bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20vPnC; 13vPnC; PPSV23; Saline
Intervention description: 20vPnC; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine; Placebo
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a
      20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and
             older.

          2. Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease, defined as disease not requiring significant change in therapy in the
             previous 6 weeks or hospitalization for worsening disease within 12 weeks before
             receipt of investigational product.

          3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing
             potential.

        Exclusion Criteria:

          1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.

          2. History of microbiologically proven invasive disease caused by S pneumoniae.

          3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
             pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
             or without dialysis, clinically unstable cardiac disease, or any other disorder that,
             in the investigator's opinion, excludes the subject from participating in the study.

          4. Pregnant female subjects or breastfeeding female subjects.
An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide; Syringe; Needle; Vial Adapter for Device
Intervention description: Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.; Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.; Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.; Vial adapter for device is approved for use in Japan by PMDA.
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to evaluate the long-term safety and efficacy of
      teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent
      SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the
      TED-C14-004 (NCT02340819) study.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants who meet all of the following criteria will be enrolled in this study:

          1. Ability to voluntarily provide written, signed, and informed consent to participate in
             the study.

          2. Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage
             3 or Stage 4.

          3. Females of childbearing potential must agree to comply with the contraceptive
             requirements of the protocol.

          4. An understanding, ability, and willingness to fully comply with study procedures and
             restrictions.

        Exclusion Criteria:

        There are no exclusion criteria for this study.
A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Olumacostat Glasaretil Gel, 5.0%; Olumacostat Glasaretil Gel, Vehicle
Intervention description: Gel containing Olumacostat Glasaretil; Vehicle (placebo) gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 759.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil
      Gel compared to vehicle in patients with acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent and, for subjects under legal adult age, signed assent

          -  Age ≥ 9 years

          -  Clinical diagnosis of facial acne vulgaris defined as:

               -  At least 20 inflammatory lesions, and

               -  At least 20 non-inflammatory lesions, and

               -  Investigator Global Assessment of 3 or greater

        Exclusion Criteria:

          -  Active cystic acne or acne conglobata, acne fulminans, and secondary acne

          -  Two or more active nodulocystic lesions on the face

          -  Clinically significant abnormal laboratory or ECG result

          -  Subjects who are actively participating in an experimental therapy study or who have
             received experimental therapy within 30 days or 5 half-lives (whichever is longer) of
             the Baseline visit

          -  Treatment with over-the-counter topical medications for the treatment of acne vulgaris
             including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids,
             α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline

          -  Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid
             within 4 weeks prior to Baseline

          -  Treatment with a new hormonal therapy or dose change to existing hormonal therapy
             within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to,
             estrogenic and progestational agents such as birth control pills).

          -  Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks
             prior to Baseline.

          -  Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A
             supplements greater than 10,000 units/day within 6 months prior to Baseline

          -  Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8
             weeks
Maximizing Outcomes in Treating Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: AXS-07 (MoSEIC meloxicam and rizatriptan); Meloxicam; Rizatriptan; Placebo
Intervention description: AXS-07 taken once upon onset of a qualifying migraine.; Meloxicam taken once upon onset of a qualifying migraine.; Rizatriptan taken once upon onset of a qualifying migraine.; Placebo taken once upon onset of a qualifying migraine.
Intervention MeSH terms: Meloxicam; Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1594.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; AXS-07; Meloxicam; Rizatriptan; Axsome; Axsome Therapeutics; MoSEIC meloxicam

Summary:

      AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan,
      which is being developed for the acute treatment of migraine with or without aura in adults.
      AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This
      study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam,
      rizatriptan, and placebo for the treatment of a migraine attack.

      This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled
      trial. Subjects who successfully complete screening and continue to meet all entry criteria
      will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or
      placebo upon the occurrence of a qualifying migraine.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Has an established diagnosis of migraine with or without aura.

          -  Has experienced an inadequate response to prior acute treatments.

        Key Exclusion Criteria:

          -  Has previously received any investigational drug or device or investigational therapy
             within 30 days before Screening.

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the
             study.
Prospective Study of Patients With Thrombocytopenia Following HSCT
Condition: Thrombocytopenia; Hematologic Diseases
MeSH terms: Thrombocytopenia; Hematologic Diseases
Intervention: Decitabine; rhTPO; Conventional Treatment
Intervention description: Decitabine; rhTPO; immunoglobulin, glucocorticoid etc
Intervention MeSH terms: Decitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Healthy volunteers: No
Keywords: Isolated thrombocytopenia; decitabine; rhTPO

Summary:

      Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to
      an increased risk of life-threatening hemorrhage, frequent requirement of platelet
      transfusions and extended hospital stays, representing a challenging clinical problem.
      Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet
      recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent
      to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT.
      Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce
      platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted
      an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine
      in the treatment of thrombocytopenia following HSCT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;

          2. Neutrophil and hemoglobin were well recovered;

          3. Full donor chimerism was achieved;

          4. No response to conventional treatments (e.g. thrombopoietin, immunoglobulin,
             glucocorticoid alone or in combination) for a duration of at least 4 weeks;

        Exclusion Criteria:

          1. Patients with malignancy relapse;

          2. Active infections;

          3. Grade Ⅲ-Ⅳ acute GVHD or severe chronic GVHD according to National Institute of Health
             criteria;

          4. Severe organ damage;

          5. Thrombosis requiring treatment;

          6. Received decitabine following the current transplantation.
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 520.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylactic

Summary:

      The reason for this study is to see if the drug galcanezumab is safe and effective in
      participants with episodic migraine. The study will last about 53 weeks and may include up to
      12 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a diagnosis of migraine as defined by International Headache
             Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2)
             (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and
             migraine onset prior to age 50

          -  Prior to screening, participants must have a history of 4-14 migraine headache days
             and at least 2 migraine attacks per month on average within the past 3 months

        Exclusion Criteria:

          -  Are currently enrolled in any other clinical trial involving an investigational
             product or any other type of medical research judged not to be scientifically or
             medically compatible with this study

          -  Current use or prior exposure to galcanezumab or another calcitonin gene-related
             peptide (CGRP) antibody, including those who have previously completed or withdrawn
             from this study or any other study investigating a CGRP antibody

          -  Participants who are taking, or are expected to take, therapeutic antibodies during
             the course of the study (for example, adalimumab, infliximab, trastuzumab,
             bevacizumab, etc.)

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to galcanezumab

          -  Women who are pregnant or nursing

          -  History of chronic migraine, daily persistent headache, cluster headache, medication
             overuse headache, migraine with brainstem aura, or hemiplegic migraine
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma; Open-Angle Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost SR; Sham Bimatoprost SR; Selective Laser Trabeculoplasty; Sham Selective Laser Trabeculoplasty
Intervention description: Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).; Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).; Selective Laser Trabeculoplasty administered on Day 1.; Sham Selective Laser Trabeculoplasty administered on Day 1.
Intervention MeSH terms: Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of
      Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle
      glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering
      medication for reasons other than medication efficacy (e.g., due to intolerance or
      nonadherence).
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require
        IOP lowering treatment.

        Exclusion Criteria:

          -  Eye surgery (including cataract surgery) and or eye laser surgery within the past 6
             months.

          -  Enrollment in other studies using Bimatoprost SR.
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: suprachoroidal CLS-TA; suprachoroidal sham; Lucentis or Avastin
Intervention description: suprachoroidal injection of CLS-TA; sham suprachoroidal procedure; IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bevacizumab; Ranibizumab; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RVO; ME; Microneedle; Microinjection; Triamcinolone; Choroid; Choroid injection; Suprachoroidal; Anti-VEGF; Subretinal Fluid; Cystoid Macular Edema; Optical Coherence Tomography; OCT; Central Subfield Thickness; Lucentis; Avastin; Ranibizumab; Bevacizumab; Triamcinolone acetonide

Summary:

      This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed
      to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF
      agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a clinical diagnosis of RVO in the study eye

          -  Has a CST of ≥ 300 µm in the study eye

          -  Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye

          -  Is naïve to local pharmacologic treatment for RVO in the study eye

        Exclusion Criteria:

          -  Any active ocular disease or infection in the study eye other than RVO

          -  History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring
             more than one medication

          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would
             preclude participation in the study

          -  Any evidence of neovascularization in the study eye
An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Lasmiditan
Intervention description: oral tablet
Intervention MeSH terms: Lasmiditan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized, open-label study in subjects with migraine who have
      completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK
      (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is
      designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan
      100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute
      treatment of migraine. Long term efficacy will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to give written informed consent and authorize Health Insurance
             Portability and Accountability Act (HIPAA).

          -  Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed
             COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as
             enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE:
             Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks
             prior or if they have not participated in either prior study, but meet eligibility
             criteria outlined for COL MIG-302.)

          -  Females of child-bearing potential must be using or willing to use a highly effective
             form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD),
             abstinence or vasectomized partner).

          -  Able and willing to complete an electronic diary to record details of all migraine
             attacks treated with study drug.

        Exclusion Criteria:

          -  Any medical condition or clinical laboratory test which in the judgment of the
             Investigator makes the subject unsuitable for the study.

          -  Pregnant or breast-feeding women.

          -  Women of child-bearing potential not using or not willing to use highly effective
             contraception.

          -  Participant is at imminent risk of suicide (positive response to question 4 or 5 on
             the Columbia Suicide Severity Rating Scale (C-SSRS).

          -  Initiation of or a change in concomitant medication to reduce the frequency of
             migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK
             (NCT02605174).

          -  Participation in any clinical trial of an experimental drug or device since completing
             EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
Bupivacaine With Epidural Volume Extension
Condition: Spinal Anesthesia; Epidural; Anesthesia
Intervention: 10 mg Bupivacaine; 5 mg Bupivacaine
Intervention description: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space; 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neuraxial epidural techniques; Combined spinal epidural; Epidural volume extension; Transient Neurologic Symptoms (TNS)

Summary:

      In this study the investigator will address the efficacy of using low dose bupivacaine spinal
      anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing
      short obstetric procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing short obstetric procedure in the operating room requiring
             neuraxial anesthesia.

        Exclusion Criteria:

          -  coagulopathy

          -  platelets <80,000

          -  allergy to local anesthetic or fentanyl

          -  previous spinal surgery

          -  spinal or intracranial mass

          -  history of lower extremity weakness