bioihbjkbjnl/mcl2 huggingface dataset:
Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: simvastatin; ezetimibe/simvastatin
Intervention description: Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.; Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: triglycerides; hypertension; low hdl; obesity

Summary:

      To determine whether the combination of ezetimibe and simvastatin improves biomarkers of
      atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women greater than or equal to 21 years of age

          2. Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based
             on the US National Cholesterol Education Program's Adult Treatment Panel III
             guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3
             of the following 5 characteristics will be present:

               -  abdominal obesity, given as waist circumference for men > 102 cm, and for women >
                  88 cm

               -  triglycerides > 150 mg/dL

               -  HDL cholesterol < 40 mg/dL for men, and < 50 mg/dL for women

               -  blood pressure > 130/85 mm Hg

               -  fasting glucose > 100 mg/dL

        Exclusion Criteria:

          1. Patients will be excluded for a history of bleeding diathesis

          2. drug or alcohol abuse

          3. prothrombin time greater than 1.5 times control

          4. platelet count < 100,000/mm3

          5. hematocrit < 25%

          6. creatinine > 4.0 mg/dl

          7. surgery or angioplasty performed within 3 months or planned for the future

          8. history of gastrointestinal or other bleeding

          9. history of drug-induced disorders

         10. trauma, cancer, rheumatic diseases, coronary artery disease or stroke

         11. Patients participating in other investigational drug trials within one month of
             completion will be also excluded

         12. Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or
             thienopyridines, within past 6 months

         13. Patients treated with statins or aspirin within past four weeks
A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Erenumab
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Erenumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The purpose of this study is to measure the gastrointestinal emptying time using the wireless
      motility capsule (WMC) technology (FDA approved SmartPill™) in adult participants with
      migraine who are taking a monoclonal antibody (mAb) calcitonin gene-related peptide (CGRP)
      antagonist called galcanezumab or erenumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of migraine, with or without aura, as determined by the study
             investigator and in consideration of International Headache Society International
             Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)

          -  Have a frequency of less than 15 monthly headache days of which up to 14 can be
             migraine headache days.

          -  Participants can be on no more than 1 other migraine preventive treatment (except for
             tricyclic antidepressants and verapamil which are not allowed) as long as: that
             participant has had a stable dose of the oral migraine preventive treatment for a
             minimum of 2 months or participants have received onabotulinumtoxinA for a minimum of
             2 cycles prior to screening

        Exclusion Criteria:

          -  Participants with a history of gastric bezoars, swallowing disorders, severe dysphagia
             to food or pills, suspected or known strictures, fistulas, or physiological/mechanical
             GI obstruction

          -  History of any abdominal surgery within the past 3 months or GI surgery with the
             exception of cholecystectomy, appendectomy, or Nissen fundoplication

          -  History of irritable bowel syndrome (IBS), chronic constipation, Crohn's disease,
             celiac disease, ulcerative colitis, or diverticulitis

          -  Participants with type 1 or type 2 diabetes

          -  Participants with cardiac pacemakers or other implanted or portable electromechanical
             device

          -  Participants with a body mass index of ≥40 kilograms per square meter (kg/m²)

          -  Women who are pregnant or nursing

          -  Participants currently on mAb CGRP antagonists or have received a mAb CGRP antagonist
             within the past 6 months prior to visit 1

          -  Participants who have received an oral CGRP antagonist (gepant) in the last 14 days
             prior to Visit 1
Contrast Nephropathy and Nitrates
Condition: Contrast Induced Nephropathy
MeSH terms: Kidney Diseases
Intervention: Intravenous Nitroglycerin; IV Fluids
Intervention MeSH terms: Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Contrast-induced nephropathy (CIN) is a complication of percutaneous coronary angiography
      that occurs in about 10 to 20% of patients exposed to contrast media. Iodinated contrast is
      used during coronary angiography to see the coronary arteries. It has been shown that
      exposure to this agent may cause kidney injury. CIN usually goes away on its own but in some
      high risk patients it progresses into renal failure.

      This research study offers a new possible option to prevent CIN. We propose that if
      intravenous nitroglycerin is given before the procedure it may lower the chances of
      developing contrast-induced nephropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must be scheduled for percutaneous coronary angiography.

          2. Patients must have a Mehran score more or equal to 6 before the procedure.

          3. Patients must have baseline creatinine and hemoblogin drawn before the procedure.

          4. Signed informed consent.

        Exclusion Criteria:

          1. Patients on renal replacement therapy before randomization, will be excluded.

          2. Being exposed to any types of nitrates 48 hours prior to randomization,

          3. History of allergic reaction to any of the components of intravenous nitroglycerin.

          4. Exposure to contrast media 4 days prior randomization.

          5. Planned revascularization in the next 24 to 48 hours of the first PCI procedure.

          6. The patient is hypotensive (<90/60mmHg) at the time of randomization.
A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg by intravenous infusion every 4 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra
      (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8
      mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic
      therapy, for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age

          -  Confirmed moderate or severe rheumatoid arthritis

          -  Intolerability or absence of effect or decrease in effect of rheumatoid arthritis
             treatment with disease modifying antirheumatic drugs (DMARDs)

        Exclusion Criteria:

          -  Presence of infectious diseases [tuberculosis (Tb), human immunodeficiency virus
             (HIV), virus hepatitis A/B/C]

          -  Inadequate hematologic, renal or liver function

          -  Peptic ulcer disease (in acute phase)

          -  Pregnant and lactating women
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Condition: Hepatitis A Virus
MeSH terms: Hepatitis A; Hepatitis
Intervention: Comparator: VAQTA™ (Hepatitis A vaccine); Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine); Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Intervention description: VAQTA™ 0.5 mL injection; ProQuad™ 0.5 mL injection; Prevnar™ 0.5 mL injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 653.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis A Virus

Summary:

      Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and
      varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together
      with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose.
      Immunogenicity and safety data will be collected after each dose of vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12- to 15-month-old males and females with no active liver disease

          -  A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster

        Exclusion Criteria:

          -  Males and females previously vaccinated with hepatitis A, measles, mumps, rubella,
             and/or chickenpox vaccine

          -  Any immune deficiency

          -  History of allergy to any of the vaccine components

          -  History of any seizure disorder
Effects of a Pectoralis Minor Muscle Stretching Protocol
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Stretching-Asymptomatic subjects; Stretching-Subjects with shoulder pain
Intervention description: The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.; The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: shoulder; pectoralis minor; stretching; scapular kinematics

Summary:

      The purpose of this study is to verify the effects of a stretching protocol for the
      pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during
      arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened
      pectoralis minor.
    

Eligibility criteria:

        Inclusion Criteria:

        Asymptomatic subjects were included if they did not have any positive test for SIS.

        The subjects with shoulder pain were included if:

          1. they had history of shoulder, at least one week;

          2. 18 - 45 years;

          3. range of motion > 150° evaluated with digital inclinometer;

          4. one or more impingement tests positive - Neer (Neer, 1972), Hawkins (Hawkins and
             Kennedy, 1980) and Jobe (Jobe and Moynes, 1982) - associated with painful arc during
             arm elevation, or during external rotation with 90° of arm elevation;

          5. Individuals from both groups also had to present with shortened PM muscle length.

        Exclusion Criteria:

        Individuals from both groups were excluded if they:

          1. BMI (body mass index) > 28kg/m2;

          2. irradiated shoulder pain;

          3. scoliosis;

          4. history of shoulder pain with beginning traumatic;

          5. history of fracture or surgery in upper limb and rotator cuff;

          6. systemic illnesses;

          7. tape allergy;

          8. were pregnant;

          9. physiotherapy at least 6 months.
Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers
Condition: Onset and Duration of a Digital Nerve Block
Intervention: Lidocaine Digital Nerve Block; Bupivacaine Digital Block
Intervention description: Lidocaine 1% Digital Nerve Block (2 cc; Bupivacaine 0.25% Digital Block (2 cc)
Intervention MeSH terms: Lidocaine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The duration of the autonomic (sympathetic) block will last longer than the sensory block.
      The duration of the increased perfusion index will last longer than either the sympathetic or
      sensory block.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smokers

        Exclusion Criteria:

          -  History of allergic response to local anesthetics

          -  BMI >25

          -  Pregnant of nursing

          -  Current smokers or past smokers of > 1 pack year history

          -  Neurological deficit and/or injury in the upper extremities

          -  Current respiratory infection

          -  Per investigator judgement, would not be suitable for study
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Condition: Pain, Postoperative; Mammaplasty
MeSH terms: Pain, Postoperative
Intervention: Depofoam bupivacaine; Bupivacaine hydrochloride (HCl)
Intervention description: The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.; The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients undergoing breast reconstruction with tissue expanders will be treated with a local
      anesthetic during their procedure and monitor their post-operative pain level and amount of
      oral pain medication taken. This information will be used to determine if liposomal
      bupivacaine provides better and longer pain control vs. bupivacaine HCl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing breast reconstruction with tissue expander

        Exclusion Criteria:

          -  history of adverse reaction to local anesthesia

          -  chronic liver disease

          -  history of chronic preoperative consumption of narcotics or opioids

          -  history of alcohol and/or illicit drug dependence

          -  undergoing combined procedures

          -  diagnosed with neuromuscular/neurosensory disorder

          -  positive pregnancy test

          -  previous breast conservation therapy (lumpectomy with radiation treatment

          -  previous surgeries or trauma in the breast or chest region (denervation may bias pain
             perception)

          -  axillary node dissection

          -  psychosis.
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
Condition: Non-Cystic Fibrosis Bronchiectasis
MeSH terms: Bronchiectasis; Fibrosis
Intervention: Amikacin; Normal saline
Intervention description: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.; Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
Intervention MeSH terms: Amikacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Nebulized amikacin;; Non-Cystic Fibrosis Bronchiectasis;; Bacterial clearance rate of sputum；; Acute exacerbation.

Summary:

      This is a multi-centered, randomized, controlled study to assess the efficacy, indications
      and adverse reactions of combined administration of nebulized amikacin in patients with acute
      exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled
      antibiotics are more likely to cause bacterial resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female study subjects ≥18 years of age and ≤80 years of age;

          -  Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis;

          -  Confirmation of infection with Pseudomonas aeruginosa at screening;

          -  Are sensitive to amikacin;

          -  Acute exacerbation of bronchiectasis.

        Exclusion Criteria:

          -  Bronchiectasis due to special causes;

          -  Smokers;

          -  Are associated with bronchial asthma;

          -  Have any serious or active medical or psychiatric illness;

          -  Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces ≥15% after
             inhaling amikacin.
Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Intervention: Endotracheal tube insertion; Laryngeal mask airway insertion
Intervention description: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg); Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 4 Hours
Maximum age: 48 Hours
Healthy volunteers: No
Keywords: Respiratory distress syndrome; Surfactant; Tracheal intubation; Laryngeal mask airway; Newborn

Summary:

      In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via
      nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of
      surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to
      surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and
      return babies to nasal CPAP, after surfactant is given. The primary outcome measure is the
      rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a)
      early, if the baby is unable to be placed back on CPAP (needs mechanical ventilation) or, b)
      late, if the baby requires retreatment with surfactant within 8 hours or more than 2 doses of
      surfactant.

      The objective of this protocol is to reduce the need for endotracheal intubation and
      mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by
      instilling surfactant though an LMA, while achieving comparable efficacy of surfactant
      treatment.

      The hypothesis is that surfactant treatment through an LMA will decrease the proportion of
      babies with RDS who require mechanical ventilation or subsequent intubation, when compared
      with standard surfactant treatment following sedation and endotracheal intubation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild-to-moderate RDS

          -  Postnatal age 4 to 48 hours

          -  Gestational age 29 0/7 to 36 6/7 weeks

          -  Treated with nasal CPAP ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours
             to maintain SpO2 88-95%

          -  Informed consent

        Exclusion Criteria:

          -  Weight < 1000 g

          -  Airway anomalies

          -  Pulmonary air leaks

          -  Craniofacial or cardiothoracic malformations