bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20vPnC
Intervention description: 20-valent pneumococcal conjugate vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 839.0
Sex: All
Minimum age: 15 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy
      children 15 months through 17 years of age
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female children ≥15 months to <18 years of age at the time of consent.

          -  Healthy children determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

          -  For children <5 years of age, written documentation of receipt of at least 3 doses of
             13vPnC. The last dose of 13vPnC must have been administered >2 months before enrolment
             into the study

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Major known congenital malformation or serious chronic disorder

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results

          -  Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or
             planned receipt through study participation

          -  Cohorts 3 and 4: Pregnant or breastfeeding female participants
GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Intervention: fluticasone propionate/salmeterol combination DISKUS
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Bronchitis; COPD; Emphysema

Summary:

      This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease).
      This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects
      will be given breathing tests, and will record their breathing symptoms daily on diary cards.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of COPD.

        Exclusion criteria:

          -  Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other
             than COPD.

          -  Other inclusion and exclusion criteria will be evaluated at the first study visit.
Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Intervention: Dexamethasone; Placebo
Intervention description: Dexamethasone 10mg IV; Placebo Dexamethasone 10mg IV
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: migraine, emergency department, dexamethasone; Migraine with or without aura or probable migraine without aura as defined by ICHD, 2nd edition

Summary:

      Migraines are a specific type of headache that frequently recur and are very painful.
      Although there are many medications that are effective against migraines, none of these
      medications cure 100% of migraines. Another problem with migraines is that although many
      times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3
      of the time migraines recur the next day. The purpose of this research project is to see if
      adding a medication called dexamethasone to standard ER therapy will help patients get better
      quicker and stay pain-free more often than if they receive placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Migraine with or without aura; probable migraine without aura

        Exclusion Criteria:

          -  Secondary headache

          -  Allergy, contraindication or intolerance to study medication
Long-Acting Growth Hormone in Children Compared to Daily rhGH
Condition: Growth Disorders
MeSH terms: Growth Disorders
Intervention: Somavaratan; rhGH
Intervention description: Somavaratan will be administered per dose and schedule specified in the arm description.; rhGH will be administered per dose and schedule specified in the arm description.
Intervention MeSH terms: Hormones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 3 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: VRS-317; Growth Hormone Deficiency; Long Acting Recombinant Growth Hormone; Long Acting Growth Hormone; Pediatric Growth Hormone Deficiency; Growth Hormone Replacement Therapy; Versartis; Xten; Human Growth Hormone; somavaratan; growth failure

Summary:

      The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of
      treatment effect against daily injections of rhGH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronological Age ≥ 3.0 years and ≤ 10.0 (girls) and ≤ 11.0 (boys).

          -  Pre-pubertal status: Absent breast development in girls, testicular volume < 4.0 mL in
             boys.

          -  Diagnosis of growth hormone deficiency (GHD) as documented by two or more growth
             hormone (GH) stimulation test results ≤ 10.0 ng/mL.

          -  Height standard deviation score (SDS) ≤ -2.0 at screening.

          -  Weight for Stature ≥ 10th percentile.

          -  Insulin-like growth factor-I (IGF-I) SDS ≤ -1.0 at screening.

          -  Delayed bone age (≥ 6 months).

        Exclusion Criteria:

          -  Prior treatment with any growth promoting agent

          -  History of, or concurrent significant disease (for example, diabetes, cystic fibrosis,
             renal insufficiency).

          -  Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD)
             or confirmed diagnosis of a named syndrome.

          -  A diagnosis of Attention Deficit Hyperactivity Disorder.

          -  Daily use of anti-inflammatory doses of glucocorticoid.

          -  Prior history of leukemia, lymphoma, sarcoma or cancer.

          -  Treatment with an investigational drug in the 30 days prior to screening.

          -  Known allergy to constituents of the study drug formulation.

          -  Ocular findings suggestive of increased intracranial pressure and/or retinopathy at
             screening.

          -  Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
             variants.

          -  Significant abnormality in screening laboratory studies
Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide; SOC
Intervention description: 0.05mg/kg; Standard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of
      children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term
      period. It will evaluate how these children fared after the TED-C13-003 study ended. This
      study will also offer teduglutide treatment to eligible subjects, regardless of treatment
      received in TED-C13-003.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject provides written informed consent (subject, parent or legal guardian and, as
             appropriate, subject informed assent) to participate in the study before completing
             any study-related procedures.

          2. Subject completed the TED-C13-003 study (including subjects in the standard of care
             treatment arm).

          3. Subject understands and is willing and able to fully adhere to study requirements as
             defined in this protocol.

        Exclusion Criteria:

        There are no exclusion criteria for this study.
Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ipragliflozin; Sitagliptin
Intervention description: one 50 mg tablet QD; one 50 mg tablet QD
Intervention MeSH terms: Sitagliptin Phosphate; Ipragliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This is a study to assess the safety and efficacy of the addition of ipragliflozin to
      sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate
      glycemic control on sitagliptin, diet, and exercise therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has Type 2 diabetes mellitus

          -  Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy

          -  Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis

          -  History of any of the following medications: Thiazolidinediones (TZD) and/or insulin
             within 12 weeks prior to study participation, sodium glucose cotransporter 2 (SGLT2)
             inhibitors anytime

          -  Currently has a urinary tract infection or genital infection with subjective symptom
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Nivolumab; Sorafenib
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab; Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 743.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if nivolumab or sorafenib is more effective in the
      treatment of Advanced Hepatocellular Carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical
             and/or locoregional therapies; or progressive disease after surgical and /or
             locoregional therapies

          -  Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4
             weeks prior to the baseline scan

          -  Child-Pugh Class A

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

        Exclusion Criteria:

          -  Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

          -  Prior liver transplant

          -  Active, known, or suspected autoimmune disease

        Other protocol-defined inclusion/exclusion criteria apply
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
Condition: ACL Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: OOC
Intervention description: The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to determine whether the use of injectable
      osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL)
      reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides
      clinical outcomes superior to those attained via traditional ACL reconstruction and delayed
      rehabilitation protocols.
    

Eligibility criteria:

        Inclusion Criteria:

          -  any adult undergoing a surgical procedure for hamstring ACL reconstruction

        Exclusion Criteria:

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Prisoners
Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Intervention: SD-101-6.0 cream
Intervention description: SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 1 Month
Healthy volunteers: No
Keywords: Amicus Therapeutics; Scioderm, Inc.; Simplex; Recessive Dystrophic; Junctional non-Herlitz; Epidermolysis Bullosa; SD-101 6%; SD-101-6.0; Allantoin 6%; Zorblisa

Summary:

      The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in
      participants with Epidermolysis Bullosa (EB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent Form signed by the participant or participant's legal representative;
             if the participant was under the age of 18 but capable of providing assent, signed
             assent from the participant.

          -  Participant (or caretaker) must have been willing to comply with all protocol
             requirements.

          -  Participants who completed the SD-005 study (on study drug at Visit 5, approximately
             90 days from baseline).

        Exclusion Criteria:

          -  Participants who did not meet the entry criteria outlined above.

          -  Pregnancy or breastfeeding during the study. (A urine pregnancy test was performed at
             the final visit for Study SD-005 for female participants of childbearing potential and
             repeated at screening/baseline visit of Study SD-006 if these visits did not occur on
             the same day).

          -  Female participants of childbearing potential who were not abstinent or not practicing
             a medically acceptable method of contraception.
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab
Intervention description: Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as Galcanezumab in Japanese participants with migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Episodic Migraine participants: Participants who completed the treatment period of
             Galcanezumab study CGAN.

          -  Have a diagnosis of chronic migraine as defined by International Headache Society
             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines
             (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
             screening, and migraine onset prior to age 50.

        Exclusion Criteria:

          -  For Chronic Migraine participants:

               -  Are currently enrolled in or have participated within the last 30 days or within
                  5 half-lives (whichever is longer) in a clinical trial involving an
                  investigational product.

               -  Current use or prior exposure to Galcanezumab or other antibodies of calcitonin
                  gene-related peptide (CGRP) or its receptor.

               -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other
                  therapeutic proteins, or to Galcanezumab and the excipients in the
                  investigational product.

               -  History of persistent daily headache, cluster headache or migraine subtypes
                  including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine,
                  and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3
                  beta.

               -  Failure to respond to 3 or more adequately dosed migraine preventive treatments
                  from different classes (that is, maximum tolerated dose for at least 2 months).
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: BMS-663068; Placebo
Intervention description: BMS-663068; Placebo
Intervention MeSH terms: Fostemsavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068)
      is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug
      resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and non-pregnant women with chronic HIV-1 infection

          -  Antiretroviral-experienced with documented historical or baseline resistance,
             intolerability, and/or contraindications to antiretrovirals in at least three classes

          -  Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL
             (first value from Investigator, second from Screening labs)

          -  Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals
             remaining which can be effectively combined to form a viable new regimen, based on
             current and/or documented historical resistance testing and tolerability and safety

          -  Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9
             onwards in the Randomized Cohort

          -  Subjects without any remaining fully active approved antiretroviral may be enrolled in
             the Non-Randomized Cohort

        Exclusion Criteria:

          -  Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV
             are eligible)

          -  HIV-2 infection

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN

          -  Alkaline Phosphatase > 5 x ULN

          -  Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on
             atazanavir and has predominantly unconjugated hyperbilirubinemia)
Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Triptorelin Pamoate PR 3-month; Triptorelin Acetate PR 1-month
Intervention description: 15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).; 3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 300.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in
      Chinese female subjects with endometriosis by demonstrating the non-inferiority of
      triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate
      PR 1-month formulation injected 3 times consecutively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects aged from 18 to 45 years inclusive at the date of informed consent.

          -  A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6
             months prior to the screening visit.

          -  A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years
             prior to the screening visit.

          -  Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period
             of 6 months in the judgement of the investigator.

        Exclusion Criteria:

          -  A current history of undiagnosed abnormal genital bleeding.

          -  Received treatment with a GnRH agonist within 6 months prior to the screening visit.

          -  Received any other hormonal treatment within 3 months prior to the screening visit
             (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).

          -  Chronic pelvic pain that is not caused by endometriosis, that would interfere with the
             assessment of endometriosis-associated pelvic pain.