bioihbjkbjnl/mcl2 huggingface dataset:
Study of Oral Treatments for Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: SOF/LDV (sofosbuvir/ledipasvir); PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only); EBR/GZR (elbasvir/grazoprevir); Ribavirin
Intervention description: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider); Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) (2 tablets taken orally) and Dasabuvir (250 mg tablet) (1 tablet twice daily) with food for 12 to 24 weeks (treatment duration as per HCV provider); Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks; 200 mg pills (1-3 pills, 1-2 times per day)
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir; Grazoprevir; Ledipasvir; Elbasvir-grazoprevir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1275.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C

Summary:

      Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral)
      HCV treatment regimens to learn whether they worked equally well under real-world conditions.
      Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization
      to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic
      clinics were offered the opportunity to consent to be randomly assigned to one of three
      (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all
      medical care, laboratory testing, and any disease or side effect management were assumed by
      usual care conditions, and patient-reported outcomes were collected outside clinic in keeping
      with pragmatic design principles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV Genotype 1a or 1b

          -  Adult patients (age 18 years or older)

          -  Patients being prescribed HCV treatment who can begin treatment with any of the three
             HCV treatments being studied (Harvoni (SOF/LDV), Viekira Pak (PrOD) (Phase 1 only), or
             Zepatier (EBR/GZR))

        Exclusion Criteria:

          -  Inability to provide written informed consent

          -  HARVONI® is not a covered drug on benefits formulary

          -  Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic
             encephalopathy, or ascites)

          -  Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)

          -  Pregnant or breastfeeding women
Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
Condition: Neuromuscular Blockade
Intervention: sugammadex; Neostigmine; Glycopyrrolate
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Randomized Double Blinded
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participants, Care Providers, Investigators, and Outcome Assessors are blinded from the type of NMBA reversal agent used prior to completion of data collection
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep
      neuromuscular blockaded (induced by rocuronium)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for open ventral hernia repair or open colectomy

          -  ASA class I-III

          -  18 years and older

          -  Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg

          -  Subjects who have given written informed consent

        Exclusion Criteria:

          -  Subjects with medical conditions and/or undergoing surgical procedures that are not
             compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal
             forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker

          -  Subjects known or suspected to have neuromuscular disorders impairing neuromuscular
             blockade (e.g., subjects with myasthenia gravis)

          -  Subjects known or suspected to have significant renal dysfunction (e.g. creatinine
             clearance < 30 mL.min-1

          -  Subjects known or suspected to have a (family)history of malignant hyperthermia; have
             significant hepatic dysfunction

          -  Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or
             other medications used during general anesthesia;

          -  Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins
             or Rocuronium or any of its excipients

          -  Subjects who have a contraindication to, Rocuronium or Sugammadex

          -  Female subjects who are pregnant

          -  Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 kg
Pediatric Ketamine Study for Pain Management
Condition: Pain
Intervention: Ketamine; Fentanyl
Intervention description: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.; intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Intervention MeSH terms: Fentanyl; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Analgesia; pediatrics; pain management

Summary:

      Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for
      the treatment of moderate to severe pain in pediatric patients in the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 3-17,

          -  weighing less than 50kg

          -  present to the pediatric ED with moderate-severe acute pain (defined as pain greater
             than or equal to 6/10).

          -  Treating physician determines the patient to require opioid analgesia.

        Exclusion Criteria:

          -  Children with facial trauma or any abnormal nasal anatomy;

          -  developmentally delayed children;

          -  children with head trauma/increased intracranial pressure (ICP);

          -  children with known allergy to fentanyl or ketamine;

          -  children who are unable to provide pain scale assessment;

          -  children with chronic pain of greater than 4 weeks;

          -  Pregnant females;

          -  and children with a Glasgow Coma Scale (GCS)<15.
Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
Condition: Mammaplasty
Intervention: Bupivicaine HCL; Liposomal bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine
      (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in
      terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12,
      24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of
      stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead
      to greater patient satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or
             TRAM).

          -  At least 18 years of age.

          -  Female.

          -  Able to understand and willing to sign a written informed consent document.

        Exclusion Criteria:

          -  Cognitive impairment.

          -  History of abdominal surgery precluding free flap donor site.

          -  Allergy or intolerance to bupivacaine or "amide" anesthetics.

          -  Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain
             (requiring daily use of pregabalin or gabapentin) within the previous 3 months.

          -  Pregnant or breastfeeding.
EXPAREL® for Pain After Tonsillectomy
Condition: Tonsillectomy; Tonsillitis; Post-operative Pain
MeSH terms: Tonsillitis; Pain, Postoperative
Intervention: Liposomal Bupivacaine
Intervention description: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Liposomal Bupivacaine

Summary:

      The purpose of this study is to determine whether liposomal bupivacaine (long acting
      injectable anesthetic) provides greater post operative pain relief compared to the standard
      post operative pain regiment for tonsillectomy patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring
             bilateral tonsillectomy

          -  Willing and able to understand and provide written informed consent

        Exclusion Criteria:

          -  Known pregnancy

          -  Women who are currently nursing a child

          -  History of coagulopathy; such as hemophilia or Von Willebrand disease, or any
             congenital or acquired bleeding disorder

          -  Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or
             medications similar in class to these medications will exclude the patient from
             participation

          -  Inability to provide informed consent (patients under guardianship)

          -  Known hypersensitivity to local anesthetics

          -  History of cardiac disease; such as current impaired cardiovascular function, past
             history of myocardial infarction, congenital heart disease, current cardiac symptoms,
             i.e. angina, shortness of breath, or chest pain as determined by history or review of
             the medical record.

          -  History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive
             pulmonary disease (COPD), or interstitial lung disease as determined by history or
             review of the medical record.

          -  Impaired renal function as documented in the medical record in the last 3 months with
             a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60
             mL/min/body surface area (BSA) as determined by history or review of the medical
             record.

          -  History of or current hepatic disease as documented by liver function test abnormality
             in the last 3 months as determined by history or review of the medical record.
Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion
Condition: Low Back Pain
MeSH terms: Low Back Pain
Intervention: Acetaminophen; Placebo comparator
Intervention description: 1 gram of intravenous Acetaminophen; placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acetaminophen in transforaminal lumbar interbody fusion

Summary:

      The purpose of this project is to study the effects of preoperative followed by scheduled
      intravenous acetaminophen on pain control for 24 hours postoperatively after minimally
      invasive 1 or 2 level transforaminal lumbar interbody fusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years old

          -  Being scheduled to have elective primary minimally invasive 1 or 2 level
             transforaminal lumbar laminectomy interbody fusion

          -  ASA I, II, or III

          -  Informed consent form signed

        Exclusion Criteria:

          -  Anyone weighing less than 50kg (as this would require a dosing change).

          -  Hypersensitivity or contraindication to intravenous acetaminophen or opioids

          -  Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl

          -  Impairment of liver function-- defined as the inability to receive intravenous
             acetaminophen without dose adjustment as determined by the investigator; or history of
             chronic liver disease defined as history of hepatitis of any kind as recorded in the
             patient's chart

          -  Mental retardation recorded as a diagnosis in the patient's chart

          -  History of chronic pain (defined as currently receiving treatment from a specialist
             for pain)

          -  History of pain recalcitrant to intravenous morphine

          -  Impaired kidney function (defined as creatinine > 1.5)

          -  Anyone who is not a candidate for general anesthesia or any other portion of the
             investigator's standard of
Prebiotic Treatment in People With Schizophrenia - Pilot Study
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Prebiotin; Placebo
Intervention description: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI); placebo-OEI
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine changes in serum butyrate levels with the prebiotic:
      Prebiotin (12g/day), an oligofructose-enriched inulin (OEI); the effect of OEI on the
      composition of the gastrointestinal microbiota in people with schizophrenia; and the
      relationship of the composition of the gut microbiota to various clinical, cognitive, and
      neuroimaging variables.
    

Eligibility criteria:

        Inclusion Criteria:

          1. DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;

          2. Age 18-60 years

          3. Clinically stable as determined by opinion of treating clinician

          4. Currently treated with an antipsychotic, with no dose changes in last 14 days

          5. Ability to participate in the informed consent process, as determined by a score of 10
             or greater on the Evaluation to Sign Consent.

          6. BMI ≤ 35

        Exclusion Criteria:

          1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable
             Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the
             presentation or treatment of schizophrenia or significantly increase the risk
             associated with the proposed treatment protocol

          2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain
             injury, Loss of consciousness (LOC) for more than 30 minutes

          3. Intellectual disability

          4. Antibiotic or immune therapy within the last three months

          5. Prebiotic or probiotic treatment within the last three months

          6. Inability to understand English

          7. Inability to cooperate with study procedures

          8. Pregnant or lactating women secondary to pregnancy

          9. Meet DSM-5 criteria for alcohol or substance use disorders (except Tobacco Use
             Disorder) within last 3 months
FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)
Condition: Infertility
MeSH terms: Infertility
Intervention: Urofollitrophin; Follitrophin alpha
Intervention MeSH terms: Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 710.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No
Keywords: In vitro fertilization (IVF); Assisted reproduction technologies (ART); GnRH-antagonist; Follicle stimulating hormone (FSH)

Summary:

      The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety
      of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled
      ovarian hyperstimulation in a GnRH-antagonist cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18-38 years old;

          -  BMI: 18-28 kg/m2;

          -  Less than 3 previously completed IVF cycles;

          -  Basal FSH <10 IU/L and E2 <80 pg/ml;

          -  TSH < 2.5 mIU/L

          -  >10 and <30 antral follicles 2-10 mm in size for both ovaries combined

          -  AMH: >1 ng/ml (7.15 pmol/l) and <5.6 ng/ml (40.0 pmol/l)

          -  Presence and adequate visualization of both ovaries;

          -  Within 12 months of the beginning of the study, uterine cavity consistent with
             expected normal function as assessed through transvaginal ultrasound,
             hysterosalpingogram, sonohysterogram or hysteroscopic examination;

        Exclusion Criteria:

          -  Primary ovarian failure or women known as poor responders;

          -  PCO and PCOS;

          -  Severe OHSS in a previous COH cycle;

          -  Uterine malformation that may impair the possibility to get pregnant;

          -  Ovarian cysts >10 mm;

          -  Hydrosalpinx that have not been surgically removed or ligated;

          -  Endometriosis stage 3 or 4;

          -  Oocyte donation;

          -  Severe male factor;

          -  Pathologies associated with any contraindication of being pregnant;

          -  History of recurrent miscarriage (more than 3 previous miscarriages);

          -  Hypersensitivity to the study medication;

          -  Abnormal bleeding of undetermined origin;

          -  Uncontrolled thyroid or adrenal dysfunction;

          -  Neoplasias;

          -  Severe impairment of renal and/or hepatic function.
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
Condition: Chronic Sinusitis, Ethmoidal
MeSH terms: Sinusitis; Ethmoid Sinusitis
Intervention: Steroid-eluting sinus implant; Post-op standard of care
Intervention description: PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days; Post-op standard of care including debridement, irrigation, and/or topical steroids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients assigned to the treatment group underwent a bilateral in-office placement of a steroid-eluting sinus implant 7 days following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids. Patients randomized to the control group received same standard of care alone.
Masking: Double (Participant, Outcomes Assessor)
Masking description: Patients were wearing eye masked and noise-cancelling headsets during placement and follow-up endoscopies.
The primary outcome was assessed by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Steroid-eluting sinus implant; Mometasone furoate; Endoscopic sinus surgery

Summary:

      Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to
      either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid
      sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for
      6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of chronic rhinosinusitis, defined by the AAO-HNS 2015 guidelines,
             including presence of bilateral ethmoid disease.

          -  ESS including bilateral ethmoidectomy with middle meatal antrostomy within 7 days
             prior to scheduled implant placement. Concurrent septoplasty and surgical treatment of
             the other paranasal sinuses also permitted.

        Exclusion Criteria:

          -  Known history of intolerance to corticosteroids or an oral steroid-dependent
             condition.

          -  Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma