bioihbjkbjnl/mcl2 huggingface dataset:
Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Afatinib
Intervention description: Afatinib tablet once daily until progression
Intervention MeSH terms: Afatinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this single-arm, open-label trial are to assess the efficacy and safety of
      afatinib as second line treatment for patients with locally advanced or metastatic non-small
      cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line
      platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to
      the results seen in previous trials.
    

Eligibility criteria:

        Inclusion criteria:

          1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural
             effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients
             with mixed histology are eligible if adenocarcinoma is the predominant histology.

          2. Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.

          3. Measureable disease according to RECIST 1.1.

          4. Radiologically confirmed progression or recurrence of disease during or following
             first line therapy with a platinum-based chemotherapy regimen.

          5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.

          6. Adequate organ function.

        Exclusion criteria:

          1. More than one line of prior therapy for disease.

          2. Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity
             and/or intolerance of treatment.

          3. Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or
             antibody.

          4. Known pre-existing interstitial lung disease.
Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
Condition: Pain
Intervention: Bupivacaine; Hydromorphone; Fentanyl
Intervention description: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter; Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).; Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
Intervention MeSH terms: Fentanyl; Hydromorphone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Postoperative analgesia following spine surgery is difficult to manage. Current treatment
      modalities rely heavily on opioid analgesics with all of the inherent limitations and side
      effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple
      different drugs and techniques to control pain after surgery), there is no consensus
      regarding which components of this multimodal therapy provide optimal analgesia. This
      prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion
      Surgery at Zale Lipshy University Hospital. The primary objective is to determine the
      comparative efficacy of epidural analgesia, as compared with intravenous (IV)
      patient-controlled analgesia (PCA), on post-operative analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects aged 18 years or older

          -  Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels

        Exclusion Criteria:

          -  Baseline cognitive deficits sufficient to make objective pain self-assessments
             unreliable in the estimation of the Study Investigators.

          -  Immunocompromised subject

          -  Coagulopathy

          -  Severe liver and renal dysfunction

          -  Preoperative neurological deficits

          -  The dura damage during surgery

          -  Inability to follow directions or comprehend the English language.

          -  Females who are pregnant as determined by positive pregnancy test on or before the day
             of surgery.

          -  Prisoners.

          -  Patient refusal to provide informed consent.

          -  Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) or opioid
             (fentanyl) allergy if patient assigned epidural analgesia.

          -  Hydromorphone allergy if patient assigned IV PCA
Postmenopausal Pessary Users: Estrogen Versus Trimosan
Condition: Vaginosis; Vaginosis, Bacterial; Vaginal Discharge
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Vaginal Discharge
Intervention: Estrogen vaginal cream; Trimo-San vaginal gel
Intervention description: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.; Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
Intervention MeSH terms: Estrogens
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Pessary; Vaginal pH

Summary:

      The purpose of the study is to compare vaginally applied estrogen with the vaginal gel
      trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary
      users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal
             will be defined as: amenorrhea for a year or 3 months after surgical bilateral
             salpingo-oophorectomy

          -  Is a new pessary user, or has not had a pessary for a year

        Exclusion Criteria:

          -  Pregnancy

          -  Persistent Bacterial Vaginosis infection in the first two clinic encounters

          -  Currently on hormone replacement therapy

          -  Previously on hormone replacement therapy in the past 6 months

          -  Currently on antibiotics

          -  Patients with existing vaginal erosions/ulcerations
Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
Condition: Neoplasms
MeSH terms: Neoplasms
Intervention: Everolimus; Sandostatin LAR Depot
Intervention description: Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject's best interest.; Sandostatin LAR Depot was provided by Novartis or by the investigational site considering local regulations. The dose and frequency of Sandostatin LAR Intramuscular injections was the same as the last dose that was given in the parent study.
Intervention MeSH terms: Everolimus; Octreotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasms; Carcinoid tumor; Neuroendocrine tumor

Summary:

      Study to allow access to everolimus for patients who are on everolimus treatment in a
      Novartis-sponsored study and are benefiting from the treatment as judged by the investigator
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject enrolled in a Novartis-sponsored, CD&MA study receiving everolimus or
             everolimus plus Sandostatin LAR Depot and fulfilled all their requirements in the
             parent study

          -  Subject benefiting from treatment with everolimus, as determined by the guidelines of
             the parent protocol.

        Exclusion Criteria:

          -  Subject was permanently discontinued from everolimus study treatment in the parent
             study.

          -  Subject was receiving everolimus in combination with an unapproved or experimental
             treatment

        Other protocol-defined inclusion/exclusion criteria might apply
Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Albiglutide; Auto-injector
Intervention description: Albiglutide liquid drug product is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid drug product (50 mg). Subjects will receive albiglutide 50 mg through subcutaneous injection in the abdomen, thigh or upper arm region via auto-injector. Albiglutide is a glucagon-like peptide-1 agonist (GLP-1 agonist).; The auto-injector delivers the albiglutide liquid drug product in an injection volume of 1.0 mL for the 50 mg dose.
Intervention MeSH terms: rGLP-1 protein
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Healthy volunteers: No
Keywords: Extension; Long-term Safety; Pharmacodynamics; Albiglutide; Type 2 Diabetes Mellitus

Summary:

      Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an
      adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and
      has been approved by the United States (US) Food and Drug Administration (FDA), the European
      Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single
      group, multicenter, extension study to Study 200952. This extension study will provide
      extended safety, tolerability and immunogenicity data for the albiglutide liquid drug
      product. This extension study will comprise 2 study periods: treatment (26 weeks) and
      post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part
      in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed the 26 week Treatment Phase of Study 200952

          -  Male or female

          -  Able and willing to provide informed consent.

        Exclusion Criteria:

          -  Subject meets one or more of the withdrawal stopping criteria at Visit 1 (Week 26)
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
Condition: Shoulder Arthroscopy
Intervention: Bupivacaine with Epinephrine; Bupivacaine alone
Intervention description: Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Study patients will receive an injection containing a total volume of 20 mL of bupivacaine with epinephrine (0.3 mL epinephrine in 30 mL of 0.5% bupivacaine).The syringe will not be labeled, and the contents of the injection will not be disclosed to the surgeon to preserve blinding. The injection will be performed with an 18-gauge needle into the subacromial space via a posterior or lateral approach after positioning the patient in the beach chair position, but prior to prepping and draping.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale. Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.; Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Control patients will receive an injection containing 20mL of 0.5% bupivacaine alone.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale.Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Shoulder; Rotator Cuff; Epinephrine; Subacromial bursa

Summary:

      The purpose of this study is to evaluate surgeon-rated visual clarity and the need for
      increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean
      arterial pressure, operative time, and any adverse events that occur during arthroscopic
      shoulder surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position
             requiring visualization within the subacromial space

        Exclusion Criteria:

          -  Are unable to provide informed consent

          -  Non-English speaker

          -  Have a history of adverse medication reaction to epinephrine
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
Condition: Anticholinergics Toxicity
Intervention: Physostigmine; Lorazepam
Intervention description: Administration of physostigmine bolus followed by an infusion; Administration of lorazepam bolus followed by normal saline infusion
Intervention MeSH terms: Lorazepam; Physostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting
      antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism
      of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis,
      decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary
      retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or
      benzodiazepines.

      Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly
      despite evidence of safety and efficacy. To demonstrate the utility and safety of
      physostigmine, the investigators propose a randomized clinical trial of physostigmine
      compared to benzodiazepine for antimuscarinic toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >=10 and < 18 years

          -  Present to the Emergency Department or Intensive Care Unit for an antimuscarinic
             toxidrome from either a pharmaceutical agent such as antihistamine overdose, or
             natural toxins or products such as Datura stramonium

          -  Antimuscarinic toxidrome will be defined with at least one central nervous system
             agitation effect (agitation, delirium, visual hallucinations, mumbling
             incomprehensible speech), and at least 2 peripheral nervous system adverse effect
             (mydriasis, dry mucus membranes, dry axillae, tachycardia, decreased bowel sounds).

          -  Patients will also be required to have a RASS score of +2 to +4 on initial assessment.

        Exclusion Criteria:

          -  History of seizures or seizure during acute clinical course

          -  History of asthma or wheezing during clinical course Bradycardia (Heart Rate <60)

          -  Concomitant use of atropine or choline ester or depolarizing neuromuscular blocker
             during present illness and hospital course

          -  Diabetes gangrene, known intestinal obstruction or urogenital tract, vagotonic state

          -  QRS interval > 120 ms on electrocardiogram

          -  Known to be pregnant at the time of enrollment

          -  Known ward of the state
Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
Condition: Post Operative Pain (Post Laparoscopic Hernia Repair)
MeSH terms: Hernia; Pain, Postoperative; Hernia, Inguinal
Intervention: 0.5% Bupivicaine
Intervention description: Local anesthetic
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post Operative Pain; hernia repair

Summary:

      To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia
      repair on post-operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair

          -  American Society of Anesthesiology (ASA) Class I and II

        Exclusion Criteria:

          -  Conversion from laparoscopic to open surgery

          -  History of Chronic pain or ongoing treatment for chronic pain

          -  Age less than 18 yrs

          -  Allergy to local anesthetics
Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
Condition: End Stage Renal Disease; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Kidney Failure, Chronic
Intervention: Glecaprevir/pibrentasvir
Intervention description: Glecaprevir/pibrentasvir 300mg/120mg once daily by mouth for 2 weeks post-transplant.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this study, individuals without hepatitis C infection who are on the kidney transplant
      waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be
      treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg /
      pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant
      procedure and continued for 2 weeks post-renal transplant.
    

Eligibility criteria:

        Recipient Inclusion Criteria:

          -  Participants ≥ 18 years old

          -  On the deceased donor kidney waitlist at Johns Hopkins Hospital

          -  Awaiting a first or second kidney transplant

          -  No available living kidney donors

          -  On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined
             as a glomerular filtration rate <15 ml/min for ≥ past 90 days

          -  HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors
             for contracting HCV other than being on hemodialysis

          -  Calculated panel reactive anti-human leukocyte antigens (anti-HLA) antibody (flow
             cPRA) below 80%

        Recipient Exclusion Criteria:

          -  Plan to receive a multi-organ transplant

          -  Plan to receive a dual kidney transplant (including en bloc)

          -  History of prior solid organ transplant other than first kidney transplant

          -  Participating in another study that involves an intervention or investigational
             product

          -  Plan to receive a blood type incompatible kidney

          -  History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B
             (HBV) infection, defined as being on active antiviral treatment for HBV, detectable
             hepatitis B surface Ag or detectable hepatitis B DNA

          -  Unable to safely substitute or discontinue a medication that is contraindicated with
             the study medication

          -  Psychiatric or physical illness that in the opinion of the investigator would make it
             unsafe to proceed with transplantation or interfere with the ability of the subject to
             participate in the study
To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)
Condition: Urea Cycle Disorders
MeSH terms: Urea Cycle Disorders, Inborn
Intervention: HPN-100
Intervention description: Participants received individualized doses of HPN-100 orally, three times daily (TID) with meals. The initial dose was the same dose administered at the end of the HPN-100-005SE, HPN-100-007, or HPN-100-012SE studies. Dose adjustments (including frequency adjustments) were permitted as judged clinically appropriate by the investigator based on assessment of ammonia-scavenging needs (e.g., severity of the UCD defect, dietary protein intake, and urinary phenylacetylglutamine [PAGN] excretion). The maximum recommended dose of HPN-100 in participants weighing less than 20 kg was 0.53 mL/kg/day (equivalent to 600 mg/kg/day of NaPBA), and was 11.48 mL/m²/day in heavier subjects (equivalent to 13g/m²/day of NaPBA). The maximum HPN-100 dose recommended per protocol was 17.4 mL/day, which is equivalent to 20 g/day of NaPBA.
Intervention MeSH terms: 4-phenylbutyric acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Urea Cycle Disorders; GT4P; HPN-100; Sodium Phenylbutyrate (NaPBA); Glyceryl tri-(4-phenylbutyrate); Phenylbutyrate; Hyperion; BUPHENYL; hyperammonemia

Summary:

      This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate)
      in participants with a urea cycle disorder (UCD) who completed the safety extensions of
      HPN-100-005 (NCT00947544; HPN-100-005SE), HPN-100-006 (NCT00947297; HPN-100-007), or
      HPN-100-012 (NCT01347073; HPN-100-012SE). The initial studies were 1- to 2-week crossover
      studies, and their associated safety extensions were 12-month, open-label studies. All
      participants who completed the initial studies were eligible to enroll in the associated
      safety extension studies, and new participants were also permitted to enroll directly into
      the safety extension studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects who completed Studies HPN-100-005SE, HPN-100-007, or
             HPN-100-012SE

          -  Signed informed consent by participant and/or participant's legally authorized
             representative

          -  Negative pregnancy test for all females of childbearing potential

        Exclusion Criteria:

          -  Any clinical or laboratory abnormality or medical condition that, at the discretion of
             the investigator, may have put the participant at increased risk when participating

          -  Known hypersensitivity to PAA (phenylacetate) or PBA (phenylbutyrate).

          -  Liver transplant, including hepatocellular transplant

          -  Pregnant, breastfeeding or lactating females