bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Metoprolol ER; Nebivolol
Intervention description: Metoprolol ER once daily, oral administration; Nebivolol once daily, oral administration
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypertension; Nebivolol; Beta blocker; Tolerability

Summary:

      The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a
      general population of patients with mild to moderate hypertension receiving
      hydrochlorothiazide (HCTZ)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ambulatory outpatients

          -  History of hypertension being treated with two medications, one of which must be HCTZ
             and the other of which must not be a beta-blocker or clonidine

          -  SBP of 135-155 mm Hg and/or DBP of >85 mm Hg at screening (Visit 1)

          -  SBP of 140-165 mm Hg and DBP > 90 mmHg at randomization (Visit 3)

        Exclusion Criteria:

          -  Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)

          -  Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways
             disease, chronic obstructive pulmonary disease)

          -  Coronary artery disease requiring treatment with a calcium channel blocker or nitrates

          -  Clinically significant cardiovascular disease (e.g., myocardial infarction,
             cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)

          -  History of severe mental illness (including Major Depressive Disorder, psychosis,
             dementia, bipolar disorder) within 6 months of screening (Visit 1)

          -  Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin
             dopamine receptor antagonists) or antidepressants

          -  Diabetes mellitus, type I or II

          -  Participation in a previous investigational study of nebivolol at any time

          -  Receipt of treatment with an investigational study drug within 30 days of screening
             (Visit 1)

          -  History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or
             other sulfonamide-derived drugs
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole 2%; Vehicle
Intervention description: Crisaborole ointment 2%; Vehicle ointment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 620.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: No
Keywords: Eczema; Crisaborole

Summary:

      This study will evaluate crisaborole therapy once daily (QD) as a long-term topical
      maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID)
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  3 months of age and older

          -  Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria

          -  Minimum of 5% BSA affected by atopic dermatitis

          -  ISGA score of Mild (2) or Moderate (3)

        Exclusion Criteria:

        - Has any clinically significant medical disorder, condition, or disease (including active
        or potentially recurrent non AD dermatological conditions and known genetic dermatological
        conditions that overlap with AD, such as Netherton syndrome).
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20vPnC; 20vPnC; 20vPnC; 13vPnC
Intervention description: 20vPnC; 20vPnC; 20vPnC; Pneumococcal conjugate vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1710.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18
      through 49 years of age with no history of pneumococcal vaccination will be randomized in a
      2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or
      13vPnC.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults ≥18 and <50 years of age.

          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. Female subject of childbearing potential or male subject who is able to father
             children, and willing to use a highly effective method of contraception as outlined in
             this protocol for at least 28 days after the dose of investigational product; or
             female subject not of childbearing potential or male subject not able to father
             children.

        Exclusion Criteria:

          1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.

          2. 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.

          3. History of microbiologically proven invasive disease caused by S pneumoniae.

          4. Pregnant female subjects or breastfeeding female subjects (known or suspected).
A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed dose combination (FDC) tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on
      cough and physical activity using wearable technology in CF participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Forced expiratory volume in 1 second (FEV1) value ≥30% and ≤90% predicted

          -  Heterozygous for CF transmembrane conductance regulator gene (CFTR) F508del mutation
             and a minimal function mutation (F/MF genotypes)

        Key Exclusion Criteria:

          -  Clinically significant liver cirrhosis

          -  Solid organ or hematological transplantation

          -  Non-ambulatory status

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

        Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Glycopyrronium in Axillary Hyperhydrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: glycopyrronium Topical Wipes; Vehicle
Intervention description: Topical wipes containing glycopyrronium; Vehicle (placebo) topical wipes
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The study is a randomized, double-blind, vehicle controlled, parallel group study, designed
      to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to
      vehicle in subjects with axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 9 years of age.

          -  Primary, axillary hyperhidrosis of at least 6 months duration

          -  Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline

          -  Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline

          -  Sweat production of at least 50 mg over 5 minutes in each axilla assessed
             gravimetrically

        Exclusion Criteria:

          -  Prior surgical procedure for hyperhidrosis.

          -  Prior axillary treatment with an anti-hyperhidrosis medical device (approved or
             investigational).

          -  Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within
             1 year of Baseline/Day 1.

          -  Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.

          -  Axillary use of nonprescription antiperspirants within 1 week or prescription
             antiperspirants within 2 weeks of Baseline.

          -  Subjects on new or regimens of psychotherapeutic medications that have changed within
             2 months of baseline.

          -  Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless
             dosing has been stable for at least 4 months.

          -  Other treatment with glycopyrrolate within 4 weeks prior to Baseline.

          -  Secondary axillary hyperhidrosis or presence of a condition that may cause secondary
             hyperhidrosis.

          -  History of Sjögren's syndrome or Sicca syndrome.

          -  History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.

          -  Men with a history of urinary retention requiring catheterization due to prostatic
             hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

          -  History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.

          -  Other systemic diseases or active uncontrolled infections, or any other condition
             which, in the judgment of the Investigator, would put the subject at unacceptable risk
             for participation in the study.
A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Condition: Inadequately Controlled Asthma
MeSH terms: Asthma
Intervention: Tralokinumab open-label
Intervention description: Subcutaneous injection; fixed dose; 300 mg
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 28.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: open-label study; tralokinumab; subcutaneous; inadequately controlled asthma; asthma; medium to high-dose of inhaled corticosteroid; long-acting β2-agonist

Summary:

      A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese
      Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus
      Long-Acting β2-Agonist
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12 - 75 yrs

          2. Documented physician-diagnosed asthma

          3. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose
             corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and
             a long-acting beta-2 agonist (LABA)

          4. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of
             their Predicted Normal Value (PNV)

          5. Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5

        Exclusion Criteria:

          1. Pulmonary disease other than asthma

          2. History of anaphylaxis following any biologic therapy

          3. Hepatitis B, C or HIV

          4. Pregnant of breastfeeding

          5. History or cancer

          6. Current tobacco smoking or a history or tobacco smoking for ≥10 pack-years

          7. Previous receipt of tralokinumab
Single-Dose Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1
Condition: SMA
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Intervention: Onasemnogene Abeparvovec-xioi
Intervention description: Onasemnogene abeparvovec-xioi is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the human survival motor neuron (SMN) gene under the control of the cytomegalovirus (CMV) enhancer/chicken β-actin-hybrid promoter (CB).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No

Summary:

      Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene
      replacement therapy) in patients with spinal muscular atrophy (SMA) Type 1 who meet
      enrollment criteria and are genetically defined by a biallelic pathogenic mutation of the
      survival motor neuron 1 gene (SMN1) with one or two copies of survival motor neuron 2 gene
      (SMN2). Up to 30 patients < 6 months (< 180 days) of age at the time of gene replacement
      therapy (Day 1) will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with SMA Type 1 as determined by diagnosis of SMA based on gene mutation
             analysis with biallelic SMN1 mutations (deletion or point mutations) and one or two
             copies of SMN2 [inclusive of the known SMN2 gene modifier mutation (c.859G>C)]

          -  Patients must be < 6 months (< 180 days) of age at the time of onasemnogene
             abeparvovec-xioi infusion

          -  Patients must have a swallowing evaluation test performed prior to administration of
             gene replacement therapy

        Exclusion Criteria:

          -  Previous, planned or expected scoliosis repair surgery/procedure prior to 18 months of
             age

          -  Use of invasive ventilatory support (tracheotomy with positive pressure) or pulse
             oximetry < 95% saturation at screening

          -  Use or requirement of non-invasive ventilatory support for 12 or more hours daily in
             the two weeks prior to dosing

          -  Patient with signs of aspiration based on a swallowing test or whose weight-for-age
             falls below the 3rd percentile based on World Health Organization (WHO) Child Growth
             Standards and unwilling to use an alternative method to oral feeding

          -  Participation in recent SMA treatment clinical trial (with the exception of
             observational cohort studies or non-interventional studies) or receipt of an
             investigational or commercial compound, product or therapy administered with the
             intent to treat SMA (eg, nusinersen, valproic acid,) at any time prior to screening
             for this trial.
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
Condition: Unresectable or Metastatic Melanoma
MeSH terms: Melanoma
Intervention: BMS-936558; Dacarbazine; Carboplatin; Paclitaxel
Intervention MeSH terms: Paclitaxel; Carboplatin; Nivolumab; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to estimate the response rate and compare overall survival of
      patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or
      Carboplatin and Paclitaxel
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men & women ≥ 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

          -  Histologically confirmed Stage III (unresectable)/Stage IV melanoma

          -  Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

          -  Objective evidence of disease progression (clinical or radiological) during or after
             at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment
             regimens

          -  Pre-treatment fresh core, excision or punch tumor biopsy

          -  Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

        Exclusion Criteria:

          -  Any treatment in a BMS-936558 (Nivolumab) trial

          -  Subjects with condition requiring systemic treatment with either corticosteroids (>
             10mg daily prednisone/equivalent) or other immunosuppressive medications within 14
             days of study drug administration

          -  Active, known or suspected autoimmune disease

          -  Unknown BRAF status

          -  Active brain metastasis or leptomeningeal metastasis

          -  Ocular melanoma

          -  Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1
             (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Elagolix
Intervention description: Elagolix tablets administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 506.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Endometriosis associated pain; Elagolix; Gonadotropin-Releasing Hormone Antagonist; Dysmenorrhea (DYS); Non-Menstrual Pelvic Pain (NMPP)

Summary:

      A randomized study evaluating the continued safety and efficacy of elagolix in the management
      of moderate to severe endometriosis-associated pain in pre-menopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)

          -  Agrees to use required birth control methods during the study through Month 6 of the
             Post-treatment Follow-up period

        Exclusion Criteria:

          -  Clinically significant gynecological condition

          -  Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine,
             femoral neck or total hip

          -  Plans to become pregnant in the next 18 months
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness; Paresis
Intervention: ARGX-113
Intervention description: Intravenous administration of ARGX-113
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the
      ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG.
      Patients who have completed at least 1 cycle of treatment and at least 1 year of trial
      ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial
      ARGX-113-2002 to receive efgartigimod by SC administration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with the ability to understand the requirements of the trial, provide written
             informed consent, and comply with the trial protocol procedures.

          2. Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as
             specified in the protocol.

        Other more specific inclusion criteria are further defined in the protocol.

        Exclusion Criteria:

          1. Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued
             early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might
             jeopardize the safety of the patient in that trial.

          2. Pregnant and lactating women, and those intending to become pregnant during the trial
             or within 90 days after the last dosing. Women or childbearing potential should have a
             negative urine pregnancy test at SEB.

          3. Male patients who are sexually active and do not intend to use effective methods of
             contraception during the trial or within 90 days after the last dosing or male
             patients who plan to donate sperm during the trial or within 90 days after the last
             dosing.

          4. Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human
             Immunodeficiency Virus (HIV) seropositivity.

        Other, more specific exclusion criteria are further defined in the protocol.