bioihbjkbjnl/mcl2 huggingface dataset:
Travoprost Five Day Posology Study
Condition: Open-angle Glaucoma (OAG); Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Travoprost 0.004%; Travoprost Vehicle; Travoprost (Groups A, B and C)
Intervention description: 1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days; 1 drop in each eye 8 times daily for 5 days; 1 drop in each eye 8 times daily for 5 days
Intervention MeSH terms: Travoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and efficacy of three concentrations of
      travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.
    

Eligibility criteria:

        Inclusion Criteria:

          1. either sex and any race/ethnicity, ≥18 years old

          2. diagnosed with open-angle glaucoma, and/or ocular hypertension

          3. meets the following IOP entry criteria:

               -  Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye
                  qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1

               -  Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day
                  0), and at 8 AM on Day 1

          4. satisfies all informed consent requirements; able to read, sign and date the informed
             consent

        Exclusion Criteria:

          1. females of childbearing potential not meeting protocol conditions

          2. angle grade less than Grade 2 in either eye

          3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye

          4. severe central visual field loss in either eye

          5. any abnormality preventing reliable applanation tonometry in either eye

          6. hypersensitivity to prostaglandin analogues or to any component of the study
             medication
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD4818; Placebo
Intervention description: Dry Powder, inhalation, b.i.d., 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; tolerability; inhalation

Summary:

      The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable,
      safe and effective in treating COPD and, if so, how it compares with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of COPD, with symptoms for more than 1 year

          -  Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20
             cigarettes/day for 1 year)

          -  Lung function (FEV1) 40 to 80% of the predicted normal value after using a short
             acting bronchodilator

        Exclusion Criteria:

          -  Clinical suspicion of active tuberculosis

          -  Any current clinically significant respiratory tract disorder other than COPD

          -  History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or
             unstable angina
Enhancement of Pressure Healing With Pulsatile Lavage
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Intervention: Pulsatile Lavage; sham pulsatile lavage
Intervention description: pulsatile lavage to wound bed; pulsatile lavage to not directed at wound or patient
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Decubitus Ulcers; Pulsatile Lavage; SCI; Spinal Cord Injury; Wound healing; pressure ulcer

Summary:

      The purpose of this study is to investigate the use of pulsatile lavage to enhance the
      healing of pressure ulcers in individuals with spinal cord injury (SCI).

      The goals will be achieved using a repeated-measures double-blinded randomized controlled
      study of individuals with SCI who have pelvic region pressure ulcers. A total of 60 subjects
      will be recruited to this study. Participants will be randomly assigned to a treatment or
      control group. Pulsatile lavage treatment will be administered to the treatment group daily
      for a 3 week period. The control group subjects will receive daily sham pulsatile lavage
      treatment for 3 weeks. All subjects will be monitored for a 3 week period and will continue
      to receive routine pressure ulcer care, i.e. dressings and bedrest with a regular turning
      regime during their participation in the study.

      All study participants will be monitored following the study period until complete closure of
      the pressure ulcer is achieved in order to determine total interval to final closure,
      including any surgical procedures required. In addition, the economic effects of pulsatile
      lavage treatment will be evaluated through monitoring of data collected in the Computerized
      Patient Record System (CPRS), including duration of admission, duration of total bedrest
      order and duration of treatment for pressure ulcer. This data will give an initial measure of
      the cost benefits that may be achieved with the use of pulsatile lavage for the treatment of
      pressure ulcers.

      Subjects will be recruited from the Louis Stokes Cleveland Veterans Affairs Medical Center
      (CVAMC). All individuals with spinal cord injury who are admitted to the SCI Unit with pelvic
      region pressure ulcers will be considered eligible for this study. Further selection criteria
      will be employed to screen potential participants as described below. On recruitment subjects
      will be randomly assigned to 2 groups of 20 subjects. The assessment methods employed will be
      the same for each volunteer. One group will participate in the pulsatile lavage intervention,
      the second group will act as controls.
    

Eligibility criteria:

        Inclusion Criteria:

        Spinal Cord Injury

        Exclusion Criteria:

        systemic disease
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: GVAX pancreas vaccine
Intervention description: Given intradermally
Intervention MeSH terms: Pancrelipase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I pancreatic cancer; stage II pancreatic cancer; pancreatic neoplasm; adenocarcinoma of the pancreas; stage IIl pancreatic cancer; adjuvant therapy; cancer vaccine; GVAX

Summary:

      This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients
      with pancreatic cancer.
    

Eligibility criteria:

        1. Inclusion Criteria:

             A. previously vaccinated subjects must receive Gvax vaccine previously

             B. naïve and previously vaccinated subjects must meet the following criteria:

               -  have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of
                  the head, neck, tail, or uncinate of the pancreas

               -  received the last anti-cancer therapy at least 28 days ago.

               -  provide informed consent.

               -  have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

               -  have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil
                  count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)

               -  have adequate renal function (Serum creatinine ≤ 2 mg/dL).

               -  have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's
                  Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and
                  amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)

               -  agree to use adequate birth control, if of childbearing potential.

          2. Exclusion criteria:

               -  radiographical evidence of pancreatic cancer disease recurrence

               -  documented history of autoimmune diseases including systemic lupus erythematosus,
                  sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis

               -  uncontrolled medical problems

               -  systemic steroid therapy within 28 days before vaccine administration

               -  anticipated need for systemic steroid therapy within 28 days after vaccine
                  administration

               -  evidence of active infections

               -  pregnant
Inulin and S. Salivarius Reduce Halitosis
Condition: Halitosis; Tongue Diseases
MeSH terms: Tongue Diseases; Halitosis
Intervention: Inulin+SS; S salivarius; Placebo
Intervention description: Experimental treatment: A gum of inulin 1g plus Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days; Active comparator: A gum of Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days; Placebo 1 gum each 12 hours for 10 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Halitosis associated with tongue coating results from the production of volatile sulfur
      compounds by bacterial action. The use of prebiotics and probiotics might be useful in
      treating such condition. The aim of this study was to evaluate the effect of the prebiotic
      inulin combined with the probiotic Streptococcus salivarius (SS) on halitosis by coating.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients with halitosis by tongue coating;

          -  participants must accept to participate in the study;

          -  tongue coating identified by oral examination;

          -  halitosis must be confirmed by the organoleptic test.

        Exclusion Criteria:

          -  halitosis for other conditions, including periodontal diseases and non-oral
             conditions;

          -  use of antibiotics in the last 30 days;

          -  active smoking (>10 cigarettes/day);

          -  alcohol consumption (>2 drinks/day);

          -  report of pregnancy or breastfeeding;

          -  report of systemic diseases, including diabetes, kidney failure and hepatic cirrhosis.
18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Condition: Cardiac Sarcoidosis; Myocardial Inflammation
MeSH terms: Myocarditis; Sarcoidosis; Inflammation
Intervention: 18F-FSPG
Intervention description: Patients receive 8mCi of 18F-FSPG and undergo PET/MRI imaging (or PET/CT for patients with metal implants) to determine the ability of 18F-FSPG to localize to cardiac sarcoidosis or myocardial inflammation.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PET/MR

Summary:

      The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using
      18F-FSPG PET/MRI (or PET/CT for participants with metal implants).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is ≥ 18 years old at the time of the scan

          -  Patient with known or suspected cardiac sarcoidosis.

          -  Patient is capable of complying with study procedures

          -  Patient can remain still for duration of imaging procedure

        Exclusion Criteria:

          -  Patient is pregnant or nursing

          -  Metallic implants (contraindicated for MRI)

          -  History of renal insufficiency (only for MRI contrast administration)
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Condition: Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Intervention: Fluvastatin
Intervention description: Fluvastatin 40 mg daily for 3 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Persistently Antiphospholipid Antibody Positive Patients

Summary:

      The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and
      safe in reducing the risk of cardiovascular disease and blood clots in patients with
      antiphospholipid antibodies or Antiphospholipid Syndrome (APS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistently antiphospholipid-antibody positive patients (positive lupus anticoagulant
             test, anticardiolipin antibody ≥ 40 GPL /MPL, and/or anti- β2-glycoprotein I antibody
             > 20 SGU/SMU) with or without systemic lupus erythematosus

        Exclusion Criteria:

          -  Younger than 18 year-old

          -  Pregnant

          -  Planning to get pregnant within the next 6 months

          -  Taking other cholesterol lowering agents

          -  Taking other immunosuppressive medications (such as methotrexate, azathioprine,
             cellcept, enbrel, remicade, or rituximab)(Hydroxychloroquine [Plaquenil] during the
             study period is allowed).

          -  Treatment with biologic agents including anti-TNF medications and Rituximab

          -  Treatment with erythromycin, itraconazole, or clarithromycin

          -  Taking prednisone higher than 10 mg daily

          -  Taking non-steroidal anti-inflammatory drug (such as Motrin, Advil, etc) regularly

          -  Have a muscle or liver disease

          -  Have chronic renal disease requiring dialysis

          -  Have hepatitis C and/or HIV infection

          -  Have active infections requiring antibiotics

          -  Have the diagnosis of a systemic autoimmune disease (such as rheumatoid arthritis or
             systemic sclerosis) other than lupus

          -  Have diagnosis of another chronic condition requiring corticosteroid treatment more
             than 10mg daily

          -  History of an allergic reaction to cholesterol lowering agents
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Condition: Acute Hypoxemic Respiratory Failure
MeSH terms: Respiratory Insufficiency
Intervention: Lucinactant; Sham Comparator
Intervention description: Slow intra-tracheal instillation; Slow intra-tracheal instillation
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Maximum age: 2 Years
Healthy volunteers: No

Summary:

      Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated
      in young children with acute respiratory failure who require mechanical ventilation (life
      support), to determine if it is safe and if treatment with lucinactant will reduce the number
      of days a child needs mechanical ventilation (life support).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 38 weeks (corrected age) to 2 years (24 months)

          -  Intubated and mechanically ventilated (MV) for ≥ 6 hours and anticipated need for MV
             for ≥ 24 hours

          -  Persistent hypoxia

          -  Written informed consent

        Exclusion Criteria:

          -  Mechanical Ventilation for > 48 hours

          -  Oxygenation index ≥ 25, if arterial line was avialable

          -  Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely
             affecting cardiopulmonary function and gas exchange

          -  Neuromuscular disease or hypotonia

          -  Upper airway disease

          -  Baseline requirment for supplemental oxygen

          -  Untreated pneumothorax

          -  Off-label use of commercially available surfactant outside neonatal period

          -  History of prematurity and passive immunoprophylaxis with humanized monoclonal
             antibody

          -  Head injury with Glasgow Coma Scale < 8

          -  Brain death or impending brain death

          -  Do not resuscitate orders

          -  Cardiopulmonary resuscitation within 6 hours of meeting entry criteria

          -  Experimental therapy in which the intervention potentially affects respiratory
             outcomes

          -  Any transplant recipient

          -  Meconium aspiration syndrome

          -  Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected
             pertussis infection
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
Condition: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Recurrence
Intervention: Cisplatin; Panitumumab; Docetaxel; Cisplatin; Docetaxel
Intervention description: chemotherapy arm; experimental arm; chemotherapy arm; experimental arm; experimental arm
Intervention MeSH terms: Cisplatin; Docetaxel; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: SCCHNC; Metastatic; Recurrent

Summary:

      This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation
      clinical trial of docetaxel and cisplatin combination chemotherapy with and without
      panitumumab in the first-line treatment of subjects with metastatic or recurrent head and
      neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail
      the chemotherapy only arm. This study will be conducted in the United States. Approximately
      150 subjects with histologically or cytologically confirmed metastatic and/or recurrent
      SCCHN.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell
             Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or
             radiation therapy.

          -  Measurable disease by CT scan

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

          -  Age: 18 years or older

          -  Adequate hematologic, renal, metabolic, hepatic & thyroid function

        Exclusion Criteria:

          -  Prior systemic treatment for metastatic and/or recurrent SCCHN

          -  CNS metastases, or nasopharyngeal carcinoma

          -  History of interstitial lung disease

          -  History of another primary cancer

          -  Any co-morbid disease that would increase risk of toxicity

               -  Active infection requiring systemic treatment

               -  Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy
A Study of Pertuzumab in Participants With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Pertuzumab
Intervention description: Participants will receive one of two IV treatment regimens with pertuzumab: either 420 mg every 3 weeks, with an initial 840-mg loading dose, or 1050 mg every 3 weeks with no loading dose administered.
Intervention MeSH terms: Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants
      with metastatic breast cancer which has progressed during or after standard chemotherapy and
      which is not amenable to curative therapy. Those who are maintaining a response to therapy or
      who have stable disease at the end of the formal study period will continue treatment until
      disease progression or unacceptable toxicity. Approximately 120 participants will be
      enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females at least 18 years of age

          -  Histologically-confirmed metastatic breast cancer with low HER2 expression and at
             least one measurable lesion according to Response Evaluation Criteria in Solid Tumors
             (RECIST)

          -  Karnofsky performance status at least 80%

          -  Disease progression on/after up to 2 different chemotherapy regimens, including an
             anthracycline-containing therapy

          -  Left ventricular ejection fraction (LVEF) at least 50%

          -  Adequate liver function

        Exclusion Criteria:

          -  Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer

          -  Pulmonary or central nervous system (CNS) metastases

          -  Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within
             2 weeks of Day 1

          -  Previous treatment with any drug that targets the HER2 receptor family

          -  Previous treatment with corticosteroids as cancer therapy

          -  History of significant cardiac disease

          -  Major surgery or trauma within 4 weeks of Day 1

          -  Pregnant or lactating women