bioihbjkbjnl/mcl2 huggingface dataset:
Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
Condition: Nephrotoxicity
Intervention: Belatacept
Intervention MeSH terms: Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pancreas transplantation; immunosuppression; belatacept

Summary:

      Kidney damage is a major complication of current antirejection medicines used in
      transplantation. An increasing number of brittle diabetics are successfully receiving a
      pancreas transplant. One of the challenges following pancreas transplant is that a patient
      can develop kidney damage from one of their antirejection medicines, tacrolimus. The
      objective of this study is to substitute a new antirejection medicine which does not cause
      kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus
      related kidney damage to slow the progression of kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pancreas transplant alone recipients

          -  EBV IgG positive

          -  Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy

          -  Maintained on a regimen of tacrolimus, sirolimus, mycophenolate

        Exclusion Criteria:

          -  EBV IgG negative

          -  Not maintained on an immunosuppression regimen that contains tacrolimus

          -  Unable or unwilling to give informed consent

          -  Active infection

          -  History of malignancy post transplant

          -  Glomerular filtration rate < 15 mL/min
MTX Discontinuation and Vaccine Response
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; Seasonal Influenza vaccine
Intervention description: Methotrexate will be continued; all subjects will be vaccinated with a seasonal influenza vaccine
Intervention MeSH terms: Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To investigate whether a short term discontinuation of methotrexate (MTX) will improve the
      vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease
      activity in a randomized clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females > 18 years at time of consent

          -  Have a diagnosis of RA per ACR criteria

          -  Must understand and voluntarily sign an informed consent form including writing
             consent for data protection

          -  Stable doses of methotrexate over the preceding 6 weeks

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Previous anaphylactic response to vaccine components or to egg.

          -  Acute infection with T >38°C at the time of vaccination

          -  History of Guillain-Barre syndrome or demyelinating syndromes

          -  Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2
             weeks before the study

          -  Blood transfusion within 6 months

          -  Active rheumatoid arthritis necessitating a recent change in the drug regimen

          -  Any other rheumatic disease such as systemic lupus erythematosus, mixed connective
             tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary
             Sjogren's disease
Ipratropium Bromide in Peri-Operative COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: placebo; ipratropium bromide
Intervention description: normal saline; ipratropium bromide
Intervention MeSH terms: Bromides; Ipratropium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 192.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre
      trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese
      peri-operative patients with COPD under general anaesthesia.
    

Eligibility criteria:

        Inclusion criteria:

          -  All patients must sign an informed consent.

          -  Male or female patients aged >= 40 years and <= 80 years

          -  All patients must be diagnosed with COPD and must meet the following spirometric
             criterion: post-bronchodilator forced expiratory volume in 1 second (FEV1) < 70% of
             forced vital capacity (FVC) at Screening Visit (Visit 1).

          -  All patients have relatively stable COPD (i.e. have no COPD exacerbation within 4
             weeks prior to Screening Visit).

          -  All patients are about to receive selective surgical procedures of lobectomy or right
             bilobectomy or segmentectomy under general anaesthesia, whilst the estimated time of
             surgical procedures lasts for not less than 2 hours, and the estimated time of general
             anaesthesia lasts for not less than 3 hours and not longer than 5 hours.

          -  Patients must be able to perform all study related procedures including technically
             acceptable pulmonary function tests (PFTs).

        Exclusion criteria:

          -  Patients who need maintenance treatment of bronchodilators (including
             anticholinergics, ß-agonists, xanthines).

          -  Patients with a recent history (i.e. six months or less) of myocardial infarction

          -  Patients with any unstable or life-threatening cardiac arrhythmia requiring
             intervention or change in drug therapy during the last year

          -  Patients with symptomatic chronic heart failure (i.e. New York Heart Association
             functional class III-IV)

          -  Known narrow angle glaucoma

          -  Patients with prostatic hyperplasia or bladder neck obstruction with significant
             symptoms

          -  Patients with a history of asthma, allergic rhinitis or who have a blood eosinophil
             count >= 600 / mm3 (0.6×10^9/L). A repeat eosinophil count will not be conducted in
             these patients
Single Dose Bronchodilatory Study in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Zileuton extended release
Intervention MeSH terms: Zileuton
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable
      asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of asthma for at least 5 years

          -  FEV1 of 50-85% predicted

          -  Reversible airway obstruction

        Exclusion Criteria:

          -  Pregnant/nursing females

          -  Liver function tests greater than upper limit of normal
Clopidogrel and Aspirin Interaction Study-2
Condition: Drug Action Increased
Intervention: Clopidogrel; Aspirin; Aspirin
Intervention description: 600mg (2 pills); 325mg (1 pill); 81mg (1 pill)
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clopidogrel; Aspirin; Interaction

Summary:

      Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to
      prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky
      cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen
      to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with
      aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients
      with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable patients >1 month post ACS (including ST elevated myocardial infarction, non-ST
             elevated myocardial infarction or unstable angina) or stent

          -  Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week

          -  Written informed consent

        Exclusion Criteria:

          -  Age < 18 years

          -  Liver disease with ALT or bilirubin >2x upper limits of normal (ULN)*

          -  Renal impairment with creatinine clearance <30 ml/min*

          -  Deemed to be at high risk of bleeding (e.g., recent bleeding, platelet count<100x109/L
             or hemoglobin <100g/L)*

          -  Anticoagulant or NSAID therapy within the last 5 days

          -  Antiplatelet agent other than aspirin and clopidogrel within the last 10 days

          -  Uncontrolled hypertension (>=180/110mmHg)

               -  within 3 months of planned randomization
RCT Superior Hypogastric Block During LH
Condition: Hysterectomy
Intervention: Bupivacaine Hydrochloride 0.25% Injection Solution
Intervention description: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Patients will be blinded to the treatment arm; however, the surgeon will know if a patient has been randomized to receive the block during the hysterectomy.
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Laparoscopy; Superior hypogastric plexus block

Summary:

      The goal of this study is to assess the efficacy of a superior hypogastric plexus block
      (SHPB) for pain relief following a laparoscopic hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over age 18

          -  English Speaking

          -  Able to provide informed consent

          -  Undergoing laparoscopic hysterectomy for benign indications

        Exclusion Criteria:

          -  Planned laparotomy incision

          -  Planned procedure that requires dissection of the presacral space

          -  Allergy to block medication (s)

          -  Known or suspected malignancy

          -  Non-English speaker
IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: IV Acetaminophen; Saline as placebo
Intervention description: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly; 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid usage requirements; pain; IV acetaminophen; opioid usage; c-section

Summary:

      Post-operative pain management after C-section is an important topic as the number of
      elective c-sections increases each year. Pain is managed either by giving opioids or by using
      non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen
      in pain relief and its impact in the usage of post-operative opioid requirements and opioid
      associated complications. The hypothesis is that four doses of IV Acetaminophen in
      conjunction with intrathecal or epidural morphine given to the patients after c-section will
      reduce post-operative opioid requirements and opioid associated complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective full term CS patients

          -  Age 18 and above

          -  ASA I-III

        Exclusion Criteria:

          -  Allergic reaction to IV acetaminophen

          -  Not able to understand and sign the research consent

          -  Pregnancy induced hypertension or pre-eclampsia patients

          -  Planned intensive care admission patients

          -  Patients with severe hepatic impairment or active liver diseases (Two fold increase in
             any of the liver enzymes)

          -  Patients with serum creatinine>2mg/dl

          -  For nursing mothers, any evidence of hepatic dysfunction of the new born
Guanfacine in Children With Tic Disorders
Condition: Tourette Disorder; Tourette Syndrome
MeSH terms: Tourette Syndrome; Tic Disorders; Tics
Intervention: placebo; extended-release guanfacine (Intuniv)
Intervention description: Administered up to 8 weeks.; 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
Intervention MeSH terms: Guanfacine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tourette Syndrome; Tourette Disorder; Tics; Motor tics; Vocal tics; Intuniv; Guanfacine; Medication; Drug; Placebo; Child; Children; Adolescent

Summary:

      The goal of this pilot study is to obtain preliminary information on the tolerability and
      efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette
      Disorder (TD, also called Tourette syndrome).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.

          -  Between ages 6 yrs 0 mos and 17 years 0 months.

          -  Weight >/= 15 kg (33 lbs).

          -  Ability to swallow pills whole.

        Exclusion Criteria:

          -  IQ < 80.

          -  Positive pregnancy test.

          -  Positive drug test.

          -  Low blood pressure.

          -  Prior history of hypersensitivity to guanfacine.

          -  Prior failed treatment with an adequate trial of guanfacine in last 2 years.

          -  Concurrent treatment with another psychoactive medication for tics, stimulant
             medication, or Habit Reversal therapy.

          -  Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks
             with no planned changes; SSRIs are allowed.
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Recurrence; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Placebo
Intervention description: Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.; Dose-matched placebo taken orally once daily.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 644.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Fetzima; Relapse-prevention; Placebo-controlled

Summary:

      This study evaluates the efficacy, safety and tolerability of levomilnacipran
      extended-release (ER) compared with placebo in the prevention of depression relapse in major
      depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria

          -  Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th
             edition) criteria for Major Depressive Disorder (MDD)

          -  The participant must have an ongoing major depressive episode of at least 8 weeks and
             no more than 18 months

          -  The participant must have at least 3 lifetime episodes of MDD (including the current
             episode)

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control

          -  Participants who are considered a suicide risk

          -  History of non-response to 2 or more antidepressants (after adequate treatment)

          -  Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or
             mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic
             disorder

          -  Panic disorder
A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: 0.15% Brimonidine Tartrate
Intervention description: 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Healthy volunteers: No

Summary:

      This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle
      glaucoma and ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma or ocular hypertension

        Exclusion Criteria:

          -  Used Alphagan® in previous 3 months
Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Self-determination Intervention for Tobacco Dependence
Intervention description: autonomy supported behavioral intervention for tobacco dependent individuals
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 837.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Self-determination; motivation; adherence; competence; autonomy; tobacco dependence; Tobacco use and dependence; Behavior change

Summary:

      These two studies will examine the role of autonomous motivation in maintained adherence. The
      first study will determine whether smokers are still abstinent from tobacco 32 months after
      starting in a previous project (Smoker's Health Study). The purpose of the second study is to
      determine which of three treatments for tobacco dependence provides the greatest amount of
      protection from relapsing to smoking after quitting. Specifically, the investigators will
      determine if extending the length of treatment time focusing on relapse prevention and
      arranging for support from important others prevents relapse compared to community care.
      Also, the investigators will determine if providing extended treatment time and support from
      important others plus providing medications to those that don't want to quit prevents long
      term relapse compared to just extending the length of treatment time and support from others.
      Additionally, a sub set of the population will be randomized to using hand held palm devices
      to recover real-time data assessment during the last 10 months of the project.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoking 5 or more cigarettes per day.

          -  18 years of age or older.

          -  Speak and read English.

          -  Eligible regardless of desire to quit smoking

        Exclusion Criteria:

          -  Pregnancy

          -  History of psychotic illness other than depression

          -  Life expectancy of less than 24 months

          -  Dementia, or incompetence for medical decision making
Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
Condition: Intubation
MeSH terms: Emergencies
Intervention: Succinylcholine; Rocuronium
Intervention description: 1mg/kg iv; 0.6mg/kg iv
Intervention MeSH terms: Rocuronium; Succinylcholine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: intubation; intensive care; neuromuscular depolarizing agents; neuromuscular nondepolarizing agents; neuromuscular blocking agents

Summary:

      Emergency intubation of patients in intensive care is a high-risk endeavour. For many
      decades, succinylcholine has been the neuromuscular blocking agent of choice. However,
      succinylcholine may have life-threatening side effects and is contraindicated in a variety of
      diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated
      as alternative for succinylcholine. Though a recent meta-analysis found no difference in
      intubating conditions between succinylcholine and rocuronium in elective cases, there are no
      data in emergent cases in intensive care. The aim of the present study is to compare
      succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length
      of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of
      intubation, and 5) desaturations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  indication for emergency intubation in intensive care

          -  availability of qualified study physician

        Exclusion Criteria:

          -  contraindication against succinylcholine or rocuronium

          -  indication for awake fibreoptic intubation