bioihbjkbjnl/mcl2 huggingface dataset:
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief
Condition: Cesarean Section; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: IV Acetaminophen; Placebo
Intervention description: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.; 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 132.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IV Acetaminophen; Cesarean Section; Pain, Postoperative

Summary:

      This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen
      among cesarean section patients. The study hopes to find out if patients who receive
      scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain
      scores and use less narcotic pain medication than patients who do not receive IV
      acetaminophen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 18 years

          -  Scheduled cesarean section delivery

          -  Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine
             Associates

          -  Singleton pregnancy

          -  Term delivery (greater than or equal to 37 weeks)

          -  Spinal/epidural anesthesia with epidural analgesia (duramorph)

          -  Use of pfannenstiel incision

        Exclusion Criteria:

          -  Weight less than 50 kg

          -  Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)

          -  Multiple gestation pregnancy

          -  Cesarean section for pre-term delivery (less than 37 weeks)

          -  Fetal anomalies

          -  Inability to use epidural duramorph at time of procedure

          -  General anesthesia used

          -  Vertical skin incision

          -  Opioid addiction

          -  Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low
             platelet count), preeclampsia)
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Maraviroc; Maraviroc; Ritonavir; Saquinavir; Maraviroc; Ritonavir; Saquinavir; Maraviroc; Ritonavir; Saquinavir; Maraviroc; Maraviroc; Maraviroc
Intervention description: Maraviroc 300 mg (150 mg x 2 tablets) x single dose; Maraviroc 150 mg tablet twice daily x 7 days; Ritonavir 100 mg capsule twice daily x 7 days; Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days; Maraviroc 150 mg tablet once daily x 7 days; Ritonavir 100 mg capsule twice daily x 7 days; Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days; Maraviroc 150 mg tablet once every 48 hours x 7 days; Ritonavir 100 mg capsule twice daily x 7 days; Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days; Maraviroc 300 mg (150 mg x 2 tablets) x single dose; Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis; Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis
Intervention MeSH terms: Ritonavir; Saquinavir; Maraviroc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: maraviroc, pharmacokinetics, renal impairment

Summary:

      The purpose of this study is to assess whether a dosing adjustment is needed in patients with
      renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable Renal Function defined as ≤20% (25% for normal renal function) difference
             between 2 measurements of serum creatinine obtained on 2 occasions separated by at
             least 2 weeks.

          -  Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive.

          -  Total body weight >50 kg (110 lbs).

          -  Male or female subjects between the ages of 18 and 85 years.

        Exclusion Criteria:

          -  Subjects with acute renal disease and/or history of renal transplant.

          -  Supine BP at Screening ≥160 mm Hg systolic or ≥95 mm Hg diastolic.

          -  Supine BP at Screening ≤80 mm Hg systolic or ≤40 mm Hg diastolic.
Use of Sitagliptin to Decrease Microalbuminuria
Condition: Type 2 Diabetes; Microalbuminuria
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Placebo
Intervention description: Sitagliptin 100 mg/day for 3 months; Placebo 1 pill/day for 3 months
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: microalbuminuria; type 2 diabetes

Summary:

      The people being asked to participate in this study have type 2 diabetes and abnormal levels
      of protein in their urine. This indicates that they are starting to develop diabetic kidney
      disease. The standard treatment for this is the use of one of two blood pressure medicines,
      either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker
      (ARB). However, these medicines are not always completely effective in stopping/reversing the
      kidney disease. Some studies have previously suggested that another type of medicine, called
      sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from
      getting worse.

      This study is being performed to test the effectiveness of sitagliptin as compared to a
      placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it
      will reduce protein levels in their urine. Protein levels in the urine are a marker of the
      severity of kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Albumin/creatinine ratio between 30-299 mg/dl.

          -  type 2 diabetes mellitus (T2DM) with hemoglobin A1c between 7 and 9%.

          -  Stable BP control of less than 145/90 on treatment with ACE or ARB for more than three
             months prior and during the trial.

          -  Glomerular filtration rate (GFR) of 60 mL/min/1.73m2 or more.

          -  Age between 18-75 years old.

          -  For women: at least two years postmenopausal, surgically sterile, or using an
             acceptable contraceptive regiment to include oral contraceptive pill (OCP),
             intrauterine device (IUD), double barrier, depo-provera, or subcutaneous progestin
             implant and negative urine pregnancy test at trial start.

        Exclusion Criteria:

          -  Pregnancy.

          -  GFR less than 60 mL/min/73m2.

          -  Have a history of malignancy other than basal cell or squamous cell skin cancer and
             have not yet been treated, are currently being treated, or were diagnosed less than 5
             years prior to Visit 1.

          -  Advanced liver disease.

          -  Subjects cannot be on DPP-4 inhibitor or glycolipoprotein (GLP-1) agonist for at least
             4 months before the study start.

          -  Psychiatric condition that would prevent subject from following directions. Per PI
             discretion.
A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)
Condition: Asthma
MeSH terms: Asthma
Intervention: Omalizumab
Intervention description: Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 806.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This multicenter, prospective study will evaluate the baseline participant characteristics
      (including biomarkers) associated with a variety of individual and composite clinical
      outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants identified by the investigator as a candidate for treatment for asthma
             with omalizumab

          -  Confirmation of access to omalizumab through insurance or other source of funding

        Exclusion Criteria:

          -  Enrollment in any other concurrent clinical trial or observational study

          -  Participants for whom omalizumab treatment is contraindicated

          -  Participants who had a prior allergic reaction to omalizumab or its excipients

          -  Participants treated with omalizumab within the previous year

          -  Participants who received an experimental drug as part of another study within 3
             months of enrollment
The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: lidocaine; ethyl chloride; Kenalog
Intervention description: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection; topical spray; used with lidocaine in shoulder injection
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Lidocaine; Ethyl Chloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: subacromial injection; rotator cuff disease; steroid injection

Summary:

      The specific aim of this prospective study is to determine whether local anesthetics prior to
      subacromial steroid injections reduce pain and consequently if they are cost-effective in the
      treatment for shoulder pathology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18 to 70 years old

          -  Shoulder pain lasting at least 4 weeks

          -  Inability to use arm with restriction of movement and loss of full function.

          -  Able to understand study and provide voluntary, written informed consent

        Exclusion Criteria:

          -  Less than 18 or greater than 70 years old

          -  Contraindications of previous injections and previous shoulder surgery

          -  Unable to understand consent form (in the opinion of the PI)

          -  Non-English speaking individuals

          -  Medication contradictions to lidocaine, corticosteroids
A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: dornase alfa [Pulmozyme®]; dornase alfa [Pulmozyme®]
Intervention description: Inhaled once daily by Pari eRapid nebulizer.; Inhaled once daily by Pari LC Plus jet nebulizer.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate
      the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid
      nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme
      once daily chronically for at least 6 months will continue to receive Pulmozyme once daily
      for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be
      randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of
      2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study
      treatment is 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients, >/= 6 years of age

          -  Confirmed diagnosis of cystic fibrosis (CF)

          -  Receiving Pulmozyme once daily chronically for treatment of CF for at least 6 months
             prior to screening

          -  Percent predicted FEV1 >/= 40% at screening based on the Wang (males < 18 years,
             females < 16 years) or Hankinson (males >/= 18 years, females >/= 16 years)
             standardized equations

          -  Able to reproducibly perform spirometry testing and comply with study assessments

        Exclusion Criteria:

          -  An acute respiratory infection or pulmonary exacerbation within 4 weeks prior to
             randomization

          -  Initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral
             antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory
             disease within 4 weeks prior to randomization

          -  Changes in chest physiotherapy schedule within 4 weeks prior to randomization

          -  Hospitalization within 4 weeks prior to randomization

          -  Planned hospitalization during the 6-week study

          -  History of organ transplantation

          -  Participation in an investigational drug or device study within 30 day prior to
             screening
Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Afatinib
Intervention description: Afatinib tablet once daily until progression
Intervention MeSH terms: Afatinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this single-arm, open-label trial are to assess the efficacy and safety of
      afatinib as second line treatment for patients with locally advanced or metastatic non-small
      cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line
      platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to
      the results seen in previous trials.
    

Eligibility criteria:

        Inclusion criteria:

          1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural
             effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients
             with mixed histology are eligible if adenocarcinoma is the predominant histology.

          2. Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.

          3. Measureable disease according to RECIST 1.1.

          4. Radiologically confirmed progression or recurrence of disease during or following
             first line therapy with a platinum-based chemotherapy regimen.

          5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.

          6. Adequate organ function.

        Exclusion criteria:

          1. More than one line of prior therapy for disease.

          2. Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity
             and/or intolerance of treatment.

          3. Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or
             antibody.

          4. Known pre-existing interstitial lung disease.
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Bilateral erector spinae blocks using ropivacaine
Intervention description: Bilateral chest wall nerve blocks using ropivacaine.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Prospective single-arm intervention trial
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: regional anesthesia; cardiac surgery; erector spinae

Summary:

      To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for
      postoperative analgesia in children and adolescents undergoing cardiac surgical procedures
      via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open
      label, interventional study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled as part of the cardiac surgical ERAS program: Patients scheduled for
             elective surgeries for the following congenital anomalies, or similar: atrial septal
             defects (all types), partial anomalous pulmonary venous connection (non-obstructed),
             cor-triatriatum, VSD, partial AV canal, sub-aortic membrane resection, anomalous
             aortic origin of the coronary arteries, and pulmonary valve/conduit implantation

          2. Scheduled for a primary sternotomy.

          3. Ages 2 years through 17 years.

        Exclusion Criteria:

          1. Single ventricle physiology.

          2. Significant scoliosis or other anatomic contraindications to ESB.

          3. Significant intraoperative hemodynamic instability or bleeding, as ascertained by
             clinicians taking care of the patient.

          4. Patients with severe neurodevelopmental delays.

          5. Patients with previous chronic pain syndromes.

          6. Patients with a history of greater than 24 hours of postoperative or post-procedural
             opioid treatment at any point in the 2 months prior to surgery.

          7. Lack of parental consent and/or child assent.
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Lung Diseases; Fibrosis
Intervention: Dornase alfa; placebo
Intervention description: 2.5 mg inhalation dose twice daily for 14±2 days; 2.5 mg inhalation dose twice daily for 14±2 days
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: Lung disease; CF; Pulmozyme

Summary:

      This was a multicenter, randomized, double-blind, placebo-controlled study of patients with
      severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.
      Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks
      (placebo group). Patients must have had stable CF symptoms without any change in therapy for
      2 weeks prior to enrollment in order to participate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form and, if applicable, Assent Form

          -  Age ≥ 14 years old at screening

          -  Proven diagnosis of CF

          -  Ability to perform acceptable and reproducible spirometry maneuvers at screening

          -  FVC ≤ 45% predicted for race, height, age, and sex at screening

          -  Chronic use of Pulmozyme for at least 3 months in the last year and daily or twice
             daily use during the 14 days prior to screening

          -  Stable regimen of chest physiotherapy (CPT) for at least 14 days prior to screening

          -  Ability to complete the 6-minute walk test at screening

          -  Ability to complete the 6-minute walk test and spirometry at Visit 2

          -  If on routine tobramycin solution for inhalation (i.e., TOBI®) or other cycled
             antibiotic therapy, intention to either start or stop therapy at the time of Visit 2
             (based on routine therapy cycle; no other planned change in this antibiotic regimen
             for 28 days before or 28 days after Visit 2)

          -  Clinically stable with no change in medications during the 14 days prior to screening

        Exclusion Criteria:

          -  Use of an investigational drug or device within 28 days prior to screening

          -  Previous episode of acute respiratory failure requiring assisted ventilation within 2
             years prior to screening

          -  Previous lung transplant

          -  Any cardiac disease that would contraindicate performing the 6-minute walk test

          -  Pregnancy or nursing

          -  Known hypersensitivity or other contraindication to the use of Pulmozyme

          -  Previous completion or premature discontinuation of study drug or withdrawal from this
             study

          -  More than one prior screening failure for this study at any time or any prior
             screening failure for this study within the last 28 days