bioihbjkbjnl/mcl2 huggingface dataset:
Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Intervention: Plasma; Balanced crystalloids
Intervention description: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.; Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      There is a knowledge gap regarding the optimal initial fluid to achieve effective
      resuscitation and improved outcomes in septic shock. The purpose of this study is to compare
      initial resuscitation with plasma to initial resuscitation with balanced crystalloids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients meeting the following criteria will be enrolled: Have a Sepsis Screening
             Score (SSS) ≥ 4 with a suspected source of infection (Table 1); and Written informed
             consent obtained

          -  Patients meeting any of the following criteria will be randomized: Hypotension with
             MAP < 65 mmHg; Lactic acid > 4 mmol/L; Altered mental status; and Decreased urine
             output of < 0.5 mL/kg in the past hour.

        Exclusion Criteria:

          -  Pregnancy

          -  Prisoners

          -  Traumatic brain injury

          -  Evidence of ongoing hemorrhage, history of congenital bleeding disorders, therapeutic
             anticoagulation

          -  History of myocardial infarction or congestive heart failure

          -  History of acute cerebral vascular event

          -  Major burns (>20% total body surface area)

          -  History of adverse reactions to blood product transfusion

          -  Contraindications to blood transfusions (eg. Jehovah's Witness)

          -  Contraindications to central venous line and arterial line placement

          -  On intermittent hemodialysis

          -  Do-Not-Resuscitate or Comfort Care status

          -  Participation in another interventional study

          -  Pending transfer to another unit within the hospital that is not STICU or SIMU
Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: BMS-955176; EFV; TDF/FTC
Intervention description: HIV Maturation Inhibitor; EFV; TDF/FTC
Intervention MeSH terms: BMS-955176
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find at least one dose of BMS-955176 that will be safe,
      effective and tolerable for HIV-1 infected treatment naive adults.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Men and non-pregnant women, at least 18 years of age

          -  Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week
             of an antiretroviral drug

          -  Plasma HIV-1 RNA ≥ 1000 copies/mL

          -  CD4 T-cell count > 200 cells/mm3

        Exclusion Criteria:

          -  Resistance or partial resistance to any study drug determined by tests at Screening

          -  Current or historical genotypic and/or phenotypic drug resistance testing showing
             certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors

          -  Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)

          -  Blood tests that indicate normal liver function

          -  Hemoglobin < 8.0 g/dL, platelets < 50,000 cells/mm3
The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: Placement of the sponge; Mitomycin-C
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary open angle glaucoma; trabeculectomy; mitomycin-C; express mini-shunt

Summary:

      The primary focus of this study is to assess intraocular pressure and complication rates
      between patients who receive mitomycin-C using a sponge versus no-sponge.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women aged 18 years and older at screening.

          2. Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or
             pseudophakic, with visual field or optic disc changes characteristic of glaucoma.

          3. Suitable candidate for trabeculectomy with Ex-PRESS glaucoma filtration device with
             MMC in the superonasal quadrant in the study eye which the physician deems as
             medically necessary.

          4. Capable and willing to provide consent

        Exclusion Criteria:

          1. Unable or unwilling to provide consent

          2. Any previous ocular surgeries in the study eye preventing placement of the
             trabeculectomy with Ex-PRESS glaucoma filtration device with mitomycin-C in the
             superonasal quadrant

          3. Any previous glaucoma drainage devices in the study eye

          4. Any abnormality other than glaucoma in the study eye that could affect applanation
             tonometry.

          5. Presence or history of any abnormality or disorder that could interfere with the study
             procedure or prevent the successful completion of the study.

          6. Presence or history of uveitis within 10 years or any other ocular infection or
             inflammation within 14 days before day 1.

          7. Any significant unstable cardiovascular, hepatic, renal, respiratory,
             gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
             psychiatric disease.

          8. Known Pregnancy or Breastfeeding

             Physical and Laboratory Findings

          9. Conjunctival scarring precluding a superonasal implantation location.

         10. Vitreous in the anterior chamber.

         11. Abnormality preventing reliable applanation tonometry in the study eye.
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
Condition: MELAS
MeSH terms: MELAS Syndrome; Mitochondrial Encephalomyopathies; Acidosis; Acidosis, Lactic
Intervention: IW-6463 Tablets
Intervention description: IW-6463 tablets administered orally (daily)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-arm study with daily dosing for up to 29 days.
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mitochondrial disease

Summary:

      This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults
      diagnosed with MELAS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Prior genetic confirmation of a known mitochondrial disease mutation

          2. Neurological features of MELAS (can be based on medical history)

          3. Elevated plasma lactate levels at Screening Visit (≥1.0 mmol/L)

          4. Women of childbearing potential must have a negative pregnancy test prior to
             randomization and must agree to use protocol-specified contraception from the
             Screening Visit through 90 days after the final dose of study drug.

          5. Male participants must be surgically sterile by vasectomy (conducted ≥60 days before
             the Screening Visit or confirmed via sperm analysis) or must agree to use
             protocol-specified contraception and agree to refrain from sperm donation from the
             Screening Visit through 90 days after the final dose of study drug.

          6. Other inclusion criteria per protocol

        Exclusion Criteria:

          1. Positive pregnancy test at Screening or on Day 1

          2. Hypotension defined as systolic blood pressure (BP) ≤90 mmHg or diastolic BP ≤60 mmHg
             at Screening or predose at Day 1

          3. Hypertension defined as systolic BP >160 mmHg or diastolic BP >100 mmHg, at Screening
             or predose at Day 1

          4. Uncontrolled diabetes

          5. Severe gastrointestinal dysmotility as determined by the investigator that may impact
             compliance and/or oral drug administration, absorption and exposure.

          6. Unable to fast for 3-4 hours after a meal

          7. Unable or unwilling to adhere to the study schedule, lifestyle restrictions,
             assessment requirements or, in the clinical judgment of the investigator, is otherwise
             not suitable for study participation.

          8. Current or past history of clinically significant cardiomyopathy and/or cardiac
             conduction abnormality

          9. Used any nicotine-containing products (eg, cigarettes, e-cigarettes, vape pens,
             cigars) within 1 month of enrollment

         10. Other exclusion criteria per protocol
Thiamine as a Renal Protective Agent in Septic Shock
Condition: Sepsis; Kidney Injury; Thiamine Deficiency
MeSH terms: Thiamine Deficiency; Beriberi
Intervention: Thiamine Hydrochloride; Placebo
Intervention description: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.; 50ml of 0.9% NACL will serve as the placebo
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A randomization list will be prepared by an independent statistician using 1:1 randomization in blocks of two and four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 200mg dose is mixed in 5mL of normal saline. Placebo will be 50mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo controlled study to investigate the effect of
      intravenous thiamine (vitamin B1) on renal function in septic shock.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult ≥18 years of age

          2. Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and
             provision of an antimicrobial)

          3. Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)

          4. Serum lactate ≥2mmol/L

          5. Creatinine >1.0mg/dL

        Exclusion Criteria:

          1. Clinical indication for thiamine administration (alcoholism, known or highly suspected
             deficiency) or treatment with thiamine beyond the amount found in a standard
             multivitamin within the last 10 days

          2. Renal replacement therapy within the past 30 days

          3. Comfort measures only or anticipated withdrawal of support within 24 hours

          4. Protected populations (pregnant women, prisoners)

          5. Known thiamine allergy
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
Condition: Herniorrhaphy; Postoperative Pain; Inguinal Hernia
MeSH terms: Hernia, Inguinal
Intervention: Bupivacaine Collagen Sponge; Placebo collagen Sponge
Intervention description: Drug: Bupivacaine Collagen Sponge; Drug: Placebo Collagen Sponge
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess pain intensity for the first 72 hrs after after aggravated movement
      (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the
      CollaRx Bupivacaine implant or a plain collagen sponge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man ≥ 18 years

          -  Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.

          -  Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free
             technique) to be performed according to standard surgical technique under general
             anesthesia.

        Exclusion Criteria:

          -  Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.

          -  Scheduled for bilateral inguinal herniorrhaphy.

          -  Undergone a prior herniorrhaphy on the side scheduled for repair.

          -  Undergone major surgery within 3 mos of the scheduled herniorrhaphy.

          -  Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.

          -  Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or
             strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide
             antibiotics and grapefruit juice).

          -  Used long acting analgesics within 24 hours of surgery. Short acting analgesics such
             as acetaminophen may be used on the day of surgery but are subject to preoperative
             restrictions for oral intake.
ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
Condition: Graves' Ophthalmopathy (GO)
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Intervention: RVT-1401 (Administered via subcutaneous injection); Placebo (Administered via subcutaneous injection)
Intervention description: RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IMVT-1401; Graves' Orbitopathy; Thyroid Eye Disease

Summary:

      The purpose of the current study is to assess the efficacy and safety/tolerability of three
      dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In
      addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction
      in anti-TSHR IgG
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥18 years of age.

          2. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active,
             moderate to severe Graves' Ophthalmopathy (GO) with a Clinical Activity Score (CAS) ≥4
             for the most severely affected eye at Screening and Baseline (on the 7-item scale).

          3. Onset of active GO within 9 months of screening.

          4. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on
             daily life), usually associated with one or more of the following: lid retraction ≥2
             millimeters (mm), moderate or severe soft tissue involvement, proptosis ≥3 mm above
             normal for race and gender, and/or inconstant or constant diplopia.

          5. Other, more specific inclusion criteria are defined in the protocol

        Exclusion Criteria:

          1. Use of any steroid (intravenous, oral, steroid eye drops) for the treatment of GO or
             other conditions within 3 weeks prior to Screening. Steroids cannot be initiated
             during the trial. Exceptions include topical and inhaled steroids which are allowed.

          2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within
             the past 9 months prior to Baseline.

          3. Total IgG level <6 grams per liter (g/L) at Screening.

          4. Absolute neutrophil count <1500 cells per meter squared (cells/mm^3) at Screening.

          5. Participants with decreased best corrected visual acuity due to optic neuropathy as
             defined by a decrease in vision of 2 lines on the Snellen chart, new visual field
             defect, or color defect secondary to optic nerve involvement within the last 6 months
             at Screening.

          6. Previous orbital irradiation or surgery for GO.

          7. Other, more specific exclusion criteria are defined in the protocol
Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
Condition: Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: ENV515-3 Travoprost XR; ENV515-1 Travoprost XR; ENV515-3-2 Travoprost XR
Intervention MeSH terms: Travoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a multiple cohort study that will evaluate the safety and efficacy of ENV515
      travoprost XR in patients with open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of either ocular hypertension or open angle glaucoma in both eyes.

          -  Are currently treated with topical PGA for ocular hypertension in both eyes.

          -  Patients who in the opinion of the Investigator: have an IOP in both eyes that is
             considered to be adequately controlled, can be safely withdrawn from IOP medications
             in both eyes during the washout period, and who are not considered to be at
             significant risk for disease progression throughout the trial.

        Exclusion Criteria:

          -  Eye surgery (including cataract surgery) within the past 3 months.

          -  History of glaucoma related surgery.
Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Erlotinib; Bevacizumab; Paclitaxel; Carboplatin; 5-FU; Radiation therapy; Surgery
Intervention description: Erlotinib; Bevacizumab; Paclitaxel; Carboplatin; 5-FU; Radiation therapy; Surgery
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Fluorouracil; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib)
      further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation
      therapy in patients with operable esophageal cancer.

      Side effects (toxicity) information will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III

          -  No prior treatment for esophageal cancer

          -  Must be surgical candidate based on stage and location of disease

          -  Measurable or evaluable disease

          -  Able to be up and perform self care

          -  Adequate liver, renal function and bone marrow function

          -  Patients will have to have a central venous access device placed

          -  Able to give written informed consent.

          -  Age 18 or older

        Exclusion Criteria:

          -  Stage IV disease

          -  Prior cancer treatment for advanced cancer in the last 5 years

          -  Pregnant or lactating women

          -  History of stroke, transient ischemic attacks, or acute MI within the past 6 months or
             any other serious cardiovascular disease

          -  History of neurological disease

          -  Recent history of blood in the sputum or vomitus

          -  Non-healing wounds, ulcer or long bone fractures

          -  History of bleeding problems or coagulation problems

          -  History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months

          -  History of uncontrolled hypertension

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have. You can then decide if you wish to
        participate.