bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous L-Citrulline Influence on the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19
Condition: Acute Hypoxemic Respiratory Failure
MeSH terms: Respiratory Insufficiency
Intervention: L-Citrulline; Placebo
Intervention description: L-Citrulline (Turnobi) for Injection. Patients will receive an initial bolus of 20 mg/kg (maximum 1500 mg), followed by study infusion of 9 mg/kg per hour (maximum 700mg) for up to 10 days.; Patients randomized to placebo will receive equal volume bolus and study infusion of 5% dextrose water for a maximum of 10 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo controlled and Active Drug
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double Blind Clinical Trial
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous
      L-Citrulline (Turnobi) to Delay and Potentially Prevent the Need for Invasive Mechanical
      Ventilation for Acute Hypoxemic Respiratory Failure in Patients with COVID-19 (SARS-CoV2)
      Illness. To evaluate safety and efficacy of a bolus loading dose and continuous intravenous
      infusion of L-Citrulline compared to placebo in patients hospitalized with COVID-19 infection
      (SARS-CoV-2).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65 years.

          2. Clinical evidence of COVID-19 (SARS-CoV2) infection, defined as a positive COVID-19
             laboratory test plus evidence of an acute hypoxemic respiratory illness requiring
             oxygen.

          3. Admitted and transferred to floor without intubation.

        Exclusion Criteria:

          1. No consent/inability to obtain consent

          2. Patient, surrogate, or physician not committed to full support

          3. Malignant or other irreversible condition and estimated 28-day mortality ≥ 50%

          4. Moribund patient not expected to survive 48 hours (as defined by primary medical team)
             from start of study infusion

          5. End-stage Liver Disease as defined by Child-Pugh Score > 9

          6. Currently enrolled in, or participated in another study of an investigational compound
             within the last 30 days

          7. Pregnant female, or female who is breast feeding

          8. Allergy to L-citrulline or arginine or any citrulline- or arginine-containing product

          9. Patient not otherwise suitable for the study in the opinion of any of the
             investigators

         10. Requirement for intubation and invasive mechanical ventilation before study enrollment
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
Condition: Anemia; Non-dialysis Dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Vadadustat; 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: 51.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Anemia; kidney; non-dialysis dependent chronic kidney disease; CKD; NDD-CKD; renal; vadadustat; AKB-6548; hypoxia-inducible factor; hypoxia-inducible factor (HIF); HIF; prolyl-hydroxylase inhibitor (PHI); PHI; Japan; Japanese; Akebia (AKB)

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess
      the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally
      administered vadadustat in Japanese participants with anemia secondary to Non-dialysis
      Dependent Chronic Kidney Disease (NDD-CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female Japanese participants ≥20 years of age

          -  Diagnosis of chronic kidney disease (CKD) based on an estimated glomerular filtration
             rate ≤60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m^2)

          -  Hemoglobin (Hb) ≤10.5 grams per deciliter (g/dL)

          -  Not currently being treated with dialysis and not expected to start dialysis within 3
             months of screening

        Exclusion Criteria:

          -  Anemia due to a cause other than CKD or presence of active bleeding or recent blood
             loss

          -  Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic
             malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia

          -  Red blood cell transfusion within 4 weeks prior to or during screening

          -  Intravenous iron within 4 weeks prior to or during screening

          -  Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during
             screening
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: KNS-760704
Intervention description: 150 mg Q12H KNS-760704 given orally (300 mg total daily dose)
Intervention MeSH terms: Pramipexole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig; Lou Gehrig's; Lou Gehrig's disease; Motor Neuron Disease; Nervous System Diseases; KNS-760704; RTPB

Summary:

      This is an open-label, multi-center study designed to extend the evaluation of the safety,
      tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient has provided signed informed consent for this trial before the commencement of
             any study-related procedure

          2. Patient is actively participating in Knopp Protocol KNS-760704-CL201 and has completed
             the Part 2 Week 28 visit in that study or patient is actively receiving RTPB under
             Research IND #60,948

        Exclusion Criteria:

          1. Patient did not participate in Knopp Protocol KNS-760704-CL201 or patient did not
             receive RTPB under Research IND #60,948.

          2. Patient discontinued from KNS-760704-CL201 for any reason other than enrollment into
             this study (applies to patients enrolled in KNS-760704-CL201 only)

          3. Patient was not taking RTPB under Research IND #60,948 prior to April 30, 2009
             (applies to patients enrolled under Research IND #60,948 only)
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Placebo; Placebo; RG1507; RG1507; erlotinib [Tarceva]
Intervention description: iv 9mg/kg weekly; iv 16mg/kg every 3 weeks; iv 9mg/kg weekly; iv 16mg/kg every 3 weeks; 150mg oral daily
Intervention MeSH terms: Erlotinib Hydrochloride; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who
      failed at least one standard chemotherapy regimen will determine the proportion of patients
      with progression-free survival at 12 weeks following combination therapy with R1507 and
      Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to
      receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks.
      Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related
      endpoints including overall survival, objective response rate, time to response, time to
      progressive disease and duration of response will also be evaluated. The anticipated time on
      study treatment is 1-2 years, and the target sample size is <500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients >=18 years with histologically documented inoperable, locally
             advanced or metastatic (stage IIIB or IV) NSCLC;

          -  patients must have failed at least one but no more than two standard chemotherapy
             regimens;

          -  measurable disease according to the RECIST criteria;

          -  Eastern Cooperative Oncology Group (ECOG) performance status;

          -  life expectancy >12 weeks.

        Exclusion Criteria:

          -  patients with active central nervous system (CNS) lesions;

          -  prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R)
             inhibition or epidermal growth factor receptor (EGFR) targeting;

          -  administration with high doses of systemic corticosteroids;

          -  radiotherapy in the 4 weeks prior to study start;

          -  surgery or significant traumatic injury with in the last 2 weeks prior to study start.
Aspirin Resistance and Percutaneous Coronary Intervention (PCI)
Condition: Stable Angina
MeSH terms: Angina, Stable
Intervention: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel; Antiplatelet Therapy (ASA, Clopidogrel)
Intervention description: IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally; Standard antiplatelet PCI treatment
Intervention MeSH terms: polysaccharide-K; Tirofiban; Ticlopidine; Abciximab; Clopidogrel; Prasugrel Hydrochloride; Cangrelor; Eptifibatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major Adverse Cardiovascular Event; MACE; Death; MI; CK MB greater 3x Normal; Urgent Revascularization; Stent Thrombosis; Bleeding

Summary:

      The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce
      ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention
      (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age older than 18 years

          -  Scheduled for elective or ad-hos PCI

          -  Aspirin use daily for greater or equal to one week

          -  Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA

        Exclusion Criteria:

          -  Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or
             Tnl greater or equal to 0.4ng/dl

          -  administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the
             previous 30 days

          -  Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or
             increased bleeding risk or history of bleeding in the last eight weeks

          -  Previous stroke or transient ischemic attack or any intracranial pathology in the last
             six months, major surgery or trauma within the previous six weeks

          -  Platelet count less than hundred thousand per cubic millimeter or hematocrit <33% or
             hemoglobin <11 g per deciliter

          -  Subjects who received full dose low molecular weight heparin within six hours prior to
             randomization

          -  Allergy or intolerance to any of the study drugs or the presence of any serious
             comorbidity with life expectancy of ≤1year

          -  Scheduled for saphenous vein graft intervention, chronic total occlusions or with
             impaired renal function (eGFR<60ml/min) or patients who were taking anticoagulants or
             antiplatelet agents other than aspirin and clopidogrel or nonsteroidal
             anti-inflammatory drugs within two weeks before the PCI procedure
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Condition: Osteogenesis Imperfecta, Type I; Osteogenesis Imperfecta Type III; Osteogenesis Imperfecta Type IV
MeSH terms: Osteogenesis Imperfecta
Intervention: setrusumab; Calcium; Vitamin D; zoledronic acid (optional)
Intervention description: Intravenous infusion; tablets; capsules; Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, Dose-finding Study, incorporating an open-label substudy
Masking: Double (Participant, Investigator)
Masking description: Sponsor will be masked until the primary analysis of the study except for open-label substudy treatment arm. The study site pharmacist will be unmasked to treatment allocation throughout. Study treatment will be monitored by a separate unmasked monitoring team.
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteogenesis Imperfecta; Brittle Bone Disease

Summary:

      The purpose of this study is to select a suitable dose of BPS804 by measuring the
      strength/quality of bone using a special type of CT scanner. Participants will be treated for
      12 months and followed up for a further 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinical diagnosis of OI Type I, III or IV with a confirmed defect in
             the COL1A1/COL1A2 genes, as confirmed by genetic testing

          -  One or more fractures in the past 5 years

          -  Capable of giving signed consent

        Exclusion Criteria:

          -  History of skeletal malignancies or other bone diseases (other than OI)

          -  History of neural foraminal stenosis (except if due to scoliosis)

          -  History of myocardial infarction, angina pectoris, ischaemic stroke or transient
             ischaemic attack

          -  History of endocrine or thyroid/parathyroid conditions that could affect bone
             metabolism

          -  Treatment with bisphosphonates within 3 months of randomisation

          -  Treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications
             within 6 months of randomisation
Safety and Efficacy of AIN457 in Noninfectious Uveitis
Condition: Non-infectious Uveitis
MeSH terms: Uveitis
Intervention: AIN457; AIN 457; AIN457
Intervention description: AIN457 subcutaneous dose; AIN457 low dose (i.v); AIN457 high dose (i.v)
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Uveitis; eye; IL-17; IL-17A; IL17; AIN457; Vogt-Koyanagi-Harada; Behcet's; Behcet; Sympathetic ophthalmia; Multifocal choroiditis; Birdshot; HLA-B27; Birdshot retinochoroiditis; Retinal vasculitis; Sarcoidosis; Intermediate uveitis; Panuveitis; Posterior uveitis

Summary:

      This study was performed to evaluate the efficacy and safety of AIN457 for patients with
      active uveitis that requires systemic immunosuppression.
    

Eligibility criteria:

        Inclusion criteria:

          -  Active uveitis (i.e., uveitis that is not in remission).

          -  Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe
             that systemic immunosuppression is indicated.

        Exclusion criteria:

          -  Active infection.

          -  Weight must not be greater that 120kg.

        Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Intervention: human retinal progenitor cells; Mock injection
Intervention description: live suspension of 3.0 or 6.0 x 10e6 human retinal progenitor cells (hRPC) suspended in clinical grade medium injected intravitreally under local anesthesia; pressing the hub of a syringe with no needle against the eye to mimic intravitreal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Subjects, their family members and clinical staff performing key efficacy assessments will be masked to the randomization assignment of subjects. Due to the nature of some safety assessments and the sham treatment, not all personnel can be masked.
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the changes in visual function at 12 months following a single injection
      of human retinal progenitor cells compared to sham treated controls in a cohort of adult
      subjects with RP.
    

Eligibility criteria:

        Inclusion Criteria:

        Clinical diagnosis of RP confirmed by ERG and willing to consent to mutation typing, if not
        already done Best corrected visual acuity (BCVA) 20/80 or worse and no worse than 20/800
        Adequate organ function and negative infectious disease screen Female of childbearing
        potential must have negative pregnancy test and be willing to use medically accepted
        methods of contraception throughout the study

        Exclusion Criteria:

        Eye disease other than RP that impairs visual function Pseudo-RP, cancer-associated
        retinopathies History of malignancy or other end-stage organ disease, or any chronic
        disease requiring continuous treatment with system steroids, anticoagulants or
        immunosuppressive agents Known allergy to penicillin or streptomycin Treatment with
        corticosteroids or any investigational or neuroprotectant therapy within 90 days of
        enrollment Cataract surgery within 3 months prior to enrollment
Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Firsocostat; Placebo
Intervention description: Capsules orally once daily.; Placebo matched to firsocostat orally once daily.
Intervention MeSH terms: Firsocostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of firsocostat
      in adults with nonalcoholic steatohepatitis (NASH).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Meets all of the following conditions:

               -  A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)

               -  Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF)
                  with ≥ 8% steatosis

               -  Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kPa

                    -  OR

               -  A historical liver biopsy consistent with NASH and non-cirrhotic fibrosis

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine Clearance (CLcr ) as calculated by the Cockcroft-Gault equation ≥ 60 ml/min

        Key Exclusion Criteria:

          -  Pregnant or lactating females

          -  Alanine aminotransferase (ALT) > 5 x upper limit of the normal range (ULN)

          -  Other causes of liver disease including autoimmune, viral, and alcoholic liver disease

          -  Cirrhosis of the liver

               -  Prior history of decompensated liver disease, including ascites, hepatic
                  encephalopathy or variceal bleeding

          -  Body mass index (BMI) < 18 kg/m^2

          -  International normalized ratio (INR) > 1.2 unless on anticoagulant therapy

          -  Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Cannabidiol Treatment in Patients With Early Psychosis
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Cannabidiol; Placebo
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations
      in cannabis extracts. CBD has been shown to produce central effects including hypnotic,
      anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that
      treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the
      Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a
      reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1)
      Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning
      Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design,
      subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1)
      followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2)
      under double-blind conditions. The 2 study periods will be separated by a washout of at least
      2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or
      placebo) for a period of 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Primary psychotic disorder

          -  Ages 18-65 (inclusive)

        Exclusion Criteria:

          -  Current significant medical condition or other comorbidities

          -  Current substance depdendence

          -  Women who are pregnant or breastfeeding