bioihbjkbjnl/mcl2 huggingface dataset:
Lowering Serum Uric Acid to Prevent Acute Kidney Injury
Condition: Hyperuricemia
MeSH terms: Acute Kidney Injury; Hyperuricemia
Intervention: Rasburicase; Placebo
Intervention description: Rasburicase (Dose: 7.5mg in 50ml of normal saline administered over 30 minutes) or identical placebo will be administered as an (dosage form)intravenous infusion preoperatively.; Placebo drug (color-coded to appear identical to study drug) administered as an (dosage form) intravenous infusion preoperatively.
Intervention MeSH terms: Rasburicase
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac surgery; hyperuricemia

Summary:

      Acute kidney injury is associated with a rise in serum uric acid during cardiovascular
      surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury.
      We hypothesize that hyperuricemia, particularly if chronic and marked, is a risk factor for
      acute kidney injury. The preoperative lowering of serum uric acid will reduce the incidence
      of acute kidney injury following cardiovascular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or older, and

          2. Undergoing elective cardiothoracic surgery(s), alone or in combination with other
             procedures/surgery(s): thoracic aortic aneurysm, cardiac valves, coronary artery
             bypass grafting, abdominal thoracic aneurysm, other CV surgery, and

          3. Preoperative serum uric acid > 6.5 mg/dL, and

          4. Preoperative estimated glomerular filtration rate of >30ml/min/1.73m2 or higher, but
             less than 60ml/min/1.73m2

        Exclusion Criteria:

          1. Prior history of allergy/adverse reaction to Rasburicase

          2. History of any organ transplant

          3. Preoperative intra-aortic balloon pump (IABP)

          4. Known glucose 6-phosphate dehydrogenase (G6PD) deficiency

          5. Current use of natriuretic peptides
Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Condition: Colorectal Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis
Intervention: aflibercept; oxaliplatin; 5-FU; Folinic Acid
Intervention description: administration: IV infusion; administration: IV infusion; administration: IV infusion; administration: IV infusion
Intervention MeSH terms: Leucovorin; Folic Acid; Oxaliplatin; Aflibercept; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Angiogenesis; Colon cancer; Rectal cancer; Oxaliplatin

Summary:

      The primary objective of the study is to estimate the progression-free survival rate at 12
      months for the two arms of the study.

      Secondary objectives include the evaluation of overall objective response rate to treatment,
      progression-free survival, overall survival, safety and documentation of potential
      immunogenicity of aflibercept.

      This study was a non-comparative randomized trial and was not powered for a comparison of any
      of the efficacy endpoints.

      Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and
      safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of
      non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a
      check on the similarity of the current patients to the historical controls with respect to
      clinical outcome when given FOLFOX6 treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven adenocarcinoma of the colon or the rectum

          -  Metastatic disease not amenable to potentially curative treatment

        Exclusion Criteria:

          -  Prior therapy for metastatic cancer of the colon or the rectum

          -  Prior treatment with angiogenesis inhibitors

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Difluprednate 0.05% ophthalmic emulsion; Difluprednate vehicle
Intervention description: Topical ocular steroid; Inactive ingredients used as Run-In and placebo comparator
Intervention MeSH terms: Fluprednisolone; Difluprednate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 722.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dry eye; ocular discomfort

Summary:

      The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective
      in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog
      Scale (VAS) discomfort score.
    

Eligibility criteria:

        Inclusion Criteria:

        Normal subjects:

          -  No known history of dry eye disease.

          -  Non-contact lens wearer.

          -  No current use of artificial tears or any other dry eye treatment.

        OR

        Dry eye patients:

          -  At least a 6 month history of dry eye.

          -  Non-contact lens wearer.

          -  Uses artificial tears.

          -  Experiences persistent ocular discomfort.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  The presence of any acute infectious or non-infectious ocular conditions in either eye
             within 1 month of Visit 1.

          -  Severe Sjogren's Syndrome.

          -  Lid function abnormalities.

          -  Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.

          -  History of corneal surgery including refractive surgeries.

          -  History of glaucoma or ocular hypertension

          -  Other protocol-defined exclusion criteria may apply.
Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)
Condition: Lymphoma. Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab is effective in the treatment of
      DLBCL in patients that have failed or are ineligible for ASCT
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1

          -  At least one lesion that measures >1.5 cm

          -  Prior therapy and screening lab criteria must be met

          -  Appropriate contraceptive measures must be taken

        Exclusion Criteria:

          -  Known central nervous system (CNS) lymphoma

          -  History of interstitial lung disease, prior malignancy, active autoimmune disease,
             positive test for hepatitis B or hepatitis C virus

          -  Prior allogeneic stem cell transplant (SCT), chest radiation ≤ 24 weeks from study
             drug, ≥1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of
             pre-transplant conditioning regimen, prior treatment with drug targeting T-cell
             costimulation or immune checkpoint pathways

          -  Women who are breastfeeding or pregnant
A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection
Condition: Influenza A
MeSH terms: Influenza, Human
Intervention: CT-P27 90 mg/kg; CT-P27 45 mg/kg; Placebo
Intervention description: Influenza A treatment drug.; Influenza A treatment drug.; Placebo.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: All
Minimum age: 19 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: efficacy; safety

Summary:

      This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study
      evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A
      infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female subjects between the ages of 19 and 64 years, both inclusive

          -  Diagnosed with influenza A at screening using rapid influenza diagnostic test

          -  Onset of influenza symptoms and fever is within 48 hours at screening

          -  At least 2 of symptoms (moderate to severe in intensity)

          -  ≥38.0'C body temperature at screening

        Exclusion Criteria:

          -  Taking antiviral treatment for influenza or has a history of using these antivirals
             within 14 days prior to the administration of study drug

          -  Positive influenza B or A+B infection
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD8683, 50 mcg; Placebo; AZD8683, 200 mcg
Intervention description: Dry powder for inhalation, single dose; Dry powder for inhalation, single dose; Dry powder for inhalation, single dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD); safety; inhalation; long-acting muscarinic receptor antagonist (LAMA)

Summary:

      The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in
      COPD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of COPD

          -  Current or ex-smokers

          -  FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and
             post-bronchodilator FEV1/FVC < 70%

        Exclusion Criteria:

          -  Any clinically significant disease or disorder

          -  Any clinically relevant abnormal findings at screening examinations

          -  Family history or presence of glaucoma

          -  Need of long term oxygen therapy
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
Condition: Exudative Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: LHA510 ophthalmic suspension; LHA510 vehicle; Ranibizumab ophthalmic solution
Intervention description: Inactive ingredients used as a placebo comparator; For intravitreal (IVT) injection
Intervention MeSH terms: Ranibizumab; Ophthalmic Solutions; Acrizanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: LHA510; PoC; Age-related macular degeneration

Summary:

      The purpose of this study is to evaluate the efficacy of 84 successive days of topically
      administered LHA510 compared to vehicle in reducing the number of patients requiring
      intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for
      recurrence of active choroidal neovascularization (CNV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign written informed consent form;

          -  Wet AMD;

          -  IVT anti-VEGF therapy for at least 6 months and a maximum of 7 years since the 3rd
             loading dose;

          -  BCVA 50 letters (approximate Snellen equivalent 20/100) or better in the study eye;

          -  Demonstrate ability to administer eye drops (subject or care-giver);

          -  CNV recently demonstrated high need for frequent anti-VEGF therapy and a sustained
             functional and clear anatomical response to the therapy in the study eye;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Any active ocular or periocular infection or intraocular inflammation;

          -  Current or history of macular or retinal disease (if visually significant) other than
             wet AMD in the study eye;

          -  Current clinically significant vitreous hemorrhage or history of rhegmatogenous
             retinal detachment affecting the macula in the study eye;

          -  History of hypersensitivity to any of the study drugs or clinically relevant
             sensitivity to fluorescein dye or povidone iodine;

          -  Women of child-bearing potential;

          -  History of a medical condition that, in the opinion of the Investigator, would
             preclude scheduled study visits, completion of the study or a safe administration of
             investigational product;

          -  Other protocol-specified exclusion criteria may apply.
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
Condition: Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Intervention: DUR-928 30 mg; DUR-928 90 mg; DUR-928 150 mg
Intervention description: Lowest dose of 3 dose escalation arms.; Middle dose of 3 dose escalation arms.; Highest dose of 3 dose escalation arms.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Staggered parallel design.
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Alcoholic Hepatitis; acute alcoholic liver disease; progressive inflammatory liver injury; IV infusion

Summary:

      This is a research trial testing DUR-928 (an experimental medication). The purpose of this
      trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928
      in patients with moderate and severe alcoholic hepatitis (AH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to provide written informed consent (either from patient or patient's legally
             acceptable representative)

          2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2

          3. Patients with alcoholic hepatitis defined as:

               1. History of heavy alcohol abuse: > 40 g/day in females or > 60 g/day in males for
                  a minimum period of 6 months, AND

               2. Consumed alcohol within 12 weeks of entry into the study, AND

               3. Serum bilirubin > 3 mg/dL AND AST > ALT, but less than 300 U/L AND

               4. MELD score between 11-30, inclusive

          4. No evidence of active infection as determined by the investigator.

          5. Women of child-bearing potential must utilize appropriate birth control throughout the
             study duration.

          6. Male patients must agree to use a medically acceptable method of contraception/birth
             control throughout the study duration

        Exclusion Criteria:

          1. Other or concomitant cause(s) of liver disease as a result of:

               1. Autoimmune liver disease

               2. Wilson disease

               3. Vascular liver disease

               4. Drug induced liver disease

          2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B

          3. Any active malignancies other than curatively treated skin cancer (basal cell or
             squamous cell carcinomas)

          4. If female, known pregnancy, or has a positive serum pregnancy test, or
             lactating/breastfeeding

          5. Serum creatinine > 2.5 mg/dL

          6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone
             marrow, or stem cell etc.), other than cornea transplant

          7. Stage 3 or greater encephalopathy by West Haven criteria
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Upadacitinib; Placebo
Intervention description: Tablet; Oral; Tablet; Oral
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hidradenitis suppurativa (HS); Upadacitinib

Summary:

      Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in
      the axilla (underarm), inguinal (groin) and anogenital (anal and genital) regions. This study
      will evaluate how well upadacitinib compared to placebo (no medicine) works to treat
      hidradenitis suppurativa in adult participants with moderate to severe disease. The study
      will assess change in disease signs and symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.

          -  Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline, presence of HS
             lesions in at least 2 distinct anatomical areas, and draining fistula count of ≤ 20 at
             Baseline.

          -  History of inadequate response or an intolerance to adequate trial of oral antibiotics
             for treatment of HS.

          -  Required to use a daily antiseptic wash on HS lesions.

        Exclusion Criteria:

        -History of active skin disease (other than HS) that could interfere with assessment of HS,
        including skin infections requiring systemic treatment within 4 weeks of the Baseline
        visit.
Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: piclozotan; 0.9% sodium chloride (normal saline)
Intervention description: piclozotan, intravenous (IV) infusion; 0.9% sodium chloride (normal saline) intravenous (IV) infusion
Intervention MeSH terms: Piclozotan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; motor complications; dyskinesia; Motor complications associated with Parkinson's

Summary:

      The purpose of this study is to obtain preliminary information on the effect of piclozotan on
      motor complications associated with Parkinson's Disease.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Idiopathic Parkinson's disease for at least 5 years

          -  Presence of motor fluctuations and dyskinesia

          -  Stable regimen of levodopa/carbidopa for 30 days

          -  At least 25% response/improvement in Unified Parkinson's Disease Rating Scale (UPDRS)
             part III scores after dosing with regular Parkinson's disease (PD) medications

          -  Mini-Mental State Examination (MMSE) score of 25 or higher

        Main Exclusion Criteria:

          -  Atypical or secondary parkinsonism.

          -  Prior use of neuroleptic agents.

          -  History of intracranial procedures for PD.

          -  Active psychosis.

          -  History of drug or alcohol abuse in past 12 months.

          -  Cardiac conduction system abnormality.

          -  Predisposing medical condition that causes nausea or vomiting or routine use of an
             anti-emetic.
Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: SYN111; Placebo
Intervention description: 500 mg for 1 week followed by 1000 mg for 7 weeks; 0 mg tablets
Intervention MeSH terms: Rufinamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: GAD

Summary:

      A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to
      Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized
      Anxiety Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient 18-65

          -  Meet Diagnostic and Statistical Manual,(DSM) IV criteria for GAD

          -  Have moderate to severe anxiety

          -  Sign IRB (Institutional Review Board) approved consent and can comply with visits and
             procedures

          -  Women of childbearing potential must use acceptable method of contraception

        Exclusion Criteria:

          -  Have diagnosis of adjustment disorder or anxiety disorder Not otherwise specified
             (NOS)

          -  Have diagnosis of specific phobia

          -  Have diagnosis of antisocial personality disorder or other Axis II Disorder

          -  Have diagnosis of substance abuse disorder within 3 months of study entry

          -  Have diagnosis of major depressive disorder or panic disorder within 6 months of study
             entry

          -  Have diagnosis of PTSD, eating disorder substance dependence disorder within 12 months
             of study entry

          -  Have diagnosis anytime during lifetime of schizophrenia or other psychotic disorder,
             bipolar mood disorder, Obsessive-Compulsive Disorder (OCD), psychosurgery

          -  Require medication to treat GAD other than study medication

          -  Failed to show improvement with past treatment for GAD

          -  Excessively consume caffeine

          -  Are receiving treatment with prohibited medications

          -  Uncontrolled thyroid condition

          -  Positive urine drug screen

          -  Obese

          -  Clinically significant ECG finding

          -  Participating in other clinical trial

          -  Clinically significant out of range lab value

          -  Past exposure to rufinamide

          -  Pregnant or nursing females