bioihbjkbjnl/mcl2 huggingface dataset:
Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department
Condition: Bacterial Infection; Intensive Care
MeSH terms: Infections; Bacterial Infections; Emergencies
Study type: Interventional

Summary: 
      The delayed administration of an adequate antimicrobial therapy is a strong predictor of
      impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis
      Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be
      initiated within one hour following the recognition of sepsis or septic shock.

      The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which
      has been recently proposed by the Third International Sepsis Consensus Definitions Task Force
      (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor
      outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point
      for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min)
      and altered mentation (Glasgow coma scale <15). The score ranges from 0 to 3 points. A qSOFA
      value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these
      outcomes being more common in infected patients who may be septic than in those with
      uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus
      improve the outcome of patients at risk of sepsis or septic shock.

      Many patients admitted to the hospital for bacterial sepsis or septic shock are initially
      managed in the Emergency Department (ED). This study aims at investigating whether the
      routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial
      therapy in patients admitted to the ED with suspected or proven bacterial infection,
      especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3
      definition).
    


Intervention name(s): systematic calculation of qSOFA
Intervention type(s): Procedure
Intervention description(s): calculation of qSOFA for each patient
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients will be prospectively included at Emergency Department triage during 2 consecutive 6-month periods (1-month wash-out interlude between the 2 inclusion periods):
First inclusion period: usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection.
Second inclusion period: usual procedure for patient triage at Emergency Department admission PLUS routine calculation of qSOFA in all patients admitted to the Emergency Department with a suspected or proven bacterial infection. Patients with a qSOFA value ≥2 will be directly and immediately notified to Emergency Department physicians by triage nurses.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Sepsis; Shock, septic; Emergency service, hospital; Anti-infective agents; Outcome assessment
Perceived Stress and Negative Thoughts With Biomarkers in People With Type 2 Diabetes Mellitus and Healthy Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of measured and induced negative
      feelings on glucose, tumor necrosis factor alpha, and cortisol levels in healthy participants
      and participants with type 2 diabetes mellitus.
    

Detailed description: 
      Depression and Diabetes are two pathologies that are frequently comorbid. Stress and negative
      thoughts are part of both. The biological correlates of psychological and emotional life are
      not yet fully clarified, so in this study we wonder about the association between tumor
      necrosis factor alpha, cortisol, and peripheral glucose levels with depression stress,
      measured negative thoughts, and induced guilt.This is a randomized intervention study. At
      baseline, participants complete the Beck Depression Inventory, the Automatic Negative
      Thoughts Scale (ATQ-N), and the Perceived Stress Scale (PSS-14). The intervention consists of
      a written task about situations that involved feelings of guilt or neutral situations. Saliva
      and dextrostix samples are taken before the 20-minute written task, at the end, dextrostix
      and saliva samples are performed again, finally a blood sample is taken.
    

Intervention name(s): Guilty feelings
Intervention type(s): Behavioral
Intervention description(s): Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Diabetes; Depression; Stress; Negative thoughts
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose,
      placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive
      either RO5545965 or matching placebo daily for 12 days.
    


Intervention name(s): RO5545965; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending doses; Multiple ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Long Term Safety of the Sonitus SoundBite System
Condition: Hearing Loss; Unilateral Hearing Loss; Total Unilateral Deafness
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Unilateral
Study type: Interventional

Summary: 
      The objective of this study is to assess the long-term safety and quality of life improvement
      of the Sonitus SoundBite Hearing System.
    

Detailed description: 
      The Sonitus Bone Conduction Device (BCD) is a bone conduction device for single-sided
      deafness (SSD). The Sonitus BCD consists of an Oral Appliance (OA), an external microphone
      component, worn behind the ear (BTE), a calibration interface cable and a PC-controlled
      calibration software for subject calibration. The Sonitus BCD picks up sounds from a
      microphone located within the ear canal of the deaf ear, capitalizing on the acoustics of the
      natural pinna and ear canal. The signal picked up by the microphone is then transmitted
      wirelessly to a removeable bone conduction oral appliance located on the upper molars. The
      oral appliance receives the acoustic signal from the BTE and applies an equivalent vibratory
      signal to the teeth that reaches the skull via bone conduction and routed transcranially to
      the contralateral cochlea.
    

Intervention name(s): Sonitus SoundBite System; SoundBite Hearing System
Intervention type(s): Device; Device
Intervention description(s): Non Surgical Bone Conduction Device
Other intervention name(s): Sonitus Bone Conduction Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hearing Loss; Unilateral Hearing Loss; Single Sided Deafness
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Multi-Centre, Randomised, Double-blind, Placebo-controlled Study to Investigate
      the Safety, Tolerability and Pharmacokinetics of AZD1940, Including an Interaction Study,
      After Administration of Oral Multiple Ascending Doses in Adult Subjects with Chronic Low Back
      Pain
    


Intervention name(s): AZD1940; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution Multiple ascending dose given orally once daily at day 1-12; Oral solution given orally once daily on day -1 and day 14
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; safety; chronic low back pain
The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Breakthrough Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA)
      patients using the diclofenac gel.
    

Detailed description: 
      The purpose of this proposed study is to conduct a trial with knee OA patients using the
      diclofenac gel. The effectiveness of diclofenac gel in managing breakthrough pain or the
      neuropathic components of pain (e.g., the burning, soft tissue joint sensitivity, or
      allodynic components) in knee OA is unknown. It is likely that patients will use the gel in a
      as needed (prn) fashion, on top of other analgesics prescribed for their pain. The
      neuropathic components of a generally nociceptive or inflammatory condition, such as knee OA,
      are underappreciated, and typically not tracked in OA analgesic studies. Yet, evidence across
      a variety of chronic painful conditions suggests that these components are quite disabling.
      The results of this study would show whether diclofenac gel as a prn medication is beneficial
      to patients suffering from knee OA pain.
    

Intervention name(s): Diclofenac Gel
Intervention type(s): Drug
Intervention description(s): Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Other intervention name(s): Voltaren
Intervention MeSH terms: Diclofenac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee osteoarthritis
Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will compare the pharmacokinetics (PK), safety and tolerability of long-term
      infusion of lyophilized landiolol (LDLL600) against esmolol (Brevibloc) by measurement of
      blood concentrations of landiolol, esmolol and their metabolites, and by monitoring systemic
      cardiovascular and local tolerability, blood pressure (BP), ECG including heart rate (HR) and
      adverse events (AEs).
    

Detailed description: 
      12 subjects will be administered LDLL600 and Brevibloc in a double-blind, randomized,
      cross-over setting. PK, systemic cardiovascular and local tolerability and safety of 24-hour
      long infusions of three dose levels of both Investigational Medicinal Products (IMPs) during
      each treatment period will be assessed.

      Each treatment period will consist of:

      Dose level 1 (LOW) for 2 hours (h) Dose level 2 (MEDIUM)for 2 hours Dose level 3 (HIGH)for 2
      hours PK and tolerability observation at dose level 3, 2 or 1 will be continued for 18 hours
      in order to end up with a total infusion period of 24 h Post-infusion follow-up (FU)for 6
      hours after infusion termination

      The duration of the wash-out period between treatment periods will be at least two days. Each
      subject, if confirmed eligible, will complete two treatment periods in total.

      In case of poor tolerability, alternative dosing schemes will be followed.
    

Intervention name(s): LDLL600; Brevibloc
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of 3 different doses LDLL600 in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.; Comparison of 3 different doses Esmolol in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.
Other intervention name(s): Landiolol hydrochloride; Esmolol
Intervention MeSH terms: Landiolol; Esmolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PK; PD; landiolol; esmolol; healthy volunteers phase I study
Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease; Disease Progression
Study type: Observational

Summary: 
      The purpose of this study for children with a new diagnosis of Crohn's disease is to identify
      biomarkers found in the blood or stool to help predict which children are at risk of
      developing complications.
    

Detailed description: 
      It is estimated that between 15-20% of children with Crohn's disease will develop
      complications that can require surgery within the first three years of diagnosis. The purpose
      of this study for children with a new diagnosis of Crohn's disease is to identify biomarkers
      found in the blood or stool to help predict which children are at risk of developing
      complications.

      A total of 2000 children with newly-diagnosed Crohn's disease will be enrolled within 30 days
      of diagnosis. Up to 28 medical sites in the United States and Canada will participate in the
      study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population will consist of children newly diagnosed with Crohn's disease at primary
        care clinics.
      
Biospecimen description: 
      At time of enrollment, whole blood for DNA and serum will be collected in all patients. Fresh
      fecal samples will also be requested. For gene expression analysis, biopsy specimens will be
      collected during regularly scheduled endoscopies.
    
Keywords: Crohn's Disease; Inflammatory Bowel Disease
Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with
      recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1).
      The double blinded period will last 12 weeks and the treatment open phase will last up to 1
      year, and atomoxetine treatment will be administered.

      A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
    


Intervention name(s): Atomoxetine Hydrochloride; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity of H5N1 Vaccine Following H5N2
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can
      induce a long-lasting immune memory by comparing the immunologic response to two doses of the
      OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who
      did not received LAIV.
    

Detailed description: 
      This study evaluated immunogenicity of an adjuvanted A(H5N1) inactivated influenza vaccine
      (IIV) in healthy adult subjects who received A(H5N2) live attenuated influenza vaccine (LAIV)
      1.5 years earlier (September/October 2012) and compared this with a group of naive subjects
      that did not participate in the previous study. Inclusion/exclusion criteria for the
      additional group of naive volunteers mirrored those utilized in the initial study.
    

Intervention name(s): A(H5N1) inactivated influenza vaccine (IIV); A(H5N2) live attenuated influenza vaccine (LAIV)
Intervention type(s): Biological; Biological
Intervention description(s): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.; Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
Other intervention name(s): Orniflu
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: LAIV H5N2; Influenza vaccine; Russia
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is primarily being performed in order to demonstrate bioequivalence between the
      Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also
      contain a comparison of the bioavailability of the suspension given with food and on an empty
      stomach.
    

Detailed description: 
      This is an open, randomized 3-way crossover study in 12 healthy volunteers. Subjects will
      receive single oral 30-mg doses of nitisinone as a suspension (fasting and with food) and as
      hard gelatin capsules (fasting only). There will be a 2-week washout period between the
      doses.

      There will be a screening visit within 3 weeks prior to the first dose. During each treatment
      period, subjects will be admitted to the clinic from the afternoon on the day before drug
      administration (i.e., on Day -1) and remain at the clinic until the 48-hour post-dose blood
      sample has been collected in the morning of Day 3. They will then return for ambulatory visit
      in the morning of Day 4 (72-hour sample). A follow-up visit will take place 7-14 days after
      the last dose.
    

Intervention name(s): Nitisinone, capsule; Nitisinone, suspension
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nitisinone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orfadin; Nitisinone; Bioequivalence; Bioavailability
Study to Compare the Pharmacodynamics and Pharmacokinetics of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Healthy Adults.
Condition: Healthy Volunteers
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to compare the pharmacodynamics (PD), pharmacokinetics
      (PK), safety, and tolerability of acetylsalicylic acid powder for oral inhalation (i-ASA)
      with non-enteric-coated chewable aspirin (C-ASA) in healthy adults by demonstrating
      bioequivalence.

      In the first treatment period, subjects will be randomized to receive either a single dose
      (100 mg) of I-ASA powder via a Dry Powder Inhaler (DPI) OR a single dose (162 mg) of C-ASA
      tablets. After a washout period, subjects will be crossed over to receive the other treatment
      in the second treatment period. All subjects will receive both treatments during the study.
      Each single dose treatment will be followed by up to 24 hours of serial post-dose PK, PD, and
      safety/tolerability assessments.
    


Intervention name(s): ASA; non-enteric-coated chewable aspirin
Intervention type(s): Drug; Drug
Intervention description(s): powder for oral inhalation via a Dry Powder Inhaler (DPI); Orally administered
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASA; acetylsalicylic acid; cyclooxygenase-1 enzyme; oral inhalation; inhaled; myocardial Infarction
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics including dose proportionality, and
      pharmacodynamics of BI 163538 XX within a predefined dose range
    


Intervention name(s): Placebo to BI 163538 XX; BI 163538 XX
Intervention type(s): Drug; Drug
Intervention description(s): 1 single dose per subject as oral solution; 1 single dose per subject as oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Polar Body Removal Before ICSI for Oocyte Activation in Previous Fertilization Failure Cases
Condition: Fertilization
Study type: Interventional

Summary: 
      Cases which undergone ICSI before with failure of fertilization will do another ICSI cycle
      with removal of the polar body just before the ICSI procedure and sperm injection at the site
      of polar body removal. This study group will be evaluated with another group with the classic
      ICSI procedure
    

Detailed description: 
      Patients with previous fertilization failure will be divided into 2 groups:

      Group 1 (control): Will undergo classic ICSI procedure in half the MII oocyte of the same
      case.

      Group 2 (study group): The other half of the MII oocyte of the same case will undergo:

        1. Polar body removal.

        2. ICSI procedure with injection of the spermatozoon in the same zona opening (done by
           laser for polar body removal).

      Results: Will be collected with evaluation of number of 2PN zygotes, Day 1, Day 2, Day 3, Day
      5 embryos in all the cases.
    

Intervention name(s): polar body removal using zona drilling by laser then suction by injecting pipette; Classic ICSI
Intervention type(s): Procedure; Procedure
Intervention description(s): zona drilling with laser followed by polar body removal then ICSI procedure; Classic ICSI case was done be injecting sperm inside Oocyte while polar body is already existed at 6 or 12 O'clock position.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polar body removal; ICSI; Fertilization failure