bioihbjkbjnl/mcl2 huggingface dataset:
DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Intervention: Gadoterate meglumine
Intervention description: Gadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec.
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: DCE-MRI; Sorafenib response

Summary:

      The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance
      Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC)
      to treatment with Sorafenib assessed by mRECIST.
    

Eligibility criteria:

        1. Male and female adult patients (age ≥ 20 years old)

          2. Patients diagnosed with unresectable HCC [Child Pugh class A and major vascular
             invasion, extrahapatic metastasis, or progression after transarterial
             chemoembolization more than 2 times]

          3. Presence of mRECIST target lesion within liver [lesion which can be classified as a
             RECIST measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion
             suitable for repeated measure, lesion showing intraluminal arterial enhancement on
             contrast-enhanced CT or MRI]

          4. Patients planned to be treated with sorafenib

          5. Patient with liver CT performed or planned to be performed within 4 weeks before
             initiation of sorafenib treatment

          6. Patient with a life expectancy of 12 weeks or more

          7. No previous treatment with sorafenib

          8. Female patients who are surgically sterilized, or post-menopausal (minimum 12 months
             of amenorrhea) or who have a documented negative urine hCG test at screening
Morphine Added to Ropivacaine for FICB for Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine, Morphine; Ropivacaine, Saline
Intervention description: Morphine added to ropivacaine for fascia iliaca compartment block; Normal saline added to ropivacaine for fascia iliaca compartment block
Intervention MeSH terms: Morphine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      prospective, randomized double blinded study to investigate the effects of morphine as an
      adjuvant to ropivacaine on FICB
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing elective femur surgery under spinal anaesthesia

               -  Age group (18-65 years)

               -  ASA physical status I and II

        Exclusion Criteria:

          -  • Not willing to participate in the study

               -  Other painful co-morbidities (neuropathies)

               -  Allergy or any contraindication to study medication

               -  Psychiatric disorder

               -  Coagulopathy

               -  Infection at the site of the block

               -  Use of other modes of anaesthesia or analgesia besides spinal anaesthesia.
Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol
Condition: Pain
Intervention: Zaldiar; Paracetamol-Tramadol
Intervention description: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol); Postoperative analgesia with intravenous Paracetamol and Tramadol
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a
      classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with
      Zaldiar (combination of paracetamol and tramadol).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients incoming for inguinal hernia repair

        Exclusion Criteria:

          -  Preoperative abuse of analgesics
Acetazolamide Challenge With Perfusion in the Prediction of Cerebral Vasospasm
Condition: Subarachnoid Hemorrhage, Aneurysmal; Vasospasm, Cerebral
MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage
Intervention: Acetazolamide
Intervention description: 1 g acetazolamide through a peripheral IV line
Intervention MeSH terms: Acetazolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acetazolamide challenge; cerebral vasospasm; aneurysmal subarachnoid hemorrhage

Summary:

      The investigators propose a technique using cone beam CT perfusion (CBCTP) imaging with an
      acetazolamide challenge as a potential diagnostic tool to detect a defect in cerebral
      autoregulation at a time when it has not yet caused clinically apparent signs or symptoms. 30
      participants will be enrolled at the University of Wisconsin - Madison and can expect to be
      on study for about 2 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with aneurysmal subarachnoid hemorrhage presenting to our institution within
             24 hours of symptom onset

          -  Adults, 18 years of age or older

          -  Women of childbearing potential must not be pregnant (negative urine pregnancy test)

        Exclusion Criteria:

          -  Contraindication to acetazolamide (i.e. sulfonamide allergy, renal or liver failure)

          -  Contraindication to contrast media (Allergy or abnormal serum Cr and/or GFR based on
             current UW guidelines for IV contrast)

          -  Renal insufficiency, history of renal failure or renal transplant

          -  Hunt and Hess grade 1 and 5 (Attached protocol provides details on the grading scale.
             Grade 1 have lowest yield for vasospasm and Grade 5 are by definition critically ill
             and unstable patients)

          -  Critically ill patients who are unstable and who cannot undergo scans within the
             proposed timeline i.e. within 24 hours of the onset of their symptoms.
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Intervention: abatacept
Intervention description: 125 mg subcutaneously each week for 24 weeks
Intervention MeSH terms: Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Biliary Cirrhosis; Ursodeoxycholic acid; Abatacept; Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4)

Summary:

      The purpose of this study is to determine if abatacept (Orencia) is effective in patients
      with primary biliary cirrhosis who do not respond adequately to standard treatment with
      ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed PBC diagnosis based upon at least 2 of 3 criteria

               1. Anti-mitochondrial antibody (AMA) titer > 1:40

               2. Alkaline phosphatase > 1.5 times the upper limit of normal for at least 6 months

               3. Liver biopsy findings consistent with PBC

          -  Incomplete response to UDCA defined by an alkaline phosphatase > 1.67 X the upper
             limit of normal after 6 months of UDCA at a minimum dose of 13 mg/kg/d

          -  Taking a stable dose of UDCA for at least 3 months prior to Day 0

          -  aspartate aminotransferase (AST) and alanine aminotransferase ALT < 5 times the upper
             limit of normal

        Exclusion Criteria:

          -  Presence of concomitant liver diseases including viral hepatitis, primary sclerosing
             cholangitis, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's
             syndrome.

          -  Prior liver transplantation

          -  Decompensated liver disease

          -  Use of immunosuppressants within 6 months of Day 0

          -  Use of biologic agents within 12 months of Day 0
An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
Condition: Pain, Postoperative; Spine Injuries and Disorders; Narcotic Use
MeSH terms: Pain, Postoperative; Spinal Injuries
Intervention: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone
Intervention description: The study subjects will be assigned to the defined pre-op MMA regimen with standard postop oxycodone based pain control regimen given on an as needed basis. The treatment group outcomes will be compared to patients outside of the study including a historical control group (receiving only post-op pain regimen) prior to the implementation of the new regimen. The studied treatment group will receive within 3 hours before surgery an oral MMA regimen consisting of:
Acetaminophen 975 mg Celecoxib 200 mg Gabapentin 300 mg Oxycodone 10 mg Extended Release
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: A prospective cohort study
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the hypothesis that multimodal pain regimen
      (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered
      pre-operatively before elective spine surgery significantly decreases acute pain
      post-operatively as well as decreasing requirements of post-op opioids for pain control in
      PACU as compared to patients undergoing elective spine surgery without a pre-operative pain
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing elective spine surgery at NYU Winthrop

          -  Age over 18 years

        Exclusion Criteria:

          -  History of neuromuscular disorders

          -  History of inflammatory arthropathies

          -  History of spine metastases or active cancer in spine

          -  Medical History including any of the following: renal dysfunction, gastric ulcers,
             hepatic dysfunction, coagulopathic/bleeding disorders, prior adverse or allergic
             reactions to any of the medications in the study

          -  Age less than 18 years
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Condition: Anesthesia
MeSH terms: Sleep Apnea, Obstructive
Intervention: Sugammadex; Neostigmine
Intervention description: Subjects who are randomized to into the sugammadex arm (Arm I) will receive sugammadex for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm II (neostigmine group).; Subjects who are randomized into the neostigmine arm (Arm II) will receive neostigmine for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm I (sugammadex group).
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study assesses the efficacy of sugammadex against neostigmine for hastening recovery
      from neuromuscular blockade and optimizing pulmonary function in obese patients with
      obstructive sleep apnea presenting for outpatient surgery. Both drugs are used in
      anesthesiology to reverse neuromuscular blockade that is given in the setting of inducing and
      maintaining general anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  obese (body mass index [BMI] >30 kg/m2)

          -  diagnosis of obstructive sleep apnea (OSA) (with or without continuous positive airway
             pressure [CPAP] use)

          -  scheduled for surgery requiring general anesthesia and neuromuscular blockade

        Exclusion Criteria:

          -  history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction

          -  history of difficult tracheal intubation

          -  history of adverse reaction to anesthesia

          -  history of adverse reaction to rocuronium, sugammadex, and/or
             neostigmine/glycopyrrolate
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Condition: Post-Operative Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems; Anticoagulation Therapy
Intervention description: Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.
Intervention MeSH terms: Warfarin; Rivaroxaban; Dabigatran; Apixaban; Anticoagulants
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 562.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Left Atrial Appendage; Anticoagulation; CHA2DS2- VASc; HASBLED

Summary:

      Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or
      Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial
      Appendage (LAA) will be eligible to participate. Patients enrolled will be randomized 2:1 (2
      with AtriClip to 1 without AtriClip. Subjects who develop Post-operative Atrial Fibrillation
      (POAF) and receive the AtriClip will be followed for 365 days post index procedure.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients satisfying the following criteria will be considered the screening population and
        will be eligible for participation:

          -  Age > 18 years male or female.

          -  Scheduled for any non-mechanical valve and/or CABG (structural heart) procedure where
             direct access to the LAA is expected.

          -  No documented preoperative AF.

          -  CHA2DS2-VASc score of => 2.

          -  HASBLED score of => 2.

          -  Acceptable surgical candidate, including use of general anesthesia.

          -  Willing and able to provide written informed consent.

        Exclusion Criteria:

        Patients satisfying the following criteria will not be eligible for participation:

          -  Redo cardiac surgery.

          -  Mechanical heart valve or other anticipated or current requirement for anticoagulation
             therapy during the post-operative (30 day) period.

          -  Hypercoagulability conditions that may confound the study.

          -  Ejection Fraction < 30.

          -  Left Atrium > 6 cm.

          -  Severe Diastolic Dysfunction.

          -  Requires anticoagulation therapy.

          -  Patient had a stroke/cerebrovascular accident (CVA) within previous 30 days prior to
             signing informed consent.

        Intra-Operative Exclusion Criteria

          -  Presence of thrombus in the left atrium or LAA.

          -  LAA tissue is deemed friable or has significant adhesions (as evaluated by the
             surgeon) near or on the LAA making AtriClip placement overly risky.

          -  Left atrial appendage is outside the range of manufacturer's recommendations - width <
             29mm or > 50mm.

          -  Direct visualization access is not available for AtriClip placement.
Blue Light Therapy of C. Acnes
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: 5% Topical Benzoyl Peroxide Gel; Blue Light Therapy
Intervention description: Gel treatment used to treat acne; Blue light therapy treatment for acne
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This proposal aims to investigate a novel light-based treatment to reduce morbidity in
      shoulder surgical patients. This has potential to improve outcomes and reduce health care
      utilization associated with infectious complications of shoulder arthroplasty. Participants
      will be healthy male volunteers at least 18 years of age. They will be on study for
      approximately 2 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male

          -  18 years or older

        Exclusion Criteria:

          -  Allergy to benzoyl peroxide or chlorhexidine

          -  <18 years of age

          -  Previous history of shoulder infections

          -  Antibiotics taken within one month of research visit

          -  Immunocompromised state

          -  Active cancer

          -  Diabetic

          -  Skin lesions or abrasions over the deltopectoral interval

          -  Topical corticosteroid treatment to either shoulder or or systemic corticosteroid
             treatment within 2 weeks of research visit

          -  Topical benzoyl peroxide treatment to either shoulder within 2 weeks of research visit

          -  Blue light therapy treatment to either shoulder within 2 weeks of research visit

          -  Prior incision over the deltopectoral interval of either shoulder

          -  Contraindication to blue light treatment
Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: XEN® Gel Stent; Cataract Surgery
Intervention description: The XEN® Gel Stent (XEN45 implant) was placed in the study eye.; Participants diagnosed with a cataract elected to have cataract surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: XEN; Primary Open Angle Glaucoma; Filtration Device; Ab interno

Summary:

      The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45
      Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when
      medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by
      comparing medicated preoperative IOP to postoperative values. Additionally, the number of
      topical IOP-lowering medications at screening were compared to the number of IOP-lowering
      medications at 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary open angle glaucoma

          -  Participants are taking at least one and no more than four topical IOP-lowering
             medications.

        Exclusion Criteria:

          -  Angle Closure Glaucoma

          -  Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma
             associated with vascular disorders

          -  Clinically significant inflammation or infection in the study eye within 30 days prior
             to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis,
             herpes simplex infection)

          -  Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival
             pathologies (e.g., pterygium) in the target quadrant
The Impact of Arousal Threshold in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Donepezil; placebo
Intervention description: Donepezil 10mg before sleep; One piece of placebo before sleep
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Obstructive; Sleep Apnea; Arousal threshold; Donepezil

Summary:

      The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low
      arousal threshold may wake up too early during a respiratory event, before upper airway
      muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the
      respiratory arousal threshold could potentially improve the quality of sleep and sleep
      disordered breathing. Agents that raise arousal threshold are therefore likely to benefit
      some patients with OSA. The overall goal of this project is to determine the importance of
      the arousal threshold in OSA, determine which patients might benefit from a raised arousal
      threshold, and test this hypothesis by using pharmacological manipulation of the arousal
      threshold to achieve this goal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-70 years

          -  sleep study (with apnea hypopnea index>5)

          -  Diagnosis of obstructive sleep apnea

        Exclusion Criteria:

          -  Any known unstable cardiac (apart from treated hypertension), pulmonary (including
             asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.

          -  Susceptible to stomach ulcers.

          -  Pregnant women or Nursing mothers

          -  Using positive airway pressure (PAP) therapy over one week or longer

          -  Body weight <55kg

          -  History of hypersensitivity to Afrin, Lidocaine and/or Donepezil

          -  History of bleeding diathesis and/or gastrointestinal bleeding.

          -  Use of any medications that may affect sleep or breathing.

          -  A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar
             disorder, major depression, panic or anxiety disorders.

          -  Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs.

          -  More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.

          -  Deprived from sleep in the recent one week

          -  Desaturations to below 70% lasting greater than 10 seconds in duration per event in
             the sleep study (without Oxygen).