bioihbjkbjnl/mcl2 huggingface dataset:
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: GSK835726 10mg; GSK1004723 1000mcg; Cetirizine 10mg; placebo
Intervention description: GSK835726 10mg tablet; GSK1004723 1000mcg nasal spray solution; Cetirizine 10mg active comparator; placebo to match actives
Intervention MeSH terms: Cetirizine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Proof of concept

Summary:

      This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess
      the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg)
      and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal
      allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is healthy apart from seasonal allergic rhinitis, as determined by a
             physician. Can have mild asthma.

          -  Males or female using contraceptives

          -  Aged 18 - 65

          -  Weight 50kg+, BMI 19-32 kg/m2

          -  Exhibit response to Challenge Chamber and skin prick test.

          -  Non-smoker

          -  Capable of giving informed consent

          -  AST and ALT<2xULN; alkaline phosphatase and bilirubin <or=1.5xULN

        Exclusion Criteria:

          -  No nasal structural abnornmality/polyposis, surgery, infection.

          -  any respiratory disease, other than mild asthma or seasonal allergic rhinitis

          -  participated in another clinical study within 30 days.

          -  Subject has donated a unit of blood within 1 month

          -  Use of prescription or non-prescription drugs, including vitamins and st john's wort
             within 7 days of trial.

          -  History of sensitivty to drug

          -  History of alcohol/drug abuse within 12 months.

          -  Positive Hepatitis B antibody test

          -  Positive HIV antibody test

          -  Risk of non-compliance with study protocol

          -  Pregnant or llactating females

          -  Perenial allergic rhinitis

          -  Administration of oral, injectable or dermal corticosteriods within 8 weeks,
             intranasal or inhaled within 3 weeks.

          -  Past or present disease that may affect outcome, as judge by investigator

          -  Specific Immunotherapy within 2 years
Ketamine in Chronic Kid's (KiCK) Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Ketamine; Placebo
Intervention description: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 8 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Chronic pain; Child; Pediatric; Ketamine

Summary:

      This study is designed to select the most tolerable dose of oral ketamine for children with
      chronic pain. Children will be given either placebo or one of three dosages of oral ketamine
      for 2 weeks. The dosage that is most tolerable will be selected for further study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject, parent, or guardian willing and able to give informed consent

          -  NRS for pain over the past 24 hours >4 at baseline

          -  Chronic pain, which has been present for >3 months, or persisting longer than is
             normal for the underlying diagnosis

          -  Chronic pain related to physiologic diagnoses including but not limited to: cancer,
             rheumatologic disease, sickle cell anemia, cystic fibrosis, pancreatitis, and
             neuromuscular disease (e.g. Duchenne muscular dystrophy)

          -  Able to tolerate and cooperate with neurocognitive assessment

          -  Age 8-20 years old

        Exclusion Criteria:

          -  If they are known or suspected to have drug addiction

          -  Uncontrolled psychiatric disorder such as depression, schizophrenia, or bipolar
             disorder

          -  Uncontrolled hypertension

          -  Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of
             normal.

          -  Previous intolerance or allergic reaction to ketamine

          -  Pregnancy

          -  Use of CYP3A4 inhibitors or inducers within the 2-week period prior the study drug
             administration or within 5 half-lives of the respective medication, whichever is
             longer, until study conclusion.

          -  Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study
             drug administration until study conclusion.
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Condition: Leukemia, Pediatric
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Dasatinib
Intervention description: Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Dasatinib when added to standard
      chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome
      positive acute lymphoblastic leukemia
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL)

          -  Age >1 year and < less than 18 years old

          -  Induction chemotherapy ≤ 14 days according to institutional standard of care

          -  Adequate liver, renal and cardiac function

        Exclusion Criteria:

          -  Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor

          -  Extramedullary involvement of the testicles

          -  Active systemic bacterial, fungal or viral infection

          -  Down syndrome
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
Condition: Stroke; Muscle Spasticity; Motor Neuron Disease
MeSH terms: Muscle Spasticity; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Intervention: botulinum toxin Type A; botulinum toxin Type A; saline
Intervention description: botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18; botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18; Saline injection at Day 1, Week 12, Week 18
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A
      in patients with reduced lung function and focal upper limb poststroke spasticity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Abnormal pulmonary function test results;

          -  focal, upper limb spasticity, upper motor neuron syndrome

        Exclusion Criteria:

          -  Previous exposure to botulinum toxin of any serotype
An Extension Study to Further Evaluate the Safety, Tolerability of GBT440 in Patients With Sickle Cell Disease Who Participated in the Study GBT440-001
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: GBT440
Intervention description: Oral drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is an open label, single arm study which enrolled 5 subjects with SCD who previously
      participated in the GBT440-001 study (NCT02285088).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects with SCD aged 18 to 60 years inclusive and >50 kg who have
             participated in the GBT440-001 study.

          2. Subjects, who if female and of child bearing potential, agree to continue to use
             highly effective methods of contraception prior to enrollment in this study and for 3
             months after the last dose of study drug.

          3. Subjects, who if male are willing to continue to use barrier methods of contraception,
             prior to enrollment in this study to 3 months after the last dose of study drug.

        Exclusion Criteria:

          1. Subjects requiring chronic transfusion therapy.

          2. Subjects receiving a blood transfusion within 30 days of enrollment in this study.

          3. Female subjects who are pregnant, trying to become pregnant or lactating.

          4. Subjects who have a clinically relevant history or presence of respiratory,
             gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
             dermatological, connective tissue diseases or disorders, or additional risk factors
             for torsades de pointe (e.g., heart failure, hypokalemia, personal or family history
             of long QTc interval).

          5. Subjects who have a significant infection or known inflammatory process on admission
             to this study.

          6. Subjects who have acute gastrointestinal symptoms at the time of admission (e.g.
             nausea, vomiting, diarrhoea, heartburn).
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo matching BMS-945429; BMS-945429; BMS-945429; BMS-945429
Intervention description: Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label; Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label; Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label; Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to characterize the safety, efficacy and dose response of
      BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to
      Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying
      anti-rheumatic drugs (DMARDs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization.
             Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum
             weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to
             randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and
             that was decreased due to toxicity as low as 10 mg/week is allowed

          -  Inadequate response to NSAID and/or non-biologic DMARD

          -  Minimum of 3 swollen and 3 tender joints

          -  Active psoriatic skin lesions over minimum 3% body surface area

          -  high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL

        Exclusion Criteria:

          -  Previously received or currently receiving concomitant biologic therapy
FLT PET Imaging for Cervical Cancer
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Intervention: [F18]Fluorothymidine
Intervention description: FLT PET scan 5 mCi (+/- 10%)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Positron-Emission Tomography; Radiotherapy, Intensity-Modulated

Summary:

      Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to
      metabolically active tumor.

      This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The
      radiation plan is then designed to spare that area, in hopes of keeping the bone marrow
      active during therapy. Bone marrow and tumor activity will be monitored using a sequence of
      FLT PET scans during the course of chemotherapy and radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and willingness to sign a written informed consent document.

          -  Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of
             the cervix.

          -  Scheduled to receive chemo-radiation for oncologic treatment.

          -  Karnofsky of at least 60 at time of screening

          -  Life expectancy of at least 6 months.

          -  Leukocytes at least 3,000/microL

          -  absolute neutrophil count at least 1,500/microL

          -  platelets at least 100,000/microL

          -  total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)

          -  either ALT or AST less than 2.5 times the upper limit of normal

          -  creatinine less than 1.5 times the upper limit of normal

          -  non-pregnant, non-nursing, willing to use contraception

        Exclusion Criteria:

          -  oncology research protocol requiring full pelvic radiation (i.e., 4-field box
             technique) or experimental chemotherapy

          -  uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             the study requirements.

          -  subjects taking nucleoside analog medications such as those used as antiretroviral
             agents.

          -  patients who have undergone hysterectomy or will have a hysterectomy as part of their
             cancer therapy.
A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Placebo; LY3023703; Celecoxib
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Wisdom tooth extraction

Summary:

      The main purpose of this study is to test if a single dose of LY3023703 relieves pain after
      wisdom teeth removal. The study will last about one week for each participant, not including
      screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have at least 2 third molars which are clinically indicated for extraction. At least 1
             molar should be a mandibular third molar with partial or complete bony impaction

          -  Are overtly healthy as determined by medical history and limited physical examination

        Exclusion Criteria:

          -  Have chronic pain [for example (e.g.), fibromyalgia] or are experiencing episodic pain
             not related to the wisdom teeth (e.g., migraine pain) that could affect pain
             measurements as judged by the investigator

          -  Have temporomandibular joint disease or other condition which could affect pain
             processing or sensation, affect recovery from dental surgery, or otherwise affect
             ability to assess pain signal, in the opinion of the investigator

          -  Have substantial anxiety regarding dental or medical procedures as measured by the
             Corah Dental Anxiety Scale

          -  Are currently using or have recently used drugs that may confound assessment of the
             inflammatory response or pain including, but not limited to, nonsteroidal
             anti-inflammatory drugs (NSAIDs), aspirin and other analgesics, antihistamines,
             steroids, antidepressants, attention-enhancing drugs, or herbal supplements
Green Tea Extract and Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Polyphenon E (EGCG)
Intervention description: 4 capsules daily with a meal for the duration of the study
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: EGCG; polyphenols; biomarkers; prostate specific antigen

Summary:

      The purpose of the study is to see if a green tea extract can beneficially alter several
      markers of cancer risk and progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  recent biopsy positive for prostate cancer

          -  scheduled for prostatectomy

          -  must be able to swallow capsules

          -  Palpable mass by digital rectal examination (DRE)

          -  Ability to give informed consent and willingness to adhere to study protocol

          -  Age ≥ 18 years and less than 75

        Exclusion Criteria:

          -  abnormal liver function

          -  Prior hormonal or surgical therapy for prostate cancer

          -  Liver or kidney problems that would interfere with metabolism of study drug

          -  Any condition that would hamper informed consent or ability to comply with study
             protocol

          -  Participation in another research study in the last three months

          -  Known malignancy at any site other than prostate

          -  Recent consumption of green tea (5 or more cups per day, within one week prior to
             biopsy)
Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
Condition: Carcinoma, Non-small Cell
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Intervention: Dacomitinib (PF-00299804); Dacomitinib (PF-00299804)
Intervention description: Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).; In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lung cancer adenocarcinoma HER2

Summary:

      This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in
      patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or
      pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15
      years) or have known EGFR activating mutation; or patients with HER 2 amplification or
      mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced adenocarcinoma of lung, measurable disease

          -  Non-smoker, or former light (less than 10 pack years and stopped at least 15 years);
             OR

          -  patients with known EGFR activating mutation regardless of smoking status

          -  ECOG(Eastern Cooperative Oncology Group) 0-1.

        Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC;
        may have had prior therapy

        Exclusion Criteria:

          -  Active brain metastases

          -  Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had
             any number of prior lines of systemic therapy.

          -  known EGFR wild type NSCLC