bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Intervention: BMS-986259; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart failure

Summary:

      The purpose of the study is to assess the safety of BMS-986259 in stable participants
      hospitalized for acute decompensated heart failure.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants currently hospitalized for acute decompensated heart failure (ADHF)

          -  Participants must be hemodynamically stable, as assessed by the investigator

          -  Men must agree to follow specific methods of contraception, if applicable, while
             participating in the trial

          -  Women participants must have documented proof that they are not of childbearing
             potential

        Exclusion Criteria:

          -  Acute cardiovascular condition other than heart failure (HF) decompensation

          -  Cardiogenic shock at presentation to emergency room (ER) or at any time before
             randomization

          -  Recipient of ventricular assist devices or use of any cardiac extracorporeal devices,
             within 12 weeks of study randomization

          -  Participants with contraindications to vasodilator therapy such as restrictive or
             obstructive cardiomyopathy, severe mitral or aortic stenosis

        Other protocol-defined inclusion/exclusion criteria apply
Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Condition: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: Metformin; Placebo Comparator
Intervention description: Standard of Care Observation
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bronchoscopy; Metformin

Summary:

      The purpose of this study is to learn whether it is better to receive the drug Metformin with
      standard of care for lung cancer or just standard of care.
    

Eligibility criteria:

        Inclusion Criteria

          -  Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (must be
             proven SCC at the time of surgery)

          -  Medically fit for surgical resection (based on surgeon assessment)

          -  Current or prior smoker

          -  Age > 18 years old

          -  Both Male and Female

          -  Willing and able to consent to study, undergo study interventions, and take study drug

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

          -  Subject must start Metformin within 90 days of surgery.

        Exclusion Criteria

          -  Currently taking metformin or other diabetic drugs

          -  Current or previous congestive heart failure, renal failure or liver failure

          -  Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater

          -  Existing untreated or prior cancer <5 years from diagnosis

          -  Received neo-adjuvant platinum-based chemotherapy or targeted therapy

          -  Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical
             resection
Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
Condition: Kidney Failure, Acute; Renal Replacement Therapy
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Intervention: Sodium bicarbonate; Normal saline; Bicarbonate; Placebo
Intervention description: IV bicarbonate given with amount based on patient weight; IV Normal saline with volume given determined by patient weight; IV bicarbonate, dosed by weight; Normal saline, with volume given based on patient weight
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Renal Failure; Cardiac Surgery; Sodium Bicarbonate; Length of Stay; Mortality

Summary:

      The purpose of this study is to determine if the incidence of acute renal failure (ARF) in
      high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating
      patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will
      be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal
      saline. The volume of fluid given in each arm of the study is equal. All other interventions
      in those patients will be according to standard cardiothoracic anesthesia protocol at our
      institution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Calculated GFR ≤ 60 ml/min/m2 (MDRD)

        OR

          -  Any combination of two (2) of the following:

          -  Age ≥ 70

          -  Complex surgery (any of the following):

               -  CABG/Valve

               -  Redo operation

               -  Deep hypothermic arrest

          -  ≥ 2 valves

          -  History of PVD surgery

          -  EF < 35%

          -  Presence of diabetes mellitus

          -  Prior kidney transplant

        Exclusion Criteria:

          -  Age < 18

          -  Pre-existing ESRD (dialysis patients)

          -  Pre-op GFR ≤ 15 ml/min/m2

          -  Pre-op bicarbonate level ≥ 30 mEq/L

          -  Emergency surgery (unable to effectively consent)

          -  Pregnancy

          -  Heart transplant (OHT)

          -  Aortic surgery (proximal or distal)
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: K-161; Placebo (Vehicle)
Intervention description: K-161 alternate dosage; Placebo solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 238.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing
      regimen of K-161 in adult subjects with moderate to severe dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age at the time of informed consent visit.

          -  Have a reported history of dry eye disease in both eyes and a history of eye drop use
             for dry eye symptoms.

          -  Meet all inclusion criteria outlined in the clinical study protocol.

        Exclusion Criteria:

          -  Have any clinically significant ocular condition.

          -  Have a history of corneal refractive surgery and/or any other ocular surgical
             procedure within 12 months.

          -  Must not meet any other exclusion criteria outlined in the clinical study protocol.
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Condition: Pseudomonas Aeruginosa
MeSH terms: Pneumonia; Pseudomonas Infections; Healthcare-Associated Pneumonia
Intervention: MEDI3902; Placebo
Intervention description: Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.; Participants will receive a single IV dose of placebo matched to MEDI3902.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Pseudomonas aeruginosa, Pneumonia

Summary:

      Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically
      ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas
      aeruginosa.
    

Eligibility criteria:

        Inclusion Criteria:

        Colonized with P aeruginosa, expected to require prolonged intubation and mechanical
        ventilation, without any evidence of active pneumonia.

        Exclusion Criteria:

        P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current
        lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics,
        moribund participants.
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
Condition: Vulvovaginitis; Yeast Infection; Yeast Infection Vaginal; Candidiasis, Vulvovaginal
MeSH terms: Infections; Communicable Diseases; Candidiasis; Candidiasis, Vulvovaginal; Mycoses; Vulvovaginitis
Intervention: Oral Encochleated Amphotericin B (CAMB); Fluconazole
Intervention description: lipid-crystal nano-particle formulation amphotericin B
Intervention MeSH terms: Fluconazole; Amphotericin B; Liposomal amphotericin B
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy
      of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the
      treatment of moderate to severe VVC.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Informed consent

        Clinical diagnosis of moderate to severe VVC

        Negative pregnancy test

        Vaginal pH less than 4.5

        Key Exclusion Criteria:

        Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole
        antifungal drugs

        Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections
        requiring antifungal therapy

        Has received treatment for VVC within the past 30 days or has experienced 4 or more
        episodes of VVC in the past 12 months

        Has another cause of vulvovaginitis

        Has other urogenital infection(s) that would potentially alter their response to disease

        Has another vaginal or vulvar condition that would confound the interpretation of clinical
        response

        Has significant laboratory abnormality at screening

        Has any known azole-resistant Candida infection;

        Has any other condition the Investigator believes would interfere with the subject's
        ability to provide informed consent, comply with study instructions, or puts the subject at
        undue risk
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ZPL-3893787; Placebo
Intervention description: ZPL-3893787; Matched 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: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This was a randomized, double blind, placebo controlled, parallel group study in
      approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12
      and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30
      mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).
    

Eligibility criteria:

        Inclusion Criteria:

        Males and females aged 18-65 years inclusive with physician documented history or diagnosis
        of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be
        diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004)

        Eczema Area and Severity Index (EASI) of ≥12 and <48.

        An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.

        A mean pruritus score of ≥ 5 on a 0-10 scale over the 7 day Run In (Days -7 to -1)

        Atopic dermatitis affecting ≥10% BSA

        Exclusion Criteria:

        AD of such severity (EASI >48) that the subject could not comply with the demands of the
        study and/or the subject is not a suitable candidate for a placebo-controlled study

        Have concurrent skin disease (e.g. acne) of such severity in the study area that it could
        interfere with the study evaluation or presence of skin comorbidities that may interfere
        with study assessments.

        Have an active skin infection or any other clinically apparent infections.

        Hypersensitivity to mometasone or to any other ingredients contained by the topical
        corticosteroid product used as rescue medication in the study.

        Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants,
        cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the
        Run In.

        Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular,
        rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose
        (over the preceding 3 months) of inhaled or intranasal CS may participate.

        Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids
        within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic
        rhinitis are acceptable.
Memantine in Body Focused Repetitive Behaviors
Condition: Trichotillomania (Hair-Pulling Disorder); Dermatillomania
MeSH terms: Trichotillomania
Intervention: Placebo; Memantine
Intervention description: Pill that contains no medicine; Cognition-enhancing medication
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is 8 weeks long and involves subjects taking memantine or placebo. If they are
      randomly assigned to the memantine arm and are eligible to participate in the study, they
      will begin by taking 10mg once daily of memantine for two weeks, then 20mg for the remaining
      six weeks. Efficacy and safety measures will be performed at each visit. Participants will be
      randomized to receive either memantine or placebo on a 1:1 basis. This blinding will be
      maintained by the IDS pharmacy at the University of Chicago.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age ≥18 years;

          2. current DSM-5 trichotillomania or skin picking disorder; and

          3. Ability to understand and sign the consent form.

        Exclusion Criteria:

          1. Unstable medical illness based on history or clinically significant abnormalities on
             baseline physical examination

          2. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity
             rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

          4. Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or
             alcohol use disorder

          5. Illegal substance use based on urine toxicology screening

          6. Stable dose of medications for at least the past 3 months

          7. Previous treatment with memantine

          8. Cognitive impairment that interferes with the capacity to understand and
             self-administer medication or provide written informed consent
Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
Condition: Alpha-1 Antitrypsin Deficiency; Emphysema; Chronic Obstructive Pulmonary Disease
MeSH terms: Alpha 1-Antitrypsin Deficiency; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Intervention: Aspirin; Placebo; Withdrawal from alpha1 antitrypsin replacement therapy
Intervention description: 81mg aspirin taken once per day in the morning; placebo taken once per day in the morning; After the completion of the randomization to aspirin and placebo, participants who are on alpha1 replacement therapy are asked to withhold their usual alpha1 antitrypsin replacement therapy for 5 weeks. This is not randomized.
Intervention MeSH terms: Aspirin; Alpha 1-Antitrypsin; Protein C Inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: alpha-1 antitrypsin deficiency; Emphysema; chronic obstructive pulmonary disease

Summary:

      The aim of this study is to test whether aspirin improves endothelial function in alpha-1
      antitrypsin deficiency-associated lung disease, measured by pulmonary microvascular blood
      flow on magnetic resonance imaging (MRI) and with apoptotic endothelial microparticles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Alpha-1 antitrypsin deficiency (PiZZ genotype)

          -  40 years of age or older

          -  Evidence of emphysema on CT scan as read by a Radiologist

        Exclusion Criteria:

          -  Platelet count < 150,000/dL, history of intracranial hemorrhage or severe GI bleed,
             use of systemic anticoagulant, physician prescribed use of antiplatelet drug
             (including aspirin and P2Y12 receptor inhibitors), or known severe liver disease

          -  Immunosuppression by use of medications (including oral prednisone), or those with
             immunomodulatory disease (organ transplantation, autoimmune conditions or
             actively-treated malignancy)

          -  Known atrial fibrillation or left ventricular (LV) systolic heart failure

          -  Contraindication to MRI, including pregnancy, weight > 300 lbs (due to weight limits
             of the machine), those with pacemakers, aneurysm clips, cochlear implants or other
             implanted electronic devices, or severe claustrophobia;

          -  Chronic renal insufficiency (estimated GFR < 45 L/min/1.73 m2 or self report) due to
             slightly increased risk of nephrogenic systemic fibrosis from gadolinium
             administration and aspirin-related renal insufficiency

          -  Exacerbation of respiratory symptoms within the previous 6 weeks, such as that
             requiring hospitalization, oral prednisone or antibiotics to control symptoms.
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
Condition: Nasal Polyps; Asthma, Aspirin-Induced; Aspirin-exacerbated Respiratory Disease; Aspirin-Sensitive Asthma With Nasal Polyps
MeSH terms: Asthma; Respiratory Tract Diseases; Respiration Disorders; Nasal Polyps; Asthma, Aspirin-Induced; Polyps
Intervention: Ifetroban; Placebo
Intervention description: 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD; 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
Intervention MeSH terms: Ifetroban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The overall aim of the study is to determine the efficacy of oral ifetroban, a novel
      antagonist of T prostanoid (TP) receptors, as a treatment for patients with
      aspirin-exacerbated respiratory disease (AERD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of AERD, defined as meeting the diagnostic triad with:

               -  History of physician-diagnosed asthma and

               -  History of physician-diagnosed nasal polyposis and

               -  History of pathognomonic reactions aspirin or other nonselective cyclooxygenase
                  (COX) inhibitors.

          2. Stable asthma (post-bronchodilator forced expiratory volume at one second (FEV1) of
             ≥70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no
             hospitalizations or ER visits for asthma for at least the prior 6 months)

          3. Age between 18 and 70 years

          4. No current smoking (not more than one instance of smoking in the last 3 months)

          5. Non-pregnant

        Exclusion Criteria:

          1. Hypersensitivity to montelukast

          2. Current use of zileuton

          3. History of bleeding diathesis or use of anticoagulant or antiplatelet drugs

          4. Current use of any NSAIDs aside from the aspirin provided during the study

          5. Current use of beta blockers

          6. Use of any biologics within the last 4 months prior to initiating the study