bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Lavender Essential Oil
Intervention description: Lavender essential oil will be applied topically and by inhalation to the lavender group.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized study with control group and test group. Using a 1:1 treatment allocation ratio, the total of 60 patients (30 per arm) will be randomly assigned to control or treatment arm. The Statistical Investigator will generate the randomization scheme and monitor the randomization process over the course of the trial. The study will use randomization with random permuted blocks. The test group will receive 50% lavender oil diluted in fractionated coconut oil and the control group will have the current standard of care with no essential oil intervention. Fractionated coconut oil is being used because it is colorless, odorless, does not stain clothing, and has a long shelf life. It also serves as a carrier oil for the essential oil to absorb into the skin instead of evaporating off the skin due to essential oils volatile nature.
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This project will evaluate the integration of lavender essential oil in surgical patients
      during the perioperative and postoperative phase of care. The study will assess patients'
      pain, sleep quality, and mood. The goal is to support that lavender oil will decrease pain
      scores and narcotic use, increase sleep quality, and decrease anxiety by improving overall
      patient satisfaction and supporting their natural sense of well being. This research project
      will help support the use of complementary medicine in a hospital setting. The increased
      awareness and use of complementary medicine in a hospital setting will strengthen the patient
      centered care model that all hospitals strive to achieve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing any form of breast reconstruction therapy

          -  Ages 18-85

          -  At least a one night stay in hospital after surgery

        Exclusion Criteria:

          -  Use of sleeping aide drugs

          -  Use of benzodiazepines

          -  History of any of the following: asthma, eczema, allergy to flowers, smell disorders

          -  Sensitivity to lavender oil or any of its ingredients

          -  Pregnant women will be excluded from the study. During routine preoperative testing
             the patient's menstrual history or urine pregnancy test will be performed to identify
             any patient who is pregnant.
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
Condition: Coronary Artery Disease; Coronary Artery Stenoses; Valve Regurgitation, Mitral; Valve Regurgitation, Tricuspid
MeSH terms: Coronary Artery Disease; Coronary Stenosis; Tricuspid Valve Insufficiency; Mitral Valve Insufficiency
Intervention: Exparel Injectable Product; Bupivacaine Hydrochloride
Intervention description: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision); Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participants, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation in double-blind fashion
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac surgery; sternotomy; post-operative pain; sternal wound infiltration

Summary:

      The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration
      with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and
      cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft,
             valvular heart procedures, as well as other open cardiac procedures along with
             coronary artery bypass)

          -  Surgery with the use of cardiopulmonary bypass

        Exclusion Criteria:

          -  Minimally invasive heart surgery through thoracotomy approach

          -  Patient undergoing procedures under deep hypothermic circulatory arrest

          -  Patients with active infections such as infective endocarditis

          -  Emergency surgery

          -  Patients undergoing transplantations and ventricular assist device insertion

          -  Patients on any mechanical circulatory support preoperatively

          -  Patient's refusal

          -  End stage liver or renal disease

          -  Allergy to bupivacaine

          -  Patient who cannot understand the study procedure or refuse to participate

          -  Redo-sternotomy

          -  Participation in another study

          -  Patients with severe right or left ventricular dysfunction (EF< 25%)

          -  Patients requiring chronic opioids for chronic pain condition
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
Condition: Whole Cell Pertussis; Diphtheria; Hepatitis B; Tetanus; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Diphtheria
Intervention: Tritanrix™-HepB/Hiberix™ Kft.; Tritanrix™-HepB/Hiberix™; Hiberix™; Polyribosil-Ribitol-Phosphate (PRP) vaccine; Tritanrix™-HepB Kft
Intervention description: GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.; GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine; GSK Biologicals' Haemophilus influenzae type b vaccine; plain PRP polysaccharide vaccine; GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 745.0
Sex: All
Minimum age: 10 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to
      assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
    

Eligibility criteria:

        Inclusion criteria:

        For subjects receiving Plain PRP followed by DTPw-HBV:

        Male or female infant, 10 to 11 months of age, who previously completed the three-dose
        primary vaccination course with the DTPw-HBV/Hib vaccine.

        For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:

        Male or female infant, 15-18 months of age, who previously completed the three-dose primary
        vaccination course with the DTPw-HBV/Hib vaccine.

        For all subjects:

          -  Subjects who the investigator believes that their parent/guardian can and will comply
             with the requirements of the protocol.

          -  Free of obvious health problems as established by medical history and clinical
             examination

        Exclusion criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding administration of the study vaccine, or planned use during
             the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to administration of the study vaccine.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             starting 30 days before and ending 30 days after administration of the study vaccine
             with the exception of oral polio vaccine.
Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%; Moxifloxacin AF Vehicle
Intervention description: Eye drops; Inactive ingredients used as a placebo for masking purposes
Intervention MeSH terms: Moxifloxacin; Ophthalmic Solutions; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1179.0
Sex: All
Minimum age: 1 Month
Healthy volunteers: No
Keywords: pink eye; conjunctivitis; moxifloxacin; fluoroquinolone

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF
      Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial
      conjunctivitis in patients one month of age or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with bacterial conjunctivitis in 1 or both eyes;

          -  Able to understand and sign an informed consent form. If subject is <18 years of age,
             the informed consent must be understood and signed by the subject's legally authorized
             representative;

          -  Agrees to comply with the visit schedule and other requirements of the study;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;

          -  Presence of concomitant viral infection;

          -  Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical
             origin;

          -  Infants whose birth mothers had any sexually transmitted disease within 1 month prior
             to delivery;

          -  Infants undergoing treatment for retinopathy of prematurity;

          -  Contact lens wear during the course of the study;

          -  Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80)
             or better;

          -  Use of medications, as specified in the protocol;

          -  Any systemic or ocular disease or disorder, complicating factors or structural
             abnormality that could negatively affect the conduct or outcome of the study;

          -  Known or suspected allergy or hypersensitivity to fluoroquinolones;

          -  Pregnant, lactating, or of childbearing potential and not using adequate birth control
             to prevent pregnancy;

          -  Other protocol-specified exclusion criteria may apply.
Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Platelet-Rich Plasma; rehabilitation exercises
Intervention description: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections; Patients would been shown rehabilitation exercises, to perform them at home
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Platelet-rich plasma; Osteoarthritis

Summary:

      The investigators include patients attending the outpatient clinic in the area of Orthopedics
      and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which
      treatment is medical. Patients will be divided into two groups. In both groups, they will be
      given verbal, clear and detailed information on the approach to follow, the intra-articular
      application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first
      group will be held single application, while in the second group three applications will be
      made at an interval of two weeks each. Both groups will be assessed before and after
      application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western
      Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 90 years

          -  Patients with no previous treatment

          -  Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic
             findings)

        Exclusion Criteria:

          -  Age <18 and > 90 years

          -  Patients with Knee osteoarthritis grade 3-4 ( Kellgren-Lawrence based on radiographic
             findings)

          -  Patients with asociated Rheumatic syndromes

          -  Patients with anticoagulant therapy

          -  Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions,
             immunodepressed, or infections

          -  Pregnant patients

          -  Patients with prosthetic or orthotic.

          -  Patients with hemoglobin values < 11g/dl , platelets < 150,000/μL
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: pembrolizumab + epacadostat; pembrolizumab + placebo
Intervention description: Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
Epacadostat will be administered orally daily starting at Day 1 (Week 1); Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
Placebo will be administered orally daily starting at Day 1 (Week 1)
Intervention MeSH terms: Pembrolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 706.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; Metastatic Melanoma

Summary:

      The purpose of the study is to assess the efficacy, safety, and tolerability when combining
      pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic
      melanoma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed melanoma

          -  Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not
             amenable to local therapy

          -  A minimum of 1 measurable lesion by CT or MRI

          -  Provide a baseline tumor biopsy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

        Exclusion Criteria:

          -  Has received prior systemic treatment for unresectable or metastatic melanoma (except
             BRAF directed therapy)

          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
             IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint
             pathways other than anti-CTLA-4 which is permitted in the adjuvant setting

          -  Has received prior adjuvant therapy, monoclonal antibody or an investigational agent
             or device within 4 weeks or 5 half-lives (whichever is longer)

          -  Has an active infection requiring systemic therapy

          -  Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

          -  Has known history of or is positive for Hepatitis B or Hepatitis C

          -  Is pregnant or breastfeeding or expecting to conceive or father children within the
             projected duration of the study, starting with the screening visit through 120 days
             after the last dose of study treatment
Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
Condition: Lymphoma, Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: lenalidomide; Placebo; Rituximab; Cyclophosphamide; Doxorubicin; prednisone; vincristine
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 570.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: R-CHOP chemotherapy; DLBCL front line therapy; gene expression profiling (GEP) activated B-cell (ABC) type DLBCL biomarkers; Activated B-Cell (ABC) type; Diffuse Large B-Cell Lymphoma, not otherwise specified; Diffuse Large B-Cell Lymphoma, associated with chronic inflammation; Diffuse Large B-Cell Lymphoma, Epstein-Barr virus positive (EBS+) of the elderly; Diffuse Large B-Cell Lymphoma, T-cell / histiocyte-rich

Summary:

      To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide,
      doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab,
      cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in
      patients who have previously untreated ABC type DLBCL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type

          2. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma

          3. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) /
             Magnetic Resonance Imagining (MRI) scans

          4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

          5. Age 18 - 80 years; age > 80 allowed at investigator discretion if performance status ≤
             1; and each organ system score ≤ 2 using cumulative illness rating scale (CIRS)

        Exclusion Criteria:

          1. Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma

          2. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient
             has been disease free for 5 years or more

          3. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV)
             Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)

          4. Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left
             Ventricular Ejection Fraction) < 45% or peripheral neuropathy grade 2
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
Condition: Rhinitis, Allergic, Perennial; House Dust Mite Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Dust Mite Allergy
Intervention: 300 IR; Placebo
Intervention description: 300 IR tablet of HDM Allergen Extracts; Placebo tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1607.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of this study was to assess the efficacy and safety of 12 months of treatment
      with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with
      HDM-associated allergic rhinitis.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Patients with HDM-associated allergic rhinitis (AR) for at least 1 year

          -  Patients sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined on
             skin prick test and HDM-specific serum IgE

        Main Exclusion Criteria:

          -  A history of rhinitis, rhinoconjunctivitis or asthma to allergens other than HDM,
             likely to result in rhinitis symptoms during the evaluation periods

          -  Partly controlled or uncontrolled asthma

          -  Controlled asthma requiring controller treatment(s) consistent with GINA 2014
             treatment Steps 3 to 5