bioihbjkbjnl/mcl2 huggingface dataset:
Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Condition: Adjunctive Treatment of Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Pimavanserin; Placebo
Intervention description: Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily; Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily
Intervention MeSH terms: Pimavanserin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in
      subjects with major depressive disorder who have an inadequate response to antidepressant
      therapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients, aged 18 years and above

          2. A clinical diagnosis of major depressive disorder (MDD)

          3. Is being treated with one of the following SSRI or SNRI antidepressants:

               1. Citalopram

               2. Escitalopram

               3. Paroxetine

               4. Fluoxetine

               5. Sertraline

               6. Duloxetine

               7. Venlafaxine

               8. Desvenlafaxine

               9. Venlafaxine XR

          4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed

          5. If the subject is female, she must not be pregnant or breastfeeding. She must also be
             of non-childbearing potential OR must agree to use acceptable methods of contraception

        Exclusion Criteria:

          1. Has a history of psychotic disorder or is currently being treated or requires
             treatment for post-traumatic stress disorder, acute stress disorder, panic disorder,
             or obsessive compulsive disorder

          2. Has current evidence of delirium or an unstable neurological, cardiovascular,
             respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder,
             including cancer or malignancies that would affect the patient's ability to
             participate in the program

          3. Has a known history or symptoms of long QT syndrome

          4. Is determined to be inappropriate for the study for any reason

        Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to
        ensure that all criteria for study participation are met. Patients may be excluded from the
        study based on these assessments (and specifically, if it is determined that their baseline
        health and psychiatric condition do not meet all pre-specified entry criteria).
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Durvalumab; Tremelimumab (Regimen 1); Tremelimumab (Regimen 2); Sorafenib; Durvalumab (Regimen 1); Durvalumab (Regimen 2)
Intervention description: Durvalumab IV (intravenous infusion).; Tremelimumab IV (intravenous infusion).; Tremelimumab IV (intravenous infusion).; Sorafenib, as per standard of care; Durvalumab IV (intravenous infusion).; Durvalumab IV (intravenous infusion).
Intervention MeSH terms: Sorafenib; Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1324.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma Non-Resectable

Summary:

      This is a randomized, open-label, multi-center, global, Phase III study to assess the
      efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab
      monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for
      unresectable HCC. The patients cannot be eligible for locoregional therapy
    

Eligibility criteria:

        Inclusion criteria

          -  HCC based on histopathological confirmation

          -  No prior systemic therapy for HCC

          -  Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional
             therapy) or stage C

          -  Child-Pugh Score class A

          -  ECOG performance status of 0 or 1 at enrollment

        Exclusion criteria

          -  Hepatic encephalopathy within past 12 months or requirement for medication to prevent
             or control encephalopathy

          -  Clinically meaningful ascites

          -  Main portal vein tumor thrombosis

          -  Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding)
             within 12 months

          -  HBV and HVC co-infection, or HBV and Hep D co-infection
Patient-Reported Outcome Of Facial Erythema (PROOF)
Condition: Rosacea; Erythema
MeSH terms: Rosacea; Erythema
Intervention: Brimonidine tartrate was applied cutaneously once daily for 8 days.; Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of
      patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The
      feedback of patients receiving the active drug will be compared to the feedback of patients
      receiving the placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects age of 18 years or older

          -  A clinical diagnosis of facial rosacea

          -  A Patient Self-Assessment score of 4 (severe) at Baseline prior to the study drug
             application

          -  A Clinician's Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at
             Baseline prior to the study drug application

        Exclusion Criteria:

          -  More than 5 facial inflammatory lesions (papules or pustules) of rosacea

          -  Any uncontrolled chronic or serious disease or medical condition that may either
             interfere with the interpretation of the clinical trial results, or put the subject at
             significant risk if the subject participates in the clinical trial as judged by the
             investigator

          -  Known or suspected allergies or sensitivities to any component of the study drugs,
             including the active ingredient brimonidine tartrate (see Investigator's Brochure)

          -  Female who is pregnant or lactating
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis; Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic; Psoriasis
Intervention: Bimekizumab; Ustekinumab; Placebo
Intervention description: Bimekizumab will be provided at pre-specified time intervals.; Ustekinumab will be provided as dose 1 for subjects weighing <=100 kg and as dose 2 for subjects weighing >100 kg at pre-specified time intervals.; Subjects will receive Placebo at pre-specified time points.
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: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis

Summary:

      This is a study to compare the efficacy of bimekizumab versus placebo and an active
      comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis
      (PSO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age

          -  Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit

          -  Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
             >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

          -  Subject is a candidate for systemic PSO therapy and/or phototherapy

          -  Female subject of child bearing potential must be willing to use highly effective
             method of contraception

        Exclusion Criteria:

          -  Subject has an active infection (except common cold), a recent serious infection, or a
             history of opportunistic or recurrent chronic infections

          -  Subject has concurrent acute or chronic viral hepatitis B or C or human
             immunodeficiency virus (HIV) infection

          -  Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
             infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

          -  Subject has any other condition, including medical or psychiatric, which, in the
             Investigator's judgment, would make the subject unsuitable for inclusion in the study

          -  Presence of active suicidal ideation or positive suicide behavior

          -  Presence of moderately severe major depression or severe major depression

          -  Subject has any active malignancy or history of malignancy within 5 years prior to the
             Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
             carcinoma, or in situ cervical cancer
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Adjuvanted QIV (aQIV); Non-adjuvanted QIV
Intervention description: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1601.0
Sex: All
Minimum age: 12 Months
Maximum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza Vaccine; MF59 adjuvant

Summary:

      Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared
      to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial
      V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

        In order to participate in this study, all subjects must meet ALL of the inclusion criteria
        described.

          -  Subject's parent/legal guardian has voluntarily given written informed consent after
             the nature of the study has been explained according to local regulatory requirements,
             prior to study entry.

          -  Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve
             subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.

          -  For naïve subjects in parent trial V118_05 to have received two doses of the same
             study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).

        Exclusion Criteria:

          -  Previous immunization with any influenza vaccine (licensed or investigational) within
             6 months prior to enrollment.

          -  Subjects with a clinical condition representing a contraindication to intramuscular
             vaccination or blood draws.

          -  Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to
             participate in another clinical trial while enrolled in V118-05E3.

        Additional eligibility criteria may be discussed by contacting the site.
A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Condition: Lung Structure Determination
Intervention: Xe-133; Technegas
Intervention description: Xe-133 ventilation scintigraphy; Technegas ventilation scintigraphy
Intervention MeSH terms: Xenon
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Crossover Assignment
Intervention model description: Subjects will undergo standard of care Xe-133 ventilation scintigraphy per medical needs followed by investigational Technegas ventilation scintigraphy per protocol.
Masking: None (Open Label)
Masking description: Independent blinded readers will assess all ventilation scintigraphy images, masked as to subject identity and re-identified with a unique random code number (different code numbers for Xe-133 and Technegas images). The Xe-133 and Technegas images will be read in separate reading sessions in random order.
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pulmonary ventilation; ventilation scintigraphy

Summary:

      Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to
      Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas
      compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory
      distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per
      medical needs followed by Technegas ventilation imaging per study protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject at least 18 years of age.

          -  Subject is a candidate for ventilation imaging.

          -  Subject must be willing and able to provide informed consent.

          -  Subject must be stable and able to undergo Xe-133 planar imaging and Technegas planar
             imaging.

          -  Subject must be willing and agree to complete study procedures.

          -  Subject is using adequate birth control, if female and fertile. Adequate birth control
             is defined as surgical sterilization, hormone contraceptive use or intrauterine device
             (IUD).

          -  Female subject of child-bearing potential has a negative urine or serum pregnancy
             test.

          -  Subject has had or is scheduled to have a chest X-ray within 24 hours prior to the
             investigational imaging study.

        Exclusion Criteria:

          -  Subject has been administered any other radiopharmaceutical within a timeframe that
             might cause interference with study imaging.

          -  Subject is a pregnant or lactating female.

          -  Subject has received Technegas in the past.

          -  Subject has received an investigational drug within 30 days prior to dosing.

          -  Subject is hemodynamically unstable.
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
Condition: Hyperlipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bococizumab (PF-04950615; RN316); Placebo
Intervention description: 150 mg every 2 weeks, subcutaneous injection, 12 months; subcutaneous injection every 2 weeks for 12 months
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mixed dyslipidemia; high risk of cardiovascular events; multiple cardiovascular disease risk factors

Summary:

      This study is a multicenter, randomized study in subjects with high cholesterol receiving
      highly effective statins to assess the efficacy, safety and tolerability of Bococizumab
      (PF-04950615;RN316) to lower LDL-C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated with a statin.

          -  Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.

          -  High or very high risk of incurring a cardiovascular event.

        Exclusion Criteria:

          -  Pregnant or breastfeeding females.

          -  Cardiovascular or cerebrovascular event of procedures during the past 30 days.

          -  Congestive heart failure NYHA class IV.

          -  Poorly controlled hypertension.
Diabetes Prevention Program Outcomes Study
Condition: Diabetes Mellitus; Cancer; CVD
MeSH terms: Diabetes Mellitus
Intervention: DPPOS Group Lifestyle; Metformin; DPPOS Boost Lifestyle; Intensive Lifestyle Group Session
Intervention description: Quarterly group lifestyle sessions; Administered as 850mg twice per day, masked in DPP and open label in DPPOS; In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.; 16 session curriculum in group format. In DPP delivered to ILS as individual sessions
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open label phase for metformin
Enrollment: 2779.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: DPP; IGT; Prediabetes; Type 2 diabetes; Macrovascular disease; Microvascular disease; Lifestyle; Metformin; Obesity

Summary:

      The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an
      intensive lifestyle or metformin to prevent or delay the development of diabetes in a high
      risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of
      140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset
      by 58% and metformin reduced diabetes onset by 31%.

      DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable
      DPP participants. This group of participants is nearly 50% minority and represents the
      largest at risk population ever studied. Clinically important research questions remain that
      focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course
      of precisely known new onset diabetes, in particular regarding microvascular disease, CVD
      risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in
      minority populations.

      The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of
      the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and
      high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend
      annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on
      cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and
      import.
    

Eligibility criteria:

        Participation as a volunteer in the Diabetes Prevention Program (DPP).
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
Condition: Recurrent or Metastatic NPC
MeSH terms: Recurrence
Intervention: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy; Placebos
Intervention description: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy; placebo combine with chemotherapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 289.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to
      determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with
      gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as
      first-line treatment in patients with histological/cytological confirmation of recurrent or
      metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who
      fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized
      in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the
      combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3
      weeks (Q3W) in 3-week cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Age ≥ 18 years and ≤75 years.

          -  2. Histological/cytological confirmation of NPC.

          -  3. Primarily metastatic (stage IVB as defined by the International Union against
             Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition)
             or recurrent NPC that is not amenable for local regional treatment or curative
             treatment.

          -  4. At least 1 measurable lesion according to RECIST version 1.1.

          -  5. Life expectancy ≥ 3 months

        Exclusion Criteria:

          -  1. History of severe hypersensitivity reactions to other mAbs or any ingredient of
             JS001.

          -  2. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T
             lymphocyte associated protein 4 (CTLA4) receptor.

          -  3. Major surgical procedure other than for diagnosis of NPC within 28 days prior to
             randomization or anticipation of need for a major surgical procedure during the study

          -  4. History of hypersensitivity to gemcitabine or cisplatin or to any of the
             excipients.

          -  5. Female patients who are at pregnancy or lactation.