bioihbjkbjnl/mcl2 huggingface dataset:
Octaplas Pediatric Plasma Exchange Trial
Condition: Adverse Effects in the Therapeutic Use of Plasma Substitutes
Intervention: Octaplas™
Intervention description: octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 2 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Octaplas

Summary:

      To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring
      serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs),
      thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric
      patients who require therapeutic plasma exchange.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients in whom therapeutic plasma exchange (TPE) is required.

          2. Patient is male or female ≥ 2 years to ≤ 20 years of age.

          3. Patient or patient's legal representative(s)/guardian(s) has /have given voluntarily
             written and signed informed consent before any study-related procedure is to be
             performed. If children are old enough (age usually deemed by each institution) to
             understand the risks and benefits of the study, they should also be informed and
             provide their written assent.

        Exclusion Criteria:

          1. Patient with known homozygous congenital deficiency of Protein S.

             Exclusion Criteria:

          2. Patient has a history of severe hypersensitivity reaction to plasma-derived products
             or to any excipient of the investigational product.

          3. Patient has an already known IgA deficiency with documented antibodies against IgA.

          4. Patient is currently participating in another interventional clinical study or has
             participated during the past 1 month prior to study inclusion. This is not applicable
             to non-interventional trials and does not exclude patients who have been exposed to
             Investigational Medicinal Product with a washout of at least 30 days from enrollment
             in LAS-213. Concurrent participation in a device study will be considered on a case by
             case basis.

          5. Patient is pregnant.

          6. Use of Angiotensin-Converting-Enzyme-inhibitors within 72 hours of the start of the
             first infusion episode or planned used of these medications while on study.
A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: Agalsidase beta
Intervention description: Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Healthy volunteers: No
Keywords: alpha-galactosidase A; a-GAL; Fabry; GL-3; Fabrazyme

Summary:

      This is an exploratory study to evaluate changes in glycosphingolipid levels and other
      (exploratory) Fabry disease parameters in male Fabry disease participants who were previously
      treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks
      (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant and/or his parent/legal guardian is willing and able to provide signed
             informed consent, and the participant, if less than (<) 18 years of age, is willing to
             provide assent if deemed able to do so

          -  Participant is male and has been treated with agalsidase alfa at 0.2 mg/kg q2w for the
             12 months prior to switching to agalsidase beta

          -  The participant has a confirmed diagnosis of Fabry disease by alfa-galactosidase A
             (alfa-GAL) activity and/or genotyping per local standards

          -  The participant when switched to agalsidase beta receives the labeled dose, that is,
             0.9 to 1.1 mg/kg (1 mg/kg) q2w, and must be willing to maintain the labeled dose for
             the duration of the study

        Exclusion Criteria:

          -  The participant is on dialysis or is post renal transplantation

          -  The participant is in end-stage cardiac failure

          -  The participant and/or his parent or legal guardian, in the opinion of the
             investigator, is unable to adhere to the requirements of the study

          -  The participant has been switched from agalsidase alfa to agalsidase beta and does not
             have historical blood and urine samples
Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department
Condition: Nausea
MeSH terms: Emergencies; Nausea
Intervention: Inhaled isopropyl alcohol; Oral ondansetron; Inhaled normal saline; Oral placebo
Intervention description: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.; Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.; Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.; Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with
      three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl
      alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18 and older

          -  complaint of nausea and/or vomiting reported at 3 or above on verbal numerical rating
             scale at the time of triage

        Exclusion Criteria:

          -  allergy to isopropyl alcohol or ondansetron

          -  inability to breathe through nose (e.g., recent upper respiratory infection)

          -  intake of cefoperazone, disulfiram, or metronidazole within the last 24 hours

          -  mental status precluding informed consent including intoxication

          -  known QT-prolongation

          -  clinical suspicion for serotonin syndrome

          -  intravenous catheter in place prior to study start

          -  medications administered since patient arrival (e.g., in triage)
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Prednisolone Sodium Phosphate Ophthalmic Solution 1%; Tears Naturale II Ophthalmic Solution
Intervention description: One drop in each eye, four times/day for 8 days.; one drop in each eye, four times/ day (QID) for 8 days
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of the modified Conjunctival
      Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to
      treatment with a proven ocular anti-inflammatory medication,

      Prednisolone, assessed by the following measures:

        -  Ocular itching

        -  Conjunctival redness
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age & either sex, any race

          -  Willing and able to follow all instructions

          -  Positive history of ocular allergies

          -  Reproducible positive ocular allergic reaction induced by conjunctival allergen
             challenge

        Exclusion Criteria:

          -  Have planned surgery during trial period

          -  Female currently pregnant, planning a pregnancy or lactating

          -  Use of disallowed medications

          -  Have ocular infections, or ocular conditions that could affect study parameters

          -  Have moderate to severe dry eye

          -  Have used an investigational drug or device within 30 days of start of study

          -  Female that is currently pregnant, planning a pregnancy or lactating
Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: etanercept; etanercept
Intervention description: etanercept 50 mg once weekly as requested.; etanercept 25 mg or 50 mg as requested.
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque psoriasis - etanercept - response maintenance

Summary:

      This study proposes to compare 2 different methods for managing a subject with psoriasis who
      has achieved good disease control, as defined by a clinical response with a Physician Global
      Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.

      The first method involves stopping etanercept treatment on entry into the study, with the
      option to reinitiate etanercept at 50 mg once weekly after medical review and agreement
      between the subject and the investigator. The second method involves continuing on etanercept
      at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical
      review and agreement between the subject and the investigator. Subjects will be randomized
      into one of these two study arms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eighteen (18) years of age or older at the time of consent.

          -  Previously treated with etanercept for chronic plaque psoriasis for at least 12 weeks
             prior to the screening visit and received a total weekly dose of 50 mg per week for at
             least the 6 weeks preceding the day of the screening visit

          -  Having shown clinical response with a PGA inferior or equal to 1 at the screening
             visit.

          -  PGA inferior or equal to 1 at the baseline visit.

        Exclusion Criteria:

          -  Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere
             with evaluations of the effect of study medication on psoriasis.

          -  Evidence of active or previously known medical history of inflammatory arthritis (eg,
             rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis).

          -  Any biologics other than etanercept within the 20 weeks prior to the screening visit.
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Peginterferon alfa-2a
Intervention description: 180 mcg subcutaneously once per week for 48 weeks.
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in
      treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive
      chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180
      micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a
      24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12
      months, and the target sample size is less than 100 participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, 18-70 years of age;

          -  HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal
             to 6 months;

          -  anti-HBs negative;

          -  Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000
             copies/milliliters.

        Exclusion Criteria:

          -  Previous antiviral or interferon-based therapy for chronic hepatitis B;

          -  Evidence of decompensated liver disease;

          -  Chronic liver disease other than viral hepatitis;

          -  Co-infection with active hepatitis A, C or D virus;

          -  Co-infection with human immunodeficiency virus.
Global Performance Evaluation of the AMS CONTINUUM™ Device
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: CONTINUUM™
Intervention description: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Radical Prostatectomy; Vesico-Urethral Anastomosis

Summary:

      1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate
           sustainable vesico-urethral anastomosis during a radical prostatectomy procedure.

        2. To assess clinical outcomes of the Device in facilitating the vesico-urethral
           anastomosis following a radical prostatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All males ≥ 40 years old who are indicated for a radical prostatectomy will be
             eligible to participate in the study

        Exclusion Criteria:

          -  If contraindicated for surgery

          -  Inability to understand the study or a history of non-compliance with medical advice

          -  Unwilling or unable to sign an Informed Consent Form (ICF)

          -  A history of:

               1. Recurrent urinary tract infections (UTI)

               2. Recurrent stricture disease

          -  Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease)

          -  Uncontrolled insulin-dependent diabetes

          -  Chemotherapy within the past 6 months

          -  Non-topical steroid use within the past 6 months

          -  Allergy to nitinol, nickel, titanium or silicone
Test-and-treat for Influenza in Homeless Shelters
Condition: Influenza; Respiratory Viral Infection
MeSH terms: Influenza, Human; Virus Diseases
Intervention: Point-of-care molecular testing and treatment of influenza
Intervention description: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 1618.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: No
Keywords: Tamiflu; Oseltamivir; Baloxavir; Influenza; Flu; Rapid Test; Xofluza

Summary:

      This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment
      for influenza in homeless shelters within the Seattle area to determine whether this strategy
      reduced the incidence of influenza in the shelter environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Resident for 1 or more days at a participating shelter

          -  ≥2 ARI symptoms or acute cough alone

          -  Willing to take study medication

          -  Willing to comply with all study procedures, including weekly surveillance and repeat
             nasal swab at day 2/3 and day 5/6/7 post-treatment

          -  Able to provide written, informed consent and/or assent

        Exclusion Criteria:

          -  Any serious or uncontrolled medical disorder or active infection that, in the opinion
             of the investigator, may increase the risk associated with study participation or
             study drug administration

          -  Inability to consent and/or comply with study protocol

          -  Individuals who have received oseltamivir or baloxavir within past 7 days for
             treatment of influenza

          -  Individuals with known hypersensitivity to baloxavir marboxil or oseltamivir

          -  Individuals with chronic kidney disease
Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Medtronic Endeavor Resolute; Abbott Xience V
Intervention description: Medtronic Endeavor Resolute; Abbott Xience V
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2292.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Eluting Stents; Interventional Cardiology

Summary:

      The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm,
      international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The
      study is a "real world, all comers" study.

      Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent)
      system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac
      death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion
      Revascularization at 1 year in a "real world" patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimal age 18 years

          -  Symptomatic coronary artery disease

          -  Patient acceptable candidate for treatment with drug eluting stent in accordance with
             applicable guidelines

          -  Presence of one or more coronary artery stenosis >50% with reference diameter
             2.25-4.0mm which can be covered by one or multiple stents

          -  Patient indication, lesion length and vessel diameter according to 'Instructions for
             Use' of study stents

          -  Patient is willing and able to cooperate with study procedures and required follow up
             visits and patient or legal representative has been informed and agrees by signing EC
             approved written informed consent.

        Exclusion Criteria:

          -  Women of childbearing potential who do not have a negative pregnancy test within 7
             days before procedure and women who are lactating

          -  Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel,
             chromium, molybdenum, polymer coatings, Zotarolimus, Everolimus, or contrast material

          -  Participating in other trial before reaching primary endpoint

          -  Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained
             throughout the peri-surgical period.
Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study
Condition: Myelodysplastic Syndrome; Transfusional Iron Overload
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Iron Overload; Syndrome
Intervention: Deferasirox
Intervention MeSH terms: Deferasirox
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastrointestinal adverse events,; myelodysplastic syndrome,; transfusional iron overload diarrhea,; constipation abdominal pain,; vomiting

Summary:

      The objective of the study is to evaluate and compare the frequency and severity of GI
      adverse events in different dose administration regimens. The patient population consists of
      low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional
      iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day
      deferasirox or an evening dose of the same. Patients are then followed up for 6 months for
      any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to any screening procedures

          -  Male or female patients ≥ 18 years of age

          -  Patient must weigh between 45-135 kg

          -  Patients with low or intermediate (int-1) risk MDS, as determined by IPSS score or RA,
             RARS by WHO criteria. IPSS must be confirmed by a bone marrow examination within 6
             months prior to study entry and must be hematologically stable

        Deferasirox naïve:

        Sexually active pre-menopausal female patients must use double-barrier contraception, oral
        contraceptive plus barrier contraceptive, or must have undergone clinically documented
        total hysterectomy and/or oophorectomy, tubal ligation

        Exclusion Criteria:

          -  History or current GI disease

          -  Systemic diseases which could prevent study treatments

          -  Left ventricular ejection fraction< 50 % by echo cardiography

          -  Serum creatinine > 1.2 x ULN at screening

          -  Platelet counts < 25x 109/L except in cases where guidance is already given in the
             local deferasirox label

          -  AST or ALT > 2.5 xULN at screening

        Other protocol-defined inclusion/exclusion criteria may apply