bioihbjkbjnl/mcl2 huggingface dataset:
Exparel in Minimally Invasive Cardiac Surgery
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Intervention: Exparel infiltration
Intervention description: Exparel infiltrated into wound and chest tube sites
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: minimally invasive cardiac surgery; Exparel

Summary:

      The investigators are presently using Exparel, a slow released local anesthestic, in patients
      undergoing minimally invasive cardiac surgery. The primary objective of this study is to
      assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to
      provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac
      surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the
      subject's overall postoperative pain scores and postsurgical analgesic use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-75 years inclusive and American Society of Anesthesiologists physical
             status 2-4.

          -  Undergoing minimally invasive cardiac surgery.

          -  Subjects must be physically and mentally able to participate in the study and complete
             all study assessments.

          -  Subjects must be able to give fully informed consent to participate in this study
             after demonstrating a good understanding of the risks and benefits of the proposed
             components of thoracotomy and chest tube sites infiltration.

        Exclusion Criteria:

          -  History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics

          -  Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator,
             might preclude the potential successful performance of a thoracotomy and chest tube
             sites infiltration.

          -  Any subject who in the opinion of the Investigator, might be harmed or be a poor
             candidate for participation in the study.

          -  Any subject, who in the opinion of the Investigator, is on chronic pain medicine,
             including large doses of nonsteroidal antiinflammatory drugs.

          -  Subjects who have received any investigational drug within 30 days prior to study drug
             administration, or planned administration of another investigational product or
             procedure during their participation in this study.
An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum Toxin Type B
Intervention description: Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units.
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 502.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (CD)are
      planned for enrollment into this open label study. These patients will be Type B toxin naive
      patients with CD. During this study patients will receive repeat injections of MYOBLOC when
      deemed appropriate by the Investigator. However, it will be recommended that injections occur
      not more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be
      targeted for at least two years, with potential exposure for up to 7 years in patients with
      earliest enrollment
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  body weight of at least 46 kilograms

          -  History of Cervical Dystonia of at least one year's duration who in the opinion of the
             Investigator requires treatment

        Exclusion Criteria:

          -  Inability to give informed consent

          -  Patient who has been previously treated with botulinum Toxin Type B

          -  Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.

          -  History of phenol injections involving the neck or shoulder region in the last 12
             months.

          -  Patients with neck contractures or cervical spine disease
Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cognitive remediation training (CT); Healthy behavior training (HBT); Risperidone, administered orally (Oral Ris); Risperidone, administered via injection (RLAI)
Intervention description: Cognitive remediation training includes computerized cognitive training plus learning skills group.; Healthy behavior training includes group skills training in nutrition, exercise, and relaxation.; Oral risperidone at dosage judged optimal by treating psychiatrist; Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizoaffective Disorder, Depressed Type; Schizophreniform Disorder; First-Episode Schizophrenia; Supported Employment; Cognitive Remediation; Health Behavior Training; Antipsychotic Medication

Summary:

      This study will determine the effectiveness of various combinations of psychosocial therapy
      and risperidone treatment in improving work or school performance in people with
      first-episode schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or
             schizophreniform disorder

          -  First major episode of psychotic symptoms occurred within 2 years prior to study entry

        Exclusion Criteria:

          -  Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)

          -  Mental retardation (e.g., premorbid intelligence quotient (IQ) less than 70)

          -  Significant alcohol or substance use during last 6 months

          -  Unable to complete research measures in English

          -  Any condition that may make risperidone use medically inadvisable
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
Condition: Sedation
Intervention: Chloral Hydrate; Dexmedetomidine; Oral placebo; Intranasal placebo
Intervention description: Oral chloral hydrate 50 mg/kg; Intranasal dexmedetomidine 3 mcg/kg; Oral saline administered; Intranasal saline administered
Intervention MeSH terms: Dexmedetomidine; Chloral Hydrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 90.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal
      dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient scheduled for ABR exam with sedation to be administered according to protocol
             by nurse in keeping with standard practice at the TCH Audiology clinic.

        Exclusion Criteria:

          -  Patients younger than 6 months or older than 8 years

          -  Previously failed sedation

          -  Weight greater than 25 kg

          -  Weight less than 5 kg

          -  BMI above 30

          -  Diagnosis of ADHD

          -  Any patient deemed inappropriate for nurse administered sedation

          -  Patients with any cardiac disease

          -  Obstructive sleep apnea
Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)
Condition: Microscopic Hematuria
MeSH terms: Hematuria
Intervention: Premarin vaginal estrogen cream; Placebo vaginal cream
Intervention description: Inactive vaginal cream manufactured to mimic Premarin vaginal cream
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 29.0
Sex: Female
Healthy volunteers: No
Keywords: Hematuria; Menopause; Urinalysis

Summary:

      The purpose of this study is to determine if vaginal estrogen use is associated with
      resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The
      hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will
      have higher rates of resolution of hematuria after treatment course with vaginal conjugated
      equine estrogen cream compared to placebo cream
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal women

          -  Asymptomatic microscopic hematuria (three or more red blood cells per high powered
             field on a single urine microscopy) in the absence of urinary tract infection.

        Exclusion Criteria:

          -  Known urologic disease

          -  Presence of gross hematuria

          -  Presence of indwelling urologic foreign body (foley catheter, ureteral stent)

          -  Inability to obtain intravenous contrast CT scan (elevated creatinine, severe contrast
             allergy)

          -  History of pelvic irradiation or malignancy

          -  Not a candidate for vaginal estrogen

               -  Allergy to vaginal estrogen

               -  Current or prior diagnosis of breast or endometrial cancer

               -  History of deep vein thrombosis/pulmonary embolus

               -  Hypercoagulable state
A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)
Condition: Malaria
MeSH terms: Malaria
Intervention: COA566
Intervention description: COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight.
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14075.0
Sex: All
Healthy volunteers: No
Keywords: P. falciparum; malaria; asymptomatic carriers; bed-nets; ITN-insecticide-treated net; idiopathic trigeminal neuralgia; RDT-Rapid diagnostic test

Summary:

      This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and
      treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on a
      number of clinical malaria cases in children less than 5 years of age and the improvement of
      hemoglobin levels in the overall population.
    

Eligibility criteria:

        Inclusion:

          -  Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test
             (RDT).

          -  Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC)

        Exclusion:

          -  Body weight <5 kg.

          -  Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets
             or dispersible tablets.

          -  Presence of severe malaria signs and symptoms

          -  First trimester of pregnancy.

          -  Family history of congenital prolongation of the QTc interval or sudden death or with
             any other clinical condition known to prolong the QTc interval such as history of
             symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe
             cardiac disease.

          -  Taking drugs that are known to influence cardiac function and to prolong QTc interval,
             such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics
             including some agents of the following classes: macrolides, fluoroquinolones,
             imidazole and triazole antifungal agents, certain non-sedating antihistamines.

          -  Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia.

          -  Taking drugs which may be metabolized by cytochrome enzyme CYP2D6
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo
Intervention description: Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: solution for injection Route of administration: subcutaneous
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to
      severe atopic dermatitis (AD).

      Secondary Objectives:

      To evaluate the effect of dupilumab on objective and subjective quantitative sleep
      parameters, AD related outcomes, and daytime consequences of sleep deprivation.

      To continue to assess the safety and tolerability throughout the study.
    

Eligibility criteria:

        Inclusion criteria:

        Participants, male or female 18 years or older,

          -  with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications,
             2) expected severity of AD and 3) sleep disturbance.

          -  had applied skin emollients (moisturizers) at least 7 days before screening.

          -  had applied medium potency topical corticosteroids (TCS) on all active AD lesions at
             least 7 days before screening.

          -  willed and able to comply with all clinic visits and study-related procedures.

          -  provided signed informed consent.

        Exclusion criteria:

        Participants excluded from the study:

          -  with known hypersensitivity to Dupixent, clinical depression, drug abuse history,
             sleep problems not related to AD, irregular sleep pattern, active/acute infections,
             severe medical conditions, laboratory abnormalities, any condition that might present
             unreasonable risk to participants or interfered with study assessment, or any severe
             concomitant illness(es) that would adversely affect the participant's participation in
             the study, and contraindications of topical corticosteroids.

          -  at Baseline, presence of any conditions listed as criteria for study drug
             discontinuation.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Lessons on Urethral Lidocaine in Urodynamics
Condition: Urethra Issue; Pelvic Organ Prolapse; Urinary Incontinence; Vaginal Vault Prolapse; Cystocele; Uterine Prolapse; Vaginal Prolapse; Pelvic Floor Disorders
MeSH terms: Urinary Incontinence; Pelvic Floor Disorders; Cystocele; Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Intervention: Water-Based Vaginal Lubricant; lidocaine topical
Intervention description: 5cc water based jelly applied intraurethral; 5cc 2% lidocaine jelly applied intraurethral
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 63.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts
      sensation during filling (i.e., a change of more than 25% of first sensation, first desire to
      void, strong desire to void, or maximum cystometric capacity) and determine whether the use
      of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics,
      and voiding metrics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients

          -  >18 years of age

          -  Already scheduled (or being scheduled) for UDS to assess urinary incontinence

          -  Able to speak and read in English

        Exclusion Criteria:

          -  Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome

          -  Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease,
             multiple sclerosis, myasthenia gravis, recent stroke)

          -  Active UTI

          -  Pelvic organ prolapse that is unable to be easily reduced

          -  Pregnancy or breastfeeding

          -  Allergy or hypersensitivity to lidocaine or local anesthetics
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder
Condition: Autistic Disorder; Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Autistic Disorder
Intervention: Atomoxetine; Placebo
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD
      (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD
      (Autism Spectrum Disorder).
    

Eligibility criteria:

        Inclusion Criteria (most important):

          -  ASD (autistic disorder or Asperger's disorder or Pervasive Developmental Disorder -
             Not Otherwise Specified [PDD NOS])

          -  Criteria A through D for Attention-Deficit/Hyperactivity Disorder (ADHD)

          -  At least 1.5 standard deviations above the age norm for their diagnostic subtype using
             published norms for the ADHD Rating Scale-IV-Parent Version

          -  Intelligence quotient (IQ) score > 60

        Exclusion Criteria (most important):

          -  weight under 20 kg

          -  Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for ASD other than Autistic Disorder,
             PDD-NOS or Asperger's Disorder;history of Bipolar I or II disorder, schizophrenia,
             another psychotic disorder, substance abuse;Have a significant medical condition such
             as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure
             disorder identified by history, physical examination, or laboratory tests; Patients
             who have taken (or are currently taking) anticonvulsants for seizure control.

          -  patients at serious suicidal risk.

          -  Contraindication to the use of atomoxetine

          -  Patients who in the investigator's judgment are likely to need psychotropic
             medications apart from the drug. Patients who at any time during Study Period II are
             likely to begin a structured psychotherapy, likely to require hospitalization (i.e.
             in-patient treatment) or likely to be dismissed from in-patient treatment.
             Psychotherapy (including hospitalization) initiated at least 2 months prior to study
             participation is acceptable; however, after study participation has begun, only during
             Study Period III supportive or educational therapy is permitted.
Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
Condition: Human Papillomavirus Infection
MeSH terms: Infections; Papillomavirus Infections
Intervention: Gardasil
Intervention description: Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Female sex worker; Peru; Cervical infection; Cervical abnormality; Serum antibody; Vaccine acceptance; Alternative schedule; Viral infections; Human papillomavirus vaccine; Human papillomavirus (HPV); non inferiority

Summary:

      The primary objectives of this study are to determine the acceptance and potential for the
      effective use of HPV vaccine in the standard and a modified schedule in female sex workers.
      Secondary objectives include ascertaining the prevalence of HPV types among female sex
      workers by age and sexual experience.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the age of 18 and 26 years

          -  Registered female sex worker living in Lima

          -  Healthy with no known immune deficiency

          -  Willing to participate in a study of HPV vaccine including a Pap smear, three
             pregnancy tests, blood draws, and three vaccine administrations over 7 months

          -  Willing to provide informed consent

        Exclusion Criteria:

          -  Currently pregnant or planning to get pregnant in the next six months

          -  Known immune deficiency disorder

          -  Current receipt of immunosuppressive drugs

          -  Allergy to yeast or known contraindication to HPV vaccine

          -  Women who have had their cervix removed

          -  Previous HPV vaccination

          -  Current fever over 100 degrees Fahrenheit