bioihbjkbjnl/mcl2 huggingface dataset:
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Condition: Gingival Diseases
MeSH terms: Gingival Diseases
Intervention: Fluoride; Triclosan/Fluoride toothpaste; Fluoride; Fluoride; antibacterial plant extract
Intervention description: Brush twice daily; Brush twice daily; Brush twice daily; Brush twice daily; Brush twice daily
Intervention MeSH terms: Honokiol; Triclosan; Anti-Bacterial Agents; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a
      4-day brushing regiment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers 18-65 years of age.

          -  Good general health.

          -  Must sign informed consent form.

          -  Must discontinue oral hygiene on the mornings of each appointment and between sampling
             periods.

          -  No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

        Exclusion Criteria:

          -  Medical condition which requires pre-medication prior to dental procedures/visits.

          -  Medical condition which precludes eating/drinking for 12 hrs.

          -  History of allergy to common dentifrice ingredients.

          -  Subjects unable or unwilling to sign the informed consent form.

          -  Moderate or advanced periodontal disease.

          -  Two or more decayed untreated dental sites at screening.

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that can currently affect salivary flow.

          -  Current use of antibiotics.

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

          -  Pregnant or nursing women.

          -  Participation in any other clinical study within 30 days prior to enrollment into this
             study.

          -  Use of tobacco products.

          -  Subjects who must receive dental treatment during the study dates.

          -  Current use of Antibiotics for any purpose.

          -  Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Condition: Lumbosacral Radicular Pain
MeSH terms: Radiculopathy
Intervention: SP-102; Placebo
Intervention description: injection; injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: lumbosacral radicular pain; sciatica; leg pain

Summary:

      This is a research study of SP-102, an experimental medication designed to relieve pain in
      patients with a specific type of leg pain. The medication is given once by your healthcare
      professional, with a possibility of a second injection as early as about 1 month after the
      first treatment.

      The purpose of the study is to measure how well a single injection of the experimental
      medication, SP-102, relieves pain. The study will also investigate the side effects of
      SP-102.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Able and willing to read, write, and understand the English language and provide
             English language written informed consent prior to beginning any study procedures.

          -  Age 18 to 70 years (inclusive) at the Screening Visit.

          -  A diagnosis of lumbosacral radicular pain (sciatica).

          -  Agrees to follow study-specific medication requirements.

          -  If sexually active and a female of child-bearing potential or a male capable of
             bearing a child, agrees to use an effective method of birth control during the study.

          -  Has reviewed all study specific materials and has, in the opinion of the Investigator,
             the abilities to understand and appropriately complete all study procedures.

        Main Exclusion Criteria:

          -  Has radiologic evidence of a condition that would compromise study outcomes.

          -  Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention
             while in the study.

          -  Has been diagnosed with insulin dependent diabetes mellitus.

          -  Presence of any other disorder, condition or circumstance (including secondary gain)
             that, in the opinion of the Investigator, has the potential to prevent study
             completion and/or to have a confounding effect on outcome assessments.

          -  Use of any investigational drug and/or device within 30 days, or is scheduled to
             receive an investigational drug other than blinded study drug during this study.

          -  Has a body mass index ≥40 kg/m2.
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab 3 mg/kg IV; Ipilimumab 1 mg/kg IV; Nivolumab 1 mg/kg IV; Ipilimumab 3 mg/kg IV; Nivolumab 6 mg/kg IV
Intervention description: Followed by Nivolumab monotherapy; Followed by Nivolumab monotherapy; A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to ~ 480mg.
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 387.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate two different dose combinations of nivolumab and
      ipilimumab in the treatment of melanoma.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subject must have been diagnosed with stage III or/and stage IV histologically
             confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that
             is unresectable or metastatic

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Subject has not been treated by systemic anticancer therapy for unresectable or
             metastatic melanoma

        Exclusion Criteria:

          -  Subjects with active brain metastases or leptomeningeal metastases

          -  Subjects with ocular melanoma

          -  Subjects with active, known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Enoxaparin; Placebo: tablet of Rivaroxaban; Placebo: syringes of Enoxaparin
Intervention description: Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.; Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.; Placebo tablet of rivaroxaban administered once daily in the evening.; Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
Intervention MeSH terms: Enoxaparin; Rivaroxaban; Enoxaparin sodium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention of venous thromboembolism

Summary:

      The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is
      safe and prevents blood clot which may form after a knee replacement operation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients aged 18 years or above

          -  Patients scheduled for elective total knee replacement

        Exclusion Criteria:

          -  Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular
             Weight Heparin (LMWH)

          -  Contraindication listed in the labeling or conditions precluding subject treatment
             with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please
             refer to the local label of enoxaparin in your country)

          -  Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to
             contrast media)
Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: Sufentanil NanoTab PCA System/15 mcg; Placebo Sufentanil NanoTab PCA System
Intervention description: 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours.; Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours.
Intervention MeSH terms: Sufentanil; Dsuvia
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 419.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA
      System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute
      moderate to severe post-operative pain after total unilateral knee or total unilateral hip
      replacement surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients who are 18 years of age or older

          -  Patients who are scheduled for an elective cemented or uncemented total unilateral
             knee replacement or total unilateral hip replacement, under general or spinal
             anesthesia that does not include use of an intrathecal opioid

          -  Post-surgical patients who have been admitted to the PACU and are expected to remain
             hospitalized and to have acute post-operative pain requiring parenteral opioids for at
             least 48 hours after surgery

        Exclusion Criteria:

          -  Patients who have undergone a replacement of the same knee or hip

          -  Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
             of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
             surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg
             hydrocodone per tablet)

          -  Patients with an allergy or hypersensitivity to opioids
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab (75 mg); Secukinumab (150 mg); Placebo Comparator
Intervention description: Secukinumab (75 mg); Secukinumab (150 mg); Placebo Comparator
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 606.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic arthritis; PsA; ACR; CASPAR

Summary:

      This study will assess the efficacy and safety of secukinumab in patients with active
      psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs,
      DMARDs and / or TNFα inhibitor therapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or non-pregnant, non-lactating female patients at least 18 years of age

          -  Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months
             with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and
             ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)

          -  Rheumatoid factor and anti-CCP antibodies negative

          -  Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm
             diameter or nail changes consistent with psoriasis or documented history o plaque
             psoriasis

        Exclusion criteria:

          -  Chest X-ray with evidence of ongoing infectious or malignant process

          -  Subjects who have previously been treated with more than 3 different TNFα inhibitors

          -  Subjects taking high potency opioid analgesics

          -  Subjects who have ever received biologic immunomodulating agents except for those
             targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab; Placebo; Placebo; Secukinumab
Intervention description: 300 mg secukinumab; Placebo followed by 300 mg secukinumab; Placebo followed by 150 mg secukinumab; 150 mg secukinumab
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg
      secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on
      endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in
      subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers were assessed to
      evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging
      (MRI) was performed in a sub-population to assess the treatment effect on arterial vessel
      wall morphometry in atherosclerosis prone vascular beds.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic moderate to severe plaque type psoriasis for at least 6 months prior to
             randomization with a Psoriasis Area and Severity Index (PASI) score ≥ 10 at
             randomization.

          -  Inadequate response, intolerance or contraindication to cyclosporine, methotrexate and
             psoralen plus ultraviolet A light treatment (PUVA) as documented in the patient's
             medical history or reported by the patient or determined by the investigator at
             screening. Relative contraindications such as interference of patient's lifestyle with
             the treatment are accepted.

        Key Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
             guttata psoriasis) at screening or randomization.

          -  Ongoing use of prohibited psoriasis and non-psoriasis treatments.
MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: L50/H12.5/A5; L50/H12.5; Placebo to L50/H12.5/A5; Placebo to L50/H12.5
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 286.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Essential hypertension; Antihypertensive agents; Blood pressure; Uncontrolled hypertension

Summary:

      This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan
      potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg
      [A5]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in
      Japanese participants. In the second part, the safety and tolerability of long-term use of
      open-label MK-0954E in participants with hypertension will be evaluated. The primary
      hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood
      pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese
      participants with essential hypertension who are not adequately controlled following a 8-week
      treatment with filter period study drug of MK-954H.
    

Eligibility criteria:

        Inclusion criteria:

          -  Participant has a diagnosis of essential hypertension

          -  Participant is being treated with a single, or dual combination treatment for
             hypertension and will be able to discontinue the prior antihypertensive medication

          -  Participant has a mean trough SiDBP of ≥ 90 mmHg and < 110 mmHg

          -  Participant has a mean trough SiSBP of ≥ 140 mmHg and < 200 mmHg

          -  Participant has no clinically significant abnormality at screening visit

        Exclusion criteria:

          -  Participant is currently taking >2 antihypertensive medications

          -  Participant has a history of significant multiple and/or severe allergies to
             ingredients of Nu-Lotan or Preminent, amlodipine or dihydropyridine drug and thiazide
             drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)

          -  Participant is, at the time of signing informed consent, a user of recreational or
             illicit drugs or has had a recent history within the last year of drug or alcohol
             abuse or dependence

          -  Participant is pregnant or breastfeeding, or expecting to conceive OR the pregnancy
             test is positive at screening visit (Visit 1)

          -  Participant is currently participating or has participated in a study with an
             investigational compound or device within 30 days of signing informed consent
Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood
Condition: Coronary Artery Disease; Coronary Heart Disease; Dyslipidemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Dyslipidemias
Intervention: ABT-335; Placebo; Atorvastatin
Intervention description: Capsule; Capsule; Capsule
Intervention MeSH terms: Choline; Atorvastatin; Fenofibric acid; Fenofibrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 682.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to test the effect and safety of once daily ABT-335 on
      the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients
      with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol
      ("bad cholesterol") after taking atorvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with mixed dyslipidemia

          -  Qualifying cIMT thickness

        Exclusion Criteria:

          -  Patients with certain chronic or unstable medical conditions.

          -  Patients with unstable dose of medications or receiving coumadin, cyclosporine, or
             certain other medications

          -  Pregnant or lactating women or women intending to become pregnant

          -  Patients with diabetes mellitus that is poorly controlled
An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
Condition: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Intervention: Ravulizumab
Intervention description: Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.
Intervention MeSH terms: Ravulizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: External Placebo-Controlled, Open-Label Design
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Devic's Disease; Transverse Myelitis; Optic Neuritis; Relapse; Ravulizumab; Ultomiris; ALXN1210; CNS Autoimmune Disorders; Demyelinating Disorders; NMO; NMOSD

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for
      the treatment of adult participants with NMOSD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015
             international consensus diagnostic criteria.

          2. At least 1 attack or relapse in the last 12 months prior to the Screening Period.

          3. Expanded Disability Status Scale score ≤7.

          4. Participants who enter the study receiving supportive immunosuppressive therapy must
             be on a stable dosing regimen of adequate duration prior to Screening.

          5. Body weight ≥40 kilograms.

          6. Contraceptive use by men or women should be consistent with local regulations
             regarding the methods of contraception for those participating in clinical studies.

        Exclusion Criteria:

          1. History of neisseria meningitidis infection.

          2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody
             titer).

          3. Previously or currently treated with a complement inhibitor.

          4. Use of rituximab or mitoxantrone within 3 months prior to Screening.

          5. Use of IV immunoglobulin within 3 weeks prior to Screening.