bioihbjkbjnl/mcl2 huggingface dataset:
Anti-Inflammatory Agent in Sinusitis
Condition: Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps
Intervention: AZ compound; Collection of Biological Specimens; Intranasal corticosteroid; Placebo
Intervention description: 40 mg three times daily po for 12 weeks; collection of biomarkers for analysis of nasal disease; QD Nasal Spray; looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks
Intervention MeSH terms: Mometasone Furoate; Fluticasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving
      signs and symptoms of disease in patients with sinusitis.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Females must have a negative urine pregnancy test at screening unless documented to have
        a hysterectomy or be postmenopausal.

        Exclusion Criteria:

          1. Inability or unwillingness of a participant to give written informed consent or comply
             with study protocol

          2. Use of any investigational drugs within 30 days of screening.

          3. Acute infection needing antibiotic treatment at screening.
FLX475 in Combination With Ipilimumab in Advanced Melanoma
Condition: Advanced Melanoma
MeSH terms: Melanoma
Intervention: FLX475; Ipilimumab
Intervention description: Tablet; IV infusion
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasms; Ipilimumab; Antineoplastic Agents; Immunological

Summary:

      This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of
      FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated
      with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1
      (anti-PD-L1) agent.

      The study will be conducted starting with a safety run-in portion in which 6 eligible
      subjects will be enrolled and treated for at least one 3-week cycle to determine if the
      safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately
      20-subject study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IV or unresectable Stage III advanced melanoma

          -  Prior treatment with at least 2 months of anti-PD-(L)1 agent

          -  Measurable disease at baseline

          -  Tumor available for biopsy

        Exclusion Criteria:

          -  History of allergy or severe hypersensitivity to biologic agents

          -  History of Grade 3-4 immune-related adverse events leading to discontinuation of prior
             immunotherapy

          -  Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4)
             CTLA-4 antagonists
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS topical
Intervention description: topical treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following
      Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non pregnant, non lactating females

        Exclusion Criteria:

          -  Patients under 2 years of age
Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth; Birth Weight
Intervention: Omegaven; Standard lipids (primarily omega-6 fatty acids)
Intervention description: Infants will receive nutritional supplementation with omega-3 fatty acids (omegaven).; Infants will receive nutritional supplementation with standard intralipid, composed primarily of omega-6 fatty acids.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 48.0
Sex: All
Maximum age: 7 Days
Healthy volunteers: No
Keywords: ROP; Premature infant

Summary:

      Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely.
      These infants do not have enough essential fatty acids to structurally support the retina,
      the nerve tissue in the eye which allows us to see. A recent study showed that giving omega-3
      (n-3) fatty acids to these infants soon after birth made them less likely to need invasive
      treatments for eye disease. This research trial will give young infants born prematurely n-3
      fish oil treatment and look at how this changes factors in the blood that promote disease.
      Detailed blood studies comparing infants with and without ROP will be performed and the
      infants will be followed over time to assess their eye development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants born less than or equal to 30 weeks gestation or less than 1500 g at birth

        Exclusion Criteria:

          -  Patients with liver disease as tested by liver function tests (LFTs)

          -  ≤ 500 grams birthweight
Antithrombin III in Infectious Disease Caused by COVID-19
Condition: Antithrombin III Deficiency; Covid19
MeSH terms: COVID-19; Communicable Diseases; Infections; Antithrombin III Deficiency
Intervention: Antithrombin III
Intervention description: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
Intervention MeSH terms: Antithrombins; Antithrombin III
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to see if participants who have SARS-CoV-2 and low
      levels of AT3 in the blood will benefit by being given AT3.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. >18y of age,

          2. Subject or proxy who can provide informed consent

          3. Positive SARS-COV-2 by Polymerase Chain Reaction (PCR) or as determined by clinical
             team

        EXCLUSION CRITERIA:

          1. Adults or Proxy unable to consent

          2. Individuals who are not yet adults (infants, children, teenagers)

          3. Pregnant women

          4. Prisoners

          5. Patients expected to die within 24 hours or with a "do not resuscitate" order,

          6. Multi-organ failure,

          7. History of hypersensitivity or allergy to any component of the study drug,

          8. Ongoing massive surgical or unexplained bleeding,

          9. History of bleeding or clotting disorder,

         10. Severe traumatic brain injury (Glasgow Coma Scale <6),

         11. Spinal or multiple-trauma,

         12. Cancer (incurable/terminal phase) and/or patients receiving palliative care,

         13. Enrollment in another concurrent clinical interventional study if considered
             interfering with this study objectives

         14. Per study team discretion, any condition(s) that may prevent safe treatment, preclude
             adequate evaluation or adding further risk to their underlying illness.
Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype
Condition: Alpha1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: VX-864; Placebo
Intervention description: Tablets for oral administration.; Placebo matched to VX-864 for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-864 in PiZZ
      subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects must have a PiZZ genotype confirmed at screening

          -  Plasma AAT levels indicating severe deficiency at screening

        Key Exclusion Criteria:

          -  History of a medical condition that could negatively impact the ability to complete
             the study

          -  Solid organ, or hematological transplantation or is currently on a transplant list

          -  History of use of gene therapy or RNAi therapy at any time previously

        Other protocol defined Inclusion/Exclusion criteria may apply
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: RG1507; Letrozole
Intervention description: R1507 was administered at a dose 16 mg/kg every 3 weeks.; Letrozole was administered orally at a dose 2.5 mg daily.
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aim was to determine the safety and efficacy of R1507 in combination with
      letrozole in patients with advanced breast cancer. In the first part of the study a cohort of
      patients with advanced breast cancer received letrozole 2.5mg po daily in combination with
      R1507 16mg/kg every 3 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal female patients;

          -  stage IV or locally advanced breast cancer;

          -  measurable disease;

          -  letrozole failure (Part 2);

          -  Eastern Cooperative Oncology Group (ECOG) performance status <=2.

        Exclusion Criteria:

          -  previous chemotherapy for metastatic breast cancer;

          -  concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to
             receipt of study drug;

          -  history of primary malignancy in 5 years prior to study, excluding adequately treated
             basal or squamous cell cancer of skin, or cancer in situ of cervix;

          -  concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study
             drug.
11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: 11C-acetate; [18F]Fluoro-2-deoxy-2-D-glucose; Cardiac MRI
Intervention description: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate; For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG; Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pulmonary hypertension; right ventricular function; 11C acetate; FDG; ranolazine

Summary:

      This study is looking at differences in metabolism and functional imaging between pulmonary
      hypertension subjects with normal right ventricular function and persistent right ventricular
      dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

        Participation in the companion treatment protocol "A randomized, double-blind, placebo
        controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects
        with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative
        study of cellular metabolism in subjects with pulmonary hypertension with and without right
        ventricular dysfunction"

        Exclusion Criteria:

          -  Pregnancy or lactation: Women of childbearing potential must have a negative urine or
             blood pregnancy test on the day of the PET/CT scan.

          -  Severe anxiety or claustrophobia prohibiting completion of imaging

          -  Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)

          -  Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any
             other contraindication to MRI.

          -  Uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL
Effect of BIBW 2948 BS in COPD
Condition: Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic
MeSH terms: Bronchitis; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive
Intervention: BIBW 2948 BS; Placebo
Intervention description: Capsule; Capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  COPD smokers

          -  ages between 40 and 70

        Exclusion Criteria:

          -  Significant other diseases

          -  abnormal hematology

          -  abnormal liver function

          -  psychiatric disorders

          -  pulmonary obstruction

          -  asthma, allergic rhinitis

          -  dependance on oxygen

          -  patients with history of myocardial infarction

          -  patients with history of cancer

          -  women of child bearing potential

          -  antiplatelet or anticoagulation therapy
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
Condition: Bipolar Disorder I; Bipolar Disorder II; Major Depressive Episode
MeSH terms: Bipolar Disorder; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 capsule; SAGE-217 matching placebo capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and
      efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a
      current major depressive episode.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Participant had a documented history of hypomanic or manic episode and a diagnosis of
        bipolar I or bipolar II disorder with a current major depressive episode.

        Exclusion Criteria:

          1. Participant had a history of suicide attempt.

          2. Participant had current suicidal ideation with plans.

          3. Participant had a history of rapid cycling bipolar disorder.
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
Condition: Chronic Kidney Disease; End Stage Renal Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia
Intervention: Roxadustat
Intervention description: Oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney; ESRD; End Stage Renal Disease; Anemia; Oral anemia treatment; Hemoglobin levels; Hemodialysis; CKD; Chronic Kidney Disease; Peritoneal; HD; PD; Hb; Erythropoietin; Blood count

Summary:

      The purpose of this open-label extension study is to evaluate long-term efficacy and safety
      of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis
      chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat
      FibroGen-sponsored anemia study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Minimum age 18 years

          2. Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia
             study in the United States.

        Exclusion Criteria

          1. Participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study

          2. Pregnant or breastfeeding females

          3. Females of childbearing potential, unless using adequate contraception; male
             participants with sexual partners of childbearing potential who are not on birth
             control unless the male participant agrees to use adequate contraception

          4. Participants who received roxadustat in a previous study that did not demonstrate
             adequate hemoglobin response per the investigator's clinical judgment

          5. Any medical condition that in the opinion of the investigator may pose a safety risk
             to a participant in this study or which may interfere with study participation
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
Condition: Pregnant Women
Intervention: HB Prilocaine 2% (varying dose); HB Prilocaine 2%; Sufentanil; Morphine
Intervention description: Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl; The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl; 2.5µg sufentanyl; 100 µg Morphine
Intervention MeSH terms: Sufentanil; Morphine; Prilocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: scheduled cesarean delivery; spinal anesthesia; local anesthesia

Summary:

      Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly
      used for spinal injection in cesarean section. Nevertheless, its use often results in a long
      duration of motor nerve block and a haemodynamical instability. Recently developped, the
      Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for
      hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for
      intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the
      effect of the local anesthetics while decreasing their dose-related side effects, the aim of
      this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled
      cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists physical status (ASA) < III

          -  Age 18-40 year

          -  Body Weight <100 kg

          -  Height between 155 and 175 cm

          -  Gestational age>37 SA

          -  Elective cesarean delivery

          -  Singleton pregnancy

          -  Non complicated pregnancy

          -  Signed informed consent obtained prior to any study specific assessments and
             procedures

        Exclusion Criteria:

          -  Twin pregnancy

          -  History of 2 cesarean section or more

          -  Diabetes and gestational diabetes

          -  Placenta praevia

          -  Congenital foetal abnormality

          -  Patient in labour

          -  Membrane rupture

          -  Known allergy to local anaesthetics

          -  Disagreement of the patient

          -  Pregnancy-induced hypertension

          -  Pre eclampsia and eclampsia
Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Convalescent Plasma
Intervention description: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open label pilot study designed to provide access to treatment with
      investigational convalescent plasma and assess the relationship between NAb titers in the
      investigational convalescent plasma compared to changes in NAb levels in the recipient in
      hospitalized patients with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be 18 years of age or older.

          2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19
             SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment,
             test results must be positive prior to administration of convalescent plasma.

          3. Patient (or legally authorized representative, LAR) is willing and able to provide
             written informed consent and comply with all protocol requirements.

          4. For patients unable to consent, consent by the legally authorized representative (LAR)
             may be obtained by phone.

        Exclusion Criteria:

          1. Female subjects with positive pregnancy test or breastfeeding.

          2. Receipt of pooled immunoglobulin in past 30 days.

          3. Contraindication to transfusion or history of prior severe allergic reactions to
             transfused blood products.

          4. On ECMO or in refractory shock at entry