bioihbjkbjnl/mcl2 huggingface dataset:
Below Knee DVT Study
Condition: Deep Vein Thrombosis (DVT); Blood Clots
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Low Dose Enoxaparin; High Dose Enoxaparin
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lovenox; enoxaparin; DVT

Summary:

      Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis
      or DVT), which can lead to death if those clots break off and migrate to the lungs. We know
      that if there is a blood clot in the large leg veins near the hips and in the thighs,
      treating these patients with high-doses of blood thinners reduces the risk of these deaths.

      It is unclear if treating blood clots in the calf with high doses of blood thinners is better
      than using low doses. In this study, after being diagnosed with a blood clot in the calf,
      patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood
      thinner. We will then see if low dose blood thinner has similar results as high dose blood
      thinner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18 admitted to a trauma or general surgery service will be
             eligible

          -  Patients diagnosed with an isolated distal DVT

          -  Able to obtain informed consent

        Exclusion Criteria:

          -  Patients with a previous diagnosis of hypercoagulability

          -  Patients on chronic anticoagulation

          -  Patients with a history of heparin induced thrombocytopenia

          -  Patients have preexisting contraindications to anticoagulation

          -  Patients in renal failure requiring adjusted enoxaparin dosing

          -  Pregnant patients
Intravenous Lidocaine Randomized Comparative Effectiveness Trial
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Intervention: Hydromorphone; Lidocaine
Intervention description: Hydromorphone intravenous infusion; Lidocaine intravenous infusion
Intervention MeSH terms: Lidocaine; Hydromorphone
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: Double-blind
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, emergency department based, comparative effectiveness
      study of two medication for acute abdominal pain: intravenous lidocaine and intravenous
      hydromorphone. Patients will be enrolled during an emergency department visit and followed
      throughout their emergency department course and then by telephone 7 days later.
    

Eligibility criteria:

        Inclusion Criteria:Eligible patients are those who present to an ED for treatment of acute
        abdominal pain. Acute will be defined as pain for no more than seven days. At the time of
        enrollment, the ED treatment plan must include use of an intravenous opioid.

        Exclusion Criteria: Patients will be excluded from participation if they have cardiac
        conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, or PR interval
        duration > 0.2s), known renal (CKD >2) or liver disease (Childs-Pugh B or greater), are
        hemodynamically unstable, as determined by the attending physician, are pregnant or
        breastfeeding, or have a known allergy to either medication. Patients will also be excluded
        if they have used prescription or illicit opioids within the previous week, or if they have
        a chronic pain disorder, defined as use of any analgesic medication on more days than not
        during the month preceding the acute episode of pain. Patients weighing < 60kg or > 120kg
        will be excluded.

        -
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: Gabapentin; Acetaminophen; Celecoxib
Intervention MeSH terms: Acetaminophen; Celecoxib; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the investigators' study is to assess the efficacy of a single dose of
      preoperative gabapentin within an enhanced recovery after surgery protocol in acute
      postoperative pain reduction for women undergoing a minimally invasive hysterectomy.
      Participants who consent to participate will be randomized to either a control group without
      gabapentin or to a study arm and receive gabapentin 600 mg prior to their planned surgery.
      The investigators will collect data on postoperative narcotic use, subjective pain as rated
      by a numeric pain scale, in addition to any adverse effects of single dose gabapentin use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing a minimally invasive hysterectomy with surgeons operating within the
             Christiana Care Health System at the Newark location only.

          -  at least 18 years of age

          -  able to swallow tablets or capsules

        Exclusion Criteria:

          -  liver failure

          -  renal failure

          -  prior gastric bypass

          -  gastroparesis

          -  recent or current regular gabapentin use

          -  hypersensitivity to gabapentin, acetominophen, or celecoxib

          -  procedure is converted to laparotomy for any indication. (Mini-laparotomy for specimen
             removal alone will not be excluded.)
Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Condition: Asthma
MeSH terms: Asthma
Intervention: Dulera
Intervention description: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adherence monitoring; Motivational Interviewing Adherence strategies

Summary:

      40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20,
      will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3
      months. These intervention subjects will receive medication use feedback at each visit, while
      the control group will receive the standard of asthma care. Those interventional subjects
      with Dulera adherence<60% will receive feedback based on an asthma adherence disease
      management model protocol, Asthma Adherence Pathway. Intervention clinicians will been
      trained in Motivational Interviewing to reduce subject ambivalence about medication use. The
      primary hypothesis is that subjects who receive medication monitoring and Motivational
      Interviewing adherence strategies will have better asthma control, as measured by the Asthma
      Control Questionnaire, than the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Physician diagnosis of asthma of moderate severity

          2. Subjects ≥ 18 years of age

          3. Currently receiving an inhaled corticosteroid medication and being prescribed Dulera
             100/5 as part of standard of care based upon asthma severity and dosing guidelines

          4. Asthma Control Questionnaire (ACQ) result > 1.0 at entry

          5. Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs)

          6. History of reversible airway obstruction documented by treating physician Exclusion
             Criteria: intermittent asthma; emphysema, chronic obstructive pulmonary disease;
             chronic bronchitis; cystic fibrosis; medication that may have a drug interaction with
             Dulera

        Exclusion Criteria

          1. Intermittent asthma (asthma exacerbations or symptoms < 3 days/week)

          2. Diagnosis of emphysema in prior year

          3. Diagnosis at any time of: chronic obstructive pulmonary disease (COPD), chronic
             bronchitis, cystic fibrosis, bronchiectasis, Churg Strauss, Wegener's, sarcoidosis,
             pulmonary hypertension or lung cancer

          4. On any medication documented to have a drug interaction with Dulera
Cryoanalgesia vs. Epidural in the Nuss Procedure
Condition: Pectus Excavatum; Funnel Chest
MeSH terms: Funnel Chest
Intervention: Cryoanalgesia; Thoracic epidural (ropivicaine, fentanyl)
Intervention description: Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Nuss; Nuss Procedure; pectus excavatum; cryoanalgesia

Summary:

      The purpose of this study is to determine whether cryoanalgesia provides better pain control
      for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.
    

Eligibility criteria:

        Inclusion Criteria:

          -  scheduled for Nuss procedure for pectus excavatum correction

          -  at least 13 years old at the time of the procedure

        Exclusion Criteria:

          -  age less than 13 years at time of procedure

          -  use of pain medication prior to procedure

          -  pectus carinatum, Poland's syndrome, or any chest wall anomaly other than pectus
             excavatum

          -  previous repair of pectus excavatum by any technique

          -  previous thoracic surgery

          -  congenital heart disease

          -  bleeding dyscrasia

          -  major anesthetic risk factors or history of previous problem with anesthesia

          -  pregnancy

          -  inability to communicate in English
Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Bacteriostatic Normal Saline; 1% Lidocaine
Intervention description: A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.; A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Local anesthetic

Summary:

      The purpose of this study is to determine if creation of a skin wheel with bacteriostatic
      normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar
      level of anesthesia compared to 1% lidocaine. Participants will receive both types of
      anesthesia, in random order.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for an initial lumbar medial branch block

        Exclusion Criteria:

          -  Allergy to local anesthetics

          -  Fibromyalgia

          -  Inability to provide informed consent in English

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Prisoners
Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Methadone; Morphine
Intervention description: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.; To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 31.0
Sex: All
Minimum age: 2 Hours
Maximum age: 28 Days
Healthy volunteers: No
Keywords: NAS; NICU; EMMC

Summary:

      Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter
      duration of opiate medication treatment and fewer infants treated with a second drug.
    

Eligibility criteria:

        Inclusion Criteria:

        i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores > 8 in an 8
        hour time period, AND

        ii. Gestation => 35 weeks at entry defined by best obstetrical and physical exam criteria,
        AND

        iii. Medically stable condition in the opinion of the attending neonatologist, other than
        opiate withdrawal, AND

        iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.

        Exclusion Criteria:

        i. Gestation < 35 weeks at entry defined by best obstetrical and physical exam criteria.

        ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,

        iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis,
        intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission
        to the NICU.

        iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal
        course

        v. Mother consistently taking prescribed benzodiazepine at the time of delivery
Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Condition: Diabetic Ketoacidosis; Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Ketosis; Acidosis; Diabetic Ketoacidosis
Intervention: Early Glargine; Late Glargine; IV insulin infusion; IV fluid and electrolytes replacement
Intervention description: A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion; A historical retrospective control group for the adult patients admitted to the same ICU with a diagnosis of DKA and received insulin glargine after anion gap closure.; Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol; The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years old

          -  Meet DKA definition (BG ≥ 250 mg/dl, Anion Gap > 12 mEq/L, and positive Ketones in
             serum or urine)

          -  Having the capacity to sign Informed consent

        Exclusion Criteria:

          -  IV insulin infusion was initiated for more than 4 hours.

          -  Persistent hypotension (SBP<80 mmHg despite receiving 1000cc normal saline).

          -  Require Vasopressor

          -  Acute Coronary Syndrome

          -  Pregnant

          -  End-stage renal disease

          -  Unwilling to consent to participate in the trial

          -  Currently under police custody

          -  Transferred from another hospital

          -  Require emergent surgery
The Effects of Dexmedetomidine on the Heart Beat During Elective Surgery in Children
Condition: Myocardial Repolarization; Healthy
Intervention: Dexmedetomidine; Saline
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 3 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: changes in myocardial repolarization in healthy children

Summary:

      Dexmedetomidine is a sedative drug that is commonly used to improve calmness and reduce pain
      in children waking up after surgery. Some of the side effects of dexmedetomidine, such as a
      potential change in how the heart muscles contract and changes in blood sugar and potassium
      levels, are poorly understood. The current study aims to examine these changes directly in
      healthy children undergoing elective surgery by measuring the heart beats (with an
      electrocardiogram) and blood sugar and potassium at specific times before and after
      dexmedetomidine is given. The investigators aim to establish a better understanding of this
      drug's safety profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA Physical Status I-II

          -  Age 3 to 10yrs

          -  Elective surgical procedure requiring general anesthesia

          -  Use of dexmedetomidine acceptable to the staff anesthesiologist

          -  Un-premedicated

          -  Ability to read and understand English (parent/legal guardian(s) and child)

        Exclusion Criteria:

          -  Long QT syndrome (LQTS)

          -  Cardiac disease or rhythm abnormalities

          -  Family history of LQTS or abnormal cardiac conduction

          -  Currently taking medications known to prolong QT

          -  Currently taking medications known to predispose to hypokalemia

          -  Known hypersensitivity to dexmedetomidine or other study medication

          -  Weight < 5th centile or > 95th centile for age

          -  Previously diagnosed hypokalemia

          -  Impaired renal or liver function

          -  Pre-operative anxiety requiring sedatives or opioids

          -  Refusal to participate
Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Condition: Rib Fractures
MeSH terms: Fractures, Bone; Rib Fractures
Intervention: Saline infusion; Lidocaine infusion
Intervention description: Normal saline infusion at 10mL/hour; Lidocaine infusion at 1.0mg/kg/hr
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current cornerstone of pain control for rib fractures is oral and intravenous opioids,
      especially in the form of patient-controlled analgesia (IV PCA), which are are associated
      with multiple adverse effects including sedation, respiratory depression, cough suppression,
      and increased risk of delirium.

      In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in
      the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that
      IVL is overall well tolerated and have shown other beneficial effects such as
      anti-inflammatory properties. To this date, there have been no published randomized clinical
      trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture
      pain.

      Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide
      improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours
      compared to placebo in adult patients with acute traumatic rib fractures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all adult patients admitted to Stanford Health Care with two or more acute traumatic
             rib fractures

        Exclusion Criteria:

          -  hemodynamically instability

          -  mechanical ventilation

          -  polytrauma (defined as bone or organ injury outside the thorax)

          -  pregnancy

          -  incarceration

          -  local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome,
             Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or
             intraventricular block)

          -  chronic opioid use.
Hypothyroidism Treated With Calcitonin
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Intervention: Calcitonin
Intervention description: calcitonin nasal spray
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 88 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Some people with hypothyroidism have persistent symptoms despite adequate treatment with
      thyroid hormones. We are testing whether giving calcitonin to such people will improve their
      quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal TSH on levothyroxine therapy

        Exclusion Criteria:

          1. pregnant or 6 months post partum

          2. Current or previous thyroid cancer

          3. Congenital hypothyroidism

          4. any tobacco use

          5. prescribed proton pump inhibitors

          6. prescribed steroids

          7. taking armour thyroid, naturethroid, or any dessicated thyroid hormone

          8. Unstable medical conditions (CKD, Cirrhosis etc)

          9. pituitary disease