bioihbjkbjnl/mcl2 huggingface dataset:
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine 10 mg/day; Vortioxetine 20 mg/day; Fluoxetine 20 mg/day; Placebo
Intervention description: 10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed; Encapsulated tablet
Intervention MeSH terms: Vortioxetine; Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 784.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: paediatric patients

Summary:

      Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive
      symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical
      Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who
             turn 18 years during the study will be allowed to continue in the study).

          -  The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.

          -  The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45
             at the Screening Visit and at the Baseline.

          -  The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at
             the Screening Visit and at the Baseline

          -  The patient has provided assent to participation and parent(s)/legal representative
             (s) signed the Informed Consent Form.

        Exclusion Criteria:

          -  The patient has participated in a clinical study <30 days prior to the Screening
             Visit.

        Other protocol defined inclusion and exclusion criteria may apply
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
Condition: HER2+ Metastatic Breast Cancer (MBC)
MeSH terms: Breast Neoplasms
Intervention: neratinib; capecitabine; lapatinib
Intervention MeSH terms: Capecitabine; Lapatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 621.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neratinib; Nerlynx

Summary:

      This is a randomized, multi-center, multinational, open-label, active-controlled, parallel
      design study of the combination of neratinib plus capecitabine versus the combination of
      lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2
      directed regimens in the metastatic setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥18 years at signing of informed consent.

          -  Histologically confirmed MBC, current stage IV.

          -  Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+,
             with confirmatory fluorescence in situ hybridization (FISH) +.

          -  Prior treatment with at least two (2) HER2-directed regimens for metastatic breast
             cancer.

        Exclusion Criteria:

          -  Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2
             directed tyrosine kinase inhibitor.

        Note: There are additional inclusion and exclusion criteria. The study center will
        determine if you meet all of the criteria.
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Adalimumab; Placebo
Intervention description: Subcutaneous (SC) injection; Subcutaneous (SC) injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; adalimumab

Summary:

      The purpose of the study is to demonstrate the efficacy and safety, and to assess the
      pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with
      moderate to severe ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with
             biopsy.

          -  Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of
             2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or
             both.

        Exclusion Criteria:

          -  Subject with Crohn's disease (CD) or indeterminate colitis (IC).

          -  Current diagnosis of fulminant colitis and/or toxic megacolon.

          -  Subjects with disease limited to the rectum (ulcerative proctitis) during the
             screening endoscopy.

          -  Chronic recurring infections or active tuberculosis (TB).
Comparison of Psychotherapy Programs to Treat Panic Disorder
Condition: Anxiety Disorders; Panic Disorder; Agoraphobia
MeSH terms: Anxiety Disorders; Panic Disorder; Agoraphobia
Intervention: Cognitive behavioral therapy; Applied relaxation training (ART); Panic focused psychodynamic psychotherapy (PFPP)
Intervention description: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.; ART with exposure protocol will include 19 to 24 sessions over 12 weeks.; PFPP will include 19 to 24 sessions over 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PD; CBT; PFPP

Summary:

      This study will determine the relative effectiveness of three psychotherapies in treating
      people with a panic disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia

          -  History of at least one spontaneous panic attack per week within the month prior to
             study entry

        Exclusion Criteria:

          -  Active substance dependence within 6 months prior to study entry

          -  Lifetime history of any psychotic disorder, including bipolar disorder

          -  Acutely suicidal
Long-term Safety Extension to Study TRCA-301
Condition: Metabolic Acidosis
MeSH terms: Acidosis
Intervention: TRC101; Placebo
Intervention description: Oral suspension; Oral suspension
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: blood bicarbonate, kidney disease

Summary:

      This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301
      (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301
      have the option to participate in this extension study evaluating the long-term safety and
      durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease
      and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily
      (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive
      the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completed the 12-week treatment period and attended the Week 12 Visit in the parent
             study TRCA-301.

          -  Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study
             TRCA-301.

        Key Exclusion Criteria:

          -  Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the
             Investigator, requires emergency intervention or evaluation for an acute acidotic
             process.

          -  Required dialysis for acute kidney injury or worsening CKD during the parent study
             TRCA-301.

          -  Planned initiation of renal replacement therapy within 6 months following study entry.

          -  History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing
             disorders, severe gastrointestinal disorders, inflammatory bowel disease, major
             gastrointestinal surgery, or active gastric/duodenal ulcers.

          -  Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Xalatan; Xalacom
Intervention description: latanoprost 0.005%, one rop once daily in evening; latanoprost 0.005% adn timolol 0.5%, one drop, once daily
Intervention MeSH terms: Latanoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in
      Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in
      efficacy and similarity of safety between Xalacom and Xalatan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4
             weeks or more.

        Exclusion Criteria:

          -  History of no-response to timolol

          -  History of trabeculectomy

          -  History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Ciclesonide; Placebo
Intervention description: 160mcg Inhaler; Matching Placebo Inhaler
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 400.0
Sex: All
Minimum age: 12 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of Alvesco (ciclesonide)
      Inhalation Aerosol in non hospitalized patients with symptomatic COVID-19 infection in a
      multicenter, randomized, double-blind, placebo controlled study
    

Eligibility criteria:

        Inclusion Criteria

        Patients eligible for enrollment in the study must meet all the following criteria:

          1. Male and female adults and adolescents (12 years of age and above).

          2. Positive SARS-CoV-2 rapid molecular diagnostic test within 72 hours prior to
             enrollment.

          3. Patient is not currently hospitalized or under immediate consideration for
             hospitalization at the time of enrollment.

          4. Patient is currently experiencing symptoms of fever, cough, and/or dyspnea.

          5. Patient has an oxygen saturation level greater than 93%.

          6. Ability to show adequate use of MDI, including inhalation technique.

          7. Patient, parent/legal guardian, or legally-authorized representative must have signed
             a written informed consent before administration of any study-specific procedures.

        Exclusion Criteria

        Patients meeting any of the following criteria are not eligible for participation in the
        study:

          1. Existence of any life-threatening co-morbidity or any other medical condition which,
             in the opinion of the investigator, makes the patient unsuitable for inclusion.

          2. History of hypersensitivity to ciclesonide.

          3. Treatment with inhaled or intranasal corticosteroids within 14 days of the screening/
             enrollment/randomization visit.

          4. Treatment with oral corticosteroids within 90 days of the
             screening/enrollment/randomization visit.

          5. Participation in any other clinical trial or use of any investigational agent within
             30 days of the screening/enrollment/randomization visit.

          6. Currently receiving treatment with hydroxychloroquine/chloroquine.

          7. Patients with cystic fibrosis.

          8. Patients with idiopathic pulmonary fibrosis.
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin succinate suspension
Intervention description: Oral suspension
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Overactive bladder (OAB); Solifenacin succinate suspension; Phase 3; Pediatric

Summary:

      This was a 40-week study to investigate how safe and effective solifenacin solution was in
      treating children or adolescents with symptoms of overactive bladder (OAB), who completed
      study 905-CL-076 (NCT01565707).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has met the inclusion criteria of study 905-CL-076 and completed study
             905-CL-076

        Exclusion Criteria:

          -  Subject has failed the exclusion criteria of study 905-CL-076
Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS; Placebo
Intervention description: active treatment; placebo treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared
      to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of
             mild to moderate plaque psoriasis

        Exclusion Criteria:

          -  patient is< 12 years old.
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: DSP-5423P Placebo; DSP-5423P 40mg; DSP-5423P 80mg; DSP-5423P Placebo-to-Flex; DSP-5423P Active-to-Flex
Intervention description: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily; DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily; DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily; DSP-5423P Placebo:
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily; DSP-5423P Active:
DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 580.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with
      placebo in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria

          -  Patients who are aged 18 years or older at informed consent

          -  Patient understands the objectives and procedures of the study and who provide written
             voluntarily consent to participate in the study, etc.

        Exclusion Criteria:

          -  Patients who fall under a contraindication listed in the blonanserin (LONASEN) package
             insert

          -  Patients with Parkinson disease

          -  Patients who previously received blonanserin, etc.
Treatment of Adrenal Insufficiency in Children
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Intervention: Infacort®
Intervention description: dry granule formulation of hydrocortisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 1 Week
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      The study will be conducted in a total of 24 subjects before their 6th birthday, requiring
      replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or
      hypopituitarism.

      The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged
      between 2 and < 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to <2
      years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only
      if again no safety concerns emerge, then 6 neonates aged from birth to <28 days will be
      enrolled (Cohort 3).

      The decision to continue after each cohort will be based on the recommendation of an
      Independent Data Monitoring Committee (IDMC).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female children less than 6 years of age.

          2. A diagnosis of adrenal insufficiency as confirmed by an inappropriately low cortisol
             usually with other supporting tests.

          3. Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without
             fludrocortisone).

          4. Adequately hydrated and nourished.

          5. Ability of parents/carers to understand and give written Informed Consent

        Exclusion Criteria:

          1. Clinically evident acute adrenal insufficiency (adrenal crisis).

          2. Inability of the child to take oral therapy.

          3. Concomitant therapy (other than that required to treat adrenal insufficiency, Vitamin
             D, Fluoride, Thyroxine and growth hormone).

          4. Subjects with clinical signs of acute infection or fever on Day 1.

          5. Any surgical or medical condition which in the opinion of the investigator may place
             the subject at higher risk from his/her participation in the study.

          6. Parents/carers of subjects unwilling to consent to saving and propagation of
             pseudonymised medical data for study reasons.

          7. Subjects who are dependent on the investigator or the sponsor.
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Nivolumab; Ipilimumab; Placebo
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: 907.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this study, all patients must have already completed first-line chemotherapy to treat
      extensive-stage disease small cell lung cancer. The purpose of this study is to show that
      nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall
      survival when administered as consolidation treatment in patients that are stable or
      responding after chemotherapy. Patients receiving treatment will be compared with patients
      taking placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with histologically or cytologically confirmed extensive stage disease SCLC

          -  Ongoing response of stable disease or better following 4 cycles of platinum-based
             first line chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Subjects with symptomatic Central Nervous System (CNS) metastases

          -  Subjects receiving consolidative chest radiation

          -  Subjects with active, known, or suspected autoimmune disease are excluded

          -  All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1
             or baseline

        Other protocol-defined inclusion/exclusion criteria apply