bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease
Condition: Increased Risk of SARS-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19
Intervention: Bromhexine Hydrochloride
Intervention description: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days
Intervention MeSH terms: Bromhexine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized controlled trial of the efficacy and safety evaluation of oral
      administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and
      COVID-19 disease in medical personnel assisting patients with a new coronavirus disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of 18 years or more;

          2. Negative test (PCR) for SARS-CoV-2 infection;

          3. The absence of clinical manifestations of a respiratory infection;

          4. Contact with patients with laboratory and / or clinically confirmed SARS-CoV-2
             infection;

          5. Signed informed consent to participate in the study.

        Exclusion Criteria:

          1. Intolerance to Bromhexine hydrochloride;

          2. Work out of contact with SARS-CoV-2 infection;

          3. Non-compliance with the rules for the use of personal protective equipment when
             working with SARS-CoV-2 infection (the rules for the use of personal protective
             equipment in accordance with the recommendations of the Ministry of Health of Russia
             and the internal orders of the Director General of Almazov NMRC, relevant to the dates
             of research);

          4. Pregnancy and the period of breastfeeding;

          5. Other circumstances that the researcher considers inappropriate to participate in this
             study
Effect of CES on Parasympathetic Tone
Condition: Autonomic Nervous System Imbalance
Intervention: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Intervention description: low voltage alternating current transcranial electrical stimulation
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Individual calculating heart rate and heart rate variability from ECG recordings was blind to dose of stimulation. Individual collecting side effect information was not blind to dose of stimulation.
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cranial electrical stimulation; CES; heart rate variability; parasympathetic; Vagal

Summary:

      The hypothesis is that CES stimulation will dose dependently increase parasympathetic tone.
      Healthy subjects will have three 20 minute sessions of CES stimulation, at three different
      intensities of stimulation, with each session occurring on a separate day. Effect on
      parasympathetic tone will determined by measuring high frequency heart rate variability
      before, during and after the stimulation. The Fisher Wallace Stimulator (FW100) which
      delivers a low dose alternating current a varying frequencies will be used for the
      stimulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy volunteer

        Exclusion Criteria:

          -  daily psychotropic medication,

          -  use of beta blocker,

          -  pacemaker,

          -  other metal in body,

          -  history of seizures
Post-operative Analgesia in Elective, Soft-tissue Hand Surgery
Condition: Carpal Tunnel; Ganglion Cyst; Trigger Finger; De Quervain Disease
MeSH terms: Ganglion Cysts; Trigger Finger Disorder; De Quervain Disease
Intervention: Acetaminophen/Ibuprofen; Acetaminophen/Hydrocodone
Intervention description: Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free; Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adult; soft-tissue hand surgery

Summary:

      The purpose of this research study is to find out which combination of pain medications
      following surgery work the best and result in the fewest side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 18

          -  Male or Female (non-pregnant)

          -  Elective, soft tissue hand surgery indicated based on diagnosis made by either
             clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination
             of the two (carpal tunnel release, trigger finger release, first dorsal compartment
             release, ganglion cyst excision, second extensor compartment release)

          -  Subjects are capable of giving informed consent

        Exclusion Criteria:

          -  Allergy to study medication

          -  Any pre-existing pain condition requiring analgesia

          -  Fibromyalgia

          -  Recent upper gastrointestinal bleeding

          -  Coagulopathy (primary or medication-related)

          -  Renal impairment

          -  Liver disease

          -  Pregnancy

          -  Patients who consent to the study but require unexpected admission, including those
             requiring admission resulting from operative complications, will be excluded before
             randomization
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
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: HX575 recombinant human erythropoietin alfa
Intervention description: HX575 epoetin alfa i.v. will be administered according to the SmPC
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1695.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD subjects with or without dialysis treatment

Summary:

      Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of
      relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney
      Disease (CKD) subjects receiving HX575 epoetin alfa i.v.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CKD subjects with or without dialysis treatment

          -  Age over 18 years

          -  Subjects requiring i.v. ESA treatment

          -  Subjects likely to remain on i.v. ESA treatment for 6 months

          -  Provision of informed consent -

        Exclusion Criteria:

          -  Systemic immunosuppressive medication or any other drugs known to adversely affect the
             hemoglobin level

          -  Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant
             erythropoietin product

          -  History of PRCA or aplastic anemia

          -  History of anti-erythropoietin antibodies

          -  Uncontrolled hypertension

          -  Pregnant woman or nursing mother

          -  Women of childbearing potential do not agree to maintain effective birth control
             during the study treatment period.
Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation
Condition: Aging; Inflammation
MeSH terms: Inflammation
Intervention: Typhoid Vaccine; Ascorbic Acid
Intervention description: All participants will receive the typhoid vaccine.; All participants will receive ascorbic acid.
Intervention MeSH terms: Ascorbic Acid; Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The vascular response to acute inflammation and oxidative stress is non-invasively assessed in individuals who are young with low fitness, older with low fitness, or older with high fitness.
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cardiorespiratory Fitness; Endothelial Function; Oxidative Stress

Summary:

      This study focuses on whether high cardiorespiratory fitness in older adults has a protective
      effect on the vascular response to acute inflammation in comparison to low-fit older and
      young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females willing to provide informed consent

          -  18-35 or 55-75 years of age

          -  Non-smoker

          -  No use of anti-inflammatory medication within last 2 weeks

          -  Aerobically trained (defined as performing aerobic exercise on ≥4 days/week, for ≥30
             minutes, for at least the past 3 months AND a VO2max ≥75th age- and sex-specific
             percentile according to ACSM)

          -  /// OR /// Sedentary (defined as being involved in less than 30 minutes of
             moderately-intense physical activity per day, < 3 days/week AND a VO2max ≤ 50th age-
             and sex-specific percentile according to ACSM)

        Exclusion Criteria:

          -  Body mass index >35 kg/m2

          -  Pregnancy, hormone replacement therapy, or peri-menopausal

          -  Known cardiovascular (i.e. atherosclerosis, uncontrolled hypertension, stroke,
             myocardial infarction, etc.), inflammatory (i.e. Crohn's disease, arthritis, etc.), or
             metabolic (i.e. Diabetes mellitus) disease

          -  Medications known to influence cardiovascular outcomes (i.e. heart rate, blood
             pressure, endothelial function, etc)

          -  Regular use of medications to reduce inflammation (NSAIDS, aspirin, steroids, etc)

          -  Bleeding disorders

          -  Illness, other vaccination, or antioxidant use within 2 weeks prior to screening

          -  Typhoid vaccination within previous 2 years or prior adverse reaction

          -  VO2max in 51st - 74th age- and sex-specific percentile according to ACSM (measured
             during first testing visit)

          -  Non-English speaking participants
Ultrasound Evaluation of Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: Sulfur Hexafluoride; Ultrasound Elastography; Ultrasound Vascularity; Magnetic Resonance Enterography (MRE)
Intervention description: Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.; Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.; Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.; Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effectiveness of a new ultrasound technology for
      evaluating Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - Crohn's disease patients with involvement of terminal ileum (thickness > 3mm).

        Exclusion Criteria:

          -  Patients with change of medicine or going to surgery over the 6-months follow-up
             period.

          -  Patients with unreliable ultrasound images due to conditions such as large body
             habitus or poor ultrasound imaging window.

          -  Adults lacking capacity to consent.

          -  Vulnerable subjects such as prisoners.

          -  Pregnant women and nursing mothers.

          -  Patients with known or suspected right-to-left, bi-directional, or transient
             right-to-left cardiac shunts.

          -  Patients with history of hypersensitivity allergic reactions to ultrasound contrast
             agents.
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium Carbonate; Sertraline; Nortriptyline; Risperidone
Intervention MeSH terms: Risperidone; Lithium Carbonate; Sertraline; Nortriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Intervention model description: This is a pragmatical clinical trial. The patients follow a pre-established algorithm About the participant flow the results the table to indicate the number of participants who received treatment in the whole algoritm, not in each step.
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cost effectiveness; Bipolar disorder; Depressive episodes; Quality of Life

Summary:

      To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD)
      using medications available in the Brazilian Public Healthcare System (SUS). Quality of life
      assessment of these patients was also employed.

      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of
      episodes of bipolar disorder depression episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ages between 18 and 65;

          2. BD current acute mixed episode;

          3. total capacity to understand and respond to self-applied instruments;

          4. the presence of symptoms in the last 30 days;

          5. abstinence for at least 30 days for drug addicts.

        Exclusion Criteria:

          1. presence of Organic Brain Syndrome (OBS);

          2. pregnancy or lactation;

          3. criteria for psychiatric hospitalization. -
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Lyrica (pregabalin); placebo
Intervention description: 150 mg twice a day, oral administration; Twice a day, oral administration
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: epilepsy partial seizure treatment with pregabalin or placebo; vision testing

Summary:

      Patients with partial seizures currently taking 1-3 antiepileptic medications will have a
      50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to
      their current medications for 3 months. Neither the study doctor nor the patient will know
      the medication assignment. Vision testing will be performed prior to receiving the study
      treatment and at the end of the study to see if there are any changes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Epilepsy partial seizure subjects.

          -  Currently taking 1 to 3 antiepileptic drugs.

        Exclusion Criteria:

          -  Pre-existing eye diseases (glaucoma).

          -  Insufficient response to pregabalin in the treatment of partial seizure, or patients
             currently receiving pregabalin treatment.
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.
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
Condition: Hypertension in Pregnancy; Postpartum Preeclampsia
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Intervention: ACE Inhibitors and Diuretics; NIFEdipine ER
Intervention description: Hctz/Lisinopril (brand name: Zestoretic); Extended release nifedipine
Intervention MeSH terms: Nifedipine; Diuretics; Angiotensin-Converting Enzyme Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized control trial
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE)
      inhibitors (a medication that helps relax your veins and arteries to lower your blood
      pressure) with diuretics (sometimes called water pills, help rid your body of salt and water)
      will control blood pressure better than a different blood pressure medication of calcium
      channel blocker (lower your blood pressure by preventing calcium from entering the cells of
      your heart and arteries). Both medications are part of our usual care for high blood pressure
      after delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women at ≥ 18 years of age

          -  Postpartum diagnosis of persistent hypertension (2 measurements of Systolic BP ≥150
             and/or diastolic BP ≥ 100 or systolic BP ≥140 and/or diastolic BP ≥ 90 for people with
             diabetes) requiring an oral medication based on the ACOG criteria or

          -  Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum requiring blood
             pressure medication in the postpartum

          -  Chronic hypertension requiring blood pressure medication postpartum

        Exclusion Criteria:

          -  Urine output < 30 cc/h prior to screening for eligibility

          -  Creatinine > 1.4 during current admission

          -  End-stage renal disease

          -  Hypersensitivity to ACE inhibitors or sulfa drugs

          -  Idiopathic/hereditary angioedema

          -  Hyperkalemia (serum potassium >5 mEq/L) during current admission

          -  Pulmonary edema