bioihbjkbjnl/mcl2 huggingface dataset:
Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
Condition: Obesity; Premature Recovery From Anesthesia
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Nuvigil; Placebo
Intervention description: Patients will receive Nuvigil before the surgery; Placebo will be given before surgery
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea; Anesthesia Recovery Period

Summary:

      Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative
      morbidity and mortality. This group of patients is at risk of perioperative desaturations
      which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA
      patients might also need to spend the night in intensive care for more frequent monitoring
      for any desaturations episodes especially if the patient will be requiring multiple
      intravenous narcotic boluses for pain control. Several studies have looked into the most
      appropriate way to manage these patients and some recommendations have been made to avoid
      outpatient surgery with close monitoring for first 24 hours after surgery specifically if
      patient will require intravenous postoperative narcotics.

      Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA
      approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and
      obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer) or
      modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown.

      Nuvigil is longer acting product which is similar in action to Modafinil however is much
      cheaper. Nuvigil has not been previously studied for postoperative recovery. The
      investigators intend to study the effects of Nuvigil on postoperative recovery time and
      wakefulness in obstructive sleep apnea and obese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient presented for surgery under general anesthesia

          -  Documented OSA

          -  Patients with BMI above 35

        Exclusion Criteria:

          -  Coronary Artery Disease or Myocardial infarcts

          -  Mitral valve prolapse

          -  Cyclosporine, contraceptive drugs

          -  Known allergic reaction to Modafinil or any of its products
12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Asenapine; Placebo
Intervention description: Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.; Placebo fast dissolving SL tablets, BID
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 12-week study that will test the safety and efficacy of asenapine when used in
      addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I
      Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have bipolar I disorder, current episode manic or mixed

          -  Treated with lithium or valproic acid

        Exclusion Criteria:

          -  Have an unstable medical condition

          -  Clinically significant laboratory abnormality.

          -  Have a primary diagnosis other than bipolar I disorder.
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CT-P17 SC AI (adalimumab)
Intervention description: Subcutaneous Injection of Adalimumab 40mg once every two weeks
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With
      Active Rheumatoid Arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient aged 18 to 70 years, inclusive.

          -  Patient must be able and willing to self-administer subcutaneous (SC) injections via
             auto injector (AI).

        Exclusion Criteria:

          -  Patient who has previously received investigational or licensed product; biologic or
             targeted synthetic disease-modifying antirheumatic drugs for the treatment of
             rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any
             purposes.

          -  Patient who has allergies to any of the excipients of study drug or any other murine
             and human proteins, or patient with a hypersensitivity to immunoglobulin products.
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
Condition: Trichomonas Infection
MeSH terms: Trichomonas Infections
Intervention: Secnidazole; Placebo
Intervention description: Oral Granules containing secnidazole; Oral Granules of placebo manufactured to mimic secnidazole
Intervention MeSH terms: Secnidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 147.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vaginal Itching; Vaginal Discharge

Summary:

      This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed
      treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral
      dose of Solosec® containing 2 grams of secnidazole in female patients with trichomoniasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult female or post-menarche adolescent girl ≥12 years of age in general good health

          -  Have a diagnosis of trichomoniasis at the screening visit as determined by one of the
             following:

               -  positive T. vaginalis NAAT test within 30 days of screening for which treatment
                  has not been initiated.

               -  positive OSOM® rapid test.

               -  positive wet mount assessment.

          -  Agree to abstain from vaginal intercourse until the final study visit

          -  Agree not to have any vaginal penetration or use of any vaginal products for the
             duration of the study

        Exclusion Criteria:

          -  Are pregnant, lactating, or planning to become pregnant during the study.

          -  Are suspected clinically (or confirmed diagnostically) of having alternative causes of
             vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea,
             or an active genital herpes outbreak

          -  Are suspected clinically of having an acute urinary tract infection.

          -  Have active genital lesions, including primary syphilitic chancres and herpes simplex
             virus lesions, or other vaginal or vulvar conditions which could confound the
             interpretation of the clinical response, as determined by the Investigator (patients
             with genital warts may be enrolled).

          -  Have received systemic antibacterial therapy or topical antimicrobial/antifungal/
             immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft
             tissue), within 14 days prior to the Baseline Visit (Day 1).
Carnitine Supplementation and Skeletal Muscle Function
Condition: Sarcopenia
MeSH terms: Sarcopenia
Intervention: carnitine; placebo
Intervention description: 1500 mg/d l-carnitine-l-tartrate; isonitrogenous
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 65 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: carnitine

Summary:

      Research project objectives The primary aim of the current research project is to use
      carnitine supplementation as the anti-inflammatory intervention for exploring the
      relationship between inflammation and associated with aging reduction of skeletal muscle
      mass.

      Hypothesis The carnitine supplementation modulates the blood cytokines concentration.
      Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with
      aging
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with no history of gastrointestinal disorders, cardiovascular disease or
             hypertension.

        Exclusion Criteria:

          -  Subjects having any illnesses and a history of gastrointestinal disorder,
             cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer,
             alcoholism or other metabolic diseases.
A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Abicipar Pegol; Ranibizumab; Sham Procedure
Intervention description: Abicipar pegol intravitreal injection.; Ranibizumab intravitreal injection.; Sham injection.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 939.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of abicipar pegol in participants with neovascular
      age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of age-related macular degeneration in at least 1 eye

          -  Best corrected visual acuity of 20/40 to 20/320 in the study eye

          -  Best corrected visual acuity of 20/200 or better in the non-study eye

        Exclusion Criteria:

          -  History of vitrectomy, macular surgery, or glaucoma surgery in the study eye

          -  Cataract or refractive surgery in the study eye within the last 3 months
Stopping Cavities Study: Diammine Silver Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: 38% diammine silver fluoride; Water
Intervention description: treatment of cavity with study agent; Fluoride free, distilled water
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 24 Months
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: silver diamine fluoride; diammine silver fluoride; children

Summary:

      This study is being conducted to test whether the use of diammine silver fluoride (also
      called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nyvad criteria 3

          -  Active carious lesion

        Exclusion Criteria:

          -  Allergy to silver

          -  Stomatitis or oral ulcerative condition

          -  Weight less than 15 kg
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: turoctocog alfa
Intervention description: Patients will be scheduled to receive treatment with turoctocog alfa for at least 100 exposure days. In most cases, treatment will be given at home with intravenous (i.v., into the vein) self-injection by the parent/caregiver/support person.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 0 Years
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The purpose of the trial is to
      evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in
      previously untreated children with haemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age below 6 years

          -  Informed consent obtained before any trial-related activities (trial-related
             activities are any procedure that would not have been performed during normal
             management of the patient)

          -  Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or
             below 1%)

          -  No prior use of purified clotting factor products (previous exposure, equal to or less
             than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted)
             including commercially available NovoEight® /Novoeight®

        Exclusion Criteria:

          -  Known or suspected allergy to hamster protein or intolerance to trial product(s) or
             related products

          -  Previous participation in this trial defined as withdrawal after administration of
             trial product

          -  Congenital or acquired coagulation disorders other than haemophilia A

          -  Any history of Factor VIII inhibitor

          -  Ongoing treatment or planned treatment during the trial with immunomodulatory agents
             (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Condition: Skin Diseases, Infectious
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases
Intervention: PTK 0796; linezolid; moxifloxacin
Intervention description: PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg; For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution; moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution
Intervention MeSH terms: Moxifloxacin; Linezolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CSSI; Abscess; Wound; Cellulitis; Complicated Skin and Skin Structure Infections (cSSSI)

Summary:

      A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of
      complicated skin and skin structure infections (cSSSI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, ages 18 years or older

          -  Is expected to require ≥4 days of IV antibiotic therapy

          -  Has an acute complicated skin and skin structure infection with findings of systemic
             inflammatory response

          -  Female patients must not be pregnant at the time of enrollment and must agree to a
             reliable method of birth control during the study and for 30 days following the last
             dose of study drug

        Exclusion Criteria:

          -  Has received an investigational drug within past 1 month

          -  Has been previously enrolled in this protocol

          -  Has received >24 hr of a potentially effective systemic antibiotic immediately prior
             to study drug

          -  Is nursing
The Hemophilia Inhibitor Eradication Trial
Condition: Hemophilia A With Inhibitor
MeSH terms: Hemophilia A
Intervention: Eloctate ITI; Emicizumab
Intervention description: This is a factor VIII-Fc infusion protein.; This is a bispecific monoclonal antibody FVIII mimic.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase III open-label, randomized controlled trial comparing immune tolerance induction with one drug, with or without a second drug in the eradication of hemophilia inhibitors.
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Healthy volunteers: No
Keywords: hemophilia; inhibitor formation; Eloctate; Emicizumab

Summary:

      This is a multi-center randomized phase III clinical trial, the Inhibitor Eradication Trial,
      in which Eloctate ITI plus Emicizumab will be compared with Eloctate ITI alone to eradicate
      inhibitors in severe hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male adults or children > 4 months of age.

          2. Severe hemophilia A (FVIII < 0.01 U/ml).

          3. Current or past high-responding inhibitor, anti-FVIII >= 5.0 B.U., ITI-refractory or
             ITI-naive.

        Exclusion Criteria:

          1. Acquired hemophilia or any bleeding disorder other than hemophilia A.

          2. Current use of Emicizumab, or if used, > 8 weeks since last treatment.

          3. Use of an experimental drug(s).

          4. Surgery anticipated in the next 48 weeks.

          5. Life expectancy less than 5 years.

          6. Patient/parent/caretaker unable or unwilling to keep a personal diary of bleeding
             frequency and study drug treatment, make monthly visits and blood draws at weeks 4, 8,
             12, 24, 36, and 48.

          7. Other illness, condition, or reason in the opinion of the investigator that would make
             the patient unsuitable for the trial.
BOTOX® Treatment in Pediatric Upper Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy; Stroke
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: botulinum toxin Type A; Normal Saline (Placebo)
Intervention description: Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.; Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 235.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in
      pediatric patients with upper limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum weight of 10 kg/22 lb

          -  Upper limb spasticity due to cerebral palsy or stroke

        Exclusion Criteria:

          -  Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
             sclerosis, or mitochondrial disease

          -  Uncontrolled epilepsy

          -  Botulinum Toxin therapy of any serotype for any condition within the last 6 months

          -  Previous surgical treatment of the study limb (except tendon lengthening), or planned
             surgery of the study limb during the study

          -  Previous casting of the study limb for spasticity within 6 months or with a dynamic
             splint within 3 months, or planned casting or dynamic splinting for spasticity of the
             study limb or affected lower limb during the study
A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 316.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor
      necrosis factor (TNF) inhibitor-experienced participants with radiographic axial
      spondyloarthritis (rad-axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are ambulatory.

          -  Have an established diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with
             sacroiliitis defined radiographically according to the modified New York criteria.

          -  Participants have a history of back pain ≥3 months with age at onset <45 years.

          -  Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.

          -  Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range
             for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.

          -  Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

        Exclusion Criteria:

          -  Have total ankylosis of the spine.

          -  Have never taken a TNF inhibitor medication or have taken more than 2.

          -  Have recently received a live vaccine within 12 weeks or have had a vaccination with
             Bacillus Calmette-Guerin (BCG) within the past year.

          -  Have an ongoing or serious infection within the last 12 weeks or evidence of active
             tuberculosis.

          -  Have a compromised immune system.

          -  Have any other serious and/or uncontrolled diseases.

          -  Have either a current diagnosis or a recent history of malignant disease.

          -  Have had major surgery within 8 weeks of baseline, or will require surgery during the
             study.

          -  Are pregnant or breastfeeding.