bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Preoperative N1539 in Colorectal Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: N1539; Placebo
Intervention description: Once Daily; Once Daily
Intervention MeSH terms: Meloxicam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Colorectal surgery; Pain; Analgesia; N1539; Phase 3b

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of
      preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including
      clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and
      incidence of Adverse Events (AEs) and Serious AEs (SAEs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily provide written informed consent.

          -  Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal
             surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection
             and/or anastomosis.

          -  ASA physical status category 1, 2, or 3.

          -  Female subjects not pregnant or planning/attempting to become pregnant, not lactating;
             or commits to the use of an acceptable form of birth control for the duration of the
             study.

          -  Have a body mass index <40 kg/m^2

        Exclusion Criteria:

          -  Have a known allergy or hypersensitivity to any study treatment.

          -  Planned surgical procedure includes a resection beyond the peritoneal reflection, is
             related to an acute bout of diverticulitis, or is associated with an emergency
             procedure.

          -  Have a history of myocardial infarction within the preceding 12 months.

          -  Have, as determined by the investigator or the sponsor's medical monitor, a history or
             clinical manifestations of significant condition that would preclude participation.

          -  Have active or recent (within 6 months) gastrointestinal ulceration or bleeding, with
             exception of events related to an ulcerative colitis diagnosis.

          -  Have a known bleeding disorder which may be worsened with the administration of an
             NSAID.

          -  Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within
             48 hours prior to surgery.

          -  Have previously received N1539/IV meloxicam or received any investigational product
             within 30 days before dosing with study medication.

          -  Have undergone or be expected to undergo radiation therapy, chemotherapy, or other
             biological therapy for cancer treatment, within 60 days prior to screening through
             last follow-up.
Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Intervention: BAF312; Placebo
Intervention description: 0.25, 0.5, 1, and 2 mg film-coated tablets; Film-coated tablets
Intervention MeSH terms: Siponimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1653.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Secondary Progressive Multiple Sclerosis

Summary:

      Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment
      duration in patients with secondary progressive multiple sclerosis (Core Part) followed by
      extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability
      and efficacy (Extension Part).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior history of relapsing remitting MS

          -  SPMS defined as progressive increase of disability over at least 6 months

          -  EDSS score of 3.0 to 6.5

          -  No relapse of corticosteroid treatment within 3 months

        Exclusion Criteria:

          -  Women of child bearing potential must use reliable forms of contraception.

          -  Diagnosis of Macular edema during screening period

          -  Any medically unstable condition determined by investigator.

          -  Unable to undergo MRI scans

          -  Hypersensitivity to any study drugs or drugs of similar class Other protocol defined
             inclusion/exclusion may apply.
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Baricitinib; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2877.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the long-term safety and any side effects of
      baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis
      study.

      The study provides 7 years of additional treatment with baricitinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the final active treatment in study JADV (NCT01710358), JADZ
             (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS
             (NCT02265705)

        Exclusion Criteria:

          -  Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI],
             unstable angina, unstable arterial hypertension, severe heart failure, or
             cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine,
             hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed
             during a previous baricitinib study that, in the opinion of the investigator, pose an
             unacceptable risk to the participant if investigational product continues to be
             administered

          -  Have a known hypersensitivity to baricitinib or any component of this investigational
             product

          -  Had investigational product permanently discontinued at any time during a previous
             baricitinib study

          -  Had temporary investigational product interruption at the final study visit of a
             previous baricitinib study and, in the opinion of the investigator, this poses an
             unacceptable risk for participation in the study

          -  Have any other condition that, in the opinion of the investigator, renders the
             participant unable to understand the nature, scope, and possible consequences of the
             study or precludes the participant from following and completing the protocol
Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Dapsone Gel; Dapsone Gel Vehicle
Intervention description: Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.; Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Intervention MeSH terms: Dapsone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2238.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of dapsone gel versus vehicle control in
      patients with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acne vulgaris

          -  Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight,
             tanning beds) throughout the study

        Exclusion Criteria:

          -  Severe cystic acne, acne conglobata, acne fulminans, or secondary acne

          -  Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive
             cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling,
             comedo extraction) in the past week

          -  Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics,
             antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]),
             retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps
             such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium
             sulfacetamide) in the past 2 weeks

          -  Use of birth control pills strictly for acne control
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab; Cabozantinib; Sunitinib; Ipilimumab
Intervention description: Specified dose on specified day; Specified dose on specified days; Specified dose on specified days.; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 701.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is
      safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal
      cell carcinoma
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histological confirmation of RCC with a clear-cell component, including participants
             who may also have sarcomatoid features

          -  Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC
             Stage IV) RCC

          -  No prior systemic therapy for RCC with the following exception:

             i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such
             therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence
             occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

        Exclusion Criteria:

          -  Any active CNS metastases

          -  Any active, known or suspected autoimmune disease

          -  Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily
             prednisone equivalent) or other immunosuppressive medications within 14 days of
             randomization

          -  Participants who have received a live/attenuated vaccine within 30 days of first
             treatment

        Other protocol defined inclusion/exclusion criteria could apply
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Condition: Opioid-Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: NKTR-118; NKTR-118; Placebo
Intervention description: 12.5 mg oral tablet once daily; 25 mg oral tablet once daily; Oral tablet intake once daily
Intervention MeSH terms: Naloxegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Non-Cancer-Related Pain; Opioid-Induced Constipation.

Summary:

      The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of
      opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have completed the 12-week study D3820C00004 through Visit 8.

          -  Provision of written informed consent prior to any study-specific procedures.

          -  Men and women who were between the ages of >18 and <85 years at the time of the
             screening visit for study D3820C00004.

          -  Continuing to receive a stable maintenance opioid regimen consisting of a total daily
             dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more
             other opioid therapies.

          -  Willingness to continue abstinence from all laxatives and other bowel regimens
             including prune juice and herbal products throughout this additional 12-week treatment
             period, and to use only bisacodyl as rescue medication if a bowel movement (BM) has
             not occurred within at least 72 hours of the last recorded BM.

        Exclusion Criteria:

          -  Patients receiving opioid regimen for treatment of pain related to cancer.

          -  History of cancer within 5 years from the screening visit of study D3820C00004 with
             the exception of basal cell cancer and squamous cell skin cancer.

          -  Medical conditions and treatments associated with diarrhea, intermittent loose stools,
             or constipation.

          -  Other issues related to the gastrointestinal tract that could impose risk to the
             patient.

          -  Pregnancy or lactation.
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
Condition: Hepatitis B; Chronic Disease
MeSH terms: Infections; Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Chronic Disease
Intervention: entecavir; adefovir
Intervention description: Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks; Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks
Intervention MeSH terms: Entecavir; Adefovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: chronic hepatitis B infection

Summary:

      The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV)
      compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an
      antiviral medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis B treatment naive

          -  Compensated liver disease
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Buprenorphine; Buprenorphine; oxycodone immediate-release
Intervention description: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear; Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear; Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Intervention MeSH terms: Oxycodone; Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis, opioid, transdermal

Summary:

      The objective of this study is to demonstrate the effectiveness and tolerability of the
      buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal
      system (5 mg) and oxycodone immediate release in subjects with moderate to severe
      osteoarthritis pain currently treated with oral opioids. The double-blind treatment
      intervention duration is 12 weeks during which time supplemental analgesic medication
      (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in
      addition to study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by
             radiographic evidence within the last 2 years.

          -  Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.

        Exclusion Criteria:

          -  Not currently taking and tolerating opioids.

          -  Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days
             of enrollment.

          -  Requiring frequent analgesic therapy for chronic condition(s), in addition to
             osteoarthritis.

        Other protocol-specific exclusion/inclusion criteria may apply.
Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD0271 0.3% / CD1579 2.5%; CD0271 0.1% / CD1579 2.5%; Topical Gel Vehicle
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 503.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The study hypothesis are based on the assumption that :

        -  CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical
           Gel Vehicle in the overall population and in the subgroup of severe Subjects

        -  CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable
           safety and tolerability profile
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, who is 12 years of age or older at Screening visit.

          2. Clinical diagnosis of acne vulgaris with facial involvement.

          3. An IGA of Moderate (3) or Severe (4) at Baseline visit.

          4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on
             the face (including the nose) at Baseline visit.

          5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and
             closed comedones) on the face (including the nose) at Baseline visit.

        Exclusion Criteria:

          1. More than 2 acne nodules on the face at Baseline visit.

          2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
             nodulo cystic acne, or acne requiring systemic treatment.

          3. Underlying diseases or other dermatologic conditions that require the use of
             interfering topical or systemic therapy or that might interfere with study assessments
             such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This
             includes clinically significant abnormal findings, uncontrolled or serious disease, or
             any medical or surgical condition, that may either interfere with the interpretation
             of the clinical trial results, and/or put the subject at significant risk (according
             to Investigator's judgment) if he/she participates in the clinical trial.

          4. The subject has received, applied or taken some specified treatments within the
             specified timeframe prior to the Baseline visit

          5. The subject is unwilling to refrain from use of prohibited medication during the
             clinical trial.

          6. Use of hormonal contraceptives solely for control of acne.
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.