bioihbjkbjnl/mcl2 huggingface dataset:
Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data
Condition: Asthma
MeSH terms: Asthma
Intervention: Salmeterol/Fluticasone 50/250 mcg; Salbutamol 100 mcg; DISKUS™ powder inhalers
Intervention description: Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.; This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol.; Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.
Intervention MeSH terms: Fluticasone; Albuterol; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; Asthma Control Test; SERETIDE

Summary:

      The majority of asthma patients are not well controlled, despite the availability of asthma
      medication that could effectively treat the disease. In this study uncontrolled patients who
      are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide
      (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test
      (ACT) will be used to detect differences in the level of asthma control during treatment. The
      study aims to show a correlation between improvements of ACT und the level of asthma control
      which will be reached by the patients.

      The aim of the study is to show that most of symptomatic asthma patients can reach 'well
      controlled asthma' with SFC. We get information about ACT in daily practice and physicians
      are trained to use the asthma control test as a screening tool and for follow up of asthma
      management. Correlations are expected between the improvements in ACT, Quality of Life and
      asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of asthma

          -  Reversibility >12% after inhalation of 200 µg Salbutamol

          -  willingness and ability to complete daily record card on daily basis and to measure
             morning PEF on daily basis

          -  80% compliance in diary card completion asthma control status: Uncontrolled based on
             the GOAL criteria

        Exclusion criteria:

          -  Change of asthma medication during the last 4 weeks

          -  Asthma exacerbation characterized by use of oral corticoids during the last 3 months
             Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or
             equivalent per day or other controller therapy during the last 3 months

          -  upper or lower respiratory tract infection during the RUN-IN period moderate or severe
             asthma exacerbation during the RUN-IN period

          -  Non compliance with use of Discus, PEF-meter and incomplete diary card data
Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery
Condition: Smoking Cessation
Intervention: Nicoderm Patch
Intervention description: Nicotine replacement therapy patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass Surgery (CABG); Nicotine Replacement Therapy (NRT)

Summary:

      This study will determine whether or not patients who use a Nicotine Replacement Therapy
      (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after
      their surgery and have fewer post-operative complications
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is currently smoking >5 cigarettes/day for the past 30 days; there is no
             evidence that NRT is useful in those who smoke <5cpd.

          2. Patient is able to participate and willing to provide informed consent; participants
             will need to follow directions and adhere to the medication usage instructions as
             outlined in the informed consent document.

          3. Patients is willing to be contacted by phone for follow up at 1 month and 6 months
             post-discharge; these time points will assess our final outcome of cessation at 6
             months post-discharge.

        Exclusion Criteria:

          1. Patient is scheduled for surgery in < 7 days; most patients need to be using NRT
             consistently for 2 weeks for it to be fully effective.

          2. Patient is currently using a smoking cessation product (i.e. nicotine containing
             patch, gum, inhaler, lozenge, spray or nicotine containing electronic cigarette,
             varenicline, buproprion) or has used a smoking cessation aid consistently for more
             than 72 consecutive hours with the intent to reduce cigarette consumption or quit
             smoking within 30 days of the baseline Pre-admission Unit (PAU) visit; this will
             ensure the effects of the study patches will be assessed without any contamination
             from other cessation products.

          3. Patient is willing to refrain from using any other cessation products (nicotine
             containing patch, gum, inhaler, lozenge, spray, nicotine containing electronic
             cigarette, varenicline, buproprion) prior to surgery; this will allow us to track the
             usage and side effects with the study patches.

          4. Patient is allergic to the adhesive on the nicotine replacement therapy patch.

          5. Patient is unable to read and understand English or French; study materials will only
             be supplied in these two languages.
Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics
Condition: Infantile Colics
MeSH terms: Colic
Intervention: Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122); Lactobacillus reuteri DSM 17938 (108 CFU); Simethicone
Intervention MeSH terms: Simethicone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 14 Days
Maximum age: 4 Months
Healthy volunteers: No
Keywords: Infantile colics

Summary:

      A multicenter prospective, randomized comparative study will be conducted in infants with
      colic, according to Rome III criteria. Enrolled infants will be assigned at random to receive
      Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), L reuteri DSM
      17938 (108 CFU) or simethicone. Treatment will be given to subjects for 28 days and they will
      be followed for 4 weeks. Treatment success will be assessed at the end of study period. Daily
      crying and fussing times will be recorded in a structured diary, and maternal questionnaires
      will be completed to monitor changes in infant colic symptoms and adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          1. diagnosis of IC according to Rome III criteria (2);

          2. age ≥2 weeks to 4 months;

          3. breast-fed or fomula-fed infants;

          4. term delivery (≥37 weeks gestation at birth);

          5. 5-minute Apgar score ≥7; and 6) birth weight ≥2500 g

        Exclusion Criteria:

          1. a major medical problem or acute illness;

          2. family history of atopy;

          3. history of antibiotic treatment before or during the study;

          4. history of probiotic supplementation.
Trial to Optimize Mineral Outcomes in Dialysis Patients
Condition: Secondary Hyperparathyroidism; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Cinacalcet, active vitamin D analogue
Intervention description: Patients will have their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet will be dose increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
Intervention MeSH terms: Vitamin D; Calcitriol; 1 alpha-hydroxyergocalciferol; Cinacalcet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: secondary hyperparathyroidism; calcium; phosphorus; ESRD; CKD; mineral disorder

Summary:

      This trial is designed to determine if the use of a computer algorithm designed to optimize
      mineral outcomes in dialysis patients increases the number of patients achieving the desired
      target endpoints for calcium, phosphorus and parathyroid hormone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 years of age or older

          -  On outpatient hemodialysis

          -  Have a level of understanding and willingness to cooperate with the study personnel

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Currently enrolled in another interventional clinical trial

          -  Are pregnant, plan on becoming pregnant during the study period, or breast-feeding

          -  Planned parathyroidectomy within 6 months

          -  Planned kidney transplant within 6 months

          -  Life expectancy < 6 months

          -  Patient declines participation

          -  Liver function tests > 2 times the upper limit of normal
Sufentanil Infusion vs Sufentanil Bolus
Condition: Anesthesia
Intervention: Sufentanil Infusion; Sufentanil Bolus
Intervention description: Intra-operative sufentanil infusion; Intra-operative sufentanil bolus
Intervention MeSH terms: Sufentanil; Dsuvia
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 64.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion
      over bolus dosing to reduce time to extubation and reduced length of ICU stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled non-emergency cardiac surgical patients including those with planned
             procedures of CABG, AVR, and combined CABG and AVR

          -  19 to 80 years old

          -  Planned pre-operative anesthesia screening visit and/or preoperative surgical clinic
             visit.

          -  Inpatient subject that is scheduled (greater than 24hrs in advance) for a
             non-emergency cardiac surgical case

        Exclusion Criteria:

          -  Sufentanil allergy

          -  EF less than or equal to 30%

          -  Moderate or severe right ventricular dysfunction,

          -  Moderate pulmonary dysfunction, to include patients with at home 02 and/or daily
             bronchodilator therapy.

          -  End Stage Renal Disease on Dialysis

          -  Chronic Kidney Disease with GFR <30

          -  Sternotomy Re-do

          -  Emergency surgery

          -  Greater than 4 units of RBCs or FFP combined

          -  Mechanical circulatory support post-operatively such as ECMO, IABP, Impella

          -  Not eligible for rapid wean extubation protocol

          -  Requires infusion of sedative medication required during ICU admission

          -  Greater than or equal to 15 minute ICU hold within PACU
Tranylcypromine Treatment of Bipolar Depression
Condition: Bipolar Disorder I or II
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Tranylcypromine
Intervention description: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Intervention MeSH terms: Tranylcypromine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Episode; Depression NOS; Bipolar Disorder; Bipolar Disorder I; Bipolar Disorder II; Bipolar Depression; Major Depression

Summary:

      This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective
      treatment of bipolar depression. New treatments are needed, as there is little evidence that
      standard antidepressants are effective in treating this condition, and the two antipsychotic
      medications that have indications for bipolar depression can cause substantial side effects.
      This study will focus specifically on currently depressed outpatients having a bipolar
      history for whom at least one standard antidepressant medication was ineffective. Patients
      will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of Bipolar I, II

          2. Currently depressed (major depressive episode or depression NOS)

          3. Physically healthy or physically stable (i.e.,No changes in medical interventions in
             past three months or likely for the next three months)

          4. On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not
             require a mood stabilizer.

          5. Prior adequate trial on at least one antidepressant.

          6. Able to follow a tyramine-free diet

          7. Must speak English

        Exclusion Criteria:

          1. Current psychosis

          2. past psychosis not occurring during an episode of mania or depression

          3. prior nonremission to tranylcypromine 60 mg/d (or greater)

          4. currently taking effective medication precluded while taking a Monoamine Oxidase
             Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)

          5. current (last six months) drug or alcohol abuse or dependence

          6. significant suicide risk

          7. significant cardiovascular risk
Immunogenicity of Hepatitis B Vaccination Among Drug Users
Condition: Hepatitis B Vaccination
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention description: three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 480.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis B vaccination; Immunogenicity; Randomized controlled trial; Drug abuse

Summary:

      Uptake, adherence, and completion of vaccination among drug users were low, and their immune
      function and immune response to hepatitis B vaccination were also suboptimal, indicating that
      the current practice of hepatitis B vaccination can't protect drug users from HBV infection.

      This is a randomized, open-label, blank-controlled trial, conducted among drug users with
      drug rehabilitation. This study will compare the immunogenicity and safety of three
      intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug
      users
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 18 and 70 years at the enrolment

          -  current illicit drug users before drug rehabilitation

          -  negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody
             (anti-HBs) at enrollment

          -  having spent acute physiological detoxification phase

        Exclusion Criteria:

          -  any intolerance or allergy to any component of the vaccine

          -  ongoing opportunistic infection

          -  liver disease

          -  hemopathy

          -  cancer

          -  unexplained fever in the last week before the recruiting
'Effect of CRT on Defibrillation Threshold Estimates' Study
Condition: Sudden Cardiac Death
MeSH terms: Death, Sudden, Cardiac; Death
Intervention: Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
Intervention description: Patients in the study who receive Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for Cardiac Resynchronization Therapy (CRT).
Patient undergoes Defibrillation threshold (DFT) testing at implant and at 6 months. Defibrillation threshold (DFT) testing will include 3 ventricular fibrillation (VF) inductions.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this prospective study is to evaluate the effect of cardiac resynchronization
      therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization
      therapy defibrillators (CRT-D) patients. The hypothesis of the study is that defibrillation
      threshold (DFT) will decrease with 6 months of cardiac resynchronization therapy (CRT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets standard indications for a Cardiac Resynchronization Therapy -
             Defibrillator (CRT-D).

          -  Patient will be implanted with an FDA approved St Jude Medical (SJM) Cardiac
             Resynchronization Therapy - Defibrillator (CRT-D) and compatible defibrillation lead
             system.

          -  Patient is able to tolerate defibrillation threshold (DFT) testing.

          -  Patient is geographically stable and willing to comply with the required follow-up
             schedule.

          -  Patient has a life expectancy of greater than 6 months from the time of implant.

          -  Patient has stable heart failure (HF) medications at least one month prior to
             enrollment.

        Exclusion Criteria:

          -  Inability to successfully implant an intravascular lead Cardiac Resynchronization
             Therapy - Defibrillator (CRT-D) device. (i.e. exclude epicardial leads).

          -  Patient is getting his Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
             device replaced.

          -  Inability to successfully obtain the defibrillation threshold (DFT) at implant.

          -  Currently participating in a clinical trial that includes an active treatment arm or
             another data collection registry.

          -  Recent (within 24 hours) administration of Nesiritide™.

          -  Patient is on amiodarone (other antiarrhythmic agents known to affect defibrillation
             thresholds - DFTs) at the time of enrollment.

          -  Patient is pregnant.

          -  Patient is less than 18 years old.
Efficacy of Resveratrol in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Resveratrol Pill; Placebos
Intervention description: Resveratrol 500 mg; Placebo Pills
Intervention MeSH terms: Resveratrol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1)
      each morning daily for 1 month with primary outcome measures of the score change on
      depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times
      over the study period (before, in the middle, after the intervention, and in 2 week follow
      up).
    

Eligibility criteria:

        Inclusion Criteria (selectively):

          -  MDD recurrent or with single episode with melancholic features or dysthymia (DSM-5);

          -  current depression.

        Exclusion Criteria (selectively):

          -  serious or unstable disease;

          -  antidepressants intake.
Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks
Condition: Post-surgical Pain; Total Knee Arthroplasty; Foot/Ankle Surgery; Catheterization for Postop Analgesia
MeSH terms: Pain, Postoperative
Intervention: ropivacaine 0.2%
Intervention description: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: moderate pain; severe pain; surgery; postop analgesia; TKA; adductor catheter; poplital catheter; foot/ankle surgery

Summary:

      Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for
      lower extremity post-operative pain control, specifically for total knee arthroplasty and
      foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic for
      postoperative analgesia may be placed at various locations along the target nerves.
      Investigations of single-injection peripheral nerve blocks suggest that the onset of the
      block might be faster with one location over the other; but, the success rates are
      equivalent. However, remaining unknown is whether there is an optimal location to place a
      perineural catheter as part of a continuous peripheral nerve block.
    

Eligibility criteria:

        Inclusion Criteria:

          1. undergoing surgery with an adductor canal or popliteal-sciatic perineural catheter for
             postoperative analgesia following primary tri-compartment knee arthroplasty or
             foot/ankle surgery;

          2. anticipated to have at least moderate pain following surgery [NRS>3]; and,

          3. age 18 years or older.

        Exclusion Criteria:

          1. pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to
             menopause who are sexually active with the opposite sex within the previous year);

          2. inability to communicate with the investigators and hospital staff;

          3. clinical neuropathy in the surgical extremity;

          4. chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to
             surgery of at least the equivalent of 20 mg oxycodone);

          5. BMI > 40 kg/m2;

          6. allergy to study medications (lidocaine, ropivicaine);

          7. known renal insufficiency; or,

          8. incarceration.