bioihbjkbjnl/mcl2 huggingface dataset:
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
Condition: Actinic Cheilitis
MeSH terms: Cheilitis
Intervention: aminolevulinic acid hydrochloride; Photodynamic therapy with blue light
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic cheilitis; Photodynamic therapy; Levulan; Blue light

Summary:

      To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the
      treatment of actinic cheilitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be able to understand and voluntarily sign an informed consent form

          -  Must be male or female ≥ 18 years of age at the time of consent

          -  Must be able to adhere to the study visit schedule and other protocol requirements

          -  Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy
             specimen or clinical presentation

        Exclusion Criteria:

          -  Inability to provide voluntarily consent or mentally incompetent

          -  Active herpes labialis lesions

          -  Subjects with any condition which places the subject at unacceptable risk if he/she
             were to participate in the study, or confounds the ability to interpret data from the
             study

          -  Subjects with any other skin condition that might affect the evaluation of the study
             disease

          -  Pregnant or breastfeeding female subjects

          -  Subjects who have used any investigational medication within one month prior to study
             entry

          -  Subjects who have been previously exposed to PDT and/or topical Levulan therapy for
             the treatment of actinic cheilitis

          -  Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5%
             fluorouracil) within three months of study entry

          -  Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six
             months of study entry

          -  Subjects who are currently using photosensitizing agents (e.g. thiazides,
             tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk
             of augmented photosensitivity

          -  Subjects who are frequently exposed to ultraviolet radiation (e.g. lifeguards,
             construction workers, frequent sunbed users, etc.)

          -  Subjects with a history of cutaneous photosensitization, porphyria, hypersensitivity
             to porphyrins, or photodermatosis

          -  Subjects with a known hypersensitivity to Levulan

          -  Subjects who are immunocompromised
A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: Blood draw
Intervention description: One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 335.0
Sex: All
Minimum age: 4 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Prevenar; Pneumococcal disease

Summary:

      In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received
      either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular
      Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3
      years after the last vaccination) will assess the antibody concentrations in children who
      previously completed Wyeth study 0887X-101518.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects who participated in and completed Wyeth study 0887X 101518.

          -  Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

        Exclusion Criteria:

          -  Vaccination with any licensed or investigational pneumococcal vaccine since completion
             of Wyeth study 0887X 101518.

          -  History of culture proven invasive disease caused by S pneumoniae since the completion
             of Wyeth study 0887X 101518.

          -  Known or suspected immune deficiency or suppression since participation in Wyeth study
             0887X 101518.
Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients
Condition: Hypertriglyceridemia; Hyperlipoproteinemia Type IV; Hyperlipoproteinemia Type V; Hyperlipoproteinemia Type IIb; Hyperlipidemia
MeSH terms: Hyperlipoproteinemia Type IV; Hyperlipoproteinemia Type II; Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V; Hyperlipidemias; Hyperlipoproteinemias; Hypertriglyceridemia
Intervention: rosuvastatin
Intervention description: 10mg or 20mg
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Triglycerides; hypertriglyceridemia; statins; rosuvastatin; hyperlipoproteinemia; Fredrickson Type IIb or IV

Summary:

      The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and
      20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride
      levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients older than 18 years, both genders, without any previous treatment with
             statins or other lipid lowering drugs for at least 6 months

          -  With elevated triglycerides above 200 and below 800mg/dl and willing to follow all
             study procedures including assisting to clinics, fasting before blood samples and
             signing a written consent

        Exclusion Criteria:

          -  High levels of low-density lipoprotein cholesterol (LDL-C)

          -  Unstable cardiovascular condition or awaiting a myocardial revascularization

          -  Congestive cardiac failure

          -  Uncontrolled diabetes

          -  Cancer

          -  Uncontrolled hypothyroidism

          -  Familial hypercholesterolemia

          -  Liver/muscle disease

          -  Pregnancy

          -  Other
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: IV Acetaminophen
Intervention description: Details covered in arm description.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: IV Acetaminophen; Vaginal Reconstruction; Pain, Postoperative

Summary:

      This randomized controlled trial will evaluate the effects of perioperative intravenous (IV)
      acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing
      vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive
      either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive
      1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control
      group will receive placebo saline infusions at the same time intervals. All subjects will
      receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS)
      regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to
      discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects
      receiving IV acetaminophen will have lower VAS scores and decreased total narcotic
      consumption in comparison to the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women between the ages of 18 and 70 years

          -  Patients of the Division of Urogynecology at Good Samaritan and Bethesda North
             Hospitals in Cincinnati, Ohio

          -  Scheduled to undergo major vaginal reconstruction

          -  Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele
             repair, and intraperitoneal vault suspension. The addition of suburethral sling is not
             a cause for exclusion.

        Exclusion Criteria:

          -  Allergy to acetaminophen

          -  Liver disease (chronic or active)

          -  Chronic alcohol use (>1 drink/day)

          -  Bleeding diathesis

          -  Renal disease

          -  Opiate dependent or daily use

          -  History of chronic pain

          -  Mental or cognitive disorder preventing patient to accurately verbalize pain levels

          -  Undergoing abdominal or laparoscopic procedures at the time of surgery

          -  Allergy to hydromorphone

          -  Surgery is not performed under general anesthesia
Post-licensure Safety Study of IMOJEV® in Thailand
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine; IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
Intervention description: 0.5 mL, Subcutaneous.; 0.5 mL, Subcutaneous.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10000.0
Sex: All
Minimum age: 9 Months
Maximum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese encephalitis; IMOJEV®; Japanese encephalitis chimeric virus vaccine

Summary:

      The aim of this study is to further characterize the safety profile of IMOJEV®.

      Primary Objective:

        -  To describe serious adverse events (SAEs, including adverse events of special interest
           [AESIs]) up to 60 days after administration of one dose of IMOJEV®.

      Secondary Objective:

        -  To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after
           administration of one dose of IMOJEV®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children requiring vaccination against Japanese encephalitis

          -  Children aged 9 months to less than 5 years on the day of inclusion

          -  In good general health at the time of inclusion

          -  Informed consent form has been signed and dated by the parent(s)/legal guardian(s)

          -  Subject and parent(s)/legal guardian(s) are able to attend the scheduled visit and any
             additional visits that may need to be done in case of an SAE (including AESI), and are
             able to comply with all trial procedures

          -  The subject's parent(s)/legal guardian(s) have a telephone number at which they can be
             contacted throughout the study

        Exclusion Criteria:

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the vaccination

          -  Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned
             receipt of any vaccine in the 4 weeks following the study vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Children previously vaccinated with the live attenuated Japanese encephalitis vaccine
             CD-JEVAX® (SA14-14-2 LAV)

          -  Contraindications to vaccination according to the IMOJEV® Summary of Product
             Characteristics (SmPC)

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study

          -  Children who received IMOJEV® as primary vaccination in this study.
Insulin Glargine Versus Twice-Daily NPH
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin glargine at bedtime instead of NPH; NPH twice-daily
Intervention description: Insulin glargine at bedtime substituting for NPH insulin at bedtime; Addition of morning NPH to bedtime NPH
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Glargine; Type 2 diabetes; Basal insulin

Summary:

      To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH
      insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly
      NPH insulin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 18-75

          -  Type 2 diabetes diagnosed for at least 1 year

          -  Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on stable and maximum-tolerated
             doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime
             injection of NPH insulin

          -  Except for the subject's current bedtime NPH insulin, no other past history of chronic
             insulin use (other than treatment of gestational diabetes or hospitalizations of less
             than 1 week in duration)

          -  Average fasting plasma glucose level <130 mg/dL without fasting hypoglycemia

          -  Hemoglobin A1c between 7.5% and 12%

          -  Body mass index (BMI) between 20 and 40 kg/m2

        Exclusion Criteria:

          -  History of confirmed (or clinical suspicion of ) type 1 diabetes

          -  Female subjects of childbearing potential who are sexually active and not using a
             reliable form of contraception.

          -  Current pregnancy or lactation.

          -  Subjects for whom intensive insulin therapy is contraindicated

          -  Subjects with advanced proliferative diabetic retinopathy

          -  Subjects who are unable to stay on a consistent daily meal schedule

          -  History of any clinically significant renal, hepatic, cardiovascular, neurological,
             endocrinological or other major systemic disease that, in the opinion of the
             investigator, may make implementation of the protocol or interpretation of the data
             difficult.

          -  Subjects who will likely require or initiate therapy with drugs which may interfere
             with glucose metabolism during the course of the study

          -  Subjects who are in another investigational study or have received another
             investigational medication within 30 days of study entry

          -  Subjects who are unable or unwilling to comply with all components of the study
             protocol, including contacting the investigators at specified times and attending all
             scheduled follow-up visits.
Treatment Study of Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Intervention: ketamine; midazolam
Intervention description: a single IV infusion of ketamine, IV 0.5 mg/kg; a single IV infusion of midazolam, 0.045 mg/kg
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Patient, doctor and rater are masked (triple masked). Only the research pharmacist is unblinded.
Enrollment: 1.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Depression; Treatment-Resistant; ketamine; antidepressant; glutamate

Summary:

      The purpose of this study is to determine whether a single intravenous administration of an
      N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar
      depression.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients, 21-70 years;

          2. Primary diagnosis of bipolar I or II disorder as assessed by the SCID-P and confirmed
             by a study psychiatrist;

          3. Current depressive episode ≥ 8 weeks duration;

          4. History of a failure to respond to at least three (3) adequate pharmacotherapy trials
             in the current depressive episode (see above for definition for adequate trials);

          5. Subjects must be on a stable dose of divalproex ER with serum levels greater than 55
             mcg/ml prior to enrollment;

          6. Subjects must be free of psychotropic medication for at least 2 weeks (4 weeks for
             fluoxetine) prior to enrollment (with the exception of divalproex ER as above);

          7. Subjects must have scored ≥ 32 on the IDS-C30 at both Screening and Infusion Day #1
             and #2;

        Exclusion Criteria:

          1. Women who plan to become pregnant, are pregnant or are breast-feeding;

          2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory,
             cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;

          3. Clinically significant abnormal findings of laboratory parameters, physical
             examination, or ECG;

          4. Lifetime history of schizophrenia, schizoaffective disorder, OCD, mental retardation,
             pervasive developmental disorders, or Tourette's syndrome;

          5. Current presence of psychotic, mixed or manic symptoms;

          6. Lifetime history of antidepressant-induced switch to a manic episode;

          7. History of rapid cycling bipolar subtype;

          8. Drug or alcohol abuse within the preceding 3 months or dependence within the preceding
             5 years;

          9. Lifetime exposure to ketamine or phencyclidine;

         10. Patients judged by study investigator to be at high risk for suicide.
Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease
Condition: Depressive Disorder; Parkinson Disease
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Intervention: Atomoxetine; Placebo
Intervention description: 40 to 80 mg orally once daily for 8 weeks; 40 to 80 mg orally once daily for 8 weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Depression; Parkinson's Disease; Atomoxetine

Summary:

      This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression
      in people with Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic Parkinson's disease

          -  IDS score greater than 21

          -  Mini-Mental State Examination (MMSE) score greater than 15

        Exclusion Criteria:

          -  Recent deep brain stimulation

          -  Currently participating in an antidepressant trial at a less than adequate dose and
             duration

          -  Severe depression or depression with suicide ideation

          -  History of liver toxicity

          -  Unstable medical disease or comorbid psychiatric disease
A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: milnacipran; Placebo
Intervention description: Milnacipran will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.; Placebo will be given orally twice daily in tablet form at different times during the course of the study.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue.
      Researchers want to find out if "a drug" called milnacipran can help people with
      fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of
      fibromyalgia. In this study, milnacipran will be given to find out more about how it affects
      pain and thinking in people with fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  You may be eligible to take part in this study if the following are true:

               -  You are between the age of 18 and 70 years

               -  If you are female

               -  If you are right handed

               -  You have a diagnosis of fibromyalgia for at least 3 months, as defined by the
                  American College of Rheumatology 1990 Criteria

               -  You are willing to stop taking certain medicines that you may be taking on a
                  regular basis. The researchers will discuss these medications with you in detail

        Exclusion Criteria:

          -  You may not be eligible take part in this study if any of the following are true for
             you:

               -  You have problems with your heart or cardiovascular system

               -  You have problems with your liver or kidneys

               -  You have an autoimmune disease, or a whole-body infection like HIV or hepatitis

               -  You have cancer

               -  You are pregnant or breastfeeding

               -  You abuse drugs or alcohol

               -  You have suicidal thoughts or wishes

               -  You have taken milnacipran or another study drug within the last 30 days

               -  You have a medical problem not listed here that would make it unsafe for you to
                  take part in the study

               -  The research team feels that you will be unable to complete all phases of the
                  study