bioihbjkbjnl/mcl2 huggingface dataset:
Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants
Condition: Human Papillomavirus-Related Carcinoma
Intervention: Laboratory Biomarker Analysis; Recombinant Human Papillomavirus Nonavalent Vaccine
Intervention description: Correlative studies; Given IM
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections
      that usually last only a few months, but sometimes can last a long time and cause cancers of
      the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA
      trial studies how well does the nonavalent HPV vaccine (which can prevent nine different
      types of HPV) work when given in an alternative dosing schedule to heathy young research
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, medically well girls and boys

          -  Ability to understand and the willingness to sign a written informed consent document
             by the legal representative(s) of the participant

          -  Ability to understand and the willingness to sign a written assent document by the
             participant

        Exclusion Criteria:

          -  Previous vaccination against HPV

          -  The use of any investigational agent within 30 days preceding the first dose of the
             study vaccine or subsequent participation in another clinical trial at any time during
             the study period, in which the subject will be exposed to an investigational product

          -  Chronic administration of immunosuppressive agents or other immune-modifying drugs or
             chemotherapeutic agents within six months prior to the first vaccine dose; use of
             inhaled steroids, nasal sprays, and topical creams for small body areas is allowed

          -  Receiving active treatment for cancer or an autoimmune condition

          -  Confirmed or suspected immunosuppressive or immunodeficient condition

          -  Known bleeding disorders that preclude intramuscular injection (e.g., on
             anticoagulants or thrombocytopenia)

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             dysfunction, which in the opinion of the investigator precludes administration of the
             study vaccine

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine),
             including yeast allergy

          -  Are pregnant
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
Condition: COVID-19
MeSH terms: Infections; COVID-19; Respiratory Insufficiency
Intervention: Tocilizumab
Intervention description: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVD-19; Tocilizumab; Respiratory infection; 20-185; Memorial Sloan Kettering Cancer Center

Summary:

      The purpose of this study is to find out whether the study drug tocilizumab is an effective
      treatment for COVID-19 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient or designated proxy willing and able to provide informed consent prior to
             enrollment in the study.

          -  COVID-19 PCR positive on nasopharyngeal swab

          -  Aged >/= 18 years old

          -  Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with
             respiratory rate >/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) <
             93% on room air for nonintubated pts.

          -  Fever of 38.5 C or suspected respiratory infection

          -  IL-6 level >/= 80 pcg/ml

          -  Cohort #1 - non intubated Cohort #2 - intubated

          -  Women of childbearing potential must have a negative serum or urine pregnancy test

          -  Patients receiving ongoing steroid therapy are eligible

          -  Patients will be allowed to receive concurrent or sequential treatment with remdesivir

        Exclusion Criteria:

          -  Patients with uncontrolled systemic fungal and bacterial infections

          -  Patients with latent tuberculosis

          -  Patients with known hypersensitivity to tocilizumab or any component of the
             formulation

          -  Concurrent initiation of steroid therapy is not allowed

          -  Patients with uncrontroled malignant disease, with a life expectancy of 3 months or
             less
Phase II Study of Oral Nafithromycin in CABP
Condition: Community-Acquired Bacterial Pneumonia (CABP)
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Nafithromycin 800 mg 3 days; Nafithromycin 800 mg 5 days; Moxifloxacin 400 mg
Intervention MeSH terms: Moxifloxacin; Nafithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral
      Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial
      Pneumonia (CABP) in Adults
    

Eligibility criteria:

        Inclusion Criteria:

        Meet the clinical criteria for CABP based on following:

          1. Clinical symptoms (new or worsening)

          2. Vital sign abnormalities

          3. Laboratory abnormalities

          4. Radiographic evidence of CABP

          5. PORT score

        Exclusion Criteria:

          1. Subjects with any of the following confirmed or suspected types of pneumonia:

               1. Aspiration pneumonia

               2. Hospital-acquired bacterial pneumonia (HABP)

               3. Healthcare-associated bacterial pneumonia (HCAP)

               4. Ventilator-associated bacterial pneumonia (VABP)

               5. Pneumonia that may be caused by pathogen(s) resistant to either study drug

          2. Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial
             treatment for treatment of the current CABP

          3. Suspected or confirmed non-infectious causes of pulmonary infiltrates

          4. Subjects requiring concomitant adjunctive or additional potentially-effective systemic
             antibacterial treatment for management of CABP
High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: 3F8 monoclonal antibody and 13-cis-Retinoic Acid
Intervention description: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2.
Intervention MeSH terms: Tretinoin; Isotretinoin; Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Months
Healthy volunteers: No
Keywords: GM-CSF; MAB 3F8; RETINOIC ACID (CIS-9 & 13); 09-158

Summary:

      The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than
      standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what
      effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the
      antibody works against a very small amount of neuroblastoma (minimal residual disease) that
      is left in the bone marrow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of
             Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine
             levels.

          -  High-risk NB as defined by risk-related treatment guidelines1 and the International NB
             Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age)
             MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified
             stage 4S.

          -  The patients are post-stem cell transplantation and in first CR/VGPR, including no
             measurable MIBG-avid soft tissue tumor assessable for response.

          -  Signed informed consent indicating awareness of the investigational nature of this
             program.

        Exclusion Criteria:

          -  Creatinine > 3.0 mg/dL

          -  ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal

          -  Bilirubin > 3.0 mg/dL

          -  Patients with grade 3 or higher toxicities (using the CTCAE v3.0) related to cardiac,
             neurological, pulmonary or gastrointestinal function as determined by physical exam.
             Patients must have normal blood pressure for age.

          -  Progressive disease

          -  History of allergy to mouse proteins.

          -  Active life-threatening infection.

          -  Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.

          -  Inability to comply with protocol requirements
Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
Condition: Primary Systemic Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: Doxycycline
Intervention description: Doxycycline will be continued until one of the following criteria is met:
Patient has completed 1 year of doxycycline therapy
Patient develops any grade 3-4 toxicity related to doxycycline use.
Intervention MeSH terms: Doxycycline
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: 18 Years
Healthy volunteers: No
Keywords: AL amyloidosis; amyloidosis; light chain amyloidosis

Summary:

      In this study the investigators want to find out more about the addition of the antibiotic,
      doxycycline, to standard anti-amyloid therapy in people with amyloidosis. The investigators
      want to find out whether doxycycline improves the response to standard anti-amyloid therapy
      and whether it causes any problems (side effects).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with biopsy proven AL amyloidosis.

          2. Patients ≥ 18 years of age are eligible.

          3. Patient must provide informed consent.

          4. All patients must have measurable amyloid organ involvement of a vital organ (eg.
             heart, liver, kidneys). Localized amyloidosis will also be eligible as long as the
             amyloid involvement is radiologically measurable.

          5. A negative pregnancy test will be required for all women of child bearing potential.
             Breast feeding is not permitted.

          6. Patients who have previously been taking doxycycline will be eligible as long as there
             is no contraindication to stay on doxycycline 100 mg twice daily (BID) for 1 year in
             the opinion of the treating physician.

          7. Creatinine clearance of >25 ml/min.

        Exclusion Criteria:

          1. Patients with severe malabsorption syndrome precluding absorption of oral agents will
             be excluded.

          2. Known intolerance or allergic reactions with doxycycline.

          3. Previous chemotherapy for AL amyloidosis.
ARJ C13 Urea Breath Test System
Condition: H. Pylori Infection
Intervention: PyloPlus UBT System; Histology; Rapid Urease Test; H.pylori Culture
Intervention description: Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.; Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist; Biopsy specimen obtained and placed onto Rapid Urease Test; Biopsy specimen obtained and sent to lab for culture analysis
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea
      Breath Test to predicate devices on the market.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age at the time of visit

          -  Patients who are experiencing the effects of gastritis

          -  Written informed consent (and assent when applicable) obtained from subject and
             ability for subject to comply with the requirements of the study

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Study subjects currently taking antibiotics

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data

          -  Fasting required one hour prior to testing

          -  Study subjects shall not consume the following items prior to the test: Mouthwash,
             Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to stimulate the effect
             of ketone production that may result from some diets), Alcohol
Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
Condition: Healthy Volunteers; Norovirus
Intervention: NoV Vaccine
Intervention description: NoV vaccine injection administered.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate descriptively the long-term immunogenicity of at
      least 1 NoV vaccine administration.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Male and female participants who previously received at least 1 dose of NoV vaccine in
        trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have
        baseline and post-vaccination data, and completed the primary vaccination trial protocol as
        initially described.

        Exclusion Criteria:

          1. Participation in any clinical trial is allowed, on condition that no investigational
             product is administered within 30 days prior to blood sampling.

          2. In the opinion of the investigator, the participant is not medically eligible to
             provide blood specimens.

          3. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, may interfere with the participant's ability to
             participate in the trial.
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
Condition: Perianal Crohn's Disease
MeSH terms: Crohn Disease
Intervention: BLI-1300 low dose; BLI-1300 high dose; placebo
Intervention description: topical ointment; topical ointment; topical ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's disease; perianal; inflammatory bowel disease; fistula

Summary:

      This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is
      designed to determine the effects of BLI-1300 ointment on perianal pain associated with
      active Perianal Crohn's Disease (PCD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must give written informed consent.

          -  Male or female subjects, 18 years of age.

          -  Confirmed diagnosis of Crohn's Disease.

          -  Subject must have a 3 month documented history of perianal Crohn's Disease (PCD) and
             with clinical evidence of active PCD.

          -  Subject must have a Crohn's Disease Activity Index (CDAI) total score of ≤ 350 at
             Visit 2.

          -  Subjects must have a qualifying perianal pain score at Visits 1 and 2.

        Exclusion Criteria:

          -  Women of childbearing potential who are not using adequate contraception.

          -  Women who are pregnant or breastfeeding.

          -  Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF)
             inhibitors, immunosuppressants, steroids).

          -  Subjects taking strong analgesics that could interfere with pain measurements.
             Subjects with a perianal abscess requiring incision and drainage.

          -  Subjects with anal stenosis.

          -  Subjects with fistulae outside the immediate perianal area.

          -  Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks.

          -  Subjects who have had significant anorectal surgery for Crohns disease within the past
             8 weeks.
A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Nemolizumab
Intervention description: Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Nemolizumab; Atopic dermatitis

Summary:

      The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in
      adolescent participants with AD.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Male or female participants ≥ 12 to < 17 years of age

          -  Chronic AD that has been documented for at least 2 years

          -  Eczema Area and Severity Index (EASI) score ≥ 16

          -  Investigator's Global Assessment (IGA) score ≥ 3

          -  AD involvement ≥ 10% of Body Surface Area (BSA)

          -  Documented recent history of inadequate response to topical medications

          -  Women of childbearing potential must agree to be strictly abstinent or to use an
             effective and approved method of contraception throughout the study and for 12 weeks
             after the last study drug injection.

        Key Exclusion Criteria

          -  Body weight < 30 kilogram (kg)

          -  Cutaneous infection within 1 week or any infection requiring treatment with oral or
             parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week

          -  History of hypersensitivity (including anaphylaxis) to an immunoglobulin product
             (plasma-derived or recombinant, example., monoclonal antibody)

          -  Any medical or psychological condition, or any clinically relevant laboratory
             abnormalities that may have put the subject at significant risk according to the
             investigator's judgment
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Intervention: Imsidolimab
Intervention description: Humanized monoclonal antibody
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GPP

Summary:

      The main objectives of this study are to evaluate the efficacy, safety and tolerability of
      imsidolimab in adults with active GPP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active GPP

          -  Japanese Dermatology Association (JDA) severity index total score of at least 6 and
             erythema with pustules accounting for at least 10% of body surface area or a moderate
             severity score on Generalized Pustular Psoriasis Physician's Global Assessment
             (GPPPGA)

          -  Must be candidates for systemic therapy or phototherapy

        Exclusion Criteria:

          -  Erythrodermic, guttate psoriasis, drug induced GPP

          -  Any other ongoing inflammatory disease that interfere with the Investigator's ability
             to evaluate the subject's response to therapy

          -  History of recurrent or chronic infection

          -  ongoing use of psoriasis prohibited medication

        Other protocol-defined inclusion/exclusion criteria may apply