bioihbjkbjnl/mcl2 huggingface dataset:
Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
Condition: Unresected Stage IIIb to IVM1c Melanoma
MeSH terms: Melanoma
Intervention: Talimogene Laherparepvec
Intervention description: The initial dose of talimogene laherparepvec is up to 4.0 mL of 10^6 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 10^8 PFU/mL.
Intervention MeSH terms: Talimogene laherparepvec
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T-VEC; CD8+ cell density; objective response rate; unresected; Melanoma

Summary:

      The study is a phase 2, multi centered, single arm study designed to evaluate the correlation
      between cluster of differentiation 8-positive (CD8+) cell density and objective response rate
      in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the
      safety and tolerability profile of talimogene laherparepvec.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provided informed consent prior to initiation of any study-specific
             activities/procedures

          2. Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended

          3. Candidate for intralesional therapy

          4. Measurable disease with greatest diameter ≥ 10 mm

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          6. Adequate organ function

        Other Inclusion Criteria May Apply

        Exclusion Criteria:

          1. Clinically active cerebral metastases.

          2. Bone metastases

          3. Primary ocular or mucosal melanoma

          4. Active herpetic skin lesions or prior complications of herpes simplex virus type 1
             (HSV-1) infection (eg, herpetic keratitis or encephalitis)

          5. Requires intermittent or chronic systemic (intravenous or oral) treatment with an
             antiherpetic drug (eg, acyclovir), other than intermittent topical use

          6. Female subject is pregnant or breast-feeding, or planning to become pregnant during
             study treatment and through 3 months after the last dose of talimogene laherparepvec

          7. Female subject of childbearing potential who is unwilling to use acceptable method(s)
             of effective contraception

        Other Exclusion Criteria May Apply
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: JTE-051; Placebo
Intervention description: Active drug tablets containing JTE-051; Placebo tablets identical in appearance to the active drug tablets
Phase: Phase 2
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
Maximum age: 75 Years
Healthy volunteers: No
Keywords: JTE-051; Active Rheumatoid Arthritis; Efficacy; Safety; Tolerability; Rheumatoid Arthritis

Summary:

      This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of
      JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are
      receiving background non-biologic disease-modifying anti-rheumatic drug therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of RA prior to the Screening Visit.

          -  Active disease despite ongoing therapy with up to two non-biologic disease-modifying
             anti-rheumatic drugs, including methotrexate at both the Screening and Baseline
             Visits.

          -  Screening hs-CRP ≥1.2 x upper limit of normal (ULN).

        Exclusion Criteria:

          -  Prior/current exposure to biologic and/or kinase inhibitor therapy.

          -  Known history or presence of polyneuropathy of any cause and no presence of clinically
             active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.

          -  Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or
             hepatitis C (HCV) virus at the Screening Visit.

          -  Positive drug of abuse and alcohol test results.

          -  History of a clinically-significant infection that required oral antimicrobial or
             antiviral therapy within 8 weeks prior to Day 1.
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: CSJ117; Placebo
Intervention description: CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
CSJ117 = inhaled monoclonal antibody fragment; Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.
Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 335.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CSJ117; uncontrolled asthma

Summary:

      The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses
      (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to
      standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect
      to change from baseline in FEV1 at the end of 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed asthma

          -  Male and female patients aged ≥18 and ≤75 years

          -  Patients who have been treated with medium or high dose ICS plus LABA with up to 2
             additional controllers

          -  Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal

          -  A positive reversibility test

          -  ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.

        Exclusion Criteria:

          -  Patients who have a cigarette smoking history of greater than 10 pack years or current
             smokers

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using specified methods of contraception during
             dosing of study drug and until 12 weeks after last study drug treatment

          -  Patients with a history of immunodeficiency disease or hepatitis B, untreated and not
             cured hepatitis C or HIV.
High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
Condition: Solid Tumors; Brain Tumors
MeSH terms: Neoplasms; Brain Neoplasms
Intervention: Amifostine
Intervention description: Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on day -1 twenty four hours after prior dose of amifostine.
Intervention MeSH terms: Amifostine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Solid Tumors; Brain Tumors

Summary:

      This is a study of amifostine to determine how effective it is in the reduction of infection
      in a high dose chemotherapy regimen with autologous stem cell rescue in children with high
      risk, relapsed or refractory pediatric solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High risk Ewing's Sarcoma Family Tumors (ESFT) including Ewing's Sarcoma, Askin's
             tumor, peripheral PNET

          -  High risk desmoplastic small round cell tumors (DSRCT)

          -  Relapsed Wilm's tumor, diffuse anaplastic Wilm's tumor

          -  High risk brain tumors including PNET/Medulloblastomas/germinomas

          -  Relapsed germ cell tumors

          -  Metastatic or relapsed rhabdoid tumors

          -  Other relapsed/refractory pediatric embryonal tumors

          -  Less than 30 years of age

          -  Performance >= 50%

          -  Cancer Diagnosis verification and staging

          -  Disease Response and Recovery

          -  Adequate Organ Function (Renal, Liver, Cardiac)

        Exclusion Criteria:

          -  Uncontrolled Infection

          -  Pregnancy or Breastfeeding (For Females)

          -  Disease Progression

          -  Uncontrolled Intercurrent Illness

          -  HIV Positive

          -  Receiving other Investigational Agents

          -  Amifostine Allergy
Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Leuprorelin Acetate Depot; Elagolix; Placebo to Elagolix; Placebo to Leuprorelin Acetate
Intervention description: Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection; Elagolix tablets administered orally; Placebo tablet administered orally; Saline solution administered as an intramuscular injection
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: bone mineral density,endometriosis,pelvic pain

Summary:

      This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418)
      compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month
      period followed by an additional three months of treatment on elagolix.
    

Eligibility criteria:

        Inclusion Criteria

          -  Female, aged 18 to 45 years, inclusive

          -  Have moderate to severe pelvic pain due to endometriosis

          -  Have been surgically (laparoscopy) diagnosed with endometriosis within the last 5
             years and have recurrent or persistent endometriosis symptoms

          -  Have regular menstrual cycle (23-33 day)

          -  Agree to use two forms of non-hormonal contraception during the study

        Exclusion Criteria:

          -  Received a Gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or
             have received any of these agents within 6 months of the start of screening.

          -  Received subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular (i.m.)
             medroxyprogesterone acetate (DMPA-IM), or have received either of these agents within
             3 months of the start of screening.

          -  Are currently using hormonal contraception or other forms of hormonal therapy or
             received such treatment within the last month

          -  Have had surgery for endometriosis within the last month

          -  Are using systemic steroids on a chronic or regular basis within 3 months

          -  Have uterine fibroids or other pelvic lesions ≥ 3 cm in diameter

          -  Have had a hysterectomy or oophorectomy

          -  Have pelvic pain that is not caused by endometriosis

          -  Have unstable medical condition or chronic disease

          -  Have been pregnant within the last 6 months and is currently breast feeding
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: OPA-15406; Vehicle ointment
Intervention description: OPA-15406 topical ointment; OPA-15406 1%-matching placebo topical ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 10 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis, Eczema

Summary:

      The purpose of this study is to investigate the effectiveness and safety of 2 concentrations
      of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants 10-70 years of age

          -  Diagnosis of AD

          -  History of AD for at least 3 years

          -  AD affecting greater than or equal to 5% and less than or equal to 40% of total body
             surface area (BSA) at Baseline

          -  Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate)
             in the selected treatment area(s)

        Exclusion Criteria:

          -  Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.

          -  Concurrent diseases/conditions and history of other diseases/conditions in the
             selected treatment area(s) that may have an impact on the study assessments.
A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Intervention: IRX-2; Cyclophosphamide; Indomethacin; Zinc; Omeprazole
Intervention description: IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.; Single i.v. injection of low-dose (300 mg/m2) on Day 1; 21 days of oral indomethacin, 25 mg. 3 times daily; 21 days of zinc gluconate (65 mg) as part of an oral multivitamin; 21 days of 20 mg. orally
Intervention MeSH terms: Zinc; Indomethacin; Cyclophosphamide; Omeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open Label Single Arm Phase 2a trial of Safety of IRX-2 in Patients with Operable Head and Neck Cancer
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; Immunotherapy; IRX-2; Mouth Cancer; Throat Cancer

Summary:

      This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2
      Regimen in patients with untreated, resectable squamous cell cancer of the head and neck
      (HNSCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity,
             oropharynx, hypopharynx, or larynx.

          -  No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or
             emergency procedure required for supportive care.

          -  Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable
             with curative intent.

          -  Life Expectancy of greater than 6 months

        Exclusion Criteria:

          -  Stage IVB Squamous Cell Carcinoma

          -  Use of any investigational agent within the previous 30 days

          -  Uncontrolled cardiovascular disease

          -  Myocardial infarction within the last 3 months

          -  Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts

          -  Positive for hepatitis B or C or HIV

          -  Evidence of distant metastases

          -  Clinical gastritis or peptic ulcer within the last 6 months

          -  Stroke within the last six months
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Condition: Feeding; Difficult, Newborn; Growth Failure; Necrotizing Enterocolitis; Sepsis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Premature Birth; Birth Weight; Failure to Thrive
Intervention: Lactobacillus reuteri; Placebo
Intervention description: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day; Oil drops without Lactobacillus reuteri
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 134.0
Sex: All
Minimum age: 1 Day
Maximum age: 3 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Probiotics; Lactobacillus reuteri; Prematures; Enteral feeding; Motility; Necrotizing enterocolitis; Sepsis; Weight

Summary:

      Mortality and incidence of severe complications is still high among extremely premature
      infants. Common causes of severe complications in this population are poor nutrition,
      necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common
      problem resulting in prolonged need for intravenous lines and poor nutrition.

      The aim of the study is to evaluate whether supplementation with the probiotic bacterium
      Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight
      increases feeding tolerance to breast milk and thereby improves nutrition, increases growth
      and reduces serious complications and mortality in this population. Beyond this, possible
      mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Birth weight < 1000 g

          -  Gestational age: v23+0-V27 +6.

          -  Age < 72 hours at inclusion.

          -  Signed informed consent by parents.

        Exclusion Criteria:

          -  Fatal or complex congenital malformation at inclusion time.

          -  Chromosomal defect at inclusion time.

          -  No realistic hope of survival at inclusion time.

          -  Gastrointestinal malformation at inclusion time.

          -  Participation in another study which aims to influence nutrition, growth, feeding
             tolerance or necrotizing enterocolitis.
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
Condition: Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Intervention: ADX-N05; Placebo
Intervention description: 150 mg once a day for seven days followed by 300 mg once a day for seven days; Placebo to match ADX-N05 once a day for 2 consecutive weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in
      the treatment of excessive daytime sleepiness in adults with narcolepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of narcolepsy

          -  Good general health

          -  Willing and able to comply with the study design and schedule and other requirements

        Exclusion Criteria:

          -  If female, pregnant or lactating

          -  Customary bedtime later than midnight

          -  History of significant medical condition, behavioral or psychiatric disorder
             (including suicidal ideation), or surgical history

          -  Any other clinically relevant medical, behavioral or psychiatric disorder other than
             narcolepsy that is associated with excessive sleepiness

          -  History of significant cardiovascular disease

          -  Body mass index >34

          -  Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day

          -  History of alcohol or drug abuse within the past two years

          -  Nicotine dependence that has an affect on sleep
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: GDC-0853
Intervention description: Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No

Summary:

      This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term
      safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who
      have completed Study GA30044 (NCT02908100) up to 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to comply with the study protocol, in the investigator's judgment

          -  Completion of Study GA30044 up to 48 weeks

          -  Acceptable safety and tolerability during Study GA30044 as determined by the
             investigator

        Exclusion Criteria:

          -  Met protocol-defined treatment-stopping criteria during Study GA30044

          -  An adverse event in Study GA30044 that required permanent discontinuation of study
             drug

          -  In the opinion of the investigator, any new, significant, uncontrolled comorbidity or
             new clinical manifestation (related to SLE or not) that requires medications not
             allowed in this protocol; or could put the participant at undue risk from a safety
             perspective

          -  Any uncontrolled or clinically significant laboratory abnormality that would affect
             safety, interpretation of study data, or the participant's participation in the study
             in the opinion of the investigator in consultation with the Medical Monitor