bioihbjkbjnl/mcl2 huggingface dataset:
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: BI 695501; HUMIRA
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      The primary objective of this trial is to compare the clinical efficacy of BI 695501 with
      EU-approved Humira® in patients with active Crohn's disease (CD).

      Secondary Objectives:

      The secondary objectives of this trial are to compare the efficacy and safety of BI 695501
      with EU-approved Humira® across the induction and maintenance phases.
    

Eligibility criteria:

        Inclusion criteria:

          -  Males and females aged >=18 and =<80 years at Screening who have a diagnosis of
             moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic
             evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must
             have all of the following:

               -  Crohn's Disease Activity Index (CDAI) score of >=220 and =<450

               -  A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening

               -  Presence of mucosal ulcers in at least one segment of the ileum or colon and a
                  SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as
                  assessed by ileocolonoscopy and confirmed by central independent reviewer(s)
                  before randomization

          -  Anti-tumor necrosis factor (TNF) patients or patients previously treated with
             infliximab who had initially responded and who meet one of the following criteria:

               -  Responded and developed secondary resistance due confirmed anti-infliximab
                  anti-drug antibody formation, which caused infliximab depletion

               -  Responded and became intolerant

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Patients with ulcerative colitis or indeterminate colitis

          -  Patients with symptomatic known obstructive strictures

          -  Surgical bowel resection performed within 6 months prior to Screening or planned
             resection at any time while enrolled in the trial

          -  Patients with an ostomy or ileoanal pouch

          -  Patients with short bowel syndrome

          -  Patients who have previously used infliximab and have never clinically responded

          -  Patients who have previously received treatment with adalimumab, or who have
             participated in an adalimumab or adalimumab biosimilar clinical trial

          -  Further exclusion criteria apply
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Condition: Neurotrophic Keratopathy
Intervention: RGN-259; Placebo
Intervention description: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.; It is composed of the same excipients as RGN-259 but does not contain Tβ4
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neurotrophic Keratopathy; NK

Summary:

      The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic
      Solution compared to placebo for the treatment of NK.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be male or female of any race, at least 18 years of age

          -  Have provided verbal and written informed consent.

          -  Be able and willing to follow instructions, including participation in all study
             assessments and visits;

          -  Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of
             childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to
             use an adequate method of birth control throughout the study period.

        Exclusion Criteria:

          -  Have any clinically significant slit lamp findings at Visit 1 that in the opinion of
             the investigator may interfere with the study parameters;

          -  Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin
             inflammation or active ocular allergy that requires treatment

          -  Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the
             investigator, is the primary cause of the persistent epithelial defect;

          -  Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active
             inflammation (e.g. follicular conjunctivitis) not related to NK

          -  Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the
             study;

          -  Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior
             to Visit 1 or anticipates use of contact lenses during the study period;

          -  Have an uncontrolled systemic disease that in the opinion of the investigator may
             interfere with the study parameters;

          -  Anticipate a change in immunosuppressive therapy during the course of the study;
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Condition: Head and Neck Carcinoma; Radiation-Induced Dermatitis
MeSH terms: Head and Neck Neoplasms; Dermatitis; Radiodermatitis
Intervention: Dakin's solution; Placebo
Intervention description: Apply modified Dakin's solution (0.005 to 0.01%) topically; Applied topically
Intervention MeSH terms: Sodium Hypochlorite; Eusol; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase 3 trial studies how well modified Dakin's solution works in reducing
      radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with
      head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce
      inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.

      Radiation therapy in this study is regulatory medical care based on the patient's needs and
      the radiation oncologist's judgment. It is not possible nor necessary to explicitly define
      the dose or duration of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Head and neck cancer who plan to undergo radiation therapy to the head and neck region

          -  At least 18 years of age

          -  Able to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Prior radiation therapy to the head and neck region or prior chemotherapy for head and
             neck cancer (induction chemotherapy NOT excluded)

          -  The physician-approved radiation treatment plan indicates a maximum prescription dose
             of less than 45 Gy

          -  Scleroderma or discoid lupus
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: Duloxetine Hydrochloride
Intervention description: Administered orally
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine
      hydrochloride in Japanese children and adolescents with depressive disorder.
    

Eligibility criteria:

        -  a) Participants extended from B058(1701A3631) study.

          -  b) New participants.

        Inclusion Criteria

          -  a) Participants who have completed 7 weeks of dosing in the B058(1701A3631) study and
             give signed informed consent to continue duloxetine administration in this study.

          -  b) Participants diagnosed with Major Depressive Disorder or persistent depressive
             disorder and completely meet the criteria of major depressive episode as defined by
             the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with
             the Mini International Neuropsychiatric Interview for Children and Adolescents
             (MINI-KID) ver.7.0.2.

          -  b) Participants whose incipient age of depression was ≥7 years old.

        Exclusion Criteria:

          -  a, b) Have a current or previous diagnosis (DSM-5) of the following as judged by the
             investigator:

               -  Neurodevelopmental disorders

               -  Schizophrenia spectrum and other psychotic disorders

               -  Bipolar and related disorders

               -  Trauma and stressor-related disorders

               -  Disruptive · Impulse Control · and Conduct disorders

          -  a, b) Have a current diagnosis (DSM-5) of the following as judged by the investigator:

               -  Obsessive-compulsive and related disorders

               -  Anorexia nervosa, Bulimia nervosa, Binge-eating disorder

               -  Sleep-wake disorders

               -  Neurocognitive disorders

               -  Disruptive mood dysregulation disorder

          -  a, b) Have personality disorders, in the judgment of the investigator.
A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661/Ivacaftor; Ivacaftor; Placebo matched to VX-661/ ivacaftor; Placebo matched to Ivacaftor
Intervention description: Fixed dose combination tablet, oral use; Tablet, oral use; Fixed dose combination tablet, oral use; Tablet, oral use
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 248.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination
      with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF)
      who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation
      predicted to have residual function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heterozygous for F508del-CFTR and a second allele with a CFTR mutation predicted to
             have residual function

          -  Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to (≥) 40 percent
             (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height
             during screening

          -  Sweat chloride value ≥60 millimole per liter (mmol/L) during screening OR as
             documented in the participant's medical record

          -  Stable CF disease as judged by the investigator

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant

          -  An acute upper or lower respiratory infection, pulmonary exacerbation

          -  History of solid organ or hematological transplantation

          -  Ongoing or prior participation in an investigational drug study (including studies
             investigating VX-661, lumacaftor [VX-809], and/or ivacaftor) within 30 days of
             screening

          -  Pregnant and nursing females

          -  Sexually active participants of reproductive potential who are not willing to follow
             the contraception requirements
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 619.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD

Summary:

      The purpose of this study is to measure the effectiveness and safety of TD 4208, an
      investigational drug being developed to treat people with moderate to very severe COPD,
      compared to placebo, a treatment without activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older

        Exclusion Criteria:

          -  Females who are pregnant, lactating, breast-feeding or planning to become pregnant
             during the study
ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
Condition: Acute Hepatic Porphyria; Acute Intermittent Porphyria; Porphyria, Acute Intermittent; Acute Porphyria; Hereditary Coproporphyria (HCP); Variegate Porphyria (VP); ALA Dehydratase Deficient Porphyria (ADP)
MeSH terms: Porphyria, Acute Intermittent; Porphyrias, Hepatic; Coproporphyria, Hereditary; Porphyria, Variegate; Porphyria, Erythropoietic; Porphyrias
Intervention: Givosiran; Placebo
Intervention description: Givosiran by SC; Matching placebo (normal saline [0.9% NaCl]) by SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 94.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acute Intermittent Porphyria (AIP); Acute Hepatic Porphyria (AHP); Hereditary Coproporphyria (HCP); Variegate Porphyria (VP); ALA dehydratase deficient porphyria (ADP) (ALAD); RNAi therapeutic; Porphyria

Summary:

      The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1),
      compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic
      Porphyrias (AHP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 12 years of age

          -  Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary
             Corproporhyria, Variegate Porphyria, aminolevulinic acid (ALA) dehydratase deficient
             porphyria)

          -  Elevated urinary or plasma porphobilinogen (PBG) or ALA values within the past year,

          -  Have active disease, with at least 2 documented porphyria attacks within the last 6
             months

          -  Willing to discontinue or not initiate the use of prophylactic hemin throughout the
             study.

          -  Women of child bearing potential must have a negative serum pregnancy test, not be
             nursing, and use acceptable contraception

        Exclusion Criteria:

          -  Clinically significant abnormal laboratory results

          -  Anticipated liver transplantation

          -  History of multiple drug allergies or intolerance to subcutaneous injections

          -  Active HIV, hepatitis C virus, or hepatitis B virus infection(s)

          -  History of recurrent pancreatitis
2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients
Condition: Surgical Site Infections; Post Operative Complication
MeSH terms: Infections; Surgical Wound Infection; Postoperative Complications
Intervention: 2% chlorhexidine gluconate cloths
Intervention description: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: skin flora

Summary:

      Surgical site infection (SSI) following spinal surgery is a frequent complication and results
      in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a
      frequent complication that has been reported to occur in 0.7-12.0% of patients and result in
      higher postoperative morbidity, mortality and health care costs. Vanderbilt University
      Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision
      surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of
      risk factors is thus important in the development of strategies to prevent these potentially
      devastating infections. This study proposes a randomized, controlled trial of neuro-spine
      patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op
      surgical site infections in spine patients.

      Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect
      (decrease rates) of SSI compared to patients who receive routine standard of care (soap and
      water pre-op, day of surgery and daily post-operative).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients scheduled for a neuro-spine procedure and have 2 of the following risk factors:

          -  Diabetic OR

          -  BMI>30 OR

          -  ASA>2 OR

          -  pre-operatively hospitalized OR

          -  >60 years old OR

          -  chronic steroids/immunosuppressive medications OR

          -  prior history of SSI

        Exclusion Criteria:

          -  Unable to consent

          -  Non English speaking

          -  Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate
             cloths

          -  Current infection or history of spine infections

          -  Patients with tumors or intradural spinal pathology.
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: PF-06410293; Adalimumab
Intervention description: PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.; Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 597.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 3; adalimumab; rheumatoid arthritis

Summary:

      The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab
      in combination with methotrexate in subjects with moderately to severly active rheumatoid
      arthritis who have had an inadequate response to methotrexate.

      In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a
      subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study
      treatment (PF-06410293) at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4
             months.

          -  At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening
             and baseline.

          -  Hs-CRP equal or greater than 8 mg/L.

          -  Must have received methotrexate for at least 12 weeks and been on a stable dose for at
             least 4 weeks prior to the first study dose.

        Exclusion Criteria:

          -  Evidence of untreated or inadequately treated latent or active TB.

          -  Evidence of uncontrolled, clinically significant diseases, including moderate or
             severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.

          -  History of infection requiring hospitalization or parenteral antimicrobial therapy
             within 6 months prior to first dose of study drug.

          -  May have received no more than 2 doses of one biologic therapy (other than adalimumab
             or lymphocyte depleting therapy).

          -  Any second DMARD must be washed out prior to the first study dose.