bioihbjkbjnl/mcl2 huggingface dataset:
L-Menthol Injection as a Novel Technique During Colonoscopy
Condition: Colonic Polyps; Colon Cancer
MeSH terms: Colonic Neoplasms; Colonic Polyps
Intervention: Peppermint Oil; Placebo
Intervention description: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640 mg of L-Menthol).; During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, also has 0 mg of L-Menthol).
Intervention MeSH terms: Peppermint oil; Menthol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 82.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Colon Cancer; Colonic Polyps; L-Menthol; C-Mint

Summary:

      The primary objective of this double-blinded, prospective, randomized placebo-controlled
      study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of
      peppermint oil solution vs placebo application during colonoscopy. The investigators
      hypothesize that ADR will be increased with the use of the peppermint oil solution and thus
      further reduce the risk of colon cancer by means of colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 50 years of age in Caucasians or 45 years of age in African-Americans.

          2. Patients undergoing primary screening colonoscopy (either average risk or
             increased-risk) or surveillance colonoscopy after prior screening/surveillance
             colonoscopy.

          3. Capable of understanding instructions, adhering to study schedules and requirements,
             and willing to provide informed consent.

        Exclusion Criteria:

          1. History of colectomy, partial or complete

          2. Symptoms suggesting possible colorectal stenosis or cancer

          3. Inflammatory bowel disease

          4. Familial polyposis syndromes

          5. History of, or current diagnosis of colorectal cancer

          6. American Society of Anesthesia Physical Stats (ASA PS) score of IV or greater

          7. Non-correctable coagulopathy

          8. Currently receiving anti-thrombotic therapy, with an INR > 1.5

          9. Poor prep, total BBPS score < 6, or any part of the colon < 2.

         10. Patients with known allergy to peppermint oil or peppermint containing products.

         11. Patients taking calcium channel blockers (Amlodipine, Nifedipine, Verapamil,
             Diltiazem, Dihydropyridine, Felodipine, etc).
Study of Ambrisentan in Participants With Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Ambrisentan
Intervention description: Tablet administered orally once daily
Intervention MeSH terms: Ambrisentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to monitor the long-term safety of ambrisentan in
      adult participants with pulmonary hypertension. The available ambrisentan doses for this
      study are 2.5, 5, or 10 mg administered orally once daily. Investigators will be able to
      adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose
      adjustments is required. Participants receiving other therapies for pulmonary hypertension
      that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in
      this study and continue to receive such therapies. Participants enrolled in this study will
      receive treatment with ambrisentan until such time as the investigator or participant chooses
      to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor
      stops the study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men and women with pulmonary hypertension who are discontinuing a clinical study of
             ambrisentan due to study closure by the sponsor. Eligible participants are those
             participating in countries where ambrisentan is not yet commercially available.
             Participants participating in countries where ambrisentan is commercially available
             may be eligible if they do not qualify for treatment per the current prescribing
             information of that country.

        Key Exclusion Criteria:

          -  Participants who have discontinued an ambrisentan clinical study for any other reason
             than sponsor-initiated study closure are not eligible.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
Condition: Hypoglycemia; Diabetes Mellitus; Drug-Specific Antibodies
MeSH terms: Diabetes Mellitus; Hypoglycemia
Intervention: Nasal Glucagon
Intervention description: 3 mg nasal glucagon powder
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Hypoglycemia; Glucagon; Anti-glucagon Antibody; Immunogenicity

Summary:

      Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years
      will be selected for inclusion in the study. The target is to obtain treatment response and
      user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of
      hypoglycemia. The population will be enriched to include participants who suffer from
      impaired hypoglycemia awareness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female Person with diabetes (PWD) lives with or is in frequent contact with
             one or more caregivers who are available to administer the glucagon in case of an
             episode of severe or moderate hypoglycemia

          -  With a history of type 1 diabetes >1 year

          -  At least 18 years of age but not older than 75 years

          -  Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.

          -  PWD will be otherwise healthy according to medical history, general physical
             examination (including vital signs), nasal examination, and laboratory tests
             (biochemistry, hematology, and urinalysis).

          -  For female subjects, a urine pregnancy test must be negative.

        Exclusion Criteria:

          -  Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.

          -  Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic
             drugs.
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: GP2013; rituximab
Intervention description: Type: Biological/Vaccine; Type: Biological/Vaccine
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A subset of patients is switched from GP2013 to MabThera or continued with MabThera during the maintenance phase, for these patients the treatment is finished as an open labeled parallel arm study. The original treatment assignment is kept blinded.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 629.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Follicular Lymphoma; Biosimilar; GP13-301; rituximab; Antibodies; CD20

Summary:

      The purpose of this study is to demonstrate comparability of the ORR in patients with
      previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive
      MabThera-treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with previously untreated advanced stage, CD20-positive FL

          -  Patient with ECOG performance status 0, 1 or 2.

        Exclusion Criteria:

          -  Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a

          -  Patient who has previously received any prior therapy for lymphoma

          -  Patient with evidence of any uncontrolled, active infection (viral, bacterial or
             fungal).

          -  Patient with any malignancy within 5 years prior to date of randomization, with the
             exception of adequately treated in situ carcinoma of the cervix uteri, basal or
             squamous cell carcinoma or non-melanomatous skin cancer.

        Other protocol-defined inclusion/exclusion criteria may apply
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: E10030; ranibizumab; E10030 sham intravitreal injection
Intervention description: Pressure on the eye with a syringe with no needle
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 627.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; choroidal neovascularization; Fovista®; E10030; Lucentis®

Summary:

      The objectives of this study are to evaluate the safety and efficacy of intravitreal
      administration of Fovista® administered in combination with Lucentis® compared to Lucentis®
      monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related
      macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Active subfoveal choroidal neovascularization (CNV) secondary to AMD

          -  Presence of sub-retinal hyper-reflective material (SD-OCT)

        Exclusion Criteria:

          -  Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral
             supplements of vitamins and minerals

          -  Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless
             of indication (including intravitreal corticosteroids)

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication

          -  Subjects with subfoveal scar or subfoveal atrophy are excluded

          -  Diabetes mellitus
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
Condition: Hematological Malignancies; Acute Lymphoblastic Leukemia (ALL); Acute Myelogenous Leukemia (AML); Chronic Myelogenous Leukemia (CML); Myelodysplastic Syndrome (MDS); Lymphoma; Acute Leukemia
MeSH terms: Lymphoma; Leukemia; Neoplasms; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hematologic Neoplasms; Myelodysplastic Syndromes
Intervention: NiCord® (omidubicel); Cord Blood Unit
Intervention description: Cord blood unit
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is an open-label, controlled, multicenter, international, Phase III, randomized
      study of transplantation of NiCord® versus transplantation of one or two unmanipulated,
      unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid
      leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required
      disease features rendering them eligible for allogeneic transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Applicable disease criteria

          -  Patients must have one or two partially HLA-matched CBUs

          -  Back-up stem cell source

          -  Adequate Karnofsky/Lansky Performance score

          -  Sufficient physiological reserves

          -  Signed written informed consent

        Exclusion Criteria:

          -  HLA-matched donor able to donate

          -  Prior allogeneic HSCT

          -  Other active malignancy

          -  Active or uncontrolled infection

          -  Active/symptoms of central nervous system (CNS) disease

          -  Pregnancy or lactation
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lumateperone; Placebo
Intervention description: Lumateperone 42 mg (ITI-007 60 mg tosylate); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind,
      parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I
      or Bipolar II disorder having a major depressive episode.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis
             of Bipolar I or Bipolar II disorder

          -  experiencing a current major depressive episode

          -  able to provide written informed consent

        Major Exclusion Criteria:

          -  any female subject who is pregnant or breast-feeding

          -  any subject judged to be medically inappropriate for study participation
Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel (prefilled syringe, weekly intravenous IV administration).; Placebo (prefilled syringe, weekly IV administration).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450
      milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive
      disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Visit 1

          -  Treatment naive in the current episode or have inadequate response to 1-3
             antidepressant therapies given at adequate dose and duration in the current episode

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study

               5. Dissociative disorder

               6. Posttraumatic stress disorder

               7. MDD with psychotic features

          -  Significant suicide risk, as judged by the investigator
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: belimumab
Intervention description: Recombinant, fully human, monoclonal antibody
Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE; Belimumab; Antibodies; Systemic Lupus Erythematosus; Lupus; Autoimmune Diseases

Summary:

      This is a long-term continuation study to provide continuing treatment to subjects with SLE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or
             Week 48 visits, respectively.

        Exclusion Criteria:

          -  Have developed any other medical disease or condition that has made the patient
             unsuitable for this study in the opinion of their physician.
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL261; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epilepsy; seizure clusters; acute repetitive seizures; rescue treatment

Summary:

      This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared
      with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased
      seizure activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has been admitted to the institution's EMU for seizure characterization or
             pre-surgical evaluation, or such admission is planned within 28 days

          -  Subject body weight is ≥ 40 kg to ≤ 125 kg (inclusive)

          -  Subject has an established diagnosis of partial or generalized epilepsy

        Exclusion Criteria:

          -  Subject has history of status epilepticus in the 6 months prior to Screening

          -  Subject has a progressive neurological disorder such as brain tumor, demyelinating
             disease, or degenerative central nervous system (CNS) disease that is likely to
             progress in the next 12 months

          -  Subject has respiratory failure (or is at risk for respiratory failure) or other
             severe cardiorespiratory disease with New York Heart Association Class III or IV
             functional status, or requires supplemental oxygen

          -  Subject has acute narrow-angle glaucoma

          -  Subject is receiving chronic benzodiazepine treatment (defined as an average of ≥ 4
             administrations per week) and cannot safely withdraw from such treatment within the
             washout period prior to treatment
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Condition: Glaucoma; Open Angle or Ocular Hypertension
MeSH terms: Ocular Hypertension
Intervention: brinzolamide 1% ophthalmic suspension; Azopt 1%
Intervention description: brinzolamide 1% ophthalmic suspension; Azopt 1%, RLD
Intervention MeSH terms: Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this prospective study is to demonstrate the therapeutic equivalence of
      topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic
      suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and females 18 years of age or older,

          -  diagnosed with primary open-angle glaucoma or ocular hypertension.

        Exclusion Criteria:

          -  Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal
             tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle
             glaucoma,

          -  ocular hypertension.
16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
Condition: Anklyosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab (75 mg); Placebo; Secukinumab (150 mg)
Intervention description: Secukinumab 75 mg s.c.; Placebo; Secukinumab 150 mg s.c.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing spondylitis; AS; Chronic inflammatory disease; Inflammatory back pain; Secukinumab; Prefilled syringe; PFS; Subcutaneous injection; AIN457; AIN457F; AIN457F2310; adult

Summary:

      This study assessed the efficacy and safety of secukinumab in patients with active ankylosing
      spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or
      TNFα inhibitor
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female patients

          -  Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray)
             fulfilling the Modified New York criteria for AS (1984)

          -  Patients should have been on NSAIDs with an inadequate response

          -  Patients who were regularly taking NSAIDs as part of their AS therapy are required to
             be on a stable dose

          -  Patients who had been on an anti-TNFα agent (not more than one) must have experienced
             an inadequate response

        Exclusion Criteria:

          -  Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process

          -  Patients with total ankylosis of the spine

          -  Patients previously treated with any biological immunomodulating agents except for
             those targeting TNFα

          -  Previous treatment with any cell-depleting therapies