bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Epidural Local Anesthetics on Propofol Induction
Condition: General Anesthesia; Propofol Target-controlled Infusion; Thoracic Epidural Anesthesia
Intervention: Lidocaine; Bupivacaine; Ropivacaine; Normal Saline
Intervention description: General anesthesia combined with thoracic epidural 1% lidocaine; General anesthesia combined with thoracic epidural 0.25% bupivacaine; General anesthesia combined with thoracic epidural 0.3% ropivacaine; General anesthesia combined with thoracic epidural 0.9% normal saline
Intervention MeSH terms: Lidocaine; Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The investigators designed a prospective, randomized, placebo-controlled study to determine
      whether thoracic epidural anesthesia(TEA) with different local anesthetics has different
      influences on the propofol dose during induction.
    

Eligibility criteria:

        Inclusion Criteria:

        Surgery for thoracotomies, BMI: 18-25 Kg/m2, American Society of Anesthesiologists(ASA)
        classification I or II.

        Exclusion Criteria:

        liver or kidney disease, alcohol dependence, take sedative recently, contraindications for
        epidural anesthesia.
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Condition: Tachycardia, Ventricular; Ventricular Fibrillation
MeSH terms: Tachycardia; Ventricular Fibrillation; Tachycardia, Ventricular
Intervention: Implantable Cardiac Defibrillator
Intervention description: Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 925.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ATP; Thachy; FVT

Summary:

      The purpose of this study is to estimate and quantify the difference in efficacy of two
      sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an
      episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via
      ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD
      implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve
      quality of life outcomes for patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ICD indications (Class I-II A) according to the guidelines (patient with coronary
             artery disease [CAD] or non-CAD in primary or secondary ICD prevention)

          -  Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for
             FVT via VF

        Exclusion Criteria:

          -  Patient's life expectancy less than 1 year due to a non-cardiac chronic disease

          -  Patient on heart transplant list which is expected in < 1 year

          -  Patient's age less than 18 years

          -  ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD)

          -  Unwillingness or inability to provide written informed consent

          -  Enrollment in, or intention to participate in, another clinical study during the
             course of this study

          -  Inaccessibility for follow-up at the study center

          -  Ventricular tachyarrhythmias associated with reversible causes

          -  Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients

          -  Other electrical implantable devices (neurostimulators, etc.)

          -  Mechanical tricuspid valve
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Intervention: Magnesium Oxide; MIYAIRI-BM
Intervention description: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg; MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg
Intervention MeSH terms: Magnesium Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 6 Months
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare the differences of fecal microflora between constipated and non-constipated
      healthy children, and evaluate the efficacy of probiotics in reducing symptoms of
      constipation and the influence of intestinal microflora in children with functional
      constipation.
    

Eligibility criteria:

        Inclusion Criteria:

        Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4
        years old is as the following:

          1. Two or fewer defecations per week.

          2. At least one episode per week of incontinence after acquiring toileting skills.

          3. History of excessive stool retention.

          4. History of painful or hard bowel movements.

          5. Presence of a large fecal mass in the rectum.

          6. History of large-diameter stools that may obstruct the toilet. Children aged 6 months
             - 4 years old is evaluated as functional constipation if two of the situations
             mentioned above lasted for one month.

        Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and
        above is as the following:

          1. Two or fewer defecations in the toilet per week.

          2. At least one episode of fecal incontinence per week.

          3. History of retentive posturing or excessive volitional stool retention.

          4. History of painful or hard bowel movements.

          5. Presence of a large fecal mass in the rectum.

          6. History of large diameter stools that may obstruct the toilet. Children aged 4 years
             old and above is evaluated as functional constipation if two of the situations
             mentioned above happens at least once per week

        Exclusion Criteria:

          1. gastroesophageal reflux disease

          2. inflammatory bowel disease

          3. cardiopulmonary diseases

          4. liver disease

          5. renal disease

          6. genetic diseases

          7. endocrinal diseases

          8. received abdominal surgeries
Community Care for Croup (RCT)
Condition: Croup
MeSH terms: Laryngitis; Croup
Intervention: Prednisone; Dexamethasone
Intervention description: 2 mgs/kg for 3 days; 0.6 mgs for one day, then placebo for 2 days
Intervention MeSH terms: Dexamethasone; Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 1 Year
Maximum age: 8 Years
Healthy volunteers: No
Keywords: Primary Care; Treatment; Croup; Corticosteroids; Prednisone; Dexamethasone; Randomized trial

Summary:

      This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for
      3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate
      croup. It was conducted in a practice-based research network of community pediatricians in
      the St. Louis area. Outcomes included additional health care for croup, duration of symptoms,
      nights of disturbed sleep, parental stress, missed work days, and adverse events. Our
      hypothesis was that community-based treatment of children with mild or moderate croup with
      multiple doses of prednisone is superior to a single dose of dexamethasone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children aged 1 to 8 years old (not yet reached their 9th birthday), who have croup
             symptoms for less than or equal to 48 hours and have a physician diagnosis of mild or
             moderate croup.

        Exclusion Criteria:

          -  Severe croup or impending respiratory failure;

          -  another reason to indicate the need for hospitalization;

          -  symptoms or signs to suggest another cause of stridor;

          -  active varicella infection;

          -  diabetes;

          -  known immunodeficiency disease;

          -  chronic respiratory disease such as CF (Cystic Fibrosis);

          -  prescribed a controller medication or oral steroids for asthma in the past 12 months;

          -  a history of TB(tuberculosis) in a household member;

          -  treatment for seizures;

          -  treatment with epinephrine or oral corticosteroids for this croup episode before
             enrollment;

          -  not accompanied by their legal guardian;

          -  the accompanying adult will not be in the same household as the child for the next
             four days;

          -  parent/legal guardian is unavailable for telephone follow-up or does not speak
             English.
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal; Neonatal Opioid Withdrawal Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome; Substance Withdrawal Syndrome
Intervention: Morphine PRN; Morphine scheduled
Intervention description: Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.; Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Maximum age: 28 Days
Healthy volunteers: No
Keywords: morphine; Finnegan

Summary:

      Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to
      intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  newborn greater than or equal to 35 weeks gestation

          -  intrauterine opioid exposure

          -  signs and symptoms of opioid withdrawal

        Exclusion Criteria:

          -  congenital anomalies or suspected genetic condition

          -  co-morbid conditions that require sedation or analgesia due to clinical condition

          -  ongoing need for respiratory support
Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Intervention: continuous high frequency oscillator (CHFO); Acetylcysteine; dornase alfa
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: atelectasis; continuous high frequency oscillator; acetylcysteine; dornase alfa

Summary:

      The purpose of this study is to evaluate whether a therapy that uses a machine called a
      continuous high frequency oscillator (CHFO) is more successful at removing mucus than
      medications that thin out the mucus.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent from parent or legal guardian.

          2. Age < 18 years and admitted to the PICU or PCICU.

          3. Conventionally ventilated.

          4. Mucolytics are being initiated by clinical team for treatment of atelectasis.

          5. Endotracheal tube ≥ 3.5 mm internal diameter.

        Exclusion Criteria:

          1. Receiving chronic mucolytic or continuous high frequency oscillation therapy.

          2. Clinically significant pleural effusion.

          3. Status post cardiothoracic surgery with open chest.

          4. Pneumothorax.

          5. Pulmonary hemorrhage.

          6. Escalating doses of vasoactive agents (i.e. dopamine or epinephrine).
Study of Glycemic Control on Liver Transplantation Outcomes
Condition: Evidence of Liver Transplantation; Hyperglycemia; Rejection
MeSH terms: Hyperglycemia
Intervention: Insulin
Intervention description: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Liver; transplantation; Glucose; Hyperglycemia; Insulin; Rejection; Hypoglycemia

Summary:

      Many but not all studies have shown improvement in morbidity and mortality with intensive
      glycemic management postoperatively. In this study, the investigators propose to determine
      whether improved glycemic control using intensive insulin treatment immediately
      postoperatively will improve outcomes in patients undergoing liver transplant using a
      prospective, controlled, randomized, parallel-group study design targeting two different
      glucose levels, 140 and 180 mg/dL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Require Liver Transplantation

          2. Age 18 - 80

          3. Able to give informed consent personally or via a family member who has appropriate
             authorization to do so if patient unconscious.

          4. Expected survival following transplantation for > 1 year.

          5. Glucose level over 180 mg/dL postoperatively

        Exclusion Criteria:

          1. Inability of patient or family member to give informed consent

          2. Not expected to survive for > 1 year following liver transplantation.

          3. Previous liver transplantation

          4. Acute liver failure

          5. Living related donor
Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Lifestyle intervention
Intervention description: Patients of active group were assigned to receive activities of the program for life style changes. Patients in control group were managed in frames of routine clinical practice. No any investigational drug therapy was used.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; lifestyle change; weight management; control of glycemic in HbA1C and FPG

Summary:

      This study was aimed to achieve of long-term weight loss in T2DM patients by use of
      comprehensive lifestyle changes program, providing patients with structured diet, exercise
      plan, group behavioral support and group education. Additionally the study was designed to
      establish reduction of the body weight leads to the improvement of glycemic and lipid
      metabolism, and also reducing blood pressure level. The study was also directed to show that
      lifestyle changes program in T2DM patients can lead to decreasing of hospitalization rate and
      healthcare consumption. In order to demonstrate a change from standard of care, data were to
      be collected from a parallel cohort from the same centers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent. Written informed consent must be obtained before any
             assessment is performed.

             •≥ 18 years

          -  Type 2 diabetes

          -  The Body Mass Index is from 28 to 40 kg/m^2

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation.

          -  Type 1 diabetes

          -  Proliferative retinopathy

          -  Renal impairment: serum creatinine >1.5 mg/dL, creatinine clearance < 40 ml/min and/or
             proteinuria

          -  The lack of ability to perform the physical exercises due to the orthopedic or
             cardiovascular disorders

          -  Chronic alcoholism, acute alcoholic intoxication
Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Diet support group; Group counseling and exercise
Intervention description: Diet support group weekly and exercise sessions 3 times/week, placebo medication; Support group weekly and exercise sessions 3 times/week for 24 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Weight loss; Support group; Exercise; Atomoxetine

Summary:

      The study investigates the use of Atomoxetine in combination with exercise and a diet support
      group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All
      patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective
      Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Schizophrenia or schizoaffective Disorder

          -  Taking olanzapine or clozapine for at least 6 months

          -  Weight gain of 7% over baseline or BMI greater than or equal to 27

        Exclusion Criteria:

          -  Current treatment with methylphenidate, clonidine, tricyclic antidepressants,
             bupropion and venlafaxine

          -  Treatment with other medications known to cause weight gain unless weight stable on
             medication for 6 months

          -  Current treatment with other medications for weight loss unless weight stable for 6
             months

          -  Mental Retardation

          -  Alcohol or Substance Dependence within the last 6 months

          -  Pregnancy

          -  Alcohol or Substance Abuse within the lat month

          -  Uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three
             consecutive readings despite adequate treatment
24-hour IOP-lowering Effect of 0.01% Bimatoprost
Condition: Intraocular Pressure; Glaucoma; Ocular Hypertension
MeSH terms: Ocular Hypertension
Intervention: 0.01% bimatoprost
Intervention description: 0.01% bimatoprost once in the evening for 4 weeks
Intervention MeSH terms: Bimatoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in
      patients with glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary open-angle glaucoma or ocular hypertension

        Exclusion Criteria:

          -  Women of childbearing potential previous glaucoma surgery presence of other eye
             disease
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)