bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: Simvastatin; Vytorin; Placebo; Ezetimibe
Intervention description: Simvastatin 20mg daily for 3 months.; Vytorin 20/10mg daily for 3 months.; Placebo one tablet daily times 3 months.; Ezetimibe 10mg daily for 3 months.
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled clinical trial with 4 arms
Masking: Double (Participant, Care Provider)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metabolic Syndrome; LDL subfraction L5; The reduction of LDL in patients with Metabolic Syndrome; The prevalence of L5 in patients with Metabolic Syndrome; The reduction of L5 in patients with Metabolic Syndrome

Summary:

      The purpose of this study is:

        -  To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.

        -  To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting
           factor and reduce L5 in Metabolic Syndrome patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines
             will be recruited.

          -  The 5 criteria are:

               1. abdominal obesity (men>40 inches, women >35 inches);

               2. TG> 150mg/dL;

               3. low HDL-C (men < 40mg/dL, women < 50 mg/dL);

               4. high blood pressure (>or=130/>or=85 mmHg);

               5. fasting glucose > or = 110mg/dL.

          -  People with different ethnic backgrounds will be included.

        Exclusion Criteria:

          -  symptomatic coronary artery disease

          -  peripheral vascular disease

          -  cerebral ischemia (stroke)

          -  smoking

          -  hypothyroidism

          -  kidney diseases

          -  consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the
             last 3 months

          -  women who are pregnant, nursing, or planning to become pregnant
The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold
Condition: Healthy
MeSH terms: Hypersensitivity
Intervention: Intervention 1; Washout Period; Intervention 2
Intervention description: Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 1 (Day 1).; The wash-out period will be between intervention 1 and intervention 2. 13 days in length.; Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 2 (Day 14).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Volunteers

Summary:

      Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The
      vast majority of basic science studies suggested a large effect of oxytocin in minimizing
      acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and
      pain in humans. Since addictive properties of oxytocin have not been described, the drug may
      have important application in the management of acute and chronic pain. No studies have
      examined the effect of intranasal oxytocin on pain sensitivity and threshold.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and females volunteers, English speaking

        Exclusion Criteria:

          -  Pregnancy, lactation, allergy to preservatives, mental disease, any chronic pain and
             any current use of analgesics, anxiety or depression.
Mortality Reduction After Oral Azithromycin Contingency: Mortality Study
Condition: Childhood Mortality
Intervention: Azithromycin; Placebo
Intervention description: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months; Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66228.0
Sex: All
Minimum age: 1 Month
Maximum age: 60 Months
Healthy volunteers: No
Keywords: Childhood mortality; Mass treatment; Azithromycin; Infection

Summary:

      MORDOR was a cluster-randomized placebo controlled trial that assessed the efficacy of mass
      azithromycin distributions for the prevention of childhood mortality. All communities were
      subsequently treated with mass azithromycin for one year. The present trial re-randomized
      communities to azithromycin or placebo for the fourth and fifth year of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Communities- All communities eligible for MORDOR (NCT02047981)

          -  Individuals-All children aged 1-60 months (up to but not including the 5th birthday),
             as assessed via biannual census

        Exclusion Criteria:

          -  Refusal of village chief (for village inclusion), or refusal of parent or guardian
             (for individual inclusion)
A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment, 2%; Hydrocortisone butyrate cream, 0.1%; Pimecrolimus cream, 1%; Crisaborole Vehicle
Intervention description: Applied twice a day (BID); Applied BID; Applied BID; Applied BID
Intervention MeSH terms: Hydrocortisone; Pimecrolimus; Hydrocortisone-17-butyrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The investigational products above are masked for appearance, and will be placed into identical cartons. Once removed from the product cartons, the investigational products could be discerned from each other based on commercial product tube shape/size and should only be handled by unblinded site personnel.
Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.
Enrollment: 237.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis, Crisaborole ointment 2%, TCS, TCI

Summary:

      This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%;
      crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice
      daily (BID) in subjects who are at least 2 years of age with mild-moderate AD.

      A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to <18 years
      old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or
      Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be
      conducted at select sites.
    

Eligibility criteria:

        Inclusion Criteria:

        Is male or female 2 years and older at the Screening visit/time of informed consent/assent
        diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at
        least 5% BSA.

        Exclusion Criteria:

        Has any clinically significant medical disorder, condition, or disease (including active or
        potentially recurrent non AD dermatological conditions and known genetic dermatological
        conditions that overlap with AD, such as Netherton syndrome.

        Subjects in Cohort 1 are excluded if they have a contraindication for treatment with
        hydrocortisone butyrate cream 0.1%

        Subjects in Cohort 2 are excluded if they have a contraindication for treatment with
        pimecrolimus cream, 1%
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Condition: Tibial Tubercle Osteotomy
MeSH terms: Hemarthrosis
Intervention: Tranexamic Acid (TXA)
Intervention description: One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Tibial Tubercle Osteotomy; Tranexamic Acid

Summary:

      The purpose of the proposed study is to evaluate the effects of administering intravenous
      tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle
      osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and
      swelling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing TTO

          -  Age 18-60

          -  Willing and able to provide consent

        Exclusion Criteria:

          -  Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects,
             dementia, etc.)

          -  Younger than 18 years of age

          -  Older than 60 years of age

          -  Any patient considered a vulnerable subject

          -  Have bleeding or clotting disorder

          -  Preoperative anticoagulation therapy

          -  Abnormal coagulation profile

          -  Renal disorder or insufficiency

          -  Sickle cell disease
Preterm Infant Inhaled Albuterol Dosing
Condition: Bronchopulmonary Dysplasia; Very Low Birth Weight
MeSH terms: Bronchopulmonary Dysplasia; Birth Weight
Intervention: Varied albuterol dose response
Intervention description: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to 33w6d. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a sinlge dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 14 Days
Healthy volunteers: No
Keywords: Bronchopulmonary dysplasia; very low birth weight; albuterol; pulmonary function test

Summary:

      The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in
      premature babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic
      lung disease of prematurity and is associated with increased morbidity and mortality, longer
      hospital stays, and increased healthcare utilization. Albuterol is an inhaled medication
      frequently used in premature infants with chronic lung disease and in people with asthma. It
      is believed to be safe, but the optimal dose for infants is not clear. The investigators
      hypothesize that albuterol may help a subset of premature infants with lung disease, but they
      need to determine the best dose prior to doing research about how effective it is for chronic
      lung disease/BPD. Response to each of three doses of albuterol will be measure using
      pulmonary function tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  very low birthweight infant (<1500g)

          -  gestational age at birth <32 weeks

          -  age 14 or more days and corrected to 28w0d to 33w6d gestational age

          -  continuing to require respiratory support and/or supplemental oxygen

        Exclusion Criteria:

          -  chromosomal abnormalities

          -  major congenital anomalies

          -  congenital heart disease, except atrial septal defect and patent ductus arteriosus

          -  clinical providers determine subject too unstable to undergo pulmonary function
             testing
Vildagliptin Versus Dapagliflozin on Glucagon
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Vildagliptin; Dapagliflozin
Intervention description: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks; Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks
Intervention MeSH terms: Dapagliflozin; Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects
      on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2
      diabetes and whether this is associated with effects on glucose homeostasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written consent has been given.

          2. Patients with type 2 diabetes treated with a stable dose of metformin during the last
             three months

          3. Age 20-70 years.

          4. HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1.

          5. Ability to complete the study

        Exclusion Criteria:

          1. Use of other glucose-lowering therapy than metformin within three months prior to
             visit 1.

          2. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.

          3. Type 1 diabetes, positive GAD antibodies

          4. Estimated glomerular filtration rate <60 ml/min

          5. Acute infections which may affect blood glucose control within 4 weeks prior to visit
             1

          6. Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.

          7. Any history of acute pancreatitis

          8. Any history of anaphylaxis, angioedema, and exfoliative skin conditions including
             Stevens-Johnson syndrome.

          9. Liver disease such as cirrhosis or chronic active hepatitis

         10. History of coronary heart disease or heart failure class III or IV

         11. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at
             least one unit of blood within the past 2 weeks or a blood transfusion within the past
             8 weeks.

         12. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment
             (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.

         13. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable
             for the study

         14. Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
Azithromycin for Children Hospitalized With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Azithromycin; Placebo
Intervention description: Azithromycin suspension (200mg/5mL)
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; Acute asthma exacerbation; Pediatric; Azithromycin; Macrolide; Length of Stay; Hospital Medicine

Summary:

      Asthma is a chronic lung condition in children, and often requires hospitalization for acute
      exacerbations. Azithromycin has been used successfully in other chronic lung diseases,
      including cystic fibrosis. Despite limited clinical evidence, some pediatricians use
      azithromycin in children hospitalized with asthma, citing either treatment of atypical
      pathogens or its proposed anti-inflammatory properties. This study proposes a clinical trial
      to determine if azithromycin will shorten length of stay in children hospitalized with acute
      asthma exacerbations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  4-12 years of age

          -  Admission diagnosis of asthma at the Children's Hospital at Montefiore

          -  History of persistent asthma (as defined by National Heart, Lung, and Blood Institute)

        Exclusion Criteria:

          -  Concurrent bacterial infection requiring antibiotics

          -  Antibiotics received within previous 2 weeks

          -  Contraindication to azithromycin (including allergy to macrolides)

          -  Chronic lung disease other than asthma (including bronchopulmonary dysplasia, cystic
             fibrosis, bronchiectasis) or home oxygen requirement

          -  Immunodeficiency (primary or acquired)

          -  Chronic systemic steroid use

          -  Invasive or non-invasive mechanical ventilation required acutely as result of current
             asthma admission

          -  Significant cardiac co-morbidity (including hemodynamically significant cardiac
             disease or arrhythmia)

          -  Liver disease (hepatitis)

          -  Pregnancy

          -  Seizure disorder, currently on anti-epileptic medication)

          -  Receiving albuterol every 4 hours (q4h) at the time of enrollment

          -  Previous enrollment in study
The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis
Condition: Rhinosinusitis; Chronic Eosinophilic Rhinosinusitis; Allergic Rhinosinusitis
MeSH terms: Sinusitis; Rhinitis, Allergic
Intervention: Budesonide; Saline alone
Intervention description: Participants will undergo 4-week treatment course that includes budesonide powder added to saline rinse.; Participants will undergo 4-week treatment course that includes lactose (placebo) powder added to saline rinse.
Intervention MeSH terms: Budesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: sinusitis; rhinosinusitis; rhinitis; nasal lavage

Summary:

      The goal of this research project is to explore the impact of the addition of budesonide to
      high-volume, low-pressure nasal sinus saline irrigation (aka "Neti-Pot"-type systems) for
      patients with chronic rhinosinusitis with or without nasal polyps.
    

Eligibility criteria:

        Inclusion Criteria:

        Twelve (12) weeks or longer of two or more of the following signs and symptom consistent
        with chronic rhinosinusitis (CRS)

        • mucopurulent drainage (anterior, posterior, or both), nasal obstruction
        (congestion),facial pain-pressure-fullness, and decreased sense of smell

        AND inflammation documented by one or more of the following findings:

          -  purulent (not clear) mucus or edema in the middle meatus or ethmoid region,

          -  polyps in nasal cavity or the middle meatus, and/or

          -  radiographic imaging showing inflammation of the paranasal sinuses

        Exclusion Criteria:

          -  Unable to speak English

          -  History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary
             condition

          -  Dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma
             and chronic obstructive pulmonary disease.

          -  History of oral or systematic antibiotic use in the past 2 weeks

          -  History of nasal or sinus surgery within past 6 weeks

          -  History of cerebrospinal fluid leak

          -  History of allergy to budesonide or other topical steroids

          -  Pregnant or breast feeding

          -  Current infection or history of one of the following infections: Tuberculosis (TB)
             lung infection, or Herpes infection of the eye.

          -  Baseline SNOT-22 total scores below 9 were excluded due to the inability to achieve a
             minimally clinically improved difference
Cost- Effectiveness and Quality of Life Assessment in Mood Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder; Mood Disorders
Intervention: Lithium; Valproic Acid; Carbamazepine
Intervention MeSH terms: Carbamazepine; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cost effectiveness; Bipolar disorder; Mixed episodes; Quality of life

Summary:

      To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD)
      mixed episodes using medications available in the Brazilian Public Healthcare System (SUS),
      and assessment of the quality of life of these patients.

      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of
      episodes of bipolar mixed 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.