bioihbjkbjnl/mcl2 huggingface dataset:
Melatonin CR for the Treatment of Impaired Sleep Maintenance in 4-8 Year Old Children With Autism Spectrum Disorders
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders; Autism Spectrum Disorder
Intervention: Natrol
Intervention description: 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime.
Intervention MeSH terms: Melatonin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 4 Years
Maximum age: 8 Years
Healthy volunteers: No
Keywords: Impaired sleep maintenance; Autism Spectrum Disorders; Pediatric

Summary:

      The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in
      4-8 year old children with autism spectrum disorders and sleep problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female children,

          -  ages 4-8 years,

          -  diagnosed with an ASD, including

          -  Pervasive Developmental Disorder NOS (PDD, NOS),

          -  Asperger's Syndrome, or

          -  Autistic Disorder, and followed in the Munroe Meyer Developmental Pediatrics Clinic.
             Documented impaired sleep maintenance (ISM) based on parent-report and 7 day somnolog
             (sleep diary).

          -  Clinician rating of 4 (moderately ill) or worse on CGI-S. Rating is based on the
             clinician's experience with evaluating and treating this patient population.

          -  Previous discussion during a clinic appointment about sleep difficulties, including
             review of sleep hygiene and basic behavioral interventions/strategies.

          -  Current problems of overnight awakenings recorded on the Children's Sleep Habits
             Questionnaire (CSHQ) despite behavioral intervention.

          -  Stable psychotropic medication treatment for the past 4 weeks.

        Exclusion Criteria:

        Treatment with Melatonin or Melatonin CR during the past month or previous failed treatment
        with Melatonin CR.

        Presence of a previously unevaluated medical condition which may be the etiology of the
        nighttime awakenings. There is no contraindication for use of Melatonin CR in patients with
        obstructive sleep apnea.
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
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Condition: Hospitalization; Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Chlorhexidine gluconate (CHG); Iodophor (10% povidone-iodine)
Intervention description: 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.; Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13952.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nursing Homes; Health Facilities; Infections; Readmissions; Multi-Drug resistance; Antibiotic Use

Summary:

      This is a cluster-randomized trial of nursing homes to assess whether decolonization with
      routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce
      hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant
      organism (MDRO) prevalence. The comparator arm will be routine bathing care.
    

Eligibility criteria:

        Inclusion Criteria

        Nursing homes will be eligible to participate if they meet the following criteria:

          -  Licensed nursing home in Orange County or Southern Los Angeles County serving adults

          -  Minimal use of chlorhexidine bathing*

          -  Minimal use of nasal decolonization* *Minimal use defined as <15% of residents
             receiving at least one chlorhexidine bath or nasal decolonization treatment during
             their nursing home stay.

        Exclusion Criteria

        Nursing homes will not be eligible to participate if they meet the following criteria:

          -  Facilities routinely using decolonization

          -  Dedicated psychiatric nursing homes

          -  Facilities with a resident population with >=20% combative patients

          -  Pediatric facilities

        Note: in any participating nursing home, residents with active end-of-life comfort care
        only measures are excluded
EASY: Extended Access to Sollpura Over Years
Condition: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Liprotamase
Intervention description: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No
Keywords: exocrine pancreatic insufficiency; cystic fibrosis; pancreatic enzyme replacement therapy

Summary:

      Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and
      amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be
      formulated without enteric coating for administration either as a capsule or as a dosing
      solution dissolved in water or juice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency
             who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral
             Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic
             Fibrosis)

        Exclusion Criteria:

          -  Any medical, psychological, or social condition that may put the subject at increased
             risk by participating in this study.

          -  Females who are nursing, pregnant, intending to become pregnant, or intending to nurse
             during the time of the study.
Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
Condition: Pain, Migraine
MeSH terms: Migraine Disorders
Intervention: Aspirin, acetaminophen and caffeine; Sumatriptan; Placebo
Intervention description: 2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg); 100 mg Sumatriptan; placebo
Intervention MeSH terms: Aspirin; Acetaminophen; Sumatriptan; Caffeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 752.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain, Migraine

Summary:

      The main purpose of this study is to compare the efficacy and safety of aspirin,
      acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of
      migraine.
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female aged 18 years and over.

          2. International Headache Society (IHS) diagnosis of migraine without aura or typical
             aura with migraine headache.

          3. History of experiencing at least 1, but not more than 8, acute migraine attacks
             monthly during the previous year.

          4. History of at least moderate migraine pain intensity, if left untreated.

        Exclusion criteria:

          1. Headache symptoms which may be due to or aggravated by:

               -  Recent (within 6 months) head or neck trauma (e.g., whiplash)

               -  Head or neck pain secondary to an orthopedic abnormality

               -  Cluster headache

               -  Specific migraine variants (e.g., basilar-type artery migraine, ophthalmoplegic
                  migraine, hemiplegic migraine, migraine aura without headache)

               -  Other serious, non-migraine causes of headache (e.g., increased intracranial
                  pressure, intracranial bleeding, meningitis, malignancy)

               -  Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)

          2. Routine use (≥ 10 days per month, on average) of any medication having the potential
             to interfere with the pharmacologic effects or evaluation of the study medications
             (e.g., narcotic and non-narcotic analgesic products (prescription or
             over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics,
             hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs).

          3. History of vomiting during more than 20% of migraine episodes or confined to bedrest
             for more than 50% of migraine episodes.

        Other protocol-defined inclusion/exclusion criteria may apply
Ideal Steroids for Asthma Treatment in the PICU
Condition: Asthma Childhood
MeSH terms: Asthma
Intervention: Dexamethasone
Intervention description: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Arm Treatment Group with a Prospective, Comparative Cohort Receiving Standard Care
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Determine if differences in (1) pediatric intensive care unit length of stay, (2) continuous
      nebulized albuterol duration, and (3) a composite outcome of advanced asthma therapy
      incidence including use of non-invasive ventilation (NIV), terbutaline, inhaled helium and
      mechanical ventilation between cohorts of children admitted with status asthmaticus to the
      PICU treated with either IV dexamethasone (DM) or methylprednisolone (MP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria are children 5 to 17 years of age with primary admission diagnoses
             of acute asthma exacerbation or status asthmaticus admitted to the PICU

        Exclusion Criteria:

          -  children with existing tracheostomy, cystic fibrosis, and pulmonary hypertension
A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])
Condition: Nephrolithiasis; Urinary Tract Infections
MeSH terms: Urinary Tract Infections; Nephrolithiasis; Kidney Calculi
Intervention: nitrofurantoin monohydrate/macrocrystalline capsules; ampicillin; gentamicin; vancomycin; ceftriaxone
Intervention description: 1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily; IV (2 g); IV (5 mg/kg); IV (1 g); IV (2 g)
Intervention MeSH terms: Vancomycin; Gentamicins; Ceftriaxone; Ampicillin; Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      When patients are going to have surgery to remove large kidney stones (percutaneous
      nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of
      prophylactic preoperative oral antibiotics; currently both the use of prophylactic
      preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be
      within standard-of-care.

      This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics
      to determine if the use of preoperative prophylactic antibiotics decreases the postoperative
      risk of localized urinary tract infection (UTI) and/or systemic infection that started in the
      urinary tract (sepsis or urosepsis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal stone of any size for which PCNL is recommended

        Exclusion Criteria:

          -  eGFR < 60 mL/min/1.73 m2

          -  cirrhosis and/or hepatitis

          -  Pregnancy

          -  Positive preoperative urine culture within 2 weeks

          -  History of temperature >=38.3 C associated with nephrolithiasis or sepsis thought to
             be due to urinary source within 12 months prior to randomization

          -  Current internalized ureteral stent, nephrostomy tube, or nephroureteral stent

          -  Antibiotic use within 2 weeks prior to randomization

          -  Severe hydronephrosis (defined by > =2cm in largest dimension) preoperatively as
             judged on CT scan, abdominal X-ray, ultrasound, or fluoroscopy.
Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Bupivacaine
Intervention description: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 155.0
Sex: All
Healthy volunteers: No

Summary:

      The objective of the study is to compare the efficacy of adductor canal blocks versus
      periarticular bupivacaine injections for pain management in total knee arthroplasty. This
      randomized clinical trial will compare outcomes between adductor canal blocks, periarticular
      bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this
      study will help determine the most appropriate perioperative pain management strategy for
      patients undergoing a total knee arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients undergoing an unilateral primary total knee arthroplasty under the care of the
        two senior arthroplasty surgeons.

        Exclusion Criteria:

        - Allergy to bupivicaine or liposomal bupivicaine.
Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Intervention description: 2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic macular edema; Intravitreal injection

Summary:

      To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first
      year of treatment with aflibercept according to the EU Label.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or 2 diabetes mellitus

          -  Diagnosis of DME secondary to diabetes mellitus involving the center of the macula
             (defined as the area of the center subfield on OCT) in the study eye

          -  Decrease in vision determined to be primarily the result of DME in the study eye

          -  BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen
             equivalent of approximately 20/40 to 20/320.)

        Exclusion Criteria:

          -  Pregnancy and lactation

          -  Mismatch with inclusion criteria
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: celecoxib; Ibuprofen; Naproxen
Intervention description: 100 to 200 mg twice daily, taken by mouth; ibuprofen 600 mg to 800 mg three times daily, taken by mouth; naproxen 375mg to 500 mg twice daily, taken by mouth
Intervention MeSH terms: Ibuprofen; Celecoxib; Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24081.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To answer the question of overall benefit: risk of celecoxib when compared to two most
      commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs)
      in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or
      rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited.
      The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each
      treatment group will be assessed accordingly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing
             cardiovascular disease and who require and eligible for chronic, daily therapy with an
             NSAID to control arthritis sign and symptoms.

        Exclusion Criteria:

          -  Subjects have had a recent cardiovascular event, unstable cardiovascular conditions,
             or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;

          -  Subjects with medical or laboratory abnormality that would make the subject
             inappropriate for entry into this trial

          -  Subjects require treatment with aspirin > 325 mg /day

          -  Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or
             esomeprazole, etc.
Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia
Condition: Focal Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Intervention: Botulinum toxin, type B
Intervention description: Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
Intervention MeSH terms: Botulinum Toxins
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: 25 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Myloboc; Botulinum Toxin Type B; Focal Dystonia; Musicians; Muscle Relaxants; Motor Impairments; Motor Performance; Tremor; Abnormal Postures

Summary:

      This study uses a computerized method of musical instrument digital interface (MIDI)
      quantification of performance before and after treatment with botulinum toxin type B (Myobloc
      ®, Solstice Neurosciences). Myobloc is a purified and diluted form of botulinum toxin used
      medically to relax unwanted muscle spasms and movements. The aim of the study is to determine
      the feasibility of quantifying change in performance following treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Focal, task-specific dystonia clinically determined to be the result of a high level
             of musical skill and intensive performance history

        Exclusion Criteria:

          -  Neurological disorders other than dystonia

          -  Patients who are clinically depressed, demented or otherwise unable to perform
             appropriately or sit through 1 hour of testing

          -  Patients who have undergone pallidotomy, thalamotomy or deep brain stimulator
             implantations

          -  Patients who have who recently have taken medications with extrapyramidal or
             tremorogenic side effects