bioihbjkbjnl/mcl2 huggingface dataset:
Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
Condition: Psychomotor Agitation
MeSH terms: Psychomotor Agitation
Intervention: Clonidine; Placebo
Intervention description: Injection - during surgery; Injection - during surgery
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 379.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Anaesthesia; Children; Clonidine; Sevoflurane; Postoperative agitation; Prevention; Pharmacokinetics; Safety

Summary:

      Clonidine is widely used off-label in children for several indications. Clonidine is used for
      treatment and/or prevention of postoperative agitation in children anaesthetised with
      Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators
      don´t have data for characterization of the pharmacokinetic profile among age-groups for
      children 1-6 years.

      In this study the investigators want to investigate if IV Clonidine administered at the end
      of surgery can prevent/reduce postoperative agitation. Secondary outcomes include
      measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  scheduled for surgery with Sevoflurane as the choice of anesthesia.

        Exclusion Criteria:

          -  ASA classification >2

          -  Premedication with Clonidine

          -  Ex-premature (born before week 37+0 AND <60 weeks old)

          -  Intubated before anaesthesia and/or no plans for extubation after anaesthesia.

          -  Critical illness with haemodynamic instability.

          -  Active bleeding.

          -  Cancer.

          -  Cardiac diseases including arrhythmias.

          -  Malignant hyperthermia.

          -  Mental retardation.

          -  Neurological illness with agitation-like symptoms.

          -  Weight >50 kg.

          -  Allergy to Clonidine.

          -  Patients treated with methylphenidate / Concerta.
Suvorexant and Trauma Related Insomnia
Condition: Insomnia; Posttraumatic Stress Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic
Intervention: suvorexant; placebo
Intervention description: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia; Pill with inactive ingredients
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Problems sleeping are common after exposure to highly threatening experiences and can occur
      with and without a diagnosis of posttraumatic stress disorder (PTSD). Established treatments
      for PTSD are limited for addressing insomnia and many insomnia treatments appear to be
      limited in the context of PTSD. Suvorexant is FDA approved for insomnia and among approved
      drugs has a unique mechanism of action that may be well suited for targetting arousal at
      night dysregulated by trauma. The investigators will evaluate the efficacy of suvorexant for
      insomnia that developed in relation to trauma exposure, utilizing a placebo control, and
      polysomnography to identify biomarkers of response, in a six week trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physically healthy adults age 18-55 who meet DSM-5 criteria for insomnia and Criterion
             A (exposure to a traumatic event) for PTSD. The index trauma must have occurred within
             the past 5 years and at least 3 months before enrolling, and insomnia symptoms must
             have started or worsened after the exposure to the index trauma

        Exclusion Criteria:

          -  Psychiatric disorders other than insomnia, PTSD and specific phobias; including
             bipolar and psychotic disorders and meeting criteria for DSM-5 moderate alcohol or
             drug use disorders within the past year.

          -  Diagnosis of a sleep disorder other than insomnia including PSG findings of
             apnea/hypopnea or periodic limb movement indices > 10/hour;

          -  Medical conditions that require consistent use of medication or compromise sleep;

          -  History of moderate to severe traumatic brain injury or mild traumatic brain injury
             with ongoing post-concussive symptoms;

          -  Suicidal ideation with intent to act or with specific plan and intent in the past 6
             months (Type 4 - 5 ideation on the Columbia Suicide Severity Rating Scale) or a
             concerning history of prior suicidal behavior.

          -  Caffeine use exceeding 5 cups of coffee per day or its equivalent;

          -  Habitual bedtimes after 3 AM, habitual rise times after 10 AM, or habitual napping >
             1hour/day;

          -  Pregnancy or breastfeeding, or expecting to conceive while in study;

          -  Positive urine toxicology.
EVARREST™ Fibrin Sealant Patch Post-Market Study
Condition: Hemorrhage; Soft Tissue Bleeding
MeSH terms: Hemorrhage
Intervention: EVARREST™ Fibrin Sealant Patch; Standard of Care
Intervention description: EVARREST™ Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.; Standard of Care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemostasis

Summary:

      The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant
      Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal
      (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac
      thoracic (chest area) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥18 years of age, requiring an elective or urgent, open intra-abdominal,
             retroperitoneal, pelvic or non-cardiac thoracic surgical procedures;

          -  Subjects or legally authorized representative must be willing to participate in the
             study and provide written informed consent.

          -  Presence of an appropriate Target Bleeding Site as identified intra-operatively by the
             surgeon;

        Exclusion Criteria:

          -  Subjects with known intolerance to blood products or to one of the components of
             EVARREST™ or unwilling to receive blood products;

          -  Female subjects who are pregnant or nursing.

          -  TBS is from a large defect in an artery or vein where the injured vascular wall
             requires repair and maintenance of vessel patency or where there would be persistent
             exposure of EVARREST™ to blood flow and/or pressure during absorption of the product;

          -  TBS with major arterial bleeding requiring suture or mechanical ligation;

          -  TBS within a contaminated or infected area of the body;

          -  Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony
             confine;

          -  Subjects with any intra-operative findings identified by the surgeon that may preclude
             conduct of the study procedure;
Study Of RV-39 In Patients Who Also Have Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone propionate/salmeterol; fluticasone propionate; placebo
Intervention description: comparator; Comparator; Placebo
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Rhinovirus; Asthma

Summary:

      This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain
      clinic visits will include a physical examination, lung function tests, inflammatory cell
      analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA
      approved virus through their nose which is known to cause the common cold. All study related
      medications and medical examinations will be provided at no cost to the subject. The drugs
      used in this study are approved for the age group under study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have asthma for at least 3 months prior to the study.

          -  Have been using an allowed pre-study asthma therapy for at least 3 months prior to
             study.

          -  Demonstrate airway hyperresponsiveness following inhalation of bronchoconstrictor.

          -  Have a positive allergic status antibody test.

        Exclusion Criteria:

          -  Have a history of life-threatening asthma.

          -  Been hospitalized for asthma within the 24 months prior to the study.

          -  Have certain conditions that would make study participation unsafe.

          -  The study doctor will evaluate other inclusion and exclusion criteria.
Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Montelukast
Intervention description: 1 pill per day for 4 months
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Children; Sleep; Obstructive Sleep Apnea

Summary:

      The investigators leading hypotheses are:

        -  Oral therapy with montelukast may lead to improved sleep study findings in children with
           mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of
           adenoids and tonsils for OSAS.

        -  A significant proportion of the children with OSAS treated with montelukast will show
           reduced severity of OSAS, and this will remove the need for surgical intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible for inclusion in the study will be symptomatic snoring children >2 years of
             age and < 10 years of age, who snore and have an apnea hypopnea index (AHI) >2/hrTST
             (hour total sleep time), and in whom T&A is therefore contemplated. Also among these,
             we will include children referred for evaluation for snoring who have a history of
             allergic rhinitis.

        Exclusion Criteria:

          -  Exclusion criteria will include: Hypersensitivity to montelukast, immunodeficiency or
             immunosuppressant therapy, craniofacial, neuromuscular, syndromic or defined genetic
             abnormalities, acute upper respiratory tract infection, systemic corticosteroid
             therapy or antibiotic therapy in the 2 weeks previous to the study, and children who
             already had adenotonsillectomy. In addition, children chronically receiving oral
             antihistamine preparations or nasal decongestants will be required to continue using
             these medications throughout the duration of the study. Patients receiving
             immunotherapy will continue on the same regimen without escalation of dose and
             frequency throughout the duration of the study. In addition, patients with severe OSA
             who in the opinion of their treating physicians require early surgical intervention
             for their OSA will be excluded from eligibility to the study.
Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Iodixanol; Ioxaglate; Bivalirudin
Intervention description: contrast media used during coronary angiography; contrast media used during coronary angiography; A direct thrombin inhibitor
Intervention MeSH terms: Bivalirudin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary angiography; Percutaneous coronary intervention; Contrast media; Platelet activity; Thrombin generation; Fibrinolysis

Summary:

      The aim of this study is to determine how two different types of iodinated contrast media
      (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific
      markers of thrombogenesis and platelet function in patients undergoing coronary angiography,
      and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary
      intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet
      function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be more than 18 years of age

          -  referred for coronary angiography and on dual anti-platelet therapy (aspirin and
             clopidogrel).

        Exclusion Criteria:

          -  on warfarin

          -  on low molecular weight heparin within 12 hours of coronary angiography or
             unfractionated heparin with activated clotting time >150 at time of procedure -on
             cilostazol

          -  on persantine

          -  on non- steroidal anti-inflammatory medications (ibuprofen/motrin/advil,
             naproxen/aleve, indomethacin, sulindac, etodolac, diclofenac, celecoxib) within 72
             hours of procedure

          -  on prasugrel (not an exclusion criteria for ST-segment elevation myocardial infarction
             registry

          -  undergoing coronary angiography via radial access

          -  undergoing planned diagnostic coronary angiography only

          -  unable to tolerate dual anti-platelet therapy

          -  with known allergy to CM

          -  received CM within 24 hours of coronary angiography

          -  on dialysis

          -  do not consent or are unable to give consent

          -  are participating in another competing study.
Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness
Condition: Occasional Sleeplessness
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Diphenhydramine Hydrochloride; Placebo
Intervention description: 30 mL at bedtime; 30 mL at bedtime
Intervention MeSH terms: Diphenhydramine; Promethazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The present study was conducted to investigate the impact of diphenhydramine hydrochloride on
      the ability to initiate sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be male or female subjects, ≥18 years of age to 55 years of age, who report that they
             are currently experiencing occasional sleeplessness characterized by difficulty
             initiating sleep (ie, taking ≥30 minutes to fall asleep) on average 2-4 times per week
             for less than 1 month;

          -  be in good general health without clinically significant disease (no previously
             diagnosed sleep disorders);

          -  if female, have a negative screening pregnancy test and agree to be on approved
             methods of birth control throughout the study

        Exclusion Criteria:

          -  have a clinically significant illness within 30 days of Screening;

          -  are taking medication that could interfere with the study medication;

          -  have been under a clinician's care for insomnia treatment and control within the past
             year or has a history of insomnia or is currently taking prescription medications for
             insomnia;

          -  are currently taking medications known to effect sleep function;

          -  have current or past history of serious, severe or unstable physical or psychiatric
             illness;

          -  have current diagnosis of severe urinary retention;

          -  have current diagnosis of untreated narrow angle glaucoma;

          -  had participated in a clinical drug study or used an investigational new drug during
             the previous 30 days;

          -  have any clinically significant or abnormal finding in physical examination, vital
             signs, ECG, or clinical laboratory tests that may affect the subject's safety or
             outcome of the study;
Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Intervention: Trivalent Influenza Vaccine; Placebo
Intervention description: A single dose of 10^(7.0 ± 0.5) FFU per strain of trivalent influenza vaccine will be administered as intranasal spray on Day 1.; A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy

Summary:

      This prospective annual release study is designed to evaluate the safety of 3 new influenza
      virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza
      season
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 49 years

          -  Written informed consent

          -  Participant available by telephone

          -  Ability to understand and comply with the requirements of the protocol, as judged by
             the Investigator

        Exclusion Criteria:

          -  Concurrent enrollment in another clinical study up to 180 days after receipt of
             investigational product (Day 181)

          -  History of hypersensitivity to any component of the vaccine, including egg or egg
             protein or serious, life threatening, or severe reactions to previous influenza
             vaccinations

          -  Any condition for which the inactivated influenza vaccine is indicated, including
             chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma),
             chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or
             hemoglobinopathies that required regular medical follow-up or hospitalization during
             the preceding year

          -  Acute febrile (greater than [>] 100.0 degrees Fahrenheit [F] oral or equivalent)
             and/or clinically significant respiratory illness (example, cough or sore throat)
             within 14 days prior to randomization

          -  Any known immunosuppressive condition or immune deficiency disease, including human
             immunodeficiency virus infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barré syndrome
CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma
Condition: Retinoblastoma
MeSH terms: Retinoblastoma
Intervention: carboplatin periocular injection; CEV chemotherapy
Intervention description: chemotherapy together with/without 20mg/2ml carboplatin periocular injection; vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
Intervention MeSH terms: Carboplatin; Etoposide; Vincristine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Healthy volunteers: No
Keywords: Retinoblastoma; carboplatin

Summary:

      This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular
      retinoblastoma
    

Eligibility criteria:

        Inclusion Criteria:

          -  IRSS stage II or stage IIIa RB patients.

          -  for patients with IRSS stage II disease, if scleral surface invasion alone was
             observed, only systemic chemotherapy was administered, whereas other IRSS stage II and
             IIIa patients received systemic chemotherapy plus additional local chemotherapy.

          -  no tumor-related treatment was given prior to this chemotherapy regimen.

        Exclusion Criteria:

          -  metastasis, including lymph node metastasis.

          -  the diagnosis of IRSS stage I or above in the non-target eye.
Contralateral ReSTOR / Monofocal or Phakic Eye
Condition: Cataracts
MeSH terms: Cataract
Intervention: ReSTOR
Intervention description: AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AcrySof; ReSTOR; Multifocal; Intraocular Lens

Summary:

      Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or
      phakic eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral operable cataract

          -  Candidate for presbyopic intraocular lens (IOL)

        Exclusion Criteria:

          -  Ocular comorbidities compromising primary outcome

          -  Bilateral cataracts