bioihbjkbjnl/mcl2 huggingface dataset:
Dopamine Enhancement of Fear Extinction Learning in PTSD (1R21MH108753)
Condition: Stress Disorder, Post Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Placebo; Levodopa
Intervention description: Sugar pill packaged to resemble levodopa; EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Intervention MeSH terms: Levodopa
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: Female
Minimum age: 25 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Posttraumatic Stress Disorder; functional Magnetic Resonance Imaging; Levodopa (L-DOPA); Exposure Therapy; Fear Extinction

Summary:

      The purpose of this study is to investigate a new use for a medication called levodopa
      (L-DOPA). L-DOPA has been approved for use in Parkinson 's disease, but not for Posttraumatic
      Stress Disorder (PTSD). L-DOPA is thought to enhance certain cognitive abilities that the
      investigators believe may be affected among women with PTSD. It is hypothesized that L-DOPA
      may enhance fear extinction learning to a conditioned fear stimulus. If this is true, L-DOPA
      may improve outcomes for those undergoing certain types of therapy for PTSD, though that aim
      is beyond the scope of this project. Additionally, the investigators are testing whether an
      individual's genetic profile affects how well L-DOPA works to enhance cognitive abilities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25-50 years of age

          -  PTSD related to physical or sexual assault

          -  Medically healthy

          -  English speaking

        Exclusion Criteria:

          -  Claustrophobia, or the inability to lie still in a confined space

          -  Major medical disorders (e.g., HIV, cancer)

          -  Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips,
             artificial heart valves, inner ear (cochlear) implants, artificial joints, and
             vascular stents)

          -  Electronic or magnetic implants, such as pacemakers

          -  Permanent makeup or tattoos with metallic dyes

          -  Currently pregnant

          -  A self-reported history of loss of consciousness (greater than 10 minutes)

          -  Physical disabilities that prohibit task performance (such as blindness or deafness)

          -  Psychotic disorders (e.g., schizophrenia)

          -  Any other condition that the investigator believes might put the participant at risk
Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Quetiapine Fumarate XR
Intervention description: oral, once daily, flexible dose
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute schizophrenia; PANSS

Summary:

      This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy
      and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment
      of acute schizophrenic patients. The eligible patient will be assigned to study treatment
      with Quetiapine XR on Day 1.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition (DSM-IV) criteria

          -  PANSS total score of at least 70 at enrolment and at assignment Day 1

          -  CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at
             assignment Day 1 and with worsening of the patient's condition during the 3 weeks

        Exclusion Criteria:

          -  Known intolerance or lack of response to quetiapine fumarate

          -  Administration of a depot antipsychotic injection within one dosing interval (for the
             depot) before assignment

          -  Substance or alcohol dependence at enrolment

          -  Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV
             criteria within 4 weeks prior to enrolment
Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
Condition: Procedural Sedation; Regional Anesthesia Block; Orthopedic Surgery
Intervention: Fospropofol disodium; Fospropofol disodium; Placebo + Midazolam; Fentanyl
Intervention description: 10 mg/kg bolus; 6.5 mg/kg bolus; Placebo bolus plus midazolam. The dose of midazolam will be based on the patient's weight: 1 mg for patients <60 kg; 1.5 mg for patients ≥60 kg to <90 kg; or 2 mg for patients ≥90 kg; All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients <60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.
Intervention MeSH terms: Midazolam; Fentanyl; Fospropofol; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Procedural sedation; Regional Anesthesia block; Orthopedic surgery; Lusedra; Fospropofol disodium; Midazolam

Summary:

      How does Lusedra compare with current standard of care (midazolam) for minimal to moderate
      sedation for regional anesthesia blocks prior to orthopedic surgery?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing elective orthopedic surgery

          -  With a regional block prior to surgery

          -  Able to consent and complete the assessments and procedures

          -  If female, must be surgically sterile, postmenopausal, or not pregnant or lactating
             and using an acceptable method of birth control for at least 1 month prior to surgery
             with a negative urine pregnancy test at screening

          -  American Society of Anesthesiologists Physical Classification System status category
             P1 to P4

        Exclusion Criteria:

          -  History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or
             benzodiazepine

          -  Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated
Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
Condition: Influenza Prophylaxis
MeSH terms: Influenza, Human
Intervention: Stratis Jet Injector; Needle and Syringe; 2011-2012 Fluzone trivalent inactivated influenza vaccine
Intervention description: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine; Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Jet Injector; Stratis®; PharmaJet; Jet Injection

Summary:

      The primary objective of this study was to evaluate if administration of a seasonal flu
      vaccine using a jet injector device is comparable to traditional needle and syringe delivery
      for eliciting an immune response. A secondary objective was to compare the safety of the two
      delivery methods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and male subjects ages 18 to 59 years

          -  Healthy volunteers

          -  Able to provide informed consent and understand study procedures per ICH/GCP
             guidelines

          -  Plans to remain in study area for length of the trial; able to adhere to study visit
             and follow-up schedule

          -  Able to complete study diary

        Exclusion Criteria:

          -  Unwilling or unable to undergo the two blood draws per protocol

          -  Have received influenza vaccination in the last twelve months

          -  Have received any vaccination in the last month

          -  Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other
             immunosuppressive drugs

          -  Received recent blood, blood products, or parenteral preparations of immunoglobulin
             (within 3 months)

          -  Suffers from allergic reactions to egg, gelatin, or neomycin or has a history of
             anaphylactic shock, asthma, urticaria, or other allergic reactions to vaccinations.

          -  Had any serious adverse event associated with a prior vaccination

          -  Has immunodeficiency or autoimmune disease (including HIV)

          -  History of chronic alcohol abuse

          -  Participating in another study concurrently

          -  Pregnant or breastfeeding during the study
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Intervention: IM epinephrine 1:1000; No intervention
Intervention description: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.; A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
Intervention MeSH terms: Epinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Status asthmaticus; Asthma exacerbation; Epinephrine; Adjunctive therapy

Summary:

      Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled
      bronchodilators (β2 agonists) for children with severe asthma exacerbation.

      Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists)
      for children with severe asthma exacerbation.

      Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose
      of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects
      20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by
      an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23
      gauge one inch needle.

      In addition to the study intervention, the standardized treatment pathway based on the
      current asthma guidelines in use at the investigator's center will be utilized. This pathway
      includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration
      and dosages of these other interventions will be administered at the discretion of the
      treating provider.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than 6 years and less than 18 years

          2. Pre-existing diagnosis of asthma

          3. Presenting to the ED with an asthma exacerbation

        Exclusion Criteria:

          1. History of chronic lung or upper airway disease other than asthma

          2. History significant, uncorrected congenital heart disease or cardiac arrhythmia

          3. History of thyroid disease

          4. Impending respiratory failure

          5. Allergy to epinephrine

          6. Pregnancy

          7. PEFR>60% of predicted and clinical asthma score less than 8
Continuous Chest Compressions vs AHA Standard CPR of 30:2
Condition: Out of Hospital Cardiac Arrest
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Intervention: Standard CPR; Continuous chest compressions
Intervention description: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first.; Continuous chest compressions during the first 6 minutes of the resuscitation.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23711.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac arrest; cardiopulmonary resuscitation

Summary:

      The primary aim of the trial is to compare survival to hospital discharge after continuous
      chest compressions (CCC) versus standard American Heart Association (AHA) recommended
      cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients
      with out-of-hospital cardiac arrest (OOHCA). The primary null hypothesis will be that the
      rate of survival to hospital discharge is not affected by use of continuous compressions with
      passive or positive pressure ventilation (intervention group) versus CPR with compressions
      interrupted for ventilation at a ratio of 30:2 (control group).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or more (or local age of consent);

          -  Initial fire/Emergency Medical Services (EMS) chest compressions provided by
             Resuscitation Outcomes Consortium (ROC) study participating agency dispatched to the
             scene;

          -  Lack of the exclusion criteria below

        Exclusion Criteria:

          -  EMS witnessed arrest;

          -  Written do not attempt resuscitation (DNAR) orders;

          -  Obvious primary asphyxia or respiratory cause of arrest (drowning, strangulation,
             hanging)

          -  Advanced airway placed prior to ROC EMS arrival, or pre-existing tracheostomy

          -  Traumatic cause (blunt, penetrating, burn) of arrest;

          -  Known prisoners;

          -  Known pregnancy;

          -  Uncontrolled bleeding or exsanguination

          -  Mechanical compression device used during study-assigned compression cycles
Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia
Condition: Hypoxia, Altitude
MeSH terms: Altitude Sickness; Hypoxia
Intervention: Cetirizine; Placebo oral capsule; Hypoxia
Intervention description: Cetirizine tablet 10 mg; Gelatin placebo; Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft
Intervention MeSH terms: Cetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study seeks to determine whether a simple, single intervention of Cetirizine / Zyrtec®
      use can improve exercise performance of active individuals when acutely exposed to altitude.
      For this project, healthy subjects will perform steady state and progressive work rate
      exercise, endurance performance time trials, and repeated sprint performance time trials in
      the laboratory at a simulated altitude of 3000m (9900ft) after dosing with 10 mg of
      Cetirizine or a placebo in a repeated measures design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physically active a minimum of 120 minutes a week, as determined by questionnaire

          -  18-35 years of age

          -  Classified as low risk, based on the modified PAR-Q questionnaire, BMI, and
             non-smoking status

          -  No history of pulmonary disease and pulmonary function classified as normal, as
             defined by the following measurements being 80% of predicted values: forced vital
             capacity (FVC), forced expired volume in one second (FEV1) and FEV1/FVC, according to
             the American Thoracic Society standards.

        Exclusion Criteria:

          -  Current smoker

          -  Women who are pregnant or could possibly be pregnant

          -  BMI > 25 kg/m2

          -  A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire

          -  History of pulmonary disease or <80% of predicted FCV, FEV1 and/or FEV1/FVC.

          -  A history of renal or liver disease, due to possible interaction effect with
             Cetirizine

          -  Currently taking any prescription or over the counter medications for the treatment of
             allergies, or taking any of the below listed drugs known to have a moderate or higher
             interaction effect with Cetirizine:

        isocarboxazid tranylcypromine bosutinib clobazam crizotinib daclatasvir eliglustat
        hyaluronidase lomitapide lurasidone ombitasvir/paritaprevir/ritonavir phenelzine ponatinib
        ritonavir vemurafenib
Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)
Condition: Flushing
MeSH terms: Flushing
Intervention: Quercetin; Placebo
Intervention description: Quercetin 500, 1000, or 2000 mg PO one time; Placebo PO one time
Intervention MeSH terms: Quercetin
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Skin; pharmacology; metabolism; lipid

Summary:

      Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective
      drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a
      peculiar adverse effect referred to as "flushing', which consists of redness, warmth,
      tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due
      to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess
      whether a presently available dietary supplement known as quercetin, which is a flavonoid,
      can reduce the flushing that occurs with niacin. We will also assess whether using quercetin
      to prevent flushing from niacin, can improve how niacin lowers cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women from the age of 21 to 75, inclusive - 16 subjects, 8 men, 8 women.

          2. Ability to understand and agree to informed consent.

          3. Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures.

        Exclusion Criteria:

          1. Contra-indications or known intolerance to the study medications.

          2. History of congestive heart failure, carcinoid, rosacea, renal failure (GFR<60
             ml/min/m2).

          3. Active liver disease.

          4. Active diabetes (defined as any history of type 1 diabetes, or history of type 2
             diabetes plus one or more of the following: fasting glucose>= 126mg/dL at screening or
             use of anti-diabetic medications within 12 months, or glucose>200mg/dL 2 hours after a
             75 g oral glucose challenge within 12 months.

          5. History of major surgery within the past 6 weeks, or anticipated major surgery during
             the course of the study, or any history of organ transplant.

          6. History of drug abuse within the past 3 years, or regular alcohol use of greater than
             14 drinks per week.

          7. Women who are pregnant, plan to conceive or lactate.

          8. Peri-menopausal women or women currently experiencing flushing.

          9. Currently taking vasoactive medications, anti-hypertensives, anti-histamines,
             Selective Serotonin Re-uptake Inhibitors (SSRIs), NSAIDS, oral steroids, leukotriene
             inhibitors, supplemental quercetin and > 50mg niacin.
Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients
Condition: Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Intervention: Klorhex® Gel, rinse and spray; Conventional IPT; Full-mouth IPT
Intervention description: Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks).; Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.; Initial periodontal treatment was performed in 2 sessions within 24 hours.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Periodontal Debridement; Gingival Crevicular Fluid; Aggressive Periodontitis; Interleukin-1beta; Interleukin-17; Bacteria

Summary:

      The purpose of this study is to determine whether full-mouth disinfection is effective in the
      initial periodontal treatment of generalized aggressive periodontitis on clinical parameters,
      gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal
      pathogen levels compared with conventional initial periodontal treatment and full-mouth
      initial periodontal treatment.

      The investigators' hypothesis is to test whether full-mouth disinfection in the initial
      periodontal treatment of generalized aggressive periodontitis enhance the clinical,
      biochemical and microbiological parameters in comparison to conventional initial periodontal
      treatment and full-mouth initial periodontal treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No systemic diseases that could influence the outcome of the therapy

          -  No smoking

          -  No medications affecting periodontal tissues

          -  No pregnancy or lactation

          -  Presence of at least 15 teeth

        Exclusion Criteria:

          -  Received antibiotic treatment in the previous 3 months

          -  Smokers

          -  Pregnancy and lactation

          -  Received periodontal treatment in the previous 6 months

          -  Presence of less than 15 teeth

          -  Presence of systemic diseases