bioihbjkbjnl/mcl2 huggingface dataset:
Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: rituximab
Intervention description: anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)
Intervention MeSH terms: Rituximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 120.0
Sex: All
Minimum age: 8 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: type 1 diabetes; age; course of disease; autoantibodies; C-peptide levels

Summary:

      Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease
      immune-mediated destruction of beta cells and result in preserved beta-cell function in
      patients with type 1 diabetes of recent onset.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of type 1 diabetes

          -  The age of subjects between 8 and 70 years old

          -  Course of disease within 12 months

          -  Presence of at least one type of detectable islet autoantibody [zinc transporter 8
             antibody(ZnT8A),glutamic acid decarboxylase antibody(GADA),protein tyrosine
             phosphatase-2 antibody(IA-2A),insulin autoantibody(IAA)]

          -  Fasting C-peptide levels of at least 0.2 pmol/mL

        Exclusion Criteria:

          -  Confirmed diagnosis of type 2 diabetes

          -  Severe chronic or acute complications of diabetes

          -  Severe infection or damage to the immune response

          -  Presence of chronic latent infection in vivo

          -  Viral hepatitis B patients whose hepatitis B virus(HBV)DNA > log10^5

          -  Liver and kidney dysfunction, alanine aminotransferase(ALT), aspartate
             aminotransferase(AST), and creatinine more than 2 times the upper limit of normal

          -  Hypotension, systolic blood pressure(SBP) ≤ 90mmHg, diastolic blood pressure(DBP) ≤
             60mmHg

          -  Patients with rheumatoid arthritis

          -  Allergic to any component of this drug

          -  Pregnancy, breast-feeding women

          -  Use of other immunosuppressive agents 3 months before selected
Xanthine Oxidase Inhibition in Renal Transplant Recipients
Condition: Complications of Renal Transplant
Intervention: allopurinol or placebo; Placebo
Intervention description: Daily active drug (allopurinol administered orally) administered orally for 3 years.; Sugar pill administered orally for 3 years.
Intervention MeSH terms: Allopurinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: cardiovascular disease; kidney transplantation

Summary:

      Cardiovascular disease is the leading cause of mortality in kidney transplantation. The
      enzyme xanthine oxidase may play an important role in the cardiovascular disease of kidney
      transplant recipients. Inhibiting this enzyme with allopurinol may improve vascular health
      and protects against cardiovascular complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 years or older

          -  both genders

          -  recipients of living donor or deceased-donor kidney transplant with stable renal
             function

        Exclusion Criteria:

          -  history of gout

          -  allergy to allopurinol

          -  use of azathioprine
Reduction in Pain Intensity Following IV or Oral Pain-relieving Products
Condition: Pain
MeSH terms: Pain
Intervention: IV Acetaminophen (Treatment A); Oral Acetaminophen (Treatment B); Placebo (Treatment C); Morphine (Treatment D)
Intervention description: Acetaminophen administered by intravenous (IV) infusion; Acetaminophen administered by oral tablets; Placebo administered by IV infusion or oral tablets; Morphine administered by IV infusion
Intervention MeSH terms: Acetaminophen; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: comparison

Summary:

      The purpose of this study is to evaluate two experimental pain models to see if they would be
      useful for comparing different products for reduction in pain intensity.

      The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental
      pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen,
      oral acetaminophen, placebo, and IV morphine.
    

Eligibility criteria:

        Inclusion Criteria

          1. Must have a health status of "healthy" assessed by the investigator and defined as no
             clinically significant deviation from normal medical history, physical examination,
             vital signs, and clinical laboratory determinations.

          2. Must be male, Caucasian, between 18 and 55 years of age (inclusive) at the time of the
             screening.

          3. Must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m2 with a minimum weight of 110
             pounds (50 kg) at screening.

        Exclusion Criteria

          1. A positive test result for human immunodeficiency virus (HIV), hepatitis B (surface
             antigen), or hepatitis C virus antibody at Screening.

          2. A history of any drug allergy, hypersensitivity, or intolerance to acetaminophen,
             morphine, or capsaicin or to any of the excipients in the IV or oral formulations
             used.

          3. A positive test result for drugs of abuse, alcohol, or cotinine.

          4. Fitzpatrick Skin Type V or VI (based on a Skin Type score of greater than 30.

          5. A history of conditions which might be specifically contraindicated or require caution
             to be used during the administration of any drug in the study.

          6. Any other medical, psychiatric and/or social reason for exclusion as determined by the
             investigator.
Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Olopatadine HCl ophthalmic solution, 0.1%; Epinastine HCl ophthalmic solution, 0.05%
Intervention MeSH terms: Olopatadine Hydrochloride; Pharmaceutical Solutions; Ophthalmic Solutions; Epinastine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of Olopatadine
      Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05%
      in a population of healthy, adult Japanese patients (20 years of age or older) with a history
      of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to
      receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic
      solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with
      Japanese cedar pollen will be performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be Japanese and live in Japan;

          -  History of allergic conjunctivitis;

          -  Positive skin test reaction to Japanese cedar at Visit 1;

          -  Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2;

          -  Able and willing to avoid all disallowed medications during the specified period;

          -  Able to discontinue wearing contact lenses during the specified period;

          -  Sign Informed Consent;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  History of hypersensitivity to the study drug or compounds;

          -  Any ocular condition that, in the opinion of the investigator, could affect the
             patient's safety;

          -  Ocular surgical intervention within 3 months or refractive surgery within 6 months
             prior to the start of the study;

          -  Presence of active ocular infection;

          -  Use of disallowed medications as specified in the protocol;

          -  Pregnant, nursing, or planning to become pregnant during the study;

          -  Other protocol-defined exclusion criteria may apply.
Dexmedetomidine Versus Propofol in Vitreoretinal Surgery
Condition: Retinal Detachment
MeSH terms: Retinal Detachment
Intervention: Dexmedetomidine infusion; propofol
Intervention description: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug; propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: sedation for vitreoretinal surgery

Summary:

      The investigators would like to determine if using Dexmedetomidine alone or in a reduced dose
      can prevent or reduce the incidence of adverse effects, while providing adequate sedation,
      and respiratory stability as compared to propofol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists rating of I-III

          -  good renal and liver function

        Exclusion Criteria:

          -  renal and hepatic insufficiency

          -  uncontrolled diabetes

          -  uncontrolled hypertension

          -  severe cardiac disease Class III or IV

          -  heart blocks

          -  chronic use of sedatives, narcotics, alcohol or illicit drugs

          -  allergy to either propofol or dexmedetomidine

          -  pregnancy or inability to tolerate technique of the study drugs
The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery
Condition: Pain
Intervention: Sufentanyl
Intervention description: As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block.
As comparator 1cc normal saline is added to bupivacain in control group for Tap block.
Intervention MeSH terms: Sufentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cesarean Delivery; TAP block; sufentanyl; Narcotic dosages

Summary:

      Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound
      guide can reduce narcotic dosage, side effects and pain after cesarean delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female 18 to 40 Years

          -  class ASA 1 and 2

          -  candidates for elective cesarean section

        Exclusion Criteria:

          -  renal failure

          -  liver failure

          -  cardiac disorder

          -  coagulopathy

          -  hepatomegaly

          -  splenomegaly

          -  drug sensitivity and abuse

          -  morbid obesity

          -  smoking

          -  history of post operative nausea and vomiting

          -  motion sickness

          -  local hypoesthesia
A Study to Compare Neostigmine vs Sugammadex in Length of PACU Stay in Patients Undergoing Sleeve Gastrectomy Surgery
Condition: Postoperative Nausea and Vomiting; Respiratory Conditions Due to Other External Agents
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Intervention: Sugammadex; Neostigmine
Intervention description: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.; Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sugammadex; post anesthesia care unit recovery

Summary:

      The investigators will track bariatric patients who received sugammadex versus neostigmine in
      the post anesthesia care unit until discharge and assess their length of stay and possible
      nausea / vomiting / hypoxia episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients having sleeve gastrectomy

          -  Surgeries performed by a particular surgeon - Dr. Sam Wasser

          -  Body Mass Index greater than 35

          -  American Society of Anesthesiologists Score II and III patients

        Exclusion Criteria:

          -  Patients having a different type of bariatric surgery including but not limited to
             duodenal switch, gastric bypass, hand-assisted laparoscopic sleeve gastrectomy

          -  Sleeve gastrectomy's performed by other surgeons than Dr. Sam Wasser.

          -  Pregnancy

          -  Allergic to sugammadex, Zofran or scopolamine

          -  Chronic Obstructive Pulmonary Disease or Asthma that is uncontrolled

          -  American Society of Anesthesiologists Score I, IV, V patients
Multimodal Versus Opioid aNalgesia in carDiAc Surgery
Condition: Postoperative Pain; Postoperative Delirium
MeSH terms: Emergence Delirium
Intervention: Dexmedetomidine
Intervention description: The use of multimodal painkillers pre, per and postoperative
Intervention MeSH terms: Lidocaine; Magnesium Sulfate; Pregabalin; Dexmedetomidine; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare standard "Fentanyl - Tramadol - Paracetamol - Oxycodone" regimen to a multimodal
      painmanagement "pregabalin- minimal fentanyl-ketamine-lidocain-dexmedetomidine- paracetamol"
      to determine which therapy provides the most comfort, the fastest extubation time, the least
      pain and the least delirium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing first time cardiac surgery by median sternotomy

          -  Elective surgery or semi-urgent: there needs to be time to provide 1 hour before
             surgery the intake of pregabalin

          -  ≥ 18 years for men

          -  Women who are in menopause

          -  Possibility to communicate with the patient to score pain and comfort

          -  Signed Informed Consent, signed by subject able and willing to provide written
             informed consent for study participation

        Exclusion Criteria:

          -  Urgent surgery

          -  Women who are in premenopause

          -  Hypersensitivity to any of the study medication

          -  In case of direct postoperative revision the patient is NOT excluded.
A Comparison of UGSB and GA to IV Narcotics and GA for Post-Op Pain in Children With Supracondylar Fractures.
Condition: Supracondylar Fractures
MeSH terms: Fractures, Bone
Intervention: Fentanyl; Ropivacaine
Intervention description: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.; Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
Intervention MeSH terms: Fentanyl; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 78.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study compares nerve blocks to IV pain medicines in children with broken arms. We are
      trying to see if blocking the nerves in the broken arm results in better pain control and
      less side effects than injections of morphine into a vein after surgery for a broken elbow.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Supracondylar fracture (2) Age 2-17 years (3) American Society of Anesthesiologists
        Status 1 -3 (4) Scheduled for closed reduction with percutaneous pinning under general
        anesthesia

        Exclusion Criteria:

          1. Pulseless extremity

          2. Compromised neurologic status on exam (specifically assessment of radial, ulnar, and
             median nerve)

          3. Known allergy to local anesthetics (7) Not scheduled for closed reduction with
             percutaneous pinning under general anesthesia

          4. Bleeding diathesis

          5. American Society of Anesthesiologist (ASA) status 4 or higher.

          6. Sleep apnea by polysomnography
A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
Condition: Influenza; Influenza-like Illness; Influenza Vaccines
MeSH terms: Influenza, Human
Intervention: Egg based influenza vaccines; Recombinant influenza vaccines; Cell-culture based influenza vaccines
Intervention description: Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.; Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.; Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019,2019-2020, 2020-2021, and 2021-2022).
Masking: None (Open Label)
Enrollment: 15449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine

Summary:

      A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study
      arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based
      vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons
      (2018-2019, 2019-2020, 2020-2021, and 2021-2022).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Eligible for care in Department of Defense medical facilities (Defense Enrollment
             Eligibility Reporting System eligible)

          2. ≥18 years of age.

          3. At a participating Military Treatment Facility site for the purpose of receiving a
             seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.

          4. Able to speak English and able to provide informed consent

          5. Able to receive and respond to texts and/or emails, or a military recruit

        Exclusion Criteria:

          1. Adults intending to receive or who have received the current seasons FluMist Vaccine
             (LAIV)

          2. Adults who have already received a flu vaccine within the current season

          3. Individual who cannot receive a flu vaccine or standard dosing due to another medical
             condition

          4. Allergic to gentamicin, polymyxin and/or neomycin

          5. Individuals who fail to meet the inclusion criteria