bioihbjkbjnl/mcl2 huggingface dataset:
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.
Condition: Unresectable Stage III NSCLC
MeSH terms: Pneumonia
Intervention: Multiparametric Mobile Technology
Intervention description: Using a spirometer, an armband, and a tablet to collect data.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC; Non-Small Cell Lung Cancer; durvalumab; Stage III; Stage IIIA; Spirometer; Spirometry; PROs; Mobile Applications; Digital Applications; Stage IIIB; Stage IIIC; Device; Parametric; Pneumonitis

Summary:

      A study of whether mobile devices can improve the detection of pulmonary AEs (including
      pneumonitis) in stage III NSCLC patients post-CRT, while on durvalumab.
    

Eligibility criteria:

        Select Inclusion Criteria:

          -  Patient has unresectable Stage III NSCLC that has not progressed following concurrent
             platinum-based chemotherapy and radiation therapy and is eligible to receive
             durvalumab according to the US FDA approved package insert.

          -  Patient is able and willing to use the mobile application and connected devices.

          -  Patient is able to complete QoL assessments.

        Select Exclusion Criteria:

          -  Patient is currently oxygen dependent.

          -  Patient has comorbidities that will prevent consistent and reliable measurement
             assessments with multiparametric mobile technology including severe chronic
             obstructive pulmonary disorder (COPD), severe asthma, congestive heart failure [CHF],
             interstitial lung disease [ILD], and others.

          -  Patients on other immunotherapy or systemic immunosuppressants.

          -  Patients with active or prior autoimmune disease or history of immunodeficiency.

          -  Currently pregnant women.
Long-term Follow-up of Fingolimod Phase II Study Patients
Condition: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Assessments arm
Intervention description: Protocol required assessments not provided in standard of care
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 177.0
Sex: All
Healthy volunteers: No
Keywords: Multiple Sclerosis, MS, RRMS, relapsing forms of multiple sclerosis, fingolimod, FTY720, Gilenya

Summary:

      This study collected follow-up data on approximately 90% of participants who were randomized
      and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or
      required. Participants were required to be assessed at one or two visits, preferably at the
      original study site, but the option to be interviewed via phone or seen at home was provided.
      Information was gathered also on deceased participants. Assessments were performed only once
      within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple
      Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale
      (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed.

          -  Randomized in study FTY720D2201 and received at least one dose of study drug.

        Exclusion Criteria:

          -  None
Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Escitalopram; Interpersonal Psychotherapy; Clinical Monitoring
Intervention description: Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.; 16 sessions of interpersonal psychotherapy (IPT); 16 weeks of depression care management(DCM). No psychotherapy will be provided.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 319.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Elderly; Remission; Escitalopram; Interpersonal Psychotherapy; Psychotherapy; Caregiving; Late-Life

Summary:

      This study will determine whether adding interpersonal psychotherapy to treatment with the
      antidepressant escitalopram will be more effective in reducing symptoms of depression than
      antidepressant medication alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of unipolar major depression

          -  Hamilton Rating Scale for Depression (HRSD) (17 item) score of 15 or higher

          -  Speaks English

          -  Willing to discontinue other psychotropic medications

          -  Availability of family member or other caregiver

          -  Hearing capacity adequate to respond to a raised conversational voice

        Exclusion Criteria:

          -  Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or
             any psychotic disorder

          -  Folstein Mini-Mental Status Exam (MMSE) of 17 or lower

          -  Suicidal

          -  History of treatment non-adherence in other Center protocols

          -  History of documented non-response to citalopram in other Center protocols

          -  History of non-tolerance to escitalopram therapy
Study to Assess the Efficacy and Safety of Raxone in LHON Patients
Condition: Leber's Hereditary Optic Neuropathy (LHON)
MeSH terms: Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber
Intervention: Idebenone
Intervention MeSH terms: Idebenone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy
      and safety of Raxone® in the long-term treatment of LHON patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Impaired visual acuity in affected eyes due to LHON

          2. No explanation for visual loss besides LHON

          3. Age more or equal 12 years

          4. Onset of symptoms ≤5 years of Baseline

          5. Confirmation of either G11778A, G3460A or T14484C LHON mtDNA (for the Intent-to Treat
             (ITT) population, not required for enrolment)

          6. Written informed consent obtained from the patient

          7. Ability and willingness to comply with study procedures and visits

          8. Women of Childbearing Potential (WCBP) who have a negative urine or serum pregnancy
             test at Baseline visit and who are willing to use a highly effective contraceptive
             measure and maintain it until treatment discontinuation.

        Exclusion Criteria:

          1. Patient has provided natural history data to the Case Record Survey (SNT-CRS-002)

          2. Any previous use of idebenone

          3. Any other cause of visual impairment (e.g. glaucoma, diabetic retinopathy, AIDS
             related visual impairment, cataract, macular degeneration, etc.) or any active ocular
             disorder (uveitis, infections, inflammatory retinal disease, thyroid eye disease,
             etc.)

          4. Known history of clinically significant elevations (greater than 3 times the upper
             limit of normal) of aspartate aminotransferase (AST), alanine transaminase (ALT) or
             creatinine

          5. Patient has a condition or is in a situation which, in an investigator's opinion may
             put the patient at significant risk, may confound study results or may interfere
             significantly with the patient's participation in the study

          6. Participation in another clinical trial of any investigational drug within 3 months
             prior to Baseline

          7. Hypersensitivity to the active substance or to any of the following excipients (as
             listed in section 6.1 of Raxone SmPC): Lactose monohydrate, Microcrystalline
             cellulose, Croscarmellose sodium, Povidone K25, Magnesium stearate, Colloidal silica,
             Macrogol 3350, Poly(vinyl alcohol), Talc, Titanium dioxide, Sunset yellow FCF (E110).

          8. Women who are pregnant or have a positive pregnancy test at Baseline visit

          9. Women who are breastfeeding
Subantimicrobial Doxycycline in Acne
Condition: Acne Vulgaris; Pediatrics
MeSH terms: Acne Vulgaris
Intervention: Doxycycline Hyclate
Intervention description: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acne Vulgaris; Doxycycline; Sub-Antimicrobial; Pediatrics

Summary:

      Antibiotic resistance is a public health problem that worsens the more physicians prescribe
      standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most
      common dermatologic conditions among pediatric populations. As such, clinicians can make a
      large impact by practicing good antibiotic stewardship while still addressing the impact of
      acne on adolescents' self-esteem. Subantimicrobial doxycycline maintains its
      anti-inflammatory effects while eliminating antimicrobial properties and associated risks of
      drug resistance. Few studies, focused primarily on adults, have shown that subantimicrobial
      doxycycline is efficacious in treating acne from a physician standpoint. The investigators
      aim to investigate the patient experience of acne treatment with subantimicrobial dose
      doxycycline in the pediatric population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented moderate to severe facial acne

        Exclusion Criteria:

          -  Other skin conditions on the face

          -  Previous antibiotic treatment for acne

          -  Use of antibiotics for any reason within the past month

          -  Use of new prescription regiment for acne within the last 3 months

          -  Positive pregnancy test in the clinic

          -  Cognitive impairments
Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
Condition: Immune Response to Influenza Vaccine; Influenza A Virus Infection; Influenza B Virus Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Herpesviridae Infections
Intervention: LAIV; IIV
Intervention description: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.; A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Immune response to influenza vaccine; PCR confirmed Influenza A virus; PCR confirmed Influenza B virus

Summary:

      The purpose of this study is to assess the serologic and cell-mediated immune response to
      licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in
      children 5-17 years old. The effects of prior infection and or prior season vaccination will
      be examined. Children will be followed during the influenza season to identify
      laboratory-confirmed influenza (i.e. vaccine failure).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 5-17 years for the duration of the study period (Sept 1, 2014-Apr 1, 2015)

          -  Enrolled in either the immune response study or the vaccine effectiveness study
             conducted at the site in the 2013-14 influenza season

          -  If enrolled in the vaccine effectiveness study the previous season must have either
             been vaccinated and infected with influenza or unvaccinated and uninfected with
             influenza

        Exclusion Criteria:

          -  Children with contraindications to either the quadrivalent live attenuated influenza
             vaccine or to the trivalent inactivated influenza vaccine will be excluded.

          -  Anyone unwilling or unable to complete all required study activities including
             informed consent

          -  Subjects who already received the influenza vaccine for the 2014-15 season
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Fluticasone furoate Nasal Spray 110 mcg; Placebo
Intervention description: Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations.; Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hay Fever; Daytime somnolence; Cognition

Summary:

      The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed
      thinking because of the hay fever will improve when treated with an effective anti-hay fever
      medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate
      better thinking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of
             study in the season of the study.

          -  Allergy skin tests positive for the airborne allergens present at the study time
             within the past 12 months.

          -  A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.

          -  Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep
             scales of drowsiness on 3 of 7 days.

          -  Ability to read, understand and give informed consent.

          -  Ability to understand and carry out responsibilities of the study

        Exclusion Criteria:

          -  Any chronic disease or other acute disease, which could influence central nervous
             system.

          -  The use of any medication, which could affect central nervous system function.

          -  Unwillingness to participate in the study.

          -  Inability to understand testing procedures or use of medication.

          -  Hypersensitivity to fluticasone or vehicle of nasal sprays.

          -  Any sleep disorders including obstructive sleep apnea.
Study to Evaluate Weight-based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT
Condition: Obesity; Venous Thrombosis; Anticoagulants
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Enoxaparin 0.5 mg/kg once daily
Intervention description: Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.
Intervention MeSH terms: Enoxaparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Obesity; venous thrombosis; Anticoagulants

Summary:

      Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients.
      Consensus guidelines recommend using medications such as heparin or low-molecular-weight
      heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a
      fixed dose that is the same for everyone. The appropriate dose of medication in patients with
      severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in
      severely obese patients may not provide adequate protection against DVT. The purpose of this
      study is to evaluate a weight-based dose(0.5 milligrams per kilogram of body weight) of the
      commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable
      levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0.5mg/kg once
      daily in severely obese patients will lead to predictable blood levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese patients (BMI>35kg/m2)>18 years of age admitted to medical service and
             considered at increased risk for DVT and whom pharmacological prophylaxis is being
             considered by treating physician.

        Exclusion Criteria:

          -  Pregnancy

          -  Currently on alternate therapeutic anticoagulant (warfarin, heparin, LMWH)

          -  Platelet count <100,000, CrCl <30ml/min, or coagulopathy

          -  recent (within 14 d) stroke, trauma, or major surgical procedure

          -  Active bleeding or deemed at increased bleeding risk by the investigator.
Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Condition: Clostridium Difficile Infection; Prophylaxis; Vancomycin
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Vancomycin Oral
Intervention description: This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Intervention MeSH terms: Vancomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if oral vancomycin used as primary Clostridium
      difficile prophylaxis can reduce the incidence of this infection in high-risk patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  "High-risk" patients defined as: age older than 65, on gastric acid suppression, and
             select antibiotics

          -  Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor
             antagonists

          -  Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin),
             clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin
             (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem

        Exclusion Criteria:

          -  Failure to meet all three requirements for "high risk"

          -  Vancomycin allergy

          -  Active clostridium difficile infection prior to inclusion

          -  Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin
             taper)

          -  Receipt of medications that also treat Clostridium difficile (metronidazole,
             rifaximin, fidaxomicin)

          -  Pregnant or breastfeeding
Evaluate Recovery of Testosterone for Patients Using Eligard
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Eligard (TM)
Intervention description: Eligard (TM) 22.5 mg administered at baseline and Month 3
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Male
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Prostate Cancer

Summary:

      The purpose of this study is to determine if testosterone will recover to 90% by year 1 after
      using Eligard.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be outpatient, not hospitalized

          -  Male Patient between ages 50-80, inclusive

          -  Histologically/Cytologically graded adenocarcinoma of the prostate

          -  Must have T1, T2 or T3a adenocarcinoma of the prostate

          -  Must be a candidate for radiation therapy. Hormone refractory patients excluded

          -  WHO/ECOG score of 0,1 or 2

        Exclusion Criteria:

          -  NO evidence of urinary tract that would put the patient at risk in the opinion of the
             Investigator.

          -  Used the following treatments for prostate Cancer

             *immunotherapy *chemotherapy *External Beam Radiation *brachytherapy *hormonal therapy
             *biological response modifiers

          -  Prior Prostate Surgery (excluding TUNA or TURP)

          -  Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which
             could alter the function of these organs

          -  Use of Investigational Drug, Biologic or device within five half-lives of its
             physiological action or three months prior to base line, whichever is longer

          -  Over the counter or alternative medical therapies which have estrogenic or
             anti-androgenic effect

          -  uncontrolled CHF within 6 months to baseline

          -  Myocardial Infarct, coronary vascular procedure or Clinically
             SignificantCardiovascualr Disease within 6 months of baseline Visit

          -  Venous thrombosis with in 6 Months of Screening

          -  Uncontrolled Hypertension defined as >170/100 or Symptomatic Hypotension within 3
             months of Baseline

          -  Insulin dependant Diabetic Patients Must not administer in an anatomic region where
             they will receive Eligard.

          -  Drug or Alcohol Abuse 6 months prior to Baseline

          -  Other Serious Illness at the discretion of the Investigator

          -  Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose
             for 3 months prior to Baseline

          -  Hypersensitivity to GnRH, GnRH agonists