bioihbjkbjnl/mcl2 huggingface dataset:
Topical Ruxolitinib Lichen Planus
Condition: Lichen Planus
MeSH terms: Lichen Planus
Intervention: INCB018424
Intervention description: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Topical INCB018424
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed
      by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment
      and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and
      Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict
      responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA
      sequencing on responsive and non-responsive tissue at week 4.
    

Eligibility criteria:

        Subjects must be able to understand and comply with the requirements of the study and
        communicate with the investigator.

        Subjects must give written, signed, and dated informed consent before any study related
        activity is performed.

        When appropriate, a legal representative will sign the informed consent according to local
        laws and regulation

        Both men and women must be at least 18 years of age at the time of screening

        Subjects must have clinical and histological features of LP

        LP must involve between 2 and 20% of the BSA

        Subjects must have a minimum of 10 lesions of LP

        Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined
        by failure of at least one established treatment for LP

        Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole
        Oral sulfasalazine Oral retinoid
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Condition: Corneal Edema
MeSH terms: Corneal Dystrophies, Hereditary; Corneal Edema; Fuchs' Endothelial Dystrophy; Edema
Intervention: Netarsudil Ophthalmic; Netarsudil Ophthalmic
Intervention description: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution; Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Corneal Edema; Fuchs Corneal Dystrophy; Netarsudil Ophthalmic Solution

Summary:

      Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their
      efficacy in reducing or resolving corneal edema in subjects with FCD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults aged 18 years or older

          2. Documented diagnosis of FCD

          3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline
             Visit, in the eligible eye(s)

          4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the
             eligible eye(s)

        Exclusion Criteria:

          1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be
             required in the study eligible eye(s) within the study period

          2. Clinically significant ocular disease (other than FCD) or trauma in the eligible
             eye(s) which could interfere with study interpretation

          3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal
             refractive surgery in the eligible eye(s)
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Multivalent; Tdap; polysaccharide
Intervention description: Pneumococcal conjugate vaccine; Tetanus, diphtheria, acellular pertussis vaccine; 23-valent pneumococcal polysaccharide vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Observer-blinded
Enrollment: 511.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a
      2-arm parallel design in each stage.

      In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination
      will be randomized equally to receive either a single intramuscular dose of multivalent
      pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis
      combination vaccine (Tdap) (control group).

      In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2
      months prior to investigational product administration will be randomized equally to receive
      either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the
      licensed 23-valent pneumococcal polysaccharide vaccine (control group).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 1: Healthy male or female adults 50 to 64 years of age with no history of
             pneumococcal vaccination

          -  Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated
             with Prevnar 13 >= 2 months prior to investigational product administration

        Exclusion Criteria:

          -  Stage 1: Vaccination within 12 months before investigational product administration
             with diphtheria-, pertussis-, or tetanus-containing vaccine

          -  Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior
             dose of Prevnar 13
Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: SB-742457; Donepezil; Placebo
Intervention description: investigational drug; comparator; comparator
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 576.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; Cognition; SB-742457

Summary:

      The study is designed to investigate the efficacy, safety and tolerability of SB-742457
      versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an
      experimental treatment which increases the levels of certain chemicals in the brain that are
      often decreased in patients with Alzheimer's disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects and their caregivers must provide informed consent prior to study entry.

          -  Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's
             disease with a documented 6-month history of AD symptoms

          -  Subjects must have a regular caregiver who is willing to attend visits, oversee the
             subject's compliance with the study and report on the subject's status.

          -  Female subjects of child-bearing potential must agree to pregnancy testing and
             approved form of birth control.

        Exclusion criteria:

          -  Diagnosis of possible, probable or definite vascular dementia.

          -  History/evidence of any other CNS disorder that could be interpreted as a cause of
             dementia

          -  History of known or suspected seizures, loss of consciousness or significant head
             trauma

          -  Subjects with ECG, blood pressure and laboratory values outside of protocol criteria
             are excluded.

          -  Subjects with known photosensitivity

          -  Subjects with a history of previous exposure to SB-742457, taking agents for which
             there is a theoretical risk of interaction with SB-742457, or taking medication for
             Alzheimer's disease or centrally acting agents which might impact study outcomes may
             not participate.
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries; Tendon Injuries
Intervention: allogenic adipose stem cell injection; fibrin glue/normal saline injection; normal saline injection
Intervention description: Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.; Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise; Total 1cc of normal saline injection and range of motion exercise
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: adipose derived mesenchymal stem cell; allogeneic stem cell; Rotator cuff tear

Summary:

      Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal
      stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with
      supraspinatus partial thickness tear by ultrasonographic guided injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinically diagnosed as rotator cuff tear (supraspinatus partial thickness tear)

          -  recurrent pain in spite of conservative treatment such as physical therapy,
             medication, steroid injection

          -  symptom duration is over 3 months

          -  supraspinatus partial thickness tear proven ultrasonography and magnetic resonance
             image(MRI)

          -  patient that can understand the clinical trials

        Exclusion Criteria:

          -  patient that underwent other injection treatment within 6 weeks

          -  some associated diseases (adhesive capsulitis, full thickness supraspinatus tear,.
             arthritis of related joint to the target lesion, muscle weakness or atrophy,
             innervated by suprascapular nerve, paralysis of related joint to target lesion,
             proximal humeral fracture, infectious disease, bilateral rotator cuff tear,
             generalized pain syndrome, radiculopathy, rheumatoid arthritis, impaired sensibility,
             dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or
             fibrin glue and contraindication to MRI

          -  patient that enrolled other clinical trials within 30 days

          -  history of drug/alcohol addiction, habitual smoker, operation, allergic reaction to
             fibrin glue, local anesthetics and bovine-derived proteins and severe medical disease.
A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Disease Progression
Intervention: LUM/IVA; LUM/IVA; Placebo
Intervention description: FDC tablets or granules for oral administration.; FDC granules for oral administration.; Placebo matched to LUM/IVA for oral administration.
Intervention MeSH terms: Ivacaftor
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: Double blinded in Part 1, and Open label in Part 2
Enrollment: 51.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression
      in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects with confirmed diagnosis of CF.

          -  Homozygous for F508del (F/F).

          -  Subjects who weigh ≥8 kg without shoes and wearing light clothing at the Screening
             Visit.

        Key Exclusion Criteria:

          -  Any clinically significant laboratory abnormalities at the Screening Visit that would
             interfere with the study assessments or pose an undue risk for the subject.

          -  Solid organ or hematological transplantation.

          -  History of any illness or comorbidity reviewed at the Screening Visit that, in the
             opinion of the investigator, might confound the results of the study.

        Other protocol defined Inclusion/Exclusion criteria may apply.
Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-PSMA
Intervention description: Positron Emission Tomography/Computed Tomography (PET/CT) imaging with 68Ga-PSMA:
68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to find out whether imaging of the prostate with a new molecule
      called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of
      patients to be useful to find recurring prostate cancer following initial cancer treatment.
      This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers
      that would be considered in need for treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent MRI of the prostate has resulted in at least one lesion suspected to represent
             prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)

          -  Treating physician has already indicated a need for a prostate biopsy procedure.

          -  Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or
             b) single or multiple negative prior biopsies.

        Exclusion Criteria:

          -  Prostate biopsy within 12 weeks before enrollment

          -  Acute prostatitis within the last 6 months

          -  Current non-urologic bacterial infection requiring active treatment with antibiotics

          -  Active other malignancy (except basal cell or squamous cell skin cancer) within the
             last 2 years

          -  Body weight greater than 350 lbs (158 Kg)

          -  Inability or unwillingness to receive a prostate biopsy procedure

          -  Unable to lie flat, still, or tolerate a PET/CT scan

          -  Unable to provide own consent

          -  Concurrent severe and/or uncontrolled and/or unstable medical disease other than
             prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial
             infarction within 6 months prior to study participation, unstable and uncontrolled
             hypertension, acute renal failure of any intensity, chronic renal or hepatic disease,
             severe pulmonary disease).
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
Condition: Pain; Needle Phobia
Intervention: EMLA Cream; Synera Patch
Intervention description: 60 minutes x1; 20 minutes x1
Intervention MeSH terms: Lidocaine; Tetracaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: EMLA; venipuncture; children; Synera patch; pediatric; Lidocaine/prilocaine

Summary:

      This study compares the efficacy of the Synera patch with Eutectic Mixture of Local
      Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children in outpatient clinics requiring venipuncture for medical care

          -  Ages 4-12 years old

          -  The ability to demonstrate proper understanding of the Wong-Baker FACES Pain Ranking
             Scale

          -  Parents of enrolled children need to be present during the procedure and be willing to
             rate their child's pain

        Exclusion Criteria:

          -  Damaged or inflamed skin at the designated application site

          -  Known sensitivity to components of Synera or EMLA (lidocaine, tetracaine, or local
             anesthetics of the amide or ester type, Para Aminobenzoic (PABA) derivatives)

          -  Contraindications to SYnera or EMLA use (Severe hepatic disease, history of
             drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)

          -  Use of analgesics during the past 24 hours
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
Condition: Respiratory Syncytial Virus
MeSH terms: Infections; Virus Diseases
Intervention: Rilematovir; Placebo
Intervention description: Rilematovir 250 mg will be administered orally.; Placebo matching to rilematovir will be administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with
      respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory
      tract disease (LRTD) symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute
             respiratory syncytial virus (RSV) infection

          -  Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must
             be scored as at least 'moderate' if the symptoms did not pre-exist before RSV onset,
             or one of which is scored worse than usual if the symptoms pre-existed

          -  Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase
             chain reaction [PCR] or other) on a bilateral nasal mid-turbinate swab sample

          -  Has at least one of the following high-risk conditions that predispose them to
             RSV-related disease progression: a. age greater than or equal to (>=) 65 years, b.
             congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d.
             asthma

          -  Randomized to study intervention treatment within 72 hours after onset of any of the
             RSV symptoms or worsening of pre-existing symptoms

          -  Not be hospitalized during screening (emergency room or hospital observation status
             for an anticipated duration of less than [<] 24 hours are not considered as
             hospitalization)

        Exclusion Criteria:

          -  Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the
             excipients of rilematovir or placebo formulation

          -  Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial
             arrhythmia, or sustained ventricular arrhythmia

          -  Participant has known or suspected (from medical history or participant examination)
             chronic or acute hepatitis B or C infection

          -  Immunocompromised conditions

          -  Living in institutional care or assisted living facility and also receiving acute care
             management for any respiratory condition
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
Condition: AL Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: NEOD001; Placebo
Intervention description: NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates; Saline Bag
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: amyloidosis; ntprobnp; NEOD001; Prothena; PRONTO; amyloid; plasma cell dyscrasia; immunotherapy

Summary:

      This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled,
      two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered
      intravenously in adults with AL amyloidosis who had a hematologic response to previous
      treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT])
      and have persistent cardiac dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥18 years

          2. Confirmed diagnosis of systemic AL amyloidosis

          3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic
             response

          4. Cardiac involvement

          5. NT-proBNP ≥650

        Exclusion Criteria:

          1. Non-AL amyloidosis

          2. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma

          3. NT-proBNP >5000

          4. Received Plasma cell directed chemotherapy within 6 months

          5. Received autologous stem cell transplant (ASCT) within 12 months