bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; Tralokinumab Dose 1; Tralokinumab Dose 2; Tralokinumab Dose 3
Intervention description: Subcutaneous injection with placebo; Subcutaneous injection with tralokinumab; Subcutaneous injection with tralokinumab; Subcutaneous injection with tralokinumab
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with
      atopic dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician diagnosis of atopic dermatitis for greater than (>) 1 year

          -  Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body
             surface area

          -  EASI score of >= 12

          -  SCORAD of >= 25

          -  IGA score of >= 3

          -  Effective birth control in line with protocol details

        Exclusion Criteria:

          -  History of anaphylaxis following any biologic therapy

          -  Hepatitis B, C or human immunodeficiency virus

          -  Pregnant or breastfeeding

          -  History of cancer

          -  Previous receipt of tralokinumab
An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: M281
Intervention description: M281 injection administered as intravenous infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: M281; Generalized Myasthenia Gravis

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of M281 in
      participants with generalized myasthenia gravis (gMG)
    

Eligibility criteria:

        Participants must be ≥18 years of age with a documented history of Generalized Myasthenia
        Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, previously
        participated in the MOM-281-004 study, had no major eligibility deviations or other major
        protocol deviations or not met any of the stopping criteria or discontinued study drug in
        the MOM-M281-004 study for any reason other than the need for rescue therapy as specified
        in the MOM-M281-004 study.

        Additional, more specific criteria are defined in the protocol.
Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
Condition: Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia; Non Follicular Indolent Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia
Intervention: Umbralisib
Intervention description: Oral Daily Dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research study will evaluate the safety and efficacy of a study drug called Umbralisib
      (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia
      that has come back or that has not responded to standard treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Waldenstroms Macroglobulinemia

          -  Relapsed or refractory after at least one prior treatment regimen

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

        Exclusion Criteria:

          -  Any major surgery, chemotherapy or immunotherapy within the last 21 days

          -  Evidence of hepatitis B virus, hepatitis C virus or known HIV infection

          -  Prior autologous stem cell transplant within 6 months of study entry
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Placebo Inhalation Solution; SPX-101
Intervention description: Normal Saline Inhalation Solution; SPX-101 Inhalation Solution
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: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult
      subjects with cystic fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of cystic fibrosis

          -  ppFEV1 (percent predicted FEV1) between 50.0% and 80.0%

          -  Stable CF Lung Disease

          -  Males and non-pregnant, non-lactating females

        Exclusion Criteria:

          -  Significant unstable co-morbidities within 28 days of screening

          -  Has received an investigational drug within 28 days of screening
A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
Condition: Alzheimer Disease (AD)
MeSH terms: Alzheimer Disease
Intervention: Zagotenemab; Placebo
Intervention description: Administered IV; Administered IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Memory problems; Cognitive impairment; PERISCOPE-ALZ; Dementia; Tauopathy; Neurofibrillary tangles

Summary:

      The purpose of this study is to evaluate the safety and efficacy of a study drug that targets
      an abnormal protein in the brain found in people with Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have gradual and progressive change in memory function for >6
             months.

          -  Participants must have a family member or close friend who is with you at least 10
             hours per week and can attend study appointments.

        Exclusion Criteria:

          -  Participants must not have significant neurological disease affecting the nervous
             system, other than AD, that affects cognition or may affect completion of the study.

          -  Participants must not have serious or unstable illness that could interfere with the
             analysis of the study or has a life expectancy <24 months.

          -  Participants must not have history of cancer within the last 5 years with the
             exception of certain types of skin, cervical, prostate, and other cancers that are not
             likely to recur or spread.

          -  Participants must not have serious risk for suicide.

          -  Participants must not have history of drug or alcohol use disorder within the last 2
             years.

          -  Participants must not have multiple severe drug allergies

          -  Participants must not have HIV, Hepatitis B or Hepatitis C

          -  Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin
             (IVIG) therapy
Modafinil for Smoked Cocaine Self-Administration
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Modafinil 0 mg; Modafinil 200 mg; Modafinil 400 mg; Cocaine 0 mg; Cocaine 12 mg; Cocaine 25 mg; Cocaine 50 mg
Intervention description: Modafinil (0 mg/day); Modafinil (200 mg/day); Modafinil (400 mg/day); Cocaine (0 mg/day); Cocaine (12 mg/day); Cocaine (25 mg/day); Cocaine (50 mg/day)
Intervention MeSH terms: Cocaine; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: cocaine; modafinil; self-administration; DRD4

Summary:

      Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2
      days/week), but the effects of modafinil on cocaine self-administration in the laboratory
      have not been studied. The present study investigated the effects of modafinil maintenance on
      cocaine self-administration by frequent users (4 days/week) under controlled laboratory
      conditions. During this 48-day double-blind, crossover design study, the effects of modafinil
      maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were
      examined in nontreatment seeking cocaine-dependent individuals (n = 8).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Smokes cocaine

          2. Has patterns of smoked cocaine use in terms of frequency and amount which parallel or
             exceed those administered in the study.

          3. Age 21-50.

          4. Able to give informed consent, and comply with study procedures.

          5. Normal body weight Within normal weight range (for appropriate frame) according to
             1983 Metropolitan Weight tables -

        Exclusion Criteria:

          1. Current seizure disorder, heart disease or a history of serious adverse effects due to
             cocaine.

          2. Dependence on substances (other than cocaine or nicotine) or a history of dependence
             on alcohol

          3. Request for drug treatment

          4. Judged to be noncompliant with study protocol.

          5. Current use of any psychotropic medication.

          6. Clinical laboratory tests outside normal limits that are clinically unacceptable to
             the study physician (BP > 140/90; BUN, creatinine, LFTs > 3x ULN; hematocrit < 34 for
             women, < 36 for men; pseudocholinesterase deficiency)

          7. History of myocardial infarction or ischemia, clinically significant left ventricular
             hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse

          8. Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other
             than transient psychosis due to drug abuse

          9. Current parole or probation Self-report during interview -
Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Etokimab; Placebo
Intervention description: Humanized monoclonal antibody, administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ANB020; etokimab; eczema; moderate to severe

Summary:

      This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of
      multiple doses of etokimab in adult participants with atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female participants must be 18 to 75 years of age, at the time of signing the
             informed consent.

          2. Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m^2) at screening.

          3. Clinically confirmed diagnosis of AD.

          4. Eczema Area and Severity Index (EASI) score ≥ 16, body surface area (BSA) involvement
             ≥ 10%, and an Investigator's Global Assessment (IGA) score (5-point scale) ≥ 3 at
             baseline.

          5. Participants with a history of inadequate response to topical treatment, use of
             systemic treatments to treat AD, and/or for whom topical treatments are otherwise
             medically inadvisable.

          6. Daily use of non-medicated emollient for at least 7 days prior to baseline.

        Exclusion Criteria:

          1. Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole
             within 2 weeks before dosing.

          2. Prior exposure to an anti-interleukin (IL)-33 antibody.

          3. Exposure to an investigational or licensed or other anti T-helper 2 (Th2) type
             cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is
             longer.

          4. History of prior exposure to any investigational or biologic systemic treatment within
             5 half lives of the screening or is currently enrolled in another clinical study.

          5. Have received systemic treatment for AD (including systemic corticosteroids,
             immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning
             booth) within 4 weeks before screening.

          6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or
             murine monoclonal antibodies.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Condition: Atopic Dermatitis; Plaque Psoriasis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Intervention: PF-07038124 ointment; Vehicle ointment
Intervention description: PF-07038124 ointment at 0.01% with QD dosing for 6 weeks; Vehicle ointment with QD dosing for 6 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: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: atopic dermatitis, plaque psoriasis

Summary:

      This study is being conducted to provide data on efficacy, safety, tolerability and PK of
      PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild
      to moderate plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an
             Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD
             covering 5% to 20% (inclusive) of BSA.

          -  Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for
             at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3
             (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.

        Exclusion Criteria:

          -  Presence of skin comorbidities that would interfere with study assessment or response
             to treatment.

          -  Current or recent history of severe, progressive, or uncontrolled renal, hepatic,
             hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or
             neurological disease.

          -  Other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk
             of study participation or, in the investigator's judgment, make the participant
             inappropriate for the study.
Biology and Experience of Eating in Women With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: Naloxone; Placebo
Intervention description: 4 mg / 0.1 ml; 0.1 ml
Intervention MeSH terms: Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Binge eating

Summary:

      The purpose of this study is to understand how the opioid system is involved in eating
      behavior.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese, as defined by BMI greater than or equal to 30

          -  Self-reported binge eating as defined in the Diagnostic and Statistical Manual of
             Mental Disorders (DSM-5), in the last 4 weeks

          -  If sexually active with men, must agree to use birth control until the final study
             visit is complete (e.g., barrier methods, oral contraceptive)

          -  Subject must be able to complete written informed consent procedures and be able to
             comply with the requirements of the study.

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Severe hypotension (< 90/60 mmHg)

          -  Recent or current use of vasoconstrictor or vasodilator medication

          -  Current or history of diabetes

          -  Allergies to any ingredients in naloxone hydrochloride

          -  History of or current alcoholism or drug dependence

          -  Bulimia Nervosa as defined in DSM 5

          -  Current or past use of opiate-containing medications in the last 30 days

          -  Plan to use opiate-containing medications during study participation period

          -  Medical conditions that are contraindicated with intranasal procedures: Nasal septal
             abnormalities, nasal trauma, epistaxis, excessive nasal mucus, and intranasal damage
             caused by the use of substances (e.g., cocaine)

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the subject or the quality of the data
A Phase II Study of M2951 in SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; M2951; M2951; M2951; M2951
Intervention description: Participants received placebo matched to M2951 orally for 52 weeks.; Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.; Participants received 75 mg of M2951 orally QD for 52 weeks.; Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.; Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 469.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus; M2951; Placebo; Dose response; Oral Corticosteroids; Safety; Efficacy; Autoimmune And Inflammatory Disorders

Summary:

      M2951 is an investigational drug under evaluation for treatment of autoimmune and
      inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of
      M2951 in participants with Systemic Lupus Erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible male and female participants, aged 18 to 75 years

          -  Must have diagnosis of SLE with either the Systemic Lupus International Collaborating
             Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of
             Rheumatology (ACR) classification criteria for SLE, of at least six months duration
             prior to Screening

          -  SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI
             greater than or equal to (>=) 4) at Screening Visit

          -  And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or
             anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith
             (anti-Sm) antibody at the time of Screening

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participants are not eligible for this study if they have active, clinically
             significant interstitial lung disease or pulmonary arterial hypertension

          -  Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)

          -  Acutely worsened renal function

          -  Central nervous system SLE

          -  Or within two weeks prior to Screening or during Screening: use of oral
             corticosteroids greater than (>) 30 mg daily prednisone equivalent

          -  Use of injectable corticosteroids, or change in dose of corticosteroids.

          -  Other protocol defined exclusion criteria could apply
Soy Protein and Breast Cancer Risk Reduction
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: soy milk; cow's milk
Intervention description: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.; Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo controlled, 2 parallel groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Research pharmacist dispensed blinded assigned sachets according to a pre-generated randomization list. Pharmacists were blinded to all other aspects of the research protocols.
Subjects, investigators, research staff, and statisticians were all blinded to treatment assignment.
Enrollment: 321.0
Sex: Female
Minimum age: 30 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: soy diet; breast cancer; ovarian hormones; breast density; prevention

Summary:

      Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian
      hormones and breast density are considered breast cancer risk markers. We propose to test the
      hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a
      corresponding reduction in breast density comparing to casein protein.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy premenopausal women

          -  30 to 40 years old

          -  normal mammograms

          -  regular menstrual cycles

        Exclusion Criteria:

          -  abnormal mammograms

          -  first degree relatives with breast cancer

          -  pregnant or lactating

          -  peri- or post-menopause

          -  breast augmentation, reduction, and lifting

          -  on oral contraceptive medications or exogenous hormones

          -  medically prescribed diets

          -  allergic reaction to soy or cow's milk