bioihbjkbjnl/mcl2 huggingface dataset:
Lidocaine in ERAS for FESS
Condition: Intraoperative Bleeding
MeSH terms: Blood Loss, Surgical
Study type: Interventional
Phase: Phase 2

Summary: 
      Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known
      that bleeding during FESS can affect directly to the visibility of safe landmarks and
      surgical outcomes.
    

Detailed description: 
      Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the head and
      neck field. It is known that bleeding during FESS can affect directly to the visibility of
      safe landmarks and surgical outcomes.

      Use of vasoactive drugs to control bleeding is not without pitfalls. Systemic effects of
      epinephrine may constitute a potential hazard in patients with hypertension, ischemic heart
      disease, anemia, preexistent liver or renal damage and endocrine dysfunction
      (hyperthyroidism, pheochromocytoma and diabetes mellitus).

      Lidocaine is a prototypical local anesthetic, but it also has systemic effects that are
      mediated by inhibitory effects on N-methyl-d-aspartate receptors and leukocyte priming.
      Consequently, systemic lidocaine is antiinflammatory, analgesic, and antihyperalgesic.
      Randomized clinical trials, however, have produced mixed results. Several studies have shown
      reduction in postoperative opioid consumption and pain scores, whereas others have failed to
      show a benefit.
    

Intervention name(s): Lidocaine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): IV Lidocaine infusion; IV normal saline infusion
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Early Feeding Following Percutaneous Gastrostomy Tube Placement
Condition: Gastrostomy
Study type: Interventional

Summary: 
      This study plans to learn more about the safety of early feeding following placement of a
      feeding tube. Doctors in other specialties feed patients 4 hours after patients receive a
      feeding tube. However, Interventional Radiologists typically wait to feed patients for 24
      hours following feeding tube placement. The investigator would like to demonstrate that
      feeding after 4 hours does not increase complications and can actually reduce the burden to
      patients who receive a feeding tube.
    


Intervention name(s): Feeding at 4 hours
Intervention type(s): Other
Intervention description(s): Patients will be fed 4 hours after their gastrostomy tube placement procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastrostomy; Feeding; G-tube
dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
Condition: Peripheral Arterial Vascular Occlusion
Study type: Interventional

Summary: 
      The study is designed to produce early safety and performance data in a small group of
      patients requiring repair of a peripheral vascular endarterectomy (incision into an artery
      feeding the limbs which requires a patch to repair the incision after removal of an
      atherosclerotic plaque that was stopping usual blood flow to the limbs).

      Data is being collected to show the procedure is safe and allows for normal blood flow to be
      resumed.

      Data will be used to facilitate CE Mark submission.
    


Intervention name(s): dCell Vascular Patch
Intervention type(s): Device
Intervention description(s): Implantation of a dCell Vascular Patch as part of an Endarterectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endarterectomy; dCell; Tissue Regenix Ltd; TRL; Vascular Patch; Treatment
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
Condition: Typhoid
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever
      vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
      The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.
    

Detailed description: 
      This was a randomised, double-blind, placebo-controlled, single dose, dose escalation study
      with 4 dosing cohorts. Within each cohort, 45 evaluable subjects were planned (36 subjects
      receiving M01ZH09, 9 receiving placebo).
    

Intervention name(s): Dose of 5.0 x 10^9 CFU (Cohort 1); Dose of 7.5 x 10^9 CFU (Cohort 2); Dose of 1.1 x 10^10 CFU (Cohort 3); Dose of of 1.7 x 10^10 CFU (Cohort 4); Placebo (Cohorts 1-4 pooled)
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration; S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration; S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration; S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration; Excipients only, single dose, oral administration
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis
Condition: Atopic Dermatitis; Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the clinical efficacy of 3% (w/w) GW842470X cream
      applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema
      Area Severity Index (EASI) assessment of disease severity and to investigate the safety of
      and tolerability of 3% GW842470X cream on diseased skin of adult patients.
    


Intervention name(s): GW842470X cream
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: atopic dermatitis; GW842470X; PDE4 inhibitor
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether different types of breathing therapies in
      patients with COPD III-IV decrease dyspnea and increase activity.
    

Detailed description: 
      In the treatment of COPD-Patients different kinds of breathing therapy techniques are used,
      but many of them are not reassessed yet.

      Dyspnea is one of the predominant symptoms of COPD patients and has negative impacts on the
      activity of the patients. Dyspnea during exertion leads to avoiding activity and results in a
      deconditioning of muscles and of the cardiovascular system.

      Thus breathing therapy techniques seem to be useful, which may lead to a decrease of dyspnea
      and an increase of activity.

      The purpose of this study is to determine whether reflective breathing therapy is more
      effective on decreasing dyspnea and increasing activity than conventional breathing therapy.
    

Intervention name(s): conventional breathing therapy; reflectory breathing therapy
Intervention type(s): Other; Other
Intervention description(s): duration: 60 minutes.; duration: 60 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breathing therapy; reflective breathing therapy; COPD; chronic obstructive pulmonary disease
Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment
Condition: Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate how subjects with mild or moderate liver problems
      process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.
    


Intervention name(s): GW679769
Intervention type(s): Drug
Intervention description(s): GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning
Intervention MeSH terms: Casopitant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: emesis liver problems hepatic impairment GW679769
Amphotericin B Suspension in Refractory Chronic Sinusitis
Condition: Chronic Sinusitis
MeSH terms: Sinusitis; Chronic Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B
      suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during
      16 weeks of treatment in patients with refractory, postsurgical CS.
    


Intervention name(s): SinuNase
Intervention type(s): Drug
Intervention description(s): Lavage
Other intervention name(s): Amphotericin B Suspension
Intervention MeSH terms: Amphotericin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Sinusitis; Chronic Rhinosinusitis
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Condition: Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      Midazolam is often given before surgery to sedate a patient before anesthesia is given.
      Children are often given a small dose either by mouth or squirted into the nose. Children
      will often spit out the oral midazolam, making it difficult to know how much medicine, if
      any, they have received. Giving midazolam into the nose is more reliable, but children may
      complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also
      occur when midazolam is squirted alone into the nose. The purpose of this study is to see if
      adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam
      easier and more comfortable without affecting how the midazolam works as a sedative. This is
      follow up to the pilot study, Project # 994. This will expand the previous study, with
      additional participants and revised xylocaine concentration
    


Intervention name(s): Midazolam; xylocaine; saline placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): midazolam 0.2 mg/kg given intranasally; intransal xylocaine given in conjunction with intranasal midazolam; intranasal saline given as placebo
Intervention MeSH terms: Lidocaine; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject
Condition: Immunoscience
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male
      subjects
    


Intervention name(s): Prenisolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects
Condition: Healthy; Long QT Syndrome
MeSH terms: Long QT Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as
      assessed by the QTc interval.
    


Intervention name(s): ERB-041
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Healthy; Cardiac; Pharmacokinetics
PENNVAX-B With or Without IL-12 or IL-15 as a DNA Vaccine for HIV Infection
Condition: HIV Infection
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of
      PENNVAX-B with or without co-administration of constructs containing DNA encoding for the
      expression of either IL-12 or IL-15.

      Primary objectives

        1. To determine the safety of HIV-1 DNA constructs (PENNVAX-B).

        2. To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs
           when given with PENNVAX-B.

      Secondary objectives

        1. To compare the various vaccine groups for their immunological responses to several HIV-1
           antigens, utilizing the ELISPOT assay.

        2. To analyze antibody responses to the vaccine antigens over time.

        3. To measure CD8 cell proliferative responses to vaccine antigens over time.
    


Intervention name(s): PENNVAX-B; GENEVAX IL-12-4532; PLACEBO; IL-15 adjuvant
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): PENNVAX-B is a cocktail of three expression plasmids. The plasmids include the genes which encode a synthetic HIV-1 envelope protein (pEY2E1-B), Gag (gagCAM02), and Pol (pK2C1). Each plasmid is manufactured to a concentration of 4.0 mg/mL and is formulated with bupivacaine (0.25%) as a facilitating agent for DNA uptake. All plasmids (2.0 mg each gag, pol, env) are premixed by the manufacturer in the same vial.; GENEVAX IL-12-4532 This molecular adjuvant plasmid contains nucleotide sequences necessary for expression of the human IL-12 protein. IL-12 DNA is formulated at a concentration of 2.0 mg/mL with bupivacaine (0.25%).; PLACEBO; pIL15EAM is a plasmid that encodes human IL-15 and has been optimized to express 87 fold higher than native IL-15 DNA and 5.7 fold higher than an earlier generation optimized IL-15 DNA construct. This plasmid is formulated at a concentration of 4.0 mg/mL with bupivacaine (0.25%).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV infection; DNA vaccine; IL-12 adjuvant; IL-15 adjuvant
Cerebral Bases of Arithmetics Processing
Condition: Neural Bases of Arithmetic Processing
Study type: Interventional

Summary: 
      The aim of this study was to identify neural correlates involved in arthmetics processing in
      adults and children aged 8 to 14 with normal cognitive function. Brain area will be
      identified by functional magnetic resonance imaging (IRMf).
    


Intervention name(s): neuropsychological testing; functional magnetic resonance imaging; simple arithmetic operations
Intervention type(s): Other; Other; Other
Other intervention name(s): IRMf
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
FMRI of Stress and Addictive Disorders
Condition: Cocaine Dependence; Opioid Dependence; Alcoholism; Pathological Gamblers; Adolescents
MeSH terms: Alcoholism; Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Observational

Summary: 
      The purpose of this study is to explore whether frontal brain activation in response to
      stress varies as a function of the presence or extent of early trauma and whether or not this
      effect is greater in women compared to men. To examine the effect of stress on thinking and
      remembering. To examine the separate and interactive effects of stress, addiction,
      withdrawal, and genetics; and to examine fMRI brain activation associated with stressful,
      reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video
      clips in addicted individuals and in healthy controls.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cocaine dependent individuals, opioid dependent individuals, alcohol dependent individuals,
        healthy controls, adolescent subjects, pathological gamblers
Oculomotor Markers and Attachment in Adolescents
Condition: Emotion Dysregulation
Study type: Interventional

Summary: 
      The study aims to identify specific visual scanning patterns of attachment pictures in
      adolescent with different attachment style.
    

Detailed description: 
      Oculomotor parameters will be assessed during visualization of 2 sets of pictures. The first
      set presents a distress picture and is followed by a slide composed of 3 pictures (one
      representing comfort, one representing complicity and the last representing a neutral scene).

      Psychophysiological parameters (skin conductance reactivity-SCR) is also assess during this
      visualization.
    

Intervention name(s): oculomotor parameter recording; attachment scale interview (ASI); psychophysiological recording; psychometric assessment; parent interview
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): visual scanning behavior is assessed during visualization of emotional pictures; ASI is used to determine the attachment style of each participant; this consists of the measurement of the skin conductance reactivity (SCR) during the picture visualization; self administered questionnaires are used to assess anxiety, depression and alexithymia.; an interview of the adolescent parent is performed in order to assess the confusion of the parent-child role and the interaction between the child and its parent.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: attachment; oculomotor marker; emotion regulation
Efficacy of IMPACT in Infant Siblings of Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Over a 5 year period infant and baby siblings of children with autism spectrum disorders
      (ASD) will be recruited to this study and will be randomized into 2 groups. Parents of the
      intervention group will receive 12 weeks of coaching in how to implement this intervention.
      Parents randomized to the control group will not receive intervention coaching. Both groups
      will attend a series of clinic appointments for data collection that occur at 3 month
      intervals over a 9 month period.
    

Detailed description: 
      This two-site randomized controlled trail (RCT) will include a sample of 80 siblings of
      children with ASD (Sibs-ASD) (11 months, 15 days to 18 months, 15 days) who are stratified on
      initial cumulative-risk status for communication disorder and then randomly assigned to
      Ingersoll's Improving Parents As Communication Teachers (ImPACT; Ingersoll & Dvortcsak, 2010)
      treatment or to a business-as-usual (BAU) control condition. The following hypotheses will be
      tested:

        1. Compared to the BAU Control, children assigned to the ImPACT group will show (a) more
           growth on pivotal skills and language level, and (b) a lesser degree of ASD
           symptomatology and language delay.

        2. Pretreatment, cumulative-risk level will statistically interact with (i.e., moderate)
           treatment assignment to predict children's (a) change in pivotal skills and language,
           and (b) severity of autism symptoms and language delay.

        3. Compared to the BAU Control, parents in ImPACT will have more optimal parenting stress
           and parenting efficacy, at least in parents with average or below average depressive
           symptoms prior to treatment (i.e., depressive symptoms will moderate the effect of
           ImPACT on parental stress and parenting efficacy).

        4. The effect that ImPACT has on growth of pivotal skills and language will be mediated by
           parents' frequency and fidelity of use of ImPACT strategies at immediate post-treatment.

        5. The effect of ImPACT on degree of children's language delay and ASD symptomatology at 6
           months post-treatment will be mediated by their pivotal skill level at 3 months
           post-treatment.
    

Intervention name(s): Impact Parent Training; No Impact
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages
Condition: Hemorrhage; Intracerebral, Nontraumatic; Ischemic Strokes; Diffusion Weighted Imaging Lesions
MeSH terms: Stroke; Ischemic Stroke; Cerebral Hemorrhage; Ischemia; Hemorrhage; Body Weight
Study type: Observational

Summary: 
      Intracerebral hemorrhage (ICH) occurs when small arteries in the brain rupture due to
      weakening by age, high blood pressure, and/or elevated cholesterol. In addition to artery
      rupture, recent data suggests that patients with ICH are also at risk for developing
      occlusion of arteries during the acute phase, called ischemic strokes. Data suggests these
      ischemic strokes can negatively impact patient outcomes. Diffusion weighted imaging (DWI) is
      a sequence on Magnetic Resonance Imaging (MRI) that is a sensitive marker for ischemic
      strokes in the brain. In this proposal, our primary aim is examine prospectively the effect
      DWI abnormalities have on functional outcomes in patients with ICH. Our hypothesis is that
      the DWI abnormalities found on MRI of the brain lead to worse functional outcomes in patients
      with ICH
    

Detailed description: 
      Diffusion weighted imaging (DWI) is a sensitive method to assess for secondary ischemia in
      patients with acute brain injury. By comparing the outcomes of patients with and without DWI
      abnormalities, we would able to assess the impact these lesions have on functional recovery
      in patients with ICH. Since no direct therapies exist for this disease, DWI abnormalities may
      be a novel target for intervention to improve outcomes. If traditionally assessed functional
      outcomes are not affected by DWI, the mechanism behind these lesions would still warrant
      further evaluation and potential treatment. Detection of subclinical infarcts has emerged as
      a potential surrogate marker for subsequent risk of stroke, vascular dementia, and cognitive
      impairment. Furthermore, the cause behind DWI lesions in acute ICH may lead to better
      understanding the pathophysiologic interplay between ischemic and hemorrhagic strokes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects for this study will be selected from patients admitted with a primary
        intracerebral hemorrhage to Rush University Medical Center's Neurosciences Intensive Care
        Unit.
      
Keywords: Intracerebral Hemorrhage; Ischemic Stroke; Diffusion Weight Imaging Abnormalities; Neurologic Outcome