bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: PF-04965842 100 mg; PF-04965842 200 mg; Placebo
Intervention description: PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks; PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks; Placebo, administered as two tablets to be taken orally once daily for 12 weeks
Intervention MeSH terms: Abrocitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

Summary:

      B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with
      a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy
      and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily,
      will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients
      will have an option to enter a long-term extension study after completing 12 weeks of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older with a minimum body weight of 40 kg

          -  Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
             to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS
             severity 4)

          -  Recent history of inadequate response or inability to tolerate topical AD treatments
             or require systemic treatments for AD control

        Exclusion Criteria:

          -  Unwilling to discontinue current AD medications prior to the study or require
             treatment with prohibited medications during the study

          -  Prior treatment with JAK inhibitors

          -  Other active nonAD inflammatory skin diseases or conditions affecting skin

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q
             wave interval abnormalities, current or history of certain infections, cancer,
             lymphoproliferative disorders and other medical conditions at the discretion of the
             investigator

          -  Pregnant or breastfeeding women, or women of childbearing potential who are unwilling
             to use contraception
Enhancing Adaptations to Exercise
Condition: Inflammation
MeSH terms: Inflammation
Intervention: n3-PUFA; Placebo; Biopsy; Body Composition Scan
Intervention description: The DHA/EPA softgels will each contain ~465mg of EPA and ~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule will contain SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (~381 mg) and poloxamer 237, NF (~8.8 mg).; Looks exactly like the study drug but contains soybean oil with no active ingredient.; Two muscle biopsies from the upper part of one leg. A small (~1cm) incision will be made through the skin, and a needle will then be used to remove the muscle.; Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Exercise; muscle function

Summary:

      Researchers are trying to understand how chronic inflammation affects muscle function and
      responses to exercise.They are also trying to determine if suppressing chronic inflammation
      using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise
      responsiveness in older adults.
    

Eligibility criteria:

        Inclusion criteria:

          -  Men and women between the ages of 20-35 years

          -  Men and women between the ages of 65-85 years

        Exclusion criteria:

          -  Regular use of omega-3 nutritional supplements

          -  Diabetes or fasting plasma glucose > or equal to 126 mg/dL

          -  Anemia (female subjects hemoglobin of <11 g/dl and male subjects hemoglobin <12 g/dl)

          -  Active coronary artery disease or history of unstable macrovascular disease (unstable
             angina, myocardial infarction, stroke, and revascularization of coronary, peripheral
             or carotid artery within 3 months of recruitment)

          -  Renal failure (serum creatinine > 1.5mg/dl)

          -  Chronic active liver disease (AST>144 IU/L or ALT>165 IU/L)

          -  Oral warfarin group medications or history of blood clotting disorders.

          -  international normalized ratio (INR) >2.01.5

          -  Smoking

          -  Pregnancy or breastfeeding

          -  Alcohol consumption greater than 2 glasses/day or other substance abuse

          -  Untreated or uncontrolled hypothyroidism

          -  Debilitating chronic disease (at the discretion of the investigators)

          -  Fish or shellfish allergy
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
Condition: Primary Systemic (AL) Amyloidosis
MeSH terms: Amyloidosis
Intervention: NEOD001; Placebo
Intervention description: NEOD001, is a humanized immunoglobulin G1 monoclonal antibody, which specifically targets misfolded light chain aggregates and amyloid deposits. NEOD001 is proposed for use to target the misfolded light chain protein in subjects with AL amyloidosis.; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm
      efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will
      remain on-study until study completion, which will occur when all primary endpoint events
      (all-cause mortality or cardiac hospitalizations) have been reached.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age ≥ 18 years

          2. Newly diagnosed, AL amyloidosis treatment naïve

          3. Bone marrow consistent with plasma cell dyscrasia

          4. Confirmed diagnosis of AL amyloidosis

          5. Cardiac involvement

          6. Planned first-line chemotherapy contains a proteasome-inhibiting agent administered
             weekly

          7. Adequate bone marrow reserve, hepatic and renal function

        Key Exclusion Criteria:

          1. Non-AL amyloidosis

          2. Meets diagnostic criteria for symptomatic multiple myeloma

          3. Subject is eligible for and plans to undergo ASCT

          4. History of Grade ≥ 3 infusion-associated AEs or hypersensitivity to another monoclonal
             antibody, or known hypersensitivity to diphenhydramine or acetaminophen
In Vivo Efficacy Study of Patient Preoperative Preps
Condition: Bacterial Reduction Post-product Application
Intervention: 3M CHG/IPA Prep C; 3M CHG/IPA Prep CH; ChloraPrep; Normal Saline
Intervention description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: surgical skin prep; CHG; IPA

Summary:

      The objective of this study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA
      Prep on skin flora of the abdominal and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good health

          -  Minimum skin flora baseline requirements on abdomen and groin

        Exclusion Criteria:

          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin
             disorders (including acne) on the applicable test area

          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days

          -  Use of systemic or topical antibiotics, steroid medications, or any other products
             known to affect the normal microbial flora of the skin within 14 days prior to
             screening and treatment days
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
Condition: Cold Agglutinin Disease
MeSH terms: Anemia, Hemolytic, Autoimmune
Intervention: sutimlimab
Intervention description: Pharmaceutical form: solution for injection Route of administration: intravenous (IV)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This was a multi-center, single treatment-group, open-label study to provide sutimlimab to
      the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT
      number: NCT03347396) or CADENZA (NCT number: NCT03347422) studies and benefitted from
      sutimlimab treatment in Japan.

      • Study and treatment duration: the period between the participant's completion of the
      CARDINAL and CADENZA studies and sutimlimab or other appropriate CAD therapy becoming
      commercially available to participants in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

        --Participant must be adults.

          -  Participants who had been enrolled in and had completed Part B of CARDINAL or CADENZA
             study.

          -  Participants who had ongoing diagnosis of CAD.

          -  Participants who continued to require treatment for CAD upon completion of
             participation in the previous study evidenced by return of CAD-related symptoms of
             anemia and/or deterioration on markers of hemolysis after the end of study visit
             following the 9-week safety follow up period. (9-week follow up period).

          -  Participants who had acceptable benefit/risk profile.

          -  Participant who had acceptable infection risk.

          -  Participants who had no available appropriate alternative therapy for CAD.

          -  Body weight >= 39 kg.

          -  Gave signed informed consent.

        Exclusion Criteria:

        --Clinical diagnosis of systemic lupus erythematosus or immune complex-mediated autoimmune
        disorders.

          -  Participants who met recent Rituximab and/or immunosuppressive therapy.

          -  Any of the following medical conditions:

               1. Active, serious intercurrent illness which precluded enrolment until recovery was
                  complete.

               2. Pregnancy or breast-feeding.

          -  End of Study visit in CARDINAL or CADENZA took place more than 3 months before
             Baseline visit in this study.

          -  Hypersensitivity reactions to sutimlimab or components thereof, or other allergy that,
             in the opinion of the Investigator, contraindicated participation in the study.
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: IDP-124 Lotion; IDP-124 Vehicle Lotion
Intervention description: IDP-124 Lotion, twice-daily application; IDP-124 Vehicle Lotion, twice-daily application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 338.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic
      Dermatitis in Pediatric and Adult Subjects
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female at least 2 years of age and older

          -  Written and verbal informed consent must be obtained; subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit)

          -  Nonimmunocompromized male or female who failed to respond adequately to other topical
             prescription treatment for AD or for whom those treatments are not advisable

          -  Subjects must be willing to comply with study instructions and return to the clinic
             for required visits; subjects under the age of consent must be accompanied by the
             parent or legal guardian at the time of assent/consent signing

        Key Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or who wish to become pregnant during the
             study period

          -  Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg,
             clinically infected AD)

          -  Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline,
             which would interfere with evaluations

          -  History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or
             ichthyosis (other than ichthyosis vulgaris)
In-vivo Efficacy of Patient Preoperative Prep
Condition: Surgical Skin Preparation
Intervention: ZuraPrep; ChloraPrep; ZP Vehicle
Intervention description: Apply topically.; Apply topically.; Apply topically.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to demonstrate the antimicrobial efficacy of the ZP
      Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good health

          -  Minimum skin flora baseline requirements on abdomen and groin

          -  Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder
             near or on the applicable test area.

        Exclusion Criteria:

          -  Topical or systemic antimicrobial exposure within 14 days prior to screening and
             treatment days, including antibiotics.

          -  Subjects with a history of skin sensitivity, skin allergies, or skin cancer.

          -  Subjects who are pregnant, attempting pregnancy or nursing.
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: CSF-1; Vehicle
Intervention description: One drop bilaterally twice daily for approximately 2 weeks.; One drop bilaterally twice daily for approximately 2 weeks.
Intervention MeSH terms: Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 309.0
Sex: All
Minimum age: 45 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study
      evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have presbyopia.

        Exclusion Criteria:

        Subjects must not:

          -  Have any contraindications to the study medications or diagnoses that would confound
             the study.
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM; IVA
Intervention description: Fixed Dose Combination (FDC) granules (LUM/IVA).; FDC granules (LUM/IVA).
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: No

Summary:

      This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and
      ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF),
      homozygous for F508del (F/F).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants will be 1 to less than 2 years of age on day 1 of the relevant part of
             the study

          -  Homozygous for F508del (F/F)

        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 participants

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply.
ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: CyclASol topical ocular, eye drops; Vehicle topical ocular, eye drops
Intervention description: Cyclosporine A solution in vehicle; Vehicle
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 834.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this pivotal trial is to assess the efficacy, safety and tolerability of
      CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye
      Disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed ICF (Informed Consent Form)

          -  Patient-reported history of DED in both eyes

          -  Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Women who are pregnant, nursing or planning a pregnancy

          -  Unwillingness to submit a urine pregnancy test at screening and the last visit (or
             early termination visit) if of childbearing potential, or unwillingness to use
             acceptable means of birth control

          -  Clinically significant slit-lamp findings or abnormal lid anatomy at screening

          -  Ocular/periocular malignancy

          -  History of herpetic keratitis

          -  Active ocular allergies or ocular allergies that may become active during the study
             period

          -  Ongoing ocular or systemic infection at screening or baseline

          -  Wear of contact lenses within 3 months prior to screening or anticipated use of
             contact lenses during the study

          -  Use of topical Cyclosporine A or Liftigrast within 2 months prior to screening

          -  Intraocular surgery or ocular laser surgery within the previous 6 months, or have any
             planned ocular and/or lid surgeries over the study period

          -  Presence of uncontrolled systemic diseases

          -  Presence of known allergy and/or sensitivity to the study drug or its components

          -  Randomized in a previous CyclASol trial
Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Glucagon
Intervention description: 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes.
      Subjects will be administered insulin to induce a low normal glycemic state and will then
      receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center
      (CRC) or comparable setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with T1D for at least 6 months at Screening.

          -  current usage of daily insulin treatment.

        Exclusion Criteria:

          -  pregnant or nursing

          -  renal insufficiency

          -  hepatic synthetic insufficiency

          -  aspartate or alanine aminotransferase > 3 times the upper limit of normal

          -  hematocrit less than or equal to 30%

          -  use of > 2.0 U/kg total insulin dose per day

          -  inadequate venous access

          -  current seizure disorder

          -  history of pheochromocytoma or disorder with increased risk of pheochromocytoma

          -  history of insulinoma

          -  history of glycogen storage disease.

          -  active use of alcohol or drugs of abuse

          -  administration of glucagon within 14 days of the first treatment visit

          -  participation in other studies involving an investigational drug or device within 30
             days