bioihbjkbjnl/mcl2 huggingface dataset:
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Condition: Locally Advanced or; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant
Intervention description: fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.
Intervention MeSH terms: Fulvestrant
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      This single-arm study aims to assess the safety and tolerability profile of
      Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally
      advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events
      after Fulvestrant (Faslodex®) for about 6 months
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post menopausal status women

          -  Outpatient or inpatient with locally advanced or metastatic breast cancer who have
             failed with prior anti-estrogen therapy.

          -  Estrogen receptor positive

          -  Radiographic progression of disease after the prior therapy

          -  Patients who agree to participate in this study and sign the informed consent

        Exclusion Criteria:

          -  Patients who are treated with fulvestrant

          -  Patients who are being treated with the other antitumor agents

          -  Pregnancy or lactating women

          -  History of hypersensitivity to any of included ingredients (eg. Castor oil)

          -  Patients who are considered not fit for the study by investigators

          -  Patients who have severe dysfunction of liver or kidney
To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
Condition: Gastroesophageal Reflux Disease; GERD; Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic; Heartburn
Intervention: esomeprazole 20 mg
Intervention description: esomeprazole 20 mg once daily for 8 weeks
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: esomeprazole 20mg; heartburn; rabeprazole 10mg; reflux esophagitis; Phase IV

Summary:

      Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving
      rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant
      improvement of heartburn after 8-week treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male of female aged 20 years or more

          -  History of reflux esophagitis

          -  Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily,
             for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the
             past 7 days prior to Visit 1.

          -  Persisting symptoms of heartburn experienced at least 2 days during the past 7 days
             prior to Visit 1.

        Exclusion Criteria:

          -  Use of other PPIs and/or H2RA during rabeprazole treatment

          -  History or having other gastrointestinal diseases

          -  History of upper gastrointestinal surgery

          -  Initiation of medications that can affect digestive functions within 4 weeks before
             study treatment

          -  Inability to complete questionnaires
Ketoconazole Foam 2% for the Treatment of Versicolor
Condition: Tinea Versicolor
MeSH terms: Tinea Versicolor
Intervention: Ketoconazole 2% Foam
Intervention description: Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Intervention MeSH terms: Ketoconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tinea versicolor; ketoconazole

Summary:

      Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as
      a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to
      determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients, aged 19 years and over.

          2. Clinical presentation of tinea versicolor.

          3. Positive KOH using calcofluor.

          4. The ability to provide informed consent (including photography release)

        Exclusion Criteria:

          1. Use of topical antifungal to the affected area in the past 30 days

          2. Use of topical steroid to the affected area in the past 14 days

          3. If female, positive urine pregnancy test at screening (female patients of childbearing
             potential must be practicing a reliable method of birth control, not be planning a
             pregnancy, not be breast-feeding during the study)

          4. Patients with a dermatologic condition in the region of the treatment site that in the
             investigator's opinion may interfere with the study results

          5. Current diagnosis of immunocompromising conditions

          6. Any medical or psychiatric condition that may interfere with treatment or compliance
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval
Condition: Infertility, Female; Pain, Postoperative
MeSH terms: Infertility; Infertility, Female; Pain, Postoperative
Intervention: IV Acetaminophen; PO Acetaminophen; Placebo IV Acetaminophen; Placebo PO Acetaminophen
Intervention description: IV Acetaminophen for pain control during procedure; PO Acetaminophen for pain control during procedure; Placebo IV Acetaminophen; Placebo PO Acetaminophen
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 161.0
Sex: Female
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: in vitro fertilization; oocyte retrieval; acetaminophen; postoperative pain control

Summary:

      In this research study we want to learn more about how effective certain medications are at
      reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the
      time between the retrieval and discharge from the hospital. We will compare three types of
      pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and
      placebo (no medication), which is the current typical care.
    

Eligibility criteria:

        Inclusion Criteria:

        [ ] Patient is 18 years or over, undergoing oocyte retrieval. [ ] Patient is
        English-speaking.

        Exclusion Criteria:

        [ ] Allergy/hypersensitivity to acetaminophen or opiates. [ ] Any history of liver disease,
        history of alcohol depending, or renal impairment as reported in the electronic health
        record.

        [ ] Any history chronic opiate use or chronic pain disorder reported in the electronic
        health record.

        [ ] Weight less than 50kg as reported in the medical record.
Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
Condition: Pain
MeSH terms: Acute Pain; Sprains and Strains
Intervention: Celecoxib; oral Diclofenac
Intervention description: celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg; diclofenac 75 mg tablet BID (twice a day)
Intervention MeSH terms: Celecoxib; Diclofenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of the acute pain due to cervical; sprain; Celecoxib; NSAID; Diclofenac

Summary:

      This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In
      Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain

        Exclusion Criteria:

          -  Recent Cervical Sprains Or Other Cervical Conditions
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Condition: Exocrine Pancreatic Insufficiency (EPI)
MeSH terms: Pancreatic Neoplasms; Exocrine Pancreatic Insufficiency
Intervention: Pancrelipase; Placebo
Intervention description: Pancrelipase is administered orally as capsules with a meal or snack; Placebo is administered orally as capsules with a meal or snack
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Exocrine Pancreatic Insufficiency (EPI); Pancreatic Cancer; Creon; Pancrelipase

Summary:

      This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to
      pancreatic cancer. This study will include resected participants who are post pancreatic
      cancer surgery, and an additional cohort in non-resected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a
             life expectancy of at least 5 months at screening

          -  Participant's pancreatic cancer must involve the head and/or neck of the pancreas

          -  Confirmed exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1
             (FE-1) ≤ 150 µg/g stool at screening

          -  A positive Sudan stain for participants without history of fat malabsorption (fat
             malabsorption is defined as clinical steatorrhea, or measured stool fat > 7 g/day, or
             positive stool results by Sudan stain) within 1 week of screening -- Positive stool
             results are defined as increased level of neutral OR total fats

        Exclusion Criteria:

          -  Participant has neuroendocrine pancreatic cancer

          -  Participant has fibrosing colonopathy

          -  Participant has any other malignancy within 1 year of screening

          -  Participant has uncontrolled gout, including those with a recent flare within 60 days
             of screening

          -  Participant has other significant organ or bone marrow abnormality within 60 days of
             screening
Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
Condition: Relapsing Forms of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: BG00012 (DMF)
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effect of symptomatic therapies on
      gastrointestinal (GI)-related events reported by participants with relapsing forms of
      multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical
      practice setting.

      The secondary objectives of this study are as follows:

        -  To evaluate GI-related events requiring symptomatic therapy and the role of those
           therapies over time in participants with relapsing forms of MS initiating therapy with
           DMF in the clinical practice setting.

        -  To evaluate GI-related events that lead to DMF discontinuation after the use of
           symptomatic therapy in participants with relapsing forms of MS initiating therapy with
           DMF in the clinical practice setting.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Decision to treat with DMF must precede enrollment.

          -  Naïve to DMF or fumaric acid esters.

          -  Resides in the US and has a confirmed diagnosis of a relapsing form of MS.

          -  Satisfies the approved therapeutic indication(s) for DMF.

        Key Exclusion Criteria:

          -  Inability to comply with study requirements or, at the discretion of the Investigator,
             is deemed unsuitable for study participation.

          -  History of significant GI disease, chronic use of GI symptomatic therapy, active
             malignancies.

          -  Is participating in any other interventional clinical trial.

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
Condition: Kidney Transplant Infection
Intervention: Sirolimus; Everolimus; Mycophenolic acid
Intervention description: sirolimus combined to reduced dose of tacrolimus; everolimus combined to reduced dose of tacrolimus; Control arm: mycophenolate combined to regular tacrolimus
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1209.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus
      versus everolimus and tacrolimus versus mycophenolate and tacrolimus.

      The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant
      medical need in the absence of pharmacological prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Recipients, adults of the first living or deceased donor kidney transplant;

          2. Patients who agreed to participate in the study and signed the informed consent form

        Exclusion Criteria:

          1. Receptors with a medical history of nephrotic syndrome or focal and segmental
             glomerulosclerosis confirmed as the etiology of end-stage renal disease;

          2. Receptors with poor understanding about chronic kidney disease and its treatment
             alternatives;

          3. Receptors with early history of non compliance to treatment with immunosuppressive
             drugs;

          4. Retransplantation;

          5. Multi-organ recipients;

          6. Recipients with BMI> 30 kg / m2;

          7. KDPI> 80%;

          8. Cold ischemia time greater than 24 hours;

          9. Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class
             II;

         10. Women of childbearing potential who do not undertake contraceptive methods (condoms or
             oral contraceptives).

         11. Patients receiving immunosuppressive therapy prior to transplantation, except low dose
             of prednisone;

         12. Patients with severe uncontrolled dyslipidemia;

         13. Patients who have a known contraindication for administration of any of the
             immunosuppressive drugs provided for in this study;
Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients
Condition: MRSA - Methicillin Resistant Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections
Intervention: Vancomycin continuous infusion; Vancomycin intermittent dosing interval
Intervention description: Vancomycin 24 hour intravenous continuous infusion; Vancomycin intravenous infusion at rate 1000mg/hr
Intervention MeSH terms: Vancomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected
      methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to
      optimize the dosing of vancomycin for this critically ill population. The most efficacious
      method of administering vancomycin is debated in the literature. Since vancomycin is
      associated with slow bactericidal activity, it is important to closely monitor serum
      concentrations so as to achieve early target serum concentration, particularly when treating
      aggressive S. aureus infections. One study has shown that vancomycin infused continuously may
      enable faster and more consistent achievement of a therapeutic serum concentration when
      compared to intermittent infusion. A faster achievement in the goal serum vancomycin
      concentration would be a protective factor for intensive care unit mortality in patients with
      MRSA infection.

      Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a
      vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this
      nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve
      target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram
      with a continuous infusion. The aim is to determine which of the two dosing nomogram is more
      efficient and safer for SICU patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and non-pregnant female > 18 years of age admitted to Surgical ICUs with
             suspected infection

          -  Calculated creatinine clearance > 60ml/min

        Exclusion Criteria:

          -  Age < 18 years

          -  Allergic to vancomycin

          -  Calculated creatinine clearance < 60ml/min

          -  Pregnant

          -  Vancomycin administration more than 8 hour and less than 24 hour prior to study
             enrollment

          -  Anticipated vancomycin treatment less than 2 days for surgical prophylaxis
Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Condition: Dysphonia
MeSH terms: Dysphonia; Hoarseness
Intervention: Lansoprazole; Placebo
Intervention description: Lansoprazole 30 mg taken by mouth daily for 3 months; placebo taken by mouth daily for 3 months
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: horseness

Summary:

      This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary
      control alone will improve pediatric hoarseness symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy children with a diagnosis of dysphonia age 3-18 years.

          2. Dysphonia must be present for at least one month duration.

          3. May have vocal cord nodules present.

          4. Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially
             life-threatening cause, including but not limited to laryngeal papillomatosis,
             congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms.

          5. Must be able to cooperate with recording of voice for analysis(3 seconds of sustained
             vowel).

          6. Caregiver must be able to read, write, and understand English.

          7. Patient with history of diagnosed asthma must have their asthma well controlled and
             treated at the time of enrollment for study.

        Exclusion Criteria:

          1. Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal
             papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant
             neoplasms. This will be determined by visualization with flexible fiberoptic
             laryngoscopy.

          2. Dysphonia must not be due to an acute upper respiratory infection.

          3. Must not have been treated with proton pump inhibitor medication in the past 12
             months.

          4. Inability of child to cooperate with recording of voice for analysis.

          5. Inability of caregiver to read, write, and understand English.

          6. Mental retardation, cognitive impairment, or developmental delay.

          7. History of allergic reaction of any kind to lansoprazole or any other proton pump
             inhibitor.
Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: clobetasol propionate spray 0.05%; Vehicle spray
Intervention description: Apply enough product to cover affected areas topically twice daily at least 8 hours apart; Apply enough product to cover affected areas topically twice daily at least 8 hours apart
Intervention MeSH terms: Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the safety and efficacy of clobetasol
      propionate spray versus vehicle spray for the management of moderate to severe plaque
      psoriasis of the scalp.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp

        Exclusion Criteria:

          -  Subjects who need systemic treatment for their body psoriasis

          -  Subjects who have surface area involvement too large (>20% Body Surface Area [BSA])
             that would require more than 50 grams per week of study product