bioihbjkbjnl/mcl2 huggingface dataset:
Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation
Condition: Type 2 Diabetes; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Diabetes Mellitus
Intervention: Placebo; Sitagliptin
Intervention description: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.; Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
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: 19 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes; Kidney Transplant; Sitagliptin

Summary:

      This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin
      resistance) will delay or prevent kidney transplant patients from getting diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of a kidney transplant at UNMC, including cadaveric or living donor
             transplant.

        Exclusion Criteria:

          -  A previous diagnosis of diabetes or previous criteria for diabetes, according to the
             American Diabetes Association, not previously recognized as diabetes.

          -  Simultaneous transplant of another solid organ, such liver or heart.

          -  Patient unable to take oral medication.

          -  Patient unable to give informed consent.

          -  Hypersensitivity to sitagliptin.
Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
Condition: SARS-CoV Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Severe Acute Respiratory Syndrome
Intervention: Losartan
Intervention description: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications.
Intervention MeSH terms: Losartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus; Angiotensin receptor blocker; SARS-CoV-2; COVID-19

Summary:

      The purpose of this research is to identify whether or not Angiotensin Receptor Blockers
      (ARB) can halt the progression to respiratory failure requiring transfer into the intensive
      care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate
      hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the
      researchers hypothesize that the addition of an ARB is beneficial in abating acute lung
      injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed COVID-19 positive test result

          -  Mild to moderate respiratory symptoms of COVID-19.

          -  Systolic blood pressure ≥ 105 mmHg.

          -  Screen within 3 days of a positive COVID-19 test.

          -  Age ≥18 years old.

          -  Access to a phone in the hospital room or an electronic device that is capable of
             receiving phone or video calls.

          -  Able to read/write/speak English or Spanish fluently.

          -  Subjects must have the capacity to provide consent or an appropriate LAR to provide
             informed consent.

          -  Negative pregnancy test for women of childbearing potential and subject is randomized
             to the study arm.

        Exclusion Criteria:

          -  Severe allergy to any ARB or ACE-inhibitor, including angioedema

          -  In the intensive care unit at screening.

          -  Home meds include any kind of ACE inhibitor or ARB

          -  Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time
             during treatment in the study treatment arm)

          -  Hyperkalemia >5.0 mmol/L at baseline or any time during treatment in the study
             treatment arm

          -  Creatinine Clearance < 30 ml/min at baseline or any time during treatment in the study
             treatment arm
Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery
Condition: Pain
Intervention: Bupivacaine; Placebo
Intervention description: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients > 50 kgs; Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients > 50 kgs
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bupivacaine; Cardiac Surgery; Pediatrics; Nerve Block

Summary:

      All pediatric patients who undergo cardiac surgery require analgesic medications for
      postoperative pain control and many require sedation to facilitate comfort with cares.
      Parasternal infiltration of local anesthetic for nerve blocks is a simple option to
      postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve
      block administered in pediatric patients undergoing cardiac surgery will reduce the
      requirement of Opioids and other pain medications as well as decrease postoperative pain
      scores. This is a prospective, double-blind, randomized controlled trial. Subjects are
      randomized to receive either 0.25% Bupivacaine or normal saline following their
      cardiothoracic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 0-17 years old at time of surgery

          -  Society of Thoracic Surgeons- European Association for Cardio-Thoracic Surgery (STAT)
             mortality categories 1-3

          -  Surgical intervention requiring median sternotomy

          -  Expected extubation within 24 hours of surgery

        Exclusion Criteria:

          -  Known allergic reaction or hypersensitivity to Bupivacaine or to any local anesthetic
             agent of the amide type

          -  Delayed sternum closure
Acute Cough Study In Children
Condition: Common Cold; Infections, Upper Respiratory Tract
MeSH terms: Common Cold; Respiratory Tract Infections
Intervention: Dextromethorphan; Placebo
Intervention description: A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg); A single 10 mL dose of matching placebo syrup
Intervention MeSH terms: Dextromethorphan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: randomized; parallel; double-blind; placebo-controlled; cough; efficacy; safety; dextromethorphan

Summary:

      15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the
      number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough
        due to a cold or acute URTI characterized by:

          -  Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1;

          -  At least 5 coughs during the second 30-minute period of the 60-minute baseline period.

        General good health, aside from a common cold, and has no contraindications to the study or
        rescue medication

        Exclusion Criteria:

          -  Acute, subchronic, or chronic cough due to any other condition other than a common
             cold

        History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological,
        hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Data Collection
Intervention description: No study treatment was administered as part of this study
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 662.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Cladribine; High Disease Activity

Summary:

      The objective of this study was to collect data both retrospectively and prospectively in
      order to evaluate the long-term outcomes, durability of effect, and real-world treatment
      patterns following treatment with Cladribine Tablets or placebo in participants with multiple
      sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and
      CLARITY/CLARITY-EXT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with relapsing remitting multiple sclerosis (RRMS) randomised in
             CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (>=)
             1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo

          -  Participants with their first clinical demyelinating event randomised in ORACLE MS
             clinical trial who have received >= 1 course of IMP Cladribine Tablets or placebo

          -  Participants who has sign informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form and this protocol

        Exclusion Criteria:

          -  Participants who has any uncontrolled disease state other than MS, that in the
             Investigator's opinion, constitutes an inappropriate risk or a contraindication for
             participation in the study or that could interfere with the study objectives, conduct,
             or evaluation

          -  For study participants at selected sites where MRI assessment will be conducted
             following exclusion criteria will apply to MRI assessments only:

          -  Female study participants who are pregnant

          -  Participants who are taking Cladribine Tablets as part of another study at the time of
             the start of this study
Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)
Condition: Asthma; Allergic Rhinitis; Atopic Dermatitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Dermatitis
Intervention: Omalizumab; Placebo
Intervention description: Xolair (Omalizumab) will be given by subcutaneous injection according to Ige level and weight calculation.; Placebo, given by subcutaneous injection.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to look at measures that will help scientists understand the way
      Omalizumab, an FDA-approved anti-allergy medication, works.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild or moderate persistent asthma

          -  Allergic rhinitis

          -  Atopic dermatitis

        Exclusion Criteria:

          -  Other lung diseases

          -  Blood clotting disorder

          -  Pregnant or lactating women
Fluid Balance Study in Sick Neonates
Condition: Very Low Birth Weight Infant
MeSH terms: Birth Weight
Intervention: physician no insight in the fluid balance chart
Intervention description: physician had no insight in the fluid balance chart during the first 3 days of admission of the patient when the balance is recorded
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 170.0
Sex: All
Maximum age: 28 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: recording fluid balance; reliability; utility; sick neonate; fluid balance; inpatient; sick

Summary:

      The purpose of this study is to determine if routinely recording fluid balance in sick
      neonates admitted to the pediatric ward is reliable and useful. The investigators' hypothesis
      is that it is not useful and reliable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sick neonates admitted to the neonatal ward

        Exclusion Criteria:

          -  Admitted elsewhere before admission to the neonatal ward

          -  Indication for recording fluid balance

          -  Impossibility to measure the weight every day

          -  No consent parents
Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Telaprevir; Ribavirin; Pegylated Interferon Alfa-2a
Intervention description: Tablet; Tablet; Subcutaneous Injection
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: VX-950, Incivek

Summary:

      The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination
      with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in
      treatment-experienced Black/African American and non-Black/African American participants with
      Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a
      prior course of interferon-based therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants self-identify as Black/African American (Group A) or did not
             self-identify as Black/African American (Group B)

          -  Participants have Genotype 1 CHC and laboratory evidence of hepatitis C virus (HCV)
             infection for at least 6 months

          -  Participants did not achieve sustained viral response 24 weeks after last dose of
             study drug (SVR24), after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of
             standard duration

        Exclusion Criteria:

          -  Participants have received previous treatment with telaprevir or any other protease
             inhibitor(s) for CHC

          -  Participants who have evidence of hepatic decompensation

          -  Participants have diagnosed or suspected hepatocellular carcinoma

          -  Participants have any other cause of significant liver disease in addition to HCV

          -  Participants are currently abusing illicit drugs or alcohol, or have history of
             illicit substance or alcohol abuse within 2 years before the screening visit

          -  Participants who participated in any investigational drug study within 90 days before
             dosing
A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: etanercept; etanercept; placebo
Intervention description: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.; etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo.; placebo subcutaneous (SC) injections once weekly for 8 weeks.
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Etanercept; Axial Spondyloarthritis; NSAIDs sparing effect

Summary:

      This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of
      etanercept with that of placebo in adult subjects with axial Spondyloarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 18 years and over at the time of consent to the study.

          -  Diagnosis of SpA, as defined by the ASAS criteria for axial SpA

          -  Axial involvement refractory to previous or current intake of NSAIDs, defined as at
             least 2 NSAIDs at maximum tolerated dose determined from past medical history taken
             for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.

          -  Active axial involvement defined by mini BASDAI

        Exclusion Criteria:

          -  Subjects who are investigational site staff members or subjects who are Pfizer
             employees directly involved in the conduct of the trial.

          -  Subjects who have received any previous treatment with etanercept or other TNFα
             inhibitors or biologic agents.

          -  Subjects with a known or expected allergy, contraindication, or hypersensitivity to
             etanercept or its excipients.
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; DMARDs (disease-modifying antirheumatic drugs)
Intervention description: 8 mg/kg iv every 4 weeks for 24 weeks; stable doses at investigator's prescription
Intervention MeSH terms: Antirheumatic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label single arm study will evaluate the efficacy and safety of tocilizumab added
      to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to
      severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will
      receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition
      to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is
      24 weeks, and the target sample size is 200.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/= 18 years of age

          -  moderate to severe active rheumatoid arthritis of >/=6 months duration

          -  inadequate clinical response to current non-biologic DMARDs

          -  current DMARDs must be at stable dose for 8 weeks prior to study entry

          -  oral corticosteroids (</=10mg/day prednisone or equivalent) and NSAIDs must be at
             stable dose for >/=4 weeks prior to screening

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA

          -  history of or current inflammatory joint disease other than RA

          -  previous treatment with any biologic DMARD

          -  functional class IV as defined by the ACR classification

          -  intra-articular or parenteral corticosteroids within 6 weeks prior to screening
The Effect on Depressive Symptoms in ECF Residents With COPD
Condition: Chronic Obstructive Pulmonary Disease; Depression
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Depression; Depressive Disorder
Intervention: Advair diskus
Intervention description: Advair diskus 50/250 1 inhalation bid for 16 weeks
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 94 Years
Healthy volunteers: No
Keywords: COPD; Depression; Nursing Home

Summary:

      The purpose of this study is to assess the effect of treatment with Advair Diskus on
      depression using the Cornell depression scale in COPD patients in the nursing home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and women nursing home residents up to age 95

          -  Stated diagnosis of COPD or FEV1/FVC <0.7 or being treated with an anticholinergic

          -  Presence of depressive symptoms as measured on MDS 3.0 Section D SUM

          -  Free from conditions likely to be fatal within six months

          -  Able to read or understand English

          -  Able and willing to provide informed consent or has a guardian/LAR who can provide
             informed consent

        Exclusion Criteria:

          -  Currently pregnant

          -  Unable to read and understand English

          -  Free from conditions likely to be fatal within six months

          -  Enrolled in hospice

          -  New treatment with antidepressant within the last 90 days.

          -  Current or recent use (within the last 90 days) of Advair Diskus

          -  Unwilling or unable to provide informed consent

          -  Expected to be discharged within 3 months