bioihbjkbjnl/mcl2 huggingface dataset:
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.
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
Condition: Juvenile Idiopathic Arthritis (JIA)
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: VIMOVO 250/20; VIMOVO 375/20; VIMOVO 500/20
Intervention description: 250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months; 375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months; 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Intervention MeSH terms: Naproxen; Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent or legal guardian is able to provide written informed consent and patient is
             able to provide written assent if appropriate.

          -  Male and female adolescents aged 12 to 16 years at the time of enrollment.

          -  Diagnosed with JIA, including all the International League of Associations for
             Rheumatology JIA subtypes: oligoarthritis, polyarthritis (both rheumatoid factor [RF]+
             and RF-), psoriatic arthritis, enthesitis-related arthritis, undifferentiated
             arthritis, and systemic arthritis.

          -  Based upon investigator judgment, it is determined appropriate for the patient to
             undergo 6 months of continuous treatment with VIMOVO.

          -  Body weight > 31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass
             index for age.

        Exclusion Criteria:

          -  In systemic JIA patients, presence of systemic features (ie, fever, rheumatoid rash,
             serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to
             start of study drug.

          -  Currently taking (ie, within 4 weeks prior to start of drug) naproxen > 20 mg/kg/day
             or > 1000 mg total daily dose.

          -  Hemoglobin ≤ 8.5 g/dL.

          -  Individuals who have cardiovascular or cerebrovascular disease, based on history or
             risk factors.

          -  Any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other
             medical conditions indicated by medical/surgical history, physical, or laboratory
             examination that might put the patient at greater risk during the study.
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
Condition: Post Operative Anterior Chamber Inflammation (Flare)
MeSH terms: Inflammation
Intervention: Ketorolac Tromethamine 0.45%; Bromfenac 0.09%
Intervention description: Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.; Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Bromfenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Approximately 50 patients undergoing cataract surgery will be randomized in an even
      allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09%
      BID. Patients will be instructed to begin dosing study medication in the operative eye the
      day before surgery and continue dosing until day 14. KOWA flare measurements will be
      performed at postoperative day one and postoperative day 14. The amount of anterior chamber
      inflammation (flare) will be objectively measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be 18 years of age or older

          -  Scheduled for cataract surgery by phacoemulsification

          -  Subject must be willing to comply with all study requirements and be willing to give
             informed consent

        Exclusion Criteria:

          -  Any subject that has a history of uveitis or active iritis

          -  Subject can have no previous intraocular surgery with the exception of refractive
             surgery. but not within 6 months

          -  No ocular use of prostaglandins within 2 weeks of surgery

          -  Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs
             (NSAIDs) or immunosuppressants within 14 days prior to surgery

          -  Contraindications to NSAIDs

          -  Active ocular infection
Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Condition: Nail Diseases; Nail Abnormality
MeSH terms: Nail Diseases; Nails, Malformed
Intervention: Hydrocodone 5Mg/Acetaminophen 325Mg Tab; Acetaminophen 1000mg; Ibuprofen 400 mg
Intervention description: 5 mg/325 mg tablet; 1000 mg tablet; 400 mg tablet
Intervention MeSH terms: Acetaminophen; Ibuprofen; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: nail diseases; nail biopsy; nail procedure; pain management

Summary:

      The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone
      for nail-procedure associated pain management. The investigators hypothesize that ropivacaine
      with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for
      managing pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing fingernail or toenail, excision, or shave biopsy

          -  Must understand and voluntarily sign an informed consent form

          -  Must be male or female and aged 18-95 years at time of consent

          -  Must be able to adhere to the study visit schedule and other protocol requirements

        Exclusion Criteria:

          -  Subject is unable to provide written informed consent for any reason

          -  Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy

          -  Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any
             other chronic pain

          -  Subject has a history of opioid or alcohol use disorder

          -  Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency
             or a history of kidney disease, or has underlying liver disease

          -  Subject has a history of severe constipation

          -  Subject is sensitive or allergic to any of the elements included in this study

          -  Subject is unable to complete the required pain dairy

          -  Subject is pregnant, planning pregnancy, or nursing
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Selegiline Transdermal System; Placebo
Intervention description: EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study; Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Intervention MeSH terms: Selegiline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 308.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Mental Health; Adolescents; Major Depressive Disorder; Depression; Adolescent Depression; Pediatric Depression

Summary:

      The primary purpose of your participation in this study is to help answer the following
      research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is
      safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major
      Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male / Female outpatients 12 to 17 years of age diagnosed with Major Depressive
             Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised [CDRS-R] with
             a total score of at least 45 at screening.)

          -  Female patients must test negative on a pregnancy at visit 1.

          -  Weight and height must be greater than the 10th percentile according to age and
             height,

          -  Assent and consent must be given.

        Exclusion Criteria:

          -  Have a serious or unstable medical illness, psychological condition, clinically
             significant laboratory or ECG result, hypersensitivity to selegiline, or any other
             condition that in the opinion of the investigator would compromise participation in
             the study or be likely to lead to hospitalization during the course of the study.

          -  Have a current or previous diagnosis of bipolar disorder, psychotic depression,
             schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive
             disorder, pervasive development disorder or borderline personality disorder, as
             determined by the investigator.

          -  Have a risk of suicide

          -  Female patients who are either pregnant, nursing or have recently given birth.

          -  Use of any protocol prohibited medications or substances.
Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone Versus Intramuscular Progesterone
Condition: Reproductive Techniques, Assisted
Intervention: Subcutaneous progesterone; Intramuscular progesterone
Intervention description: subcutaneous progesterone 25 mg/day; intramuscular progesterone 50 mg/day
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Masked samples for histological evaluation and assessment of gene expression
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: endometrial receptivity; endometrial predecidualization; endometrial genomics; endometrial receptivity array

Summary:

      Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus
      intramuscular progesterone 50 mg/day, to determine whether there are differences in the
      endometrial transformation and endometrial receptivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female aged between 18 and 34 years

          -  BMI between 18 and 28 kg/m2

          -  Endometrial thickness > 7 mm the day of progesterone treatment initiation (day of
             follicular puncture)

          -  Follicular maturation with a single bolus of GnRH agonist

          -  Egg donors who undergo a cycle of ovarian stimulation in the IVI Barcelona Centre

          -  Egg donors selected in accordance with the requirements of Law 14/2006 of 26 May 2006
             on Assisted Human Reproduction Techniques

          -  Informed consent has been signed and dated

        Exclusion Criteria:

          -  Known allergy to progesterone formulations or their excipients

          -  Known allergy to estrogens

          -  Known thrombophilias

          -  Alcohol, drug or psychotropic medication dependence

          -  Concurrent participation in another study

          -  Concomitant medication that may interfere with the study medication and ovarian
             stimulation

          -  Failure to comply with the requirements for egg donors in accordance with Law 14/2006
             of 26 May 2006 on Assisted Human Reproduction Techniques
Assessment and Prevention of Acute Post-herniotomy Pain
Condition: Hernia
MeSH terms: Hernia
Intervention: Ketorolac postoperative; postoperative Patrol; intraoperative analgesia; intraoperative analgesia
Intervention description: Ketorolac 10mg 1cp x 3/die; acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die; ketorolac 30 mg iv; Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Herniotomy

Summary:

      The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two
      different therapeutical protocols per os: ketorolac versus association of
      acetaminophene+tramadol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females over 18 years, under 80 years, scheduled for elective herniotomy

          -  Classification American Society of Anesthesiologists (ASA) I: without systemic disease

          -  Classification ASA II or III (mild systemic disease or severe systemic disease that
             limits the activity without invalidity).

          -  Patients with hernia typ 2, 3a, 3b (classification NYHUS (1993))

          -  Signed informed consent

        Exclusion Criteria:

          -  ASA III, IV

          -  Emergency surgery

          -  Recovery in intensive care unit after surgery

          -  habitual opioid consumption

          -  NSADs allergy

          -  cognitive or mental alterations

          -  coagulopathy

          -  piastrinemia < 100.000/mm3
An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis
Condition: Vulva; Candidiasis
MeSH terms: Candidiasis
Intervention: Miconazole plus Hydrocortisone
Intervention description: Participants will apply miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the affected vulvar (the tissues around the opening to the vagina) area and the treatment should be continued without interruption. Participants will be assessed for signs and symptoms of vulvar candidiasis at Day 14. Medication will be continued till Day 28, if signs and symptoms of vulvar candidiasis are not cured clinically on Day 14.
Intervention MeSH terms: Miconazole; Hydrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Vulvar Candidiasis; Miconazole; Hydrocortisone; Daktacort Feminine Care Cream

Summary:

      The purpose of this study is to evaluate the efficacy and safety of miconazole plus
      hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast
      infection of the vulva).
    

Eligibility criteria:

        Inclusion Criteria: - Positive potassium hydroxide (KOH) mount / Gram stain (a method used
        to diagnose bacterial infection) of vulvar (the tissues around the opening to the vagina)
        scrapings - Vulvar candidiasis with at least mild pruritus Exclusion Criteria: -
        Participants with vaginal candidiasis (yeast infection of the vagina) - History of allergy
        to miconazone (an antifungal agent, is used for skin infections such as vaginal yeast
        infections) and/or other components of the study drug - Pruritus caused by etiologic (the
        cause) agents aside from fungi - Tuberculous (bacterial infection that usually results in a
        serious lung disorder) skin infection - Herpes simplex (viral infection), vaccinia (vaccine
        used to eradicate smallpox), all forms of varicella (infection caused by the
        varicella-zoster virus), and vulvar malignancy (cancer)
Tranexamic Acid Dosing for Total Joint Arthroplasty
Condition: Arthropathy of Hip; Arthropathy of Knee
MeSH terms: Joint Diseases
Intervention: Tranexamic Acid
Intervention description: Comparison of 3 different doses of the drug
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tranexamic Acid; Total Joint Arthroplasty; Intraoperative Blood Loss

Summary:

      The purpose of this study is to determine the effect of increasing doses of tranexamic acid
      (TXA) on limiting blood loss during total knee and total hip arthroplasty as defined by a
      change in hemoglobin from pre-operative baseline to the first post-operative day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing primary unilateral total knee arthroplasty or primary unilateral
             total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/
             New York Presbyterian Hospital.

        Exclusion Criteria:

          -  Non-English speaking.

          -  Patient refusal to participate.

          -  Weight exceeding 100kg.

          -  Baseline hemoglobin of less than 10.

          -  Repeat, revision, or bilateral surgery.

          -  Known sensitivity or allergy to Tranexamic Acid.

          -  Active intra-vascular clotting.

          -  History of coagulopathy or congenital thrombophilia.

          -  Thromboembolic event in the 12 months prior to enrollment.

          -  Percutaneous coronary intervention requiring a drug eluting stent in the 12 months
             prior to enrollment.

          -  History of anticoagulant medication use unless stopped prior to surgery as recommended
             by and in accordance with the American Society of Regional Anesthesia Guidelines.

          -  Use of a general anesthetic in the current anesthetic.

          -  Blood transfusion for a hemoglobin value which deviates from the study's transfusion
             protocol.
A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Chlorambucil; Cyclophosphamide; Fludarabine; Rituximab
Intervention description: 10 mg/m^2 orally on Days 1-7 of each 28-day cycle for 6 cycles; 150 mg/m^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles; 20 mg/m^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles; 375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)
Intervention MeSH terms: Cyclophosphamide; Chlorambucil; Rituximab; Fludarabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab)
      in combination with either fludarabine and cyclophosphamide or with chlorambucil in
      participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable
      somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously
      [IV] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or
      32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with
      chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study
      treatment was 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, 60-70 or >70 years of age

          -  Cumulative Illness Rating Scale (CIRS) comorbidity score >/=7 if patient is 60-70
             years old

          -  Previously untreated B-cell chronic lymphocytic leukemia

          -  Binet stage B, C or A with progression

          -  ECOG performance status 0-2

        Exclusion Criteria:

          -  Small-cell lymphoma

          -  Autoimmune hemolytic anemia

          -  Concomitant malignant disease during enrollment, except for basal cell carcinoma of
             the skin

          -  Chemotherapy for concomitant malignant disease within 12 months prior to study
             enrollment

          -  Richter's syndrome