bioihbjkbjnl/mcl2 huggingface dataset:
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
Condition: Xerostomia; Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Xerostomia; Syndrome
Intervention: Rebamipide
Intervention MeSH terms: Rebamipide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 104.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide
      on dry mouth in patients with Sjögren's syndrome in comparison with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome
             (1999): 1998 research report on immunological intractable diseases specified by the
             Japanese Ministry of Health and Welfare)

          2. Patients aged 20 years or older at time of consent

          3. Patients with dry mouth

          4. Patients with decreased salivation

        Exclusion Criteria:

          1. Patients who have developed dry mouth clearly due to a cause other than Sjögren's
             syndrome

          2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant,
             etc.)

          3. Patients who have received rebamipide within 3 months prior to obtaining informed
             consent

          4. Patients who are pregnant, possibly pregnant, or lactating

          5. Patients with a history of hypersensitivity to rebamipide

          6. Patients who have received any other investigational drug within 3 months prior to
             obtaining informed consent

          7. Patients who are otherwise judged inappropriate for inclusion in the study by the
             investigator or subinvestigator
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Intervention: RIST4721; Placebo
Intervention description: RIST4721 oral solution; Placebo oral solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PPP

Summary:

      A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and
      Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 6-month history of PPP as defined by the presence of pustules on palms
             and/or soles, but without evidence of infection on palms and soles

          -  Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and
             Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment
             (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule
             count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh
             pustule count on both right/left palms and soles)

          -  Males and females must be willing to use birth control as indicated

        Exclusion Criteria:

          -  Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total
             Body Surface Area (BSA) at Day -1

          -  Subject is known to have an immune deficiency or is immunocompromised

          -  Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis

          -  Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies
             for PPP within 4 weeks
A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
Condition: Multicentric Castleman's Disease
MeSH terms: Castleman Disease
Intervention: Siltuximab
Intervention description: Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.
Intervention MeSH terms: Siltuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multicentric Castleman's Disease; Multicentric; Castleman; Siltuximab; Long term safety

Summary:

      The purpose of this study is to evaluate the long-term safety of siltuximab in patients with
      multicentric Castleman's disease (MCD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has multicentric Castleman's disease

          -  Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment
             arm)

          -  Have had their last administration of study treatment (siltuximab or placebo) less
             than 6 weeks (window of plus 2 weeks) prior to first dose

          -  Patients must not have had disease progression while receiving siltuximab. For those
             patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have
             received less than 4 months of siltuximab following crossover will also be eligible

          -  Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of
             siltuximab for this study

        Exclusion Criteria:

          -  Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of
             consent as reason for discontinuing treatment from previous sponsor-initiated
             siltuximab study

          -  Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study

          -  Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies,
             to murine, chimeric, human proteins or their excipients
A Multicenter Assessment of ALD403 in Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: ALD403; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Migraine Disorders; ALD403

Summary:

      The purpose of this study is to assess ALD403 in the prevention of migraine headache in
      chronic migraineurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year

          -  During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days
             were assessed as migraine days with at least 5 migraine attacks as recorded in the
             eDiary

          -  Headache eDiary was completed on at least 22 of the 28 days prior to randomization

        Exclusion Criteria:

          -  Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional
             pain syndrome) or any pain syndrome that requires regular analgesia

          -  Psychiatric conditions that are uncontrolled and untreated, including conditions that
             are not controlled for a minimum of 6 months prior to screening.

          -  History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
             daily persistent headache, migraine with brainstem aura, sporadic and familial
             hemiplegic migraine

          -  Unable to differentiate migraine from other headaches

          -  Subject has received botulinum toxin for migraine or for any other medical/cosmetic
             reasons requiring injections in the head, face, or neck within 4 months prior to
             screening.

          -  Have any clinically significant concurrent medical condition

          -  Receipt of any monoclonal antibody treatment within 6 months of screening (within or
             outside a clinical trial)

          -  Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
PD of VAY736 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: VAY736; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Treatment was unblinded at an individual patient level at Week 24 to determine their progress in the study (follow-up, open-label VAY736 or End of Study Visit).
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: primary Sjögren's syndrome, pharmacodynamics

Summary:

      This study was designed to evaluate the safety, tolerability, pharmacokinetics and
      therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS
      patients
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Fulfilled revised European US consensus criteria for pSS

          -  ESSDAI value ≥ 6

          -  Elevated serum titers at screening of ANA (≥ 1:160)

          -  Seropositive at screening for anti-SSA and/or anti-SSB antibodies

          -  Stimulated whole salivary flow rate at screening of > 0 mL/min

        EXCLUSION CRITERIA:

        - Prior or previous use of (specific dosages and intervals prior to study start may apply):
        B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig
        (abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause
        dry mouth.

        Hydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to
        randomization is allowed

          -  Active or recent history of clinically significant infection

          -  Vaccination within 2 month prior to study

          -  History of primary or secondary immunodeficiency
AC105 in Patients With Acute Traumatic Spinal Cord Injury
Condition: Acute Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Intervention: AC105; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute; Traumatic; SCI; Spinal Cord Injury

Summary:

      The principal aim of this study was to establish the feasibility of rapid administration,
      safety, and tolerability of AC105 in patients with acute spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 18 and 65 years of age, inclusive

          -  Acute traumatic SCI, at a neurological level between C4 and T11

          -  No evidence of penetrating or transection injury (e.g. caused by projectile or stab
             wound)

          -  Neurological ASIA Impairment Scale A, B or C

          -  Patient is able to provide written or verbal witnessed consent. If unable to provide
             either, consent may be provided by legally authorized representative (LAR)

          -  Patient is able to initiate treatment within time window of injury

        Exclusion Criteria:

          -  Known allergy or hypersensitivity to polyethylene glycol

          -  Mental impairment or other conditions that would preclude a reliable ASIA exam or
             adequate consent

          -  Positive urine pregnancy test result

          -  Serum creatinine level ≥ 2 mg/dL

          -  History or active renal failure or dialysis

          -  Mean arterial blood pressure < 60 mmHg despite vasopressor treatment

          -  On a current regimen of digoxin

          -  Chronic use of magnesium salts prior to the SCI (within 1week of presentation) and/or
             the use of magnesium salts in the acute care setting prior to the administration of
             investigational product

          -  Any other medical condition that, in the judgment of the investigator, would preclude
             provision of informed consent, make participation in the study unsafe, or unreasonably
             complicate follow-up or the interpretation of study outcome data or may otherwise
             interfere with achieving the study objectives

          -  In the judgment of the Investigator, cannot adequately provide informed consent, is
             likely to be non-compliant, or may be unable to cooperate with study requirements
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo matching BMS-945429; BMS-945429; BMS-945429; BMS-945429
Intervention description: Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label; Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label; Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label; Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to characterize the safety, efficacy and dose response of
      BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to
      Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying
      anti-rheumatic drugs (DMARDs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization.
             Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum
             weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to
             randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and
             that was decreased due to toxicity as low as 10 mg/week is allowed

          -  Inadequate response to NSAID and/or non-biologic DMARD

          -  Minimum of 3 swollen and 3 tender joints

          -  Active psoriatic skin lesions over minimum 3% body surface area

          -  high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL

        Exclusion Criteria:

          -  Previously received or currently receiving concomitant biologic therapy
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: nemolizumab (CIM331); Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic
      dermatitis patients who are inadequately controlled by or intolerant to topical therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 and ≤65 years of age at the time of consent.

          -  Patients with Atopic Dermatitis

          -  Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit

          -  Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit

          -  static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

        Exclusion Criteria:

          -  Serological evidence of hepatitis B virus or hepatitis C virus infection

          -  Known human immunodeficiency virus infection

          -  Ongoing treatment with specific or non-specific hyposensitization therapy for AD

          -  Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week
             prior to randomization

          -  History of infection including skin infection requiring treatment with oral or
             intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to
             randomization.

          -  Evidence of tuberculosis (TB) infection as defined by a positive purified protein
             derivative (PPD) and/or positive interferon-gamma release assay.

          -  Pregnant or lactating women.
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Intervention: Cenicriviroc
Intervention description: Cenicriviroc immediate release tablets
Intervention MeSH terms: Cenicriviroc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This rollover study will provide open-label treatment with cenicriviroc and will assess the
      long-term safety of continued treatment with cenicriviroc in participants who participated in
      either the CENTAUR study 652-2-203 [NCT02217475] or the AURORA study [NCT03028740].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of both Treatment Period 1 and Treatment Period 2, of the
             CENTAUR Study (652-2-203), including a Year 2 liver biopsy.

          -  Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated
             liver-related clinical outcome in Part 1 or Part 2 of the study of:

          -  Histopathological progression to cirrhosis

          -  Model for end-stage liver disease (MELD) score ≥ 15

          -  Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a
             diuretic)

          -  Hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed,
             hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial
             peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid
             bacterial culture).

        Exclusion Criteria:

          -  Prior or planned liver transplantation

          -  Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary
             biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's
             disease, hemochromatosis, or iron overload, or Alpha-1 antitrypsin (A1AT) deficiency.
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
Condition: Central Neuropathic Pain; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Neuralgia; Sclerosis
Intervention: AVP-923-45; AVP-923-30; AVP-923-20; Placebo
Intervention description: AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.; AVP-923-30 (dextromethorphan 30 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.; AVP-923-20 (dextromethorphan 20 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.; Matching placebo capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses
      of AVP-923 capsules in the treatment of central neuropathic pain in participants with
      multiple sclerosis.
    

Eligibility criteria:

        Main Inclusion Criteria:

        Multiple Sclerosis (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive
        multiple sclerosis [SPMS]), Clinical history and symptoms of central neuropathic pain
        (dysesthetic pain) for at least 3 months prior to screening, pain rating scale (PRS)
        baseline score = or > 4, No MS relapse within previous 30 days.

        Main Exclusion Criteria:

        Personal history of complete heart block, QT interval corrected for heart rate (QTc)
        prolongation, or torsades de pointes, family history of congenital QT interval prolongation
        syndrome, Myasthenia Gravis, Beck Depression Inventory Second Edition (BDI-II) score > 19