bioihbjkbjnl/mcl2 huggingface dataset:
Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
Condition: Colonoscopy; Adjunct Anesthesia Medication
Intervention: Diphenhydramine; Placebo
Intervention MeSH terms: Diphenhydramine; Promethazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Fentanyl; Midazolam; Sedation; Patient tolerance; Duration of colonoscopy

Summary:

      To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce
      the amount of standard sedatives used during colonoscopy in patients on chronic opioids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-64 years undergoing screening, surveillance, diagnostic and
             therapeutic colonoscopy

          -  Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at
             least 3 days per week for more than 3 months

        Exclusion Criteria:

          -  Inability to execute informed consent

          -  Allergy to Diphenhydramine, fentanyl or midazolam

          -  Known or suspected pregnancy

          -  Endoscopic procedure without sedation

          -  Patient scheduled to have other endoscopic procedures on the same day

          -  Prior alimentary tract surgery

          -  Severe cardiopulmonary disease (ASA IV)

          -  Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure
Cilostazol After Lower Extremity Arterial Revascularization Trial
Condition: Peripheral Arterial Disease; Claudication (Finding)
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
Intervention: Cilostazol
Intervention description: 100 mg twice daily for 90 days
Intervention MeSH terms: Cilostazol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: leg pain; claudication

Summary:

      Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm
      (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the
      treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to
      collect quality of life data on patients undergoing peripheral revascularization in order to
      determine the sample size required to adequately power a trial of Cilostazol versus usual
      care without Cilostazol and its effect on quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 35 years of age

          -  Atherosclerotic peripheral arterial disease

          -  Able to provide informed consent

          -  Lower extremity open or endovascular revascularization.

        Exclusion Criteria:

          -  Known CHF (class III/IV)

          -  Allergic reaction to phosphodiasterase inhibitors

          -  Intracranial bleeding within 3 months or active bleeding peptic ulcer disease

          -  Traumatic vascular injuries requiring revascularization

          -  Pregnant or breast feeding women or women who plan to get pregnant over the study
             period

          -  Planned ipsilateral major amputation within 30 days of index procedure

          -  Moderate to severe hepatic impairment.
Evaluating Vitamin D3 Supplement on Post-Op Outcomes
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Vitamin D; Control
Intervention description: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.; Patients randomized to the control will receive a placebo
Intervention MeSH terms: Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The aim of this study is to determine if vitamin D supplementation is associated with
      differences in short-term recovery in patients following total knee arthroplasty compared to
      patients who do not receive supplementation. If so, vitamin D supplementation has the
      potential to become widely incorporated into the routine care for patients undergoing knee
      replacements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient undergoing primary total knee arthroplasty for osteoarthritis

          -  Age ≥ 18 years old

          -  Willingness to undergo randomization and return for all scheduled visits

        Exclusion Criteria:

          -  Age > 80 years old

          -  American Society of Anesthesiologists (ASA) Score ≥ 4

          -  Other supplemental vitamin D or Calcium use including their analogs: ergocalciferol,
             calcitriol, dihydrotachysterol, and paricalcitol

          -  Current cancer

          -  Malabsorption syndromes

          -  Inability to take medications orally

          -  Renal impairment defined as a glomerular filtration rate (GFR) < 30 mL/minute or
             creatinine >1.3 mg/dL

          -  History of hypercalcemia defined as albumin-corrected hypercalcemia >12 mg/dL
Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.
Condition: Cervical Cancer; Uterine Cancer
MeSH terms: Endometrial Neoplasms; Uterine Neoplasms
Intervention: 18F fluciclovine; 18F fluciclovine PET
Intervention description: Each subject will receive one IV dose of 18F fluciclovine for PET scanning; Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      18F Fluciclovine is a recently FDA- approved radiopharmaceutical for prostate cancer
      biochemical recurrence, which is only minimally eliminated by the kidneys and therefore the
      image interpretation is not affected by nonspecific urine activity in the ureters and
      bladder, which is advantageous for pelvic imaging. Recent literature suggests that
      Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new
      opportunities for noninvasive probing of glutamine metabolism and clinical use in patient
      management. Current literature indicates that amino acid transporters including that of
      glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may
      have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging
      properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic
      malignancies.

      Given the lack of current clinical data, a pilot study providing a direct comparison of
      Fluciclovine PET with FDG PET is warranted. The investigators seek to conduct a pilot study
      with 10 subjects to evaluate the clinical utility of Fluciclovine PET for staging of cervical
      cancer and endometrial cancer. This research will compare the diagnostic performance of the
      research Fluciclovine PET/MRI with the standard-of-care FDG PET/CT as an exploratory
      endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  18 years and older

          -  Biopsy-proved cervical cancer or endometrial cancer within three months of study
             enrollment

          -  Standard-of-care (SOC) FDG PET/CT exam performed within 30 days of study enrollment

        Exclusion Criteria:

          -  Female < 18 years old

          -  No history of cervical cancer or endometrial cancer

          -  Primary biopsy > 3 months of study enrollment

          -  Systemic therapy or radiation therapy initiated

          -  SOC FDG PET/CT exam performed > 30 days of study enrollment

          -  Therapeutic procedures (chemotherapy, radiation therapy) have been initiated

          -  Pregnancy or lactation

          -  Claustrophobia or inability to tolerate the imaging procedure on the PET/MR scanner

          -  Individual is not willing to give informed consent
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Condition: Asthma
MeSH terms: Asthma
Intervention: Seretide; Flixotide
Intervention description: Seretide; Flixotide
Intervention MeSH terms: Fluticasone; Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: asthma; exacerbation; persistent; bronchial hyperresponsiveness; mild; GINAII

Summary:

      An 18 months randomised double-blind study with two parallel arms with start dose of inhaled
      SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be
      up-titrated until well controlled is achieved, After 6 months the treatment continues without
      changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that
      the combination therapy with SERETIDE controls mild persistent asthma better than inhaled
      corticosteroids(FLIXOTIDE) alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to give informed consent.

          -  Males or females aged 18-70.

          -  Able to understand and complete dairy cards.

          -  Mild persistent asthma according to GINA. In addition, at randomisation subjects were
             required to have: 1. Day time symptoms more than once a week but not every day. 2.
             Night-time symptoms not more than once a week. 3. FEV1 >80% predicted 4. PC20 <8mg/mL

        Exclusion Criteria:

          -  Change to regular asthma medication in 4-weeks prior to visit 1.

          -  Use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.

          -  Lower respiratory tract within 4 weeks of Visit 1

          -  Received investigational study drug within 4 weeks of visit

          -  Smoking history of >10 pack years of more.

          -  Serious uncontrolled disease.

          -  Medical conditions or medications known to affect the assessments or endpoints.

          -  Evidence of alcohol or drug abuse.

          -  Known pregnancy or planned pregnancy.

          -  Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or
             lactose.

          -  Previous enrollment in the study
The Effect of Lumify™ Eyedrops on Eyelid Position
Condition: Eyelid Droop
MeSH terms: Blepharoptosis
Intervention: Brimonidine tartrate ophthalmic solution 0.025%; Sterile balanced saline solution
Intervention description: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface); One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
Intervention MeSH terms: Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the research is to see if Lumify™ has an effect on eyelid position.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 18 and above able to provide informed consent to participate

          -  Subject with stable ocular health, defined as no ocular conditions requiring ongoing
             topical therapy or recent surgical intervention

        Exclusion Criteria:

          -  Adults unable to consent

          -  Prisoners

          -  Pregnant women.

          -  Known contradictions or sensitivities to study medication (brimonidine)

          -  Ocular surgery within the past 3 months or refractive surgery within the past six
             months

          -  Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital
             surgery

          -  Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or
             blepharospasm)

          -  Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 <
             1mm)

          -  Any ocular or systemic condition that, in the opinion of the investigator, would
             confound study data, interfere with the subject's study participation, or affected the
             subject's safety or trial parameters

          -  Presence of an active ocular infection

          -  Prior (within 5 days of beginning study treatment) use of eye whiteners (eg,
             vasoconstrictors), decongestants, antihistamines (including over the counter and
             herbal topical ophthalmic medications), phenylephrine dilating drops, any other
             topical ophthalmic agents

          -  Inability to sit comfortably for 15 - 30 minutes
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Intralesional Triamcinolone 10 mg/mL; Intralesional Triamcinolone 20 mg/mL; Intralesional Triamcinolone 40 mg/mL; Placebo
Intervention description: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.; Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.; Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.; Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Currently, there is limited evidence showing increased resolution of HS flares with higher
      doses of intralesional triamcinolone (ILTAC) as well as a difference in side effect profile
      between the doses. The goal of this study is to determine the efficacy of treating HS flares
      with ILTAC-10, ILTAC-20 and ILTAC-40 and to investigate the side effect profile for each
      dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 13 years old.

          -  Subject must voluntarily sign and date an informed consent, approved by an independent
             ethics committee / institutional review board.

          -  Subject is willing to comply with the procedures in this protocol.

          -  The subject must be diagnosed with HS and receiving care at HSC

          -  Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score
             between 2 and 5

          -  The subject must have an inflamed nodule or abscess at the time of enrollment.

        Exclusion Criteria:

          -  The subject has an HS-PGA score of 0 or 1

          -  The subject has received ILTAC less than 8 days prior to the initial visit.

          -  The subject does not have capacity to consent to the study.

          -  The subject is has taken systemic steroids at least 4 weeks prior to the time of
             enrollment.

          -  The subject has a known allergy or history of adverse reaction to steroids.

          -  The subject is pregnant.

          -  Subjects who have received a biologic therapy two weeks before and during the study
             period.
Ultrasound-guided Injection for DeQuervain's
Condition: DeQuervain's Tenosynovitis
MeSH terms: Tenosynovitis
Intervention: Betamethasone; Ultrasound
Intervention description: Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
Intervention MeSH terms: Betamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: wrist; tendonitis; dequervain's; tenosynovitis

Summary:

      The investigators aim to perform a prospective study to evaluate the effectiveness of blind
      corticosteroid injections to US-guided injections for the treatment of de Quervain's disease.
      The results of the study will be used to validate current injection protocols or support the
      incorporation of ultrasonography to treat the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pain with palpation at 1st dorsal compartment at wrist and positive Finkelstein's Test

        Exclusion Criteria:

          -  Patients with evidence of osteoarthritis or degeneration of the wrist.
Repeatability in Hyperpolarized 3-Helium With MRI
Condition: Radiation Exposure
Intervention: Prone hyperpolarized 3 helium gas scan; Supine hyperpolarized 3 helium gas scan; Vitals; Pulmonary Function Tests; Initial protocol MRI scan
Intervention description: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.; Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.; Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes; Initial scan to determine placement
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to assess and test the reproducibility and results of
      hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the
      lungs in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must be between the ages of 18 and 90

          -  must have a Body Mass Index (BMI) of < 32 and weigh < 200 lbs.

        Exclusion Criteria:

          -  if female, must not be pregnant or breastfeeding

          -  must not have any metal objects in or on their body including body piercings that
             cannot be easily removed, bullets, metallic fragments or slivers in eyes, skin, etc.,
             pacemaker or defibrillation, aneurysm clips, cochlear implants, coronary stents, or
             neurostimulation.

          -  must not have a history of claustrophobia, panic disorders, anxiety attacks, atrial
             fibrillation, uncontrolled high blood pressure, frequent ventricular ectopic rhythm,
             hemodynamic instability, kidney dysfunction or heart disease.
Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage; Headache
Intervention: Gabapentin; Placebo
Intervention description: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.; Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: aSAH; SAH

Summary:

      The purpose of this study is to see how much gabapentin will reduce headaches associated with
      subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication
      prescribed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain
             and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction
             angiogram or MRA)

          3. Have symptomatic headache

          4. Able to swallow and verbalize pain score

          5. No known allergy to gabapentin or fentanyl

          6. Numeric pain score ≥ 5

          7. Ability to provide written personal consent

        Exclusion Criteria:

          1. Gabapentin use prior to SAH admission

          2. Renal failure with creatinine clearance less than 30 mL/min

          3. Unable to receive standard of care pain medications

          4. Pregnant or breastfeeding patients

          5. History of severe depression defined by the Diagnostic and Statistical Manual of
             Mental Disorders, 4th Edition, Text Revision (DSM IV)
Fenofibrate in Type 2 Diabetes
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Fenofibrate
Intervention description: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
Intervention MeSH terms: Fenofibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once
      in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in
      diabetic retinopathy offers an important translational research opportunity. The
      investigator's global proteomic study will provide new clues as to how fenofibrate protects
      vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes of at least one year's duration; stable glycemic control (no more than
             1.0% change in HbA1c in the previous six months, but no limit on HbA1c)

          -  Triglycerides >150 mg/dL (in the previous six months)

        Exclusion Criteria:

          -  Previous use of Fenofibrate or other fibrates

          -  Pregnancy

          -  Active malignancy

          -  Recent cardiac event or congestive heart failure

          -  Active liver disease

          -  Significant renal impairment (serum creatinine > 2mg/dl)