bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Secukinumab 10 mg/kg; Canakinumab 10 mg/kg; Placebo
Intervention description: Secukinumab was prepared in a sterile water solution.; Canakinumab was prepared in a sterile water solution.; The placebo solution for infusion contained 5% glucose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Dry eye; IL17/ IL-1β; Biologic

Summary:

      This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg
      or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the
      pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were
      assessed. Blood samples were collected for the analysis of the effect of secukinumab and
      canakinumab on select biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients age 18-85 with a diagnosis of moderate to severe dry eye.

          -  Schirmer test without anesthesia ≥ 1 and < 10 mm wetting over 5 minutes in at least 1
             eye.

          -  Tear break up time < 7 seconds in at least 1 eye.

          -  Corneal staining score ≥ 3 (National Eye Institute [NEI] grading scale).

          -  Conjunctival redness of ≥ 1.

          -  Ocular surface disease index of modest to severe.

          -  Ability to provide informed consent.

        Exclusion Criteria:

          -  Pregnant or breastfeeding women.

          -  Hemoglobin < 10 g/dl.

          -  Total white blood count (WBC) outside the range of 3000-14,000/µl.

          -  Platelets < 100,000/µl.

          -  Use of ocular, periocular, or systemic steroids within 60 days prior to screening.

          -  Use of contact lenses or prior corneal refractive surgery in either eye.

          -  Requirement of eye drop use during the study.

          -  Anesthetic or neurotrophic corneas.

          -  Temporary punctal plugs.

          -  Recent or planned exposure to live vaccinations.

          -  Other protocol-defined inclusion/exclusion criteria may apply.
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
Condition: Transfusional Iron Overload; β-thalassemia Major; Pediatric Rare Anemia
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Intervention: Deferasirox
Intervention description: Deferasirox in children from 1 to 18 years old was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters and on increasing or decreasing Liver Iron Concentration (LIC), and serum ferritin. Deferasirox was available as 125 mg, 250 mg and 500 mg tablets.
Intervention MeSH terms: Deferasirox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: β-thalassemia major; iron overload; deferasirox; pediatric rare anemia

Summary:

      In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox
      in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients
      who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in
      this extension trial and receive chelation therapy with deferasirox for up to 4 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the planned 12-month core trial, (NCT00390858).

          -  Female patients who have reached menarche and who were sexually active were to use
             double-barrier contraception, oral contraceptive plus barrier contraceptive, or must
             have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal
             ligation.

          -  Written informed consent obtained from the patient, and/or from the parent or legal
             guardian in accordance with the national legislation.

        Exclusion Criteria:

          -  Pregnant or breast feeding patients

          -  Patients with a history of non-compliance to medical regimens and patients who are
             considered by the investigator as potentially unreliable.

        Other protocol-defined exclusion criteria may apply.
Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Resveratrol; Vitamin D3
Intervention description: Resveratrol vs placebo given for 15 days.; Vitamin D3 100,000 IU given on day one.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Coronavirus; SARS-CoV-2; COVID; Vitamin D3; Cholecalciferol; Supplement; Polyphenol; Resveratrol; Stilbene; phytoalexin

Summary:

      Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help
      fight coronavirus as well as help protect the body from the effects of disease (COVID-19)
      caused by the infection. In this proof-of-concept pilot study we will compare the effects of
      resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients who test positive for infection with SARS-CoV-2.

          -  Age ≥45 years

          -  Mild COVID-19 based on World Health Organization (WHO) Baseline Severity
             Categorization

          -  Symptom duration ≤ 10 days, or <72 hours of new respiratory symptoms.

          -  Patient must have access to the internet or a smartphone to complete surveys.

          -  English-speaking patients

        Exclusion Criteria:

          -  Diagnosed or suspected cognitive impairment that would prevent the patient from
             cooperating with study procedures, as judged by the screening clinician

          -  Asymptomatic patients (e.g. patients who were screened without symptoms but tested
             positive)

          -  Known or suspected liver disease or Hepatitis C

          -  Known kidney disease with estimate Glomerular Filtration Rate (eGFR) <60

          -  Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors,
             immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow
             therapeutic window.

          -  Allergy to grapes or rice.

          -  Co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current
             cancer treatment, severe Chronic Obstructive Pulmonary Disease (COPD) or Congestive
             Heart Failure (CHF))

          -  Currently pregnant

          -  Hospitalization
Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
Condition: Decrease in Night Vision; Disturbance; Vision, Loss
Intervention: Phentolamine Mesylate Ophthalmic Solution 1%; Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention description: Topical Sterile Ophthalmic Solution; Topical Sterile Ophthalmic Solution
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Night Vision Disturbances; NVD; Glare; Halos; Starbursts; Nyxol

Summary:

      The objectives of this study are:

        -  To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the
           four endpoints:

             1. Contrast sensitivity

             2. Low contrast visual acuity

             3. Wavefront aberrometry

             4. Subjective questionnaire

        -  To assess the safety of ophthalmic phentolamine mesylate
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients ≥ 18 years of age

          2. Currently experiencing severe night vision difficulty as reported subjectively

          3. At least two patches below the normal range at any two frequencies in Contrast
             Sensitivity done under mesopic conditions with glare

          4. Improvement in low contrast visual acuity (LCVA) in dim light during illumination of
             contralateral eye

          5. Good general health

          6. Written informed consent to participate in this trial

          7. Ability to comply with all protocol mandated procedures and to attend all scheduled
             office visits

        Exclusion Criteria:

          1. Patients with untreated cataracts grades 1-4

          2. Patients who wear contact lenses

          3. Less than 5 weeks post-refractive surgery (LASIK or PRK)

          4. Less than 5 weeks post intraocular lens insertion

          5. Low blood pressure (systolic <120 mm Hg or diastolic <80 mm Hg)

          6. A history of heart rate abnormalities

          7. Administration of any investigational drug within 30 days of study initiation

          8. Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1

          9. Use of any systemic alpha adrenergic antagonists (Appendix 1)

         10. Known local or systemic hypersensitivity to adrenergic antagonists

         11. For women of childbearing potential: currently pregnant or lactating, or unwilling to
             use birth control during the study
Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Intervention: NNC0142-0002; placebo
Intervention description: A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).; A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy
      of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis
      (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987)
             criteria, obtained at least three months prior to dosing with the trial product

          -  Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at
             least five tender and five swollen joints (can be the same), including one swollen
             wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to
             fifth)

          -  Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks,
             with stable dose for at least 4 weeks prior to dosing

          -  Ability to be examined by Magnetic Resonance Imaging (MRI)

          -  Having failed no biologic therapies for RA and no more than two non-biologic disease
             modifying antirheumatic drugs

        Exclusion Criteria:

          -  Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)

          -  Any ongoing chronic or active infectious disease or microbial infection requiring
             systemic oral or intravenous treatment against infection within 1 month prior to trial
             start

          -  Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m^2
Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)
Condition: Persistent or Permanent Non-valvular Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AZD0837; Aspirin
Intervention description: ER formulation; Oral form
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and tolerability of AZD0837 in patients
      with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for
      up to 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Either one of the following risk factors is sufficient for inclusion (high risk
             patient)

          -  Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), >30
             days prior to randomization)

          -  Previous systemic embolism or at least one of the following risk factors are needed
             for inclusion: Age ≥75 years

          -  Symptomatic congestive heart failure

          -  Impaired left ventricular systolic function

          -  Diabetes mellitus; Hypertension requiring anti-hypertensive treatment

          -  In addition to AF the patient must be appropriate for but unable or unwilling to take
             VKA therapy

        Exclusion Criteria:

          -  Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or
             systemic embolism within the previous 30 days prior to randomization

          -  Conditions associated with increased risk of major bleeding
Study of Tremelimumab in Patients With Advanced Solid Tumors
Condition: Urothelial Bladder Cancer; Triple-negative Breast Cancer; Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma; Urinary Bladder Neoplasms; Triple Negative Breast Neoplasms
Intervention: Tremelimumab monotherapy; MEDI4736 monotherapy; MEDI4736 + tremelimumab combination therapy
Intervention description: IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 150 Years
Healthy volunteers: No
Keywords: Urothelial bladder cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Advanced Solid Tumors, Tremelimumab, MEDI4736, ORR

Summary:

      A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with
      Advanced Solid Tumors
    

Eligibility criteria:

        Inclusion Criteria:

        1. histologically or cytologically documented solid tumor malignancies, including but not
        limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible
        for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not
        previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest
        diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography
        (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for
        accurate repeated measurements.

        Exclusion criteria:

        1. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2.
        History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or
        inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic
        or treated and stable off steroids and anti-convulsants for at least 14 days prior to study
        treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF)
        ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Condition: Nonalcoholic Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: PXL770; Placebo Oral Capsule
Intervention description: Oral capsule; Oral 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: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12
      weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have given written informed consent

          -  Body mass index (BMI) ≥ 25 to ≤ 50 kg/m²

          -  For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or
             under stable oral glucose lowering drug

          -  Estimated glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73m²]

          -  Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males

          -  Hepatic steatosis (MRI-PDFF ≥ 10%)

          -  Effective contraception for women of child bearing potential

        Exclusion Criteria:

          -  Evidence of another form of liver disease

          -  Evidence of liver cirrhosis

          -  Evidence of hepatic impairment

          -  Positive serologic evidence of current infectious liver disease

          -  History of excessive alcohol intake

          -  Acute cardiovascular disease with 24 weeks prior to screening

          -  Uncontrolled high blood pressure

          -  Any disease which in the Investigator's opinion which in the Investigator's opinion
             would exclude the patient from the study

          -  Use of non-permitted concomitant medication

          -  Pregnancy or lactation
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Mirikizumab; Placebo
Intervention MeSH terms: Mirikizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: inflammatory bowel disease; IL-23; biologic

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of the study drug
      Mirikizumab in participants with active Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported
             stool frequency and abdominal pain.

          -  Inadequate response or failure to tolerate at least one of the following:
             aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg,
             azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for
             the treatment of CD.

        Exclusion Criteria:

          -  Have complications of CD such as strictures, stenoses, or any other manifestation for
             which surgery might be indicated, or that could confound the evaluation of efficacy.

          -  Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis,
             indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous
             colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.

          -  Have had any kind of bowel resection, diversion, or placement of a stoma within 6
             months or any other intra-abdominal surgery within 3 months prior to screening.

          -  Are unsuitable for inclusion in the study in the opinion of the investigator or
             sponsor for any reason that may compromise the subject's safety or confound data
             interpretation.
Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: carboplatin; docetaxel
Intervention description: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25); 75 mg/m² intravenously, once, every 3 weeks
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells
      that remain after surgery.

      PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel
      works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Histologically confirmed non-small cell lung cancer

               -  Stage I-IIIA disease

          -  Must have undergone a complete resection

          -  Must begin adjuvant chemotherapy within 8 weeks of surgical resection

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

          -  Platelet count ≥ 100,000/mm^3

          -  Serum creatinine normal OR creatinine clearance ≥ 40 mL/min

          -  Bilirubin normal

          -  Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase
             (ALT) must meet 1 of the following criteria:

               -  AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)

               -  AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN

               -  AP ≤ 5 times ULN AND AST and ALT normal

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 3 months
             after study therapy

        Exclusion criteria:

          -  Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are
             excluded.

          -  Women who are currently or planning to breast feed.

          -  Those with peripheral neuropathy ≥ grade 2

        PRIOR CONCURRENT THERAPY:

          -  2-8 weeks since prior surgery and recovered