bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
Condition: Autoimmune Disorder; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Primary Sjögren's Syndrome
MeSH terms: Arthritis; Arthritis, Rheumatoid; Sjogren's Syndrome; Lupus Erythematosus, Systemic; Autoimmune Diseases; Syndrome
Intervention: branebrutinib; abatacept; branebrutinib placebo
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Abatacept; Branebrutinib
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-blind
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of treatment with
      branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or
      Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept
      treatment in study participants with active Rheumatoid Arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

        Sub-study for Systemic Lupus Erythematosus (SLE)

          -  Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating
             Clinics (SLICC) classification

          -  Diagnosed with SLE more than 24 weeks before screening visit

        Sub-study for primary Sjögren's Syndrome (pSS)

          -  Moderate to severe pSS, meeting ACR-EULAR classification criteria

        Sub-study for active Rheumatoid Arthritis (RA)

          -  Moderate to severe adult-onset RA

          -  ACR global functional status class I to III

        Women and men must agree to follow instructions for methods of contraception.

        Exclusion Criteria:

        Sub-study for SLE

          -  Certain other autoimmune diseases and overlap syndromes

        Sub-study for pSS

          -  Certain other immune-mediated diseases, active fibromyalgia, or other medical
             conditions

        Sub-study for RA

          -  Diagnosis with juvenile arthritis or idiopathic arthritis before age 16

        For all sub-studies:

          -  History of any significant drug allergy

          -  Active infection, significant concurrent medical condition, or clinically significant
             abnormalities

        Other protocol defined inclusion/exclusion criteria could apply
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Condition: Chronic Kidney Diseases; Inflammation
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Inflammation
Intervention: Ziltivekimab
Intervention description: human IgG1k anti-human IL-6 monoclonal antibody
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: Matching placebo
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IL-6; CRP; Chronic Kidney Disease; Cardiovascular Disease; Inflammation

Summary:

      Patients with chronic kidney disease, who have evidence of systemic inflammation with
      increased cardiovascular risk, will be enrolled into this trial. The purpose of this trial is
      to determine a dose to select for a potential cardiovascular outcome trial with Ziltivekimab.
      Doses to be tested will be 7.5 mg, 15 mg and 30 mg subcutaneous monthly compared to placebo
      for six months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

          -  Stage 3-5 CKD

          -  hs-CRP > 2.0 mg/L

          -  Comply with contraception

        Exclusion Criteria:

          -  Low neutrophil count

          -  Low platelet count

          -  Spot urine protein to creatinine ration > 4000 mg/g

          -  ALT/AST >2.5x ULN

          -  TSAT < 10%

          -  Positive TB test

          -  Evidence of HIV, hepatitis B

          -  Blind or illiterate

          -  Expected to require blood transfusion

          -  Thromboembolic event within 12-weeks

          -  Evidence of active infection

          -  Peptic ulcer disease, diverticulitis, inflammatory bowel disease

          -  Uncontrolled hypertension

          -  Planned coronary revascularization

          -  Major cardiac surgery, CHF

          -  Active malignancy, bone marrow or organ transplant

          -  Allergy to study drug

          -  Treatment with investigational drug, treatment with HIF stabilizer or ESA

          -  Use of immunosuppressive drugs, systemic antibiotics

          -  Breastfeeding, any other significant medical history
CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA)
Condition: Geographic Atrophy
MeSH terms: Geographic Atrophy; Atrophy
Intervention: CLG561; LFG316; Sham injection
Intervention description: Empty syringe (without a needle) placed against the eye
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 114.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Geographic atrophy (GA); Macular degeneration; Dry age-related macular degeneration (AMD); Intravitreal (IVT); Retinal diseases; Fundus auto fluorescence (FAF)

Summary:

      The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days)
      intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as
      compared to sham in subjects with geographic atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign written informed consent form;

          -  Geographic atrophy in both eyes;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Pregnant or lactating women and women of child-bearing potential;

          -  Any medical condition (systemic or ophthalmic) that may preclude the safe
             administration of test article or safe participation in this study;

          -  Any contraindications or hypersensitivities to any component of the LFG316 or CLG561
             solution;

          -  Any contraindications to IVT injections;

          -  Ocular surgery in either eye within 90 days of screening;

          -  Uncontrolled ocular hypertension or glaucoma in the study eye;

          -  Other protocol-specified exclusion criteria may apply.
Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Prednisolone
Intervention description: Prednisolone (5mg per kg) will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 1 Month
Maximum age: 30 Months
Healthy volunteers: No
Keywords: Duchenne Muscular Dystrophy; Corticosteroids; Infants; Young Children; Toddlers

Summary:

      While it has been known for many years that corticosteroid use benefits boys with Duchenne
      Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4
      years of age. The primary reason for the delay is that daily corticosteroid use has many side
      effects including short stature, obesity, and osteoporosis. A recent randomized blinded study
      of weekend oral corticosteroid use over one year showed equal improvement in strength with
      fewer side effects, particularly as related to growth and cushingoid changes. The
      investigators will test the efficacy of oral weekend corticosteroid use in infants and young
      boys with DMD who are under age 30 months. The investigators have demonstrated that the
      Bayley-III Scales of Infant development shows that infants and young boys in this age group
      who are untreated decline in abilities when compared to their peers. Here, in this Phase 2
      historically controlled trial, the investigators will use these two measures and treat boys
      at five Muscular Dystrophy Association-DMD centers
    

Eligibility criteria:

        Inclusion Criteria:

          1. Appropriate degree of weakness for age, creatine kinase greater than 20 times the
             upper limit of normal, and genetic mutation known to be causative for Duchenne
             muscular dystrophy .

          2. Appropriate degree of weakness for age, creatine kinase greater than 20 times the
             upper limit of normal and genetic or biopsy confirmation of Duchenne muscular
             dystrophy in a primary relative (e.g. brother or maternal uncle).

          3. De-identified, genetic studies will be reviewed by collaborator Kevin Flanigan, MD
             prior to enrollment of subjects.

          4. Age at entry: one month through 30 months.

        Exclusion Criteria:

          -  Prior treatment with corticosteroids
A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection
Condition: Tendinosis; Tendinitis
MeSH terms: Tendinopathy
Intervention: Tenotomy (no injection); Ultrasound guided platelet rich plasma injection
Intervention description: Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy.; Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called "Ultrasound guided platelet rich plasma injection."
Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
Subjects will see their referring physician two weeks after treatment to begin physical therapy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness of various treatment soft
      tendinosis also known as tendinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects with a diagnosis of tendinosis of the hip.

          -  Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis
             by tenotomy.

        Exclusion Criteria:

          -  pregnancy

          -  risk of bleeding due to anticoagulant medication

          -  presence of malignancy

          -  steroid injection less than 3 months before enrollment
Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: EPI-589
Intervention description: An immediate release film-coated table at a 250 mg dosage strength will be administered per dose and schedule specified in arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is an open label study with 30-day run in phase to establish baseline parameters, 90-day
      treatment phase, and a 90-day withdrawal phase to determine long-term effects, duration of
      treatment response, and potential effects of EPI-589 therapy on known trajectory.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of possible, probable, laboratory supported probable, or definite ALS by E1
             Escorial Criteria

          -  Forced vital capacity (FVC) ≥ 70% of predicted

          -  Weakness onset within 3 years

          -  Agreement to use contraception if within reproductive years

          -  Willingness and ability to comply with study procedures

          -  Stable regimen of dietary supplements and /or riluzole for at least 30 days prior to
             enrollment

          -  Abstention from use of other investigative or non-approved drugs

          -  Participants must be able to swallow 0.375 * 0.700 inch tablets

        Exclusion Criteria:

          -  Allergy to EPI-589

          -  Use of ventilation

          -  Participation in other intervention studies

          -  Diagnosis of any other neurologic disease

          -  Malignancy within the past 2 years

          -  History of stroke

          -  History of brain surgery

          -  Hepatic insufficiency with liver function tests (LFTs) greater than 3 times upper
             limit of normal (ULN)

          -  Renal insufficiency requiring dialysis

          -  End stage cardiac failure

          -  Participation in a trial of a device, drug, or other therapy for ALS within 3 months
             of screening or during the trial
Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Dutasteride; Placebo
Intervention description: 0.5 mg capsule given orally on daily basis; Identical placebo
Intervention MeSH terms: Dutasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the drug dutasteride increases expression of
      genes that slow the growth of prostate cancer during treatment with intermittent androgen
      ablation therapy (hormone therapy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven prostate cancer

          -  Patients are hormone-naive

          -  Patients either to begin androgen ablation therapy with luteinizing hormone-releasing
             hormone (LHRH) agonist or already receiving therapy with LHRH agonist

          -  Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis

          -  Must have an intact prostate (no previous surgery or XRT)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Recovery from any major infection or surgical procedure

          -  Signed informed consent

        Exclusion Criteria:

          -  Known intolerance or allergy to dutasteride

          -  Concomitant chemotherapy, biologic therapy, or XRT to prostate

          -  Bilateral orchiectomy

          -  Prior malignancy within 5 years of registration
Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543; CTP-543 Matching Placebo
Intervention description: Administered as 12 mg tablets.; Administered as tablets to aid treatment masking.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and tolerability of once-daily versus twice-daily
      dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical presentation compatible with alopecia areata with a current episode lasting
             at least 6 months and not exceeding 10 years at the time of Screening. Total disease
             duration greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

        Exclusion Criteria:

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or untreated actinic
             keratosis on the scalp.

          -  Treatment with systemic immunosuppressive medications within 3 months of screening or
             during the study, or biologics within 6 months of screening or during the study.

          -  Clinical lab results outside the normal range.
Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab
Intervention description: Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the safety of Nivolumab in participants with advanced or metastatic
      non-small cell lung cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non small cell lung cancer (Squamous or non-squamous)

          -  At least one prior anti-cancer therapy that did not work

          -  ECOG Performance Scale 0-1

        Exclusion Criteria:

          -  Cancer that has spread to the brain or leptomeninges unless there is no evidence of
             progression by MRI for 8 weeks after treatment is complete and within 28 days before
             first dose of study drug

          -  Active, known or suspected autoimmune disease or infection

          -  Prior immuno-oncology therapy

          -  Corticosteroids within 2 weeks of study drug administration

        Other protocol defined inclusion/exclusion criteria could apply
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: SHR0302; Placebo
Intervention description: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a Janus kinase inhibitor).; Placebo Oral Tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II
      study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe
      active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time
      needed to induce clinical response in active ulcerative colitis patients.

      This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment
      phase, will have the option to enter a blinded active arms 8-week extension phase. Early
      withdrawn subjects during the first treatment phase can not enter the extension phase. The
      total duration of the study participation, including extension and follow-up, will be
      approximately 18 weeks.

      SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal
      transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation.
      Therefore it has the potential to be a treatment for ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female subject age ≥ 18 and ≤75 years of age at randomization.

          -  Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and
             endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline
             should not exceed 10 days and allow central over read turn over before randomization).

          -  Subject should have at least three-month history of Ulcerative Colitis diagnosis at
             randomization.

        Exclusion Criteria:

          -  Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's
             disease.

          -  Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or
             less).

          -  Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure
             to treatment).