bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Pentazocine on Manic Symptoms
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Talwin Nx
Intervention description: Talwin NX 50mg po twice
Intervention MeSH terms: Pentazocine
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: 60 Years
Healthy volunteers: No
Keywords: bipolar disorder; mania; manic state; opiate; kappa

Summary:

      The opiate neurotransmitter system is thought to be involved in many abnormal mood states.
      Some researchers have suggested that changes in this system may trigger the switch to/from
      manic and depressive states in bipolar disorder. One problem with most of the currently
      available opiate medications is that they can produce addiction/dependence. A particular kind
      of opiate medication known as kappa-opiates may be able to produce changes in this system
      with much less risk of addiction. This study looks at Talwin (a combination of pentazocine
      and naloxone), a medication which affects the kappa and mu opiate systems. The study will
      examine whether two doses of Talwin affect manic symptoms in people who have been admitted to
      the hospital. This study will give more information about the involvement of the opiate
      system in bipolar disorder, and give important information for use in developing new
      treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Young Mania Rating Scale (YMRS) greater than 14

          -  Inpatient

        Exclusion Criteria:

          -  History of opiate abuse/dependence

          -  Recent history of substance abuse

          -  Pregnancy

          -  Unstable medical issues

          -  Use of opiate medications for pain management
Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Minocycline
Intervention description: BPX-01 1 or 2% topical gel will be applied to face once daily
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This is a multi center open label study intended to provide photo documentation and time to
      response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to
      severe non-nodular inflammatory acne vulgarism.
    

Eligibility criteria:

        Inclusion Criteria:

        - moderate to severe inflammatory non-nodular acne vulgaris

        Exclusion Criteria:

          -  female subject who is breastfeeding, pregnant or planning a pregnancy during the study

          -  have other skin condition or disease that would interfere with the study

          -  have had any prior treatment with minocycline

          -  have a known or suspected allergy to tetracycline class products

          -  have used OTC medications for the treatment of facial acne within the last 14 days

          -  have used any prescription topical or oral medications for the treatment of facial
             acne in the last 28 days

          -  have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last
             8 weeks
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Condition: Congenital Hyperinsulinism; Hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy; CHI; PHHI
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia; Hyperinsulinism
Intervention: F-DOPA; PET scan
Intervention description: 0.08-0.16 mCi/kg once
Intervention MeSH terms: Dihydroxyphenylalanine
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Congenital Hyperinsulinism; Hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy; CHI; PHHI; F-DOPA; L-fluoro-dihydroxyphenylalanine

Summary:

      Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these
      children may require surgery. In this study, researchers affiliated with the University of
      Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of
      hyperinsulinism that may be cured by surgery. Eligible participants in this study will have
      positron emission tomography (PET) scans with F-DOPA prior to surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any age, but primarily infants 0-6 months.

          -  Children with confirmed diagnosis of congenital hyperinsulinism.

        Exclusion Criteria:

          -  Cases in which surgery will not be considered by parents or guardians.
TExT-MED + FANS Full Trial
Condition: Diabetes
Intervention: TExT-MED; FANS
Intervention description: messages designed to inspire motivation and behavior change; SMS delivered messages to family members to improve social support
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mobile health; social support; health disparity; Latino

Summary:

      This is an intervention to study incorporating social support into mHealth interventions for
      low-income, ED patients with diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18

          -  HbA1c>8.5

          -  Social support person identified and contacted

        Exclusion Criteria:

          -  unable to consent

          -  does not speak/read English or Spanish
Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; CG1940/CG8711
Intervention description: Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.; Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out what effects, good and bad, the combination of
      docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before
      removal the prostate (prostatectomy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have clinical stage 1-3 disease and no radiographic evidence of
             metastatic disease

          -  Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of
             being free from biochemical progression at 5 years after surgery of <60%.

        Exclusion Criteria:

          -  Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for
             prostate cancer, prior hormonal therapy (except finasteride or dutasteride for
             obstructive voiding symptoms)

          -  Male patients unwilling to use effective means of contraception are excluded.
             Contraception should be continued for 3 months after treatment.

          -  Prior malignancy will not exclude the patient. (Patients can not have active cancer or
             be undergoing active treatment). The Principal Investigator will make final decision
             regarding eligibility since the end point is pathological complete response.
Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access
Condition: Stroke; Intracranial Hypotension; Cerebral Edema
MeSH terms: Brain Edema; Intracranial Hypotension; Hypotension
Intervention: Intraosseous; Hypertonic saline
Intervention description: Intraosseous administration of hypertonic saline; Intraosseous administration of hypertonic saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: prospective case series
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hypertonic saline is used to treat elevated intracranial pressure. Intraosseous vascular
      access has been used to administer fluids and medications. This study combines these to
      administer 3% hypertonic saline via IO.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NCCU patients in which osmotherapy with HTS is planned (standard of care

          -  Does not already have a CVC or PICC.

        Exclusion Criteria:

          -  <18 years old

          -  Known pregnancy

          -  Long bone fracture in the targeted site

          -  Proximity to prosthetic joint

          -  Excessive tissue/absence of anatomical landmarks

          -  History of osteopetrosis

          -  Previous significant orthopedic procedure at site

          -  Prosthetic limb or joint

          -  IO catheter use in the past 48 hours of the target bone

          -  Infection at the area of insertion

          -  Hypersensitivity to lidocaine
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma; Diffuse Large Cell Lymphoma; Mantle Cell Lymphoma; Transformed Lymphoma; Other Subtypes of B-cell Lymphoma; Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Rituximab 375 mg/m2
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: non-Hodgkin's lymphoma; diffuse large cell lymphoma; mantle cell lymphoma; transformed lymphoma; other subtypes of B cell lymphoma; recurrent lymphoma

Summary:

      Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas,
      but is limited by relapse occurs in 40 to 50% of subjects.

      This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose
      therapy increases the event-free survival in diffuse aggressive lymphomas and low grade
      lymphomas, as an alternative to the limitations of conventional therapy.

      Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about
      50% with very little toxicity. Rituximab is hypothesized to be a candidate for
      post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen;
      rituximab has impressive independent anti-tumor activity; and the antibody has little
      toxicity outside of the acute administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  B-cell, CD20+ NHL

          -  Evidence of engraftment post-autologous peripheral blood stem cell transplant
             (PBSC-T), aka autologous stem cell transplant (ASCT)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

          -  Creatinine < 2 mg/dL

          -  Bilirubin < 2.0 mg/dL

          -  Liver function tests (LFTs) < 5 x upper limit of normal (ULN)

        Exclusion Criteria:

          -  Graft source from bone marrow

          -  Non-responders [progressive disease (PD) or stable disease (SD)] to prior anti-CD20
             therapy

          -  PD after ASCT

          -  Post-ASCT radiotherapy

          -  Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including
             rituximab

          -  Evidence of active pneumonitis

          -  Evidence of active infection

          -  Concurrent prednisone or other systemic steroid medication

          -  Nitrosourea therapy within 6 weeks of the first treatment with rituximab

          -  Presence of anti-murine antibody (HAMA) reactivity
Early Treatment for Acute ACL Tear
Condition: Anterior Cruciate Ligament (ACL) Tears
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: Kenalog or placebo; Kenalog then Placebo; Kenalog; Placebo
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Pharmaceutical Solutions; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 14 Years
Maximum age: 33 Years
Healthy volunteers: No

Summary:

      This research study is the first of its kind and will allow health care professionals and
      researchers to answer many questions about the reasons why anterior cruciate ligament (ACL)
      injury leads to knee pain and disability and osteoarthritis. We also hope that this study
      will be the beginning of new, more powerful and safer drugs to help patients with ACL
      injuries heal sooner and return to sports or daily activities pain free. Study participants
      will be recruited from the University of Kentucky and Vanderbilt University.

      The purpose of this research is to gather information on how safe and effective Kenalog® is
      in alleviating knee pain following ACL rupture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  currently participating in sporting activities

          -  Normal contralateral knee status

          -  Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity

        Exclusion Criteria:

          -  underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.)

          -  have been diagnosed with hepatitis B or tuberculosis

          -  currently have an infection, including infection of the skin

          -  have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs

          -  other major medical condition requiring treatment with immunosuppressant or modulating
             drugs.

          -  A history of chronic use of non-steroidal anti-inflammatory drugs

          -  previous exposure or allergic reaction to Kenalog

          -  prior knee surgery (Ipsilateral or contralateral)

          -  have received any investigational drug with 4 weeks of study Visit 1
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands
Condition: Platysmal Bands
Intervention: AbobotulinumtoxinA dose 1; Placebo; AbobotulinumtoxinA dose 2; AbobotulinumtoxinA dose 3
Intervention description: Treatment of platysmal bands; Treatment of platysmal bands; Treatment of platysmal bands; Treatment of platysmal bands
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the
      treatment of platysmal bands.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe platysmal bands at maximum contraction as assessed by the
             Investigator using a photographic scale

          -  Platysmal bands graded as Level 3 or 4 at maximum contraction as assessed by the
             subject using a photographic scale

        Exclusion Criteria:

          -  Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or
             chest within 12 months prior to study treatment
Investigation of Contralateral Arytenoid Sparing IMRT for T1a & T2a Larynx Cancer & Analysis of Post-treatment Laryngeal Function
Condition: Laryngeal Neoplasms
MeSH terms: Laryngeal Neoplasms
Intervention: IMRT Radiation
Intervention description: Radiation to Larynx
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T1a Larynx Cancer; T2a Larynx Cancer

Summary:

      The aim of this study is to define a new treatment technique for T1a larynx cancer that
      maintains excellent local control with less extensive radiation fields. It is thought that
      this will lead to patients having fewer changes to their voice and a higher quality of life
      after treatment when compared to the current standard treatment.
    

Eligibility criteria:

        -  Inclusion Criteria:

               -  Patients with T1a or T2a squamous cell carcinoma of the glottic larynx (tumor
                  limited to one vocal cord with normal cord mobility).

               -  Patients must be able to read and write English to comply with the questionnaire
                  portions of the protocol.

               -  ECOG performance status of 0 or 1.

          -  Exclusion Criteria:

               -  Patients with verrucous or adenocarcinoma

               -  Patients with T1 tumors on both cords (T1b)

               -  Patients with T2b-T4 true larynx tumors

               -  Patients with primary supraglottic tumors that involve the true larynx

               -  Patients with a prior or concurrent malignancy (other than nonmelanoma skin
                  cancer or carcinoma in-situ of the cervix) are ineligible unless the previous
                  cancer was treated 5 years or more prior to the current tumor and the patient has
                  remained continually disease free

               -  Patients who have received prior radiation to the head and neck

               -  Pregnant or breastfeeding women
Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; CP-690,550; CP-690,550; CP-690,550; CP-690,550; CP-690,550; placebo
Intervention description: 4 blinded tablets administered BID; 4 blinded tablets administered BID; 4 blinded tablets administered BID; 4 blinded tablets administered BID; 4 blinded tablets administered BID; Oral tablets; Placebo
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 509.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DMARD therapy

Summary:

      The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6
      dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with
      active rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active rheumatoid arthritis

          -  Inadequate response to stably dosed methotrexate

        Exclusion Criteria:

          -  Current therapy with any DMARD or biologic other than methotrexate
A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies
Condition: Various Advanced Cancer
MeSH terms: Neoplasms
Intervention: Nivolumab; Ipilimumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 6 Months
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and effectiveness of nivolumab alone and
      in combination with ipilimumab in pediatric patients with high grade primary central nervous
      system (CNS) malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have received standard of care therapy, and there must be no potentially-curative
             treatment available, in one of the following cohorts:

          -  A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with
             radiation therapy (RT) but no chemotherapy

          -  A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma
             (HGG) previously treated with surgical resection and RT

          -  A histologically confirmed medulloblastoma that has relapsed or is resistant to at
             least one line of prior therapy including surgery, RT, and chemotherapy

          -  A histologically confirmed ependymoma that has relapsed or is resistant to at least
             one line of prior therapy including surgical resection and RT

          -  A histologically-confirmed high grade CNS malignancy "other than above" which is
             recurrent or progressive after at least one line of prior therapy

          -  Lansky play score (LPS) for ≤ 16 years of age or Karnofsky performance scale (KPS) for
             > 16 years of age assessed within two weeks of enrollment must be >= 60

          -  A tumor sample must be available for submission to central laboratory (not required
             for DIPG)

        Exclusion Criteria:

          -  An active, known, or suspected autoimmune disease

          -  A concurrent condition requiring systemic treatment with either corticosteroids or
             other immunosuppressive medications within 14 days of start of study treatment

          -  Known history of positive test for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome (AIDS).

        Other protocol defined inclusion/exclusion criteria apply
Studies With 1,25-Dihydroxycholecalciferol
Condition: Hypocalcemia; Rickets
MeSH terms: Rickets; Hypocalcemia
Intervention: 1,25-Dihydroxycholecalciferol
Intervention description: Usual doses of 1,25-dihydroycholecalciferol are 0.25-1 ug per day. All patients in this study received very high doses or 5-20 ug per day.
Intervention MeSH terms: Dihydroxycholecalciferols; Calcitriol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Healthy volunteers: No
Keywords: Calciferol; Hypocalcemia; Rickets

Summary:

      Vitamin D in the diet undergoes changes in the liver and kidneys to several forms. Patients
      suffering from disorders with Vitamin D resistance are unable to absorb calcium from food.
      Patients diagnosed with these disorders will be evaluated and treated with high doses of
      another form of Vitamin D (1,25-dihydroxyvitamin D3). Patients will be monitored and observed
      throughout the study to avoid experiencing side effects from the medication.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Patients with hereditary resistance to calcitrol.