bioihbjkbjnl/mcl2 huggingface dataset:
Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone Furoate/Vilanterol Inhalation Powder; Fluticasone Furoate Inhalation Powder; Fluticasone Propionate Inhalation Powder; Placebo Inhalation Powder 1; Placebo Inhalation Powder 2
Intervention description: Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks; Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks; Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks; Placebo in novel dry powder inhaler once daily; Placebo in Diskus inhaler twice daily
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 587.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Fluticasone propionate; asthma; vilanterol; GW642444; Fluticasone furoate

Summary:

      The purpose of the study is to compare the efficacy and safety of fluticasone
      furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with
      fluticasone furoate inhalation powder administered alone once daily each evening in
      adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over
      a 24-week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient at least 12 years of age

          -  Both genders; females of childbearing potential must be willing to use birth control
             method

          -  Pre-bronchodilator FEV1 of 40-90% predicted

          -  Reversibility FEV1 of at least 12% and 200mls

          -  Current asthma therapy that includes an inhaled corticosteroid for at least 12 weeks
             prior to first visit

        Exclusion Criteria:

          -  History of life-threatening asthma

          -  Respiratory infection or oral candidiasis

          -  Asthma exacerbation within 12 weeks

          -  Concurrent respiratory disease or other disease that would confound study
             participation or affect subject safety

          -  Allergies to study drugs, study drugs' excipients, medications related to study drugs

          -  Taking another investigational medication or medication prohibited for use during this
             study
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Condition: Melanoma
MeSH terms: Melanoma; Recurrence
Intervention: Ipilimumab; Nivolumab; Placebo matching Ipilimumab; Placebo matching Nivolumab
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 906.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether nivolumab is better than ipilimumab to
      prevent recurrence of melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 15 years of age Except: where local regulations and/or institutional policies
             do not allow for subjects < 18 years of age (pediatric population) to participate. For
             those sites, the eligible subject population is ≥ 18 years of age

          -  Completely removed melanoma by surgery performed within 12 weeks of randomization

          -  Stage IIIb/C or Stage IV before complete resection

          -  No previous anti-cancer treatment

        Exclusion Criteria:

          -  Ocular or uveal melanoma

          -  History of carcinomatosis meningitis

          -  History of auto-immune disease

          -  Treatment directed against the resected melanoma that is administrated after the
             surgery

        Other protocol-defined inclusion/exclusion criteria apply
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Condition: Compensated Cirrhosis; Nonalcoholic Steatohepatitis
MeSH terms: Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Intervention: Obeticholic acid (10 mg); Obeticholic acid (10 mg to 25 mg); Placebo
Intervention description: Tablets administered orally once daily.; Tablets administered orally once daily.; Tablets administered orally once daily.
Intervention MeSH terms: Chenodeoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 919.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Compensated Cirrhosis; Nonalcoholic Steatohepatitis; Fatty Liver Disease; NASH

Summary:

      The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747)
      can lead to histological improvement in fibrosis with no worsening of NASH in adults with
      compensated cirrhosis due to NASH.
    

Eligibility criteria:

        Key inclusion criteria:

        1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the
        NASH CRN scoring system determined by central reading

        Key exclusion criteria:

          1. Current or past history of a clinically evident hepatic decompensation event, such as
             ascites, hepatic encephalopathy (HE), or variceal bleeding

          2. Current or past history of CP score ≥7 points

          3. Model for End-stage Liver Disease (MELD) score > 12

          4. ALT ≥ 5 X ULN

          5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method

          6. Hemoglobin A1c (HbA1c) ≥ 9.5 %

          7. Evidence of other known forms of chronic liver disease such as alcoholic liver
             disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease,
             iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or
             suspected hepatocellular carcinoma (HCC)

          8. History of liver transplant, or current placement on a liver transplant list
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: 23-PPV; 13-PCV Booster; Influenza Vaccine; KLH; OCR; TT Vaccine
Intervention description: The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).; The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).; The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).; KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).; OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.; The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, open-label study will evaluate the immune response to vaccines
      (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide
      vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine
      [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose
      of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RMS in accordance with the revised McDonald criteria

          -  Received at least one previous immunization against TT or tetanus and diphtheria
             (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)

          -  Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive

          -  For sexually active female participants of reproductive potential, use of reliable
             means of contraception

        Exclusion Criteria:

          -  Contraindications for or intolerance to oral or IV corticosteroids, including IV
             methylprednisolone, according to the country label

          -  Known presence of other neurologic disorders

          -  Treatment with any investigational agent within 24 weeks of screening or 5 half-lives
             of the investigational drug, whichever is longer, or treatment with any experimental
             procedure for multiple sclerosis
AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
Condition: Conjunctivitis, Allergic
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AGN-229666; Vehicle to AGN-229666; Olopatadine
Intervention description: One drop of AGN-229666 in the eye on Days 1 and 15.; One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.; One drop of olopatadine in the eye on Days 1 and 15.
Intervention MeSH terms: Olopatadine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of AGN-229666 for the prevention of
      allergen-mediated conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

        -Japanese patients living in Japan with a history of allergic conjunctivitis.

        Exclusion Criteria:

          -  Presence of active eye infection (bacterial, viral, or fungal)

          -  History of an eye herpetic infection.
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Intervention: G-Pen (glucagon injection); Lilly Glucagon (glucagon injection [rDNA origin])
Intervention description: 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector; 1 mg of Lilly glucagon reconstituted from lyophilized powder
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen
      (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for
      hypoglycemia rescue of adult patients with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with type 1 diabetes mellitus for at least 24 months

          -  usage of daily insulin treatment

          -  random serum C-peptide concentration < 0.5 ng/mL

        Exclusion Criteria:

          -  pregnant or nursing

          -  HbA1c >9.0%

          -  renal insufficiency

          -  hepatic synthetic insufficiency

          -  aspartate or alanine aminotransferase > 3 times the upper limit of normal

          -  hematocrit less than or equal to 30%

          -  use of > 2.0 U/kg total insulin dose per day

          -  inadequate bilateral venous access in both arms

          -  congestive heart failure, New York Heart Association class II, III or IV

          -  active malignancy within 5 years, except basal cell or squamous cell skin cancers

          -  history of breast cancer or malignant melanoma

          -  major surgical operation within 30 days

          -  current seizure disorder.

          -  current bleeding disorder, treatment with warfarin, or platelet count below 50,000

          -  history of pheochromocytoma or disorder with increased risk of pheochromocytoma

          -  history of insulinoma

          -  history of glycogen storage disease.

          -  positive for HIV, hepatitis C virus or active hepatitis B virus infection

          -  whole blood donation of 1 pint (500 mL) within 8 weeks

          -  active substance or alcohol abuse

          -  administration of glucagon within 28 days

          -  participation in other studies involving an investigational drug or device within 30
             days
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine
Intervention description: Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side.
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single intervention group, bilateral erector spinae blocks with 0.2% ropivacaine, to assess the feasibility of this technique for postoperative pain control following surgeries involving sternotomies in children.
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: erector spinae block; regional anesthesia; sternotomy; ropivacaine

Summary:

      Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral
      continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort
      of children undergoing surgical sternotomy prior to planning an appropriately powered,
      randomized, controlled trial of the same.

      Hypothesis: The investigators' primary hypothesis is that utilizing bilateral erector spinae
      blocks for post-sternotomy pain is a feasible intervention for consideration in a larger
      trial by demonstrating a 75% or greater successful intervention completion rate without any
      major adverse outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled as part of the cardiac surgical ERAS program.

          2. Scheduled for a primary sternotomy.

          3. Ages 3-21 years.

        Exclusion Criteria:

          1. Patients undergoing reoperative procedures.

          2. Significant scoliosis or other anatomic contraindications to ESB.

          3. History of bleeding or current therapeutic dose anticoagulant use.

          4. Significant intraoperative hemodynamic instability or bleeding, as ascertained by
             clinicians taking care of the patient.

          5. Patients with severe neurodevelopmental delays.

          6. Patients with previous chronic pain syndromes.

          7. Patients with a history of opioid treatment at any point in the 2 months prior to
             surgery.

          8. Lack of parental consent and/or child assent.
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
Condition: Adult Growth Hormone Deficiency; Growth Hormone Disorder
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: somapacitan; somatropin
Intervention description: Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.; Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of
      once weekly dosing of somapacitan (administered with an investigational pen) with daily
      Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in
      previously human growth hormone (hGH) treated adults with growth hormone deficiency.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years
        of age at the time of signing informed consent - Adult growth hormone deficiency diagnosed
        for 6 months or longer (defined as 180 days) prior to screening - Treatment with hGH (human
        growth hormone) for at least 6 months at screening - If applicable, hormone replacement
        therapies for any other hormone deficiencies, adequate and stable for at least 90 days
        prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant
        disease or history of malignancy. Exceptions to this exclusion criterion: Resected in situ
        carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete
        local excision. / Subjects with GHD (growth hormone deficiency) attributed to treatment of
        intracranial malignant tumours or leukaemia, provided that a recurrence-free survival
        period of at least 5 years is documented in the subject's file - For patients with surgical
        removal or debulking of pituitary adenoma or other benign intracranial tumour within the
        last 5 years: Evidence of growth of pituitary adenoma or other benign intracranial tumour
        within the last 12 months (defined as below or equal to 365 days) before randomisation.
        Absence of growth must be documented by two post-surgery MRI or CT scans. The most recent
        MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to
        270 days) prior to randomisation
Multi-Center Study of New Medications to Treat Vaginal Infections
Condition: Vaginal Infection
MeSH terms: Infections
Intervention: Terconazole; Placebo
Intervention MeSH terms: Terconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the
      treatment of vaginal infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:

          -  Capable of providing written informed consent or assent

          -  Currently not menstruating and not anticipating menses during treatment

          -  If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically
             sterile, or practicing an acceptable form of birth control

          -  Negative pregnancy test

          -  Other criteria as identified in the protocol

        Exclusion Criteria:

          -  Other infectious causes of vulvovaginitis

          -  Subject has recently used, or is expected to require the concomitant use of prohibited
             medications/products

          -  Nursing mother

          -  Use of any investigational drug within 30 days of enrollment

          -  History of hypersensitivity to any ingredient/component of the formulations

          -  Other criteria as identified in the protocol
Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset
Condition: Stroke
MeSH terms: Stroke
Intervention: alteplase
Intervention MeSH terms: Tissue Plasminogen Activator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours
      after onset of stroke symptoms in Chinese patients with acute ischemic stroke
    

Eligibility criteria:

        Inclusion criteria:

        Age >= 18 years at screening(visit 1A) but <= 80 years Signed and dated written informed
        consent in accordance with good clinical practice and local legislation prior to admission
        to the trial Diagnosis of ischemic stroke with a measureable neurological deficit on
        National Institute of Health Stroke Scale (NIHSS) Thrombolytic therapy can be initiated
        within 3 to 4.5 hours of stroke onset Further inclusion criteria apply

        Exclusion criteria:

        Evidence of intracranial haemorrhage (ICH) on the (Computer Tomography) CT/(Magnetic
        Resonance Imaging)MRI-scan or symptoms suggestive of subarachnoid haemorrhage, even if the
        CT/MRI-scan is normal Acute bleeding diathesis Severe stroke as assessed clinically( e.g.
        National Institute of Health Stroke Scale>25) and/ or imaging demonstrates multi-lobar
        infarction (hypodensity >1/3 cerebral hemisphere) Severe uncontrolled arterial
        hypertension, e.g. systolic blood pressure>185 mmHg or diastolic blood pressure>110mmHg, or
        aggressive management (intravenous medication) necessary to reduce blood pressure to these
        limits Blood glucose <50mg/ dL or >400 mg/dL Any history of prior stroke in previous 3
        months, or any history of prior stroke with concomitant diabetes Seizure at stroke onset
        Further exclusion criteria apply