bioihbjkbjnl/mcl2 huggingface dataset:
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Condition: Acute, Perforated Appendicitis
MeSH terms: Appendicitis
Intervention: Povidone-iodine irrigation; No irrigation
Intervention description: Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.
1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister.; Patients allocated to the control group will not undergo intra-abdominal irrigation.
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 100.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Povidone-iodine irrigation

Summary:

      The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for
      decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis.
      Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal
      irrigation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children who undergo an appendectomy for perforated appendicitis. (Appendicitis:
             Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization
             of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or
             a fecalith at the time of operation.)

        Exclusion Criteria:

          -  Patients presenting with simple or gangrenous appendicitis

          -  Patients with a history of iodine sensitivity, thyroid disease or renal disease

          -  Patients undergoing interval or incidental appendectomy

          -  Patients/parents/legal guardians who are both non-English and non-Spanish speaking
Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
Condition: Asthma
MeSH terms: Asthma
Intervention: QGE031
Intervention description: QGE031 120 mg/mL solution for subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No
Keywords: asthma; allergic asthma; QGE031; open-label; IgE; long-term safety

Summary:

      This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma
      patients who completed study CQGE031B2201.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  forced Expiratory Volume in one second ( FEV1) >= 40% predicted

          -  patients who completed CQGE031B2201 study

        Key Exclusion Criteria:

          -  life-threatening asthma attack, intubation, respiratory arrest during or after
             completion of CQGE031B2201 study

          -  new malignancy

          -  ongoing SAE from CQGE031B2201 that was assessed as related to study drug

          -  patient experienced platelets drop to < 75,000/uL

          -  patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity
             reactions

          -  patient is pregnant
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MSTT1041A; Placebo
Intervention description: Participants will receive subcutaneous (SC) MSTT1041A; Participants will receive SC placebo
Intervention MeSH terms: Astegolimab
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: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants
      with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a
      16-week treatment period, and an 8-week follow-up period.
    

Eligibility criteria:

        Inclusion criteria

          -  Ability to comply with the study protocol

          -  Chronic AD that has been present for at least 3 years before the screening visit

          -  Documented recent history (within 6 months before the screening visit) of inadequate
             response to treatment with topical medications (medications or treatments applied
             directly to part of the body) or for whom topical treatments are otherwise medically
             inadvisable

        Exclusion criteria

          -  Prior treatment with MSTT1041A

          -  Treatment with any investigational therapy (with the exception of biologics) within 8
             weeks or within 5 half-lives whichever is longer, before screening

          -  Treatment with any cell-depleting agents within 6 months before screening, or until
             lymphocyte count returns to normal, whichever is longer

          -  Treatment with other biologics within 3 months or 5 half-lives before screening,
             whichever is longer

          -  Comorbid conditions that may interfere with evaluation of investigational medicinal
             product

          -  History or evidence of substance abuse that would pose a risk to participant safety,
             interfere with the conduct of the study, have an impact on the study results, or
             affect the participant's ability to participate in the study

          -  History of anaphylaxis, hypersensitivity to a biologic agent, or known
             hypersensitivity to any component of the MSTT1041A or placebo injection

          -  Planned surgical intervention during the course of the study

          -  Pregnant or breastfeeding, or intending to become pregnant during the study

          -  Participant who is a member of the investigational team or his/her immediate family
Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
Condition: Familial Chylomicronemia Syndrome; Lipoprotein Lipase Deficiency; Hyperlipoproteinemia Type 1
MeSH terms: Hyperlipoproteinemia Type I; Hyperlipoproteinemias; Hyperlipidemias; Syndrome
Intervention: AKCEA-ANGPTL3-LRx
Intervention description: AKCEA-ANGPTL3-LRx at dose 20 mg, administered via SC injection QW.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Familial Lipoprotein Lipase Deficiency; Hyperlipoproteinemias; Familial Hyperlipoproteinemia Type 1; Hyperlipoproteinemia Type I; Hyperchylomicronemia, Familial; Lipoprotein Lipase Deficiency, Familial; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Metabolic Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn

Summary:

      This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for
      reduction of triglyceride (TG) levels in participants with FCS.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genetically confirmed chylomicronemia syndrome.

          -  Fasting triglycerides greater than or equal to (>=) 750 milligrams per deciliter
             (mg/dL) [8.4 millimoles per liter (mmol/L)] at Screening.

        Key Exclusion Criteria:

          -  Diabetes mellitus if newly diagnosed or if glycated hemoglobin (HbA1c) >= 9.0%.

          -  Active pancreatitis within 2 weeks of screening.

          -  Acute coronary syndrome within 6 months of screening.

          -  Major surgery within 3 months of screening.

          -  Treatment with Glybera therapy within 2 years of screening.

          -  Previous treatment with AKCEA-ANGPTL3-LRx.

          -  Have any other conditions in the opinion of the investigator which could interfere
             with the patient participating in or completing the study.
Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: bevacizumab; Erlotinib
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      This study will evaluate the combination of bevacizumab and erlotinib in elderly patients
      with advanced non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or
             recurrent after primary surgery or radiotherapy.

          -  ECOG PS 0-1

          -  70 years of age or older

          -  Must have measurable disease

          -  ANC > 1500, platelets > 100,000

          -  Total bilirubin </= 1.5, SGOT * SGPT < 5 x ULN

          -  Able and willing to swallow and absorb oral medication

          -  Able and willing to sign consent

          -  Request archival diagnostic tissue for EGFR expression but not required

        Exclusion Criteria:

          -  Proteinuria as demonstrated by UPC ratio >/= 1.0

          -  Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or
             anti-angiogenesis agent (includes thalidomide)

          -  Prior treatment for advanced stage disease, with the exception of surgery or radiation
             (no systemic)

          -  History of gross hemoptysis within 1 month of enrollment unless treated with surgery
             or radiation

          -  Evidence of bleeding diathesis or coagulopathy or other serious/acute internal
             bleeding within 6 months of enrollment.

          -  Current, ongoing treatment with full dose warfarin or equivalent

          -  Current(within 10 days)use of aspirin (> 325mg/day) or other NSAID with antiplatelet
             activity

          -  History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6
             months. Clinically significant PVD

          -  Known CNS disease except for treated brain mets.

          -  Squamous cell histology

          -  Blood pressure > 150/100 that cannot be ameliorated with standard anti-hypertensives

          -  History of hypertensive crisis or hypertensive encephalopathy

          -  NYHA grade II or > CHF

          -  History of MI within 6 months of enrollment

          -  Major surgery, open biopsy, significant trauma within 28 days of enrollment

          -  Pregnancy, lactation

          -  Abdominal or other fistula, abcess, perforation
Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: P-321 Ophthalmic Solution; P-321 Ophthalmic Solution placebo
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive
      techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the
      administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry
      eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent

          2. Male or female subjects aged 18 to 80 years

          3. Have a history of predominantly tear-deficient dry eye of mild to moderate severity,
             supported by a previous clinical diagnosis

          4. Have normal lid anatomy

          5. Subjects must:

               1. Remain on current medications for the duration of the study and have been on the
                  current medication regimen at least during the past 28 days

        Exclusion Criteria:

          1. Have undergone refractive eye surgery in either eye during the past 12 months

          2. Have undergone uncomplicated cataract surgery in either eye during the past 3 months

          3. Have undergone previous eyelid surgery in either eye (External blepharoplasty, not
             resulting in exposure or abnormal blinking is allowed)

          4. Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular
             area within 3 months prior to Visit 1

          5. Subjects that have a systemic, multi-organ disease requiring active medical or
             surgical treatment are excluded with the exception of subjects with SS or GVHD

          6. Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or
             wear scleral lens.

          7. Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or
             trichiasis
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Omega 3 pentaenoic acid; icosapent ethyl
Intervention description: Encapsulated omega-3 pentaenoic acid; Encapsulated omega-3 acid ethyl esters
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ≥18 y of age

          -  Judged to be in generally good health

          -  Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening

          -  Body mass index of ≥20.0 kg/m2

          -  No clinically significant findings in a 12-lead ECG or physical examination

          -  Willing and able to undergo the scheduled study procedures

          -  Understands study procedures and signs forms documenting informed consent to
             participate in the study

        Exclusion Criteria:

          -  Laboratory test result of clinical significance

          -  Uncontrolled hypertension

          -  Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic,
             pulmonary, pancreatic, neurologic, or biliary disorder

          -  History of human immunodeficiency virus, hepatitis B or hepatitis C infection

          -  Used any medication intended to alter the lipid profile within 4 weeks of the first
             qualification visit

          -  Active systemic infection

          -  A condition the Investigator believes would interfere subject ability to provide
             informed consent and/or comply with the study protocol
A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Recombinant human C1 inhibitor; Placebo
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: HAE; Hereditary Angioedema; Prophylaxis

Summary:

      Primary Objective:

      To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of
      angioedema attacks in patients with HAE

      Secondary Objective:

      To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the
      prophylaxis of angioedema attacks in patients with HAE
    

Eligibility criteria:

        Inclusion Criteria:

        Patients fulfilling the following criteria at Screening are eligible for participation in
        the study:

          1. Age 13 years or older

          2. Laboratory confirmed diagnosis of HAE

          3. A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3
             consecutive months).

          4. Female patients of childbearing potential who are sexually active must be willing to
             use an acceptable form of contraception.

          5. Provided written informed consent (and written assent for minors)

          6. Willingness and ability to comply with all protocol procedures

        Exclusion Criteria:

        Patients who meet any of the following criteria at Screening are to be excluded from study
        participation:

          1. Patients with medical history of allergy to rabbits or rabbit-derived products
             (including rhC1INH)

          2. Diagnosis of acquired angioedema (AAE)

          3. Patients who are pregnant, or breastfeeding, or are currently intending to become
             pregnant

          4. Treatment with any investigational drug in the past 30 days

          5. Patients with any condition or treatment that, in the opinion of the Investigator,
             might interfere with the evaluation of study objectives

          6. Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
Condition: Polymyositis; Dermatomyositis
MeSH terms: Dermatomyositis; Polymyositis
Intervention: BAF312; Placebo
Intervention MeSH terms: Siponimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Inflammatory muscle disease, Muscle weakness, Myositis, inflammatory myopathy, inclusion body myositis, skin rash, autoimmune, difficulty swallowing, dysphagia

Summary:

      This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a
      novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive
      to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12
      week, randomized, placebo controlled period, followed by another 12 weeks where all subjects
      received BAF312 treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with disease at least 3 months before study

          -  Muscle weakness

          -  Received corticosteroids with or with out disease modifying antirheumatic drugs at
             least 3 months before study however not responding to this therapy

        Exclusion Criteria:

          -  Other idiopathic inflammatory myopathies

          -  Myopathy other than polymyositis and dermatomyositis

          -  Patients with late stages of disease
A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Disease Progression
Intervention: fluorouracil (5FU); leucovorin; bevacizumab [Avastin]; capecitabine [Xeloda]; oxaliplatin
Intervention description: standard FOLFOX regimen; standard FOLFOX regimen; 7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks; standard XELOX regimen; standard XELOX or FOLFOX regimen
Intervention MeSH terms: Leucovorin; Bevacizumab; Capecitabine; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label single arm study will evaluate the efficacy and safety of Avastin added to
      XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st
      line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv
      infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin)
      chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and
      leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until
      disease progression, and the target sample size is 100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >/=18 years of age

          -  metastatic colorectal cancer

          -  at least 1 measurable lesion according to RECIST v. 1.1

          -  patients with disease progression with prior FOLFIRI + Avastin therapy who are not
             candidates for primary metastasectomy

          -  disease progression </= 8 weeks after last dose of Avastin

          -  ECOG </=2

          -  No more than 8 weeks between 1st-line treatment with FOLFIRI + Avastin and 2nd-line
             treatment with XELOX or FOLFOX + Avastin

        Exclusion Criteria:

          -  disease progression > 8 weeks after last Avastin administration

          -  clinically significant cardiovascular disease

          -  CNS disease except for treated brain metastasis

          -  history of other malignancies within 2 years prior to start of study treatment (with
             the exception of curatively treated basal and squamous cell carcinoma of the skin or
             in situ carcinoma of the cervix)

          -  major surgery, open biopsy, or significant traumatic injury within 28 days prior to
             start of study treatment