bioihbjkbjnl/mcl2 huggingface dataset:
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
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: DSXS
Intervention description: Active treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      this study is to evaluate the potential of DSXS to suppress HPA axis function in patients
      with moderate to severe atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a definite clinical diagnosis of stable atopic dermatitis

        Exclusion Criteria:

          -  Patient is under the age of 2
Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OC-02 (simpinicline) nasal spray; Placebo (vehicle) nasal spray
Intervention description: OC-02 (simpinicline) nasal spray, 11.1 mg/ml; Placebo (vehicle) nasal spray
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray
      compared to placebo on signs and symptoms of dry eye disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used and/or desired to use an artificial tear substitute for dry eye symptoms
             within 60 days prior to Visit 1

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
             as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser
             epithelial keratomileusis, laser-assisted in-situ keratomileusis, photorefractive
             keratectomy or corneal implant) within twelve months of Visit 1

          -  Have a history or presence of any ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with dry eye
             disease are allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject
Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Carboplatin; Proton Radiotherapy; Paclitaxel
Intervention description: 2 area under curve (AUC) by vein Weekly; 2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks).; 50 mg/m^2 by vein Weekly
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; Proton Radiotherapy; Proton Beam; Paclitaxel; Taxol; Carboplatin; Paraplatin; NSCLC

Summary:

      The goal of this clinical research study is to learn if proton radiotherapy given with
      standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally
      advanced NSCLC. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically documented NSCLC.

          2. Inoperable stage IIIA (T1--3N2MO, T3N1MO) and IIIB (T1-3N3MO, T4NO-3MO) disease
             excluding malignant pleural effusion.

          3. Performance score Karnofsky Performance Status (KPS) 70-100, Weight loss: less or
             equal to 10% in 6 months prior to diagnosis.

          4. Patient consented for the protocol

          5. Induction chemotherapy is allowed.

        Exclusion Criteria:

          1. Prior chest radiotherapy.

          2. Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ
             of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial
             transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated
             more than 3 years ago for cure.

          3. Pregnancy. Patients (men and women) of child bearing potential should use an effective
             (for them) method of birth control throughout their participation in this study.

          4. Off study criteria: a) If a patient is found to have distant metastasis during
             treatment and/or immediate after the treatment (<60 days) indicating inaccurate cancer
             stage, he or she will be taken off study. b) If a patient does not follow up at MD
             Anderson and does not forward his or her medical records such as CT, PET/CT, pulmonary
             function test (PFT) or pathology report as required by protocol, he or she will be
             taken off study. c) If a patient does not have any required post-treatment evaluation
             such as images, he or she will be taken off study.
Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria
Condition: Cystinuria
MeSH terms: Cystinuria
Intervention: Tiopronin
Intervention description: Phase 1: No medication, Phase 2: 500mg PO daily x 7 days (total 500mg), Phase 3: 500mg PO BID x 7 days (total 1g), Phase 4: 1g PO BID x 7 days (total 2g)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the minimum effective dose of the cysteine binding
      thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine
      solubility in the urine, in patients with cystinuria to evaluate the effect of escalating
      doses of cystine binding thiol drugs on the cystine capacity of the urine. The overall goal
      will be to help guide therapy and ultimately minimize unnecessary side effects caused by
      larger dosages.

      Cystinuria is a rare genetic disease that can lead to significant morbidity in affected
      patients due to the recurrent nature of the disease. This study will follow the levels of
      urine cystine capacity in order to help guide treatment and to use lower than usually
      prescribed Tiopronin doses to decrease the potential side effects while maintaining
      therapeutic benefit. This will increase adherence with the medications by decreasing the
      burden of the large number of pills that need to be taken daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a confirmed laboratory diagnosis of cystinuria who meet the following
             criteria: (1) stone analysis demonstrating cystine as a component, or (2) increased
             urinary cystine excretion (>250mg/24hrs in adults).

          -  A medical regimen that includes Tiopronin.

          -  Willing to use a medically accepted form of birth control, if female and of child
             bearing- potential

          -  Ability to reliably urinate in a collection vessel and measure urine volume.

          -  Ability to give informed consent.

          -  Documentation of a stable complete blood count (CBC) and urinalysis (UA) in the six
             month period prior to the date of enrollment.

          -  Enrollment in Rare Kidney Stone Consortium (RKSC) Protocol 6401 (Cystinuria Registry)

        Exclusion Criteria:

          -  Women who are pregnant, breastfeeding, or trying to become pregnant

          -  Patients with renal colic

          -  Patients who are scheduled to undergo a surgical procedure

          -  Inability to give informed consent
Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
Condition: Hormone Deficiency; Aging
Intervention: Growth Hormone Releasing Hormone (GHRH )
Intervention description: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Growth Hormone Releasing Hormone; Growth Hormone Insufficiency; Aging; Growth Hormone; Physiologic Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones

Summary:

      The purpose of the study is to evaluate the effect of a naturally occurring hormone, called
      Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body.
      GHRH stimulates the production of growth hormone (GH), which regulates the build up of many
      tissues in the body, including muscles and bones. Many elderly people have low levels of GH.
      The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH
      and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in
      four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass,
      physical performance, and how the body uses sugar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of 65 years or older

          -  Fasting IGF-1 level <135ng/ml

          -  BMI 23-40 kg/m2

          -  Capable of giving informed consent

        Exclusion Criteria:

          -  Diabetes mellitus or use of hypoglycemic agents

          -  Known coronary artery disease

          -  Liver disease, abnormal liver function tests (LRTs>2x upper limit of normal) or
             inflammatory bowel disease

          -  Renal insufficiency (serum creatinine > or = to 1.4 mg/dL)

          -  Hematocrit < 33% or > 50%

          -  History of malignancy < 5 years other than basal cell of the skin

          -  Chronic pulmonary disease or other systemic disorders which affect glucose hemostasis

          -  Use of growth hormone, corticosteroids, thiazide diuretics, estrogen supplements or
             androgen supplements

          -  Inability to perform strength or performance testing

          -  Uncontrolled hypertension (blood pressure >160/95

          -  NYHA Class III or IV heart failure

          -  Current smoking

          -  Alcohol use > or = to 30g/day

          -  Serious or unstable medical or psychological conditions that, in the opinion of the
             investigator, would compromise the subject's safety or successful participation in the
             study

          -  Participation in an investigational drug study within 6 weeks prior to screening visit

          -  Plan to change diet or exercise regimen during the study period
Prostaglandin Inhibition for Emphysema
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Intervention: 600 mg ibuprofen three times daily for 48 weeks; Placebo three times daily
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 46 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Emphysema; Prostaglandin E; Bronchoalveolar lavage

Summary:

      The Prostaglandin Inhibition for Emphysema (PIE) study will determine if a currently
      available therapy, ibuprofen 600 mg three times daily, can block PGE production in the lower
      respiratory tract and if this results in improvement in measures of lung repair function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 45 years

          -  Emphysema (>5% of voxels <950 Hounsfield Units determined on the CT scan performed as
             part of the COPDGene study as quantified at the COPDGene radiology center). An
             equivalent scan as determined by the radiology center is also acceptable.

          -  Post-bronchodilator FEV1 > 35% predicted)

          -  Smoker or ex-smoker (10 pack years minimum)

        Exclusion Criteria:

          -  Contraindication to bronchoscopy or other study procedures

          -  Pregnancy of plans to become pregnant within six months

          -  Aspirin-sensitive asthma

          -  Regular use of systemic glucocorticoid

          -  Regular use of an NSAID (low dose aspirin for cardiac disease is acceptable and
             subjects taking only this regularly will be eligible)

          -  Unstable medical condition

          -  History of myocardial infarction or unstable angina within six months

          -  Allergy to or history of adverse effect from ibuprofen or other NSAID

          -  History of gastrointestinal bleeding within one year

          -  Any condition that, in the opinion of the investigator, places the subject at untoward
             risk

          -  Inability to provide informed consent
Helping Olfaction and Nutrition On Renal Replacement
Condition: End Stage Renal Disease; Olfactory Disorders
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: Theophylline
Intervention description: The study medication will be provided by Foundation Care.
Intervention MeSH terms: Theophylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: End stage renal disease; Olfaction; Dialysis; Hemodialysis; Malnutrition

Summary:

      This clinical trial examines whether nasal theophylline administration can improve olfaction
      and nutrition in hemodialysis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ESRD requiring chronic outpatient hemodialysis

          -  Able to provide written consent

          -  Defects in smell identification and/or smell threshold detection as measured by
             "Scratch-and-sniff" University of Pennsylvania Smell Identification Test (UPSIT) and
             Smell Threshold Test

        Exclusion Criteria:

          -  Prior allergic reaction to theophylline

          -  Patients currently treated with theophylline for clinical indication

          -  Pregnancy or lactation

          -  ESRD patients on peritoneal dialysis

          -  Patients hospitalized at the time of study enrollment
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: GLPG1972; Placebo
Intervention description: Film-coated tablets of GLPG1972 for oral use.; Film-coated tablets of matching placebo for oral use.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 932.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is a phase 2, 52-week international, multi-regional, multi-center, randomized,
      double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male participants or female participants of non-childbearing potential and not
             breastfeeding.

          -  Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2.

          -  Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the
             American College of Rheumatology.

          -  History of knee pain for at least 6 months and on the majority of days (> 50%) during
             the preceding month.

          -  Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS,
             100 mm) at screening and inclusion visits.

          -  Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the
             target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other
             analgesics

        Exclusion Criteria:

          -  Severe clinical knee malalignment according to the investigator.

          -  Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral
             side).

          -  Knee prosthesis already foreseen within the study period (whichever side).

          -  Hip prosthesis recently implanted (< 1 year) or foreseen within the study period
             (whichever side).

          -  Previous osteotomy on the inferior limbs (whichever side).

          -  Surgical operation on the target knee within the 12 months prior to the screening
             visit or planned during the study.

          -  Diagnostic arthroscopy of the target knee within the 6 months prior to the screening
             visit or planned during the study.

          -  Other pathologies affecting the target knee.

          -  Any contraindication to magnetic resonance imaging (MRI) including the inability to
             undergo a knee MRI exam because of inability to fit in the scanner or knee coil.
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Condition: Candida Vulvovaginitis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Vulvovaginitis
Intervention: Fluconazole; SCY-078
Intervention description: Oral Antifungal comparator; Investigational Antifungal
Intervention MeSH terms: Fluconazole; Ibrexafungerp
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, double-dummy, active-controlled, dose-finding
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 186.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, double-dummy, active-controlled,
      dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus
      oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute
      Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per
      treatment group) will be enrolled and randomized into the study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Subject is a female of at least 18 years of age

          2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive
             microscopic examination with 10% KOH in a vaginal sample revealing yeast forms
             (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

        Key Exclusion Criteria:

          1. Subject has any vaginal condition other than AVVC that may interfere with the
             diagnosis or evaluation of response to therapy, such as suspected or confirmed
             concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)

          2. Need for systemic and/or topical (vaginal) antifungal treatment, including
             prescription or over-the-counter products during the study and treatment for VVC 28
             days prior to randomization

          3. Subject is actively menstruating at the time of the Baseline visit.

          4. Subject has uncontrolled diabetes mellitus.

          5. Subject has a vaginal sample with pH >4.5.

          6. Subject has a history of or an active cervical/vaginal cancer.