bioihbjkbjnl/mcl2 huggingface dataset:
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Intervention: heliox; oxygen
Intervention description: continuous heliox therapy; continuous oxygen therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 2 Months
Maximum age: 12 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: heliox; bronchiolitis; racemic epinephrine

Summary:

      The purpose of this study is to assess whether children with moderate to severe bronchiolitis
      treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven
      nebulization will have improvements in measurements of airway more rapidly than those treated
      with conventional air-oxygen driven nebulization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any child 2-12 months old seen in the emergency department.

          -  A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score
             (M-WCBS).

          -  Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory
             phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest
             radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV)
             infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal
             secretions.

        Exclusion Criteria:

          -  No child will be excluded based on race or gender

          -  Patients under the age of 2 months or greater than 12 months

          -  Patients with cyanotic heart disease

          -  Patients with lobar pneumonia, defined by results of chest radiographs.

          -  The presence of interstitial disease or diffuse patchy marking consistent with
             atelectasis on chest radiographs will not exclude patients.

          -  Patients with croup.

          -  Patients with foreign body aspiration.

          -  Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic
             lung disease.

          -  Patients with liver or renal disease.

          -  Patients with sickle cell anemia.

          -  Patients requiring mechanical ventilation.

          -  Patients who develop supraventricular tachycardia secondary to racemic epinephrine
             administration.

          -  Patients with tracheomalacia or bronchomalacia.

          -  Patients who had received bronchodilators within 2 hours of initiation of the study.

          -  Patients who had received systemic corticosteroids within 72 hours of enrollment

          -  Patients who suffered from persistent airway hyperreactivity in the 3 months before
             the study.

          -  Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: UT-15C (treprostinil diolamine)
Intervention description: UT-15C extended release oral tablet three times daily
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 471.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PAH; PH; FREEDOM; 6 minute walk test; treprostinil; open label

Summary:

      This study is an international, multi-center, open-label study designed to provide oral
      treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have
      completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety
      of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participated in United Therapeutics Study TDE-PH-310

          -  All women of childbearing potential (WOCBP) must have practiced true abstinence from
             intercourse when it was in line with their preferred and usual lifestyle or used 2
             different forms of highly effective contraception for the duration of the study and
             for at least 30 days after discontinuing study medication.

          -  Males who participated in the study must have used a condom during the length of the
             study and for at least 48 hours after their last dose of study medication.

        Exclusion Criteria:

          -  The subject was pregnant or lactating.

          -  The subject had received infused or inhaled prostacyclin therapy for 29 days or more.

          -  The subject was prematurely discontinued from TDE-PH-310 for reasons other than a
             clinical worsening event.

          -  The subject developed a concurrent illness or condition during the conduct of
             TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their
             overall health if they enrolled in this study.
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: OTO-201 (ciprofloxacin)
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 501.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Otitis media; Ear infection; Tympanostomy tubes

Summary:

      This is an 8-week, multicenter, open-label study in which eligible subjects with a history of
      otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is
      designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement
      with common concurrent surgeries and any middle ear effusion status.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 17 years, inclusive

          -  Subject has a history of otitis media requiring bilateral tympanostomy tube placement

          -  Subject's caregiver is willing to comply with the protocol and attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of prior ear or mastoid surgery, not including myringotomy or
             myringotomy with TT placement

          -  Subject has been designated for any other surgical procedure that would occur
             concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal
             endoscopy, and nasal cautery for epistaxis

          -  Subject has a history of sensorineural hearing loss