bioihbjkbjnl/mcl2 huggingface dataset:
Improving Pneumococcal Vaccination Rates in an Ambulatory Pre-surgical Testing Setting
Condition: Community Acquired Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      The purpose of this quality improvement project is to improve the immunization rates of an
      at-risk adult population seen in an ambulatory healthcare environment, through the use of
      targeted health education messages regarding pneumococcal immunization. Patients seen in an
      out-patient pre-surgical testing center will receive 1) a one-page written information sheet
      that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this
      message, provided by the clinical staff, during the patient's interview.

      At-risk adult patients (as defined by Centers for Disease Control) seen in an ambulatory
      healthcare environment (a pre-surgical testing center) will receive a one page, "gain-framed"
      message that emphasizes the benefits of pneumococcal vaccinations. This educational material
      will be reviewed and reinforced by clinical staff during the assessment phase of the clinical
      visit. Among this group, there will be increased vaccination rate compared with at-risk adult
      patients who did not receive this communication (prospective vs retrospective data).
    

Detailed description: 
      The purpose of this project was to improve the immunization rates of an at-risk adult
      population seen in an ambulatory environment, through the use of targeted and evidence-based
      health education messages regarding pneumococcal immunization and staff training on the use
      of gain-framed messaging.

      We hypothesized that there would be an increase in immunization rates for at-risk adults
      following implementation of the intervention.

      The objective of the project was to increase our local immunization rate by 30% (from 20% to
      50%) and to provide tools and processes that can be utilized in other ambulatory healthcare
      settings.
    

Intervention name(s): Focused Health Education
Intervention type(s): Other
Intervention description(s): A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.
The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it.
Other intervention name(s): Patient literature and staff education, reinforcement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pneumococcal vaccination rates, ambulatory settings
Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety study of AADC gene transfer (VY-AADC01) in subjects with Parkinson's disease.
    

Detailed description: 
      Parkinson's disease is a neurodegenerative disorder involving loss of neurons that release
      dopamine in the striatum. To compensate for the loss of dopamine, patients are typically
      prescribed levodopa medication which is converted to dopamine by the enzyme Aromatic L-Amino
      Acid Decarboxylase (AADC). As Parkinson's disease progresses, levodopa therapy becomes less
      effective and is associated with motor fluctuations, involuntary movements and other
      complications.

      This study will primarily investigate the safety of increasing AADC levels in the striatum
      via AADC gene delivery. The hAADC gene is packaged into a gene transfer vector derived from a
      common, non-pathogenic virus (AAV2) to which >90% of humans have been exposed. This
      investigational drug, termed VY-AADC01, will be injected directly into the striatum during a
      neurosurgical procedure that is performed with real-time MRI imaging to monitor delivery.

      Subjects will continue to take Parkinson's disease medications, including levodopa.

      The safety and potential clinical responses to VY-AADC01 will be assessed by repeated
      clinical evaluations of Parkinson's disease, cognitive tests, laboratory blood tests and
      neuroimaging. Clinical evaluations will be performed over a 3 year follow-up period. A test
      to specifically assess the clinical response to levodopa will be performed once before AADC
      gene delivery and approximately 6 months after.
    

Intervention name(s): VY-AADC01
Intervention type(s): Biological
Intervention description(s): Neurosurgical delivery of VY-AADC01 to the brain.
Other intervention name(s): AAV2-hAADC
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: VY-AADC01
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PD; Parkinson's disease; Aromatic Amino Acid Decarboxylase; AADC; AAV2-AADC; AAV2; Viral Vector; Gene Therapy; Gene Transfer; MRI; PET; VY-AADC01
Effect of Recombinant Human Interferon α-2b Spray on Herpangina
Condition: Herpangina
MeSH terms: Herpangina
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness
      of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric
      patients with herpangina.
    


Intervention name(s): Recombinant Human Interferon α-2b Spray; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).; Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aged 1-7 years old, within 72 hours of onset patients with herpangina
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
Condition: Fractures; Dislocations; Abscess; Anesthesia; Analgesia
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      We, the investigators at Queen's University, propose to conduct a randomized, double-blind,
      feasibility trial comparing low-dose ketamine versus fentanyl as adjuncts to Emergency
      Department procedural sedation with propofol. The outcomes of interest will be safety, with
      respect to hemodynamic and respiratory adverse effects, as well as efficacy, with respect to
      adequacy of sedation and analgesia, recovery profiles and patient/physician satisfaction. Our
      hypothesis, based on a review of existing anesthesia literature, is that low-dose ketamine
      may be a safer and more efficacious alternative to fentanyl when used as an adjunct to
      propofol-assisted procedural sedation.
    

Detailed description: 
      This initial, single-centre feasibility study will have the following specific objectives:

        -  Comparison of low-dose ketamine with fentanyl as adjunct to propofol-assisted emergency
           department procedural sedation, with respect to safety and efficacy parameters;

        -  Pilot of a blinded emergency department sedation and analgesia protocol, including drug
           doses, concealment techniques, and data collection tools, to determine the feasibility
           of a subsequent larger, multi-centre trial;

        -  Determination of the true incidence of the primary outcome measures in the study
           population, using the study drug administration doses and protocol, such that an
           accurate sample size may be estimated for a future, adequately-powered, multi-centre
           trial;

        -  Validation of a newly-developed ordered, categorical rating scale for the reporting of
           respiratory and hemodynamic adverse events occurring during emergency department
           procedural sedation and analgesia.
    

Intervention name(s): ketamine
Intervention type(s): Drug
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: procedural sedation
Increasing Physical Activity Among Breast Cancer Survivors With Depression
Condition: Depression; Physical Activity; Breast Cancer
MeSH terms: Breast Neoplasms; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Pilot study to assess a multi-component intervention to increase physical activity among
      breast cancer survivors with depression.
    

Detailed description: 
      The research project is a pilot study to assess the effects of a multi-component intervention
      in increasing physical activity among breast cancer survivors with depression. Individuals
      meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6
      month follow up. Intervention components will include print-based education, self-monitoring,
      Active Living counseling, and facility access. Blood samples will be collected at baseline.
      Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points
      during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed
      using Fitbits to measure weekly minutes of moderate/vigorous activity.
    

Intervention name(s): Print-based education; Fitbit; Active Living counseling; Facility Access
Intervention type(s): Behavioral; Device; Behavioral; Other
Intervention description(s): All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.; Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.; The Active Living counseling program consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.; Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look at how the emptying of the participant's stomach after a meal is
      affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the
      study will also look at the effect of semaglutide on the participant's appetite and energy
      intake. Participants will either get semaglutide or "dummy" medicine - which treatment any
      participant gets is decided by chance. Participants will take 1 injection per week. The study
      medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will
      last for about 27 weeks (from first treatment to last check-up). Participants will have 8
      visits at the clinic with the study doctor.
    


Intervention name(s): Semaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive gradually increasing doses of semaglutide (subcutaneous [s.c.], in the thigh, abdomen or upper arm) injection once weekly, until they reach a dose of level of 2.4 mg, which they will continue for 5 weeks.; Participants will receive once weekly injections of semaglutide matched placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Spirometry Using Electrical Impedance Tomography
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of this study is to test spirometry measurements using EIT with a calibration
      using tidal volume obtained from the simultaneous standard spirometry measurement. Another
      goal is to compare, based on the calibration, the spirometry parameters obtained from
      separate measurements using EIT and the standard spirometry using a pneumotachograph.

      All spirometry measurements will be conducted in accordance with the latest available
      standards of the American Thoracic Society (ATS) and European Respiratory Society (ERS) from
      the year 2005, including their emendation from 2017.
    

Detailed description: 
      Adding the pneumotachograph and antibacterial filter to the respiratory system can lead to
      increased dead space, flow resistance, and change the respiratory pattern. All of these
      negative features and reduced patient co-operation affect the measured results and their
      interpretation. The aim of this study is to test spirometry measurement using EIT and
      evaluate such spirometry parameters as forced vital capacity (FVC), forced expiratory volume
      exhaled in the first second of a forced expiration (FEV1) and ratio of FEV1/FVC called
      Tiffeneau index (TI) based on recalculation using the calibration constant. The study will be
      conducted using Ergostik (Geratherm, Germany) spirometer and EIT system Pulmovista 500
      (Dräger, Germany).
    

Intervention name(s): Spirometric examinations realized using the EIT; Simultaneous measurement by spirometer and EIT
Intervention type(s): Device; Device
Intervention description(s): Spirometric examinations will be realized using the EIT alone.; Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: During the experiment, six measurements will be performed for each examined individual to calculate the spirometric parameters of FVC, FEV1 and Tiffenea's index (TI) FEV1/FVC. Spirometry measurements will be performed in a randomized order: two standard spirometric examinations, two spirometric examinations using EIT and two simultaneous measurements using both methods.
Each subject will undergo all six measurements.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: electrical impedance tomography; spirometric examination; bioimpedance; FVC; FEV1; Tiffeneau index
ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
Condition: Chronic Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of
      ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b,
      treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced
      Asian adults with compensated cirrhosis.
    


Intervention name(s): ABT-450/r/ABT-267; ABT-333; ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet
Other intervention name(s): ombitasvir/paritaprevir/ritonavir; ombitasvir also known as ABT-267; paritaprevir also known as ABT-450; dasabuvir
Intervention MeSH terms: Ritonavir; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV Infection; Compensated Cirrhosis
Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study were to assess the tolerability and safety of E2007 in patients
      with refractory partial or generalised seizures and to assess the pharmacokinetics of E2007
      in epileptic patients receiving at least one concomitant anti-epileptic drug.
    


Intervention name(s): E2007; E2007; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 mg of E2007 was administered by mouth once daily.; 2 mg of E2007 was administered by mouth once daily.; Placebo once daily of oral tablet formulation to be taken in the morning, one hour before breakfast, with a glass of water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; E2007; partial seizures; generalized seizures
Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody (hMAb) BIWA 4 in Patients With Head and Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The general aim of the present study was to assess the safety and tolerability of
      intravenously administered Technetium 99m (99mTc) and Rhenium-186 radionuclide (186 Re)
      -labelled hMAb BIWA 4, to confirm preferential accumulation in the tumour of 99mTc - labelled
      hMAb BIWA 4, to determine the maximum tolerated radiation dose of 186 Re-labelled hMAb BIWA 4
      and to propose a safety dose for phase II development.
    


Intervention name(s): 99mTc - labelled hMAb BIWA 4; 186 Re - labelled hMAb BIWA 4; unlabelled hMAb BIWA 4 - low dose; unlabelled hMAb BIWA 4 - medium dose; unlabelled hMAb BIWA 4 - high dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics
      (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to
      scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH).
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, parallel group, placebo controlled, multicenter
      study investigating the safety, tolerability, pharmacokinetics and activity of multiple oral
      doses of GS 9450 in adults with NASH. Approximately 110 subjects 18 75 years of age with
      elevated ALT (> 60 U/L at screening), fatty liver on screening ultrasound, and biopsy-proven
      NASH will be randomized (1:1:1:1:1) to one of five parallel treatment groups (22 subjects per
      treatment group) as follows:

      GS-9450 1mg by mouth (PO) once daily, GS-9450 5 mg PO once daily, GS-9450 10 mg PO once
      daily, GS-9450 40 mg PO once daily, or Matching placebo PO once daily Qualifying subjects
      will be stratified by the presence/absence of type 2 diabetes (i.e., on/off oral diabetic
      medication at entry) and by geographic region (US and France). Following randomization,
      subjects will return within five business days later for a baseline visit, at which time they
      will be dispensed study medication and enter a 4-week treatment phase. Upon completion of the
      treatment phase, subjects will enter a 4 week off-treatment follow-up period. Each subject's
      participation in the study will last up to approximately 12 weeks (inclusive of screening,
      treatment phase, and off-treatment follow-up period).
    

Intervention name(s): GS-9450; GS-9450 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily; Placebo to match GS-9450 administered orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill
      combination in patients with uncomplicated essential hypertension not adequately controlled
      (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone.
    


Intervention name(s): Valsartan/amlodipine 160/5 mg; Valsartan 160 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.; Valsartan 160 mg capsule taken orally once daily.; 1 capsule or tablet taken orally once daily
Other intervention name(s): Exforge® 160/5mg; Diovan® 160mg
Intervention MeSH terms: Amlodipine; Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood pressure; hypertension; Exforge; valsartan/amlodipine
Polydextrose for Patients With Chronic Kidney Disease
Condition: Chronic Kidney Diseases; Constipation
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Constipation
Study type: Interventional

Summary: 
      Constipation is a common complication in patients with chronic kidney disease (CKD),
      especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most
      important causes of constipation. The study aims to investigate the possible influence of
      polydextrose (PDX) supplementation on constipation in patients with CKD on HD.
    


Intervention name(s): Polydextrose
Intervention type(s): Dietary Supplement
Intervention description(s): Administration of 3g polydextrose per day, for 2 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment