bioihbjkbjnl/mcl2 huggingface dataset:
COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients
Condition: COVID-19; SARS-CoV 2
MeSH terms: COVID-19
Intervention: Povidone-Iodine Nasal Spray and Gargle; Povidone-Iodine Nasal Spray and Gargle; Povidone-Iodine Nasal Spray and Gargle
Intervention description: Healthcare workers will receive standard PPE and a pre- and post-study nasal swab COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle (10% diluted 1:30) to use at the beginning of their shift, in the middle, and at the end of their shift.; Patients will receive standard of care treatment and a pre- and post-study nasal spray COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle shortly after admission or preoperatively.; Community members will receive a pre- and post-study nasal swab COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle (10% diluted 1:30) to use at home.
Intervention MeSH terms: Iodine; Cadexomer iodine; Povidone-Iodine; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; SARS-CoV 2; Health Care Workers; COVID-19 Prophylaxis

Summary:

      Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi,
      and viruses. It has been previously used in both intranasal preparations against Methicillin
      Resistant Staphylococcus Aureus (MRSA) as well as oral preparations in in-vitro studies of
      Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), Middle Eastern Respiratory Syndrome
      Coronavirus (MERS-CoV), influenza H1N1, and rotavirus with good efficacy. This study will
      evaluate the efficacy of PVP-I as prophylaxis in Coronavirus Disease 2019 (COVID19)-negative
      front-line health care workers, hospital patients, and community members.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthcare worker OR

          -  patient with expected hospital stay of 7+ days OR

          -  patient admitted for major surgery OR

          -  community member

          -  COVID19 negative by nasal swab test

          -  asymptomatic for COVID19

          -  able to consent

        Exclusion Criteria:

          -  positive for COVID19 by nasal swab

          -  symptomatic for COVID19

          -  unable to consent
Pegylated Interferon Lambda Treatment for COVID-19
Condition: COVID-19; COVID
MeSH terms: COVID-19
Intervention: Pegylated interferon lambda
Intervention description: 180 mcg subcutaneous injection of pegylated interferon lambda
Intervention MeSH terms: Interferons
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Single blind
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID; Coronavirus

Summary:

      Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda
      (180 mcg SC injection) vs.placebo in up to 20 subjects with COVID-19 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  Confirmed COVID-19 diagnosis based on PCR analysis of respiratory secretions

          -  Positive SARS-CoV-2 RT-PCR test must be within 48 hours of randomization

        Exclusion Criteria:

          -  Clinically-significant illness or any other major medical disorder that in the opinion
             of the investigator, may interfere with subject treatment, assessment or compliance
             with the protocol

          -  Treatment with IFN or other immunomodulatory/immunosuppressive agent within 12 months
             before screening.

          -  Respiratory compromise requiring ventilatory support other than nasal cannula (mask,
             bipap or intubation and mechanical ventilation)

          -  History of treatment with any of the following medications within five half-lives or
             30 days before administration of the study drug (whichever is longer): anti-IL-6,
             anti-IL6R antagonists, Janus kinase inhibitors, ustekinumab (anti-IL-12/23), or anti
             IL-23 agents (guselkumab).

          -  Life threatening SAE during the screening period

          -  Pregnant or Nursing Females

          -  Platelet count <90,000 cells/mm3

          -  WBC count <3,000 cells/mm3

          -  ANC <1,500 cells/mm3

          -  Hb <11 g/dL for women and <12 g/dL for men

          -  CrCl < 50 mL/min

          -  Bilirubin level ≥ 1.5x ULN

          -  INR ≥1.5 (except in the setting of concomitant anticoagulant use)

          -  CRP > 200 mg/L

          -  Clinically-relevant alcohol or drug abuse within 12 months of screening

          -  Known hypersensitivity to Interferons

          -  Current or planned participation in an investigational new drug (IND) trial from
             30-days prior to randomization through Day 14 post treatment
Defibrotide TMA Prophylaxis Pilot Trial
Condition: Thrombotic Microangiopathies
MeSH terms: Thrombotic Microangiopathies
Intervention: Defibrotide
Intervention description: Defibrotide is an anticoagulant and fibrinolytic agent that has been shown to be an effective treatment in other endothelial disorders such as hepatic veno-occlusive disease.
Intervention MeSH terms: Defibrotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Defibrotide 6.25mg/kg administered intravenously for 28-35 days
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Maximum age: 30 Years
Healthy volunteers: No
Keywords: hematopoeitic stem cell transplant; prophylactic defibrotide

Summary:

      Thrombotic microangiopathy (TMA) is a common complication in the stem cell transplant
      population. Certain populations within the hematopoietic stem cell transplant (HSCT)
      population are at a higher risk than others. Defibrotide is an endothelial stabilizing agent
      which may prevent the endothelial damage that triggers TMA in HSCT patients. The feasibility,
      safety, and efficacy of defibrotide prophylaxis in a pediatric transplant population is
      unknown. Twenty five patients age 0 to 30 years receiving autologous or allogeneic
      hematopoeitic stem cell transplant who meet TMA high risk criteria will be enrolled. Patients
      will receive Defibrotide for 28-35 days starting before conditioning, and will be closely
      monitored for any adverse events up through 6 months post-transplant. The feasibility of
      administering defibrotide will be evaluated as well as incidence of TMA.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 0-30 years of age

          2. Life expectancy > 6 months

          3. Eastern Cooperative Oncology Group or Karnofsky Performance Status >40

          4. Meets minimum organ function requirements per institutional standard of care guiding
             clearance for autologous or allogeneic stem cell transplantation.

          5. Patients must meet TMA High-Risk criteria 5A or 5B below:

        5A. Patients undergoing tandem autologous transplant with thiotepa in one or more of the
        conditioning regimens

        OR:

        5B. . Patients with at least 3 of the following characteristics:

          1. >10 years of age

          2. Non-Caucasian race/ Hispanic ethnicity

          3. Undergoing haploidentical transplant

          4. Minor ABO blood group mismatch

        Exclusion Criteria:

          1. Age >30 years

          2. Life expectancy < 6 months

          3. Known bleeding diathesis or bleeding risk deemed by the treating physician to be a
             contraindication to administration of anticoagulants.

          4. Known hypersensitivity reaction to defibrotide

          5. Any patient not meeting TMA High-Risk criteria

          6. Pregnant women are excluded from this study because they will be receiving teratogenic
             therapy as part of the stem cell transplant.
A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; atenolol; placebo
Intervention description: 5 mg daily or 10 mg daily; 25 mg daily or 50 mg daily; one tablet daily
Intervention MeSH terms: Atenolol; Nebivolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension; prevention; endothelial function

Summary:

      This is a randomized, double-blind, placebo-controlled study comparing the efficacy of
      nebivolol and atenolol at improving small artery elasticity and reducing cardiovascular
      disease risk in subjects with early vascular disease. Approximately 75 subjects with
      borderline/elevated blood pressures and impaired endothelial function, as measured by
      arterial elasticity scores, will be recruited and assigned to treatment groups using a block
      randomization scheme. Patients will be randomly allocated to nebivolol, atenolol or placebo,
      and then followed for 9 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  borderline blood pressure (120-145/80-90 mm Hg);

          -  borderline or abnormal small artery elasticity (C2) as measured by pulse contour
             analysis;

          -  treatment-naive for all blood pressure medications including diuretics for at least 30
             days prior to baseline visit;

          -  able to walk on a treadmill for 3 minutes;

          -  female patients with reproductive potential must use an approved contraceptive method
             if appropriate (for example, intrauterine device [IUD], birth control pills, or
             barrier device during and for 1 month after the last dose of study drug;

          -  voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

        Exclusion Criteria:

          -  history of intolerance to beta-blockers or clear contraindications to their use;
             current pharmaceutical treatment of blood pressure;

          -  known history of cardiovascular disease (myocardial infarction, coronary artery bypass
             graft, unstable angina, uncontrolled arrhythmias, stroke, etc.);

          -  known history of diabetes; known history of hepatic, renal or gastrointestinal
             disorder;

          -  known history of any illness that may cause additional risk (as determined by study
             investigator);

          -  pregnant or lactating women [when used during pregnancy, beta-blockers may cause fetal
             harm];

          -  participation in a concomitant clinical trial.
A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Prexasertib
Intervention description: Administered IV
Intervention MeSH terms: Prexasertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DNA damage repair; replication stress

Summary:

      The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with
      platinum-resistant or refractory recurrent ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.

          -  Cohorts 1 to 3: Have platinum-resistant disease and have documented test results
             assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.

          -  Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.

          -  Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.

          -  Cohort 3: Are BRCA positive and have previously received a PARP.

          -  Cohort 4: Have primary platinum refractory disease.

          -  Have adequate organ function.

          -  Must be able and willing to undergo mandatory tumor biopsy.

        Exclusion Criteria:

          -  Cohorts 1-3: Have previously received all of the following agents at any time in the
             platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and
             paclitaxel.

          -  Have known central nervous system malignancy or metastasis.

          -  Have previously participated in any study involving a checkpoint kinase 1 inhibitor or
             have hypersensitivity to the study drug or excipients.

          -  Have at least one of the following:

               -  history of abdominal fistula or gastrointestinal perforation

               -  intra-abdominal abscess within last 3 months prior to the first dose of study
                  drug

               -  a radiographically confirmed bowel obstruction within 3 months prior to the first
                  dose of study drug

          -  Have a symptomatic human immunodeficiency virus infection or symptomatic
             activated/reactivated hepatitis A, B, or C (screening is not required).

          -  Have a serious cardiac condition.

          -  Have a history of prior radiotherapy to the whole pelvis.

          -  Have chronic daily treatment with corticosteroids, excluding inhaled or topical
             steroids.

          -  Have known factors that may increase the risk of infection while on study drug
             treatment. These may include, but are not limited to, an indwelling peritoneal
             catheter or open wounds. Catheters for vascular access are permitted.
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mirikizumab
Intervention description: Administered IV and SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Interleukin-23 (IL-23) antibody; IL-23p19; Pediatric

Summary:

      This study was designed to evaluate how the body processes and removes mirikizumab. The study
      also evaluated safety and disease response in pediatric participants with UC taking
      mirikizumab. The study lasted about 52 weeks and included up to 18 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants weighing >10 kg

          -  Participants must have a diagnosis of ulcerative colitis for at least 3 months before
             the planned start date for the study medications

          -  Participants must have moderately to severely active UC as defined by a Modified Mayo
             Score (MMS) within 14 days before the first dose of study treatment

          -  Participants must have evidence of UC extending proximal to the rectum

          -  Participants must have demonstrated an inadequate response to, a loss of response to,
             or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor
             (JAK-inhibitor) or to biologic therapies for UC

        Exclusion Criteria:

          -  Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel
             disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary
             sclerosing cholangitis

          -  Participants must not have had surgery to remove part of their colon

          -  Participants must not have current evidence of toxic megacolon

          -  Participants must not have received any of the following for treatment of UC:
             cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas,
             corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within
             1 week of screening endoscopy

          -  Participants must not have had an inadequate response to Interleukin-12 p40 subunit
             antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19
             antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: LIB003
Intervention description: 300 mg SC Q4W
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of
      additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women 18 years or older

          2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic
             cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk
             for CVD based on American Heart Association/American College of Cardiology (AHA/ACC)
             CVD risk calculator, or aged 40 years and older with diabetes and moderate- to
             high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous
             familial hypercholesterolemia (HeFH)

          3. patients who met original entry criteria in, and completed, the double-blind,
             placebo-controlled 16-week Phase 2 study (LIB003-002)

        Exclusion Criteria:

          1. patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2
             study (LIB003-002)

          2. <18 years of age

          3. pregnant or women of childbearing potential not using acceptable birth control
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: SUN13834; Placebo
Intervention description: Low dose, orally 3 times a day (tid) for 28 days of SUN13834; Placebo, orally (tid) for 28 days of SUN13834
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; SUN13834

Summary:

      The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in
      adult participants with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants between 18 and 65 years of age.

          -  A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic
             Dermatitis criteria

          -  At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at
             Screening and prior to randomization (as per Amendment 2 and 3). Under the original
             protocol and Amendment 1, no minimum EASI score was required.

        Exclusion Criteria:

          -  Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic
             corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal
             or otic corticosteroids are allowed).

          -  Use of phototherapy or tanning beds within 6 weeks of screening

          -  History of reactive airway disease (asthma) requiring hospitalization in an intensive
             care unit in the last 5 years.

          -  Presence of a clinically significant disorder involving the cardiovascular,
             respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or
             neurologic system(s) or psychiatric disease (as determined by the Clinical
             Investigator) that will interfere with the interpretation of data from this patient
             (eg, renal impairment with non-atopic pruritus).
C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
Condition: Antibody Mediated Rejection of Kidney Transplant
Intervention: C1-INH (Berinert)
Intervention MeSH terms: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is an open-label, single arm trial in which patient who have ongoing antibody mediated
      rejection of a kidney transplant deemed refractory to maximal medical therapy are given the
      complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing
      antibody mediated injury. A maximum of 5 patients will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant with acute antibody mediated rejection refractory to standard
             therapy

        Exclusion Criteria:

          -  Patients with known intolerance of or anaphylaxis to Berinert
Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: GSK239512; Placebo
Intervention description: Histamine H3 Antagonist; Placebo to match GSK239512
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: H3 Antagonist; Schizophrenia; double blind; Histamine; randomised; placebo controlled; Cognition

Summary:

      This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512
      compared to placebo in patients with schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of Schizophrenia

          2. No acute exacerbation of symptoms requiring hospital admission or step up care in the
             previous six months.

          3. Not on any symptomatic treatment for cognition

        Exclusion Criteria:

          1. Poses a significant homicidal or suicidal risk or evidence of previous homicidal or
             suicidal risk.

          2. Co-morbid psychiatric or significant physical illness

          3. Alcohol or drug abuse or dependence.