bioihbjkbjnl/mcl2 huggingface dataset:
Intra-operative Digital vs. Standard Mammography
Condition: Breast Cancer
Intervention: Intra-operative Mammography; Standard Mammography
Intervention description: The patient's breast specimen will be imaged in the operating room in an intra-operative imaging device - Biovision SN #30042; There is not an added device associated with this arm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mammography

Summary:

      A breast biopsy in the operating room may be needed in up to 15% of patients with an
      abnormality on mammogram. When an abnormality is present but there is no palpable mass, the
      abnormality must be localized with a wire before going to the operating room. This technique
      is also used when a breast cancer is present but there is no mass, in order to perform a
      targeted lumpectomy. Once the abnormality is surgically removed, the specimen with the wire
      is taken to the breast imaging department for a specimen x-ray to ensure that the targeted
      abnormality is present within the specimen. If the abnormality is close to the edge of the
      specimen, additional tissue is often removed.

      A newer method for evaluating the specimen is to perform imaging in the operating room.
      Portable digital mammography units are available for this purpose. The Biovision digital
      specimen mammography system is FDA-approved and currently in use in over 200 centers in the
      United States. Several studies have shown that intra-operative digital mammography is as
      accurate as standard specimen mammography and takes less time to perform. It may also
      decrease the chance of having to go back to the operating room to take more breast tissue
      after lumpectomy because of cancer cells near teh margin(s) of the specimen on final
      pathology. Having to go back to the operating room to take more tissue is called a
      re-excision.

      The purpose of this study is to compare standard specimen mammography to intra-operative
      specimen mammography to quantify potential operating room time savings and to determine if
      the use of intra-operative specimen mammography decreases re-excision rates. We aim to see if
      intra-operative specimen mammography is more efficient and if it decreases re-excision rates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed with a breast abnormality undergoing an excisional biopsy with wire
             localization or newly diagnosed with invasive breast cancer or ductal carcinoma
             undergoing a lumpectomy with wire localization

          -  Ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Recurrent breast cancer

          -  Palpable masses not requiring wire localization
Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
Condition: Vasomotor Rhinitis
MeSH terms: Rhinitis; Rhinitis, Vasomotor
Intervention: Olopatadine HCL (Patanase) Nasal Spray, 0.6%; Azelastine HCl (Astelin) Nasal Spray, 137 mcg
Intervention description: 2 sprays/ nostril BID; 2 sprays/ nostril BID
Intervention MeSH terms: Azelastine; Olopatadine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: vasomotor rhinitis; chronic non-allergic rhinitis; VMR

Summary:

      The purpose of this study is to examine safety and efficacy of Patanase and Astelin in
      treating the symptoms of non-allergic vasomotor rhinitis (VMR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis

          -  Negative skin tests to a panel of allergens and positive histamine test within last 2
             years

          -  History of symptoms related to defined VMR triggers

        Exclusion Criteria:

          -  Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of
             study medications

          -  Bacterial or viral infection within 14 days of first visit. Diagnosis of acute
             sinusitis within 30 days of first visit

          -  Chronic use of drugs that can cause rhinitis
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
Condition: Erectile Dysfunction; Prostate Cancer
MeSH terms: Erectile Dysfunction
Intervention: Tacrolimus; Placebo
Intervention description: oral; oral
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: Male
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Treatment effectiveness; Treatment efficacy; Investigational, Therapies; Immunosuppressant; Erectile dysfunction; Prostatectomy

Summary:

      The purpose of the study is to compare the safety and effectiveness of Prograf in the
      prevention of erectile dysfunction in men after a radical prostatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate
             cancer.

        Exclusion Criteria:

          -  Patient is > 65 years of age

          -  Patient has been diagnosed with Type 1 or Type 2 diabetes

          -  Patient is actively smoking on a daily basis
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
Condition: Ocular Hypertension; Glaucoma, Open-Angle
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: Fluticasone propionate inhaler; Saline placebo inhaler
Intervention description: fluticasone propionate 250 µg metered-dose inhaler; saline metered dose inhaler
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Corticosteroids; Bronchodilator Agents; Intraocular Pressure

Summary:

      The purpose of this study is to determine whether a commonly prescribed orally inhaled
      corticosteroid treatment will induce a clinically meaningful elevation in intraocular
      pressure, when administered to patients with ocular hypertension (OHT) or open-angle glaucoma
      (OAG). Based on the response to high-dose corticosteroids, this patient group is more likely
      than the normal population to demonstrate this adverse effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 85 years, inclusive

          -  Mild-moderate open-angle glaucoma/ocular hypertension with cup:disc ratio <0.85
             vertically and humphrey visual field mean deviation >-12.00 (BOTH EYES must meet this
             criteria for patient to be included)

          -  Glaucoma well-controlled, defined by IOP < 21 mmHg and at target with no visual
             field/disc progression for at least 6 months (BOTH EYES must meet this criteria for
             patient to be included)

        Exclusion Criteria:

          -  Any form of steroid medication use within the prior 6 weeks

          -  Any previous intra-ocular surgery or refractive surgery in the study eye

          -  no light perception (i.e. blindness) in either eye

          -  unwilling/unable to give consent

          -  unwilling to accept randomization

          -  patient potentially unavailable for follow-up visits
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
Condition: Low Back Pain; Shoulder Pain; Neck Pain
MeSH terms: Shoulder Pain; Back Pain; Low Back Pain; Neck Pain
Intervention: Tramadol HCl-Paracetamol
Intervention description: Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement.
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1059.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Low back pain; Shoulder pain; Neck pain; Tramadol hydrochloride; Paracetamol

Summary:

      The purpose of this study is to evaluate the efficacy and safety of tramadol
      hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to
      severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to
      the bones) outpatient or emergency setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intermittent or persistent pain for less than 3 months, required analgesic therapy,
             orthopedic surgery and emergency call participants suffering with severe neck,
             shoulder, low back pain or chronic neck, shoulder, lower back pain, acute (a quick and
             severe form of illness in its early stage) exacerbation pain

          -  Pain intensity to be assessed using Numerical Rating Scale (NRS), NRS score more than
             or equal to 4 (from 0 to 10, 0 = no pain, 10 = extreme pain)

          -  During normal pain and stable feeling, can study pain assessment methods and can fill
             in pain control diary

          -  Be willing to participate in the study and must give written informed consent

        Exclusion Criteria:

          -  Have used strong opium kind of medication 7 days prior to the enrolment

          -  Have severe mental disease or using antipsychotic (agent that control agitated
             psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and
             exert a quieting effect) medication for medical treatment

          -  Drug abuse/dependence, or chronic alcohol abuse/depend on history

          -  Pregnant or lactating women

          -  Unable to tolerate tramadol or any failed treatment in past by using tramadol

          -  Comparatively more severe pain in other parts of the body than that of the pain
             mentioned in the research
Supervised Asthma Medication in Schools (SAMS)
Condition: Childhood Asthma
MeSH terms: Asthma
Intervention: Supervised asthma therapy in schools
Intervention description: Therapy observed daily in school. Asthma education by American Lung Association
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 442.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The investigators hypothesize that school-based, direct supervision of daily controller
      therapy will result in more effective asthma control, as assessed by the Asthma Control
      Questionnaire than usual care. Additionally, as the result of enhanced asthma control and
      resulting decrease in health care utilization, school-based, direct supervision of daily
      controller therapy will result in lower cost per quality-adjusted life year (QALY) gained
      than usual care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A child with asthma attending a Tucson Unified School District elementary school
             selected for the study.

        Exclusion Criteria:

          -  No asthma.

          -  Not attending a Tucson Unified School District elementary school selected for the
             study.
A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Duloxetine hydrochloride; Placebo
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 776.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized,
      placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to
      compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on
      depression in patients aged 18-65. Data from the two trials will be reported in both
      individual and pooled analyses. Pooling the two studies will allow for increased power to
      detect differences between duloxetine and placebo on secondary and exploratory objectives.
      Only one data lock is planned for this study, when all patients have completed all study
      procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients

          -  Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder
             (MDD)

          -  Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at
             visits 1 and 2

          -  Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at
             visits 1 and 2

          -  Have a degree of understanding such that the patient can provide informed consent,
             complete protocol required assessments and communicate intelligibly with the
             investigator and study coordinator.

        Exclusion Criteria:

          -  Patients judged clinically to be at serious suicidal risk in the opinion of the
             investigator

          -  Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia

          -  Patients who have any current (within the past six months) DSM-IV-TR primary Axis I
             disorder other than MDD

          -  Patients with uncontrolled narrow-angle glaucoma

          -  Patients who have a serious medical illness that is in the opinion of the investigator
             not stabilized or is likely to require intervention, hospitalization, or use of an
             excluded medication during the course of the study.
Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis
Condition: Synkinesis
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis; Synkinesis
Intervention: Neuromuscular Retraining Therapy (4 months); Chemodenervation (4 months); Neuromuscular Retraining + Chemodenervation
Intervention description: Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis.; A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.; Participants will receive both interventions for the last 4 months of their time on study.
Intervention MeSH terms: Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      This proposal will prospectively assess the social, physical, and emotional recognition
      function in participants with synkinesis. It will measure the effectiveness of neuromuscular
      retraining therapy to improve muscle coordination compared to chemodenervation, the more
      established treatment modality, in a single-blinded, randomized control trial using
      clinician- and patient-reported outcomes measures. The hypothesis tested is that participants
      undergoing neuromuscular retraining therapy will achieve greater improvement on clinical
      outcome measures as compared to participants receiving chemodenervation.

      In this clinical trial, 36 participants undergoing treatment for synkinesis will be enrolled
      into one of two treatment arms: chemodenervation or neuromuscular retraining therapy.
      Participants can expect to be on study for approximately 8 months.

      Participants who enroll in this mixed methods investigation will be recruited from patients
      of the University of Wisconsin Facial Nerve Clinic and also be enrolled in a another study
      for assessment [Perception of Emotion Expression in Clinical Populations with Facial
      Paralysis, IRB approval 2015-0366].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has ipsilateral synkinesis of facial muscles

          -  It has been at least four months since their onset of peripheral facial paralysis from
             any cause

          -  Ability to read and write in English

        Exclusion Criteria:

          -  previous treatment with reanimation surgery (except for upper eyelid weight placement)

          -  intolerance or contraindication to botulinum toxin injection

          -  previous treatment for synkinesis with chemodenervation or neuromuscular retraining
             therapy

          -  pregnant and/or breastfeeding women

          -  participants with impaired decision-making capacity, including those with severe
             psychiatric illnesses
Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: PL nasal spray; fluticasone furoate (FF); PL eye drops; olopatadine (OLO)
Intervention description: 2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week; 2 puffs of FF nasal spray in each nostril once a day for 1 week; 1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week; 1 drop of OLO eye drops in each eye once a day for 1 week
Intervention MeSH terms: Fluticasone; Xhance; Olopatadine Hydrochloride; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      People who have hayfever or allergic rhinitis often complain about eye symptoms associated
      with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The
      purpose of this study is to better understand the generation of eye symptoms in patients with
      allergic rhinitis. We have previously shown that placing the substance that subjects are
      allergic to in their nose causes both nose and eye symptoms. This can be explain by a
      parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily
      explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we
      are going to address one possible explanation for the itch; does an axonal neurogenic reflex
      stimulate mast cells in the eye to release histamine, which then causes the itch? We will do
      this by placing an antihistamine drop in the eye and challenge the nose with allergen. We
      will also attempt to demonstrate that mast activation isn't effected by blocking the
      initiating of the reflex with a nasal steroid, as done in our previous study, and showing
      that the addition of an antihistamine does not add to the reduction of symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between 18 and 45 years of age.

          2. History of grass and/or ragweed allergic rhinitis.

          3. Positive skin test to grass and/or ragweed antigen.

          4. Positive response to screening nasal challenge.

        Exclusion Criteria:

          1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

          2. Pregnant or lactating women.

          3. Upper respiratory infection within 14 days of study start.

          4. forced expiratory volume at one second (FEV1) <80% of predicted at screening for
             subjects with history of mild asthma.
A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain
Condition: Pain
MeSH terms: Musculoskeletal Pain
Intervention: Aspirin and Ketamine; Oral Ketamine
Intervention description: Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin; Proprietary oral formulation of 0.5mg/kg of ketamine
Intervention MeSH terms: Aspirin; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Emergency Medicine, Pain, Pain Management, Musculoskeletal; Emergency Medicine; Pain; Pain Management; Musculoskeletal

Summary:

      Acute Pain is one of the most frequent chief complaints and the main reason for visiting the
      Emergency Department (ED). The acute pain in the ED is largely prevalent across the country
      with recent literature demonstrating that 61-91% of patients are admitted to the ED due to a
      variety of acute painful syndromes. There is a lack of good options for pain control in such
      settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 and older

          -  acute musculoskeletal pain

          -  initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating
             scale.

          -  awake, alert, and oriented to person, place, and time

        Exclusion Criteria:

          -  altered mental status,

          -  allergy to aspirin and ketamine,

          -  pregnant

          -  unstable vital signs (systolic blood pressure <90 or>180 mm Hg, pulse rate <50 or >150
             beats/ min, and respiration rate <10 or >30 breaths/min)

          -  inability to provide consent

          -  consumption of Aspirin or NSAID's within 6 hours of arrival to the ED

          -  active PUD

          -  history of GI Hemorrhage

          -  history of renal and hepatic insufficiency

          -  past medical history of alcohol or drug abuse

          -  schizophrenia