bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo - Controlled Period (CP); Ustekinumab 45 mg - CP; Placebo to ustekinumab 45 mg - after CP; Ustekinumab 45 mg - after CP
Intervention description: Placebo, Weeks 0-12; Ustekinumab 45 mg, Weeks 0-12; Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16; Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Psoriasis; Psoriatic Arthritis; Ustekinumab; CNTO 1275

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the
      treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be of Taiwanese or Korean ancestry living in Taiwan or South Korea, respectively

          -  Have a diagnosis of plaque-type psoriasis at least 6 months prior to first
             administration of study agent (patients with concurrent psoriatic arthritis may be
             enrolled)

          -  Have plaque-type psoriasis covering at least 10% of total body surface area at
             screening and at the time of first study agent administration

          -  PASI score of 12 or greater at the time of screening and at time of first study agent
             administration

          -  Candidate of phototherapy or systemic treatment of psoriasis (either naïve or history
             of previous treatment)

          -  Be able to adhere to the study visit schedule and other protocol requirements

          -  Capable of giving informed consent prior to any study related procedures.

        Exclusion Criteria:

          -  Currently have a non-plaque form of psoriasis

          -  Have current drug-induced psoriasis

          -  Are pregnant or nursing or planning pregnancy (both men and women) while enrolled in
             the study

          -  Have used any investigational drug within the previous 4 weeks or 5 times the half
             life of the investigational agent, whichever is longer

          -  Have used any biologic within the previous 3 months or 5 times the half life of the
             biologic, whichever is longer

          -  Have been hospitalized in the past 3 years for asthma, ever required intubation for
             treatment of asthma, currently require oral corticosteroids for the treatment of
             asthma, or required more than one short-term course of oral corticosteroids for asthma
             within the previous year

          -  Have a history of latent or active granulomatous infection, including TB,
             histoplasmosis, or coccidioidomycosis prior to screening.
Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: amlodipine; telmisartan; telmisartan and amlodipine
Intervention description: amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w; telmisartan 80mg for the 8w, no titration required; telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 858.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to demonstrate that following eight weeks of treatment
      the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line
      therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the
      monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe
      hypertension. A key secondary objective is to identify the duration of treatment required to
      demonstrate the superiority of the FDC over both of the monotherapies.
    

Eligibility criteria:

        Inclusion criteria

          1. Ability to provide written informed consent in accordance with Good Clinical Practice
             and local legislation

          2. Age 18 years or older

          3. Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater
             than 95 mmHg at randomisation

          4. Ability to stop any current antihypertensive therapy without unacceptable risk to the
             patient (Investigators discretion)

        Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood
        Pressure [DBP] >/= 95 mmHg
MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: MK-0954A; Losartan; Placebo to MK-0954A; Placebo to losartan 100 mg; Placebo to losartan 50 mg
Intervention description: Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily; Tablet containing losartan potassium (100 mg), once daily; Placebo tablet to match MK-0954A, once daily; Placebo tablet to match losartan 100 mg, once daily; Placebo tablet to match losartan 50 mg, once daily
Intervention MeSH terms: Losartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 336.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Essential hypertension; Uncontrolled hypertension; Antihypertensive agents; Blood pressure

Summary:

      This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension
      participants who are not adequately controlled with losartan.
    

Eligibility criteria:

        Inclusion criteria:

          -  Participant has a diagnosis of essential hypertension.

          -  Participant is not treated with antihypertensive medication and meets
             protocol-specified blood pressure criteria.

          -  Participant is treated with single antihypertensive medication, and meets
             protocol-specified blood pressure criteria.

          -  Participant is being treated with up to dual oral antihypertensive medications, and
             will be able to discontinue the prior antihypertensive medication.

          -  Participant has no clinically meaningful findings to be disqualified from the study at
             the discretion of the investigator.

        Exclusion criteria:

          -  Regarding hypertension, 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 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 a recent history within the last year of drug or alcohol abuse or
             dependence.

          -  Participant is pregnant or breastfeeding or expecting to conceive or has a positive
             pregnancy test at the screening visit.

          -  Participant is currently participating or has participated in a study with an
             investigational compound (except losartan at any doses) or device within 30 days of
             signing informed consent.
High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: Oxytocin; Placebo nasal spray
Intervention description: The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day; A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.
Intervention MeSH terms: Oxytocin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for
      treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly
      reduce tinnitus severity and disability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration.

          -  Subjects must have had a normal otolaryngologic evaluation within the past year with
             no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of > 16.

          -  Subjects must have tinnitus loudness rating of >4/10.

        Exclusion Criteria:

          -  Subjects who are being treated for tinnitus < 6 months due to the acute nature of
             their condition

          -  Subjects who have a slight handicap according to the Tinnitus Handicap Inventory
             Severity Scale.

          -  Those with tinnitus of a muscular or vascular etiology

          -  Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin
             nasal spray.

          -  Women of childbearing age will not be approached for participation due to the risk of
             oxytocin-induced uterine contractions.

          -  Subjects who suffer from migraines.

          -  Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe
             renal disease.
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
Condition: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Intervention: V503
Intervention description: V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1212.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to
      45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33,
      45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult
      women as compared with GMTs in young adult women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  good physical health

        Exclusion Criteria:

          -  history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results

          -  history of HPV-related condition

          -  history of known prior vaccination with an HPV vaccine

          -  pregnant

          -  user of recreational or illicit drugs

          -  history of severe allergic reaction, including known allergy to any vaccine component

          -  immunocompromised

          -  history of certain medications or is currently taking or has taken certain medications
             (details will be discussed at the time of consent)

          -  has thrombocytopenia or other coagulation disorder

          -  concurrently enrolled in a clinical study of investigational agent
Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Recurrence; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Duloxetine; placebo
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of duloxetine compared with
      placebo in the prevention of depressive recurrences among patients with recurrent major
      depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be at least 18 years old.

          -  Patient must be diagnosed with depression and have had previous episodes of
             depression.

          -  Patient must sign informed consent.

        Exclusion Criteria:

          -  Female and pregnant or breastfeeding.

          -  History of bipolar disorder, schizophrenia, or other psychotic disorders.

          -  Suffer from a serious medical illness (other than depression) or abnormal laboratory
             result that would require a change in medication, intervention, or hospitalization.

          -  Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within
             14 days of the start of the study, or potential need to use a MAOI within 5 days of
             finishing the study.

          -  Have taken an antidepressant called fluoxetine within 30 days of the start of the
             study.
Regional Anesthesia and Breast Cancer Recurrence
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms; Recurrence
Intervention: General anesthesia and opioids; Regional analgesia and propofol
Intervention description: General anesthesia, usually with sevoflurane, and opioid analgesia; Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
Intervention MeSH terms: Anesthetics; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2108.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Breast Cancer; Anesthesia; regional; cancer recurrence; Anesthesia; inhalational; Analgesia; opioid

Summary:

      In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy
      with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral
      anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be
      followed for up to 10 years to determine the rate of cancer recurrence or metastasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary breast cancer without known extension beyond the breast and axillary nodes
             (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)

          -  Scheduled for unilateral or bilateral mastectomy with or without implant (isolated
             "lumpectomy" will not qualify)

          -  Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least
             five nodes)

          -  Written informed consent, including willingness to be randomized to morphine or
             regional analgesia

        Exclusion Criteria:

          -  Previous surgery for breast cancer (except diagnostic biopsies)

          -  Inflammatory breast cancer

          -  Age < 18 or > 85 years old

          -  Scheduled free flap reconstruction

          -  ASA Physical Status ≥ 4

          -  Any contraindication to epidural or paravertebral anesthesia and analgesia (including
             coagulopathy, abnormal anatomy)

          -  Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine

          -  Other cancer not believed by the attending surgeon to be in long-term remission

          -  Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality
P3 Long Term Safety Study of Once Daily SB204 in Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: SB204 4%
Intervention description: Open label, topical SB204 4%
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a multi-center, open label long-term safety (LTS) study to be conducted in
      approximately 600 subjects with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

        Exclusion Criteria:

          -  Terminated early from an SB204 Phase 3 pivotal study for any reason

          -  Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants
             stopping study drug application

          -  Have used medications or vitamins during the 12 weeks immediately preceding this study
             which were reported to exacerbate acne.
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: LEO43204 gel; Vehicle gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to compare the short term efficacy of LEO 43204 gel with
      vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive
      days as field treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment
             area of sun-damaged skin on the full balding scalp (the balding part of the scalp
             should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)

          -  Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking
             area of 50 cm2 (8 In2). The tracking area must be within the treatment area

        Exclusion Criteria:

          -  Location of the treatment area (balding scalp) within 5 cm of an incompletely healed
             wound or within 5 cm of a suspected BCC or SCC

          -  Treatment with ingenol mebutate gel in the treatment area within the last 12 months

          -  Lesions in the treatment area that have: atypical clinical appearance (e.g.
             hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g.
             did not respond to cryotherapy on two previous occasions)

          -  History or evidence of skin conditions other than the trial indication that would
             interfere with the evaluation of the trial medication (e.g. eczema, unstable
             psoriasis, xeroderma pigmentosum)
Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: adalimumab; placebo
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection; Placebo pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: acne; psoriasis; hidradenitis suppurativa; TNF; HS; PIONEER I; acne inversa; boil; placebo controlled; Double blind; adalimumab

Summary:

      A study to evaluate the safety and efficacy of treatment with adalimumab in adults with
      moderate to severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults must have a diagnosis of HS for at least 1 year prior to Baseline.

          -  HS lesions must be present in at least two distinct anatomical areas, one of which
             must be at least Hurley Stage II or Hurley Stage III.

          -  Subject must have stable HS for at least 60 days prior to Screening visit and at
             Baseline visit.

          -  Subject must have experienced an inadequate response to at least a 90-day treatment of
             oral antibiotics for treatment of HS.

          -  Subject must have a total AN count of greater than or equal to 3 at baseline.

        Exclusion Criteria:

          -  Subject was previously treated with adalimumab or another anti-tumor necrosis factor
             (anti-TNF) therapy (e.g., infliximab or etanercept).

          -  Subject received any oral antibiotic treatment for HS within 28 days prior to
             Baseline.

          -  Subject received oral concomitant analgesics (including opioids) for HS-related pain
             within 14 days prior to Baseline visit.

          -  If entering the study on concomitant oral analgesics for non-HS related pain:

               -  Subject on opioid analgesics within 14 days prior to Baseline visit;

               -  Subject not on a stable dose of non-opioid oral analgesics for at least 14 days
                  prior to the Baseline visit ("as needed" is not considered a stable dose).