bioihbjkbjnl/mcl2 huggingface dataset:
D2560C00015 FluMist Annual Safety Study 2018
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Intervention: Bivalent influenza vaccine; Placebo
Intervention description: A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.; A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bivalent.; Influenza.; FluMist Quadrivalent.; Vaccine Prevention in Healthy Adults.

Summary:

      This prospective annual release study is designed to evaluate the safety of 2 new influenza
      virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza
      season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 49 years

          -  Written informed consent

          -  Subject available by telephone

          -  Ability to understand and comply with the requirements of the protocol, as judged by
             the Investigator

        Exclusion Criteria:

          -  Concurrent enrollment in another clinical study up to 180 days after receipt of
             investigational product (Day 181)

          -  History of hypersensitivity to any component of the vaccine, including egg or egg
             protein or serious, life threatening, or severe reactions to previous influenza
             vaccinations

          -  Any condition for which the inactivated influenza vaccine is indicated, including
             chronic disorders of the pulmonary or cardiovascular systems (example (eg], asthma),
             chronic metabolic diseases (eg, diabetes mellitus), renaldysfunction, or
             hemoglobinopathies that required regular medical follow-up or hospitalization during
             the preceding year

          -  Acute febrile (greater than [>]100.0 degrees Fahrenheit [F] oral or equivalent) and/or
             clinically significant respiratory illness (example, cough or sore throat) within 14
             days to randomization

          -  Any known immunosuppressive condition or immune deficiency diseases, including human
             immunodeficiency virus infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barre syndrome.
A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab
Intervention description: Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application).
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1660.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: secukinumab; AIN457; Moderate to severe plaque psoriasis; immune-mediated systemic disease; scaly patches; papules; plaques; itching

Summary:

      Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients
      with or without prior exposure to systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged at least 18 years at time of Screening.

          -  Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to
             Screening and candidate for systemic therapy.

          -  Other protocol defined inclusion criteria may apply. Please refer to the protocol.

        Exclusion Criteria:

          -  Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g.
             drug-induced psoriasis at Screening.

          -  Patients with previous treatment with any agent targeting interleukin (IL)-17 directly
             or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential unless they use effective contraception
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
Condition: Physiological Effect of Drugs; Morphine; Analgesics; Analgesics, Opioid; Central Nervous System Depressants; Narcotics
Intervention: 2% lidocaine with 1:200,000 epinephrine and epidural morphine; 3% 2-chloroprocaine and epidural morphine
Intervention description: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.; Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
Intervention MeSH terms: Lidocaine; Epinephrine; Morphine; Chloroprocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: cesarean delivery; c-section; chloroprocaine; lidocaine; morphine; post-operative pain; post-cesarean analgesia

Summary:

      The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural
      morphine administration will be not inferior to the effect of epidural 2% lidocaine with
      1:200,000 epinephrine on total opioid use for 24h
    

Eligibility criteria:

        Inclusion Criteria:

          -  pregnant patients

          -  live singleton pregnancy

        Exclusion Criteria:

          -  BMI >40

          -  obstructive sleep apnea

          -  drug abuse

          -  chronic pain

          -  chronic opioid use

          -  nonfunctioning epidural
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
Condition: Lumbar Spondylosis; Lumbar Spondylolisthesis; Adult Degenerative Lumbar Scoliosis
MeSH terms: Scoliosis; Spondylolisthesis; Spondylosis
Intervention: teriparatide; Placebo
Intervention description: Teriparatide 20 ug subcutaneous injection daily for 12 weeks; Saline solution
Intervention MeSH terms: Teriparatide; Parathyroid Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effects of 12 weeks of daily treatment with
      teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral
      spine fusion surgery for degenerative conditions of the lumbar spine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 60-90 years with lumbar spondylosis, spondylolithesis, or adult
             degenerative scoliosis, including disc pathology, stenosis, deformity, instability, or
             postdecompression revision, who are scheduled to undergo three-level or greater
             posterolateral lumbar spinal fusion.

          -  Willing and able to use a pen-type delivery system to administer daily subcutaneous
             injections.

        Exclusion Criteria:

          -  Use of bone morphogenic protein (BMP) posterolaterally during the fusion procedure.

          -  Previous spinal fusion at the intended fusion levels.

          -  Prior use of Forteo (teriparatide).

          -  Use of digoxin.

          -  Paget's Disease of bone.

          -  History of primary skeletal malignancy, presence of bone metastases, or previous
             skeletal exposure to therapeutic irradiation.

          -  Elevated serum calcium, serum PTH >70 pg/ml, 25-hydroxyvitamin D <12 ng/mL, or active
             liver disease.

          -  History of symptomatic nephro- or urolithiasis in the past two years.

          -  History of malignant neoplasm in the past five years, except for superficial basal
             cell carcinoma or squamous cell carcinoma.

          -  Carcinoma in situ of the uterine cervix treated in the past year.
MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
Condition: Infertility
MeSH terms: Infertility
Intervention: menotropin; recombinant FSH
Intervention MeSH terms: Menotropins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 620.0
Sex: Female
Minimum age: 21 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant
      Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in
      women undergoing controlled ovarian stimulation (COS) following GnRH treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days,
             with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy.

          -  Subjects must be high responders, defined as subjects who have a serum anti-Müllerian
             hormone (AMH) ≥5 ng/mL at screening.

          -  Documented history of infertility (e.g., unable to conceive for at least 12 months or
             for at least 6 months if receiving donor sperm) with a Day 2 or Day 3 serum FSH level
             between 1 and 12 IU/L (inclusive), the results of which should be obtained within 6
             months prior to randomization.

        Exclusion Criteria:

          -  Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).

          -  History of recurrent miscarriage not followed by a live birth (recurrent is defined as
             two (2) or more consecutive miscarriages).

          -  Previous in vitro fertilization (IVF) or assisted reproductive technology (ART)
             failure due to a poor response to gonadotropins. Poor response is defined as
             development of ≤2 mature follicles or history of 2 previous failed cycle cancellations
             prior to oocytes retrieval due to poor response.
Phenylephrine Versus Ephedrine in Pre-eclampsia
Condition: Pre-eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Intervention: Phenylephrine; Ephedrine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Ephedrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Cesarean delivery; Spinal Anesthesia

Summary:

      Phenylephrine administration is associated with reductions in CO and SctO2 compared with
      ephedrine when used for blood pressure management in women with pre-eclampsia undergoing
      cesarean delivery under spinal anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking

          -  Age ≥18 yrs

          -  Pre-eclampsia (mild, or severe)

          -  Non-laboring women

          -  CD under spinal anesthesia

        Exclusion Criteria:

          -  Height < 5'0"

          -  Allergy to phenylephrine or ephedrine, or any other standardized medication

          -  Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III
             and IV)

          -  Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

          -  History of recent amphetamine or cocaine use.

          -  Subject enrollment in another study involving a study medication within 30 days of CD

          -  Any other physical or psychiatric condition which may impair their ability to
             cooperate with study data collection
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Condition: Perinatal Depression; HIV-1-infection
MeSH terms: Asphyxia Neonatorum; Depression; Depressive Disorder
Intervention: Sertraline; Interpersonal therapy
Intervention description: daily SSRI (Sertraline 25mg); 11 sessions over a 24-week period
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline initial dose of 25 mg tablet versus IPT in a 1:1 ratio commenced between six and 8 weeks postpartum and continued through 30 weeks postpartum.
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: perinatal depression; HIV; Antiretroviral Treatment; Interpersonal psychotherapy

Summary:

      This pilot study will evaluate, through quantitative and qualitative methods, whether
      different treatments for postpartum depression are feasible and acceptable in postpartum HIV
      infected women on antiretrovirals (ART). The study will take place at several clinics in
      Lusaka, Zambia.
    

Eligibility criteria:

        Inclusion criteria:

          -  18 years of age or older

          -  Documentation of confirmed HIV-1 infection

          -  Six to eight weeks postpartum

          -  Currently taking ART treatment

          -  Able and willing to provide written informed consent

          -  Willing to adhere to study visit schedule

          -  PND diagnosis confirmed by Mini-International Neuropsychiatric Interview

        Exclusion criteria:

          -  Taking an ADM in the prior 12 months prior to enrollment

          -  Actively suicidal

          -  Known or suspected allergy or contraindication to first line Sertraline

          -  Any other condition (social or medical) which, in the opinion of the study staff,
             would make trial participation unsafe or complicate data interpretation.
Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy
Condition: Hot Flashes
MeSH terms: Prostatic Neoplasms; Hot Flashes
Intervention: Isoflavone; Placebos
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 39.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prostate cancer; soy; androgen deprivation; quality of life; isoflavones

Summary:

      This study will look at the effects of a soy supplement called Revival on memory, quality of
      life, and hot flashes in men with prostate cancer who are being treated with testosterone
      suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will
      result in at least a 50% reduction in hot flashes compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men > or =21 with prostate CA and hypogonadism for at least 3 months

        Exclusion Criteria:

          -  on growth promoting agents

          -  on appetite stimulating agents

          -  on Prednisone and others
US Guided GNB vs Saline Injection for TKA
Condition: Postoperative Pain; Total Knee Arthroplasty; Nerve Block
MeSH terms: Pain, Postoperative
Intervention: bupivacaine; saline
Intervention description: Group 1 will receive genicular nerve block using bupivacaine; Group 2 will receive genicular nerve block using normal saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: anesthesiology; pain; arthroplasty

Summary:

      Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee
      analgesia for patients recovering from total knee replacement surgery compared to saline
      injection?

      Hypotheses:

      The investigators hypothesize that the combination of ultrasound-guided adductor canal block
      (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to
      decreased systemic side effects and improved overall satisfaction compared to
      ultrasound-guided saline injection for patients undergoing minimally invasive elective total
      knee arthroplasty (TKA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants 40 to 85 years old who are presenting for minimally invasive total knee
             arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks.

          -  Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing
             arthrotomy that does not extend beyond 1cm proximal to the patella and surgical
             techniques that focus on soft tissue protection.

        Exclusion Criteria:

          -  Patient refusal

          -  American Society of Anesthesiologists physical status classification of 4 or higher

          -  Pre-existing neuropathy in the femoral or sciatic distribution

          -  Coagulopathy

          -  Infection at the site

          -  Chronic opioid use (greater than 3 months)

          -  Pregnancy

          -  Medical conditions limiting physical therapy participation

          -  Any other contra-indication to regional anesthesia
Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Educational handout; Verbal script; Hyaluronic Acid
Intervention description: The educational handout will include information on self-management strategies.; The verbal script will include details on self-management strategies that will be reviewed with the patient.; All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence,
      and even safety of the individuals who suffer from it. One of the most powerful tools for
      these patients can be education on self-care and self-management strategies that can be
      taught to a patient by a physician, physical or occupational therapist, or a nurse. These
      self-management strategies can help patients treat daily stiffness through exercise or manage
      flares of osteoarthritis. There is a lack of consensus on the best teaching methods to
      accomplish the goal of educating our patients. Feedback from both patients and providers
      regarding teaching methods is needed. This study will evaluate teaching methods on
      self-management strategies for patients who are undergoing hyaluronic acid injections for
      knee osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of co-investigator physicians

          -  Age 18+ years

          -  Diagnosis of symptomatic knee osteoarthritis

          -  Scheduled for a hyaluronic acid injection into the knee

          -  Provider is available to administer teaching method

        Exclusion Criteria:

          -  Patients who are already enrolled in the study

          -  Non-English speaking
Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
Condition: Overactive Bladder; Urinary Urge Incontinence; Urinary Bladder, Neurogenic; Painful Bladder Syndrome
MeSH terms: Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Cystitis, Interstitial
Intervention: Onabotulinumtoxin A (BoNT); belladonna; Morphine; Placebo; Active B&O suppository of belladonna
Intervention description: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.; Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.; matching placebo to B&O suppository; belladonna 16.2mg and morphine 7.5mg
Intervention MeSH terms: Morphine; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os)
      can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder
      for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial
      cystitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Met clinical criteria under outside care or during the Principal Investigator's
             routine standard of care for BoNT injection therapy

          -  No contraindication to BoNT therapy as outlined by drug manufacturer guidelines

          -  Participants have elected to have the BoNT injection therapy prior to being offered
             enrollment into the study for either overactive bladder (OAB), neurogenic detrusor
             overactivity (NDO), or refractory interstitial cystitis (IC)

        Exclusion Criteria:

          -  Currently pregnant

          -  Currently nursing a baby

          -  Anticipated geographic relocation within the first 3 months following treatment

          -  Allergy to morphine, belladonna, or opiates

          -  Patients will be excluded if participating in another research study

          -  Individuals unable to provide informed consent or to complete two-week follow-up
             bladder testing (post-void residual) or data collection will also be excluded