bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.
Condition: Pneumonia, Ventilator-associated; Pneumonia, Staphylococcal
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Pneumonia, Staphylococcal
Intervention: ASN100; Placebo
Intervention description: monoclonal antibody combination of ASN-1 and ASN-2; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia; S. aureus; Mechanically ventilated

Summary:

      The purpose of this study is the prevention of Staphylococcus aureus pneumonia in
      mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a
      human pathogenic bacterium that causes severe infections, including pneumonia and sepsis.
      Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including
      ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a
      significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is
      an investigational monoclonal antibody product that targets the toxins produced by S. aureus
      to protect subjects from developing S. aureus pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subject is currently hospitalized and is mechanically ventilated endotracheally (i.e.,
        orotracheal or nasotracheal) and, in the Investigator's opinion, will require ongoing
        ventilator support for at least 48 hours;

        Exclusion Criteria:

          -  Subject has a chest X-ray or thoracic computed tomography (CT) scan that is definitive
             for a diagnosis of pneumonia

          -  Subject has a known and documented ETA culture showing heavy colonization with a
             -Gram-negative organism at enrollment or at any time during the Screening period;

          -  Significant Neutropenia

          -  Severe non-pulmonary source of infection.

          -  Subjects with a known history or current (suspected) diagnosis of cytokine release
             syndrome associated with the administration of peptides, proteins, and/or antibodies.
Ghrelin Repeated Dose Study
Condition: Frailty in Aging
MeSH terms: Frailty
Intervention: ghrelin
Intervention description: ghrelin administration subcutaneously for 7 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting
      (sarcopenia) and unintentional weight loss. There are currently no approved therapies for
      frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the
      brain. The investigators already know that a single dose of Ghrelin improves food intake
      immediately after the dose in frail older people. In this study, the investigators are trying
      to find out if repeated daily doses of ghrelin will help frail older people improve food
      intake for multiple days in a row.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals with three, four or five frailty criteria using the Fried frailty criteria

        Exclusion Criteria:

          1. Diabetes mellitus or fasting glucose ≥ 126 mg/dL

          2. Hospitalization for stroke, myocardial infarction, coronary artery bypass graft
             surgery, vascular surgery in the past six months.

          3. New York Heart Association Class III or IV congestive heart failure

          4. Therapy for cancer in the past 12 months, except non-melanoma skin cancer

          5. BMI ≥ 30 kg/m2

          6. Current use of corticosteroids other than topical, ophthalmic, and inhaled
             preparations

          7. Therapy with megestrol acetate or dronabinol within the last 6 weeks

          8. Thyroid stimulating hormone measured as < 0.4 mU/L or greater than 10mU/L

          9. Abnormal liver function tests (LFTs > 2x upper limit of normal)

         10. Hemoglobin < 11g/dL

         11. Insulin-like growth factor-I (IGF-I) above the age-specific reference range

         12. History of surgery within the last 30 days

         13. Unstable medical or psychological conditions or unstable home or food environment

         14. Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 24/30

         15. Depression (defined as a score of > 11 on the Geriatric Depression Questionnaire)
Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661; Ivacaftor; Placebo matched to VX-661; Placebo matched to ivacaftor
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and
      pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in
      participants with cystic fibrosis (CF) who are homozygous or heterozygous for the
      F508del-CFTR mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with confirmed diagnosis of CF

          -  Must have the F508del-CFTR gene mutation in both alleles (Groups 1, 2, 3, 4, 5, 6).
             Group 7 participants must have the F508del-CFTR mutation on 1 allele, and gating
             mutation G551D on the second allele and have been on their physician prescribed 150 mg
             KalydecoTM q12h (commercially available ivacaftor) for at least 28 days at the
             Screening Visit.

          -  Forced expiratory volume in 1 second(FEV1) 40% to 90% (inclusive) of predicted normal
             for age, gender, and height (Knudson standards) at screening

          -  Weight >40 kg and BMI >18.5

          -  Participants of child-bearing potential and who are sexually active must meet the
             contraception requirements.

        Exclusion Criteria:

          -  History of any illness that, in the opinion of the investigator, might confound the
             results of the study or pose an additional risk in administering study drug to the
             participant.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 4 weeks before Study Day
             1.

          -  History of solid organ or hematological transplantation

          -  Participation in a clinical study involving administration of either an
             investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever
             is longer) before screening

          -  History of alcohol, medication, or illicit drug abuse within 1 year prior to screening

          -  Pregnant, breast-feeding, or not willing to follow contraception requirements
Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Intervention: 2 mg IV hydromorphone
Intervention MeSH terms: Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 298.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain; Acute; Emergency Department; Severe; Hydromorphone; Dilaudid; Adult

Summary:

      The purpose of this study is to determine the safety and speed of onset of 2mg intravenous
      hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency
      department with acute severe pain
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than 21 years

          2. Age less than 65 years of age

          3. Pain with onset within 7 days

          4. ED attending physician's judgment that patient's pain warrants use of morphine

          5. Normal mental status

        Exclusion Criteria:

          1. Prior use of methadone

          2. Use of other opioids or tramadol within past seven days

          3. Prior adverse reaction to hydromorphone.

          4. Chronic pain syndrome

          5. Alcohol intoxication

          6. SBP <90 mm Hg

          7. Use of MAO inhibitors in past 30 days

          8. C02 measurement greater than 46
A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: PAD induction
Intervention description: Open Label Treatment:
Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1, 4, 8 & 11), Doxorubicin 20 mg/m2 i.v. (D1 & 4), Dexamethasone 20 mg p.o. (D1, 2, 4, 5, 8 , 9, 11 & 12)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; transplant eligible; doxorubicin; dexamethasone; bortezomib; bortezomib resistance; PAD induction; PIMMS Trial

Summary:

      The purpose of this study is to determine efficacy of treatment with bortezomib (in
      combination with doxorubicin and dexamethasone) in previously untreated patients with
      Multiple Myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously diagnosed with multiple myeloma

          -  eligible for autologous stem cell transplantation

          -  meets pre-treatment lab criteria (as defined within protocol).

        Exclusion Criteria:

          -  Previously received treatment for multiple myeloma (including prior therapy with
             radiation or pulsed dexamethasone), except localised radiation to a solitary lesion or
             plasmacytomas or 4 days of corticosteroid therapy

          -  have a current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of
             undetermined significance (MGUS), or Waldenström Macroglobulinemia

          -  have a history of any other malignancy within 5 years before enrolment

          -  have other significant comorbidities.
PT003 MDI Cardiovascular Safety Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: PT005 MDI; PT001 MDI; PT003 MDI; Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Intervention description: PT005 MDI administered as two puffs BID for 14 days; PT001 MDI administered as two puffs BID for 14 days; PT003 MDI administered as two puffs BID for 14 days; Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 237.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This study is primarily a safety study. The primary and secondary endpoints are based on
      24-hour Holter monitor assessments obtained on Day 14 relative to baseline.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Signed written informed consent

          -  40 - 80 years of age

          -  Clinical history of COPD with airflow limitation that is not fully reversible

          -  Females of non-child bearing potential or females of child bearing potential with
             negative pregnancy test; and acceptable contraceptive methods

          -  Current/former smokers with at least a 10 pack-year history of cigarette smoking

          -  A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70

          -  A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of
             predicted normal values

          -  Able to change COPD treatment as required by protocol

          -  Acceptable baseline (Visit 2) Holter monitor recording

        Key Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Primary diagnosis of asthma

          -  Alpha-1 antitrypsin deficiency as the cause of COPD

          -  Active pulmonary diseases

          -  Prior lung volume reduction surgery

          -  Abnormal chest X-ray (or CT scan) not due to the presence of COPD

          -  Hospitalized due to poorly controlled COPD within 3 months of Screening

          -  Clinically significant medical conditions that preclude participation in the study
             (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma,
             symptomatic prostatic hypertrophy)

          -  Cancer that has not been in complete remission for at least 5 years

          -  Treatment with investigational study drug or participation in another clinical trial
             or study within the last 30 days or 5 half lives

          -  Clinically significant abnormal findings during the baseline Holter recording

          -  Patients with a pacemaker or ICD/CRT/CRT_D devices

        Other inclusion/exclusion criteria as defined by the protocol
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
Condition: Leg Ulcer; Diabetic Foot Ulcer; Pressure Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Leg Ulcer; Pressure Ulcer; Ulcer
Intervention: Leia
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing
      performance properties is fulfilled and that the dressing is safe when used on wound types
      such as pressure ulcer, leg ulcer, and diabetic foot ulcer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Low to highly exuding chronic wound(wound history > 2 months) such as Leg Ulcer,
             Pressure Ulcer Category III to IV or Diabetic Foot Ulcer

          -  Male of female, 18 years and above

          -  Signed Informed Consent Form

        Exclusion Criteria:

          -  Pregnancy or lactation

          -  Wound size not suitable for the wound dressing size

          -  Known allergy/hypersensitivity to any of the components in the dressing
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
Condition: Delirium; Fall Injury
MeSH terms: Delirium
Intervention: care.coach Avatar (HELP-Protocolized)
Intervention description: care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: patient satisfaction; HCAHPS; loneliness; delirium; falls; HELP; hospitals; geriatrics; elder care

Summary:

      Through NINR project 1R44NR017842-01 which preceded the present study, the investigators
      enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based
      protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration
      with hospital-based electronic medical record (EMR) systems. In the present study, the
      investigators seek to validate the efficacy of the new avatar platform, as measured by
      reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to
      gather patient and outcomes data at a scale sufficient to begin developing machine learning
      algorithms for intelligent, automatic assignment of protocols to maximize patient engagement
      and clinical efficacy, and for intelligent, automatic screening of delirium to assist care
      teams in positive identification of delirium. Therefore, the present study comprises a
      two-year randomized between-groups comparison across multiple hospitals to compare outcomes
      with the new generation of care.coach avatars as the intervention versus usual care only as
      the control. Each study group will be geographically distributed across participating
      research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New
      York, with additional hospitals to join the study over the course of two years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)

        Exclusion Criteria:

          -  aggression or combativeness with intent to harm self or others

          -  severe hearing impairment and simultaneous severe vision impairment, despite assistive
             devices

          -  no comprehension of either Spanish or English
Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF; Placebo
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the effect of sustained virologic
      response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS)
      and on neurocognition as measured by neurocognitive tests. This study will also evaluate the
      antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose
      combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.

      During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF
      FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit,
      participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

          -  Chronic genotype 1 HCV infection

          -  Screening laboratory values within defined thresholds

          -  Use of protocol-specified method(s) of contraception if female of childbearing
             potential or sexually active male

        Exclusion Criteria:

          -  Clinically-significant illness (other than HCV) or any other major medical disorder
             that may interfere with treatment, assessment, or compliance with the protocol.
             Current or prior history of any of the following:

               -  Hepatic decompensation

               -  Solid organ transplantation

               -  Significant pulmonary or cardiac disease

               -  Chronic liver disease of a non-HCV etiology

               -  Hepatocellular carcinoma (HCC)

               -  Infection with hepatitis B virus (HBV)

               -  Infection with human immunodeficiency virus (HIV)

               -  History of recent epilepsy (within 2 years of screening) or cerebral vascular
                  accident (CVA)

               -  Structural brain damage

          -  Presence of cirrhosis

          -  Contraindication to MRI

          -  Pregnant or nursing female

          -  Prior treatment NS5A directly-acting antiviral agent. Any interferon (IFN)-containing
             regimen within 8 weeks of Screening
Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments
Condition: Colorectal Neoplasm
MeSH terms: Colorectal Neoplasms
Intervention: CP-751, 871
Intervention description: Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Refractory Colorectal; Single arm; Phase 2

Summary:

      This study will test if there is any survival benefit in patients with refractory metastatic
      colorectal cancer that receive CP-751, 871.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have stage IV colorectal cancer

          -  Patients whose disease has worsened despite prior anti-cancer therapy

          -  Patients who have satisfactory bonemarrow, kidney and liver function

        Exclusion Criteria:

          -  Patients who are being simultaneously treated with another anti-cancer therapy.

          -  Patients who have previously received anti-cancer therapy that works like CP-751, 871
             (targets insulin-like growth factor receptor)

          -  Patients that are pregnant or breast-feeding