bioihbjkbjnl/mcl2 huggingface dataset:
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: QAW039; Placebo
Intervention description: QAW039 once daily; Placebo once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 675.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: QAW039, uncontrolled asthma

Summary:

      A randomized, multicenter, double-blind, placebo- controlled parallel-group study to
      determine the efficacy and safety of QAW039, compared with placebo, when added to
      standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with
      uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1
      second (FEV1) at the end of 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.

          -  Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose
             ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor
             antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1
             and the doses have been stable for at least 4 weeks prior to Visit 1.

          -  FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18
             years.

          -  Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days
             of the placebo run- in period.

          -  Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in
             period.

          -  Demonstrated reversible airway obstruction.

          -  Asthma control questionnaire (ACQ) score ≥ 1.5.

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of enrollment, or within 30
             days, whichever is longer.

          -  A resting QTcF (Fridericia) ≥450 msec (male) or

             ≥460 msec (female).

          -  Pregnant or nursing (lactating) women.

          -  Serious co-morbidities.

          -  Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
             >2 mg of pitavastatin.

        Other protocol-defined inclusion/exclusion criteria may apply.
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Condition: Liver Disease
MeSH terms: Liver Diseases
Intervention: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate); Hepatic Venous Pressure Gradient (HVPG)
Intervention description: The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease; Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease
Intervention MeSH terms: Cholic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hepatic Venous Pressure Gradient (HVPG) testing; HepQuant-SHUNT; Liver Function

Summary:

      This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt
      (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to
      Hepatic Venous Pressure Gradient testing in patients with liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver disease patient scheduled to have an Hepatic Venous Pressure Gradient (HVPG)
             procedure

          -  At time of enrollment, being between the ages of 18 and 75

        Exclusion Criteria:

          -  Concomitant treatment with both a beta blocker and an ACE inhibitor

          -  Concurrent hepatic malignancy. Patients with a history of treated HCC can be included
             if there is no evidence of recurrent disease at the time of this study.

          -  Unstable angina or history of myocardial infarction or congestive heart failure within
             6 months prior to enrollment into this study

          -  Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min/1.73m2)

          -  Crohn's disease or any active intestinal inflammatory condition

          -  Having had an ileal resection

          -  Diabetic Gastroparesis

          -  Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed prior
             to HQ SHUNT testing.

          -  Inability to consent for one's self
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Placebo; Vilazodone
Intervention description: Viibryd
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder, GAD

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      relative to placebo in the treatment of generalized anxiety disorder (GAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatient, 18-70 years of age

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder

          -  Minimum score of 20 on Hamilton Rating Scale for Anxiety

        Exclusion Criteria:

          -  Women who are pregnant or who will be breastfeeding during the study

          -  Patients with a history of:

               1. Any manic or hypomanic or mixed episode, including bipolar disorder and
                  substance-induced manic, hypomanic or mixed episode

               2. Any depressive episode with psychotic or catatonic features

               3. Panic disorder with or without agoraphobia
A Controlled Trial of Erenumab in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo
Intervention description: Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Intervention MeSH terms: Erenumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 261.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the efficacy and safety of erenumab for prevention of
      migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent/assent prior to initiation of any study specific
             activities/procedures.

          -  Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age
             upon entry into screening.

          -  History of migraine (with or without aura) for greater than or equal to 12 months
             before screening according to the International Headache Society Classification ICHD-3
             (Headache Classification Committee of the International Headache Society, 2018) based
             on medical records and/or patient self-report

          -  Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months
             before screening based on the following criteria:

               1. CM is defined as greater than or equal to 15 headache days per month of which
                  greater than or equal to 8 headache days on average across the 3 months meet
                  criteria as migraine days

               2. EM is defined as less than 15 headache days per month of which at least 4 or more
                  headache days on average across the 3 months meet criteria as migraine days

        Exclusion Criteria:

          -  Subjects greater than 50 years of age at migraine onset.

          -  History of cluster headache or hemiplegic migraine headache.

          -  Unable to differentiate migraine from other headaches.

          -  Migraine with continuous pain, in which the subject does not experience any pain-free
             periods (of any duration) during the 1 month before the screening period.

          -  Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in
             situ within the last 5 years.

        Other exclusion criteria may apply
Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
Condition: Non-segmental Vitiligo
MeSH terms: Vitiligo
Intervention: Ruxolitinib cream; Vehicle
Intervention description: Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Vehicle cream is a topical formulation applied as a thin film to affected areas.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 330.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vitiligo; non-segmental; JAK inhibitor

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in
      adolescent and adult participants with non-segmental vitiligo for whom total body involved
      vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5%
             BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body
             vitiligo area (facial and nonfacial) not exceeding 10% BSA.

          -  Agree to discontinue all agents used to treat vitiligo from screening through the
             final safety follow-up visit. Over-the-counter preparations deemed acceptable by the
             investigator and camouflage makeups are permitted.

          -  Must be willing to take appropriate contraceptive measures to avoid pregnancy or
             fathering a child for the duration of study participation.

        Key Exclusion Criteria:

          -  No pigmented hair within any of the vitiligo areas on the face.

          -  Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or
             other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy,
             postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus,
             chemical leukoderma, and tinea versicolor).

          -  Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo
             or other pigmented areas.

          -  Use of protocol-defined treatments within the indicated washout period before
             baseline.
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: ponesimod; teriflunomide
Intervention description: film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning; film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning
Intervention MeSH terms: Teriflunomide; Ponesimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1133.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: relapsing multiple sclerosis

Summary:

      International clinical trial to compare ponesimod and teriflunomide in relapsing multiple
      sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

        Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010
        with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses).

        Subjects must have active disease evidenced by one or more MS attacks with onset within the
        period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset
        within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing
        (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization.

        Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be
        treatment-naïve or previously treated with MS disease modifying therapy.

        Exclusion Criteria:

        Subjects with significant medical conditions or therapies for such conditions (e.g.,
        cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating
        or pregnant women are not eligible to enter the study.

        Subjects with contraindications to MRI or with clinically relevant medical or surgical
        conditions that, in the opinion of the investigator, would put the subject at risk by
        participating in the study are not eligible to enter the study.
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Nivolumab; Docetaxel/Paclitaxel
Intervention MeSH terms: Paclitaxel; Docetaxel; Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 419.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable
      advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men & women ≥20 years of age

          -  Histologically confirmed unresectable advanced or recurrent esophageal cancer

          -  Refractory to or intolerant of standard therapy

          -  ECOG Performance Status score 0 or 1

          -  A life expectancy of at least 3 months

        Exclusion Criteria:

          -  Current or past history of severe hypersensitivity to any other antibody products

          -  Patients with multiple primary cancers

          -  Patients with any metastasis in the brain or meninx that is symptomatic or requires
             treatment

          -  Patients with active, known or suspected autoimmune disease
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Condition: Obesity; Overweight; Metabolism and Nutrition Disorder
MeSH terms: Obesity; Overweight; Nutrition Disorders
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have
      obesity or overweight.

      The main purpose is to learn more about how tirzepatide affects body weight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with
             at least one of the following comorbidities: hypertension, dyslipidemia, obstructive
             sleep apnea, cardiovascular disease

          -  Have a history of at least one self-reported unsuccessful dietary effort to lose body
             weight

        Exclusion Criteria:

          -  Have Diabetes Mellitus

          -  Have a self-reported change in body weight >5 kg within 3 months prior to screening

          -  Have obesity induced by other endocrinological disorders

          -  Have had a history of chronic or acute pancreatitis

          -  Have a history of significant active or unstable Major Depressive Disorder (MDD) or
             other severe psychiatric disorder within the last 2 years

          -  Have any lifetime history of a suicide attempt

          -  Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple
             endocrine neoplasia syndrome type 2 (MEN-2)
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma (ESCC)
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Intervention: Cisplatin; Oxaliplatin; Fluorouracil (5-FU); Capecitabine; Paclitaxel; Tislelizumab; Placebo
Intervention description: Administered IV; Administered IV; Administered IV; Administered orally; Administered IV; Administered IV; Placebo to match Tislelizumab
Intervention MeSH terms: Paclitaxel; Capecitabine; Fluorouracil; Oxaliplatin; Tislelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 649.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first
      line treatment in combination with chemotherapy in participants with advanced
      unresectable/metastatic esophageal squamous cell carcinoma (ESCC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Pathologically (histologically) confirmed diagnosis of ESCC

          2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced
             recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition),
             if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a
             treatment-free interval of at least 6 months is required.

        Key Exclusion Criteria:

          1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation

          2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC

          3. Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed
             cell death protein ligand-1 (PD-L1) or PD-L2

          4. Participants with evidence of fistula (either esophageal/bronchial or
             esophageal/aorta)

          5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent
             drainage or medical intervention (clinically significant recurrence requiring an
             additional intervention within 2 weeks of intervention)

          6. Evidence of complete esophageal obstruction not amenable to treatment

          7. Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional
             Risk Index (NRI) < 83.5 per investigator's choice

          8. Locally advanced esophageal carcinoma that is resectable or potentially curable with
             radiation therapy per local investigator.

          9. Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV)
             carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus
             (HCV)

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; CP-690,550
Intervention description: 5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.; 10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4488.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: long-term; open-label; safety

Summary:

      The purpose of this study is to determine the long-term effectiveness and safety of
      CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study
      only after participating in another "qualifying" study of CP-690,550

      A sub-study will be conducted within the A3921024 study, this study will evaluate the immune
      response to pneumococcal and influenza vaccines in patients receiving CP-690,550
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have participated in a randomized "qualifying" study of CP-690,550 for
             the treatment of rheumatoid arthritis

        Vaccine sub-study visit

          -  Subjects actively participating in Study A3921024 must have completed at least 3
             months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80%
             compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.

        Exclusion Criteria:

          -  Serious medical conditions that would make treatment with CP-690,550 potentially
             unsafe

        Vaccine sub-study visit

          1. Any documented influenza or pneumococcal infection within the last 3 months prior to
             randomization in this study

          2. Received any vaccine within 1 month prior to randomization in this study

          3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years
             of randomization in this study.