bioihbjkbjnl/mcl2 huggingface dataset:
Mifepristone Induction for Fetal Demise
Condition: Intrauterine Fetal Demise; Fetal Death
MeSH terms: Fetal Death; Stillbirth
Intervention: Mifepristone; placebo
Intervention MeSH terms: Mifepristone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mifepristone; randomized controlled trial; vaginal delivery; progesterone receptor modulator; induction of labor

Summary:

      Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or
      placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational
      age or greater.

      Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when
      compared to placebo, and in conjunction with other pharmacologic methods for induction of
      labor.

      Expected outcomes: The addition of a progesterone receptor modulator will expedite time to
      delivery of the fetus and ultimately improve the experience associated with induction of
      labor for fetal demise.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Intrauterine fetal death as confirmed by absence of cardiac motion on ultrasound by
             Attending physician at the time of admission to the hospital.

          2. Estimated gestational age greater than 20 weeks

          3. Hemodynamically stable and appropriate for induction of labor as per primary clinical
             health team in house

          4. Women with one prior low transverse cesarean delivery

        Exclusion Criteria:

          1. History of 2 or more low transverse cesarean deliveries

          2. Prior classical cesarean delivery

          3. History of abdominal myomectomy

          4. Known or suspected allergic reaction to mifepristone

          5. Known or suspected adrenal gland disease

          6. Known or suspected bleeding diatheses or coagulopathies

          7. Known or suspected use of QTc-prolonging medication

          8. Known maternal medical or physical conditions that prohibits vaginal delivery
Randomized Controlled Trial for Exparel Hip Fracture
Condition: Hip Fractures
MeSH terms: Fractures, Bone; Hip Fractures
Intervention: Exparel; Sodium Chloride
Intervention description: Subcutaneous injection at conclusion of surgical fixation of hip fracture; Saline Injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized study looking at the effect that a long-acting local
      anesthetic has on pain control in patients having surgery for hip fractures. The
      investigators are conducting the study to see if that reduces the amount of pain medicine
      needed after surgery, and if it reduces other medical complications after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 55 or older

          -  Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or
             hemiarthroplasty

          -  Able to consent

          -  Isolated injury

        Exclusion Criteria:

          -  OTA/AO 31B1 (Impacted/slightly displaced)

          -  Baseline dementia or cognitive deficit

          -  Inability to consent

          -  Chronic Opioid use

          -  End stage liver disease with Model for End-Stage Liver Disease (MELD) greater than 20.

          -  End stage renal disease as defined by patients requiring hemodialysis at least twice
             weekly

          -  Polytrauma, defined as: concurrent upper or lower extremity fracture, pelvis fracture,
             spine fracture, rib fractures, or facial fractures, Blunt chest or abdominal trauma
             resulting in diagnosed organ injury, Head trauma resulting in intracranial bleed or
             diagnosed concussion

          -  Allergy to amide-type local anesthetics

          -  Prisoners (unlikely to be accessible for follow-up)
Medrol Dosepak Taper for Delayed Post-op Recovery After TKA
Condition: Total Knee Arthroplasty
Intervention: Methylprednisolone; Placebo
Intervention description: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM <90° at 8 weeks; 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM <90° at 8 weeks
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methylprednisolone; Delayed recover; range of motion

Summary:

      To evaluate the efficacy of a methylprednisolone taper on patients with decreased range of
      motion (ROM) or delayed recovery in the acute postoperative period following total knee
      arthroplasty (TKA).

      Patients with decreased ROM or delayed recovery six weeks to three months post-TKA will
      improve ROM and patient-reported outcomes at two weeks post-treatment initiation of
      methylprednisolone taper, as compared to similar patients who receive a placebo taper.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient undergoing primary TKA with a diagnosis of osteoarthritis

          -  ≥ 18 years old

          -  ROM <90° by 3 weeks postoperatively without improvement to >90° by 6 weeks

          -  Requiring a 30-pill oxycodone refill

          -  NSAID allergy

          -  Thigh circumference discrepancy >2cm between legs from 3 to 6 weeks

          -  Defense and Veterans Pain Rating Scale (DVPRS) > 5 between 3 and 6 weeks

          -  Willingness to undergo randomization

        Exclusion Criteria:

          -  Reported chronic corticosteroid or opiate use

          -  Suspected or confirmed periprosthetic joint infection

          -  Revision TKA

          -  Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture,
             or post-traumatic arthritis

          -  American Society of Anesthesiologists (ASA) score ≥ 4

          -  Reported history of liver or renal disease

          -  Uncontrolled diabetes

          -  Immunosuppression

          -  ≤ 18 years old

          -  Inability to take oral medications

          -  Unable to provide consent
MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
Condition: Acute Pulmonary Edema
MeSH terms: Pulmonary Edema; Edema
Intervention: Midazolam; Morphine
Intervention description: Dose use according to the product technical sheet; Dose use according to the product technical sheet
Intervention MeSH terms: Midazolam; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute heart failure; morphine; midazolam; in-hospital mortality

Summary:

      Acute pulmonary edema (APE) is a common condition in the emergency room, associated with
      considerable mortality. The use of intravenous morphine in the treatment of APE remains
      controversial and Benzodiazepines have been suggested as an alternative for morphine to
      relieving dyspnoea and anxiety in the patients with APE. The MIdazolan versus MOrphine in APE
      trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate
      the efficacy and safety of morphine in patients with APE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with acute pulmonary edema with dyspnoea and anxiety

        Exclusion Criteria:

          -  Patients with known severe liver disease.

          -  Patients with known severe renal disease.

          -  Patients with expectation of death from other illness during the course of the trial.
Liposomal Bupivacaine vs Peripheral Nerve Block
Condition: Pain, Acute; Surgery; Anesthesia; Opioid Use
MeSH terms: Acute Pain
Intervention: Liposomal bupivacaine; Peripheral Nerve Block
Intervention description: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area; Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Liposomal bupivacaine has gained interest in recent literature for its potential to be an
      effective adjunct to other pain control modalities in a multi-modal approach to
      post-operative pain control. The goal of this investigation is to compare the efficacy of
      local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block
      in terms of post-operative pain scores after elective ankle and hindfoot surgery. The
      investigators hypothesize that there will not be a significant difference in the pain scores
      of these two groups in opioid naïve patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 18 years of age or older

          2. Patients undergoing elective primary ankle or hindfoot surgery (ankle arthrodesis,
             subtalar arthrodesis, triple arthrodesis, total ankle arthroplasty, peroneal tendon
             debridement/transfer, Cavus Reconstruction, Medial Displacement Calcaneal Osteotomy,
             Dwyer Osteotomy)

        Exclusion Criteria:

          1. Patients who are undergoing revision surgical procedure

          2. Patients who have taken opioid pain medications in the past 3 months prior to surgical
             procedure

          3. Patients who have allergies to any of the medications or components of medications
             investigated in the study

          4. Patients currently incarcerated

          5. Patients who cannot read and speak English
Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases; Liver Cirrhosis; Fibrosis
Intervention: Perfusion MRI
Intervention description: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: liver fibrosis; liver cirrhosis; chronic hepatitis; magnetic resonance imaging

Summary:

      Patients with chronic liver disease are at high risk of developing liver scarring (fibrosis),
      with ultimate risks of cirrhosis and liver cancer that may require liver transplant. The
      investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI)
      techniques (MR diffusion, perfusion and elastography) to assess the degree of liver damage in
      patients with chronic liver disease. These techniques combined could reach high diagnostic
      performance for detection of liver fibrosis; and could decrease the number of liver biopsies,
      which have risks and sample only a small portion of the liver.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic liver disease (including viral hepatitis, alcoholic hepatitis, non alcoholic
             steatohepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, etc..)

          -  18 years of age and older

          -  Liver biopsy (percutaneous or transjugular or surgical) performed within 6 months, as
             part of routine clinical care.

          -  Liver transplant or liver resection performed within 6 months, as part of routine
             clinical care.

          -  Patient is able to give informed consent for this study and agrees to provide a blood
             sample

        Control group

          -  Patients without history of liver disease and healthy volunteers

          -  18 years of age and older

          -  Subject is able to give informed consent for this study and agrees to provide a blood
             sample

        Exclusion Criteria:

          -  Age less than 18 years

          -  Unable or unwilling to give informed consent

          -  Contra-indications to MRI

          -  Electrical implants such as cardiac pacemakers or perfusion pumps

          -  Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial
             hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or
             steel implants

          -  Ferromagnetic objects such as jewelry or metal clips in clothing

          -  Pregnant subjects

          -  Pre-existing medical conditions including a likelihood of developing seizures or
             claustrophobic reactions.
ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Shared Decision Making
Intervention description: This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1400.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus Type 2

Summary:

      The purpose of this study is to evaluate whether a combination of pharmacist-delivered
      patient engagement techniques improves disease control and medication adherence among
      patients with poorly-controlled diabetes compared with usual care. These engagement
      techniques include shared decision-making and brief negotiated interviewing and are delivered
      telephonically.
    

Eligibility criteria:

        Inclusion:

          -  Commercially-insured beneficiaries

          -  Receive all medical/prescription drug benefits through Horizon

          -  On ≥1 one oral hypoglycemic agent

          -  Latest HbA1c measurement ≥ 8% (within previous 6 months)

          -  Provided phone number to Horizon

        Exclusion:

        - Currently using any insulin
Budesonide in Patients With Immune Mediated Enteropathies
Condition: Enteropathy; Celiac Disease; CVID Enteropathy; Collagenous Sprue; Autoimmune Enteropathy
MeSH terms: Celiac Disease; Intestinal Diseases; Collagenous Sprue
Intervention: Withdrawal of Oral Budesonide
Intervention description: The intervention arm will taper and stop budesonide therapy (withdrawal).
Intervention MeSH terms: Budesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, open-label withdrawal of budesonide versus continued budesonide therapy in patients with immune-mediated enteropathies that have had symptomatic and histologic improvement
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Researchers are trying to determine if withdrawal of budesonide therapy in patients with
      immune-mediated enteropathies doing well on therapy will result in worsening symptoms,
      histology, quality of life, and micronutrient/nutritional status when compared to continued
      therapy.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients will be recruited from the Division of Gastroenterology and Hepatology and
             the Mayo Clinic in Rochester, MN.

          -  Adult patients with immune mediated enteropathies who have had improvement in symptoms
             and histology on oral budesonide therapy.

        Exclusion Criteria

          -  Age <18 years

          -  Positive stool gluten testing in patients with refractory celiac disease

          -  Small bowel malignancy or history of small bowel malignancy

          -  Refractory celiac disease type 2

          -  Post-transplant lymphoproliferative disorder associated enteropathy

          -  No prior improvement in symptoms and histology with budesonide therapy

          -  Discontinuation of budesonide therapy prior to the trial

          -  Other concurrent systemic corticosteroids

          -  Other immune mediating medications, for example but not limited to azathioprine,
             6-mercaptopurine, cyclosporine, methotrexate, anti-TNF monoclonal antibodies, alpha-4
             beta-7 integrin inhibiting monoclonal antibody, interleukin 12/23 inhibiting
             monoclonal antibody, JAK inhibitors.
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Condition: Appendicitis
MeSH terms: Appendicitis
Intervention: Piperacillin/Tazobactam; Surgical Treatment
Intervention description: 24 hours of IV antibiotic administration; Appendectomy
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Several prior studies have demonstrated that medical management of acute appendicitis in
      adults is a safe first-line therapy option. This study aims to determine whether
      non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior
      to operative management in a pediatric population. This study will be a randomized controlled
      trial comparing non-operative management with antibiotics to surgical management of
      uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than
      surgery for the treatment of uncomplicated appendicitis in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  first episode of appendicitis

          -  Pain < 48 hours

          -  White blood cell count < 18,000

          -  temperature < 103º F

          -  radiographic evidence of acute appendicitis on ultrasound or CT without evidence of
             perforation

          -  appendiceal diameter < 11 mm

          -  ability to take oral antibiotics

        Exclusion Criteria:

          -  Prior antibiotic treatment for appendicitis

          -  presence of medical condition prohibiting surgical therapy

          -  radiographic or clinical evidence of abscess or perforation

          -  appendiceal mass, positive pregnancy test

          -  other diagnosis equally as likely as appendicitis

          -  pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or
             appendiceal diameter ≥ 11 mm

          -  inability to take oral antibiotics.
Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Aromasin (exemestane)
Intervention description: the dosage, frequency and duration base on the LPD approved by SFDA.
Intervention MeSH terms: Exemestane
Phase: Phase 4
Study type: Interventional
Masking: None (Open Label)
Enrollment: 564.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; Aromasin; adjuvant chemotherapy; endocrine therapy

Summary:

      Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women
      with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years
      of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of
      adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial
      waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since
      then, there is currently lack of systematic collection and analysis for the efficacy and
      safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Interventional
      Study is being proposed to collect data systematically and to assess the efficacy and safety
      of Aromasin® adjuvant setting in Chinese population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.

          -  ER positive.

          -  The patient must be postmenopausal woman.

          -  The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will
             switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will
             necessarily precede and will be independent of the decision to enroll patients in the
             study).

        Exclusion Criteria:

          -  Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving
             Aromasin® treatment, there is evidence of a local relapse or distant metastasis of
             breast cancer, or a second primary cancer.

          -  Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase
             inhibitors (not Aromasin®).