reduces
      progression of noncalcified coronary artery plaque.

      DESIGN, SETTING, AND PARTICIPANTS:

      In the Targeting Inflammation Using Salsalate in Cardiovascular Disease (TINSAL-CVD) trial
      participants were randomly assigned to 30 months of salsalate or placebo in addition to
      standard, guideline-based therapies. Randomization was computerized and centrally allocated,
      with patients, health care professionals, and researchers masked to treatment assignment.
      Participants were overweight and obese statin-using patients with established, stable
      coronary heart disease.

      INTERVENTIONS:

      Salsalate (3.5 g/d) or placebo orally over 30 months.

      MAIN OUTCOMES AND MEASURES:

      The primary outcome was progression of noncalcified coronary artery plaque assessed by
      multidetector computed tomographic angiography. Secondary outcomes were other measures of
      safety and efficacy.
    

Intervention name(s): Salsalate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months; Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months
Other intervention name(s): Disalcid; Placebo to Salsalate
Intervention MeSH terms: Salicylsalicylic acid; Sodium Salicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronary Artery Disease; Inflammation; Overweight; Metabolic Syndrome; Salsalate
SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects
Condition: MDD
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics
      (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy
      volunteers (HV)
    

Detailed description: 
      The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics
      (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy
      volunteers (HV) to identify repeated dose levels that are safe and well-tolerated.
    

Intervention name(s): ABX-002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ABX-002; Placebo
Other intervention name(s): Methyl amide prodrug
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Double-Blind, Randomized, Placebo-Controlled Single and Multiple Ascending Doses in Healthy Adult Subjects
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer
Condition: Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the objective response rate and safety in
      platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients
      treated with vinorelbine and gemcitabine combination chemotherapy.
    

Detailed description: 
      Other objectives of this study are to evaluate Progression-free survival and measure CA-125
      response rate.
    

Intervention name(s): Vinorelbine and Gemcitabine
Intervention type(s): Drug
Intervention description(s): Gmcitabine 1000㎎/㎡ mix in normal saline 100ml iv for 30min andVinorelbine 25㎎/㎡ mix in normal saline 50 ml iv for 5-10min on D1 and 8 every 21 days cycle
Other intervention name(s): Gemcibine and Navelbine
Intervention MeSH terms: Gemcitabine; Vinorelbine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian cancer
C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the
      available C-arm Cone-Beam Computed Tomography (CBCT) data acquisition systems currently
      widely available worldwide in interventional angiography suites to enable acute ischemic
      stroke patients to be imaged, triaged, treated, and assessed using a single modality in one
      room.
    

Detailed description: 
      This is an evaluation to determine the efficacy of the use of C-arm CBCT with SMART RECON
      novel software for the rapid assessment of time-resolved CTA and CT perfusion in the setting
      of ischemic cerebrovascular events. As a leading center for the treatment of cerebrovascular
      disease in the Midwest as well as being one of the first Comprehensive Stroke Centers in the
      United States we have a large potential patient group to assess.

      The pilot plan is to compare conventional CT/CTA/CTP acquired during the clinical work up
      with C-arm CBCT/CTA/CTP acquired in the angiography suite at initiation of therapy. The C-arm
      CBCT acquisition provides whole brain coverage (compared to only 8 cm brain coverage with
      conventional CT) with less radiation and higher resolution; the CT perfusion maps obtained
      using C-arm CBCT and new reconstruction algorithms provides better perfusion maps.
    

Intervention name(s): C-Arm Cone Beam Computed Tomography
Intervention type(s): Diagnostic Test
Intervention description(s): C-ARM CBCT angiogram and CBCT perfusion imaging using prototype software (SMART-RECON) can rapidly and accurately assess the cerebral blood flow maps in the setting of decreased blood flow to the brain (ischemic cerebrovascular events). This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the angiography suite.
Other intervention name(s): C-ARM CBCT
Intervention model: Single Group Assignment
Intervention model description: Single center, open label, single-arm, pilot study
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Stroke
Effect of Blueberry Supplementation on Alzheimer's Biomarkers
Condition: Mild Cognitive Impairment; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to study the effects of blueberries on neuronal, glial, and
      pathology blood biomarkers in Mild Cognitive Impairment (MCI) and to estimate sample size for
      future confirmatory studies. The blood biomarkers to be measured are Neurofilament light
      (NfL), glial fibrillary acidic protein (GFAP), Aß40, Aß42, p-tau181, and cytokines, using an
      ultra-sensitive state-of-the-art immunoassay.
    

Detailed description: 
      After determining subject eligibility and after subjects have abstained from consuming all
      berry fruits (including red wine) for 2 weeks, subjects will have blood drawn for biomarkers
      and will then will undergo 12 weeks of blueberry supplementation in the form of 18 grams
      lyophilized blueberry powder mixed with water and taken twice daily with meals. All subjects
      will be asked to abstain from berry fruits (including red wine) for the duration of the 12
      week trial. Subjects will receive telephone calls at 4 and 8 weeks to check compliance as
      well as concomitant medications and adverse events and then all subjects will return at 12
      weeks for a repeat biomarker blood draw. Plasma NfL, GFAP, Aβ40, Aβ42, p-tau181, and cytokine
      biomarker assays will be done using the Quanterix SR-X instrument, a new, state-of-the-art
      digital immunoassay platform employing Simoa technology, which enables the detection and
      quantification of biomarkers previously difficult or impossible to measure.
    

Intervention name(s): lyophilized blueberry supplement
Intervention type(s): Dietary Supplement
Intervention description(s): lyophilized blueberry supplement bid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: MCI; biomarkers; memory loss