bioihbjkbjnl/mcl2 huggingface dataset:
A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called
      Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in
      NCT02214355). The registrations have been revised so all parts of this single trial (Parts
      A-C) are now included in this single registration (NCT02214433).

      The primary purpose of each part is provided below:

        -  10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450
           (tablet formulation) under varying gastric conditions

        -  40 volunteers participate in PART B to assess the safety, tolerability and PK of
           multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or
           twice daily.

        -  An additional 10 volunteers participate in PART C which is designed to assess the
           absolute bioavailability of various formulations of Debio 1450 under varying gastric
           conditions

      The dose administered during Part A is based on the safety, tolerability and PK data from
      study Debio 1450-102 [NCT02162199], a single ascending dose (SAD) study, in which single oral
      doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based
      on the available safety and PK data from preceding cohorts.
    


Intervention name(s): Placebo IV Solution; Debio 1450 IV Solution; Placebo Tablet or Capsule; Debio 1450 Tablet; Debio 1450 Capsule; Debio 1450 Oral Solution; Pantoprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A sterile IV solution of 5% dextrose in water; A white to off-white powder (40 mg Debio 1450 per vial) to be reconstituted and formulated in a sterile IV solution of 5% dextrose in water; Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule; Debio 1450 40 mg coated tablets; Debio 1450 40 mg capsules; Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water; Pantoprazole 40 mg orally
Intervention MeSH terms: Pantoprazole; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Antibiotic; Antibiotic Resistant Bacterial Infection
Safety Study of an Additional MVA Vaccine in Volunteers Who Received 3 DNA Vaccines Followed by 2 MVA Vaccines
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine the safety and immunogenecity of a third MVA in the
      HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA
      vaccines.

      The investigators postulate that the Immune responses that were observed in the HIVIS 03
      trial are likely to wane over time. To date it is unknown how these responses should best be
      maintained. In this study the investigators seek to boost immune responses, especially the
      antibody responses induced by the second MVA boost.

      Since the HIV specific antibodies were induced only after the second MVA injection, it is
      hypothesized that a 3rd MVA will give rise to even higher and sustained antibody titers.
    


Intervention name(s): Modified Vaccinia Ankara
Intervention type(s): Biological
Intervention description(s): Healthy volunteers will receive intramuscularly 1 injection of MVA-CMDR 1ml (Total 10 power 8 pfu) boost injection in the left deltoid muscle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effects of IL-1 Beta on the HPA-axis in Obese Persons
Condition: Metabolic Syndrome; Hypersecretion; Cortisol
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      In obese individuals cortisol production and secretion is increased but the underlying
      mechanism is not known. Obesity leads to a pathological activation of the innate immune
      system partly driven by tissue production of IL-1β. Furthermore, IL-1β is also known to
      stimulate the release of adrenocorticotropin hormone (ACTH). Therefore, the investigators
      hypothesise that in obese individuals tissue inflammation stimulates ACTH via IL-1β, thereby
      explaining the observed hypercortisolism.
    


Intervention name(s): Anakinra
Intervention type(s): Drug
Intervention description(s): Anakinra 100mg s.c. x 5
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting
Condition: Severe Traumatic Pain; Numeric Pain Rating Scale > 5 / 10
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute
      traumatic pain in prehospital and Emergency departments (ED).

      The investigators hypothesize that IN administration of Sufentanil is equal as compared with
      Intra veinous (IV) administration of Morphine wich is widely recommended in ED.

      The investigators study is a multicentric, comparative, randomized, double-blind,
      double-placebo study, comparing quality of analgesia in both groups 30 minutes after first
      administration of opiates.

      The investigators also asses side effects and patient satisfaction in both groups.
    


Intervention name(s): Morphine; Sufentanil; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous administration Patient receives simultaneously IV morphine administration and IN placebo spray.
Pain is controlled by:
at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg
at 10 minutes and if NPRS>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg
at 20 minutes and if NPRS>3: Pacebo (1 spray) + morphine IV 0,05mg/kg; Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV placebo administration and IN sufentanil spray.
Pain is controlled by:
at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV; Intravenous administration Patient receives simultaneously IV placebo administration and IN sufentanil spray.
Pain is controlled by:
at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV; Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV morphine administration and IN placebo spray.
Pain is controlled by:
at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg
at 10 minutes and if NPRS>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg
at 20 minutes and if NPRS>3: Pacebo (1 spray) + morphine IV 0,05mg/kg
Other intervention name(s): saline solution; NaCl 0.9%; saline solution; NaCl 0.9%
Intervention MeSH terms: Sufentanil; Morphine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute Pain; Traumatic Pain; Emergency setting; Prehospital setting; Analgesia; Intranasal device; Intra veinous injection; Sufentanil citrate; Morphine Sulfate
Ambulatory Versus Conventional Approach Diagnosing OSA
Condition: OSA
Study type: Interventional

Summary: 
      Very few studies have examined different models of care involving initial ambulatory
      home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who
      benefit from continuous positive airway pressure (CPAP), and reducing the need for
      polysomnography (PSG). This study aims to assess the role of an ambulatory approach with home
      diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the
      conventional approach in managing OSA in terms of improvement of clinical outcome but the
      former approach will lead to substantial cost savings.
    

Detailed description: 
      We conducted a prospective, randomized, controlled continuous positive airway pressure (CPAP)
      parallel study on new referrals to the Respiratory Clinic, Prince of Wales Hospital, with
      suspected obstructive sleep apnea (OSAS). OSAS was defined by apnea-hypopnea index(AHI) 5/hr
      or more of sleep plus excessive daytime sleepiness or two of the following symptoms: choking
      or gasping during sleep, recurrent awakenings from sleep, unrefreshed sleep, daytime fatigue,
      and impaired concentration. All patients with suspected OSAS underwent assessment at the
      clinic with the Epworth sleepiness score(ESS) and symptoms evaluation. Patients who had ESS
      score>9 or at least two OSAS symptoms as described above were invited to join the study. They
      were randomized into either group A)home-based management approach or group B)hospital-based
      management approach by a random table by a third party not involved in the trial.
    

Intervention name(s): Home sleep study; conventional polysomnography
Intervention type(s): Device; Device
Intervention description(s): The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events; conventional type I sleep study according to international guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback
Condition: Speech Sound Disorder
MeSH terms: Speech Sound Disorder
Study type: Interventional

Summary: 
      Previous research suggests that biofeedback can outperform traditional interventions for RSE,
      but no controlled studies have tested this hypothesis in the context of app-delivered
      biofeedback. The objective of this aim is to use the staRt app to test our working hypothesis
      that speakers will make larger gains in /r/ accuracy when app-based treatment incorporates
      biofeedback, compared to a non-biofeedback condition. With a network of cooperating SLPs,
      this project will recruit 15 children with /r/ misarticulation to receive 8 weeks of
      intervention using staRt. Individual sessions will be randomly assigned to include or exclude
      the visual biofeedback display. Randomization tests will be used to evaluate, for each
      individual, whether larger increments of change are associated with biofeedback and
      non-biofeedback sessions.
    


Intervention name(s): Traditional articulation treatment; Visual-acoustic biofeedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Traditional articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract can be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound.; In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum generated by the staRt app. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3. Knowledge of performance feedback will typically involve reference to the location of the third peak or 'bump' on the visual display.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Children with /r/ misarticulation will receive 16 sessions/8 weeks of intervention using staRt. Individual sessions will be randomly assigned to include the visual biofeedback display (visual-acoustic biofeedback treatment) or exclude it (traditional treatment). Participants will receive an equal number of sessions (8) of each type.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: speech; articulation; motor development
Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients
Condition: Accidental Puncture of Artery During Catheter Insertion
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the success rate using ultrasound as guidance during
      central venous cannulation in pediatric cardiac surgical patients.
    

Detailed description: 
      Central venous access may be essential in pediatric patients for fluid and a blood product
      administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic
      monitoring. Obtaining central venous access in pediatric patients can be challenging, failure
      rates in pediatric patients range from 5% to 19% with reported complication rates from 2.5%
      to 22%. The landmark technique has been standard approach for many years. In comparison with
      landmark method, in pediatric patients, the use of ultrasound is associated with an increased
      success rate decreased operative time, reduced number of cannulation attempts , and a
      decreased number of carotid artery punctures. This study is designed to evaluate the success
      rate, complications, time taken for successful cannulation and their correlation with cross
      sectional area of the vein.
    

Intervention name(s): Central Venous Catheterization
Intervention type(s): Device
Intervention description(s): Ultrasound guided internal jugular venous catheterization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma
      membrane-mediated and do not require gene transcription and translation. One of these
      non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular
      smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic
      receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g.
      locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists
      (e.g. inhaled beta-adrenergic agonists).
    

Detailed description: 
      Inhaled glucocorticosteroids typically are not recommended for the treatment of acute asthma
      attacks. This practice is based on the fact that glucocorticosteroids by themselves do not
      cause rapid bronchodilation. However, the acute inhibition of adrenergic agonist disposal by
      the non-genomic action of glucocorticosteroids could lead to bronchial vasoconstriction by
      locally released norepinephrine thereby decongesting the airway wall, and potentiate the
      bronchodilator effect of a concomitantly administered beta-adrenergic agonist through the
      same mechanism. The purpose of this study is to assess the vasoconstrictive effects of single
      and repetitive high-dose budesonide inhalations in moderate to severe asthmatics who use
      inhaled glucocorticosteroids regularly. As a secondary endpoint, airway inflammation and
      airway function will also be measured with the expectation that acute improvements in airflow
      might be detectable as a result of airway decongestion, notably in subjects with moderately
      severe asthma who have lower baseline lung function.
    

Intervention name(s): Budesonide 360ug; Budesonide 720ug; Budesonide 1440ug; Budesonide720ug 4 times; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single inhaled dose of 360ug budesonide from a DPI.; A single inhaled dose of 720ug budesonide from a DPI.; A single dose of 1440ug of the budesonide from DPI.; 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.; A single inhaled dose of placebo from a DPI.
Other intervention name(s): Pulmicort Flexhaler; Pulmicort Flexhaler; Pulmicort Flexhaler; Pulmicort Flexhaler; sugar pill
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Asthma, airway blood flow, budesonide, glucocorticosteroid.
Relationship of Vasoactive Peptide Levels to Portal Pressure and Patient Outcomes in Patients With Hepatic Cirrhosis
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal; Liver Cirrhosis
Study type: Observational

Summary: 
      Investigate vasoactive medicators in portal hypertension on stored sera
    


Observational model: Defined Population
Time perspective: Other
Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in
      severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with
      elevated eosinophil levels.
    

Detailed description: 
      Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of
      inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with
      c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. This is a
      multicenter, double-blind, randomized, parallel-group (ascending dose titration of masitinib
      to 6.0 mg/kg/day and matching placebo), comparative study of oral masitinib in the treatment
      of patients with severe asthma, uncontrolled with high dose of inhaled corticosteroid and
      with elevated eosinophil levels. Eligible patients will be treated during at least 48 weeks.
    

Intervention name(s): Masitinib; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): AB1010; Placebo Oral Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Severe persistent asthma; Eosinophil; Tyrosine kinase inhibitor
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if late doses of Infasurf surfactant given when
      patients are receiving inhaled nitric oxide will interact to improve surfactant function and
      increase survival without BPD in treated infants.
    

Detailed description: 
      This is a multi-center, blinded, randomized controlled clinical trial to evaluate the effects
      of booster doses of exogenous surfactant (Infasurf®, calfactant) in addition to inhaled
      nitric oxide (iNO) on the outcome of survival without bronchopulmonary dysplasia (BPD, or
      chronic lung disease of prematurity, characterized by chronic lung dysfunction) at 36 weeks'
      post-menstrual age (PMA) in extremely low gestational age (ELGAN) infants that are at high
      risk of the development of BPD. This multi-center trial, with a planned enrollment of 524
      infants, will also enable us to evaluate for any adverse effects of late surfactant treatment
      on short- and long-term outcomes, as we will be collecting data on effects of dosing of late
      surfactant, co-morbidities of prematurity and neurodevelopmental and pulmonary outcome at 1
      year and 24 months corrected age. In addition, we will collect biological specimens for
      evaluation of the effects of late surfactant replacement therapy (administered as described
      in this trial) on surfactant function and inflammatory markers.
    

Intervention name(s): Infasurf surfactant (ONY, Inc.); Sham (No Treatment)
Intervention type(s): Drug; Drug
Intervention description(s): Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.; Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Other intervention name(s): Treatment; Control
Intervention MeSH terms: Pulmonary Surfactants; Calfactant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nitric oxide; surfactant; BPD; prematurity; neonates; iNO; pulmonary outcome; neurodevelopmental outcome; Infasurf; lung function; Surfactant Dysfunction; Bronchopulmonary Dysplasia
Protective Immune Mechanisms in Alcoholic Hepatitis
Condition: Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Observational

Summary: 
      The purpose of this study is to investigate the production, effects and interactions of the
      hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.
    

Detailed description: 
      The investigators will study hepatic biopsies from patients with alcoholic hepatitis. In
      these biopsies, the investigators will assess the production of IL-22 and which cells produce
      the cytokine. The investigators will study the expression of the IL-22 receptor and also the
      production of the IL-22 binding protein, which can inhibit the actions of the cytokine.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University
        hospital
      
Biospecimen description: 
      Whole blood, serum, plasma, PBMC's, hepatic leukocytes
    
Keywords: Alcoholic hepatitis; IL-22; Kupffer cells
Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects
Condition: Hypercholesterol
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the antioxidative effects of alkylresorcinols
      (AR), originating from the rye fiber, on serum LDL particles and the use of AR or it's
      metabolites as biomarkers for rye fiber intake and the effect of additional plants sterols,
      incorporated in the rye bread, on serum total and LDL cholesterol concentration.
    


Intervention name(s): Rye-2008
Intervention type(s): Dietary Supplement
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Rye fiber; Alkylresorcinols; Plant sterols; Cholesterol; Antioxidant; Effects of plant sterols in rye bread on serum lipids; Effects of alkylresorcinols in rye fiber on LDL particles