bioihbjkbjnl/mcl2 huggingface dataset:
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Parcopa; carbidopa-levodopa (Sinemet)
Intervention description: at subjects current stable dose of comparator; at subjects current stable dose
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 31 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's disease; time to "on"; delayed on

Summary:

      To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth,
      works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's
             disease for at least three years duration

          -  Patients requiring levodopa for their PD

          -  Good subjective response to levodopa

          -  Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose
             failures

          -  A UPDRS -off- motor score of at least 25

          -  Subjects willing to give informed consent

          -  Subjects who are able and willing to comply with study procedures

          -  If female of child-bearing potential, will use one of the approved birth control
             measures:

               1. Hormonal contraceptives

               2. Spermicidal and barrier

               3. Intrauterine device

               4. Partner sterility

        Exclusion Criteria:

          -  Subjects with evidence of significant dementia

          -  Subjects with significant oral lesions

          -  History of unstable cardiac disease including angina or congestive heart failure
             within 3 months prior to study entry

          -  History of clinically significant renal disease including renal insufficiency of
             sufficient degree to require adjunctive treatment or dietary restrictions

          -  History of clinically significant hepatic disease, including previously documented
             cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.

          -  Subjects with poor response to levodopa

          -  Women who are pregnant, breast-feeding, or planning to become pregnant during this
             study are excluded from participation due to unknown effects of the study drug on the
             fetus.
Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)
Condition: Prostatectomy; Pain
Intervention: Acetaminophen (Ofirmev); Placebo
Intervention description: The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.; The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: Male
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acetaminophen

Summary:

      To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its
      potential to improve hospital efficiency and patient outcomes. The investigators compare the
      addition of IV acetaminophen versus placebo on postoperative anesthesia care unit recovery
      times, inpatient hospital length of stay (LOS), postoperative pain scores, consumption of
      opiates as rescue agents and side effects among patients undergoing robotic-assisted
      laparoscopic prostatectomy (RALP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing robotic-assisted laparoscopic prostatectomy

          -  ≥18 years old males

          -  American Society of Anesthesiologists class 1-4

        Exclusion Criteria:

          -  Chronic opiate use

          -  Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic
             steatohepatitis, history of alcoholism, liver function test results greater than 3
             times upper limit of normal in the past 3 months)

          -  Allergy/hypersensitivity to acetaminophen

          -  Patients with baseline dementia

          -  Chronic diathesis

          -  Chronic kidney disease
Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
Condition: PT-NANBH
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: 8 weeks SOF/LED; 12 weeks SOF/LED
Intervention description: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.; Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Intervention MeSH terms: Ledipasvir, sofosbuvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis C, genotype 6

Summary:

      The primary objectives of this study are to describe the efficacy of:

        1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6

        2. 12-week treatment of SOF/LED for all other HCV-6 populations
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age ≥18 years

          2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as
             genotype 6

          3. Selected to start on treatment by their treating providers

          4. Willing and able to provide informed consent

          5. Able to comply with dosing instructions for study drug administration and able to
             complete the study schedule of assessments

          6. Females of childbearing potential must have a negative serum pregnancy test at
             Screening and a negative pregnancy test on Baseline

          7. Male subjects and female subjects of childbearing potential who engage in heterosexual
             intercourse must agree to use protocol specified method(s) of contraception

          8. Lactating females must agree to discontinue nursing before the study drug is
             administered

        Exclusion Criteria:

          1. Previous recipient of a liver transplant

          2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
Foot and Ankle Clinic Application for Liposomal Related Anesthetic
Condition: Ankle Arthrodesis; Hindfoot Arthrodesis; Tibitalocalceal Arthrodesis
Intervention: Exparel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to review the use of surgeon applied liposomal release
      anesthetic (Exparel) for post operative analgesia.

      Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post
      operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by
      the use of this modality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis,
             hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular
             arthrodesis

          -  Patients over the age of 18

          -  The subject is psychosocially, mentally, and physically able to understand and comply
             with the requirements of the study

        Exclusion Criteria:

          -  < 18 years of age

          -  Patients with a history of infection

          -  Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the
             arms or legs due to damaged nerves

          -  Patients having surgery on both feet at the same time

          -  Patients having any other different type of foot and ankle surgery
Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
Condition: Thyroid Cancer; Postsurgical Hypothyroidism
MeSH terms: Thyroid Neoplasms; Hypothyroidism
Intervention: Levothyroxine
Intervention description: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps. Initial dose 1.5-1.8 mcg per kg, orally and daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: levothyroxine

Summary:

      In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than
      the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and
      more unpredictable TSH (thyroid stimulating hormone) levels.

      The investigators therefore hypothesize that following thyroidectomy for Stage I/II
      differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more
      predictable TSH results and in turn require fewer dose adjustments to achieve optimal hormone
      levels in the postoperative period.

      The aim of this investigation is to compare the use of levothyroxine in liquid gel capsules
      to tablet form for TSH suppression following thyroidectomy for presumed stage I/II
      differentiated thyroid cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II

          -  Planned total or near-total thyroidectomy

          -  Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively

          -  Normal serum TSH within 12 months preceding surgery

        Exclusion Criteria:

          -  AJCC Stage III or greater

          -  Undifferentiated, Anaplastic or Medullary Thyroid Cancer

          -  Planned postoperative TSH goal other than 0.1-0.5 mU/L

          -  History of gastrointestinal malabsorption or gastric bypass surgery

          -  Pregnancy

          -  Use of medications that alter the absorption or metabolism of levothyroxine

          -  Prior use of levothyroxine
Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia
Condition: Hip Pain
Intervention: bacteriostatic saline; buffered lidocaine
Intervention MeSH terms: Lidocaine; Benzyl Alcohol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare infiltration pain and anesthetic efficacy between
      lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip
      injections.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  age 18-75 years

          -  referred for US-guided intraarticular hip injections in the Mayo Clinic Sports
             Medicine Center, Physical Medicine & Rehabilitation Clinic, or Musculoskeletal Clinic

        EXCLUSION CRITERIA:

          -  chronic opioid use

          -  opioid use on day of procedure

          -  history of fibromyalgia or other diffuse chronic pain syndrome

          -  pain behavior during the clinical encounter as judged by the injectionist

          -  anesthetic administration time outside the designated 5-15 second time frame
Optimizing Local Anesthetic Concentration for Continuous Lumbar Plexus Nerve Blocks
Condition: Hip Arthroplasty; Hip Pain
Intervention: 0.1% Ropivacaine; 0.4% Ropivacaine
Intervention description: Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (12mL/h); Basal Dose (12 mg/h); Bolus Volume (4 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h); Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (3 mL/h); Basal Dose (12 mg/h); Bolus Volume (1 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: postoperative pain; perineural catheter; continuous peripheral nerve block; posterior lumbar plexus; hip surgery; psoas compartment; postoperative analgesia

Summary:

      This is a research study to determine if the concentration of local anesthetic through a
      catheter next to the nerves that go to the hip that is undergoing surgery, affects muscle
      strength and sense of touch experienced after surgery. This study is looking at the varying
      concentrations of local anesthetic placed through the catheter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary, unilateral hip arthroplasty

          -  age greater than or equal to 18 years

          -  postoperative analgesic plan includes perineural local anesthetic infusion

        Exclusion Criteria:

          -  morbid obesity as defined by a body mass index greater than 40

          -  chronic high dose opioid use

          -  history of opioid abuse

          -  neuro-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle

          -  vulnerable populations i.e., children, pregnant women, or prisoners
Topical Steroid Formulation and Wet Wraps
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: 0.1% triamcinolone CREAM; 0.1% triamcinolone OINTMENT
Intervention description: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.; Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
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: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Wet Wraps; Topical Steroid

Summary:

      The purpose of this study is to

        1. Compare efficacy of 0.1% triamcinolone containing wet wrap as an ointment or as a cream
           formulation in patients with moderate to severe atopic dermatitis

        2. The relative patient/subject acceptance and adherence will also be compared between the
           two wet wrap types
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients between the ages of 3-17 experiencing a symmetric, bilateral flare of atopic
             dermatitis

          2. The flares must reach a certain threshold for inclusion based on the investigator's
             global assessment scale

        Exclusion Criteria:

          1. Systemic infection or bacterial skin infections

          2. Eczema herpeticum

          3. Evidence of suppression of the Hypothalamic-Pituitary-Adrenal axis

          4. Non-English or Non-Spanish speaking
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
Condition: Raynaud Phenomenon
MeSH terms: Raynaud Disease
Intervention: AbobotulinumtoxinA; Saline solution
Intervention description: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution; Non-bacteriostatic saline solution
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a two-arm parallel assignment involves two groups of participants. One group/hand receives the abobotulinum toxin A, and the other group/hand receives a saline solution (control).
Masking: Double (Participant, Investigator)
Masking description: This is a double-blind placebo-controlled trial.
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Raynaud Phenomenon; AbobotulinumtoxinA

Summary:

      This study aims to investigate the effect of abobotulinum toxin A on the symptoms of
      Raynaud's phenomenon.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult between 18 and 80 years of age

          -  Must have health insurance

          -  Must have a current diagnosis of Raynaud's phenomenon

        Exclusion Criteria:

          -  Allergy to abobotulinum toxin A or its components

          -  Diagnosis of myasthenia gravis

          -  Previously received abobotulinum toxin vaccine

          -  Previously undergone upper extremity vascular surgery (including surgical
             sympathectomy)

          -  Currently receiving aminoglycoside antibiotics

          -  Received abobotulinum toxin A treatment in either hand in the past 6 months

          -  Pregnant women

          -  Women currently breastfeeding

          -  Current tobacco smoker (use in the past 12 months)

          -  Unable to read and speak English

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Prisoners
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.
Condition: Unresectable Stage III NSCLC
MeSH terms: Pneumonia
Intervention: Multiparametric Mobile Technology
Intervention description: Using a spirometer, an armband, and a tablet to collect data.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC; Non-Small Cell Lung Cancer; durvalumab; Stage III; Stage IIIA; Spirometer; Spirometry; PROs; Mobile Applications; Digital Applications; Stage IIIB; Stage IIIC; Device; Parametric; Pneumonitis

Summary:

      A study of whether mobile devices can improve the detection of pulmonary AEs (including
      pneumonitis) in stage III NSCLC patients post-CRT, while on durvalumab.
    

Eligibility criteria:

        Select Inclusion Criteria:

          -  Patient has unresectable Stage III NSCLC that has not progressed following concurrent
             platinum-based chemotherapy and radiation therapy and is eligible to receive
             durvalumab according to the US FDA approved package insert.

          -  Patient is able and willing to use the mobile application and connected devices.

          -  Patient is able to complete QoL assessments.

        Select Exclusion Criteria:

          -  Patient is currently oxygen dependent.

          -  Patient has comorbidities that will prevent consistent and reliable measurement
             assessments with multiparametric mobile technology including severe chronic
             obstructive pulmonary disorder (COPD), severe asthma, congestive heart failure [CHF],
             interstitial lung disease [ILD], and others.

          -  Patients on other immunotherapy or systemic immunosuppressants.

          -  Patients with active or prior autoimmune disease or history of immunodeficiency.

          -  Currently pregnant women.
Intercostal Nerve Cryoablation for Postoperative Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Intercostal Nerve Cryoablation; Bupivacaine liposomal injectable suspension; Patient-controlled analgesia (PCA)
Intervention description: Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.; Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).; Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cryoablation

Summary:

      The purpose of the study is to assess the efficacy of intercostal nerve cryoablation on the
      magnitude and duration of postoperative pain control both in patients undergoing
      thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Descending/thoracoabdominal incision is planned

          -  There is reasonable expectation that the patient will be extubated within 48 hours
             after surgery

        Exclusion Criteria:

          -  The patient has a known allergy to morphine or any opioid

          -  The patient has a known chronic pain disorder or takes daily opioid medication > 1
             month prior to surgery

          -  The surgeon/anesthesiologist concludes that the period for intubation will be likely
             be for more than 48 hours after surgery There is anticipated difficulty communicating
             pain status due to language or other barriers at the investigator discretion.