bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics
Condition: Pain; Cancer
Intervention: Fentanyl D-trans
Intervention description: Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Pain; Cancer; TTS-Fentanyl D-trans; Durogesic D-trans

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic
      System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so
      the drug will enter the body through the skin) treatment in cancer participants of Korea with
      inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and
      participant's satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who complains of cancer pain

          -  Participants who have taken non-opioid analgesics for the past one month for cancer
             pain relief purpose, but still have average 4 or higher pain level on the Visual
             Analogue Scale (VAS) for the last 24 hours

          -  Participants with an estimated life expectancy of at least 2 months

          -  Participants who are able to communicate with the investigator

          -  Participants who can avoid getting pregnant appropriately if there is a possibility of
             pregnancy during this study period

        Exclusion Criteria:

          -  Participants participating in another clinical trial

          -  Participants with a history of oversensitive reaction to a narcotic analgesic or with
             an existing history of drug abuse

          -  Participants who have active skin disease, avoiding application of the transdermal
             system

          -  Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic
             obstructive pulmonary disease)

          -  Participants undergoing chemotherapy/radiotherapy right now or is going to get
             chemotherapy/radiotherapy within the study period
Regional Block for Postoperative Free Flap Care
Condition: Pain Management
Intervention: ropivicaine 0.2%
Intervention description: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia
      for head and neck patients undergoing microvascular free flap reconstruction.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age > 18

          -  Able to consent for themselves

          -  Undergoing a head and neck surgery at UAB with reconstruction using either a forearm
             free flap or a fibula free flap

        Exclusion criteria:

          -  Age < 18

          -  Unable to consent for themselves

          -  Non-English speakers

          -  Non-resectable tumor

          -  Have a known opioid tolerance, or are on a home opioid regimen for a chronic
             condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new
             cancer diagnosis will be allowed).

          -  Patients with known hepatic failure, renal failure, or sulfa allergy, as determined by
             standard of care labs drawn within 30 days of enrollment
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Olopatadine 0.1%; Tranilast 0.5%; Placebo (Olopatadine); Placebo (Tranilast)
Intervention description: one drop in one eye; one drop in one eye; one drop in contralateral eye; one drop in contralateral eye
Intervention MeSH terms: Olopatadine Hydrochloride; Tranilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: conjunctivitis

Summary:

      To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal
      allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining
             consent).

          2. Positive cases in whom blood specific IgE antibody quantification against cedar pollen
             showed class 2-6 in a health checkup conducted within the past 3 years.

          3. Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were
             judged eligible as subjects of the said study by the investigator or co-investigator
             from the results of medical examination conducted on the day of the study or prior to
             it.

          4. Cases who gave consent on study participation of their own free will in writing, with
             understanding the contents of the said study.

        Exclusion Criteria:

          1. Cases with an ocular disease that requires treatment other than allergic
             conjunctivitis.

          2. Cases with an inflammatory ocular disease in the external/anterior part of the eye
             that may affect drug efficacy evaluation.

          3. Cases with a respiratory disease such as bronchial asthma other than allergic
             rhinitis.

          4. Cases with past history of anaphylaxis.

          5. Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.

          6. Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).

          7. Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be
             pregnant during the study period.

          8. Other cases who are judged ineligible for participation in the main study by the
             doctor in charge of the study.
A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Dornase alfa; Placebo
Intervention description: 2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days; 2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 3 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Pulmozyme; CF

Summary:

      This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed
      to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life
      (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF).
      Approximately 40 patients were planned to be enrolled in this study. However, only 3 patients
      were eligible for random allocation and received treatment: 1 patient in the Pulmozyme group
      and 2 patients in the placebo group. All 3 patients completed the study assessments but did
      not have usable pulmonary function test (PFT) data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form

          -  Aged 3-5 years

          -  Diagnosis of cystic fibrosis

        Exclusion Criteria:

          -  Children taking scheduled inhaled Pulmozyme or hypertonic saline within 56 days prior
             to Visit 1 or any Pulmozyme in the 28 days before Visit 1

          -  Involvement in a clinical intervention trial within the 4 weeks prior to Visit 1

          -  Use of an investigational drug or device within 28 days prior to Visit 1

          -  Any other condition that might increase the risk of participation to the patient in
             the judgement of the investigator
Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
Condition: Contact Lens Discomfort; Dry Eye
MeSH terms: Dry Eye Syndromes
Intervention: Systane Complete
Intervention description: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group will be randomized Systane Complete, and one group will be randomized to no treatment.
Masking: Double (Participant, Investigator)
Masking description: The patients who are randomized to Systane Complete will be masked to the brand of the artificial tears.
There will be a masked examiner who does not know the subject's study group.
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Artificial Tears; Systane Complete; Contact Lens Discomfort; Dry Eye; Daily Disposable Contact Lenses

Summary:

      Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort
      and the dry eye associated with CLs because new artificial tear formulations have the
      potential to outperform the available CL rewetting drops. While off-label, McDonald et al.
      have previously shown that using a common artificial tear, Systane Ultra, before and after CL
      use is an effective means for treating daily disposable CL wears who have CL discomfort.
      Recently, a new formulation of artificial tears, Systane Complete, was released to the
      market. Systane Complete is a unique formulation that has combined elements from both Systane
      Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for
      evaporative dry eye) to create an artificial tear with an indication for aqueous deficient,
      evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the goal of
      this study is to determine in a randomized clinical trial if Systane Complete is able to
      effectively improve the symptoms of patients who have CL discomfort.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self-reported contact lens discomfort

          -  Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12

          -  Daily disposable contact lens wearer

          -  Best-corrected visual acuity of 20/30 or better

        Exclusion Criteria:

          -  All other contact lens types (e.g., currently wearing two week or monthly replacement
             contact lenses or hard contact lenses)

          -  Non-compliant daily disposable contact lens wearers (must regularly replace contact
             lenses daily)

          -  Systemic health conditions known to alter tear film physiology

          -  History of ocular surgery within the past 12 months

          -  History of severe ocular trauma, active ocular infection, or inflammation

          -  Currently using Accutane or eye medications

          -  Pregnant or breast feeding
Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Intervention: hCG; hCG
Intervention description: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger; Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Intervention MeSH terms: Chorionic Gonadotropin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: OHSS, GnRH agonist trigger, low dose hCG, PCOS, IVF

Summary:

      This a prospective randomized double blind study involving patients at high risk of OHSS
      development with peak serum E2 levels < 4,000 pg/ml comparing the ongoing pregnancy rates in
      patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant
      hCG 1,500 IU 35 hours after GnRH agonist trigger.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome
             (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must
             have > 14 follicles of over 11 mm in diameter and with peak serum E2 levels < 4,000
             pg/mL on the day of trigger of oocyte maturation.

        Exclusion Criteria:

          -  Hypothalamic dysfunction, Patients with < 14 follicles < 11 mm in diameter, peak serum
             E2 levels >= 4,000 pg/mL.
Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
Condition: Wheezing; Allergy
MeSH terms: Respiratory Sounds
Intervention: Cholecalciferol; Cholecalciferol
Intervention description: Once the dietary intake of vitamin D has exceeded 200 IU/Day, the infants will receive placebo until they are 6 months of age adjusted for prematurity; Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Maximum age: 1 Year
Healthy volunteers: No

Summary:

      The goal of this study is to identify a vitamin D supplementation strategy that best promotes
      the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational
      age). This is a high risk population that seems to have unique vitamin D needs, and
      inappropriate supplementation may promote wheezing or allergy. The results of this study will
      help form nutritional recommendations for the approximately 100,000 black infants born at
      30-36 weeks gestational age in the U.S. every year.
    

Eligibility criteria:

        Inclusion criteria:

          1. 28 0/7-36 6/7 weeks gestational age (GA) at birth;

          2. family identifies the child as black or African American;

          3. < 28 days of supplemental oxygen (subsequent oxygen therapy for < 72 hrs for a brief
             subsequent illness or surgery will be allowed);

          4. admitted to a participating site NICU, special care nursery, transitional care
             nursery, or well-baby nursery as a neonate; and

          5. < 40 weeks corrected GA at enrollment.

        Exclusion criteria:

          1. BPD (> 28 days of supplemental oxygen);

          2. pre-existing diagnosis of moderate to severe osteopenia of prematurity and/or alkaline
             phosphatase > 700;

          3. history of fracture;

          4. gastrointestinal surgery, including for NEC;

          5. known gastrointestinal malabsorption;

          6. major congenital anomaly;

          7. congenital pulmonary or airway disorder (e.g., cystic fibrosis, tracheomalacia,
             swallowing disorder, bronchopulmonary sequestration);

          8. documented wheezing or stridor prior to enrollment;

          9. previous vit. D supplementation with > 400 IU/day;

         10. family plans to move more than 60 miles from CWRU or other pre-defined radius at other
             sites;

         11. baseline hypo- or hypercalcemia, hypo- or hyperphosphatemia; and

         12. baseline 25(OH) D level < 10 ng/ml.
Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Phenylephrine; Epinephrine; Arginine Vasopressin
Intervention description: 5 subjects will get Phenylephrine during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.; 5 subjects will get Epinephrine during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 0.5-1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.; 5 subjects will get Arginine Vasopressin during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.
Intervention MeSH terms: Phenylephrine; Vasopressins; Arginine Vasopressin; Epinephrine; Racepinephrine; Oxymetazoline; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Pulmonary arterial hypertension (PAH) is a disease where the blood pressure in the pulmonary
      arteries (PAP) is high. PAH increases the risk of adverse events, including death, during and
      or after procedures. The severity of baseline PAH correlates with the incidence of major
      complications, such that those with PAP higher than their systemic blood pressure (SBP) had a
      8 fold increased risk of complications. These children present for procedures where an acute
      exacerbation of their chronic illness-termed Pulmonary Hypertensive (PH)crisis, can occur,
      often resulting in death if not detected and managed expeditiously. Unfortunately there is
      little data and no consensus in the pediatric literature on how PH crisis should be managed.

      --------------------------------------------------------------------------------
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting for cardiac catheterization procedure with a diagnosis of PAH
             either by previous cardiac catheterization or echocardiography

        Exclusion Criteria:

          -  Children presenting for cardiac catheterization who do not have PAH;

          -  Children with PAH but with intracardiac shunts
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Ixekizumab; Adalimumab
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Adalimumab; Ixekizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 566.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab
      versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic
      disease-modifying anti-rheumatic drugs (DMARD) naive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of established diagnosis of active psoriatic arthritis for at least 6 months,
             and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

          -  Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3
             (out of 66) swollen joints

          -  Presence of active plaque psoriasis with a BSA ≥3%

          -  Men must agree to use a reliable method of birth control or remain abstinent during
             the study

          -  Women must agree to use reliable birth control or remain abstinent during the study
             and for at least 12 weeks after stopping treatment

          -  Have had an inadequate response when treated with 1 or more conventional synthetic
             disease-modifying antirheumatic drugs (csDMARDs)

        Exclusion Criteria:

          -  Current or prior use of biologic agents for treatment of Ps or PsA

          -  Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other
             than PsA

          -  Have participated in any study with interleukin 17 (IL-17) antagonists, including
             ixekizumab

          -  Serious disorder or illness other than psoriatic arthritis

          -  Serious infection within the last 3 months

          -  Active Crohn's disease or active ulcerative colitis

          -  Active vasculitis or uveitis

          -  Diagnosis of or history of malignant disease <5 years prior to randomization

          -  Women who are breastfeeding
Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: etanercept (EnbrelTM); methotrexate
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate Rheumatoid Arthritis

Summary:

      To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN)
      + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in
      subjects with moderate RA who were treated with MTX monotherapy, but continue to have
      moderate disease activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.

          -  Documented evidence, confirmed by a blinded 3rd party assessor, of at least one
             erosion observed by X-ray at randomization based on X-ray taken at the screening
             visit.

          -  Have received MTX as stable dose for 28 days prior to the screening visit.

        Exclusion Criteria:

          -  Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF)
             -a inhibitors, anakinra or other biological agents.

          -  Receipt of any DMARD, other than MTX, within 28 days before screening.