bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
Condition: Group B Streptococcal Infections
MeSH terms: Streptococcal Infections
Intervention: Multivalent group B streptococcus vaccine; Placebo
Intervention description: Various formulations at three dose levels; Saline Control
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study
      evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged
      18 to 49 years of age with no history of group B streptococcal vaccination will be randomized
      to receive either a single intramuscular dose of multivalent group B streptococcus vaccine
      (various formulations at 3 dose levels) or a placebo (saline control).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adults (male and female) 18 to 49 years of age at enrollment who are
             determined by medical history, physical examination, and clinical judgment of the
             investigator to be eligible for inclusion in the study.

          2. Negative urine pregnancy test at Visit 1 for all female subjects who are of
             childbearing potential.

        Exclusion Criteria:

          1. Male subjects and female subjects of childbearing potential who are unwilling or
             unable to use a highly effective method of contraception as outlined in this protocol
             for at least 3 months after the last dose of investigational product.

          2. Acute or chronic medical or psychiatric condition or laboratory abnormality that may
             increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the subject inappropriate for entry into this
             study. Chronic medical conditions include human immunodeficiency virus, chronic
             hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C
             virus infection.

          3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
             to any vaccine.

          4. History of microbiologically proven invasive disease caused by group B streptococcus
             (Streptococcus agalactiae).

          5. Previous vaccination with any licensed or investigational group B streptococcus
             vaccine, or planned receipt during the subject's participation in the study (through
             the last blood draw).
Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting
Condition: Coronary Artery Bypass Grafting; Cardiopulmonary Bypass; Reperfusion Injury
MeSH terms: Reperfusion Injury
Intervention: Periostat; Placebo Oral Tablet
Intervention description: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.; In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Doxycycline; coronary artery bypass grafting

Summary:

      The purpose of this study is to determine whether doxycycline (Periostat) at a
      sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting
      (CABG) surgery with cardiopulmonary bypass (CPB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Aged 18 through 80 years, inclusive

          -  Scheduled for primary CABG surgery with CPB

        Exclusion Criteria:

          -  Females of childbearing potential

          -  Emergency CABG

          -  Previous sternotomy

          -  Planned simultaneous surgery (i.e. valve repair or carotid endarterectomy)

          -  Myocardial infarction within 48 hours

          -  Pre-operative atrial fibrillation

          -  Pre-operative ventricular pacing or left bundle branch block (LBBB)

          -  Known hypersensitivity to tetracycline class antibiotics

          -  Renal failure requiring dialysis
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
Condition: Acute Kidney Injury; Congenital Heart Disease
MeSH terms: Acute Kidney Injury; Heart Diseases; Heart Defects, Congenital; Wounds and Injuries
Intervention: Sodium Bicarbonate; Sodium Chloride
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
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Pediatric; Sodium bicarbonate; Acute kidney injury; Cardiac surgery

Summary:

      The proposed study will investigate the effect of sodium bicarbonate on the prevention of
      acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The
      investigators hypothesize that the occurrence of acute kidney injury will be less in children
      treated with sodium bicarbonate in the perioperative period when compared to placebo. The
      specific aims of this proposal are as follows:

      1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in
      pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate
      on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether
      treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid
      balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To
      determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects age ≤18 years

          2. Subjects scheduled for cardiac surgery with cardiopulmonary bypass

        Exclusion Criteria:

          1. Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the
             Schwartz formula

          2. Subjects with known cystic kidney disease or posterior ureteral valves (subjects with
             solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be
             excluded if renal function is preserved)

          3. Subjects with known metabolic disorder

          4. Premature infants born <30 weeks gestation and <30 days old due to risk of
             intraventricular hemorrhage

        Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane
        oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the
        study.
Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
Condition: Severe Hypertriglyceridemia (sHTG)
MeSH terms: Pancreatitis; Hypertriglyceridemia
Intervention: evinacumab; Placebo
Intervention description: Administered by Intravenous (IV); Administered by Intravenous (IV)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective is to determine the change in Triglyceride (TG) levels following 12
      weeks of repeated Intravenous (IV) doses of evinacumab.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Previous documentation in the patient's medical records of a fasting serum TG
             measurement ≥ 1000 mg/dL (11.3 mmol/L) on more than 1 occasion, and all fasting TG
             values ≥500 mg/dL (5.6 mmol/L) at screening

          2. History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years

          3. On stable lipid-modifying diet with or without medications (eg, statins, niacin,
             omega-3 fatty acids). Lipid-modifying diet and doses of medications should be stable
             for at least 4 weeks (6 weeks for fibrates, 8 weeks for PCSK9 inhibitors) prior to
             screening

          4. Body mass index (BMI) of 18-40 kg/m2

        Key Exclusion Criteria:

          1. A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of
             screening

          2. Lipid apheresis or plasma exchange treatment within the last 4 weeks or plans to
             undergo apheresis or plasma exchange during the time frame of the study

          3. History of class 3/4 heart failure at any time in the past, or hospitalization for
             heart failure, diagnosis of a myocardial infarction, stroke, Transient ischemic attack
             (TIA), unstable angina, Coronary artery bypass surgery (CABG), Percutaneous coronary
             intervention (PCI), carotid surgery/stenting within 3 months before the screening
             visit

          4. History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia,
             or contraindications to receiving heparin (eg, allergic reaction to heparin)

          5. Previous treatment with Glybera® in the past 5 years or treatment with lomitapide or
             mipomersen in the past 6 months

          6. Pregnant or breast feeding women

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Intervention: placebo administration; EMLA; propofol; fentanyl citrate
Intervention description: Given topically; Given topically; Given IV; Given IV
Intervention MeSH terms: Lidocaine; Fentanyl; Anesthetics, Local; Prilocaine; Lidocaine, Prilocaine Drug Combination; Propofol; Anesthetics
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Maximum age: 22 Years
Healthy volunteers: No

Summary:

      This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients
      undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the
      skin and reducing movement when applied prior to lumbar punctures and may reduce the amount
      of sedation necessary
    

Eligibility criteria:

        Inclusion Criteria:

        Pediatric oncology patients undergoing a lumbar puncture in the Pediatric Sedation Suite;
        patients may or may not be receiving intrathecal chemotherapy

        Exclusion Criteria:

        Patients undergoing additional procedures during the same anesthetic such as bone marrow
        aspirate or biopsy will be excluded because they will likely require higher doses of
        propofol than those undergoing LP alone Patients who are allergic to or not tolerant of
        EMLA cream, propofol, or fentanyl will be excluded Patients who are pregnant will be
        excluded Patients having their LPs done by students will be excluded
Study of Promethazine for Treatment of Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Intervention: Promethazine; Sugar pill
Intervention MeSH terms: Promethazine; Diphenhydramine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetic Gastroparesis; Promethazine

Summary:

      Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed
      gastric emptying will be recruited to participate in the study. Using double-blinded
      methodology, study participants will be randomly assigned to one of two treatment arms:
      promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days.
      The primary outcome will be the change in gastroparesis symptom severity, as measured by the
      Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants
      will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores,
      adverse events and treatment compliance will be assessed. It is hypothesized promethazine
      treatment will be superior to placebo in improving symptoms of gastroparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-65 years of age

          -  clinical diagnosis of diabetic gastroparesis.

          -  EGD without evidence of gastric outlet obstruction within the past five years

          -  gastric emptying scintigraphy test demonstrating >10% solid food retention at 4 hours
             within the past three years.

        Exclusion Criteria:

          -  the inability or unwillingness to provide informed consent

          -  currently pregnant or breast feeding

          -  prior placement of a gastric stimulator

          -  pyloric botulinum toxin injection within the past 12 months

          -  prior gastric surgery

          -  history of a connective tissue disorder

          -  use of narcotic medication within the past four weeks

          -  hemoglobin A1C >12 mg/dL within the past 3 months

          -  current or recent (within past 4 weeks) use of promethazine, metoclopramide or
             domperidone

          -  hypersensitivity or prior adverse reaction to promethazine

          -  concomitant use of phenothiazines (i.e. prochlorperazine, chlorpromazine) or other
             agents likely to increase extrapyramidal reactions

          -  concomitant use of tiotropium or ipratropium

          -  narrow angle glaucoma

          -  urinary retention

          -  Parkinson's disease

          -  significant psychiatric disease

          -  history of seizure.
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
Condition: Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Enoblituzumab; Retifanlimab; Tebotelimab
Intervention description: Anti-B7-H3 antibody; Anti-PD-1 antibody; PD-1 X LAG-3 bispecific DART molecule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab
      administered as first-line treatment to patients with recurrent or metastatic squamous cell
      carcinoma of the head and neck.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven, recurrent or metastatic squamous cell carcinoma of the head and
             neck (SCCHN) not curable by local therapy

          -  No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the
             exception of systemic therapy completed > 6 months prior if given as part of
             multimodal treatment for locally advanced disease)

          -  Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients
             may not have a primary tumor site of upper esophagus, salivary gland, or nasopharynx
             (any histology)

          -  Availability of formalin-fixed, paraffin embedded tumor specimen or contemporary
             biopsy for immunohistochemical evaluation of pharmacodynamic markers of interest

          -  Willing to consent for baseline and on-treatment biopsy.

          -  Performance status 0 or 1

          -  Life expectancy of 6 months or more

          -  Adequate end organ function

          -  At least one radiographically measurable lesion

          -  PD-L1 expression level that is either

               1. Positive (combined positive score [CPS] ≥ 1) for the retifanlimab cohort, or

               2. Negative (CPS < 1) for the tebotelimab cohort

          -  Results available from human papilloma virus p16 status for oropharyngeal cancer

          -  Acceptable laboratory results

        Exclusion Criteria:

          -  Disease suitable for local therapy administered with curative intent

          -  Progressive disease within 6 months of completion of curatively intended systemic
             treatment for locoregionally advanced SCCHN

          -  Radiation or other non-systemic therapy within 2 weeks prior to the first dose of
             study drug

          -  Prior therapy with an anti-B7-H3, anti-PD-1, anti-PD-L1, or anti-LAG-3 agent
Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
Condition: Esophageal Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: MatriStem PSM
Intervention description: All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esophageal Reinforcement; ACell MatriStem; 13-178

Summary:

      The purpose of this study is to see if implanting MatriStem will lower the risk of one of the
      more common complications after stomach or esophagus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient 18 years of age or older

          -  Pathologically confirmed Gastric, Gastroesophageal Junction (GEJ) or Esophageal,
             adenocarcinoma at either MSKCC or a participating site (biopsy may be performed at
             other institutions but slides must be confirmed at MSKCC or a participating site, as
             is routine care at our institution)

          -  Patient undergoing any resection requiring an anastomosis to the esophagus for
             curative intent. Including but not limited to esophagectomy or total gastrectomy.

          -  Subject is willing to provide written informed consent

          -  Subject is willing and able to comply with the follow-up regimen

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Intraoperative evidence of metastatic or locally-unresectable disease

          -  Patients with known sensitivity or allergy to porcine materials.

          -  Patients undergoing any resection requiring an anastomosis to the esophagus for
             palliative intent.
Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
Condition: Liver Transplant; Kidney Transplant
Intervention: PPM-based Computation Assisted Drug Dosing; Tacrolimus
Intervention description: Tacrolimus dosing based on application of PPM.; Dosing of calcineurin inhibitor, tacrolimus
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Phenotypic Precision Medicine (PPM); Tacrolimus; Calcineurin Inhibitors

Summary:

      Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver
      and/or kidney transplant recipients to show improvement in maintaining drug trough levels
      within the target range.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults undergoing liver and/or kidney transplantation

        Exclusion Criteria:

          -  transplant patients with contraindications to tacrolimus
Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS)
Condition: Muscle Weakness
MeSH terms: Muscle Weakness; Paresis
Intervention: 3-4 Diaminopyridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: fluctuating muscle weakness; hyporeflexia; autonomic Dysfunction

Summary:

      The main purpose for this study is to provide access to 3,4 DAP, a drug which has
      demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic
      Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The
      disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and
      autonomic dysfunction.
    

Eligibility criteria:

        Inclusion Criteria: -Male or female majority between 45 and 60 years of age

          -  diagnosed with Lambert-Eaton Myasthenic Syndrome.

          -  subjects must be taking full dose of pyridostigmine

        Exclusion Criteria: - does subject have a history of liver problems?

          -  does subject have a history of prolonged QTc syndrome (which is a condition where
             there is prolongation between the start of the Q wave and the end of the T wave in the
             heart's electrical cycle).