bioihbjkbjnl/mcl2 huggingface dataset:
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Condition: Scoliosis; Pain
MeSH terms: Scoliosis
Intervention: Methadone; Normal Saline; Morphine
Intervention description: Perioperative IV methadone to be given; control arm; Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Methadone; Gabapentin; Postoperative Pain; Posterior Spinal Fusion; Pediatric

Summary:

      Acute pain management following major surgical procedures in pediatric patients continues to
      be a challenge, especially after extensive posterior spine fusions.

      Spine surgery is particularly traumatic, initiating pain in both peripheral and central
      pathways. While the standard management of post-surgical pain involves a multimodal approach,
      opioids provide the predominant benefit. However, opioid use is associated with many adverse
      effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease
      total opioid consumption and adverse effects as well as improve satisfaction with pain
      management after scoliosis repair.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 10-18 years

          -  Idiopathic scoliosis

          -  Fusion levels planned for 10 or greater

          -  English speaking

          -  American Society of Anesthesiology (ASA) class 1 - 3

        Exclusion Criteria:

          -  Current narcotic use / History of substance use disorder

          -  Morphine, hydromorphone or methadone allergies

          -  Pregnancy

          -  Seizure disorders

          -  Bleeding disorders

          -  Neuromuscular scoliosis

          -  History of renal or hepatic disease

          -  Long QT syndrome

          -  Obstructive sleep apnea

          -  Body mass index > 40

          -  Inability to tolerate standard analgesic medications (gabapentin, ketorolac,
             acetaminophen)

          -  Non-English speaking
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
Condition: HOCM, Hypertrophic Obstructive Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Intervention: Mavacamten; Placebo
Intervention description: Mavacamten Capsules Other names: MYK-461; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel group treatment study with 2 treatment groups; subjects and investigators are blinded to treatment and dose for the first 16 weeks of treatment. Mavacamten dose is blinded throughout the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, multi-center study in the United
      States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of
      septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive
      hypertrophic cardiomyopathy (oHCM [also known as HOCM]) who are eligible for SRT based on
      ACCF/AHA 2011 and/or ESC 2014 guidelines.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  At least 18 years old at screening and body weight > 45 kg at screening

          -  Diagnosed with oHCM consistent with current ACCF/AHA 2011 and meet their
             recommendations for invasive therapies

          -  Referred or under active consideration within the past 12 months for SRT procedure and
             willing to have SRT procedure

          -  Has documented left ventricular ejection fraction (LVEF) ≥ 60% at Screening

          -  Has documented oxygen saturation at rest ≥ 90% at Screening

        Key Exclusion Criteria:

          -  Persistent or permanent atrial fibrillation and subject not on anticoagulation for ≥ 4
             weeks prior to screening and/or not adequately rate controlled ≤ 6 months prior to
             screening

          -  Previously treated with invasive septal reduction (surgical myectomy or percutaneous
             alcohol septal ablation [ASA])

          -  For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose
             adjustment of these medications < 14 days prior to screening or an anticipated change
             in regimen during the first 16 weeks of the study

          -  Any medical condition that precludes upright exercise stress testing

          -  Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at
             screening

          -  Prior treatment with cardiotoxic agents, such as doxorubicin or similar

          -  Has a history or evidence of any other clinically significant disorder, condition, or
             disease that would pose a risk to subject safety or interfere with the study
             evaluation, procedures, or completion
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
Condition: Heart Transplantation; Liver Transplantation; Kidney Transplantation
Intervention: FK506E
Intervention description: oral
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 850.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FK506E; Heart Transplantation; MR4; Tacrolimus; Advagraf; Kidney Transplantation; Renal Transplantation

Summary:

      The purpose of this study was to offer patients who had participated in one of the phase II
      PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until
      commercial availability of the drug and to record long term efficacy and safety data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who had already participated in the previous phase II pharmacokinetic or
             phase III studies with FK506E (MR4).

          -  Patients capable of understanding the purpose and risks of the study, who had been
             fully informed and given written informed consent to participate in the study.

        Exclusion Criteria:

          -  Pregnant women or nursing mothers.

          -  Women unwilling or unable to use adequate contraception during the study.
Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)
Condition: Anesthesia, General; Neuromuscular Blockade
Intervention: Sugammadex; neostigmine
Intervention description: After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered.; After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Intervention MeSH terms: Atropine; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 308.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex
      compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects
      for registration purposes in China.
    

Eligibility criteria:

        Inclusion Criteria:

        -Subjects who are willing to provide informed consent; be between 18 and 64 years old; are
        American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for
        elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which
        requires neuromuscular blockade using rocuronium; be compliant with the dose/visit
        schedules, and use an accepted method of contraception (if applicable).

        For China only: Subjects of Chinese descent born in China, never emigrated out of China and
        have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe,
        never emigrated out of Europe and have a European home address.

        Exclusion Criteria:

        -Subjects with expected difficult intubation, neuromuscular disorders affecting
        neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet,
        (family) history of malignant hyperthermia, allergy to general anesthesia medications,
        contraindication to study drugs, breast feeding, pregnant, participation in previous or new
        trials, a clinically significant condition that may interfere with the trial, or membership
        in the (family of) study/sponsor staff.
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Condition: Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Recurrent; Prostate Cancer Metastatic
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: 18F-DCFPyL; PET/CT Imaging
Intervention description: A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL; PET/CT imaging will be acquired 1-2 hours post-PyL injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Positron emission tomography; biochemical recurrence; rising PSA; PET/CT; Diagnostic; Imaging; PSMA; radical prostatectomy; BCR

Summary:

      This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging
      in patients with suspected recurrence of prostate cancer who have negative or equivocal
      findings on conventional imaging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male >/= 18 years of age

          -  Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with
             subsequent definitive therapy

          -  Suspected recurrence of prostate cancer based on rising PSA after definitive therapy
             on the basis of:

               1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a
                  confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or

               2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that
                  is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic
                  Radiology and Oncology [ASTRO]-Phoenix)

          -  Negative or equivocal findings for prostate cancer on conventional imaging performed
             as part of standard of care workup within 60 days prior to Day 1

          -  Life expectancy ≥6 months as determined by the investigator

          -  Able and willing to provide informed consent and comply with protocol requirements

        Exclusion Criteria:

          -  Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within
             five (5) physical half-lives prior to Day 1

          -  Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH
             agonist or antagonist) for prostate cancer

          -  Treatment with ADT in the past 3 months of Day 1

          -  Receipt of investigational therapy for prostate cancer within 60 days of Day 1

          -  Subjects with any medical condition or other circumstances that, in the opinion of the
             investigator, compromise the safety or compliance of the subject to produce reliable
             data or completing the study
Emergency Treatment of Coral Snake Envenomation With Antivenom
Condition: Coral Snake Bite; Toxic Effect of Coral Snake Venom
MeSH terms: Emergencies; Snake Bites
Intervention: Snake (Micrurus) North American immune F(ab')2 Equine
Intervention description: 5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Healthy volunteers: No
Keywords: Envenomation; Coral Snake; Antivenom; Micrurus fulvius

Summary:

      The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and
      death from the bite of a coral snake.

      Funding Source - FDA OOPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of any age. Presenting for emergency treatment of coral snake bite.

        Exclusion Criteria:

          -  Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: certolizumab pegol (CDP870, CZP); Placebo
Intervention description: Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4; Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CDP 870; Certolizumab Pegol; CIMZIA ®; Crohn's disease; Induction; Clinical remission; Clinical response

Summary:

      The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing
      clinical remission in patients with moderate to severe Crohn's disease as compared with
      placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male/female

          -  18 - 75 years inclusive

          -  diagnosis of Crohn's disease confirmed

          -  moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)

          -  no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

        Exclusion Criteria:

          -  previous participation in a certolizumab pegol study

          -  general exclusion criteria as common for studies in this indication
Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: pregabalin; pregabalin; pregabalin; placebo
Intervention description: 600mg/day; 450mg/day; 300mg/day; placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 747.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the
      efficacy and safety of pregabalin in patients with fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ACR criteria for fibromyalgia

          -  A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an
             average score more or equal to 4 on 4 daily pain diaries

        Exclusion Criteria:

          -  Patients with other severe pain conditions

          -  Patients with severe depression

          -  Patients taking excluded medications
A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: Sitaxentan
Intervention description: sitaxentan sodium 100 mg
Intervention MeSH terms: Sitaxsentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: sitaxentan sodium hypertension

Summary:

      The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were
      demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU,
      Canada and Australia. In this study, the safety and efficacy after administrations of
      sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be
      investigated in Japanese PAH patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a current diagnosis of symptomatic PAH

          -  Has 6MWT distances from 150 to 450 meters and distance

        Exclusion Criteria:

          -  Previous exposure to an endothelin receptor antagonist

          -  Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
             >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.

          -  Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5
             minutes at Screening.
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.
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Condition: Venous Thrombosis
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Intervention: Enoxaparin; warfarin; Placebo for apixaban; Placebo for enoxaparin; Placebo for warfarin; apixaban
Intervention description: solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.; tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months; tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months; solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.; tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months; tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Intervention MeSH terms: Enoxaparin; Warfarin; Enoxaparin sodium; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5614.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of an investigational blood thinner,
      apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep
      vein thrombosis (DVT) or pulmonary embolism (PE)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  Clinical diagnosis of DVT or PE

        Exclusion Criteria:

          -  Contraindications for enoxaparin or warfarin

          -  Active bleeding or high risk for serious bleeding

          -  Short life expectancy

          -  Uncontrolled high blood pressure

          -  Significantly impaired kidney or liver function