bioihbjkbjnl/mcl2 huggingface dataset:
Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
Condition: Surgery
Intervention: Acetaminophen; Ibuprofen 600 mg; Oxycodone
Intervention description: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed); 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed); The number of tablets of oxycodone prescribed is the only difference between the two arms.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Oxycodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized to receive one of two prescription regimens.
Masking: Single (Outcomes Assessor)
Masking description: The treating provider and the patient know their prescription. The outcomes assessor will be blinded when administering the postoperative surveys.
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ambulatory; narcotics; opioids; postoperative; gynecology; laparoscopy; pain; surgery

Summary:

      Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the
      opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing
      in the post-operative period. There is wide variation in the prescribing practices for
      post-operative pain control and there is no standard of care for pain control after minor
      laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to
      show that on average half of the opioids prescribed are unused by the patient. The aim of the
      study is to evaluate two opioid prescription regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be over 18 years of age

          -  Scheduled for outpatient gynecologic laparoscopy

        Exclusion Criteria:

          -  Significant renal or liver disease is present that would alter prescribing patterns

          -  Chronic opioid use or abuse

          -  Allergy to acetaminophen, ibuprofen, other nsaids or narcotic medications

          -  Conversion of surgery to exploratory laparotomy
Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Sagramostim; Saline -- placebo comparator
Intervention description: 5 subjects 250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. Data and Safety Monitoring Board will then review data and recommend whether to continue at the same current recommended dose for additional subjects or to reduce the dose by half if excessive leukocytosis occurs; subcutaneous injection
Intervention MeSH terms: Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; neuropsychological assessment; Granulocyte-Macrophage Colony-Stimulating Factor; Leukine

Summary:

      A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested
      for its ability to be tolerated by Alzheimer's disease patients and potentially to improve
      their memory.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age 55 to 85 years;

          2. should have a mild-to-moderate AD diagnosis (MMSE 10-26 inclusive);

          3. should have evidence of elevated cortical amyloid by PET using florbetapir F18
             (Amyvid) [i.e. a positive scan], assessed qualitatively according to the Amyvid
             product label.

          4. if on anti-dementia treatment should be on stable treatment for at least 2 months
             (i.e. cholinesterase inhibitor and/or Memantine or Axona);

          5. stable on all other medications for at least 30 days prior to screen;

          6. should be fluent in English;

          7. should be physically able to participate by medical history, clinical exam and tests;

          8. should have a study partner to accompany them to scheduled visits.

        Exclusion Criteria:

          1. clinically relevant arrhythmias;

          2. a resting pulse less than 50;

          3. active cancer other than non-melanoma skin cancers;

          4. use of another investigatory drug within 2 months of screening;

          5. significant stroke or head trauma by history or MRI;

          6. contraindication for having a MRI;

          7. diagnostic and Statistical Manual of Mental Disorders-IV criteria for a current major
             psychiatric disorder;

          8. sensitivity to yeast or yeast products;

          9. impaired kidney function as measured by a Glomerular Filtration Rate less than 60
             milliliters/min;

         10. preexisting fluid retention, pulmonary infiltrates, or congestive heart failure;

         11. history of moderate-to-severe lung disease;

         12. history of moderate-to-severe liver disease;

         13. pregnant women, or any women who feel they are likely to become pregnant during the
             study;

         14. prisoners.
A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Fixed-Combination Bimatoprost/Brimonidine; Bimatoprost Ophthalmic Solution 0.01%; Vehicle Ophthalmic Solution; Brimonidine Tartrate Ophthalmic Solution 0.2%
Intervention description: One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.; One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.; One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.; One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Intervention MeSH terms: Brimonidine Tartrate; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared
      with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ocular hypertension or glaucoma

          -  Requires intraocular pressure (IOP)-lowering therapy

        Exclusion Criteria:

          -  Cataract surgery in one eye

          -  Ocular laser or intraocular surgery within 6 months

          -  Refractive surgery in either eye

          -  Anticipated use of contact lenses during the study

          -  Expected use of artificial tears during the study
A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Mavrilimumab 30 mg; Mavrilimumab 100 mg; Mavrilimumab 150 mg; Placebo
Intervention description: Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks; Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.; Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.; Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.
Intervention MeSH terms: Mavrilimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Mavrilimumab; CAM-3001

Summary:

      The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of
      mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with
      moderate-to-severe adult onset Rheumatoid Arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of adult onset Rheumatoid Arthritis (RA) in line with the protocol

          -  Moderately active disease in line with the protocol

          -  A pre-defined number of swollen joints in line with the protocol

          -  Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs
             (DMARDs)

          -  No evidence of respiratory disease.

        Exclusion Criteria:

          -  A rheumatic autoimmune disease other than RA, or significant systemic extra-articular
             involvement secondary to RA

          -  A history of, or current, inflammatory joint disease other than RA

          -  Previous treatment with the investigational drug

          -  Discontinuation of a biologic DMARD due to lack of efficacy

          -  Non-compliant concurrent medications

          -  Non-compliance with medical history criteria.
Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men
Condition: Obese Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Intervention: Investigational new drug company code: BGS649; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Open-label in Part 1 and double-blind in Part 2.
Enrollment: 29.0
Sex: Male
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Obese; obesity; hypogonadism; hypogonadotropic; hyperestrogenemic; testosterone; hypogonadal

Summary:

      This study is designed as a 2-part study, with Part 1 being open-label to best determine the
      appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo
      controlled design. The study aims to assess the safety and tolerability of BGS649, and
      determine whether or not BGS649 is able to normalize testosterone levels and improve insulin
      sensitivity in obese, hypogonadotropic hypogonadal (OHH) men
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males who meet the criteria of obese, hypogonadotropic hypogonadism defined as:

               -  Patients with a Body Mass Index (BMI) ≥ 30 kg/m2

               -  Patients with a morning serum total testosterone level < 300 ng/dL on at least
                  two separate occasions during the Screening and/or Baseline periods.

               -  Patients with inappropriately low gonadotropins at screening given the low
                  testosterone:

          -  Luteinizing hormone (LH) ≤ ULN

          -  Follicle stimulating hormone (FSH) ≤ ULN

          -  Estradiol within or above the normal range (defined as ≥ LLN of the approved assay)

               -  Normal hypothalamic/pituitary function, including:

          -  Prolactin: within the normal range

          -  Thyroid stimulating hormone (TSH): within the normal range

          -  Ferritin: within the normal range

          -  Patients agree to use a barrier method of contraception (e.g., condom), for the
             duration of the study and for at least 3 months following their Study Completion visit
             to prevent BGS649 exposure to their partners.

        Exclusion Criteria:

          -  Patients with hypogonadism, not related to obesity or as a result of other underlying
             issues

          -  Patients with significant major organ class illness (e.g. kidney or liver disease).

          -  Other protocol-defined inclusion/exclusion criteria may apply
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: onabotulinumtoxinA; Normal Saline
Intervention description: OnabotulinumtoxinA injected into protocol-specified areas on Day 1.; Placebo (normal saline) injected into protocol-specified areas on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 258.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with
      placebo as treatment for major depressive disorder (MDD) in adult females.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe major depressive disorder

        Exclusion Criteria:

          -  Prior treatment with botulinum toxin of any serotype for any reason

          -  Use of antidepressant medication for depression within 2 weeks of study

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Condition: Peripheral T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: SP-02L (darinaparsin for injection)
Intervention description: Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized
      study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory
      patients with peripheral T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each
             country/region

          -  Patients aged ≥20 years on the date of informed consent

          -  Patients with histologically confirmed diagnosis of one of the following:

               -  Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)

               -  Angioimmunoblastic T-cell Lymphoma (AITL)

               -  Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative)

          -  Relapsed or refractory patients with a treatment history of at least one regimen with
             antitumor agents for the above disease

          -  Have at least 1 measurable lesion

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          -  Patients with a life expectancy of at least 3 months as determined by the investigator
Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Cetuximab/Gemcitabine; Radiotherapy
Intervention description: Once weekly Cetuximab, twice weekly Gemcitabine for six weeks; Daily radiotherapy for 28 days
Intervention MeSH terms: Gemcitabine; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage I, II, III pancreatic adenocarcinoma; Radiographically measurable disease

Summary:

      This study is designed to establish the safety and efficacy of a combination of Erbitux
      (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic proof of pancreatic adenocarcinoma

          -  Clinical stage I, II, or III disease

          -  Radiographically measurable disease

          -  Tumor tissue for epidermal growth factor receptor (EGFR) status by
             immunohistochemistry

          -  Signed protocol consent

          -  Karnofsky performance status of at least 70%

          -  Age > or = to 18 years

          -  Patients must either not be of child bearing potential or have a negative pregnancy
             test within 72 hours of treatment.

          -  Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul.

          -  Creatinine < 1.5 x upper limit of normal (ULN)

          -  Bilirubin < 1.5 x ULN; AST < 2.5 x ULN.

        Exclusion Criteria:

          -  Acute hepatitis or known HIV

          -  Active or uncontrolled infection

          -  Significant history of cardiac disease

          -  Prior therapy which affects or targets the EGF pathway

          -  Prior severe infusion reaction to a monoclonal antibody

          -  Any concurrent chemotherapy not indicated in the study protocol or any other
             investigational agents

          -  Any previous chemotherapy or abdominal or pelvic radiotherapy

          -  No prior malignancy is allowed except for adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, or malignancy for which the patient has
             been disease free for five years.

          -  Any severe pre-existing medical or psychiatric condition, which, in the opinion of the
             attending physician, will interfere with safe and appropriate treatment and follow-up
             on study
Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: 18F-fluoroestradiol
Intervention description: Patients will receive the FES tracer during a PET/MRI scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Purpose: The primary objective is to evaluate the sensitivity and specificity of
      18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis.

      Participants: A total of 12 participants will be recruited from individuals with clinically
      suspected endometriosis who are scheduled for planned operative laparoscopy at the University
      of North Carolina at Chapel Hill (UNC).

      Procedures (methods): This is a prospective, one arm, single center study of 12 subjects with
      clinically suspected endometriosis to demonstrate FES PET/MR's clinical utility for diagnosis
      of endometriosis. This study will be an evaluation of the radiotracer, FES, which binds to
      estrogen receptors and has previously been used to study estrogen receptor expression in
      tumors, to detect endometriosis. Participants will undergo one FES PET/MR scan within 4 weeks
      prior to their scheduled surgery. Participants will also complete questionnaires regarding
      their condition, pain, and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Female of childbearing age

          -  Clinically suspected (symptomatic) endometriosis.

          -  Scheduled for planned operative laparoscopy with no hormone treatment for at least two
             cycles

          -  Able to provide informed consent or assent

        Exclusion Criteria:

          -  Male

          -  Institutionalized subject (prisoner or nursing home patient)

          -  Known history of breast, ovarian or endometrial cancer.

          -  Pregnant or breast-feeding women
Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section
Condition: Anesthesia
Intervention: Levobupivacaine; Fentanyl; Sufentanil; Levobupivacaine; Levobupivacaine
Intervention description: this used in intratechal area and for spinal anesthesia in ceserean section; this used in intratechal area and for spinal anesthesia in ceserean section; this used in intratechal area and for spinal anesthesia in ceserean section; this used in intratechal area and for spinal anesthesia in ceserean section; this used in intratechal area and for spinal anesthesia in ceserean section
Intervention MeSH terms: Fentanyl; Sufentanil; Levobupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: regionel anesthesia; levobupivacaine; ceserean section

Summary:

      45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to
      march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15
      µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal
      administration. Hemodynamic parameters, characteristics of sensory and motor blockade,
      peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the
      first analgesic requirement and adverse effects were recorded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  pregnant women with a single live fetus aged 18-45 years old and classified as ASA I,
             undergoing elective cesarean section, were included the study in november 2006 to
             march 2007

        Exclusion Criteria:

          -  Multiple pregnancies,

          -  preterm labor,

          -  eclampsia,

          -  preeclampsia,

          -  concomitant diabetes mellitus,

          -  allergy to local anesthetics, fentanyl or sufentanil,

          -  contraindication for regional anesthesia were the exclusion criteria.