bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
Condition: Moderate to Severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ISB 830 - Part 1 Group 1; ISB 830 - Part 1 Group 2; ISB 830 - Part 1 Group 3; Placebo - Part 1 Group 4; ISB 830 - Part 2 Group 5; Placebo - Part 2 Group 6
Intervention description: Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks; Subcutaneous injection (SC) every 2 weeks
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: 462.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ISB 830, OX40, atopic dermatitis

Summary:

      Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate
      the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic
      dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1,
      and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a
      16 week blinded treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis
             for >1 year as defined by American Academy of Dermatology Consensus Criteria.

          -  Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.

          -  EASI score of ≥12 at screening or ≥16 at baseline.

          -  IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is
             moderate and 4 is severe)

          -  Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3
             over the previous 24 hours.

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Prior treatment with ISB 830

          -  Treatment with biologics

          -  Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy
             within 4 weeks of baseline

          -  Active chronic or acute infection requiring systemic treatment
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Apremilast; Apremilast; Placebo; Placebo
Intervention description: Orally twice a day (BID); Orally twice a day (BID); Orally twice a day (BID); Orally twice a day (BID)
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Atopic Eczema

Summary:

      A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with
      moderate to severe atopic dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females, aged ≥ 18 years (≥ 20 for Japanese subjects) at the time of consent.

          2. Have a diagnosis of atopic dermatitis for ≥ 12 months.

          3. Have moderate to severe atopic dermatitis which is considered inappropriate for
             topical therapy or which cannot be adequately controlled by topical therapy.

          4. Meet the laboratory criteria as defined per protocol

          5. Females of Childbearing Potential (FCBP) must have a negative pregnancy test at
             Screening and Baseline. Sexually active FCBP must use one of the approved
             contraceptive options required per protocol while on and for at least 28 days after
             the last dose of study medication

          6. Male subjects (including those who have had a vasectomy) who engage in activity in
             which conception is possible must use barrier contraception while on and for at least
             28 days after the last dose of study medication.

        Exclusion Criteria:

          1. Active tuberculosis (TB) or a history of inadequately treated tuberculosis.

          2. Positive for hepatitis B surface antigen or hepatitis C antibody

          3. Pregnant or breast feeding

          4. History of allergy to any component of the study medication.

          5. Active skin infection requiring systemic antimicrobials at Baseline.
Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: AZD3199; AZD3199; AZD3199 Placebo
Intervention description: Inhaled via single inhaler device (SID); Inhaled via Turbuhaler inhaler; Inhaled via Turbuhaler inhaler and SID
Intervention MeSH terms: AZD-3199
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; patients; lung function

Summary:

      The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single
      doses of three different dry powder inhalation formulations of AZD3199 administered via
      Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and
      compared to placebo in patients with persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated written informed consent prior to any study specific
             procedures

          -  Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on
             a highly effective contraceptive method for at least 3 months prior to Visit 1 and be
             willing to continue on the chosen contraceptive method throughout the study.

          -  Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to study
             start

          -  A history of asthma for at least 6 months.

          -  Body Mass Index (BMI) 19-30 kg/m2

        Exclusion Criteria:

          -  Significant disease or disorder which, in the opinion of the Investigator, may either
             put the patient at risk because of participation in the study, or influence the result
             of the study, or the patient's ability to participate in the study

          -  History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
             judged by the Investigator or history of hypersensitivity to β2-agonists in general or
             to AZD3199 and/or excipients

          -  Prolonged QTcF > 450 msec or shortened QTcF <340 msec

          -  History of alcohol/drug abuse or excessive intake of alcohol as judged by the
             Investigator

          -  Pregnancy or lactation
A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
Condition: Smoking Cessation
Intervention: APD356-lorcaserin hydrochloride; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 603.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo
      will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12).
      The target quit date was Day 15.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females aged 18-65 years, inclusive

          2. ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past
             year and who are motivated to quit smoking

          3. Able to give signed informed consent

          4. Eligible female patients will be:

               1. non-pregnant

               2. non-lactating

               3. agree to use an acceptable method of effective contraception during the study

          5. Eligible male patients agree to use contraception when sexually active with a female
             partner who is not using an acceptable method of birth control

          6. Body weight of ≥50 kg (110 pounds), inclusive

          7. Considered to be in stable health in the opinion of the investigator

        Exclusion Criteria:

        Patients who meet any of the following criteria will be excluded from the study.

          1. Prior or current use of lorcaserin HCl

          2. Prior participation in any study of a nicotine vaccination

          3. Use of other therapies for smoking cessation is not allowed within 3 months of
             screening through study exit

          4. Use of tobacco products other than cigarettes

          5. Prior use of fenfluramine or dexfenfluramine

          6. Serious or unstable medical condition or clinically significant new illness within the
             6 months prior to screening

          7. Previous participation in any clinical study within 6 weeks prior to the screening
             visit

          8. History of severe allergies, severe drug or excipient allergy or hypersensitivity

          9. History of significant cardiovascular condition

         10. History of other significant medical conditions

         11. Significant risk of suicide

         12. Anticipated use of any agents that are associated with valvulopathy and/or pulmonary
             hypertension

         13. Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis
             C

         14. Recent history of alcohol or drug/solvent abuse

         15. Concurrent participation in the study by more than one member of the same household

         16. Not suitable to participate in the study in the opinion of the investigator
Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis
Condition: Glomerulosclerosis, Focal Segmental
MeSH terms: Glomerulosclerosis, Focal Segmental
Intervention: VX-147
Intervention description: Tablets for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in
      participants with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis
      (FSGS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  APOL1 genotype of G1/G1, G2/G2, or G1/G2

          -  FSGS diagnosed by kidney biopsy

        Key Exclusion Criteria:

          -  Evidence of non-APOL1-mediated FSGS

          -  Participants with known sickle cell disease

          -  Solid organ or Bone marrow transplant

        Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy Study of Dysport RU and Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: Botulinum toxin type A; Botulinum toxin type A; Placebo
Intervention description: I.M. (in the muscle) injection on day 1 (single treatment cycle); I.M. on day 1 (single treatment cycle); I.M. on day 1 (single treatment cycle)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: Female
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the dose response versus placebo of a single treatment of
      Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of
      moderate to severe glabellar lines at maximum frown.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female between 30 - 60 years of age

          -  Moderate to severe vertical glabellar lines at maximum frown at baseline

        Exclusion Criteria:

          -  Silicone injections into the upper face

          -  Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or
             photorejuvenation within the previous 12 months

          -  Any planned facial cosmetic surgery during the study period

          -  A history of ablative skin resurfacing of the area to be treated during the study.
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 812.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades
      3-4), treatment-related, select adverse events in patients with advanced or metastatic
      Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or
      after at least 1 systemic therapy.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  ECOG Status: PS 0-1 & PS 2

          -  Subjects with histologically or cytologically-documented SqNSCLC

          -  Subjects must have experienced disease progression or recurrence during or after one
             prior platinum doublet-based chemotherapy regimen

          -  Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria

          -  Subjects with treated or asymptomatic CNS metastases

          -  Prior palliative radiotherapy must have been completed at least 14 days prior to study
             drug administration

          -  Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy,
             immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or
             standard or investigational agents for treatment of NSCLC, must be completed 28 days
             prior to the first dose of nivolumab

          -  Males and Females, ages 18 or older

        Exclusion Criteria:

          -  Subjects with untreated, symptomatic CNS metastases

          -  Subjects with carcinomatous meningitis

          -  Subjects with active, known or suspected autoimmune disease.

          -  Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,
             anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or
             drug specifically targeting T-cell costimulation or checkpoint pathways) or who have
             previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
Condition: Neoplasms, Unknown Primary
MeSH terms: Neoplasms, Unknown Primary
Intervention: Oxaliplatin; Capecitabine
Intervention description: 130 mg/m2 IV day 1 of 21 day cycle; 1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasms, Unknown Primary

Summary:

      In this phase II trial, we will evaluate the feasibility and efficacy of the
      oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy
      regimen for the treatment of carcinoma of unknown primary site. Patients who are relapsed
      after a previous response to treatment will be eligible, as well as those who were refractory
      to first-line therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Histologically confirmed carcinoma of unknown primary site

          -  Progressive disease after treatment with one previous chemotherapy regimen.

          -  Treatment with one previous immunotherapy or biotherapy regimen.

          -  No previous treatment with oxaliplatin, capecitabine, or 5-FU.

          -  Previous treatment with other platinum agents

          -  Patients must have measurable or evaluable disease

          -  ECOG Performance Status more than 2

          -  Adequate bone marrow, liver and kidney function

          -  Understand the nature of this study and give written informed consent.

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Age < 18 years

          -  History of treatment of any invasive malignancy within the last 5 years

          -  Coexistent medical illnesses

          -  Clinically significant cardiac disease

          -  Preexisting peripheral neuropathy > grade 1

          -  Lack of physical integrity of the upper gastrointestinal tract

          -  Pre-existing uncontrolled coagulopathy

          -  Women who are pregnant or lactating

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.
Inhaled GM-CSF Therapy of Autoimmune PAP
Condition: Autoimmune Pulmonary Alveolar Proteinosis
MeSH terms: Pulmonary Alveolar Proteinosis
Intervention: Baseline WLL; Sargramostim; Rescue WLL
Intervention description: Scheduled bilateral WLL; Inhaled GM-CSF; Unscheduled bilateral WLL
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Whole lung lavage; GM-CSF; Sargramostim; aPAP

Summary:

      This is a prospective, randomized, open-label, long-term, phase 2 study of inhaled
      granulocyte/macrophage-colony stimulating factor following whole lung lavage therapy in
      patients with autoimmune pulmonary alveolar proteinosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female of male 18 years of age or older

          -  Diagnosis of autoimmune PAP

          -  Able and willing to provide written informed consent

          -  Eligible for whole lung lavage determined as the presence of persistent or progressive
             respiratory failure (PaO2 at rest < 60 mm Hg) or desaturation < 90% or > 5 percentage
             points during standard exercise

        Exclusion Criteria:

          -  Diagnosis with secondary PAP, congenital PAP, or hereditary PAP

          -  Contraindication to whole lung lavage

          -  Contraindication to administration of inhaled GM-CSF

          -  Chronic lung disease associated with already existing respiratory failure, such as
             emphysema or pulmonary fibrosis, chronic heart failure, ischemic heart disease, active
             pulmonary embolism, progressive cancer, and other severe metabolic conditions
Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
Condition: Malignancy; Metabolic Disease; Genetic Disorder
MeSH terms: Genetic Diseases, Inborn; Metabolic Diseases
Intervention: Thymoglobulin (rATG)
Intervention description: Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.
Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy.
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: allogeneic hematopoietic stem cell transplantation; pharmacokinetics; pediatrics

Summary:

      This study will describe the pharmacokinetic disposition of biologically active rabbit
      anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of
      the conditioning regimen in children undergoing hematopoeitic stem cell transplantation
      (HSCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who are scheduled to receive ATG 2.5mg/kg/day for 3 days as part of the
             preparative regimen for HSCT, as determined by the responsible HSCT physician.

          -  Written, informed consent

        Exclusion Criteria:

          -  Hypersensitivity to rabbit proteins or to any product excipients

          -  Active acute or chronic infections, which would contraindicate any additional
             immunosuppression

          -  Known pregnancy or breastfeeding
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
Condition: Neuroblastoma; Opsoclonus-myoclonus
MeSH terms: Neuroblastoma; Opsoclonus-Myoclonus Syndrome; Myoclonus; Ocular Motility Disorders
Intervention: anti-CD20 (Rituximab)
Intervention description: 4 weekly doses of IV rituxan at 375 mg/m2 on days 1, 8, 15 and 22
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 2 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: neuroblastoma; Opsoclonus-myoclonus; rituximab

Summary:

      The purpose of this study is to evaluate the feasibility of giving four weekly doses of
      Rituximab (anti-CD20 antibody) in the treatment of children with refractory neuroblastoma
      associated opsoclonus-myoclonus. Patients must have continued symptoms of opsoclonus,
      myoclonus and or ataxia despite surgical resection and a minimum of one month of steroid
      therapy. Evaluations include clinical symptoms of opsoclonus-myoclonus and ataxia as well as
      detailed evaluation of learning and development.
    

Eligibility criteria:

        Inclusion Criteria:

        Pathologic confirmation of diagnosis of neuroblastoma Surgical resection of primary tumor
        Symptoms of OMS despite a minimum of one month of steroid therapy Must meet all laboratory
        criteria to demonstrate adequate organ function -

        Exclusion Criteria:

        Patients currently receiving systemic chemotherapy for treatment of neuroblastoma Patients
        with documented active infection Patients who are HIV, Hep B or Hep C positive Organ
        toxicity from any prior therapy or surgical intervention must be resolved prior to study
        entry

        -