bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Octagam 10%
Intervention description: Octagam 10% was supplied as a ready-to-use solution in glass bottles.
Intervention MeSH terms: Immunoglobulins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for
      intravenous administration. Octagam 5% is currently registered in about 80 countries. This
      study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura
      (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that
      Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria.

          -  Platelet count ≤ 20 x 10^9/L.

        Key Exclusion Criteria:

          -  Chronic refractory ITP patients.

          -  Thrombocytopenia secondary to other diseases, or drug related thrombocytopenia.

          -  Administration of IGIV, anti-D, or other platelet enhancing drugs within 30 days
             before enrollment.

          -  Administration of thrombocyte concentrates within 72 hours before baseline.

          -  Experimental treatment (eg, rituximab) within 3 months before enrollment.

          -  Prophylactic preoperative treatment for elective splenectomy.

          -  Severe liver or kidney disease.

          -  Pregnant or nursing female.

          -  History of hypersensitivity to blood or plasma derived products.

          -  Emergency operation.

          -  Live viral vaccination within the last month prior to study entry.

          -  Known IgA deficiency and antibodies against IgA.
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
Condition: Chalazion
MeSH terms: Chalazion
Intervention: SUN-131 1.5% TDS; Placebo TDS
Intervention description: SUN-131 1.5% TDS will be worn for 14 days; No active substance; Placebo TDS will be worn each day for 14 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 263.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5%
      TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The
      purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared
      with placebo TDS in the treatment of a chalazion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects aged ≥ 6 years of either sex and of any race

          2. Subjects with a diagnosis of a single chalazion

          3. Subjects with chalazion erythema score of ≥ 1

          4. Normal eyelid function without active signs of eye and eyelid infection in either eye.

          5. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid

          6. Avoid wearing contact lenses in the study eye

        Exclusion Criteria:

          1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal
             surrounding lid tissue, associated loss of tissues).

          2. History of chalazion incision and curettage in study eyelid.

          3. Multiple chalazia in any one eyelid.

          4. Active ocular or eyelid infection Presence of hordeolum in any one eyelid.

          5. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic
             dermatitis, etc.) where the study drug will be applied.

          6. Diagnosed with glaucoma in either eye.

          7. History of steroid-induced elevation of IOP.

          8. Female subjects who are pregnant or lactating.
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
Condition: Hypertension With Renal Dysfunction
MeSH terms: Renal Insufficiency; Hypertension
Intervention: LCZ696
Intervention description: 100 mg, 200 mg, 400 mg tablets.
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hypertension; Renal dysfunction; LCZ696

Summary:

      This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients
      with renal dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal findings: Hypertensive patients with renal dysfunction and stable renal
             condition at least 4 weeks before screening visit.

          -  Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline.

        Exclusion Criteria:

          -  Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.

          -  History of angioedema, drug-related or otherwise, as reported by the patient.

          -  Any other following renal disorder:

          -  Patients show eGFR < 15mL/min/1.73m^2

          -  Patients on dialysis

          -  Patients who previously entered a LCZ696 study and had been randomized or enrolled
             into the active drug treatment epoch.

        Other protocol-defined inclusion/exclusion criteria may apply.
Stopping Cavities Study: Diammine Silver Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: 38% diammine silver fluoride; Water
Intervention description: treatment of cavity with study agent; Fluoride free, distilled water
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 24 Months
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: silver diamine fluoride; diammine silver fluoride; children

Summary:

      This study is being conducted to test whether the use of diammine silver fluoride (also
      called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nyvad criteria 3

          -  Active carious lesion

        Exclusion Criteria:

          -  Allergy to silver

          -  Stomatitis or oral ulcerative condition

          -  Weight less than 15 kg
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
Condition: Hormone Refractory Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Intervention: Denosumab; Placebo
Intervention description: Administered by subcutaneous injection; Same volume subcutaneous injection
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1435.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone refractory prostate cancer; androgen independent; ADT; bone metastasis

Summary:

      The purpose of this study is to compare the treatment effect of denosumab with placebo on
      prolonging bone metastasis-free survival in men with hormone refractory (androgen
      independent) prostate cancer who have no bone metastasis at baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men with histologically confirmed prostate cancer

          -  bilateral orchiectomy at least 6 months before randomization or continuous
             androgen-deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH)
             agonist or antagonist for at least 6 months before randomization

          -  total testosterone level less than 50 ng/dL,

          -  hormone refractory (androgen independent) prostate cancer demonstrated during
             continuous ADT/post-orchiectomy defined as: 3 consecutive prostate-specific antigen
             (PSA) values with PSA1 < PSA2 < PSA3, each PSA value must be separated by at least 2
             weeks, PSA2 and PSA3 greater than or equal to 1.0 ng/mL,

          -  high risk for development of bone metastasis defined as PSA value greater than or
             equal to 8.0 ng/mL, obtained no more than 3 months before randomization OR PSA
             doubling time less than or equal to 10.0 months

        Exclusion Criteria:

          -  prior or current evidence of radiographically detectable bone metastasis

          -  known prior or current evidence of any metastatic involvement of distant organs (lymph
             node metastases in any region is acceptable)

          -  prior or current intravenous bisphosphonate administration
Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Intervention: Ketamine; Placebo
Intervention description: sub-dissociative ketamine; Normal Saline
Intervention MeSH terms: Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a prospective, randomized controlled trial which will be conducted to determine
      whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with
      chronic pain syndrome presenting to the emergency department with exacerbation of their
      chronic pain. The investigators also aim to determine whether use of SDDK can reduce the
      amount of subsequent opioid pain medications required for adequate pain relief in this
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult subjects over the age of 18 with chronic pain* presenting to the emergency
             department with exacerbation of their chronic pain as their primary complaint

          -  Subjects who are willing and able to provide informed consent. *Chronic pain defined
             as greater > 3 months of symptoms and an initial VAS pain score > 70

        Exclusion Criteria:

          -  History of overt psychosis, severe hypertension as defined by Systolic Blood Pressure
             > 180 mm Hg or Diastolic Blood Pressure >110 mm Hg, unstable angina, Coronary Artery
             Disease, Congestive Heart Failure, porphyrias, thyroid disease, seizure disorder,
             inability to provide informed consent: dementia, non-English/Spanish speakers,
             subjects in custody, suicidal, or clinically intoxicated.
A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Tazarotene Cream 0.05%; TAZORAC® (tazarotene) Cream 0.05%; Placebo
Intervention description: Tazarotene Cream 0.05% to cover only the lesions with a thin film.; TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.; Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 855.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing
      Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a
      Vehicle Control in the Treatment of Stable Plaque Psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis,
             involving at least 2% and no more than 20% of the body surface area (BSA) (not
             including the scalp and intertriginous areas)

          -  Have a minimum plaque elevation at the target lesion site of at least moderate
             severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe
             lesion at baseline should be identified as the target lesion

          -  Have an Investigator's Global Assessment (IGA) of disease severity of at least
             moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

        Exclusion Criteria:

          -  A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to
             use an acceptable form of birth control within the study participation period

          -  Have a current diagnosis of unstable forms of psoriasis in the treatment area,
             including pustular, guttate, exfoliative or erythrodermic psoriasis

          -  Have a history of psoriasis unresponsive to topical treatments
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
Condition: Hereditary Periodic Fevers
MeSH terms: Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Amyloidosis; Fever
Intervention: Canakinumab; Placebo
Intervention description: Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution.; Matching placebo to canakinumab solution for subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 1 Month
Healthy volunteers: No
Keywords: Canakinumab, interleukin-1, Hereditary Periodic Fevers, auto-inflammatory diseases

Summary:

      This study is to determine whether canakinumab is able to induce and maintain a clinically
      meaningful reduction of disease activity in participants with Hereditary Periodic Fevers
      (HPF) compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria: - Patient's written informed consent (or parent's written informed
        consent in case of pediatric patient) at screening - Male and female patients at least 2
        years of age at the time of the screening visit. Male and female patients >28 days but <2
        years eligible for open label treatment only. - Confirmed diagnosis and active flare at
        randomization - CRP >10mg/L at randomization

        Exclusion Criteria: - Use of the following therapies (within varying protocol defined
        timeframes): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF
        inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine,
        intravenous immunoglobulin, 6-Merceptopurine, azathioprine, cyclophosphamide, or
        chlorambucil, any other investigational biologics - History of malignancy of any organ
        system (other than localized basal cell carcinoma of the skin or in - situ cervical
        cancer), treated or untreated - Significant medical diseases, including but not limited to
        the following: a. History of organ transplantation b. Elevated liver enzymes ≥3x ULN d.
        Increase in total bilirubin e. Serious hepatic disorder (Child-Pugh scores B or C) f.
        Chronic Kidney Disease g. Thyroid disease h. Diagnosis of active peptic ulcer disease i.
        Coagulopathy j. Significant CNS effects including vertigo and dizziness - Any conditions or
        significant medical problems which immunecompromise the patient and/or places the patient
        at unacceptable risk for immunomodulatory therapy - Live vaccinations within 3 months prior
        to the start of the trial, during the trial, and up to 3 months following the last dose
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Condition: Other Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Indomethacin; Indomethacin; Indomethacin; Celecoxib; Placebo
Intervention description: 40 mg TID capsules; 40 mg BID capsules; 20 mg TID capsules; 200 mg capsules; Capsules
Intervention MeSH terms: Celecoxib; Indomethacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 462.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and
      effective for the treatment of postoperative bunionectomy pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female between 18 and 65 years of age

          -  For women of child-bearing potential: a woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

          -  Has undergone primary, unilateral, first metatarsal bunionectomy with no additional
             collateral procedures

          -  Patient must be willing to stay at the study site ≥ 72 hours

        Exclusion Criteria:

          -  Patient has hypersensitivity, allergy, or clinically significant intolerance to any
             medications to be used in the study, or related drugs

          -  Patient has a current disease or history of a disease that will impact the study or
             the patient's well-being

          -  Patient has used or intends to use any of the medications that are prohibited by the
             protocol

          -  Patient has a history of drug or alcohol abuse or dependence, or patient has a
             positive urine drug screen or alcohol breathalyzer test

          -  Patient has taken another investigational drug within 30 days prior to screening
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis; Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab; Adalimumab; Placebo
Intervention description: Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.; Adalimumab will be administered according to the labeling recommendations.; Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
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: 478.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis

Summary:

      This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of
      subjects with moderate to severe chronic plaque psoriasis (PSO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age

          -  Chronic plaque PSO for at least 6 months prior to the Screening Visit

          -  Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
             >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

          -  Subject is a candidate for systemic PSO therapy and/or phototherapy

          -  Female subject of child bearing potential must be willing to use highly effective
             method of contraception

        Exclusion Criteria:

          -  Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab

          -  Subject has an active infection (except common cold), a serious infection, or a
             history of opportunistic or recurrent chronic infections

          -  Subject has concurrent acute or chronic viral hepatitis B or C or human
             immunodeficiency virus (HIV) infection

          -  Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
             infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

          -  Subject has any other condition, including medical or psychiatric, which, in the
             Investigator's judgment, would make the subject unsuitable for inclusion in the study

          -  Subject has had previous exposure to adalimumab

          -  Presence of active suicidal ideation or positive suicide behavior

          -  Presence of moderately severe major depression or severe major depression

          -  Subject has any active malignancy or history of malignancy within 5 years prior to the
             Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
             carcinoma, or in situ cervical cancer