bioihbjkbjnl/mcl2 huggingface dataset:
An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.
Condition: Cancer Pain
MeSH terms: Cancer Pain
Intervention: Oxycodone Hydrochloride; Morphine Sulphate
Intervention description: Oxycodone injection; Morphine sulphate injection
Intervention MeSH terms: Morphine; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Intravenous injection in cancer pain

Summary:

      The purpose of this study is to compare of difference in NRS scores from baseline to the
      completion of treatment (5 days) in patients with administration of morphine sulfate versus
      oxycodone hydrochloride.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult men and women aged 19 years or more

          2. Patients with cancerous pain who are hospitalized or scheduled for hospitalization at
             Screening and not planned to be discharged during the study

          3. Patients with mean moderate to severe pain over the past 7 days at Screening as
             verbally confirmed (NRS 4 or higher)

          4. Subjects who voluntarily signed the Informed Consent Form for the study

          5. Subjects who are capable of understanding details of the study and verbal
             communication on pain intensity

        Exclusion Criteria:

          1. Patients who reached the narcotic analgesic dose corresponding to the followings for
             cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day,
             oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)

          2. Patients with a medical history of hypersensitivity to an ingredient of oxycodone
             hydrochloride or morphine sulfate or other narcotic analgesics

          3. Patients who have contraindications and cautions when study drugs administered.
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
Condition: Proteinuria; Transplant Glomerulopathy
MeSH terms: Proteinuria
Intervention: Acthar
Intervention description: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.
Intervention MeSH terms: Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria
      associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant recipients with confirmed transplant glomerulopathy on kidney
             biopsy.

          -  Failed standard therapy (>25% reduction in proteinuria) including maximum use of an
             ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80
             and optimization of their immunosuppression

        Exclusion Criteria:

          -  Diabetes
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Abemaciclib; Fulvestrant; Standard Chemotherapy
Intervention description: Administered orally; Administered IM; Standard chemotherapy of physician's choice administered according to product label.
Intervention MeSH terms: Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel; Capecitabine; Fulvestrant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The reason for this study is to compare the efficacy of abemaciclib, in combination with
      fulvestrant, to that of physician's choice of chemotherapy in women with hormone
      receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic
      breast cancer that has spread to internal organs. Your participation in this trial could last
      up to 31 months, depending on your cancer type and how you and your tumor respond.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be females of post-menopausal status with HR+, HER2- breast cancer
             that has spread to internal organs

          -  Participants must have had at least one endocrine therapy

          -  Participants must be willing to use a device to answer daily questions about how they
             are doing for the duration of their participation in the study

          -  If participant has diarrhea from a previous treatment, they should talk to their
             doctor to ensure they have recovered enough to participate in this study

        Exclusion Criteria:

          -  Participants must not have breast cancer that has spread to the brain if untreated and
             with symptoms

          -  Participants must not have had any systemic treatment after their breast cancer has
             spread unless it is endocrine therapy

          -  Participants must not have certain active infections including HIV or hepatitis

          -  Participants must not be pregnant or breastfeeding

          -  Participants must not have certain types of cancers or certain previous cancer
             treatments

          -  Participants must not have certain serious medical conditions, including heart or lung
             disease, or have had certain types of tissue or organ transplants
Aflibercept in Polypoidal Choroidal Vasculopathy
Condition: Neovascular Macular Degeneration
MeSH terms: Macular Degeneration; Polypoidal Choroidal Vasculopathy
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Visudyne
Intervention description: Eylea is administered as an intravitreal injection; Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
Intervention MeSH terms: Aflibercept; Verteporfin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 333.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: PCV

Summary:

      To collect data reflecting the efficacy and safety of aflibercept with and without
      photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype
      of wet age-related macular degeneration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Men and women ≥50 years of age

          -  Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study
             eye established by Indocyanine Green Angiography(ICGA) at the study center

          -  Greatest linear dimension of the lesion of < 5400 mm (approximately, 9 Macular
             Photocoagulation Study disk areas), assessed by ICGA.

          -  An Early treatment diabetic retinopathy study (ETDRS) BCVA of 73 to 24 letters in the
             study eye.

        Exclusion Criteria:

          -  Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3
             months prior to study entry

          -  Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents
             in the study eye, or systemic use of anti VEGF products within 3 months prior to study
             entry

          -  Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT)

          -  History of allergy to fluorescein used in fluorescein angiography, iodine and/or
             indocyanine green.

          -  History of allergy to aflibercept, verteporfin, or their excipients.
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Condition: Acne; Healthy
MeSH terms: Acne Vulgaris
Intervention: Altreno; Benzoyl peroxide
Intervention description: Acne patients will be assigned to Altreno once daily.; Acne patients will be assigned to BPO leave-on gel once daily.
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study objective is to characterize the shift in the diversity and abundance of the skin
      microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl
      peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A confirmed diagnosis of acne that warrants initiating topical medications.

          -  Denies use of any prescribed systemic acne treatments in the past 30 days.

          -  Denies use of any prescribed topical medications in the past 30 days.

          -  Denies use of any OTC topical acne medications in the past 14 days.

          -  Denies use of any emollients in the past 24 hours (if feasible).

          -  Denies bathing or facial washing in the past 12 hours (if feasible).

          -  Willingness to adhere to the recommended topical regimen during the duration of the
             study.

        Exclusion Criteria:

          -  Women who are pregnant, breastfeeding, or planning to get pregnant during the study.

          -  Use of any investigational drug(s) in the past 3 months.
Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair
Condition: Pain, Postoperative; Opioid Use
MeSH terms: Hernia; Pain, Postoperative; Hernia, Ventral
Intervention: Quadratus Lumborum Block; Standard Medical Management
Intervention description: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will be injected on both sides of the mid-abdomen posterior to the mid-axillary line.; Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Masking description: The participant is blinded to the treatment.
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hernia, Ventral; Pain, Postoperative; Opioid Use; Pain

Summary:

      Ventral hernia repair may be associated with significant postoperative pain. Pain is
      typically managed with intravenous (IV) and oral medications that come with their own risks,
      such as nausea, constipation, sedation, respiratory depression, increased bleeding, and/or
      kidney or liver dysfunction. The quadratus lumborum peripheral nerve block has been shown to
      produce anesthesia of the anterior abdominal wall in the T7 to L1 distribution. This study
      aims to evaluate if the addition of the quadratus lumborum peripheral nerve block (QLB) can
      improve pain scores, decrease the need for IV and oral pain medications, and/or speed the
      patients' return to normal activity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is scheduled for elective laparoscopic ventral hernia repair;

          2. The subject is ≥ 18 years and ≤ 80 years;

          3. The patient agrees to receive a quadratus lumborum block

          4. American Society of Anesthesiologists class 1-3.

        Exclusion Criteria:

          1. Subject is < 18 years of age or >80 years of age;

          2. Subject is non-English speaking;

          3. Subject is known or believed to be pregnant;

          4. Subject is a prisoner;

          5. Subject has impaired decision-making capacity per discretion of the Investigator;

          6. Significant renal, cardiac or hepatic disease per discretion of the investigator;

          7. American Society of Anesthesiologists class 4-5;

          8. Known hypersensitivity and/or allergies to local anesthetics;

          9. Chronic opioid use (daily or almost daily use of opioids for > 3 months at any point
             in their lives).

         10. Repair of a recurrent ventral hernia

         11. Repair of multiple ventral hernias

         12. Unobtainable sonographic views

         13. Lacking health insurance
Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Condition: Gastrointestinal Symptoms; Heart Transplantation
Intervention: Mycophenolate Sodium
Intervention description: 1440mg/day (720mg by mouth, twice a day)
Intervention MeSH terms: Mycophenolic Acid
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: 18 Years
Healthy volunteers: No
Keywords: Heart Transplant; gastrointestinal; Cellcept; Myfortic; GI; GI symptoms with Mycophenolate Mofetil post heart transplant

Summary:

      Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of
      mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of
      transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of
      Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of
      acute kidney rejection only. There is no clinical data of its use in heart transplant
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of either sex aged 18 and above who have undergone successful orthotopic
             heart transplant surgery.

          2. Patients who are currently taking Cellcept® and experiencing gastrointestinal
             side-effects from this standard therapy.

          3. Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to
             participate.

          4. Patients who are able to give written informed consent.

        Exclusion Criteria:

          1. Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia
             (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia
             (hemoglobin < 6g/dl) at the time of potential enrollment.

          2. Women of childbearing potential not using the contraception method(s), as well as
             women who are breastfeeding.

          3. Known sensitivity to the study drug or class of the study drug.

          4. Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study.

          5. Use of any other investigational agent in the last 30 days.
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Condition: Bile Acid Malabsorption; Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Malabsorption Syndromes
Intervention: chenodeoxycholic acid
Intervention description: 1250 mg CDCA is given with a study meal
Intervention MeSH terms: Chenodeoxycholic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral
      stimulation with chenodeoxycholic acid in the same subjects before and after elective
      cholecystectomy
    

Eligibility criteria:

        Inclusion Criteria:

          -  planned elective cholecystectomy

        Exclusion Criteria:

          -  small bowel resection

          -  right sided hemicolectomy

          -  known chronic diarrheal disease (celiac disease, lactose malabsorption, Inflammatory
             bowel diseases, incl microscopic colitis)

          -  pregnancy

          -  wish for pregnancy within next three months

          -  allergy to eggs

          -  allergy to constituents in Xenbilox (capsules with chenodeoxycholic acid)

          -  acute cholecystitis within two months

          -  chronic cholecystitis

          -  cirrhosis of the liver

          -  suspected obstructive choledocholithiasis

          -  icterus
Retapamulin for Reducing MRSA Nasal Carriage
Condition: Methicillin-Resistant Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Intervention: Retapamulin; Placebo
Intervention description: Two times a day for 5 days; Two times a day for 5 days
Intervention MeSH terms: Retapamulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MRSA; MRSA resistant to mupirocin

Summary:

      The investigators will conduct a randomized placebo-controlled double-blinded study of nasal
      decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among
      adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC >256)
      strains.

      Objectives:

        1. To determine the percent of intervention vs. control patients with successful MRSA nasal
           decolonization as determined by bilateral nares swabs following a 5-day twice-a-day
           regimen of retapamulin.

        2. To determine the time to decolonization based upon interim and final bilateral nares
           swabs.

        3. To determine the acceptability of retapamulin by surveying participants about their
           experience and adverse events experienced during this study.

      The duration of participant follow-up is expected to last up to 7 weeks.

      This study will evaluate the safety and effectiveness of Altabax (retapamulin) during
      decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level and
      high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is
      no approved substitute topical agent for decolonization of the MRSA nasal reservoir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Have a type of MRSA that is resistant to mupirocin (a drug used to treat MRSA)

        Exclusion Criteria:

          -  Allergic to retapamulin

          -  Unable to use retapamulin via your nose (i.e. nose surgery, etc.)

          -  Are pregnant and/or breastfeeding
Methadone and Medication Abortion
Condition: Pain; Medical Abortion
Intervention: Methadone Pill; Ibuprofen
Intervention description: All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.; All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.
Intervention MeSH terms: Ibuprofen; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral methadone; Pain control

Summary:

      Pain has been recognized to be the most common and predictable side effect of medication
      abortion, causing significant distress associated with the process. Yet there is little known
      about the appropriate management of pain during this process, with no current evidence based
      recommendations for optimal analgesic regimens during the first trimester.

      The goal of this study is to evaluate the efficacy of oral methadone for pain control during
      medication abortion. The current medication regimen used to perform medication abortion is a
      dose of mifepristone (antiprogesterone) orally, followed by a dose of misoprostol
      (prostaglandin analogue) 24 to 72 hours later. Patients are prescribed a standard dose of
      ibuprofen 600-800mg tabs for pain control during the process. The investigators will conduct
      a non-randomized, pilot study with 25 patients evaluated at the Boston Medical Center family
      planning clinic at 10 weeks of gestation or less for medication abortion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women requesting medication abortion up to 10 weeks gestation

          -  Fluent English speaking

          -  Able and willing to receive and send text messages and receive phone calls

          -  Opioid naive

          -  Healthy patients with no significant comorbidities

        Exclusion Criteria:

          -  Any history of drug or alcohol use, opioid use in last 30 days, chronic use of pain
             medications, or use of benzodiazepines.

          -  Any chronic disease including renal, liver, respiratory or cardiac disease

          -  Any known allergies to mifepristone, misoprostol, nonsteroidal anti-inflammatory drugs
             (such as ibuprofen) and methadone.

          -  Known history of QT prolongation