bioihbjkbjnl/mcl2 huggingface dataset:
Neuromuscular Blockade in Patients With Severe Renal Impairment
Condition: Neuromuscular Blockade; Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Cisatracurium + Neostigmine; Rocuronium + Sugammadex
Intervention description: Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate; Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex
Intervention MeSH terms: Rocuronium; Cisatracurium; Neostigmine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single site, randomized, controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blinded
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is intended to be a single-site, prospective, randomized, double-blinded study
      that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery
      with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to
      receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of
      rocuronium). A standardized anesthetic protocol that is usual and customary for the type of
      operation the patient is having will be provided to the anesthesia teams of enrolled
      subjects. The remainder of the anesthetic care of the subject will not deviate from the
      standard of care. All patients will be monitored with continuous pulse oximetry
      postoperatively for 24 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-80 years old

          -  Severe renal impairment (CrCl < 30 mL/min)

          -  Undergoing non-emergent surgery that requires neuromuscular blockade

          -  Planned extubation in the operating room immediately after surgery

          -  American Society of Anesthesiologists (ASA) physical status classification 3 to 4

          -  Willing and able to consent in English or Spanish

          -  No personal history of neuromuscular disease

        Exclusion Criteria:

          -  Age less than 18 or older than 80

          -  Patient does not speak English or Spanish

          -  Planned postoperative intubation/ventilation

          -  Allergy to sugammadex, neostigmine, glycopyrrolate, cisatracurium, or rocuronium

          -  Family or personal history of malignant hyperthermia

          -  Patient refusal

          -  Pregnant or nursing women

          -  "Stat" (emergent) cases

          -  Pre-existing muscle weakness of any etiology

          -  Patients on toremifene (a selective estrogen receptor modulator)

          -  Women on oral contraceptives who do not wish to use a non-hormonal method of
             contraception for 7 days following surgery
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: LDV/SOF; RBV
Intervention description: LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Ledipasvir, sofosbuvir drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 1 (GT-1); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; GS-5885; Ribavirin; Open Label; Sofosbuvir; Treatment-Naïve; Protease Inhibitors; PI

Summary:

      This study is to evaluate the safety, tolerability, and antiviral efficacy of
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV),
      administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis
      C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had
      previously received a regimen containing a protease inhibitor for the treatment of HCV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years, with chronic genotype 1 HCV infection

          -  HCV RNA equal to or greater than 10,000 IU/mL at screening

          -  Cirrhosis determination; a liver biopsy may be required

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Current or prior history of clinical hepatic decompensation

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
             skin cancers)

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol
Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
Condition: Childhood Glaucoma
MeSH terms: Glaucoma
Intervention: Latanoprost, Dorzolamide
Intervention description: Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)
Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost
Intervention MeSH terms: Dorzolamide; Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 1 Month
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Intraocular pressure; Latanoprost; Dorzolamide

Summary:

      Objectives:

      The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a
      selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to
      surgical procedures. Safety will be assessed, too.In the first version of the protocol 96
      eyes were forecasted to complete the enrolment. The protocol was then amended and now to
      complete the study 68 eyes should be included. This number of eyes could be achieved by
      recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for
      the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children of either sexes, aged 0-12 years

          -  Diagnosis of mono- or bilateral primary congenital glaucoma

          -  IOP greater than or equal to 22 mmHg and lower than 27 mmHg

          -  Only one previous ocular hypotensive surgical procedure for treatment of glaucoma
             among the following: goniotomy, trabeculotomy, trabeculotomy with adjunct of mitomycin
             C) (only for medical treatment at least one month before)

          -  Parent informed consent to data processing (at registration)

          -  Parent informed consent before any study procedure

        Exclusion Criteria:

          -  Secondary glaucoma (Sturge-Weber syndrome, type I neurofibromatosis, retinoblastoma,
             steroid-induced glaucoma, etc.)

          -  Presence of concomitant abnormalities of the anterior segment of the eye (cataract,
             iridocorneal dysgenesia, congenital uveal ectropion uvea, etc.)

          -  Previous treatment with the study drugs

          -  Presence of concomitant systemic diseases (asthma, hypertension, cardiac disease,
             renal failure, etc.) that needs treatment with drugs, that could influence IOP
             (steroids, beta-blockers, angiotensin-converting-enzyme inhibitor -inhibitors
             diuretics, etc.)

          -  Abnormalities of the cornea that could influence IOP readings (marked cornea edema)
Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sotagliflozin; Placebo
Intervention description: Sotagliflozin 400 mg, once daily before the first meal of the day; Placebo, once daily before the first meal of the day
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on
      Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes
      mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had given written informed consent.

          -  Young adult participants >=18 to <=30 years old at Screening, with a confirmed
             diagnosis of T1DM made at least 1 year prior to informed consent.

          -  Participants were being treated with insulin or insulin analogue delivered via
             continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).

          -  At Screening, must had A1C >= 9.0%.

          -  Must be willing and able to perform self-monitored blood glucose (SMBG) and complete
             the study diary.

          -  Females of childbearing potential must use an adequate method of contraception and had
             a negative pregnancy test.

        Exclusion Criteria:

          -  Any prior use of LX4211/sotagliflozin.

          -  Use of antidiabetic agent other than insulin or insulin analogue at the time of
             screening.

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of
             the placebo Run-in Period.

          -  Chronic systemic corticosteroid use.

          -  Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the
             Investigator.

          -  History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6
             months prior to the Screening Visit.

          -  History of severe hypoglycemic event within 1 month prior to the Screening Visit.
Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Brentuximab vedotin; Placebo
Intervention MeSH terms: Brentuximab Vedotin; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus

Summary:

      The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin
      in adults with active systemic lupus erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 years

          -  Diagnosis of SLE for at least 6 months prior to screening

          -  Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening

          -  Must have failed a treatment for SLE after a trial of at least 3 months

        Exclusion Criteria:

          -  The subject has any serious health condition, which, in the opinion of the
             Investigator, would place the subject at undue risk from the study

          -  Subject has had recent serious or ongoing infection, or risk for serious infection

          -  Subject has a history of new or recurrent malignancy within the past 5 years

          -  The subject is pregnant and/or breastfeeding

          -  The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that
             may confound clinical assessments in the study

          -  The subject has urgent, severe SLE disease activity, which, in the opinion of the
             Investigator, warrants immediate immunosuppressive therapy and would not be
             appropriate for the study
Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
Condition: Elevated Lipoprotein(a); Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Hyperlipoproteinemias; Hyperlipidemias
Intervention: ISIS 681257; Placebo
Intervention description: ISIS 681257 solution for SC injection.; Sterile normal saline (0.9% NaCl)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 286.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: IONIS-APO(a)-LRx; AKCEA-APO(a)-LRx; Dyslipidemia; Dyslipoproteinemia; Hyperlipidemia; Hyperlipoproteinemia; Hyperlipoproteinemia(a); Hyperlipoproteinemia a; Lipoprotein; Lipoprotein(a); Lipoprotein a; Lp(a); Lp a

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to
      evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of
      different doses and dosing regimens of ISIS 681257 for reduction of plasma Lipoprotein(a)
      [Lp(a)] levels in participants with hyperlipoproteinemia(a) and established cardiovascular
      disease (CVD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of CVD defined as documented coronary artery disease, stroke, or
             peripheral artery disease

          -  Lp(a) plasma level ≥ 60 mg/dL

          -  Must be on standard-of-care preventative therapy for other than elevated Lp(a) CVD
             risk factors

        Key Exclusion Criteria:

          -  Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or
             stroke/TIA

          -  Within 3 months of Screening: coronary, carotid, or peripheral arterial
             revascularization, major non-cardiac surgery, or lipoprotein apheresis

          -  Heart failure New York Heart Association (NYHA) class IV
A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Donanemab; Placebo; LY3202626
Intervention description: Administered IV; Administered IV; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: TRAILBLAZER-ALZ

Summary:

      The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813
      in early symptomatic Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gradual and progressive change in memory function reported by participants or
             informants for ≥ 6 months.

          -  MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical
             flortaucipir PET scan within 6 months prior to baseline that meets the central read
             criteria.

          -  Meet 18F flortaucipir PET scan eligibility criteria.

          -  Meet 18F florbetapir PET scan (central read) eligibility criteria.

        Exclusion Criteria:

          -  Have a history of long QT syndrome.

          -  Have received treatment with a stable dose of an acetylcholinesterase inhibitor
             (AChEI) and/or memantine for less than 2 months before randomization.

          -  Contraindication to MRI.
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Intervention: Botulinum Toxins, Type A; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: heel pain

Summary:

      The specific aim of the study is to compare the safety and efficacy of a single
      administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar
      fasciitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent, including authorization to release health information

          -  Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis

          -  Persistent heel pain for more than three months

          -  Women of child bearing potential must have negative pregnancy test at Screening and
             Injection Visits and must use an effective method of birth control during the course
             of the study

        Exclusion Criteria:

          -  Previous surgery on the midfoot or hindfoot

          -  Neuromuscular disease

          -  Systemic muscle weakness

          -  Planning a pregnancy during the study

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within the last 30 days prior to first visit
To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.
Condition: Primary Bile Acid Diarrhea
MeSH terms: Diarrhea
Intervention: LJN452; Placebo to LJN452
Intervention description: Capsules containing LJN452; Capsules containing placebo to LJN452
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary bile acid diarrhea,; FXR agonist,; bile acid malabsorption.

Summary:

      The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid
      diarrhea and to assess its safety and tolerability profile in patients with primary bile acid
      diarrhea (pBAD) to guide decision-making regarding further clinical development in this
      indication.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A history of diarrheal symptoms for at least 3 months prior to dosing - Average stool
             frequency of at least 2 per day when off therapy AND Average stool form of >5 on
             Bristol Stool Chart.

          -  Previous laboratory or radiological confirmation of bile acid malabsorption with
             either fecal bile acid loss OR 7 day 75Selenium homocholic acid taurine (75SeHCAT)
             retention.

          -  Age ≥ 18 years.

        Key Exclusion Criteria:

          -  Patients with other diagnoses leading to diarrhea, including colorectal neoplasia,
             ulcerative colitis, Crohn's disease, celiac disease, chronic pancreatitis,
             drug-induced diarrhea or active infection AND Patients who have not been investigated
             by standard clinical assessments to exclude these disorders.

          -  Treatment with bile acid sequestrants (colestyramine, colestipol, colesevelam) for 2
             weeks before the first dose of LJN452. A washout of 14 days for these agents will be
             allowed before first dosing.

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  A positive Hepatitis B surface antigen or Hepatitis C test result.

          -  History of immunodeficiency diseases, including a positive HIV (ELISA and Western
             blot) test result.
Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea, Obstructive
Intervention: Desipramine; Placebo
Intervention description: 200 mg administered 2 hours before normal sleep time; Placebo-matching desipramine administered 2 hours before normal sleep time
Intervention MeSH terms: Desipramine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
      activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
      to normal participants. Until recently, the search for medicines to activate pharyngeal
      muscles in sleeping humans has been discouraging. However, exciting new animal research has
      shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle
      activity to waking levels. In this protocol the investigators will test the effect of
      desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects)
      on genioglossus muscle activity (EMG GG) during sleep in healthy control participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy control subjects

        Exclusion Criteria:

          -  Cardiovascular disease other than well controlled hypertension

          -  Depression