bioihbjkbjnl/mcl2 huggingface dataset:
Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Placebo; Milnacipran
Intervention description: Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.; Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Milnacipran; Duloxetine; Switch; Forest Research Institute

Summary:

      The objective of this study is to evaluate the safety, tolerability and efficacy of
      milnacipran in patients with an inadequate response to duloxetine for the treatment of
      fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of fibromyalgia

          -  Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks
             immediately before Screening (Visit 1)

          -  Duloxetine must have been prescribed for the treatment of Fibromyalgia

          -  Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm

          -  At Visit 2, to be eligible to enter the randomized treatment period, must continue to
             have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current
             Duloxetine treatment.

        Exclusion Criteria:

          -  Suicidal risk

          -  History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current
             episode of major depressive disorder

          -  Myocardial infarction and/or stroke within the prior 6 months

          -  Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at
             Screening (Visit 1)

          -  Substance abuse

          -  Pulmonary dysfunction

          -  Severe renal impairment

          -  Active cardiac disease

          -  Liver disease

          -  Uncontrolled narrow-angle glaucoma

          -  Autoimmune disease

          -  Cancer

          -  Inflammatory bowel disease

          -  Unstable endocrine disease

          -  Prostatic enlargement

          -  Female patients who are pregnant or breastfeeding
Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia
Condition: Schizophrenia; Insulin Resistance
MeSH terms: Insulin Resistance; Schizophrenia
Intervention: Aripiprazole; Placebo
Intervention description: 15-mg dose once a day for 8 weeks; 1 tablet placebo dose once a day for 8 weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Glucose Metabolism

Summary:

      This study will evaluate the effects of combination treatment with aripiprazole and clozapine
      on insulin resistance, blood fat levels, and weight gain in people diagnosed with
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia (any subtype) or schizoaffective disorder (any subtype)

          -  Treatment with clozapine for at least 1 year

          -  Stable dose of clozapine for at least 1 month

          -  Well established compliance with outpatient medications

          -  Female participants of non-childbearing potential or of childbearing potential and
             willing to practice appropriate birth control methods (complete abstinence from sexual
             intercourse, female sterilization, sterilization of male partner, implants of
             levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or
             double barrier methods of contraception using spermicide with either a condom or
             diaphragm) during the study

        Exclusion Criteria:

          -  Current substance abuse

          -  Psychiatrically unstable

          -  Significant medical illness, including severe cardiovascular, hepatic, or renal
             disease

          -  History of immunosuppression

          -  Current or recent radiation or chemotherapy treatment for cancer

          -  Chronic use of steroids

          -  Pregnant or breastfeeding
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod (FTY720)
Intervention description: Hard gelatin capsules containing 0.5 mg of fingolimod.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 347.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Fingolimod; Early multiple sclerosis; Naive patients

Summary:

      This study assessed the efficacy of fingolimod in patients with short duration
      relapsing-remitting multiple sclerosis who had not been previously treated with
      disease-modifying therapies (DMTs), versus patients with the same disease duration who had
      previously received first-line DMTs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald
             criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent
             with the disease, with disease duration greater than or equal to one year and less
             than or equal to five years.

          -  Patients who have had at least two relapses in the past two years and an Expanded
             Disability Status Scale score between 0 and 3.5, inclusive.

        Patients

          -  Treatment naïve: patients who have never been treated with a Disease Modifying Therapy
             or

          -  Previously treated with a first-line Disease Modifying Therapy

        Exclusion Criteria:

          -  Patients who have received treatment with:

        Fingolimod at any time (e.g. participation in a fingolimod clinical trial),
        Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins
        in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine,
        cyclophosphamide or mitoxantrone, at any time.

        - Other protocol defined inclusion/exclusion criteria may apply
Rivastigmine in the Treatment of Postoperative Delirium: a Pilot Clinical Trial
Condition: Delirium; Postoperative Cognitive Dysfunction
MeSH terms: Delirium; Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Intervention: Rivastigmine Patch; Placebo Patch
Intervention description: Rivastigmine Patch 4.6 mg/24 hours: 5 cm2 size containing 9 mg rivastigmine applied to upper back preoperatively for a period of 24 hours; A 2x2 gauze and a Tegaderm dressing applied to upper back within 3 hours of surgery for a period of 24 hours.
Intervention MeSH terms: Rivastigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postoperative Delirium; Postoperative Cognitive Dysfunction; Rivastigmine; Exelon; Memory impairment; Delirium; Cognitive function

Summary:

      The purpose of this study is to determine whether preoperative administration of Rivastigmine
      prevents the incidence of postoperative delirium in patients undergoing major surgery as well
      as postoperative cognitive dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

        65 ≥ y.o. undergoing major elective surgery over 2 hours in length with one or more of the
        following:

          -  Preoperative cognitive impairment

          -  Age > 70 y.o.

          -  Use of psychoactive medications

          -  History of prior delirium

          -  Severe illness/co-morbidity

        Exclusion Criteria:

          -  Delirium on admission Profound dementia No spoken/written English An emergent
             procedure Hypersensitivity to Rivastigmine
Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Benzoyl Peroxide
Intervention description: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to see how often benzoyl peroxide is applied for acne.
      Use of medication was monitored electronically.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any male or female 13 to 18 years of age with a diagnosis of mild to moderate acne
             vulgaris by a dermatologist will be eligible for participation.

          -  Verbal consent of participation must be given by parent or guardian and child.

        Exclusion Criteria:

          -  Age less than 13 or greater than 18 years of age.

          -  Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.

          -  Inability to complete all study-related visits.

          -  Introduction of any other prescription medication, topical or systemic, for acne
             vulgaris while participating in the study.

          -  Subjects should not be using topical retinoids or benzoyl peroxide products, including
             Proactive® or topical prescription medications for the treatment of acne vulgaris for
             at least 2 weeks prior to beginning the study. Oral medications for the treatment of
             acne should not have been used at least 4 weeks prior to beginning the study.

          -  Women that are actively trying to become pregnant or wish to become pregnant during
             the time frame the study is to take place will be excluded.
Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir; insulin detemir
Intervention description: Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL; Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America. The aim of this trial is to explore
      how different fasting blood glucose targets affect glucose control in patients with type 2
      diabetes, when patients are empowered to do dose adjustments themselves.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  1-3 oral treatments

          -  Insulin naive

          -  BMI (Body Mass Index) less than or equal to 45

        Exclusion Criteria:

          -  Pregnancy

          -  Retinopathy

          -  Cardiac disease

          -  Uncontrolled hypertension

          -  Recurrent hypoglycaemia
Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: tacrolimus ointment
Intervention description: tacrolimus ointment to be applied twice daily to affected areas during duration of study
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 2 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: atopic dermatitis; eczema

Summary:

      The purpose of this research study is to better understand how the study drug works when
      people use it to treat atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects age 2-15.

          2. Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face
             and genital areas can be included in the body surface area determination and treatment
             area.

          3. The ability and willingness to follow all study procedures, attend all scheduled
             visits, and successfully complete the study.

          4. The ability to understand and sign a written informed consent/assent form, which must
             be obtained prior to treatment.

        Exclusion Criteria:

          1. Known allergy to tacrolimus or to any component of the formulations.

          2. The use of systemic therapy for atopic dermatitis within the past 4 weeks.

          3. Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or
             retinoids) within the past 2 weeks.

          4. Use of any investigational therapy within the past 4 weeks.

          5. Pregnant females, females who are breast feeding, or females of childbearing potential
             who are not practicing an acceptable method of birth control (abstinence, birth
             control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the
             investigator. Acceptable contraception must be used during the entire study. A
             pregnancy test will be performed on females of childbearing potential at baseline and
             at week 4.

          6. Any other condition which, in the judgment of the investigator, would put the subject
             at unacceptable risk for participation in the study.
Cryoanalgesia vs. Epidural in the Nuss Procedure
Condition: Pectus Excavatum; Funnel Chest
MeSH terms: Funnel Chest
Intervention: Cryoanalgesia; Thoracic epidural (ropivicaine, fentanyl)
Intervention description: Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
Intervention MeSH terms: Fentanyl
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: 13 Years
Healthy volunteers: No
Keywords: Nuss; Nuss Procedure; pectus excavatum; cryoanalgesia

Summary:

      The purpose of this study is to determine whether cryoanalgesia provides better pain control
      for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.
    

Eligibility criteria:

        Inclusion Criteria:

          -  scheduled for Nuss procedure for pectus excavatum correction

          -  at least 13 years old at the time of the procedure

        Exclusion Criteria:

          -  age less than 13 years at time of procedure

          -  use of pain medication prior to procedure

          -  pectus carinatum, Poland's syndrome, or any chest wall anomaly other than pectus
             excavatum

          -  previous repair of pectus excavatum by any technique

          -  previous thoracic surgery

          -  congenital heart disease

          -  bleeding dyscrasia

          -  major anesthetic risk factors or history of previous problem with anesthesia

          -  pregnancy

          -  inability to communicate in English
Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: amiodarone; Placebo
Intervention description: standard dose amiodarone; placebo delivered blinded
Intervention MeSH terms: Amiodarone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; amiodarone

Summary:

      Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are
      admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence
      that resolves as the patient recovers from their underlying condition. However, patients who
      develop AF can present with a very rapid heart rate that in some cases can put stress on the
      heart which can lead to life threatening heart attacks, low blood pressure or breathing
      problems. Not all patients with AF will have unstable heart function but those who have rapid
      heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no
      unstable heart function are two fold. Patients can be treated by controlling the heart rate
      and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be
      controlled by medication and the AF can be converted by either electrical cardioversion (an
      electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal
      of treatment should be to simply control the heart rate and wait for the patient to
      spontaneously convert to a normal heart rhythm or convert the AF with medication for patients
      who only have the rapid heart rate.

      The objective of this project is to conduct a pilot study to determine if it would be
      feasible to conduct a larger definitive trial that would answer the following question:
      Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart
      rhythm in patients with AF who have a rapid heart rate without unstable heart function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  new onset afib

        Exclusion Criteria:

          -  hemodynamically unstable
Dexamethasone for Post Cesarean Delivery Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Dexamethasone; Placebo
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Cesarean delivery; Analgesia; Pain; Dexamethasone; intrathecal morphine; spinal anesthesia

Summary:

      The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when
      used as part of a multimodal regimen to manage post cesarean delivery pain.

      We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal
      analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid
      consumption and pain
    

Eligibility criteria:

        Inclusion Criteria:

          -  English Speaking

          -  Non-laboring women

          -  Scheduled Elective Cesarean section under spinal anesthesia

          -  American Society of Anesthesiologists I-II physical status

        Exclusion Criteria:

          -  Contraindications to spinal anesthesia

          -  allergy to study medication

          -  patients with allergy to morphine

          -  patients with uncontrolled hypertension

          -  history of peptic ulcer disease

          -  liver cirrhosis

          -  diabetes mellitus

          -  glaucoma

          -  known IV drug abusers

          -  patients with chronic pain or on long term opioids

          -  patients administered steroids in the past week

          -  women with fetuses having known congenital abnormalities

          -  psychiatric illness such that they are unable to comprehend or participate in study
             questions

          -  patients on antiviral medications or live virus vaccines would also be excluded.
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
Condition: Hematologic Disease; Hemophilia A
MeSH terms: Hemophilia A; Hematologic Diseases
Intervention: Kogenate (BAY14-2222)
Intervention description: One group two treatment schedules, first on-demand then switch to prophylaxis
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 30 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Coagulation Disorders

Summary:

      The purpose of the study is to evaluate the effect of prophylactic treatment on the number of
      joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand
      treatment in a one-group two-treatment schedule design.

      In addition, the effect of prophylactic treatment on the joint function, the number of all
      bleeds, and on the quality of life compared to on-demand treatment and health-economic data
      will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A (< 1% FVIII)

          -  30-45 years of age

          -  Previously treated subject (> 100 Exposure days to any FVIII)

          -  On-demand therapy with any FVIII

        Exclusion Criteria:

          -  No history of inhibitor

          -  No planned elective orthopedic surgery during the study duration (13 months)

          -  No severe concomitant disease

          -  No history of anaphylactic or other severe reaction to previous FVIII treatment