bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Risankizumab
Intervention description: Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic

Summary:

      This study will evaluate whether adult participants with moderate to severe plaque psoriasis
      who have been treated with secukinumab or ixekizumab for at least 6 months and are
      experiencing a suboptimal response may benefit from switching to risankizumab with regard to
      skin symptoms, quality of life symptoms and psoriasis symptoms.

      Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection
      at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being
      administered at Week 40). An additional visit will occur at Week 8 for a physical exam and
      questionnaire collection. A final follow-up phone call will occur at Week 60.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months
             before Baseline (Week 0).

          -  Participant must have been on labeled secukinumab or ixekizumab treatment for at least
             6 months and are experiencing suboptimal response at time of Screening and Baseline
             visits.

          -  Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global
             Assessment (sPGA) 2/3

          -  Participant must be eligible for continued biologic therapy as assessed by the
             investigator.

        Exclusion Criteria:

          -  History of erythrodermic psoriasis, generalized or localized pustular psoriasis,
             medication-induced or medication-exacerbated psoriasis, or new onset guttate
             psoriasis, psoriatic arthritis.

          -  Participant with active skin disease other than plaque psoriasis that could interfere
             with the assessment of plaque psoriasis.

          -  History of any documented active or suspected malignancy or history of any malignancy
             within the last 5 years except for successfully treated non-melanoma skin cancer
             (NMSC) or localized carcinoma in situ of the cervix.

          -  History of major surgery within 12 weeks prior to Baseline or planned to be performed
             during the conduct of the trial as assessed by the investigator.

          -  Participant with exposure to risankizumab or any IL-23 inhibitors.
Prevention of Delirium in Inpatients Utilizing Melatonin
Condition: Delirium
MeSH terms: Delirium
Intervention: Melatonin; Placebo
Intervention description: 5 mg Melatonin nightly, beginning within 24 hours of admission; Blue capsule matching the melatonin arm
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: prevention; delirium; in-patients; melatonin,

Summary:

      A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo,
      given to patients at least 65 years old, admitted to the hospital on a general medical floor,
      to prevent delirium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inpatient admission to a general internal medicine service

        Exclusion Criteria:

          -  expected lifespan or length of stay ≤ 48 hours

          -  Non-English speaking

          -  Already taking melatonin or ramelteon at the time of randomization

          -  Presence of delirium at the time of randomization

          -  Unable to take oral medications

          -  Subject or proxy unable to provide informed consent within 18 hours of invitation or
             24 hours of admission

          -  ALT or AST (Liver function tests) > 3 times the upper limit of normal

          -  Taking warfarin, nifedipine or fluvoxamine

          -  Allergy to melatonin

          -  Unable to recall 3 words after distraction by naming the days of the week backwards
             beginning with Sunday
Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ataluren
Intervention description: Ataluren will be provided as a vanilla-flavored powder to be mixed with water or milk.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This is an open-label extension study for participants who completed a Phase 3,
      placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis
      (nmCF) not receiving chronic inhaled aminoglycosides.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of study treatment (placebo or active) in the previous Phase 3,
             double-blind study protocol (Protocol PTC124-GD-021-CF)

          -  Evidence of signed and dated informed consent/assent document(s) indicating that the
             participant (and/or the participant's parent/legal guardian) has been informed of all
             pertinent aspects of the trial.

        Exclusion Criteria:

          -  Known hypersensitivity to any of the ingredients or excipients of the study drug.

          -  Ongoing participation in any other therapeutic clinical trial.
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
Condition: Uterine Leiomyoma; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: ExAblate Enhanced Sonication
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fibroids; leiomyoma; neoplasm; benign tumors

Summary:

      This is a phase 3 study to determine the safety of the new features to the FDA approved
      ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women age 18 or older, who present with symptomatic fibroids

          2. Women who have given written informed consent

          3. Women who are able and willing to attend all study visits.

          4. Patient is pre or peri-menopausal (within 12 months of last menstrual period).

          5. Able to communicate sensations during the ExAblate procedure.

          6. Uterine fibroids, which are device accessible (i.e., positioned in the uterus such
             that they can be accessed without being shielded by bowel or bone).

          7. Fibroids(s) clearly visible on non-contrast MRI.

        Exclusion Criteria:

          1. Women who are pregnant, as confirmed by serum test at time of screening, or urine
             pregnancy test on the day of treatment

          2. Patient who desire to become pregnant in the future.

          3. Patients who are breast-feeding.

          4. Patients with an active pelvic inflammatory disease (PID)

          5. Active local or systemic infection

          6. Metallic implants that are incompatible with MRI

          7. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)

          8. Severe claustrophobia that would prevent completion of procedure in the MR unit.

          9. Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in
             the treatment path.

         10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and
             adenomatous hyperplasia.

         11. Pedunculated fibroids.

         12. Intrauterine device (IUD) anywhere in the treatment path

         13. Undiagnosed vaginal bleeding.
Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)
Condition: Anesthesia, General
Intervention: Sugammadex; Rocuronium
Intervention description: At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.; Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.
Intervention MeSH terms: Rocuronium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio
      of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes
      after the last administration of rocuronium in a wide range of surgical procedures and
      anesthetic regimens (routine use). Safety evaluation is part of the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled
             to undergo an elective surgical procedure under general anesthesia requiring
             neuromuscular relaxation with the use of rocuronium.

        Exclusion criteria:

          -  Participants with neuromuscular disorders, significant renal dysfunction, malignant
             hyperthermia, allergy to medications used in general anesthesia and in whom difficult
             intubation is expected.

          -  Participants taking medications known to interfere with neuromuscular blocking agents.

          -  Participants who are of child-bearing potential, pregnant, and breast feeding
A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
Condition: Lip Augmentation
Intervention: PN40082
Intervention description: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 84.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., met all
             inclusion/exclusion criteria; received study device, completed Visit 5 within the
             specified window; had LFGS score by the Blinded Evaluating Investigator at Visit
             3/Month 2, and had no significant protocol violations that would affect the treatment
             evaluation.

          2. If female and of childbearing potential, a negative urine pregnancy test at Visit
             1/Day 1 and the subject agrees to use adequate contraception during the study period

          3. Willing to give written informed consent

        Exclusion Criteria:

        1. Women who are pregnant, lactating, or planning a pregnancy
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIIIFc
Intervention description: Administered as specified in the treatment arm.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: Male
Minimum age: 0 Years
Healthy volunteers: No
Keywords: rFVIIIFc; A-LONG Extension

Summary:

      The primary objective of the study is to evaluate the long-term safety of recombinant human
      Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary
      objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and
      treatment of bleeding episodes in participants with hemophilia A.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965,
             NCT01458106 and NCT02502149)

          -  Ability to understand purposes and risks of the study and to provide signed and dated
             informed consent (or assent, as applicable).

        Key Exclusion Criteria:

          -  Confirmed positive high-titer inhibitor (≥5.00 BU/mL).

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mesalamine; Placebo
Intervention description: Pharmaceutical form: Granules in sachet; Route of administration: Oral use; Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g
      extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic
      remission in subjects with UC. The duration of treatment for each subject was 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

        Exclusion Criteria:

          -  Evidence of other forms of inflammatory bowel disease

          -  Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus
             [HBV], or hepatitis C virus [HCV])

          -  Disease limited to proctitis <15 cm

          -  Short bowel syndrome

          -  Prior colon resection surgery

          -  History of severe/fulminant UC

          -  Intolerant or allergic to aspirin or salicylate derivatives

          -  Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days

          -  Women who are pregnant or nursing

          -  History of known malignancy

          -  History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune
             diseases, or mental/ emotional disorders, that would interfere with their
             participation in the trial
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Vitamin D and fish oil; Fish oil (EPA/DHA) alone; Vitamin D alone; Placebo
Intervention description: 2000 IU vitamin D and 1g/d fish oil; 1 g/d fish oil; 2000 IU vitamin D; Vitamin D placebo and fish oil placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25871.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will examine whether an intervention with vitamin D or fish oil supplements can
      reduce the risk of heart failure among adult men and women during a follow up period of up to
      five years (starting from the time of randomization into the parent VITAL trial). The
      investigators hypotheses are that both vitamin D and fish oil supplements will each reduce
      the risk of heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men aged 50 or older or women aged 55 or older

          -  Be consuming no more than 800 IU of vitamin D from all supplemental sources combined
             (individual vitamin D supplements, calcium+vitamin D supplements, medications with
             vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to
             decrease or forego such use during the trial;

          -  Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined,
             or, if taking, willing to decrease or forego such use during the trial;

          -  Not be taking fish oil supplements, or, if taking, willing to forego their use during
             the trial

        Exclusion Criteria:

          -  prevalent heart failure

          -  History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient
             ischemic attack, angina pectoris, CABG, or PCI

          -  History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism,
             severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such
             as active chronic tuberculosis or Wegener's granulomatosis;

          -  Allergy to fish or soy
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
Condition: Breast - Female
Intervention: Transversus Abdominis Plane (TAP) block; Nimbus Infusion Pump IV Administration; Bupivacaine infusion; Acetominophen; Hydromorphone; Oxycodone; Ondansetron
Intervention MeSH terms: Acetaminophen; Oxycodone; Hydromorphone; Ondansetron; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to determine if pre-operative transversus abdominis plane (TAP)
      nerve blocks by continued infusion of local anesthetic post-operatively affects
      post-operative narcotic usage, as compared to a placebo TAP block, after breast
      reconstruction surgery.
    

Eligibility criteria:

        Inclusion Criteria

          -  Prior diagnosis or presumed diagnosis of breast cancer or undergoing prophylactic
             treatment.

          -  Greater than 18 years old.

          -  Female.

          -  Undergoing microsurgical breast reconstruction with abdominal free flap.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria

          -  True allergy to local anesthetics or opioids.

          -  History of addiction to narcotics within the last 24 months

          -  History of chronic pain on opioids within the last 24 months.

          -  Specific mental health issues such as schizophrenia or bipolar disorder.

          -  Patients who are pregnant.
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: HBVAXPRO™
Intervention description: Single 0.5 mL intramuscular dose
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 207.0
Sex: All
Minimum age: 8 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate the durability of protection against hepatitis B
      virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an
      estimation study, and no formal hypothesis testing was performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is healthy (based on a review of medical history and targeted physical examination)
             based on the clinical judgment of the investigator.

          -  Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or
             participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.

          -  The participant (or legally acceptable representative if applicable) provides written
             informed consent/assent for the study.

        Exclusion Criteria:

          -  Has a history of diagnosis (clinical, serological, or microbiological) of HBV
             infection.

          -  Has a known or suspected impairment of immunological function (e.g., human
             immunodeficiency virus (HIV), splenectomy).

          -  Has a known hypersensitivity to any component of the study vaccine.

          -  Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other
             malignant neoplasms affecting the haematopoietic and lymphatic system.

          -  Has a bleeding disorder contraindicating intramuscular vaccinations.

          -  Has received any hepatitis B vaccine after participation in Protocol V419-007 or
             V419-008.

          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or
             child) who is investigational site or Sponsor staff directly involved with this study.