bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy
Condition: Neuromuscular Blockade
Intervention: deep block
Intervention description: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Neuromuscular blockade; Sugammadex; Laparoscopic surgery; IL-6

Summary:

      This study is a multicenter, randomized, controlled, double-blinded, and parallel design
      study. A total of 96 patients were decided to be recruited considering a 10% dropout rate.
      Patients are randomized to receive a deep block or a moderate block. The randomization
      numbers are generated using a computer-generated randomization code (1) and are sealed in the
      opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia
      management after the induction of anesthesia. Patients, surgeons reporting the scale of
      surgical status, and another researcher analysing the cytokines levels are blinded to the
      patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective
      laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease,
      hepatic or renal function impairment, on medications affecting neuromuscular function, and
      with known allergy to the drugs to be used are excluded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists grade 1 or 2

          -  Scheduled for elective laparoscopic gastrectomy

        Exclusion Criteria:

          -  Severe respiratory or cardiac disease

          -  Severe hepatic or renal function impairment

          -  On medications affecting neuromuscular function

          -  Known allergy to the drugs to be used
Adherence in Topical Treatment of Psoriasis
Condition: Adherence
MeSH terms: Psoriasis
Intervention: Calcipotriene + Betamethasone Dipropionate; App
Intervention description: Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.; App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: psoriasis

Summary:

      Medical adherence to topical corticosteroid products in psoriasis patients is a main
      determinant for poor treatment effect.

      The investigators aim to test if a multifaceted intervention delivered in an app (MyPso
      QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM)
      (Teslo) can improve medical adherence among psoriasis patients treated with a topical
      calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©).

      The study is classified as a phase 4 study, since it is studied if improved use of Enstilar©
      results in improved treatment outcomes.

      Link to published study protocol:

      https://bmcdermatol.biomedcentral.com/articles/10.1186/s12895-018-0071-3

      Link to published results from the study:

      https://onlinelibrary.wiley.com/doi/abs/10.1111/bjd.16667
    

Eligibility criteria:

        Inclusion Criteria:

          -  Psoriasis patients aged 18-75 years with mild-moderate psoriasis. It is mandatory that
             patients have a smartphone and basic skills for use of the smartphone.

        Exclusion Criteria:

          -  aged under 18 and above 75 years, guttate psoriasis, severe degree of psoriasis, i.e.
             pustular and erythrodermic psoriasis, lack of smartphone and user skills for the
             smartphone
Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Biafine; Polysporin
Intervention description: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.; over the counter Polysporin ointment 3 times daily for 4 weeks to wounds
Intervention MeSH terms: Bacitracin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to evaluate the use of Biafine Cream on wounds created
      by removal of actinic keratosis using cryotherapy in a clinical setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must give written consent.

          -  Subjects must be >50 years of age, male or female.

          -  Subjects must have had cryotherapy treatment of at least one AK's on each forearm in
             the Dermatology Clinic.

        Exclusion Criteria:

          -  Subjects age <50 years of age.

          -  Subjects with known allergy or sensitivity to topical Biafine or polysporin ointment.

          -  Inability to complete all study-related visits.

          -  Introduction of any other prescription medication, topical or systemic, for AK while
             participating in the study.

          -  Subjects using other topical agent's glycolic acid products, alpha-hydroxy acid
             products, retinoids and chemical peel agents in the treatment areas while on study.
Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease
Condition: Sleep Disturbance; Fatigue; Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Dyssomnias; Parasomnias
Intervention: Behavioral Counseling; bupropion-SR
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 15 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inflammatory Bowel Disease; Physical Illness; Wellbutrin

Summary:

      The purpose of this study is to determine if either a targeted type of talk therapy (Phase I)
      or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals
      with Inflammatory Bowel Disease (IBD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  IBD Group:

               -  Biopsy confirmed Crohn's Disease

               -  Qualifying scores on Multidimensional Fatigue Inventory and Pittsburgh Sleep
                  Quality Index

          -  Healthy Volunteer Group:

               -  Does not meet any exclusion criteria

        Exclusion Criteria:

          -  IBD Group:

               -  Meeting criteria for active alcohol or substance abuse or dependence

               -  Current ongoing treatment with Wellbutrin

               -  Females who are pregnant or plan to become pregnant within three months

               -  Sleep disorder such as apnea, restless leg syndrome or use of Continuous positive
                  airway pressure therapy (C-PAP)/Bilevel positive airway pressure (Bi-PAP)

               -  Current IBD flare requiring hospitalization with intravenous steroid treatment

               -  Other acute medical conditions or a history of chronic inflammatory condition
                  other than IBD

               -  Hemoglobin <10 with age and gender adjustments

               -  History of seizure disorder

               -  Acute infection within seven days

          -  Healthy Volunteer Group:

               -  History or current episode of psychiatric disorder by Diagnositic and Statistical
                  Manual (DSM-IV)

               -  Current ongoing treatment with psychoactive medications

               -  Medications for sleep in previous two weeks

               -  Females who are pregnant or plan to become pregnant within three months

               -  History of IBD, epilepsy, rheumatoid arthritis, lupus

               -  Sleep disorder such as apnea, restless leg syndrome or use of Continuous positive
                  airway pressure therapy (C-PAP)/Bilevel positive airway pressure (Bi-PAP)
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Palbociclib; Letrozole
Intervention description: 125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles; 2.5 mg/d tablets orally on a continuous regimen
Intervention MeSH terms: Letrozole; Palbociclib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 252.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone receptor positive advanced breast cancer

Summary:

      A study of palbociclib in combination with letrozole as treatment of post-menopausal women
      with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole
      therapy is deemed appropriate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma
             of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole
             therapy (in the first-line advanced/metastatic disease setting).

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Adequate bone marrow, liver, and renal function.

        Exclusion Criteria:

          -  Prior treatment with any CDK inhibitor .

          -  QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc
             prolongation, or Torsade de Pointes.

          -  High cardiovascular risk, including, but not limited to myocardial infarction,
             severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary
             embolism in the past 6 months of enrollment.
Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures
Condition: Laryngoscopic Surgical Procedures
Intervention: Deep Neuromuscular Blockade; Moderate Neuromuscular Blockade; Sugammadex; Rocuronium
Intervention description: During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).
At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2.; - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: "surgical conditions"; "deep neuromuscular blockade"; "deep neuromuscular paralysis"

Summary:

      It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex
      as an reversal in endolaryngeal surgery.

      We will conduct a clinical study aiming to compare two treatment strategies; Deep
      neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will
      offer better stillness. We will also descriptively examine if patients would be safely
      discharged from a recovery room.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 - 60 years; ASA I-III.

          -  Subjects have been planned for elective endolaryngeal. Procedures (Direct Laryngoscopy
             with laser (micro-)surgery in patients with Tis, T1, T2, supraglottis and glottis
             carcinoma)

        Exclusion Criteria:

          -  Any renal impairment (CrCL < 80 ml/ min)

          -  Any hepatic impairment; Child Pugh A, B or C

          -  BMI > 30 kg m2

          -  Known or suspected generalized neuromuscular disorders

          -  Allergies to Rocuronium, Sugammadex, Sevoflurane, Propofol, fentanyl used during
             general anesthesia

          -  Hypersensitivity to the active substance or to any of the excipients

          -  Female patient who are pregnant and breastfeeding.

          -  Patient with poor Glasgow Coma Score and mental derangement who is unable to give
             informed consent.

          -  Patient with Tracheostomy tube.
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Condition: Respiratory Failure; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis; Respiratory Insufficiency
Intervention: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
Intervention description: 8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)
Intervention MeSH terms: Antiviral Agents; Sofosbuvir-velpatasvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung disease; Lung Transplant; HCV; Hepatitis C

Summary:

      This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV
      negative recipient patients, with preemptive, interventional treatment with 8 weeks of
      commercially available DAA therapy to prevent HCV transmission upon transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Met MGH transplant center criteria, listed for lung transplant

          -  Able to sign informed consent

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  HIV positivity

          -  Any contra-indication to lung transplantation per center protocol

          -  For study patients in whom Epclusa® therapy is being considered, exclusion criteria
             includes patients on the following p-glycoprotein inducers or moderate to potent CYP
             inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital,
             oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.

          -  For study patients in whom MavyretTM therapy is being considered, exclusion criteria
             includes patients on the following medications who cannot stop therapy: carbamazepine,
             rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.
Condition: Renal Angiomyolipoma
MeSH terms: Tuberous Sclerosis; Angiomyolipoma; Sclerosis
Intervention: Everolimus
Intervention description: Everolimus 2.5 mg and 5 mg tablets with dosage regimen of 10 mg orally once daily.
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single arm, open label
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TSC; tuberous sclerosis complex; AML; afinitor; everolimus; RAD001; mTOR; kidney; lymphangioleiomyomatosis; renal angiomyolipoma

Summary:

      The purpose of this study was to assess the safety and efficacy of everolimus (Afinitor®) in
      Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex
      (TSC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible for treatment with everolimus as per the locally approved label.

          -  Presence of at least one AML ≥ 3 cm in its longest diameter using CT or MRI.

        Exclusion Criteria:

          -  AML related bleeding or embolization during the 6 months prior to enrollment.

          -  History of myocardial infarction, angina or stroke related to atherosclerosis.

          -  Impaired lung function.

          -  Significant hematological or hepatic abnormality.

          -  Any severe and/or uncontrolled medical conditions.
Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
Condition: Influenza
Intervention: Influsplit SSW® 2005/2006
Intervention description: Study influenza vaccine was administered intramuscularly in the non-dominant arm
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 6 Years
Maximum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will evaluate the immune response and the tolerability of the influenza vaccine
      administered in children aged 6-13 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy children or children with an increased health risk due to an underlying
             chronic disease-such as chronic airways diseases (including asthma), chronic
             cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic
             diseases-aged between 6 and 13 years.

          -  All subjects must not have received a prior influenza vaccination.

          -  All subjects must not have had a prior influenza disease.

        Exclusion Criteria:

          -  Use of any study or unlicensed medications/ vaccine other than the study vaccine
             within 30 days of the vaccination and/or during the study period.

          -  Acute illness at the start of the study.

          -  Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities
             of the hepatic or renal function.

          -  Known allergic reactions which might be caused by the ingredients of the vaccine.

          -  Girls post-menarche: pregnancy or positive pregnancy-test

          -  Multiple sclerosis or congenital or acquired immunodeficiencies.
Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
Condition: Hepatitis B; Hepatitis; Hepatitis, Viral, Human; Hepatitis B Immunization
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis, Viral, Human; Hepatitis
Intervention: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Intervention description: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule:
1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: non-responders to conventional treatment of hepatitis B vaccination and consent to participate
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Health workers with biological risk in their tasks, who have been vaccinated as
      non-responders to conventional vaccination against Hepatitis B. To provide Health
      workers-staff with an additional protection tool against hepatitis B infection. To evaluate
      the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NHS workers -including university students doing their internships in health centres
             dependent on the National Health System (inclusion of students is regulated and
             limited by specific instructions on labour prevention in each autonomous community).

          -  Criteria defining them as NO responders to the conventional hepatitis B vaccine: anti
             HBsAb titers <10 mIU / ml following the application of six doses of conventional
             vaccine at 20 μg doses (two complete guidelines).

        Exclusion Criteria:

          -  Known allergy to the active substance or any of the other ingredients of the medicinal
             product (included in section 6 of the product data sheet).

          -  Subjects that have ever had an allergic reaction to any vaccine against hepatitis B.

          -  Subjects have a serious infection with fever.

          -  Subjects for whom informed consent is not obtained.

          -  Subjects that have not revoked the consent initially signed.
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients
Condition: Memory Impairment Due to Corticosteroid Use; Hypomania Due to Corticosteroid Use; Hippocampal Atrophy Due to Corticosteroid
MeSH terms: Mania
Intervention: Lamotrigine (Drug)
Intervention MeSH terms: Lamotrigine
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years

Summary:

      The purpose of this study is to determine if lamotrigine therapy is associated with
      improvement in mood, memory and hippocampal size and function in patients receiving chronic
      corticosteroid therapy. Standard care for mood changes associated with corticosteroid
      therapy, if severe, includes antidepressants or other medications which can influence mood.
      No therapies, other than dose reduction or discontinuation, are currently available for
      memory loss associated with corticosteroid treatment. However, very little information is
      available on the treatment of either mood or memory changes associated with corticosteroid
      treatment, thus the proposed project may improve standard care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current Corticosteroid Use of 7 mg or more for 6+ months

          -  18-65 years of age

        Exclusion Criteria:

          -  Primarily non-English speaking

          -  Pregnant/nursing woman

          -  Currently taking Depakote

          -  Currently taking Rifampin

          -  Has diagnosis of major depressive disorder, schizophrenia, PTSD, bipolar I or bipolar
             II (not related to corticosteroid use)

          -  Diseases with CNS involvement

          -  Is to start a brief steroid taper

          -  History of Alcohol/drug abuse/dependence