bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Condition: Community-Acquired Infections
MeSH terms: Community-Acquired Infections
Intervention: tigecycline
Intervention description: Dosage form: Tigecycline 50 mg for injection (Lyophilized powder in 5 mL vial) Dosage frequency: Tigecycline 100 mg loading followed by 50 mg every 12 hrs (bid) Duration of therapy: 7 to 14 days
Intervention MeSH terms: Tigecycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To purpose of this study is to assess the safety and tolerability of intravenous (IV)
      tigecycline in hospitalized subjects of Japanese descent with community-acquired pneumonia
      (CAP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized Japanese descent subjects known or suspected to have CAP with a severity
             that requires IV antibiotic treatment.

          -  Chest radiograph within 48 hours before the first dose of IV test article showing the
             presence of a new infiltrate.

          -  The presence of fever or hypothermia within 24 hours before the first administration
             of test article, and of at least two signs/symptoms of CAP within 24 hours before the
             first administration of test article.

        Exclusion Criteria:

          -  Any concomitant condition that, in the opinion of the investigator, would preclude an
             evaluation of a response or make it unlikely that the contemplated course of therapy
             could be completed.

          -  Hospital-acquired pneumonia, other lung disease including viral, fungal, or parasitic
             pneumonia, immunosuppressive conditions, and other illness, which affect evaluation of
             safety and efficacy of tigecycline.

          -  Known or suspected hypersensitivity to tigecycline or tetracyclines, or
             contraindication for these antibiotics.
Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51
Intervention description: IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in
      terms of seroconversion rate.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Healthy adults who completed the primary immunization in study IC51 309

          -  Male and female healthy subjects aged at least 18 years with written informed consent
             and either no childbearing potential or negative pregnancy test

        Main Exclusion Criteria:

        • History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency
        Virus (HIV), or drug addiction including alcohol dependence
Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients
Condition: Iron Overload
MeSH terms: Iron Overload
Intervention: Deferiprone
Intervention description: Ferriprox (deferiprone) oral solution will be given orally at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided into 3 doses, for 24 weeks.
Intervention MeSH terms: Deferiprone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Iron Overload

Summary:

      -  The primary objective is to assess the safety of Ferriprox oral solution for the
           treatment of iron overload in pediatric patients with transfusion-dependent anemia.

        -  The secondary objective is to assess the efficacy of Ferriprox oral solution in reducing
           iron overload in pediatric patients with transfusion-dependent anemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are ≤ 10 years of age.

          -  Patients who have a confirmed diagnosis of transfusion-dependent anemia, other than
             Blackfan-Diamond anemia, and have chronic iron overload requiring chelation therapy.

          -  Patients who are in a chronic transfusion program, and who have received at least
             eight (8) red blood cell transfusions per year for a minimum of one year.

          -  Patients who are iron overloaded as assessed by serum ferritin concentration greater
             than 1000 µg/L.

        Exclusion Criteria:

          -  Patients who have a diagnosis of Blackfan-Diamond anemia.

          -  Patients who have experienced neutropenia/agranulocytosis (absolute neutrophil count
             (ANC) < 1.5 x 109/L) or thrombocytopenia (platelet count < 50.0 x 109/L).

          -  Patients who have had previous treatment with Ferriprox and presented serious adverse
             reaction or intolerance requiring withdrawal of Ferriprox.

          -  Patients with evidence of abnormal liver function (ALT level > 3 times the upper limit
             of normal; entry may be delayed until values return to normal).

          -  Patients with evidence of renal failure, characterized by serum creatinine level > 2
             times the upper limit of normal; entry may be delayed until values return to normal.
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
Condition: Post-traumatic Stress Disorder; PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Placebo; Brexpiprazole
Intervention description: Once daily, tablets, orally; 1 to 3 mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or
      sertraline (SER) on PTSD symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini
             International Neuropsychiatric Interview (MINI).

          -  The patient has a Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score ≥70 at
             Screening and Baseline Visits.

          -  The reported duration of the PTSD is at least 3 months.

        Exclusion Criteria:

          -  The index traumatic event that led to development of PTSD took place more than 15
             years before screening.

          -  The patient has a severe personality disorder that in the investigator's opinion may
             interfere with the conduct of the study.

          -  The patient is at significant suicidal risk.

        Other inclusion and exclusion criteria may apply.
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
Condition: Major Depressive Disorder; Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: Quetiapine XR; Lithium carbonate; SSRI/Venlafaxine
Intervention description: 300 mg once daily (od); 900 mg once daily (od); SSRI - doses within label, Venlafaxine dose up to 225 mg/day
Intervention MeSH terms: Quetiapine Fumarate; Lithium Carbonate; Venlafaxine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 688.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; MDD; TRD

Summary:

      The primary objective of the study is to evaluate the efficacy of Quetiapine extended release
      (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine
      versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine
      versus Quetiapine extended release monotherapy in subjects with treatment resistant
      depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg
      Depression Rating Scale (MADRS) total score. As an independent objective, the primary
      objective will also be evaluated in two subgroups of patients: (1) patients who were
      resistant to two previous antidepressant therapies and (2) in the subgroup of patients with
      one previous failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the
             Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of
             the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode

          -  Current episode of depression present, at least 42 days prior to enrolment but not
             more than 18 months

          -  MADRS-Score ≥ 25 at enrolment and randomisation

        Exclusion Criteria:

          -  Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation

          -  Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the
             patient's current psychiatric status

          -  Patients who, in the investigator's judgment pose a current serious suicidal or
             homicidal risk, or have made a suicide attempt within the past 6 months
A Trial of Corticosteroids for Low Back Pain
Condition: Radicular Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Intramuscular methylprednisolone acetate; Placebo
Intervention description: Intramuscular methylprednisolone acetate 160mg; Normal saline intramuscular injection
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: low back pain; emergency department; corticosteroids

Summary:

      Low back pain is a common symptom that functionally disables many people. When the low back
      pain is accompanied by pain that shoots down the leg, it is felt to be caused by a herniated
      disc. We are conducting this study to determine if a powerful anti-inflammatory agent will
      decrease the pain and functional impairment that is associated with this illness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21-50 years old, non-traumatic low back pain for one week or less,

        Exclusion Criteria:

          -  fever, pregnancy, lactation, allergy or intolerance to study medication, suspected
             active oncologic, urologic, or gynecologic disease
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
Condition: Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: DE-117 Ophthalmic Solution; Timolol Maleate Ophthalmic Solution 0.5%
Intervention description: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months; Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 417.0
Sex: All
Minimum age: 12 Months
Healthy volunteers: No

Summary:

      This is a Phase III, randomized, double-masked, active-controlled, parallel-group,
      multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at
      Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any.
      After completing the required washout period, subjects will return for Visit 2 (Baseline, Day
      1). Subjects who meet all eligibility criteria at baseline will be randomized to receive
      double-masked treatment for 3 months.

      Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who
      meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

        -  DE-117 Ophthalmic Solution once daily and Vehicle once daily, or

        -  Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the
           efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate
           Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.
    

Eligibility criteria:

        Inclusion Criteria:

        • glaucoma or ocular hypertension

        Exclusion Criteria:

          -  Females who are pregnant, nursing, or planning a pregnancy

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             tonometric measurements
Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inflexal V
Intervention description: Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Virus; Vaccination; Inflexal V

Summary:

      The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills
      the EMA requirements for re-registration of influenza vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female and male adults aged ≥18 on Day 1

          -  Written informed consent

          -  Female subjects of childbearing potential using and willing to continue using an
             acceptable method of contraception unless surgically sterilized/hysterectomized or
             post-menopausal for more than 2 years

        Exclusion Criteria:

          -  Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or
             other acute disease

          -  Acute febrile illness (≥38.0 °C)

          -  Prior vaccination with an influenza vaccine in the past 330 days

          -  Known hypersensitivity to any vaccine component

          -  Previous history of a serious adverse reaction to influenza vaccine

          -  History of egg protein allergy or severe atopy

          -  Known blood coagulation disorder

          -  Chronic (longer than 14 days) administration of immunosuppressants or other
             immune-modifying drugs within 6 months before the first dose of the study vaccine,
             including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent
             (inhaled or topical steroids are allowed)

          -  Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer

          -  Investigational medicinal product received in the past 3 months (90 days)

          -  Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months
             (90 days)

          -  Pregnancy or lactation

          -  Participation in another clinical trial

          -  Employee at the investigational site, or relative of the investigator

          -  Subjects who in the view of the investigator will not comply with study procedures
             and/or visit requirements as per protocol
Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
Condition: Small Cell Lung Carcinoma Extensive Disease
MeSH terms: Carcinoma; Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Durvalumab; Tremelimumab; Carboplatin; Cisplatin; Etoposide
Intervention description: IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria.; IV infusions every 3 weeks for 12 weeks(4 cycles). An additional dose of tremelimumab will be administered in the week 16.; up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3; up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3; up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
Intervention MeSH terms: Carboplatin; Etoposide; Durvalumab; Tremelimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 987.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Carcinoma, Small Cell Lung; Oat Cell Carcinoma of Lung; Oat Cell Lung Cancer; Small Cell Cancer Of The Lung; Small Cell Lung Cancer

Summary:

      This is a phase III, randomized, open-label, multicenter, global study to determine the
      efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy
      (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line
      treatment in patients with extensive-stage small-cell lung cancer
    

Eligibility criteria:

        Inclusion criteria:

          1. Histologically or cytologically documented extensive disease. Brain metastases; must
             be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1
             month prior to study treatment.

          2. Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.

          3. Life expectancy ≥12 weeks at Day 1.

          4. ECOG 0 or 1 at enrolment.

          5. No prior exposure to immune-mediated therapy excluding therapeutic anticancer
             vaccines.

        Exclusion criteria:

          1. Any history of radiotherapy to the chest prior to systemic therapy or planned
             consolidation chest radiation therapy (except paliative care outside of the chest).

          2. Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical
             symptomatology suggesting worsening of PNS

          3. Active infection including tuberculosis, HIV, hepatitis B anc C

          4. Active or prior documented autoimmune or inflammatory disorders

          5. Uncontrolled intercurrent illness, including but not limited to interstitial lung
             disease.
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab; Ustekinumab
Intervention description: 300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48; Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque psoriasis; secukinumab; ustekinumab; ain457; ain457a

Summary:

      Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe
      plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must give a written, signed and dated informed consent

          -  Chronic plaque-type psoriasis present for at least 6 months before randomization

          -  Moderate to severe plaque psoriasis as defined at randomization by:

               -  PASI score of ≥12 and

               -  Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and

               -  IGA mod 2011 ≥3 (based on a scale of 0-4)

          -  Candidate for systemic therapy, defined as having psoriasis inadequately controlled
             by:

               -  Topical treatment (including topical corticosteroids) and/or

               -  Phototherapy and/or

               -  Previous systemic therapy

        Exclusion Criteria:

          -  Forms of psoriasis other than plaque psoriasis

          -  Drug-induced psoriasis

          -  Ongoing use of prohibited treatments

          -  Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A
             or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23

          -  Use of any other investigational drugs within 5 half-lives of the investigational
             treatment before study drug initiation

          -  Pregnant or nursing (lactating) women

        Other protocol-defined inclusion/exclusion criteria may apply