bioihbjkbjnl/mcl2 huggingface dataset:
YCFM (Youth Correctional Facilities Males)
Condition: Chlamydial Infection
MeSH terms: Infections; Chlamydia Infections
Intervention: Azithromycin
Intervention description: Azithromycin 1 gm PO single dose given as directly observed
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Male
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Azithromycin; Chlamydia; Correctional; Facilities; Symptoms; Urethral; Urogenital; Youth

Summary:

      The proposed study is a single center (with multiple long-term YCFs) treatment trial of the
      CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is
      designed primarily to determine the frequency of chlamydia treatment failure following
      azithromycin in males who do versus do not have urethral symptoms of urethral discharge
      and/or dysuria. Anticipated enrollment is 446 males, between the age of 12 to 21 years old,
      with subject participation duration of 28 days and study duration of 4 years. The primary
      objective of the study is to assess the microbiological efficacy of azithromycin in
      uncomplicated Chlamydia trachomatis infection in males with versus without urethral symptoms
      in YCFs.
    

Eligibility criteria:

        Inclusion Criteria:

        1.Male between the ages of 12 and 21 years 2.Residing in a long-term gender-segregated (no
        co-ed) YCF 3.Diagnosed with urogenital chlamydia as determined by a screening C.
        trachomatis NAAT 4.Anticipated length of stay at the YCF at the time of enrollment is at
        least 28 days 5.Willingness to provide written consent 6.Willingness to comply with study
        procedures

        Exclusion Criteria:

        1.Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae NAAT
        2.Clinical diagnosis of epididymitis based on review of medical records 3.Known allergy to
        azithromycin, erythromycin, any macrolide or ketolide drug 4.History of liver problems due
        to use of azithromycin 5.Having received antimicrobial therapy with activity against C.
        trachomatis within 21 days of the positive chlamydia screening NAAT or in the interval
        between the positive screening NAAT and study enrollment 6.Any concomitant infection, which
        requires antimicrobial therapy with activity against C. trachomatis 7.Previously enrolled
        in this study 8.Unable to swallow pills 9.Other exclusion criteria, per clinician judgment,
        that prohibits subject from enrolling in study
Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
Condition: Noninfectious Uveitis
MeSH terms: Uveitis
Intervention: Filgotinib; Placebo to match filgotinib; Prednisone
Intervention description: Tablet(s) administered orally; Tablet(s) administered orally; Tablet(s) administered orally
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo
      for the treatment of the signs and symptoms of noninfectious uveitis as measured by the
      percentage of participants failing treatment for active noninfectious uveitis by Week 24.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis

          -  Must have active uveitic disease at the Day 1/Baseline visit as defined by the
             presence of at least 1 of the following parameters in at least one eye despite 2 weeks
             of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral
             corticosteroid equivalent:

               -  Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion

               -  ≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN)
                  criteria

               -  ≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis
                  Nomenclature (NEI/SUN) criteria

          -  No evidence of active tuberculosis (TB) or untreated latent TB

        Key Exclusion Criteria:

          -  Participants with elevated intraocular pressures and/or severe glaucoma

          -  Confirmed or suspected infectious uveitis, including but not limited to infectious
             uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1),
             Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes
             simplex virus (HSV)

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
Condition: Bladder Pain Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Somatoform Disorders
Intervention: Gefapixant; Placebo
Intervention description: 50 or 300 mg tablets for a total daily dose of 50, 100, 150, 200, 250 or 300 mg BID, orally with food for 4 weeks; Dose matched placebo tablets, BID, orally, with food for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 107.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of gefapixant (AF-219/MK-7264) in female
      participants with moderate to severe pain associated with interstitial cystitis/bladder pain
      syndrome (IC/BPS) after 4 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women

          -  Women of child bearing potential must not be pregnant during the study and must use
             two forms of birth control

          -  Clinical evidence of Interstitial Cystitis /Bladder Pain Syndrome (IC/BPS)

          -  Have provided written informed consent

        Exclusion Criteria:

          -  History of diseases that can be confused for IC/BPS

          -  Unable to void spontaneously

          -  Immunosuppressant, intravesicular, nerve stimulator or opioid treatment for certain
             periods prior to start of the study

          -  Changes to doses of Elmiron®, antidepressant, alpha-adrenergic antagonist, H1
             antagonist, or anti-muscarinic treatment within a certain period prior to the start of
             the study
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Poziotinib
Intervention description: 8 mg oral tablets, administered QD.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Poziotinib; Metastatic Breast Cancer; HER2-positive; Pan-HER inhibitor

Summary:

      The purpose of this study is to establish the dose regimen and evaluate the preliminary
      efficacy and the safety/tolerability of poziotinib in participants with human epidermal
      growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least
      two prior HER2-directed treatment regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histopathologically confirmed primary breast cancer with metastatic lesions.

          2. Confirmed HER2 overexpression or gene-amplified tumor

          3. At least two prior HER2-directed therapy regimens for breast cancer, including
             trastuzumab and trastuzumab emtansine

          4. Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1
             (RECIST v1.1)

          5. Participant is at least 18, and ≤90 years of age.

          6. Adequate hematologic, hepatic, and renal function

          7. Eastern Cooperative Oncology Group (ECOG) performance status <= 2

        Exclusion Criteria:

          1. Previous treatment with poziotinib prior to study participation

          2. Brain metastases that are symptomatic or require therapy to control symptoms, as well
             as any history of radiation, surgery, or other therapy, including steroids, to control
             symptoms from brain metastases within 15 days of enrollment.

          3. Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or
             investigational treatment within 15 days, except for hormone therapy, palliative
             therapy, or supportive therapy.

          4. History of congestive heart failure Class III/IV according to the New York Heart
             Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring
             treatment.

          5. Cardiac ejection fraction <50%

          6. History of other malignancies within the last 5 years

          7. Participant is pregnant or breast-feeding.

          8. Unable to take drugs orally
Trial of IMO-8400 in Adult Patients With Dermatomyositis
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Intervention: IMO-8400 Dose Group 1; IMO-8400 Dose Group 2; Placebo
Intervention description: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.; IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.; normal saline subcutaneous injections once a week for 24 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: dermatomyositis; IMO-8400; Pioneer

Summary:

      The purpose of this study is to determine how safe and effective IMO-8400 is in adults with
      dermatomyositis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has definite or probable DM based on the criteria of Bohan and Peter

          -  Has a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)-Activity score
             ≥15

          -  Patients with muscle weakness are eligible; however having muscle weakness is not
             mandatory.

          -  Study participants must have a diagnostic evaluation for cancer if the diagnosis of DM
             was within 2 years prior to the Screening Visit

        Exclusion Criteria:

          -  Has ongoing severe dysphagia (e.g., requires a feeding tube) for the 3 months prior to
             Screening

          -  Has known hypersensitivity to any oligodeoxynucleotide

          -  Has a history of drug or alcohol abuse within one year of screening, or evidence of
             drug abuse by urine drug screening

          -  Has body weight >140 kg

          -  Has a diagnosis of Juvenile DM, IBM, drug-induced toxic myopathy, metabolic myopathy,
             dystrophy, cancer-associated DM, or connective tissue disease-associated DM (e.g.,
             overlap syndrome)

          -  Has received one or more of following prohibited treatments within the interval noted
             prior to Screening (Visit 1):

               1. Rituximab within 24 weeks (Note: patients who received rituximab are only
                  eligible for inclusion if B-cell counts are confirmed to be within normal limits)

               2. Intravenous corticosteroids within 12 weeks

               3. Antimalarials (e.g., hydroxychloroquine) within 36 weeks

               4. Topical corticosteroids (excluding scalp) within 2 weeks

          -  Has evidence of or has required treatment for cancer (except for treated, non-invasive
             carcinoma of the skin or cured cervical carcinoma-in-situ) within 5 years

          -  Has interstitial lung disease requiring the use of supplemental oxygen
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate
Intervention description: Telotristat etiprate capsules orally three times daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety and tolerability of orally administered
      telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, aged 18 and older

          -  Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with
             disease extent confirmed by computed tomography (CT), magnetic resonance imaging
             (MRI), or radionuclide imaging

          -  Symptomatic carcinoid syndrome (≥4 bowel movements per day)

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  ≥ 12 high-volume, watery bowel movements per day

          -  Sponsor-unacceptable clinical laboratory values for hematology and liver function
             tests at screening

          -  Karnofsky status ≤70% - unable to care for self

          -  Surgery within 60 days prior to screening

          -  A history of short bowel syndrome

          -  Life expectancy < 12 months

          -  History of substance or alcohol abuse within 2 years prior to screening

          -  Administration of any investigational drug within 30 days of screening or any
             therapeutic protein or antibody within 90 days of screening
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Valbenazine
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of
      optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with
      Tourette Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have participated in and completed Study NBI-98854-TS2003

          2. Have a clinical diagnosis of Tourette Syndrome (TS)

          3. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          4. Be in good general health

          5. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for
             amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
             cannabinoids and a negative alcohol screen

          6. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening

          2. Have a known history of long QT syndrome or cardiac arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to vesicular monoamine transporter 2
             (VMAT2) inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline

          7. Have a known history of substance (drug) dependence, or substance or alcohol abuse

          8. Have a significant risk of suicidal or violent behavior

          9. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
Condition: Narcolepsy; Excessive Sleepiness
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Intervention: JZP-110; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Driving

Summary:

      This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the
      effect of JZP-110 on driving performance in subjects with excessive sleepiness due to
      narcolepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age 21 to 65 years inclusive

          2. Diagnosis of narcolepsy per International Classification of Sleep Disorders (ICSD-3)
             or Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)

          3. BMI 18 to <40 kg/m2

          4. Willing and able to provide written informed consent

        Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Moderate or severe sleep apnea

          3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             narcolepsy that is associated with excessive sleepiness

          4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          5. History or presence of any unstable medical condition, behavioral or psychiatric
             disorder (including active suicidal ideation), or surgical history that could affect
             the safety of the subject or interfere with study efficacy and/or safety assessments
             per the judgment of the investigator

          6. History of bariatric surgery within the past year or a history of any gastric bypass
             procedure

          7. Presence or history of significant cardiovascular disease

          8. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription
             medications that could affect sleep-wake function
Intrathecal Hydromorphone for Pain Control After Cesarean Section
Condition: Pain; Cesarean Section
Intervention: Intrathecal morphine; Intrathecal hydromorphone
Intervention description: 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.; 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
Intervention MeSH terms: Morphine; Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intrathecal hydromorphone; Intrathecal morphine; Primary cesarean section; Analgesia

Summary:

      The use of intrathecal opioids for analgesia in the setting of cesarean section has become
      standard obstetric anesthesia practice. Currently, two opioids are commonly used. These
      opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of
      analgesia and act to reduce the stress response to surgery.

      Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after
      cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use
      of this medication is associated with side effects such as pruritus and nausea and vomiting.

      Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for
      cesarean delivery when morphine was unavailable. As groups began to use hydromorphone,
      retrospective data became available that demonstrated its safety and efficacy for use during
      cesarean section.

      In order to fully elucidate the analgesic and side effect properties of hydromorphone for
      cesarean delivery, a prospective randomized, double blind study comparing morphine and
      hydromorphone is necessary. The investigators need to understand whether hydromorphone is as
      effective as morphine for analgesia after cesarean section, and whether it is associated with
      fewer or more side effects. The results of the study will allow providers to make educated
      decisions to better care for their patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective primary cesarean section

          -  Females age 18-40

        Exclusion Criteria:

          -  Emergency cesarean section

          -  Anesthetic other than spinal

          -  History of chronic pain or pre-op opioid use

          -  Allergy to morphine or hydromorphone

          -  BMI>40
Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing
Condition: Wound Healing Disturbance of
MeSH terms: Wounds and Injuries
Intervention: ADIPOSE TISSUE EXTRACT; PLATELET-RICH PLASMA GEL
Intervention description: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration; Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Adipose Tissue Extract (ATE) has been found to be an autologous source of growth factors with
      proven in vitro angiogenic and adipogenic properties.It is obtained by a simple lipoaspirate
      procedure. We sought to compare the effect of ATE with another known source, platelet-rich
      plasma to compare the wound healing characteristics on skin graft donor sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  donor site indication

        Exclusion Criteria:

          -  immunosupressive states

          -  terminal renal insufficiency

          -  pregnancy

          -  coagulation dyscrasias

          -  active infection in donor site