bioihbjkbjnl/mcl2 huggingface dataset:
Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
Condition: Asthma
MeSH terms: Asthma
Intervention: xopenex
Intervention description: will receive xopenex rather than albuterol to treat acute exacerbation
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: child; emergency department

Summary:

      The purpose of this study is to determine in a large, double-blind, randomized, prospective
      pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to
      standard emergency department treatment for acute asthma exacerbations will improve the
      Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic
      albuterol. The secondary objective is to correlate clinical (hospitalization rates and
      clinical asthma scores) with plasma levels of (S)-albuterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is between the ages of 6 and 17

          -  Has previously been diagnosed with asthma by any physician

          -  Has presented to the ED with an asthma exacerbation judged by a physician to be of a
             moderate or severe degree

        Exclusion Criteria:

          -  Requires immediate resuscitation (attending physician)

          -  Is pregnant and/or breast feeding

          -  If possibly pregnant, negative pregnancy test attached

          -  Has chronic lung diseases (i.e. cystic fibrosis)

          -  Has an uncorrected congenital heart diseaseHas a suspected foreign body aspiration

          -  Is allergic to albuterol and/or levalbuterol (Xopenex)

          -  Has an initial FEV 1>70% predicted
Bispectral Index-guided Sedation for Flexible Bronchoscopy
Condition: Flexible Bronchoscopy
Intervention: Bispectral index guide propofol infusion; Clinical-judged midazolam administration
Intervention description: Induction:
Alfentanil: 5μg/kg slowly push. Propofol: 0.5-1.5mg/kg slowly push till BIS value 70.
Maintenance:
Propofol infusion (3~12 mg/kg/hour) to maintain BIS around 65~75. Alfentanil: 5μg/kg slowly push Q15min prn if severe cough.; Induction:
Alfentanil: 5μg/kg slowly push. Midazolam: 2 mg slowly push followed by increments of 2 mg/ 2min till OAA/S* 2~3.
Maintenance:
Midazolam: 2 mg/ 2min prn to keep OAA/S* 2~3 or if intolerance of procedure. Alfentanil as study arm.
*Observer's assessment of alertness/sedation (OAA/S):
Class 5: Responds readily to name spoken in normal tone.
Class 4: Lethargic response to name called in normal tone.
Class 3: Responds only to name called loudly.
Class 2: Responds only to shaking.
Class 1: No response to shaking.
Intervention MeSH terms: Midazolam; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: flexible bronchoscopy; sedation; bispectral index

Summary:

      With the advances of flexible bronchoscopy, like metallic stent, electrocautery and real time
      endobronchial ultrasound, the complexity and duration of procedures are increasing. So,
      adequate sedation and analgesia is important for both patients and bronchoscopist.

      Clinical-judged midazolam administration is the current standard. However, midazolam is
      difficult to titrated and the clinical observations are not reliable sedative indices.
      Propofol is titrated easily because of its unique pharmacokinetics. Bispectral index (BIS), a
      real time monitor of depth-of-sedation, has been applied in general anesthesia.

      We design a BIS-guided propofol sedation for bronchoscopy. Through the combination of
      advantages of propofol and BIS, we hope to provide patients a more tolerable and safety
      sedation for bronchoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients (>18 years old) requiring elective flexible bronchoscopy or Real time
             endobronchial ultrasound with transbronchial needle aspiration.

        Exclusion Criteria:

          -  American Society of Anesthesiologists classification of physical status 4 and 5,
             including hepatic or renal failure, severe obstructive sleep apnea and severe chronic
             obstructive pulmonary disease.

          -  Significant Central nervous system disorders or other factors contributing to access
             consciousness difficultly.

          -  Allergic history to study drugs.

          -  A history of glaucoma in the midazolam arm.
Schizophrenic Patients in Integrated Care
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Quetiapine XR; Integrated Care Program (ICP)
Intervention description: 400-800 mg, oral, bid; Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Integrated Care; Quetiapine

Summary:

      The purpose of the study is to investigate the well-being of schizophrenic patients treated
      with quetiapine XR combined with participation in the integrated care program compared to a
      treatment with quetiapine XR alone over a period of 18 month
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with baseline SWN-K <=70

          -  Provision of signed informed consent

          -  Out-patients with schizophrenia, schizophreniform disorder or schizoaffective
             disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum
             HAM-D cut off score of 20 points

        Exclusion Criteria:

          -  Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant
             coronary heart disease, hepatitis B or C, AIDS

          -  Patients with known cardiovascular disease or other condition predisposing to
             hypotension or family history of QT prolongation

          -  Patients who pose an imminent risk of suicide or danger to self or others
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Condition: Post-Operative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: granisetron; granisetron
Intervention description: 20 micrograms intravenously (iv) 15 min prior to end of surgery; 40 micrograms intravenously (iv) 15 min prior to end of surgery
Intervention MeSH terms: Granisetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of
      Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be
      randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril
      intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for
      tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is <3 months,
      and the planned sample size was 170 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males and females 2-16 years of age

          -  scheduled to undergo elective surgery for tonsillectomy or adenotonsillectomy
             requiring general anesthesia and endotracheal intubation

          -  scheduled for hospital admission for no longer than 24 hours

        Exclusion Criteria:

          -  known allergy or other contraindication to the use of Kytril or any of its components

          -  known allergy to any other 5HT3 antagonist

          -  history of motion sickness or post-operative nausea or vomiting

          -  nausea or vomiting in the 24 hours prior to anesthesia
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
Condition: Low Back Pain; Lumbosacral Radiculopathy; Lumbar Disc Degeneration; Lumbar Disc Herniation; Stenosis; Spondylolisthesis; Spondylolysis; Deformity of Spine
MeSH terms: Intervertebral Disc Displacement; Spondylolisthesis; Intervertebral Disc Degeneration; Spondylolysis; Radiculopathy; Low Back Pain
Intervention: Exparel; Bupivacaine
Intervention description: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL; 30 mL bupivacaine 0.5% w/v solution
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to collect information about how patients feel when doctors
      manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine
      injected into the lumbar spine at the end of surgery, compared to the patients that doctors
      use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors
      determine which approach works best for patients who will receive surgery in their lumbar
      spine in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 or older;

          2. Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc
             degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or
             deformity requiring surgical intervention;

          3. Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or
             without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;

          4. Willing to provide informed consent, participate in study, and comply with study
             protocol.

        Exclusion Criteria:

          1. Hypersensitivity or allergy to local anesthetics;

          2. Pregnant or contemplating pregnancy prior to surgery;

          3. Previous surgery in lumbar spine (i.e. other than microdiscectomy);

          4. Prior treatment for alcohol, recreational drug, or opioid abuse;

          5. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal
             infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);

          6. Surgery involving more than 2 vertebral levels;

          7. Worker's compensation or personal injury related to lumbar spine (treatment outcomes
             may be affected by patient's personal interests [21]; could also run into potential
             issues with reimbursement).

          8. Lactating women

          9. Patients with end stage liver disease
Study With Aminophylline to Attenuate of the Side Effects of Regadenoson
Condition: Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
Intervention: Aminophylline; Placebo
Intervention description: 75 mg of intravenous aminophylline; Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Intervention MeSH terms: Aminophylline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 248.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: regadenoson; lexiscan; aminophylline; SPECT; Myocardial Perfusion Imaging; pharmacologic stress test

Summary:

      The routine administration of 75 mg of intravenous aminophylline following regadenoson
      (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce
      the gastrointestinal (diarrhea and stomach upset) and other side effects related to
      regadenoson.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients referred to undergo a clinically-indicated regadenoson-stress
             myocardial perfusion imaging at Rush University Medical Center

        Exclusion Criteria:

          -  Patient refusal to participate

          -  Known allergic reaction to aminophylline.

          -  Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea,
             abdominal discomfort, nausea or vomiting.

          -  Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and
             acute coronary symptoms.

          -  Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12
             months or any seizure in the past week.

          -  Pregnant or breast-feeding women.

          -  Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).
Stereotactic Body Radiotherapy for Head and Neck Tumors
Condition: Squamous Cell Carcinoma of the Head and Neck; Nasopharyngeal Carcinoma; Salivary Gland Cancer; Head and Neck Sarcoma; Paraganglioma of Head and Neck; Chordoma of Head and Neck; Chondrosarcoma of Head and Neck; Angiofibroma of Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Nasopharyngeal Carcinoma; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms; Chondrosarcoma; Paraganglioma; Chordoma; Head and Neck Neoplasms; Angiofibroma
Intervention: stereotactic body radiotherapy; Stereotactic body radiotherapy
Intervention description: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction); 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stereotactic radiosurgery; head and neck tumors; squamous cell carcinoma of head and neck

Summary:

      This study will evaluate the local control rates as well as acute and late toxicity rates of
      stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck
      tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient age > 18 years

          -  Zubrod performance status of 0-3

          -  Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma

          -  Malignant head and neck cancers such as invasive squamous cell carcinoma,
             adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma

          -  Signed study-specific consent form

        Exclusion Criteria:

          -  Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown
             effects of RT on lactating females

          -  Patients with psychiatric or addictive disorder that would preclude obtaining informed
             consent
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
Condition: Healthy
MeSH terms: Skin Diseases
Intervention: Avagard; Purell Surgical Scrub
Intervention description: Topical solution, 6 mL, 6 applications/day for 14 days.; Topical solution, 4 mL, 6 applications/day for 14 days.
Intervention MeSH terms: Chlorhexidine gluconate
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 33.0
Sex: Female
Minimum age: 25 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Skin health

Summary:

      Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female age 25 - 55

          -  Subject agrees not to use any hand wash products on their hands other than what has
             been provided in the study.

          -  Subject agrees not to use any moisturizers or any skin products on their hands during
             the study

          -  Subject agrees to use gloves to protect hands from activities such as dish washing

          -  Subject is willing to sign the Informed Consent and HIPAA

          -  Subject agrees to comply with the study requirement

        Exclusion Criteria:

          -  Subject has a history of psoriasis, active dermatitis, skin reactions, cracked,
             irritated, broken skin, skin infection on their hands

          -  Subject has scaly skin on hands based on Visual Scoring Scale at Day 1

          -  Subject has a sensitivity or history of skin reactions to any study materials (eg,
             alcohol, chlorhexidine gluconate or zinc pyrithone or latex in the gloves)

          -  Subject has been using moisturizing products or any products on their arms and hands
             within 5 days prior to participation in the study

          -  Subject is pregnant

          -  Study coordinator believes the subject is unsuitable for inclusion in the study
Metoclopramide Versus Ketorolac for Tension-type Headache
Condition: Headache
MeSH terms: Tension-Type Headache; Headache
Intervention: Metoclopramide; Ketorolac
Intervention description: metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS; ketorolac 30mg IVSS
Intervention MeSH terms: Ketorolac; Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: headache; tension-type headache

Summary:

      Occasionally, episodic tension-type headache may be severe enough to require an emergency
      department (ED) visit. The purpose of this study is to compare two commonly used medications
      to see which is better for tension type headache. Patients who present to the ED with an
      acute tension-type headache requiring treatment with injectable medication will be randomized
      to metoclopramide or ketorolac.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute tension type headache

        Exclusion Criteria:

          -  Contraindications to investigational medications

          -  Secondary cause of headache
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
Condition: Tonsillitis
MeSH terms: Tonsillitis
Intervention: Fentanyl; Fentanyl; Dexmedetomidine; Dexmedetomidine
Intervention description: Fentanyl 1mcg/kg, Intravenous (IV); Fentanyl 2mcg/kg, Intravenous (IV); Dexmedetomidine, 2mcg/kg, Intravenous (IV); Dexmedetomidine, 4mcg/kg Intravenous (IV)
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dexmedetomidine,; fentanyl,; tonsillectomy; and adenoidectomy,

Summary:

      The primary purpose of this study is:

        1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and
           post-operative analgesia.

        2. To determine an analgesic dose response relationship for dexmedetomidine.

        3. Compare recovery characteristics of dexmedetomidine to fentanyl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All of the following criteria must be met for the potential subject to be eligible for
             participation:

               1. The subject is 2 to 12 years of age

               2. The subject's American Society of Anesthesiologists physical status is ASA I or
                  II (see appendix 1).

               3. The subject is scheduled for elective tonsillectomy with or without adenoidectomy
                  surgery (procedures with myringotomy tube placement are allowed).

               4. The subject will be hospitalized overnight after surgery

               5. The subject's parent/legally authorized guardian has given written informed
                  consent to participate; and where applicable, the subject has given appropriate
                  assent to participate.

                  Exclusion Criteria:

          -  The potential subject is NOT eligible for participation if any of the following
             exclusion criteria apply:

               1. The subject has a history or a family (parent or sibling) history of malignant
                  hyperthermia

               2. The subject has known significant renal or hepatic disorders determined by
                  medical history, physical examination or laboratory tests.

               3. The subject has a known or suspected allergy to opioid analgesics

               4. The subject is a pregnant or lactating female (if post-menarcheal, a negative
                  pregnancy test must be confirmed prior to the planned surgery time (in AMSAC)
                  consistent with current standard of care.

               5. The subject has history of. cardiovascular issues which would preclude the use of
                  dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where
                  hypotension is to be avoided).