bioihbjkbjnl/mcl2 huggingface dataset:
Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Condition: Renal Failure Chronic; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Renal Insufficiency; Kidney Failure, Chronic
Intervention: glecaprevir/pibrentasvir treatment
Intervention description: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hemodialysis; renal failure; kidney transplant

Summary:

      Open label multi center study for the donation of HCV positive kidneys to HCV negative
      recipients with interventional treatment to prevent HCV transmission upon transplantation.
    

Eligibility criteria:

        Recipient Inclusion Criteria:

          -  Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2

          -  Listed for an isolated kidney transplantation

          -  Able to understand and adhere to the study visit schedule and all other protocol
             requirements, and must voluntarily sign and date an informed consent

          -  No available medically acceptable, compatible living kidney donor

          -  Subject must agree to use an effective method of birth control per protocol
             specifications

        Recipient Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to
             immunosuppressants utilized in kidney transplant

          -  Female who is pregnant, breastfeeding, or is planning to become pregnant during the
             course of the study

          -  History of HIV

          -  HCV RNA positive

          -  HBV surface Ag-positive or detectable HBV DNA

          -  Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased
             risk of causing early graft failure as assessed by the transplant nephrologist and/or
             investigator team

          -  Presence of clinically significant liver disease

          -  Transplant candidate requiring antibody desensitization protocol for transplantation

          -  Most recent calculated panel reactive antibody (cPRA) >80%.

          -  Prior recipient of a non-renal solid organ transplant

        Donor Organ Inclusion Criteria

          -  Deceased donor organ with kidney donor profile index (KDPI) ≤0.85

          -  HCV RNA-positive

        Donor Organ Exclusion Criteria

          -  Known prior HCV treatment with direct acting antiviral medication

          -  HIV RNA-positive

          -  HBV Surface antigen-positive or HBV DNA-positive
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management
Condition: Pain
Intervention: Gabapentin; Placebo
Intervention description: Participants in this group will receive 600 mg of gabapentin given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion. Gabapentin is an FDA approved medication that is used to prevent seizures and to treat various forms of chronic and acute pain.; Participants in this group will receive 600 mg of gelatin capsules that are identical in appearance to gabapentin capsules. The placebo will be given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion.
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: 114.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Perioperative pain; Outpatient surgery; Obstetrics/gynecology; Pain management

Summary:

      This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2
      hours preoperatively in conjunction with perioperative paracervical block for surgical
      abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce
      perioperative and postoperative pain associated with surgical abortion. Additionally, the
      researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and
      consumption of pain medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women >=18 years-old

          -  Presenting for a surgical abortion

          -  Fluency in English and able to provide informed consent

          -  Has a driver to take them home following the procedure

        Exclusion Criteria:

          -  Allergy, sensitivity or contraindication to gabapentin

          -  Severe renal disease

          -  Currently using gabapentin or pregabalin

          -  Contraindication to outpatient abortion under local anesthesia
Stopping ACE-inhibitors in COVID-19
Condition: SARS-CoV-2; COVID-19
MeSH terms: COVID-19
Intervention: ACE inhibitor, angiotensin receptor blocker
Intervention description: In patients randomized to stopping / replacing ACEI or ARB, it may be necessary to switch to another drug without direct effect on the RAS system. In patients, randomized to continuation, it may be needed to stop ACEI or ARB (e.g. hypotension with beginning sepsis) irrespective of the study.
Intervention MeSH terms: Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open-label, randomized design
Masking: Single (Outcomes Assessor)
Masking description: unmasked
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ACE-inhibitors; RAS system; angiotensin receptor blockers; SARS-CoV-2; COVID-19

Summary:

      ACEI-COVID-19 is a multicenter, randomized trial testing the hypothesis that
      stopping/replacing chronic treatment with ACE-inhibitors (ACEI) or angiotensin receptor
      blockers (ARB) improves outcomes in symptomatic SARS-CoV2-infected patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and male patients competent to make a decision

          -  Proven and symptomatic SARS-CoV2 infection ≤ 5 days

          -  Patient age ≥ 18 years

          -  Provided written informed consent

          -  Chronic (≥ 1 month) ACEI/ARB therapy for treatment of arterial hypertension, diabetes
             mellitus, heart failure or coronary artery disease

          -  Stable hemodynamic conditions allowing to stop or continue treatment with ACEI/ARB
             (systolic blood pressure ≤180mmHg)

        Exclusion Criteria:

          -  Women capable of bearing children as well as pregnant and breastfeeding women

          -  Participant in another interventional trail

          -  At screening visit, no oral medication intake possible

          -  Advanced heart failure NYHA Stage III-IV

          -  Left ventricular ejection fraction <30% or NTproBNP ≥600pg/mL in case of clinical
             signs of heart failure

          -  Acute coronary syndrome ≤ 3 months

          -  Severe arterial hypertension (concomitant use of more than 4 different
             antihypertensive drug classes)

          -  Acute respiratory distress syndrome with need for mechanical ventilation

          -  Patients who at not capable of home blood pressure monitoring

          -  Patients who cannot be switched to an alternative medication
Liposomal Bupivacaine vs Dexamethasone ISB
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Exparel 133 MG Per 10 ML Injection; Dexamethasone
Intervention description: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total); 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
Intervention MeSH terms: Dexamethasone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      In this study, patients receiving shoulder arthroscopy will receive an interscalene block for
      pain management containing either liposomal bupivacaine and standard bupivacaine or standard
      bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative
      pain and block duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I-III

          -  Age 18 years or older

          -  Scheduled for elective outpatient arthroscopic shoulder surgery

        Exclusion Criteria:

          -  History of allergy to local anesthetic, or one of the study medications

          -  Pre-existing neurological deficits

          -  Psychiatric or cognitive disorders that prohibit patients from following study
             protocol

          -  History of drug or alcohol abuse

          -  Chronic opioid use (longer than 3 months)

          -  Chronic pain syndromes

          -  Infection at the site of injection

          -  Patients with severe pulmonary disease

          -  Herniated cervical disc, cervical myelopathy

          -  Contraindication for general anesthesia and/or interscalene nerve block

          -  Pregnancy

          -  Open shoulder arthrotomies.

          -  Non English speakers
Intranasal Bevacizumab for HHT-Related Epistaxis
Condition: HHT; Hereditary Hemorrhagic Telangiectasia; Epistaxis; Nose Bleeds; Nasal Bleeding
MeSH terms: Epistaxis; Telangiectasis; Telangiectasia, Hereditary Hemorrhagic; Hemorrhage
Intervention: Bevacizumab; Placebo (Saline)
Intervention description: Bevacizumab will be mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL) will be injected into each side of the nose; 4mL of saline will be mixed by the Stanford Hospital Pharmacy as a control
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HHT; Hereditary Hemorrhagic Telangiectasia; epistaxis; nose bleeds; nasal bleeding; Avastin; bevacizumab

Summary:

      This is a randomized, controlled, double-blind, placebo-controlled trial of intranasal
      Avastin (bevacizumab) injection versus saline control for control of HHT-related epistaxis
      when used in conjunction with bipolar electrocautery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient carries a diagnosis of hereditary hemorrhagic telangiectasia (HHT)

          2. The patient is to undergo treatment with electrocautery in the operating room under
             endoscopic visualization

          3. The patient is able to give informed consent

          4. The patient is at least 18 years old

        Exclusion Criteria:

          1. The patient has had prior treatment with systemic or nasal bevacizumab within the past
             year

          2. The patient has undergone electrocautery for epistaxis within the 6 months prior to
             study enrollment

          3. The patient is a minor

          4. The patient is pregnant

          5. The patient is incapable of understanding the consent process

          6. The patient has a history of HIV or another known cause of immunosuppression, or is
             actively taking immunosuppressive medications due to organ transplantation, rheumatoid
             disease, or other medical conditions.
Novartis Everolimus Transition
Condition: Graft Dysfunction; Interstitial Fibrosis
MeSH terms: Lung Diseases, Interstitial; Fibrosis
Intervention: Everolimus; Standard of Care
Intervention description: Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus; Tacrolimus, mycophenolate mofetil and steroids
Intervention MeSH terms: Everolimus
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
Healthy volunteers: No
Keywords: Everolimus; Graft dysfunction; Interstitial fibrosis

Summary:

      Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids
      in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone
      will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age and able to give informed consent.

          2. Received a first or repeat cadaveric (including ECD) or living donor renal transplant.

          3. Patient has stable graft function, defined as no change of greater than 40% of
             baseline serum creatinine and no acute rejection during the past month.

          4. Currently receiving tacrolimus, mycophenolate mofetil and prednisone as their
             immunosuppression regimen

        Exclusion Criteria:

          1. Biopsy proven acute rejection episode that occurred within the past month.

          2. Malignancy within the past 3 years, except for non-melanoma skin cancer.

          3. Currently enrolled in an investigational drug trial.

          4. Woman of child bearing potential not utilizing an effective form of birth control.

          5. Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or
             serum fasting triglycerides >500 mg/dL.

          6. Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram
             of creatinine.

          7. WBC < 2,000 cells/mm3

          8. Platelets < 75,000 cells/mm3

          9. Patients who have received an organ transplant other than a kidney.

         10. Patients with a history of biopsy proven FSGS, MPGN, or PGN.
Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
Condition: Obstruction; Catheter, Infusion Catheter (Vascular); Catheter; Complications (Indwelling Catheter)
Intervention: Heparinized saline catheter flush; Saline-only catheter flush
Intervention description: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months; The intervention group will have their port catheters flushed with saline only.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safest and most effective flushing solution for
      maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication
      rate in patients whose ports are flushed with saline only will be compared to the
      complication rate in patients whose ports are flushed with a combination of saline and
      heparinized saline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to read and understand English

          -  Has a BioFlo implanted port in place less than one (1) year

          -  Evidence of a patent BioFlo port catheter prior to enrollment in the study

          -  Is receiving active treatment (i.e., receiving a therapeutic drug) through the BioFlo
             implanted port

          -  Current treatment protocol projected to continue for a minimum of three (3) months

          -  Anticipates receiving care at the identified centers for 12 months following
             enrollment in the study

          -  Does not receive care of BioFlo implanted port at any other facility

        Exclusion Criteria:

          -  Has documented heparin platelet antibody (i.e., could not be randomized to either
             group) or other allergy to heparin

          -  Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin)

          -  Does not meet one or more of the inclusion criteria
Crossover Study From Macitentan or Bosentan Over to Ambrisentan
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Ambrisentan
Intervention description: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
Intervention MeSH terms: Ambrisentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn more about the safety and effects of switching
      treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24
      weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension
      (CTD-PAH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a Connective Tissue Disease (CTD)

          -  Age range: 18-80 years old

          -  Previous Right Heart Catheterization (RHC) demonstrating PAH

          -  Forced vital capacity (FVC) greater than 50%

          -  Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%

          -  World Health Organization (WHO) functional class II or III

          -  Able to perform a 6 minute walk test (6MWT)

          -  Stable dose of antihypertensive medications

          -  Non-pregnant females

          -  Have to be currently on stable dose of bosentan for at least 3 months

          -  Adequate acoustic images to allow for transthoracic echocardiography to be performed

        Exclusion Criteria:

          -  Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)

          -  Severe systemic hypertension greater than 170/95

          -  Patients with a prior history of cardiovascular disease

          -  WHO functional class IV status

          -  Patients with severe other organ disease felt by investigators to impact on survival
             during the course of the study.

          -  FVC less than 50% of predicted

          -  DLCO less than 50% of predicted
Trial of Alvimopan in Major Spine Surgery
Condition: Constipation
MeSH terms: Constipation
Intervention: Alvimopan; Placebo
Intervention description: Alviimopan 12 mg twice daily up to 15 doses; Placebo twice daily up to 15 doses
Intervention MeSH terms: Alvimopan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The Investigator has chosen to study the reconstructive spinal surgery patient population
      because it is believed that the use of alvimopan in these patients at the University of
      Virginia will give the scientific community significant insight into the broader
      applicability of this drug into other surgical populations, the impact of this drug on the
      perception of pain (as opposed to simply the consumption of opioids), and its impact on total
      hospital charges, resource utilization, and functional outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major spine surgery scheduled as part of clinical care

          -  18-80 years

        Exclusion Criteria:

          -  More than three doses of any opioid within one week of surgery

          -  Pregnancy

          -  Prisoners

          -  Unable to provide consent

          -  Emergency surgery

          -  Chronic kidney disease stage 5 (GFR < 15 ml/min)

          -  Severe hepatic impairment

          -  Recent myocardial infarction (within the last 3 months)
Genicular Nerve Block for Total Knee Arthroplasty
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: 15mL 0.25% bupivacaine; Genicular nerve block; Saline
Intervention description: Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline; The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.; Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Total knee replacement

Summary:

      This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after
      total knee replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects scheduled for primary elective total knee arthroplasty

          -  American Society of Anesthesiologists Physical Status I-III

          -  BMI 18-40 kg/m2

        Exclusion Criteria:

          -  Inability to cooperate with protocol

          -  Inability to understand or speak English

          -  Allergy to ropivacaine, bupivacaine or other local anesthetic

          -  Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit
             or disorder, previous trauma or surgery to ipsilateral knee, etc.)

          -  Revision knee surgery

          -  Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four
             weeks prior to surgery)

          -  History of chronic pain

          -  History of psychiatric disorder

          -  History of diabetes mellitus