bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Cedirogant; Placebo
Intervention description: Capsule, Oral; Capsule, Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Psoriasis; Plaque Psoriasis; Cedirogant; ABBV-157

Summary:

      Psoriasis is a chronic disease characterized by marked inflammation and thickening of the
      skin that results in thick, scaly skin plaques. This study assessed how safe and effective
      cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe
      psoriasis. Efficacy and safety-related measurements assessed disease activity in participants
      with plaque psoriasis.

      Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic
      plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each
      group received a different treatment. There was a 1 in 4 chance that participants were
      assigned to placebo.

      Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks.

      There may have been a higher burden for participants in this study compared to usual standard
      of care. Participants attended regular visits per routine clinical practice. The effect of
      the treatment was checked by medical assessments, checking for side effects, and
      questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

        - Participants with stable moderate to severe plaque psoriasis of at least 6 months
        duration and who are candidates for systemic therapy or phototherapy.

        Exclusion Criteria:

          -  Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab,
             ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab),
             or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.

          -  Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis,
             medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis
             or any other skin disease which may interfere with assessment of chronic plaque
             psoriasis.
Diagnostic Imaging for Clear Cell Renal Cell Carcinoma
Condition: Clear Cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Ioflupane I123
Intervention description: 185 MBq ioflupane I123 will be administered at one single occasion to the study subjects A one time dose of DaTSCAN is given via intravenous injection of 185 MBq Ioflupane (I123) .
The patient takes potassium iodine tablets prior to the DatSCAN injection to protect the thyroid gland. At the time of the DaTSCAN examination, the patient is injected intravenously at slow rate with 185MBq DaTSCAN solution.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diagnosis; Imaging

Summary:

      The main objective is to study whether imaging detection of the biomarker DAT can be used to
      detect kidney tumors identified by computer tomography (CT), which are pathologically
      assesses as being of the clear cell subtype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  suspected kidney cancer diagnosis

          -  suspected spread of the cancer

          -  patient is scheduled for surgery alternatively biopsy of kidney tumor

          -  patient is 18 years or older

          -  the patient has given their consent to participate in the study

          -  female patients of reproductive age displays negative pregnancy test

        Exclusion Criteria:

          -  known or suspected allergy to Ioflupane or sodium acetate or acetic acid or ethanol

          -  patient suffers from moderate to severe renal impairment and exhibits glomerular
             filtration rate (GFR) <40

          -  patient is medicated for Parkinson's disease

          -  patient is medicated with any of the following medications: amphetamine, benzatropine,
             buproprion, cocaine, mazindol, methylphenidate, phentermine, sertraline, levodopa,
             dexamphetamine, lisdexamphetamine, modafinil, moclobemid, venlafaxine

          -  patient is pregnant

          -  breastfeeding

          -  patient suffers from mental inability unwillingness or language difficulties resulting
             in difficulty in understanding the meaning of taking part in the study
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
Condition: Mild to Moderately Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Polyphenon E®; Placebo Oral Tablet
Intervention description: Oral capsules; Oral tablet: placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Ulcerative colitis; EGCG; Green tea polyphenols; Inflammatory bowel disease; Colitis; IBD; Green tea

Summary:

      Green tea consists of several components, with most research focusing on the polyphenol
      fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied
      extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has
      been shown to effectively reduce the inflammation associated with animal models of
      inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the
      form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female with mildly to moderately active ulcerative colitis

        Exclusion Criteria:

          -  Off prohibited medications for proscribed period of time

          -  Evidence of infectious colitis

          -  Labs outside of range

          -  Pregnancy or lactation
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MEDI0382 100 μg; MEDI0382 200 μg; MEDI0382 300 μg; PlaceboA; MEDI0382 50 ug; PlaceboB
Intervention description: Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose; Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose; Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose; 1.0 mL liquid formulation per Vial; Solution for injection, 1.0 mL per vial, 50 ug; Solution for injection in 1.0 mL pre-filled syringe.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 20 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Diabetes; MEDI0382; D5674C00001; T2DM; Type 2 Diabetes

Summary:

      This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated
      up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese
      subjects.

      The study D5674C00001 can be conducted with a reasonable expectation of safety and
      tolerability in Japanese T2DM patients. The design of this study has taken into account the
      known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as
      the translatable effects observed in nonclinical studies of MEDI0382.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.

          -  Individuals who are diagnosed with T2DM

          -  Individuals whose current condition at enrolment (Visit 1) is drug naïve

          -  BMI within the range of 24 - 40 kg/m2 (inclusive) at screening

        Exclusion Criteria:

          -  Subjects with any of the following results at screening:

          -  Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)

          -  Alanine transaminase (ALT) ≥ 2.5 × ULN

          -  Total bilirubin (TBL) ≥ 2 × ULN

          -  Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60
             mL/minute/1.73 m2 at screening

          -  Participation in another clinical study with an investigational product administered
             in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of
             screening
A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Condition: Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Faricimab; Ranibizumab; Sham Procedure
Intervention description: Faricimab will be administered as per the regimen specified in the individual arm.; Ranibizumab will be administered as per the regimen specified in the individual arm.; The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in treatment arm D at applicable visits to maintain masking.
Intervention MeSH terms: Ranibizumab; Faricimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 273.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This multiple-center, multiple-dose and regimen, randomized, double-masked active
      comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the
      efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants
      with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

      The study was designed to allow the evaluation of RO6867461 in a treatment-naive population
      (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met
      a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per
      participant was chosen as the study eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with
             a subfoveal component related to the CNV activity by FFA or SD-OCT

          -  Active CNV

        Exclusion Criteria:

          -  CNV due to causes other than AMD

          -  Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than
             50% of the total lesion area

          -  Cataract surgery within 3 months of baseline, or any other previous intraocular
             surgery

          -  Major illness or surgery within 1 month prior to Screening

          -  Glycosylated hemoglobin (HbA1c) above 7.5%

          -  Uncontrolled blood pressure
Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
Condition: Age-Related Hearing Loss
MeSH terms: Hearing Loss; Deafness; Presbycusis
Intervention: AUT00063; Placebo
Intervention description: 600 mg, orally, once a day, for 4 weeks; orally, once a day, for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: hearing loss; speech-in-noise

Summary:

      This study aims to demonstrate that the investigational drug AUT00063 is effective and safe
      in the treatment of age-related hearing loss.
    

Eligibility criteria:

        -  Be between ages 50-89 years old

          -  American-English speaking

          -  Have difficulty hearing speech in a noisy environment

          -  No recent history of middle ear disease

          -  No severe insomnia, major depressive disorders, severe anxiety or post-traumatic
             stress disorder

          -  Not a current or previous user of hearing aids. You are eligible if you were
             noncompliant and stopped wearing a hearing aid device >6 months earlier for
             intermittent use or >3 years if you were a full-time consistent user of hearing aid
             devices

          -  Not be dependent on alcohol or drugs

          -  Have not participated in another research study within 30-days

          -  If female, you must confirm to be non child bearing (post-menopausal for at least
             12-months or surgically sterile)

          -  If male, you must confirm to use a barrier method (condom)

          -  Not be a professional musician

          -  No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric,
             hepatic, renal, hematologic, immunologic, or other major disease deemed clinically
             significant by the study doctor

        While you are in the study, you must:

          -  Follow the instructions you are given

          -  Come to the study centre for all visits with the study doctor or study staff

          -  Answer the telephone at the scheduled date and time for the 2 telephone calls

          -  Tell the study doctor or study staff about any changes in your health or the way you
             feel

          -  Tell the study doctor or study staff if you want to stop being in the study at any
             time

          -  Bring your Diary to each visit

          -  Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit
             (Visit 3, Day 1) until the end of the study

          -  Use sun screen if you plan to sunbathe

          -  Not use headphones or headsets at high volume

          -  Not use hearing aids or devices at any time during the study
OTO-313 in Subjects With Unilateral Subjective Tinnitus
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Intervention: OTO-313; Placebo
Intervention description: Single intratympanic injection; Single intratympanic injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: intratympanic injection; IT injection; gacyclidine; tinnitus

Summary:

      The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral
      tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral
      tinnitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has early-onset subjective unilateral tinnitus that is persistent
             (consistently aware of their tinnitus throughout much of the waking day).

          -  Subject is able to use the diary to complete their daily tinnitus ratings.

          -  Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural
             hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear
             injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear
             barotrauma); age related hearing loss; resolved otitis media; ototoxic drug exposure.

          -  Subject is willing to comply with the protocol and attend all study visits.

        Exclusion Criteria:

          -  Subject has pulsatile tinnitus, temporomandibular joint disease (TMJ) associated with
             tinnitus perception, tinnitus resulting from traumatic head or neck injury, or
             tinnitus resulting from a tumor or stroke.

          -  Subject is pregnant, lactating, or undergoing fertility treatment.

          -  Subject has other clinically significant illness, medical condition or medical history
             at Screening or Baseline that, in the Investigator's opinion, would likely reduce the
             safety of study participation or compliance with study procedures.
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus (SLE)
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; Dapirolizumab pegol (DZP)
Intervention description: Solution for infusion, 0,9% saline; Solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus (SLE); Dapirolizumab Pegol (DZP)

Summary:

      The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab
      Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic
      Lupus Erythematosus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus
             International Collaborating Clinics (SLICC) classification criteria

          -  Moderate to severe SLE disease activity

          -  Evidence for at least 1 of the following SLE markers:

               -  Anti-dsDNA antibodies confirmed by central laboratory or

               -  Low complement confirmed by central laboratory or

               -  Antinuclear antibody (ANA) titer of >= 1:80 in combination with at least 1 of the
                  following: Historical positivity for anti-dsDNA or Positivity for extractable
                  nuclear antigen (anti-ENA) confirmed by central laboratory

          -  The subject is receiving stable SLE standard-of-care medication

        Exclusion Criteria:

          -  Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE

          -  Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the
             opinion of the Investigator, would prevent the subject from completing protocol
             required procedures and assessments.

          -  New or worsening Class III or IV lupus nephritis

          -  Chronic kidney failure stage 3b

          -  Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell
             deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or
             during the study

          -  Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)

          -  Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent
             TB (LTB) infection

          -  Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion
             (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the
             final dose of study drug

          -  History of thromboembolic events within 12 months of screening

          -  Subject has used protocol defined prohibited medications
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Condition: Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Intervention: Fluvastatin
Intervention description: Fluvastatin 40 mg daily for 3 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Persistently Antiphospholipid Antibody Positive Patients

Summary:

      The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and
      safe in reducing the risk of cardiovascular disease and blood clots in patients with
      antiphospholipid antibodies or Antiphospholipid Syndrome (APS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistently antiphospholipid-antibody positive patients (positive lupus anticoagulant
             test, anticardiolipin antibody ≥ 40 GPL /MPL, and/or anti- β2-glycoprotein I antibody
             > 20 SGU/SMU) with or without systemic lupus erythematosus

        Exclusion Criteria:

          -  Younger than 18 year-old

          -  Pregnant

          -  Planning to get pregnant within the next 6 months

          -  Taking other cholesterol lowering agents

          -  Taking other immunosuppressive medications (such as methotrexate, azathioprine,
             cellcept, enbrel, remicade, or rituximab)(Hydroxychloroquine [Plaquenil] during the
             study period is allowed).

          -  Treatment with biologic agents including anti-TNF medications and Rituximab

          -  Treatment with erythromycin, itraconazole, or clarithromycin

          -  Taking prednisone higher than 10 mg daily

          -  Taking non-steroidal anti-inflammatory drug (such as Motrin, Advil, etc) regularly

          -  Have a muscle or liver disease

          -  Have chronic renal disease requiring dialysis

          -  Have hepatitis C and/or HIV infection

          -  Have active infections requiring antibiotics

          -  Have the diagnosis of a systemic autoimmune disease (such as rheumatoid arthritis or
             systemic sclerosis) other than lupus

          -  Have diagnosis of another chronic condition requiring corticosteroid treatment more
             than 10mg daily

          -  History of an allergic reaction to cholesterol lowering agents