bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: etanercept; Topical agents
Intervention description: Administered by subcutaneous injection; Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following:
hydrocortisone 2.5%
betamethasone valerate 0.1%
betamethasone dipropionate 0.05%
clobetasol 0.05%
calcitriol
calcipotriol plus betamethsone dipropionate 0.05%
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; moderate; severe; etanercept; Enbrel; topical

Summary:

      To estimate the difference in effectiveness between treatment with etanercept 50 mg twice
      weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN)
      topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no
             morphology changes or significant flares of disease activity in the opinion of the
             investigator).

          -  Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index
             (PASI) ≥ 10 at screening and at baseline.

          -  Is a candidate for systemic therapy or phototherapy in the opinion of the
             investigator.

          -  Other inclusion criteria may apply.

        Exclusion Criteria:

          -  Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening
             visit.

          -  Has evidence of skin conditions at the time of the screening visit (eg, eczema) that
             would interfere with evaluations of the effect of etanercept on psoriasis.

          -  Diagnosed with medication-induced or medication-exacerbated psoriasis.

          -  Significant concurrent medical conditions.

          -  Has any active localized infection; requiring local intervention or chronic or
             localized infections.

          -  Other exclusion criteria may apply.
24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Condition: Hot Flashes
MeSH terms: Hot Flashes
Intervention: Brisdelle (paroxetine mesylate); Placebo capsules
Intervention description: Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.; Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
Intervention MeSH terms: Paroxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 570.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Vasomotor Symptoms; Menopause; Hot Flashes; Perimenopause; Nonhormonal therapies; Climacteric symptoms; Mesafem; Low-Dose Mesylate salt of Paroxetine (LDMP)

Summary:

      To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for
      treatment of vasomotor symptoms (VMS) associated with menopause
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female, >40 years of age

          2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60
             moderate to severe hot flashes per week for at least 30 days prior

          3. Spontaneous amenorrhea for at least 12 consecutive months

          4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause

          5. Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

        Exclusion Criteria:

          1. BMI ≥ 40 kg/m²

          2. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or
             Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS

          3. History of self-injurious behavior

          4. History of clinical diagnosis of depression; or treatment for depression

          5. History of clinical diagnosis of borderline personality disorder

          6. Use of an investigational study medication within 30 days prior to screening or during
             the study

          7. Concurrent participation in another clinical trial or previous participation in this
             trial

          8. Family of investigational-site staff
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
Condition: Psoriatic Arthritis (PsA)
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo; Risankizumab
Intervention description: Placebo for risankizumab administered by subcutaneous (SC) injection; Risankizumab administered by subcutaneous (SC) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 444.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: KEEPsAKE 2; Risankizumab

Summary:

      The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults
      with moderately to severely active psoriatic arthritis (PsA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months
             prior to the Screening Visit and fulfillment of the Classification Criteria for PsA
             (CASPAR) at Screening Visit.

          -  Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts)
             and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and
             Baseline.

          -  Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm
             diameter or nail changes consistent with psoriasis at Screening Visit.

          -  Participant has demonstrated an inadequate response or intolerance to biologic
             therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs
             (csDMARD) therapy(ies).

        Exclusion Criteria:

          -  Participant is considered by investigator, for any reason, to be an unsuitable
             candidate for the study.

          -  Participant has a known hypersensitivity to risankizumab.
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant; Placebo
Intervention description: Atogepant tablet; Placebo-matching atogepant tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 910.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Migraine; Aura

Summary:

      To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the
      prevention of migraine in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a
             diagnosis.

          -  Age of the participant at the time of migraine onset <50 years.

        Exclusion Criteria:

          -  Has a history of migraine accompanied by diplopia or decreased level of consciousness
             or retinal migraine.

          -  Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal
             autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy.

          -  History of an inadequate response to >4 medications (2 of which have different
             mechanisms of action) prescribed for the prevention of migraine.

          -  Participants with clinically significant hematologic, endocrine, cardiovascular,
             pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
Condition: Glabellar Frown Lines
Intervention: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)); OnabotulinumtoxinA (Vistabel®)
Intervention description: NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.; OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 381.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A
      preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201
      causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used
      for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This
      study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with
      OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.
    

Eligibility criteria:

        Main Inclusion Criteria:

        • Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on a
        4-point facial wrinkle scale) as assessed by the investigator's rating: 0 = 'none', 1 =
        'mild', 2 = 'moderate', 3 = 'severe'.

        Main Exclusion Criteria:

          -  Marked facial asymmetry.

          -  Ptosis of eyelid and/or eyebrow.
Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases
Condition: Immunologic Deficiency Syndromes
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Octagam 10%
Intervention description: 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 2 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration.
      Octagam 5% is currently registered in more than 60 countries. This study will evaluate the
      efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary
      immunodeficiency diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of primary immunodeficiency (acc. WHO)

          -  Previous treatment with commercial Octagam 5% every 3-4 weeks for at least 6 infusions
             intervals

          -  Documented IgG trough levels of the two previous infusions before enrollment with a
             value of at least 5.5 g/L for both

        Exclusion Criteria:

          -  Acute infection requiring intravenous antibiotic treatment within two weeks before
             screening

          -  Exposure to blood or any blood product or derivative other than commercially available
             Octagam 5%, within the past 3 months

          -  History of hypersensitivity to blood or plasma derived products

          -  Requirement of any routine premedication for IGIV treatment

          -  History of congenital impairment of pulmonary function

          -  Severe liver function impairment

          -  Severe renal function impairment or predisposition for acute renal failure

          -  History of autoimmune haemolytic anaemia

          -  History of diabetes mellitus

          -  Congestive heart failure NYHA III or IV

          -  Non-controlled arterial hypertension

          -  History of DVT or thrombotic complications with IGIV treatment

          -  Known infection with HIV, HCV or HBV

          -  Treatment with steroids, immunosuppressive or immunomodulatory drugs

          -  Planned vaccination during study period

          -  Pregnant or nursing woman
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; placebo
Intervention description: Once weekly, administrated subcutaneously (s.c. under the skin); Once weekly, administrated subcutaneously (s.c. under the skin)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 388.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to investigate efficacy and safety
      of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes.
      (SUSTAIN™ 1-Monotherapy).
    

Eligibility criteria:

        Inclusion Criteria: - For Japan only: Male or female, age above or equal to 20 years at the
        time of signing inform consent - Subjects diagnosed with type 2 diabetes and treated with
        diet and exercise for at least 30 days before screening - HbA1c 7.0 - 10.0 % (53 - 86
        mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or
        intends to become pregnant or is of child-bearing potential and not using adequate
        contraceptive method (adequate contraceptive measures as required by local regulation or
        practice) throughout the trial including the 5 week follow-up period. United Kingdom:
        Adequate contraceptive measures are defined as established use of oral, injected or
        implanted hormonal methods of contraception, placement of an intrauterine device or
        intrauterine system, barrier methods of contraception (condom or occlusive cap with
        spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole
        partner of subject), or true abstinence (when in line with preferred and usual lifestyle) -
        Any chronic disorder or severe disease which, in the opinion of the investigator, might
        jeopardise subject's safety or compliance with the protocol - Treatment with any glucose
        lowering agent(s) in a period of 90 days prior to screening. An exception is short-term
        treatment (no longer than 7 days in total) with insulin in connection with inter-current
        illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value
        above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid
        carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function
        defined as eGFR (estimated glomerular filtration rate ) below 30 mL/min/1.73 m^2 per
        modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary
        or cerebrovascular event within 90 days before randomisation - Heart failure, New York
        Heart Association class IV
A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Saxagliptin; Saxagliptin; Metformin; Placebo; pioglitazone
Intervention description: Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT); Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT); Tablets, Oral, 15-45 mg, as needed (12 months LT)
Intervention MeSH terms: Metformin; Pioglitazone; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1306.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe
      and works better than taking either saxagliptin or metformin alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Inadequate blood sugar control

          -  No current treatment with other medications to lower blood sugar

        Exclusion Criteria:

          -  Major heart, liver or kidney problems

          -  Pregnant or breast feeding
Collection of Gingival Crevicular Fluid From Periodontitis Patients
Condition: Gingival Diseases
MeSH terms: Periodontitis; Gingival Diseases
Intervention: Fluoride; Fluoride, triclosan
Intervention description: Brush twice daily for 6 weeks; Brush twice daily
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 39.0
Sex: All
Minimum age: 26 Years
Maximum age: 68 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from
      gingivitis and/or periodontitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be aged 18 to 65 years inclusive

          -  Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present

          -  Give written informed consent

          -  Be in good general health

          -  No known history of allergy to personal care/consumer products or their

          -  ingredients, relevant to any ingredients 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 visits/procedures

          -  Advanced periodontal disease

          -  5 or more decayed, untreated dental sites

          -  Diseases of the soft or hard oral tissues

          -  Orthodontic appliances

          -  Abnormal salivary function

          -  Use of prescription drugs.

          -  Use of antibiotics one (1) month prior to or during this study

          -  Use of any over the counter medications other than analgesics

          -  Erratic use of vitamin supplements

          -  Pregnant or breastfeeding.

          -  Participation in another clinical study in the month preceding this study

          -  Allergic to common dentifrice ingredients

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Extension Study Of Tanezumab In Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: tanezumab; tanezumab; tanezumab
Intervention description: Tanezumab 10 mg; Tanezumab 5 mg; Tanezumab 2.5 mg
Intervention MeSH terms: Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2147.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Tanezumab OA arthritis

Summary:

      Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have participated in previous (specific) Phase 3 trials of Tanezumab in
             osteoarthritis

        Exclusion Criteria:

          -  Willing to comply with scheduled visits and treatment plan Is medically fit to
             participate in the trial in the judgement of the Investigator
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
Condition: Healthy Donors; HIV Positive
MeSH terms: HIV Seropositivity
Intervention: collection of follow-up sample based on PRISM HIV O Plus result
Intervention description: Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.
Phase: Phase 3
Study type: Interventional
Primary purpose: Screening
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24111.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy donors; HIV positives

Summary:

      To test blood samples from volunteer donors of whole blood and blood components using a new
      investigational test that detects human immunodeficiency virus (HIV) infection. Results will
      be compared to the current HIV screening assay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy donors that have consented to study