bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Arousal Threshold in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Donepezil; placebo
Intervention description: Donepezil 10mg before sleep; One piece of placebo before sleep
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Obstructive; Sleep Apnea; Arousal threshold; Donepezil

Summary:

      The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low
      arousal threshold may wake up too early during a respiratory event, before upper airway
      muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the
      respiratory arousal threshold could potentially improve the quality of sleep and sleep
      disordered breathing. Agents that raise arousal threshold are therefore likely to benefit
      some patients with OSA. The overall goal of this project is to determine the importance of
      the arousal threshold in OSA, determine which patients might benefit from a raised arousal
      threshold, and test this hypothesis by using pharmacological manipulation of the arousal
      threshold to achieve this goal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-70 years

          -  sleep study (with apnea hypopnea index>5)

          -  Diagnosis of obstructive sleep apnea

        Exclusion Criteria:

          -  Any known unstable cardiac (apart from treated hypertension), pulmonary (including
             asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.

          -  Susceptible to stomach ulcers.

          -  Pregnant women or Nursing mothers

          -  Using positive airway pressure (PAP) therapy over one week or longer

          -  Body weight <55kg

          -  History of hypersensitivity to Afrin, Lidocaine and/or Donepezil

          -  History of bleeding diathesis and/or gastrointestinal bleeding.

          -  Use of any medications that may affect sleep or breathing.

          -  A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar
             disorder, major depression, panic or anxiety disorders.

          -  Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs.

          -  More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.

          -  Deprived from sleep in the recent one week

          -  Desaturations to below 70% lasting greater than 10 seconds in duration per event in
             the sleep study (without Oxygen).
Vapocoolant (Pain Ease) Use for Venipuncture
Condition: Pain
Intervention: Vapocoolant (Pain Ease); Nature's Tears Sterile Water
Intervention description: Topical stream 4-10 seconds duration to skin.; Topical stream 4-10 seconds duration to skin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vapocoolant

Summary:

      To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in
      decreasing the pain of venipuncture ("blood draw")
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient needing venipuncture ("blood draw') but not intravenous cannulation

          -  Adult 18 years and older up to and and including 80 years old

          -  Stable patient

          -  Mentally competent patient able to understand the consent form

        Exclusion Criteria:

          -  Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane
             or 1,1,1,2, tetrafluoroethane )

          -  Critically ill or unstable (e.g. sepsis or shock)

          -  Extremes of age: geriatric (> 80 years) or pediatric ( < 18 years old)

          -  Pregnant

          -  Venipuncture site located in area of compromised blood supply. Examples include :
             patients with peripheral vascular disease, gangrene, Raynaud's disease, Buerger's
             disease.

          -  Venipuncture site located in area of insensitive skin; patients with a peripheral
             neuropathy including diabetic neuropathy.

          -  Patient intolerant of cold or with hypersensitivity to the cold.

          -  Patient unable or unwilling to give consent.

          -  Prior experience with vapocoolant spray

          -  Currently in another research trial
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Condition: Keratitis
MeSH terms: Keratitis
Intervention: Acthar
Intervention description: Acthar gel for subcutaneous injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Severe or recalcitrant keratitis

Summary:

      We will need about 36 participants for this study.

      Volunteers might be able to participate if:

        -  they have bad noninfectious keratitis

        -  early treatments failed or were not well tolerated

      Participants will be in the study for about 22 weeks:

        -  4 weeks for tests to see if the study might be good for them

        -  12 weeks of treatment with Acthar gel

        -  4 weeks to wean off Acthar gel and follow-up with the doctor
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has severe or recalcitrant keratitis

          -  Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or
             any immunosuppressant to treat keratitis

          -  If able to reproduce, agrees to use 2 forms of effective contraception with a partner
             of the opposite sex for the duration of the study (through Visit 6)

          -  Has normal eyelids, and protocol-defined physical and medical eye attributes

          -  Agrees to avoid wearing contact lenses during the trial

        Exclusion Criteria:

          -  Is pregnant or breast-feeding

          -  Is defined as vulnerable, or is employed by, or related to anyone involved in the
             study

          -  Has a medical condition or history that might, per protocol or in the opinion of the
             investigator, compromise the participant's safety or study analysis
Chemotherapy for Patients With Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed
Intervention description: 500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease.
*Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets <50 x 10^9/L; absolute neutrophil count <1.0 x 10^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade >2; Skin Grade >2; Serum bilirubin >3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase >10 x ULN; Other non-hematologic toxicities Grade >2 (except nausea, vomiting).
Intervention MeSH terms: Pemetrexed
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is
      tailored to individual patient tolerance in patients with advanced non-small cell lung cancer
      (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or
             IV)

          -  Patients' NSCLC must have progressed following one chemotherapy regimen for palliative
             therapy with or without subsequent targeted biological therapy

          -  Disease status must be that of measureable disease as defined by Response Evaluation
             Criteria In Solid Tumors (RECIST) criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

        Exclusion Criteria:

          -  Concurrent administration of any other tumor therapy

          -  Pregnancy or breast feeding

          -  Serious concomitant disorders

          -  Inability or unwillingness to take folic acid or vitamin B12 supplementation
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
Condition: Shoulder Arthroplasty
Intervention: Liposomal bupivacaine; Bupivacaine with adjuvants
Intervention description: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine); Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Shoulder Replacement Surgery; Interscalene Nerve Block; Liposomal Bupivacaine; Shoulder pain; Regional anesthesia; Brachial plexus blockade

Summary:

      The purpose of this study is to determine whether the use of plain bupivacaine with common
      adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to
      the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing total shoulder arthroplasty (not a reverse)

          -  Age ≥ 18 years

          -  Ability to understand and the willingness to sign an IRB-approved informed consent
             document.

          -  ASA patient status I-III patients

          -  Weight Greater than or equal to 50 kg

        Exclusion Criteria:

          -  Contraindications to an interscalene block or phrenic blockade

          -  Infection at injection site

          -  Pre-existing neurological dysfunction affecting the operative extremity

          -  Chronic pain diagnosis or opioid use >40mg oxycodone daily equivalents or use of
             long-acting opioids

          -  BMI >40

          -  Uncontrolled diabetes (A1c >8.0)

          -  Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or
             opioid) in the postsurgical period for pain not strictly related to the surgery

          -  Contraindications to any pain-control agents planned for surgical or postsurgical use
             (i.e., bupivacaine, hydromorphone, etc.)

          -  Patients who are wards of the state

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to bupivacaine or liposomal bupivacaine.

          -  Patients with moderate-severe hepatic or renal impairment
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza virus vaccine (Pediatric formulation)
Intervention description: 0.25 mL, Intramuscular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 6 Months
Maximum age: 36 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Fluzone®; Children

Summary:

      To describe the safety findings from Days 0 to 44 following injection of the 2003-2004
      pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in
      the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to <
      36 months.

      To describe the immunogenicity findings from Days 0 to 44 following injection of the
      2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®,
      given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6
      months to < 36 months
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged ≥ 6 months to < 36 months.

          -  Considered to be in good health on the basis of reported medical history and limited
             physical examination.

          -  Available for the duration of the study (44 days +4 days).

          -  Parent/guardian is willing and able to provide informed consent.

          -  Parent/guardian is willing and able to meet protocol requirements.

        Exclusion Criteria :

          -  Reported allergy to egg proteins, chicken proteins, or any other constituent of the
             vaccine.

          -  Previous history of influenza vaccination or documented history of influenza
             infection.

          -  An acute illness with or without fever (temperature > 100.4 °F rectal) in the 72 hours
             preceding enrollment in the trial (defer enrollment).

          -  Clinically significant findings in vital signs or review of systems (investigator
             judgment; defer or exclude).

          -  Participation in any other clinical trial within 30 days prior to enrollment up to
             termination of the subject's participation in the study.

          -  Known or suspected impairment of immunologic function, or receipt of immunosuppressive
             therapy or immunoglobulin since birth.

          -  Personal or immediate family history of congenital immune deficiency.

          -  Developmental delay, neurologic disorder, or seizure disorder.

          -  Chronic medical, congenital, or developmental disorder.

          -  Known human immunodeficiency virus (HIV)-positive mother.

          -  Prior history of Guillain-Barré syndrome.

          -  Any condition which, in the opinion of the investigator, would pose a health risk to
             the subject or interfere with the evaluation of the vaccine.
A Study on the Effect of 2 Pen Devices on HbA1c
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Insulin Lispro; Huminsulin Regular; HumaPen Memoir; HumaPen Luxura
Intervention description: subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks; subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks; subcutaneously, daily for 24 weeks; subcutaneously, daily for 24 weeks
Intervention MeSH terms: Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 263.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory
      function, when used over 24 weeks for prandial insulin injections achieves superior glycemic
      control, when compared to the conventional HumaPen Luxura without memory function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes mellitus

          -  receiving at least 3 prandial injections per day with short-acting or analogue insulin

        Exclusion Criteria:

          -  Insulin pump therapy

          -  receiving pre-mixed insulin preparations
Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching
Condition: Pruritus
MeSH terms: Pruritus
Intervention: Cetirizine; Placebo or sugar pill
Intervention MeSH terms: Cetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is determine if long acting antihistamine like cetirizine can help
      with itching induced by opioid pain medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children age 6-18yrs on opioids who develop pruritus and are willing to participate in
             the study

        Exclusion Criteria:

          -  Children with history of chronic urticaria

          -  Children with other chronic pruritic condition like eczema, contact dermatitis,
             psoriasis

          -  Children with known hypersensitivity to cetirizine/zyrtec

          -  Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine,
             loratadine, fexofenadine, chlorpheniramine within the last 7days prior to
             randomization

          -  Children who have received Ondansetron within 24hrs prior to randomization

          -  Children who are on Tricyclic antidepressants

          -  Children who are unwilling or unable to swallow the capsule.

          -  Children with chronic liver or kidney disease
Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis
Condition: Continuous Ambulatory Peritoneal Dialysis; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: ertapenem
Intervention description: 500 mg IV once
Intervention MeSH terms: Ertapenem
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ertapenem; CAPD; dialysis

Summary:

      The objective of this study is to characterize the pharmacokinetic profile of ertapenem
      during continuous ambulatory peritoneal dialysis (CAPD).
    

Eligibility criteria:

        i. Inclusion criteria Adult patients (≥ 18 years), non-infected (afebrile, lack of
        constitutional symptoms and no leukocytosis), on a stable PD regimen (at least one month)
        are eligible for participation. Both patients with and without residual renal function will
        be studied. Non-anuric patients concurrently receiving medications with the potential to
        inhibit active tubular secretion will be allowed to enter the study after a 2-week washout
        period. These medications include H2-antagonists, trimethoprim, or probenecid. The patient
        and their physician at the Hortense and Louis Rubin Dialysis Center will contacted if any
        medication needs to be discontinued.

        ii. Exclusion criteria Patients will be ineligible for the study if they have had
        peritonitis within the previous 4 weeks, clinical signs or symptoms of active infection,
        elevated white blood cell count, or treatment with any antibiotic within the previous 2
        weeks. Patients with a hemoglobin (hgb) < 11 g/dL will be ineligible for study inclusion.
        Patients with stated or documented allergies to beta-lactams medications will not be
        eligible. Pregnant or breastfeeding women will not be eligible for inclusion. All women of
        child-bearing age will need to yield a serum hCG ≤ 5 mIU/mL within 2 weeks of the scheduled
        study day. Patients taking valproic acid will also be excluded.
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: imiquimod 5% cream
Intervention description: 1 packet (250 mg cream) 3 times per week for 4 weeks
Intervention MeSH terms: Imiquimod
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Combination treatment; Imiquimod; Cryotherapy

Summary:

      The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy
      of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and
      new ones) at follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of actinic keratoses

          -  Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or
             balding scalp:

               -  each area with a minimum of 25 cm^2 and a maximum of 50 cm^2

               -  each area with at least 6 typical, non-hypertrophic target AKs

               -  with target AK lesion counts of +/- 1 lesion between the areas

               -  each area that the patient can distinguish with respect to study drug application

          -  Able to comply with all study requirements

          -  Are willing and able to give written informed consent

        Exclusion Criteria:

          -  Uncontrolled intercurrent or chronic illness

          -  Systemic immunocompromise due to disease or treatment

          -  Clinically relevant systemic autoimmune disease

          -  Pregnant or nursing

          -  Dermatologic disease and/or condition in the treatment area that may be exacerbated by
             imiquimod or cause difficulty with examination

          -  Participation in another clinical study

          -  Allergies to imiquimod or any of the excipients in the cream

          -  Treatment within the past 90 days with any of the following:

               -  Psoralens plus ultraviolet A therapy

               -  Ultraviolet B therapy

               -  Systemic immunomodulators (e.g. oral or parenteral corticosteroids at greater
                  than physiologic doses, interferons, anti-TNF agents, cytokines)

               -  Chemotherapeutic or cytotoxic agents;

               -  Investigational agent

          -  Treatment within the past 30 days with any of the following:

               -  Surgical excision

               -  Photodynamic therapy

               -  Curettage

               -  Topical corticosteroids

               -  Laser

               -  Dermabrasion

               -  Chemical peel

               -  Imiquimod 5% cream

               -  Topical retinoids

               -  5-fluorouracil

               -  Masoprocol

               -  Pimecrolimus or tacrolimus