bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD5789 (trifarotene) 50μg/g cream; Placebo cream
Intervention description: CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.; Placebo cream applied once daily for 12 weeks
Intervention MeSH terms: Trifarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1208.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: Efficacy; Safety; Acne vulgaris

Summary:

      Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily
      for 12 weeks in subjects with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is a male or female, 9 years of age or older, at Screening visit.

          -  The Subject has moderate acne at Screening and Baseline.

          -  The subject is a female of non childbearing potential

          -  The subject is a female of childbearing potential with a negative pregnancy test and
             who is strictly abstinent or who agrees to use an effective and approved contraceptive
             method for the duration of the study and at least 1 month after the last study drug
             application.

        Exclusion Criteria:

          -  The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or
             secondary acne form (e.g.,chloracne, drug-induced acne, etc.).

          -  The subject has any uncontrolled or serious disease or any medical or surgical
             condition that may either interfere with the interpretation of the trial results
             and/or put the subject at significant risk (according to the Investigator's judgment)
             if the subject takes part to the trial.

          -  The subject has been exposed to excessive ultraviolet (UV) radiation within one month
             prior to the Baseline visit or the subject is planning intense UV exposure during the
             study (i.e., occupational exposure to the sun, sunbathing, tanning salon use,
             phototherapy, etc.)

          -  The subject is unwilling to refrain from use of prohibited medication during the
             clinical trial
Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1; Olanzapine10 mg orally daily on Days -1,0,+1 and +2; Aprepitant plus Olanzapine
Intervention description: Add aprepitant to anti-emetic regimen; add olanzapine to anti-emetic regimen; add aprepitant and olanzapine to anti-emetic regimen
Intervention MeSH terms: Olanzapine; Aprepitant; Fosaprepitant
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: autologous; myeloma; transplant

Summary:

      The purpose of this study is to help answer the following research question:

        -  Whether administration of an aprepitant containing regimen, an olanzapine containing
           regimen or regimen containing both will prevent nausea and vomiting better for patients
           undergoing an autologous stem cell transplant with melphalan chemotherapy. Both of these
           medications are approved by the United States Food and Drug Administration (FDA) for
           nausea and vomiting.

        -  Participants will be randomly assigned to one of the 3 treatment groups:

             -  Arm A: aprepitant containing anti-emetic therapy

             -  Arm B: olanzapine containing anti-emetic therapy

             -  Arm C: Aprepitant plus olanzapine containing anti-emetic therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autologous transplant containing high dose melphalan as part of the conditioning
             regimen (single or 2 day melphalan; BEAM [carmustine, etoposide, cytarabine,
             melphalan])

          -  able to tolerate oral medications

        Exclusion Criteria:

          -  Nausea/vomiting within 12 hours before planned high dose conditioning chemotherapy

          -  Any anti-emetic treatment within 24 hours before planned high dose conditioning
             chemotherapy

          -  Pregnancy

          -  Baseline corrected QT interval (QTc) > 500 ms

          -  History of seizures

          -  History of central nervous system (CNS) disease

          -  Human immunodeficiency virus (HIV)
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Condition: Juvenile Idiopahtic Arthritis
MeSH terms: Arthritis
Intervention: etanercept
Intervention description: Subjects aged <18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW).
Subjects aged greater than or equal to 18 years or >62 kg will receive etanercept SC at a dose of 50 mg QW.
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Use of etanercept to treat pediatric subjects with extended oligoarticular JIA; enthestitis related arthritis (ERA); or psoriatic arthritis (PsA).

Summary:

      This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3
      subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis
      related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96
      weeks of participation in study 0881A1-3338 (B1801014). The study contains an active
      treatment period, withdrawal/re-treatment period and a observational period (non-treatment).
    

Eligibility criteria:

        Inclusion Criteria:

        Receipt of at least 1 dose of investigational product (etanercept) and participation for
        approximately 96 weeks in study 0881A1-3338 (B1801014)

        Personally signed and dated informed consent document (and assent document, as applicable)
        indicating the subject (or legally representative/guardian) has been informed of all
        pertinent aspects of the study.

        Exclusion Criteria:

        Exclusion criteria for subject planning to continue investigational product:

        withdrawal from investigational product in study 0881A1-3338 for any reason (safety or
        non-safety).

        History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma
        in situ.
A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Ipilimumab
Intervention description: -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: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of different administration regimens of nivolumab plus
      Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Males and Females, ages 15 years ≥ of age (Except where local regulations and/or
             institutional policies do not allow for subjects < 18 years of age to participate)

          -  Subjects must have been diagnosed with stage III or/and stage IV histologically
             confirmed melanoma that is unresectable or metastatic

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Subjects have not been treated by systemic anticancer therapy for unresectable or
             metastatic melanoma

        Exclusion Criteria:

          -  Subjects with active brain metastases or leptomeningeal metastases

          -  Subjects with ocular melanoma

          -  Subjects with active, known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Levetiracetam
Intervention description: Pharmaceutical form: Film-coating tablets
Concentration: 250 mg/ 500 mg
Route of administration: oral use
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy, partial; Keppra; Levetiracetam

Summary:

      The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial
      of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their
      standard concomitant AEDs
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059

          -  Patients/the parent or guardian wish to continue treatment with L059 and to enter N165
             Follow-up Study, and also the investigator admit the necessity of the repeated intake
             of the investigational drug for the patients.

        Exclusion Criteria:

          -  Patients who had not participate in N165 Clinical Trial of L059.

          -  Patients who had participated in N165 Clinical Trial of L059 with no intention of
             entering the follow-up study taking the same medication.

          -  Patients had not been in compliance with requirements of Protocol for N165 Clinical
             Trial of L059 in the course of the study.
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: Riociguat (BAY63-2521)
Intervention description: BAY63-2521: 1mg tid -2.5 mg tid oral until end of study
Intervention MeSH terms: Riociguat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 396.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pulmonary arterial hypertension; PH; Stimulator

Summary:

      Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934)
      will be asked to participate in this long term extension study with BAY63-2521.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1

        Exclusion Criteria:

          -  Patients who have an ongoing serious adverse event from PATENT 1 that is assessed as
             related to BAY63-2521 are not allowed to participate in the extension trial.
Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Iptacopan (LNP023)
Intervention description: Taken orally b.i.d. Dosage supplied: 200mg Dosage form: Hard gelatin capsule Route of Administration: oral
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Paroxysmal nocturnal hemoglobinuria; Hemoglobin; Anemia; LNP023; Iptacopan

Summary:

      The purpose of this Phase 3 study was to determine whether iptacopan is efficacious and safe
      for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH) patients who were naïve to
      complement inhibitor therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants ≥ 18 years of age with a diagnosis of PNH confirmed by
             high-sensitivity flow cytometry with clone size ≥ 10%

          -  Mean hemoglobin level <10 g/dL

          -  LDH > 1.5 x Upper Limit of Normal (ULN)

          -  Vaccination against Neisseria meningitidis infection is required prior to the start of
             study treatment

          -  If not received previously, vaccination against Streptococcus pneumoniae and
             Haemophilus influenzae infections should be given

        Exclusion Criteria:

          -  Prior treatment with a complement inhibitor, including anti-C5 antibody

          -  Known or suspected hereditary complement deficiency

          -  History of hematopoietic stem cell transplantation

          -  Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L;
             platelets <30x109/L; neutrophils <0.5x109/L).

          -  Active systemic bacterial, viral (incl. COVID-19)or fungal infection within 14 days
             prior to study drug administration.

          -  History of recurrent invasive infections caused by encapsulated organisms, e.g.
             meningococcus or pneumococcus.

          -  Major concurrent comorbidities including but not limited to severe kidney disease
             (e.g., dialysis), advanced cardiac disease (e.g., NYHA class IV heart failure), severe
             pulmonary disease (e.g., severe pulmonary hypertension (WHO class IV)), or hepatic
             disease (e.g., active hepatitis) that in the opinion of the investigator precludes
             participant's participation in the study.
Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab 300mg every 2 or every 4 weeks; Placebo 300mg every 2 or every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 545.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acne inversa; Hidradenitis suppurativa; maladie de Verneuil; inflammatory disease; AIN457; AIN457M; secukinumab; HS; lumps; skin; lesions

Summary:

      The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on
      Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the
      maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS.
      Moreover, this study assessed the safety and tolerability of secukinumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  -Written informed consent must be obtained before any assessment is performed.

          -  Male and female patients ≥ 18 years of age.

          -  Diagnosis of HS ≥ 1 year prior to baseline.

          -  Patients with moderate to severe HS defined as:

          -  A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules
             AND

          -  Inflammatory lesions should affect at least 2 distinct anatomic areas

          -  Patients agree to daily use of topical over-the-counter antiseptics on the areas
             affected by HS lesions while on study treatment.

        Exclusion Criteria:

          -  Total fistulae count ≥ 20 at baseline.

          -  Any other active skin disease or condition that may interfere with assessment of HS.

          -  Active ongoing inflammatory diseases other than HS that require treatment with
             prohibited medications.

          -  Use or planned use of prohibited treatment. Washout periods detailed in the protocol
             have to be adhered to.

          -  History of hypersensitivity to any of the study drug constituents.

          -  History of lymphoproliferative disease or any known malignancy or history of
             malignancy of any organ system treated or untreated within the past 5 years,
             regardless of whether there is evidence of local recurrence or metastases (except for
             skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been
             treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the
             cervix or non-invasive malignant colon polyps that have been removed).

          -  Pregnant or lactating women.
Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659/TEZ/IVA; IVA
Intervention description: VX-659/TEZ/IVA FDC tablet.; IVA mono tablet.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and
      pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple
      combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes.

      The study was discontinued after completion of Part A due to Sponsor's discretion.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex,
             and height.

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary
             status.

          -  Solid organ or hematological transplantation.

        Other protocol defined Inclusion/Exclusion criteria may apply.
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Nintedanib
Intervention description: Nintedanib twice a day
Intervention MeSH terms: Nintedanib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 752.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in
      patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the
      follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and
      1199.34), who wish to continue treatment with BIBF 1120.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed Informed Consent consistent with International Conference on Harmonisation-Good
             Clinical Practices (ICH-GCP) and local laws prior to trial participation.

          2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period
             and performed the follow-up visit.

        Exclusion criteria:

          1. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper
             Limit of Normal (ULN) (Patients who completed the parent trial with transaminase
             values > 1.5 fold ULN but < 3 fold ULN are considered eligible)

          2. Bilirubin > 1.5 fold ULN

          3. Bleeding risk

          4. Planned major surgery within the next 3 months, including lung transplantation, major
             abdominal or major intestinal surgery.

          5. New major thrombo-embolic events developed after completion of the parent trial.

          6. Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.

          7. Usage of any investigational drug after completion of the parent trial or planned
             usage of a specific investigational drug during the course of this trial.

          8. A disease or condition which in the opinion of investigator may put the patient at
             risk because of participation in this trial or limit the patients' ability to
             participate in this trial.

          9. Alcohol or drug abuse which in the opinion of the investigator would interfere with
             trial participation.

         10. Pregnant women or women who are breast feeding or of child bearing potential not using
             two effective methods of birth control (one barrier and one highly effective
             non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it
             until 3 months after end of treatment.
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: SB11 (Proposed ranibizumab biosimilar); Lucentis (ranibizumab)
Intervention description: SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks; Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 705.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a randomised, double-masked, parallel group, multicentre study to evaluate the
      efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in
      subjects with neovascular AMD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 50 years

          2. Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to
             AMD in the study eye

          3. BCVA of 20/40 to 20/200 in the study eye

          4. Written informed consent form

        Exclusion Criteria:

          1. Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to
             treat neovascular AMD in either eye

          2. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis,
             trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or
             pathologic myopia

          3. Any concurrent macular abnormality other than AMD in the study eye