bioihbjkbjnl/mcl2 huggingface dataset:
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Sipuleucel-T with Booster; Sipuleucel-T without Booster
Intervention description: Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.; Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant
      treatment in men with localized prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adenocarcinoma of the prostate.

          -  Subject is scheduled for RP as the initial therapy for localized prostate cancer.

          -  Subject is ≥ 18 years of age.

          -  Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Subject has adequate hematologic, renal, and liver function.

        Exclusion Criteria:

          -  Subject has any evidence of metastasis.

          -  Subject received hormones, including luteinizing hormone-releasing hormone agonists,
             antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.

          -  Subject has received prior radiation therapy or chemotherapy for prostate cancer.

          -  Subject has received systemic steroid therapy within 14 days.

          -  Subject has a history of stage III or greater cancer, excluding prostate cancer.

          -  Subjects with a history of basal or squamous cell skin cancers are allowed, provided
             that the subject was adequately treated and is disease-free at the time of study
             screening.

          -  Subjects with a history of stage I or II cancer must have been adequately treated and
             been disease-free for ≥ 3 years prior to study screening.
Study of SCB01A in Patient With Head and Neck Cancer
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: SCB01A
Intervention description: This study is a single arm, open-label, Phase II trial
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Head and neck squamous cell carcinoma

Summary:

      To evaluate the safety and efficacy of SCB01A in head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed squamous cell carcinoma of head and neck

          2. Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic
             carcinoma, after previous treatment with platinum agent.

          3. At least one measurable tumor lesion according to RECIST

          4. Suitable Eastern Cooperative Oncology Group (ECOG) performance status

          5. All eligible patients of childbearing potential have to use effective contraception

          6. Signed informed consent before enrolment

        Exclusion Criteria:

          1. Receiving Chemotherapy, radiation therapy, major surgery or investigational agents

          2. Severe pulmonary obstructive or restrictive disease

          3. Uncontrolled inflammatory disease

          4. Clinically significant cardiac disease

          5. Results of laboratory tests

          6. Pregnancy or nursing status

          7. Known hypersensitivity to any component of SCB01A

          8. History of exposure to SCB01A or its analogues

          9. History of malignancy other than head and neck cancer

         10. History of active or significant neurological disorder or psychiatric disorder

         11. Any other reason the investigator deems the patient to be unsuitable for the study
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
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: BT-11 880 mg; Placebo
Intervention description: Oral once daily tablet; Oral once daily tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the USA. A total of 150 subjects with moderate to severe CD (CDAI Score 220-450 and a Simplified Endoscopic Index of Severity of Crohn's Disease (SES-CD) SCORED ≥ 6 (≥ 4 for isolated ileitis) will be randomized in a 1:1 ratio to receive BT-11 1,000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no) and corticosteroid use at baseline (yes/no). The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter
      induction study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;

          2. Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD
             scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read);

        Key exclusion criteria:

          1. Ulcerative colitis;

          2. Known current bacterial or parasitic pathogenic enteric infection; live virus
             vaccination within 12 weeks of screening.
TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Otelixizumab
Intervention description: Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: type 1 diabetes mellitus; diabetes mellitus type 1; type 1 diabetes; diabetes mellitus; diabetes

Summary:

      The purpose of this study is to optimize several multi-dose regimens of otelixizumab,
      determine the highest biologically active dose, evaluate biomarkers and surrogates of
      efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against
      standard safety and efficacy parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 12 to 45 years old who are in good general health

          -  Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic
             control

          -  Measurable C-peptide levels

        Exclusion Criteria:

          -  Females must not be pregnant or lactating and willing to practice contraception

          -  No prior malignancy, other than non-melanoma skin cancer

          -  Body Mass Index (BMI) > 32 at screening
Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
Condition: Pain Threshold; Mood
MeSH terms: Marijuana Abuse
Intervention: Placebo capsules; Inactive marijuana (0% THC); Low dose Dronabinol; High dose Dronabinol; Low THC marijuana; High THC marijuana
Intervention description: Placebo capsules; Inactive marijuana cigarettes (0% THC) provided by NIDA; Dronabinol 10mg; Dronabinol 20mg; marijuana cigarettes (1.98% THC) provided by NIDA; Marijuana cigarettes (3.56% THC) provided by NIDA
Intervention MeSH terms: Dronabinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Placebo-controlled, double-blind
Enrollment: 34.0
Sex: Female
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oral thc; cannabis; pain; analgesic effects; dronabinol

Summary:

      The following study is designed to determine the analgesic efficacy of smoked marijuana (0,
      1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a
      laboratory model of pain which has predictive validity for clinical use of analgesics. Oral
      THC (dronabinol) is known to have a slower onset and longer duration of action compared with
      smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and
      last longer than effects produced by smoked marijuana.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults between the ages of 21-45

          -  Current marijuana use

          -  Able to perform study procedures

          -  Women practicing an effective form of birth control

        Exclusion Criteria:

          -  Female subjects who are currently pregnant or breastfeeding

          -  Current,repeated illicit drug use other than marijuana

          -  Presence of significant medical illness

          -  History of heart disease

          -  Request for drug treatment

          -  Current parole or probation

          -  Recent history of significant violent behavior
An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Condition: Smoking Cessation
Intervention: varenicline; placebo
Intervention description: variable dosing schedule; placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking cessation; varenicline; smoking cessation treatment

Summary:

      The purpose of this study is to explore the use of an prolonged alternative dosing schedule
      using varenicline for smoking cessation leading to greater quit rates and higher rates of
      continuous abstinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  currently smoking at least 15 cigarettes daily

          -  in good health

          -  able to read and speak English fluently

          -  have a home telephone and plan to reside in Western New York for 6 months

          -  willing to make quit attempt

          -  signed informed consent

          -  who planned quit attempt.

        Exclusion Criteria:

          -  serious medical condition

          -  depression or mental health condition requiring treatment in the past year

          -  history of panic disorder, psychosis, bipolar disorder

          -  alcohol or drug abuse in the past year

          -  use of tobacco products other than cigarettes

          -  current use of other cessation pharmacotherapies

          -  pregnancy/planned pregnancy.
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Condition: Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Intervention: Elidel; Ketoconazole Cream
Intervention MeSH terms: Ketoconazole; Pimecrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: seborrheic dermatitis

Summary:

      This is an exploratory study to determine effectiveness of Elidel for the treatment of
      seborrheic dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 18 or older and sign written informed consent.

          -  Must be wiling and able to comply with protocol.

          -  Must have active seborrheic dermatitis of the face.

        Exclusion Criteria:

          -  No history of overt bacterial, viral or fungal infection of the head/neck.

          -  No history or presence of compromising dermatosis elsewhere on the skin

          -  No Parkinson's disease, HIV, infections or disorders of the central nervous system

          -  No actinically damaged skin
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: AZD2171; Fulvestrant
Intervention description: Oral tablet; intramuscular injection
Intervention MeSH terms: Fulvestrant; Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Advanced Breast Cancer

Summary:

      The purpose of this study is to determine whether AZD2171 can effectively improve time to
      tumour progression when added to fulvestrant in patients with advanced hormone sensitive
      breast cancer who progressed on prior hormonal therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Females with histological/cytological confirmation of hormone sensitive breast cancer
             with evidence of metastatic disease

          -  One or more evaluable lesions

        Exclusion Criteria:

          -  Prior hormonal therapy with fulvestrant

          -  More than one course of prior systemic cytotoxic chemotherapy for metastatic breast
             cancer

          -  Prior biologic therapy for ABC including Anti-VEGF agents

          -  Radiation therapy within 4 weeks prior to provision of consent
A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: AZD9056; Etanercept; Placebo
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid
      arthritis with regard to signs and symptoms and to determine what dose is favourable over a
      6-month treatment period. Patients will receive background treatment with either Methotrexate
      or Sulphasalazine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6
             tender/painful joints, and either have (blood tests) elevated erythrocyte
             sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following:
             documented history and current presence of positive rheumatoid factor (blood test),
             baseline radiographic erosion.

        Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate
        for at least 6 months prior to randomisation.

        Exclusion Criteria:

          -  Any other inflammatory disease in addition to RA that may interfere with the study
             (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c).
             Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.
             Persistently abnormal liver function enzymes (blood test).
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: certolizumab pegol; certolizumab pegol
Intervention description: 400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg; 200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia®; Crohn's Disease; Children and Adolescents with Crohn's Disease

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of
      certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely
      active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK),
      and immunogenicity of CZP treatment in children and adolescents with moderately to severely
      active Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who completed the C87035 study (NCT00899678) through Week 62 or assessments
             when their participation in C87035 was terminated when the study was stopped by UBC

          -  Subject completed all assessments required for Week 62/Visit 23 at the time of
             termination

          -  Subjects maintain stable regimen of concomitant medications for Crohn's Disease (CD)
             throughout study

        Exclusion Criteria:

          -  Subject who did not complete the C87035 study (Week 62 Visit), was terminated or did
             not complete all of the Week 62 assessments when their participation from C87035 was
             terminated when the study was stopped by UCB but did not complete all assessments
             required for Week 62/Visit 23 at the time of termination
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Anti-CD3 mAb; Diabetes Standard of Care Treatment; Iron supplementation
Intervention description: Daily 14-day dose escalation course at study entry, with possible second course after 12-month interval; Receipt of intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.; Immediately following randomization, all participants regardless of arm allocation begin iron supplementation with either ferrous sulfate or multivitamin with iron.
Intervention MeSH terms: Iron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: The staff at Northwest Lipid Research Laboratory were masked to the treatment assignment since they performed the mixed-meal tolerance test (MMTT) and the HgA1C assays. All study staff including the PI were masked to the results of the MMTT. They were notified of a detectable or undetectable fasting C-peptide result to assess for continuation to the next treatment cycle.
Enrollment: 83.0
Sex: All
Minimum age: 8 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: T1D; type 1 diabetes; type 1 diabetes mellitus; juvenile diabetes; autoimmune diabetes; autoimmune; anti-CD3 mAb; mAb hOKT3g1(Ala-Ala); teplizumab

Summary:

      Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 [Ala-Ala],teplizumab, MGA031) is a humanized
      antibody that is commonly used to prevent organ rejection. The purpose of this study is
      determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1
      diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 1 diabetes (according to American Diabetes Association [ADA]
             criteria) within the 8 weeks prior to study entry

          -  Weigh at least 25 kg (55 lbs)

          -  Insulin autoantibodies assessed within 10 days of any insulin use OR anti-glutamic
             acid decarboxylase (GAD) autoantibodies OR anti-ICA512/IA-2 autoantibodies

          -  Subjects or guardian(s) willing to provide informed consent

        Exclusion Criteria:

          -  Prior participation in a clinical trial that could potentially affect diabetes
             condition or immunologic status

          -  Participation in another investigational clinical trial within the 6 weeks prior to
             study entry

          -  Pregnancy or breastfeeding