bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of RAD001 in Treating Plexiform Neurofibromas (PN) Associated With Neurofibromatosis (NF1)
Condition: Plexiform Neurofibroma Associated With Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurofibroma, Plexiform
Intervention: Everolimus (RAD001)
Intervention description: oral daily dosing of tablet starting with 2.5 mg
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: RAD001,; Everolimus,; Plexiform Neurofibroma,; Neurofibromatosis Type 1

Summary:

      This study was to evaluate the antitumor activity and safety of RAD001 in patients with
      Plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).

      The aim of the study was to :

        1. determine whether RAD001, administrated orally daily on a continuous dosing schedule
           might:

             1. Increases time to disease progression (TTP) based on volumetric MRI measurements in
                children and adults with NF1 in inoperable documented progressive PN (stratum 1).

             2. Results in objective radiographic responses based on volumetric MRI measurements in
                children and adults with NF1 and inoperable PN in the absence of documented
                radiographic progression at the trail entry (stratum

        2. To evaluate the tolerability and toxicity of chronic RAD001 administration in this
           patient population as assessed by the NCI Common Toxicity Criteria, version 4.0.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinically definite diagnosis of NF1 according to the NIH consensus conference
             criteria.

          2. Patients must have PN that have the potential to cause significant morbidity, such as
             lesions that could compromise the airway or the great vessels, lesions that could
             cause nerve compression, lesions that could result in major deformity or significant
             cosmetic problems

          3. Measurable disease: patient must have at least one measurable PN amenable to
             volumetric MRI analysis.

        Exclusion Criteria:

          1. Chronic treatment with systemic steroids or another immunosuppressive agent.

          2. Evidence of an active optic glioma, malignant glioma, malignant peripheral nerve
             sheath tumor, or other cancer requiring treatment with chemotherapy or radiation
             therapy.

          3. Clinical evidence of significantly impaired lung function

          4. Pregnancy or breast feeding.

          5. Prior therapy with mTOR inhibitors (e.g.sirolimus, temsirolimus, everolimus).

          6. No contraindications for MRI assessments

        Other protocol-defined inclusion/exclusion criteria may apply
Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations
Condition: Dermatitis, Contact
MeSH terms: Dermatitis; Dermatitis, Contact
Intervention: TRUE Test allergens Fragrance Mix and Thimerosol
Intervention description: Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose
Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone
Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin
Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin
Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Thimerosal; Fragrance Mix; PVP formulation; Contact dermatitis

Summary:

      Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP)
      formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current or previous symptoms and/or history consistent with allergic contact
             dermatitis, and positive patch test (within the past 5 years) to fragrance mix AND/OR
             thimerosal.

          -  All subjects must be adults (18 years of age or older) and otherwise in good health.

          -  Pre-menopausal female subjects must consent to a urine pregnancy test; results must be
             negative for study inclusion.

          -  Informed consent must be signed and understood by each subject, and consistent with
             all institutional, local and national regulations.

        Exclusion Criteria:

          -  Subjects unable to meet inclusion requirements.

          -  Women who are breastfeeding or pregnant.

          -  Topical treatment during the last 7 days with corticosteroids or other
             immunosuppressive agents on or near the test area.

          -  Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg
             prednisone) or other immunosuppressive agents.

          -  Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.

          -  Acute dermatitis outbreak or dermatitis on or near the test area on the back.

          -  Subjects unable to comply with patch test study requirements including multiple return
             visits and activity restrictions (e.g., protecting test panels from excess moisture
             due to showering or vigorous activity).

          -  Subject participation in clinical trials of investigational drugs, treatments, or
             devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in
             this study.
A Study in Participants With End-Stage Renal Disease
Condition: Kidney Failure, Chronic
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
Intervention: LY2127399
Intervention description: 120 milligrams (mg) administered subcutaneously every 4 weeks for 20 weeks. A loading dose of 240 mg will be given as the first dose of the study medication
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: end stage renal disease; end stage kidney disease; ESRD; Uremia; Renal Dialysis

Summary:

      The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are
      a barrier to kidney transplant. Transplantation is currently the definitive treatment for
      End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have ESRD and are awaiting kidney transplant

          -  Have a stable PRA score >50%

        Exclusion Criteria:

          -  Have had a tonsillectomy

          -  Have a semi-permanent/tunneled catheter

          -  Have had intravenous immunoglobulin (IVIg) in the past 6 months

          -  Have had plasmapheresis in the past 6 months

          -  Uncontrolled hypertension

          -  Presence of clinically significant cardiac disease in the past 6 months

          -  Malignancy in the past 5 years, with the exception of cervical, basal cell and
             squamous epithelial cell cancers

          -  Have active or recent infection including herpes zoster or herpes simplex in the last
             30 days

          -  Have evidence or suspicion of active Tuberculosis (TB)

          -  Have had major surgery in the past 2 months

          -  Have had a serious infection with recovery in the past 3 months

          -  Have Hepatitis B or C or have Human Immunodeficiency Virus (HIV)
Caffeine/Propranolol Intervention for Acute Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: caffeine/propranolol combination tablet; placebo
Intervention description: caffeine/propranolol combination tablet administered orally once daily; placebo to match caffeine/propranolol combination tablet administered orally once daily
Intervention MeSH terms: Propranolol; Caffeine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a research study to assess the safety of caffeine/propranolol at different dose
      levels. We want to find out what effects, good and/or bad, it has on patients and their
      migraines.
    

Eligibility criteria:

        Inclusion Criteria:1. Subject has a minimum 12-month migraine history that the investigator
        determines meets the International Headache Society (IHS) Migraine Diagnostic Criteria for
        migraine with or without aura 2. Subject is between 18-50 years of age. 3. Subject
        experiences an average of 2-8 migraines per month. 4. If on preventive migraine therapy,
        medication regimen has been stable for 30 days and will remain stable for the duration of
        participation.

        5. Subject is able to communicate adequately and comply with the requirements of the study
        as determined by the investigator.

        6. Subject is able to read and understand the informed consent written in English and
        voluntarily consents to sign the informed consent form.

        Exclusion Criteria:1. Subject#s age of migraine onset is greater than 50 years. 2. Subject
        has more than 6 non-migraine headache days per month. 3. Subject has less than 48 hours of
        freedom from headache between attacks of migraine.

        4. Subject meets the criteria for complicated and/or brainstem migraines. 5. Subject is
        pregnant or lactating. 6. Subject has history of alcohol or drug abuse within the past 2
        years. 7. Subject has existing systolic blood pressure < 100mm Hg, existing systolic blood
        pressure > 150mm Hg, and or heart rate <50 beats per minute.

        8. Subject has heart block greater than 1st degree without a functioning pacemaker 9.
        Subject has a history of tachyarrythmias 10. Subject has uncompensated congestive heart
        failure (CHF) 11. Subject has severe chronic obstructive pulmonary disease or severe
        asthma. 12. Subject has consumed caffeine within 6 hours. 13. Subjects with existing
        generalized anxiety disorder (GAD) and/or panic disorder.

        14. Subjects with existing severe hepatic and/or renal insufficiency. 15. Subjects with
        existing Raynaud#s disease. 16. Subject is participating in another clinical trial during
        or within 30 days prior to study enrollment.
An Open-label Extension Study of PSMA ADC 2301 in mCRPC
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: PSMA ADC
Intervention description: Upon recommendation from the PI and after Sponsor approval, a subject benefiting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as measured
      by radiographic imaging and biomarkers, safety and tolerability of Prostate Specific Membrane
      Antigen Antibody Drug Conjugate (PSMA ADC) in subjects with mCRPC. Subjects who have
      participated in the PSMA ADC 2301 study and who, in the opinion of the Principal Investigator
      are likely to benefit from continued treatment with PSMA ADC are eligible for the PSMA ADC
      2301 extension study. Subjects who are benefiting from treatment may be able to receive up to
      an additional eight to sixteen doses (every 3 weeks) of PSMA ADC.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who have completed the PSMA ADC 2301 study and who, in the opinion of the
             investigator, are likely to benefit from continued treatment with PSMA ADC

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          3. If chemically castrated, subjects must agree to stay on androgen-deprivation therapy
             for the duration of the study

          4. If applicable, men must agree to commit to the use of a medically acceptable method of
             birth control (e.g., spermicide in conjunction with a barrier such as a condom) or
             sexual abstinence for the duration of the study, including 30 days after the last dose
             of study drug

        Exclusion Criteria:

          1. An acute infection requiring ongoing antibiotic therapy (e.g., UTI, indwelling
             catheter or other potential site(s) of infection)

          2. History of significant hypersensitivity reactions to PSMA ADC or any of its
             components, or to any prior investigational or approved monoclonal antibodies (mAbs),
             immunoglobulin (Ig) fusion proteins (e.g., circulating neutralizing antibodies), or
             ADC

          3. Clinically significant cardiac disease or severe debilitating pulmonary disease

          4. Any recent or ongoing medical condition that may interfere with a subject's
             participation or compliance with the study or evaluation of PSMA ADC
A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)
Condition: Breast Cancer; Metastatic Bone Disease
MeSH terms: Breast Neoplasms; Bone Diseases
Intervention: ZA; Odanacatib; Odanacatib matching placebo; ZA matching placebo
Intervention description: Single ZA 4 mg IV infusion at the start of treatment; Once-daily odanacatib 5 mg tablet for 4 weeks; Once-daily odanacatib matching placebo for 4 weeks; Single IV infusion of ZA matching placebo given at the start of treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 4-week study to examine the effects of a new experimental medication on women with
      breast cancer and established bone metastases. This study will enroll approximately 45 women.
      The primary hypotheses are: (1) odanacatib will result in a substantial suppression of
      urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous
      (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822)
      will be safe and well tolerated during 4 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has histologically or cytologically-confirmed breast cancer

          -  Patient has documented skeletal metastases

        Exclusion Criteria:

          -  Patient is undergoing current oral bisphosphonate therapy, or has a history of oral
             bisphosphonate use within 6 months of entry into study
A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)
Condition: Hepatitis C; HCV; Chronic Hepatitis C Infection; Hepatitis C Genotype 1
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450; ABT-072; Ribavirin; Ritonavir
Intervention description: tablets; tablets; tablets; capsules
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072
      and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus
      (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860
             genotype C/C.

          -  Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) -
             induced liver damage, with no evidence of cirrhosis or liver pathology due to any
             cause other than chronic HCV.

          -  Treatment naïve male or female between the ages of 18 and 65.

          -  Females must be postmenopausal for at least 2 years or surgically sterile.

          -  Be in a condition of general good health, as perceived by the investigator, other than
             hepatitis C virus infection.

          -  Body mass index 18 to < 35 kg/m^2 .

        Exclusion Criteria:

          -  Significant sensitivity to any drug.

          -  Use of herbal supplements within 2 weeks prior to study drug dosing.

          -  Positive screen for certain drugs or alcohol.

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV)
             antibody.

          -  Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic
             anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1
             month of dosing.

          -  Prior treatment with any investigational or commercially available anti-hepatitis C
             virus agents.

          -  Abnormal laboratory tests.

          -  Cirrhosis or extensive bridging fibrosis.

          -  History of cardiac disease.
A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Rituximab; Methotrexate; Methylprednisone; C. albicans; Tetanus toxoid adsorbed booster vaccine; 23-valent pneumococcal polysaccharide vaccine; Keyhole limpet hemocyanin
Intervention description: Rituximab was supplied in single-use vials.; Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.; Patients received an intradermal injection of C. albicans (0.1 mL) on the volar surface of the forearm.; Patients received an intramuscular injection of the tetanus toxoid adsorbed booster vaccine (1 mg in 0.5 mL) in the deltoid muscle.; Patients received an intramuscular injection of the 23-valent pneumococcal polysaccharide vaccine (0.5 mL) in the deltoid muscle.; Patients received a subcutaneous injection of keyhole limpet hemocyanin (1 mg)
Intervention MeSH terms: Rituximab; Methotrexate; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine; Keyhole-limpet hemocyanin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: RA; Rituxan; SIERRA

Summary:

      This was a Phase II, randomized, open-label, multicenter study designed to evaluate the
      immune response to vaccines after administration of 1000 mg of rituximab in subjects with
      active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years.

          -  Diagnosis of rheumatoid arthritis (RA) for at least 6 months.

          -  Receiving treatment for RA on an outpatient basis.

          -  Use of methotrexate (MTX) at a dose of 10-25 mg/wk (oral [PO] or subcutaneous [SC])
             for at least 12 weeks prior to Day 1, with the dose stable during the last 4 weeks
             prior to Day 1 (first day of the treatment period).

          -  If taking a background corticosteroid, use of the corticosteroid must be for at least
             12 weeks prior to Day 1 at a stable dose during the last 4 weeks prior to Day 1.

          -  If taking one non-steroidal anti-inflammatory drug (NSAID), use of a stable dose for
             at least 2 weeks prior to Day 1.

        Exclusion Criteria:

          -  Rheumatic autoimmune disease other than RA or significant systemic involvement
             secondary to RA; Sjogren's syndrome with RA is permitted.
Ketamine in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Intervention: Ketamine; Midazolam
Intervention description: 1 single dose of IV ketamine; 1 single dose of IV midazolam
Intervention MeSH terms: Midazolam; 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: 22.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Borderline Personality Disorder; Ketamine; Suicide; Social Cognition

Summary:

      The purpose of this study is to test the potential of the rapid-acting anti-depressant
      ketamine to decrease suicidality in Borderline Personality Disorder (BPD).

      The rate of completed suicide in BPD is similar to that of depression or schizophrenia. There
      is currently no specific medication treatment for BPD.

      Ketamine is an FDA-approved anesthetic agent that has been shown to rapidly decrease
      suicidality and improve mood in people with Major Depressive Disorder (MDD). Though symptoms
      overlap, effective treatments for MDD and BPD differ. This clinical trial tests if ketamine
      also decreases suicidality and improves mood in BPD.

      This trial will also measure several other outcomes after ketamine versus placebo in BPD:
      adverse events, BPD symptoms, pain, social cognition, and neuroplasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21-60

          -  Clinical diagnosis of Borderline Personality Disorder

          -  Has suicidal ideation.

          -  Fluent in English

          -  Has a current mental health treater, and agrees for study to communicate with treater

        Exclusion Criteria:

          -  Current suicidal intent

          -  Med changes in last 4 weeks

          -  Any ketamine in any context in the last one year.

          -  Current prescription for topiramate, lamotrigine, or lithium.

          -  Psychotic disorder in self or first-degree relative

          -  Current substance dependence including alcohol dependence

          -  Any history of NMDA (N-methyl-D-aspartate )-antagonist abuse

          -  Any history of opiate abuse

          -  History of major medical illness especially neurologic or cardiovascular condition, or
             any other medical contra-indication to ketamine administration at the discretion of
             the study MD.

          -  Positive urine test for drugs of abuse screening on day of ketamine administration

          -  Positive pregnancy test on day of ketamine administration

          -  At the discretion of study staff