bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Docetaxel
Intervention MeSH terms: Docetaxel; Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 639.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab improves life expectancy compared
      to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have
      failed prior platinum-based doublet chemotherapy.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Disease progression experienced during or after one prior platinum containing doublet
             chemotherapy

          -  Stage IIIb/IV or recurrent disease

          -  Male and Female ≥ 18 years of age

          -  Measurable disease per RECIST 1.1

          -  Performance Status ≤ 1

        Exclusion Criteria:

          -  History of Carcinomatous meningitis

          -  Active Central nervous system (CNS) metastases

          -  History of auto immune diseases

          -  Prior treatment with Docetaxel

          -  Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or
             checkpoint pathways
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
Condition: Lateral Canthal Lines; Glabellar Lines
Intervention: MT10109L; Placebo
Intervention description: MT10109L will be injected into either the LCL, or both the LCL and GL.; Placebo will be injected into either the GL, or both the LCL and GL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines
      (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with
      moderate to severe LCL and GL.
    

Eligibility criteria:

        Inclusion Criteria:

        -Female participants must not be pregnant or planning to get pregnant and willing to
        minimize the risk of inducing pregnancy for the duration of the clinical study and
        follow-up period.

        Exclusion Criteria:

          -  Known immunization or hypersensitivity to any botulinum toxin serotype.

          -  Any medical condition that may put the participant at increased risk with exposure to
             MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function.

          -  History of facial nerve palsy.

          -  Any uncontrolled systemic disease.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study intervention).

          -  Anticipated need for surgery or overnight hospitalization during the study.

          -  Prior exposure to botulinum toxin of any serotype for any reason.

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study.

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.

          -  Participants who plan for an extended absence away from the immediate area of the
             study site that would preclude them from returning for all protocol-specified study
             visits.
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CT-P17 SC; Humira SC
Intervention description: Subcutaneous injection of Adalimumab 40mg every two weeks; Subcutaneous injection of Adalimumab 40mg every two weeks
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 648.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients
      With Active Rheumatoid Arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female aged 18 to 75 years old, both inclusive.

          -  Patient has had a diagnosis of rheumatoid arthritis according to the 2010 American
             College of Rheumatology(ACR)/EULAR classification criteria for at least 24 weeks prior
             to the first administration of the study drug .

        Exclusion Criteria:

          -  Patient who has previously received investigational or licensed product; biologic or
             targeted synthetic disease-modifying antirheumatic drugs for the treatment of
             rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any
             purposes.

          -  Patient who has allergies to any of the excipients of study drug or any other murine
             and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Condition: Clostridioides Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Ridinilazole; Vancomycin
Intervention description: Ridinilazole 200mg dosed BID for 10 days.; Vancomycin 125mg dosed QID for 10 days.
Intervention MeSH terms: Vancomycin; Ridinilazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Clostridioides difficile infection (CDI); ridinilazole; Adolescents; vancomycin; C. Diff; Clostridium difficile; Diarrhea; Infection; Pediatric

Summary:

      Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is
      metabolized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is aged 12 to <18 years.

          -  Has signs and symptoms of CDI including diarrhea such that in the Investigator's
             opinion CDI antimicrobial therapy is required, and the subject has tested positive for
             toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed
             bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea
             information is within 24 hours prior to randomization.

        Exclusion Criteria:

          -  Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment
             active against the current episode of CDI prior to randomization.

          -  Has received ridinilazole or an investigational vaccine against C. difficile any time
             in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or
             any other investigational medicinal product for treatment of CDI or fecal microbiota
             replacement therapy within the past 3 months.

          -  Has a clinically relevant positive stool test for pathogens other than C. difficile,
             within 48 hours of randomization.

          -  Has life-threatening or fulminant CDI with evidence of hypotension, septic shock,
             peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus.

          -  Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not
             including appendectomy or cholecystectomy) within past 3 months or has the presence of
             a colostomy or ileostomy or has the likely requirement of an ostomy during the study.

          -  Is receiving treatment that generally is associated with severe diarrhea, intractable
             vomiting, severe nausea, or inability to swallow that cannot be managed with
             antiemetics or antidiarrheals and that limits the ability to take oral medications.
             Cancer treatment that does not comprise ability to take study medication or cause
             severe diarrhea is allowed.
Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage
Condition: Abscess
MeSH terms: Abscess
Intervention: oral trimethoprim/sulfamethoxazole; Placebo
Intervention description: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days; Placebo caps or suspension every 12 hours for 10 days
Intervention MeSH terms: Trimethoprim; Sulfamethoxazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 90 Days
Maximum age: 18 Years
Healthy volunteers: No
Keywords: abscess; Abscesses in the pediatric emergency population

Summary:

      The purpose of the study is to compare rates of cure of abscesses with and without antibiotic
      treatment after incision and drainage. The purpose of this study is to compare successful
      rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus
      non-antibiotic treatment after incision and drainage.
    

Eligibility criteria:

        Inclusion Criteria:

        1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage
        2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae

        Exclusion Criteria:

          1. Multiple abscesses

          2. Abscess located on the hands, face, or perineum

          3. Abscess as a result of a bite wound

          4. Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10
             days), etc.

          5. Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug
             allergy to TMP/SMX

        7.) Fever > or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on
        presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis,
        etc.

        9.) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
Condition: Renal Cell Carcinoma (RCC)
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Pembrolizumab; Epacadostat; Sunitinib; Pazopanib
Intervention description: Pembrolizumab 200 mg administered intravenously every 3 weeks.; Epacadostat 100 mg administered orally twice daily.; Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.; Pazopanib 800 mg administered orally once daily.
Intervention MeSH terms: Pembrolizumab; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal cell carcinoma; programmed cell death 1 (PD-1) inhibitor; indoleamine 2; 3-dioxygenase 1 (IDO1) inhibitor

Summary:

      The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus
      epacadostat compared to sunitinib or pazopanib in participants with locally
      advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not
      received prior systemic therapy for their mRCC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic confirmation of locally advanced or metastatic RCC with a clear-cell
             component with or without sarcomatoid features.

          -  Must not have received any prior systemic therapy for their mRCC.

          -  Measurable disease based on RECIST v1.1.

          -  Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor
             lesion as required.

          -  Karnofsky performance status ≥ 70%.

          -  Adequate organ function per protocol-defined criteria.

        Exclusion Criteria:

          -  Use of protocol-defined prior/concomitant therapy.

          -  Currently receiving or has received an investigational treatment as part of a study of
             an investigational agent or has used an investigational device within 4 weeks before
             randomization.

          -  History of severe hypersensitivity reaction to study treatments or their excipients.

          -  Active autoimmune disease that has required systemic treatment in past 2 years.

          -  Known additional malignancy that has progressed or has required active treatment in
             the last 3 years.

          -  Known active central nervous system metastases and/or carcinomatous meningitis.

          -  History of (noninfectious) pneumonitis that required steroids or current pneumonitis.

          -  History or presence of an abnormal electrocardiogram that, in the investigator's
             opinion, is clinically meaningful.

          -  Significant cardiac event within 12 months before Cycle 1 Day 1.
Addressing Involuntary Movements in Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: SD-809; Placebo
Intervention description: SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.; Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms

Summary:

      The purpose of this study is to determine whether fixed-doses of an investigational drug,
      SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of
      tardive dyskinesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of using a dopamine receptor antagonist for at least 3 months

          -  Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months
             prior to screening

          -  Subjects with underlying psychiatric diagnosis are stable and have no change in
             psychoactive medications

          -  Have a mental health provider and does not anticipate any changes to treatment regimen
             in the next 3 months

          -  History of being compliant with prescribed medications

          -  Able to swallow study drug whole

          -  Be in good general health and is expected to attend all study visits and complete
             study assessments

          -  Female subjects must not be pregnant and must agree to an acceptable method of
             contraception throughout the study

        Exclusion Criteria:

          -  Currently receiving medication for the treatment of tardive dyskinesia

          -  Have a neurological condition other than tardive dyskinesia that may interfere with
             assessing the severity of dyskinesias

          -  Have a serious untreated or undertreated psychiatric illness

          -  Have recent history or presence of violent behavior

          -  Have unstable or serious medical illness

          -  Have evidence of hepatic impairment

          -  Have evidence of renal impairment

          -  Have known allergy to any component of SD-809 or tetrabenazine

          -  Has participated in an investigational drug or device trial and received study drug or
             device within 30 days

          -  Have acknowledged use of illicit drugs

          -  Have a history of alcohol or substance abuse in the previous 12 months
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mirikizumab; Placebo
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1281.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Interleukin-23 (IL-23) antibody; IL-23p19

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in
      participants with moderately to severely active ulcerative colitis (UC) who have had an
      inadequate response to, loss of response, or intolerant to conventional or biologic therapy
      for UC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of UC for at least 3 months prior to baseline.

          -  Confirmed diagnosis of moderately or severely active UC, as assessed by the modified
             Mayo score (MMS).

          -  Demonstrated an inadequate response to, a loss of response to, or an intolerance to
             conventional or to biologic therapy for UC.

          -  If female, must meet the contraception requirements.

        Exclusion Criteria:

          -  Participants with a current diagnosis of Crohn's disease or inflammatory bowel
             disease-unclassified (indeterminate colitis).

          -  Participants with a previous colectomy.

          -  Participants with current evidence of toxic megacolon.

          -  Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19
             antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Condition: Major Depressive Disorder; Nicotine Dependence; Depression
MeSH terms: Tobacco Use Disorder; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Fluoxetine; Dextrose
Intervention description: 20mg once daily for 16 weeks; Once daily for 16 weeks
Intervention MeSH terms: Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Tobacco Use Cessation; Antidepressants

Summary:

      The primary purpose of this study is to determine whether, among smokers with elevated
      depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun
      8 weeks prior to and extended throughout standard smoking cessation treatment with
      transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking
      cessation outcomes compared to sequential pharmacotherapy with placebo medication combined
      with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers
      with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower
      levels of depressive symptoms and negative mood and higher levels of positive mood
      immediately prior to and throughout the course of smoking cessation treatment relative to the
      placebo condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Regular smoker for at least one year

          -  Currently smokes at least 10 cigarettes per day

          -  Elevated depressive symptoms

          -  Uses no other tobacco products

        Exclusion Criteria:

          -  Current Axis I disorder, including Major Depressive Disorder

          -  Psychoactive substance abuse or dependence (excluding nicotine dependence) within past
             year

          -  Current use of psychotropic medication

          -  Use of antidepressant medication within past 6 months

          -  Current suicidal risk

          -  History of significant medical illness, such as cardiovascular disease, neurological,
             gastrointestinal, or other systemic illness

          -  Pregnancy or breast feeding

          -  Use of nicotine replacement therapy or of any medication for smoking cessation not
             provided by the researchers during the quit attempt
A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vilazodone
Intervention description: Vilazodone tablets, once daily, oral administration
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone
      for the treatment of MDD in pediatric outpatients (7-17 years).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female outpatients betw een 7-17 years of age

          -  Primary diagnosis of major depressive disorder (MDD)

          -  Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

          -  Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

        Exclusion Criteria:

          -  Current (past 3 months) principal Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other
             than MDD that is the primary focus of treatment (de novo patients only)

          -  History of suicidal behavior, or requires precaution against suicide

          -  Not generally healthy medical condition

          -  Seizure disorder