bioihbjkbjnl/mcl2 huggingface dataset:
Digoxin Dosing in Heart Failure: A Simplified Nomogram Versus Standard Care
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Digoxin Dosing per Nomogram; Digoxin
Intervention description: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis).; All patients included in the trial were treated with digoxin as clinically indicated. The intervention for this study required determining the digoxin dose via a proposed nomogram.
Intervention MeSH terms: Digoxin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No
Keywords: Digoxin; Pharmacokinetics; Dosing; Heart Failure

Summary:

      Dosing methods for digoxin, a drug used to treat heart failure, have not been updated in
      decades despite evidence in recent years suggesting that blood levels of digoxin achieved
      with traditional dosing practices may increase the risk of adverse events. We developed a
      simple dosing tool that targets lower blood levels of digoxin that have been associated with
      improved outcomes compared to higher blood levels. The aim of this study is to determine if
      this simplified dosing tool is more effective than standard digoxin dosing practices at
      achieving lower blood levels and also to determine if digoxin dosing may be further optimized
      by incorporating patients' genetic information believed to influence the drug's properties.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 21 years

          -  Diagnosis of heart failure secondary to left ventricular dysfunction

          -  Receiving chronic digoxin therapy or digoxin therapy is being initiated

        Exclusion Criteria:

          -  Pregnant

          -  Unstable renal function, defined as either a rise in serum creatinine by > 0.5mg/dl
             from baseline or a decrease in creatinine clearance by 25% or more within two to four
             weeks of study entry.

          -  End-stage renal disease requiring hemodialysis

          -  Concomitant therapy with drugs known to interact with digoxin (e.g., amiodarone,
             quinidine, verapamil, macrolide antibiotics)
Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: lubiprostone
Intervention description: 24 micrograms twice daily for 1 week
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: constipation; chronic idiopathic constipation; no prior history of surgery to the colon; not on any type of medication that could alter gastrointestinal motility or transit

Summary:

      This prospective study is designed to evaluate how lubiprostone may affect gastric motor and
      sensory function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic idiopathic constipation

        Exclusion Criteria:

          -  medications that slow gastrointestinal (GI) motility

          -  prior surgery to the GI tract
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
Condition: Healthy Subjects; Renal Impairments
MeSH terms: Renal Insufficiency
Intervention: Levetiracetam 250 mg; Levetiracetam 500 mg
Intervention description: Tablet containing Levetiracetam 250 mg; Tablet containing Levetiracetam 500 mg
Intervention MeSH terms: Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Levetiracetam; Oral administration; Japanese; Non-epileptic; Healthy; Renal impaired subjects

Summary:

      This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally
      administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in
      Japanese subjects with various degrees of impaired renal function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects with normal renal function

          -  Subject is Japanese

          -  Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group
             B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage
             renal failure undergoing hemodialysis

        Exclusion Criteria:

          -  Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK
             except for renal impairments
Survey of Inhibitors in Plasma-Product Exposed Toddlers
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: PLASMA DERIVED Factor VIII; Recombinant FVIII
Intervention description: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding; Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: Male
Minimum age: 1 Minute
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Hemophilia A; Factor VIII inhibitors; vWF/FVIII; rFVIII

Summary:

      The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII
      concentrates by determining the frequency of inhibitor development in previously untreated
      patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the
      first 3 years from enrollment, whichever occurs first.

      .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects

          -  Any ethnicity

          -  Age <6 years

          -  Severe haemophilia A (FVIII:C <1%), as confirmed at enrolment by the central
             laboratory.

             o Those patients diagnosed locally as severe but subsequently found to have FVIII
             levels >= 1% on testing at the central laboratory will be separately recorded in the
             screening list.

          -  Previously untreated (0 EDs to any FVIII concentrates or blood products) or minimally
             treated (<5 EDs) with blood components, namely whole blood, fresh frozen plasma,
             packed red blood cells, platelets or cryoprecipitate.

             o Patients not meeting these criteria will be separately recorded in the screening
             list.

          -  Negative inhibitor measurement at both local and central laboratory at screening

          -  Ability to comply with study requirements

          -  Signed informed consent of legal tutors o Patients who will not accept to enter into
             the study or to be randomized will be separately recorded.

        Exclusion Criteria:

          -  Previous history of FVIII inhibitor

          -  Other congenital or acquired bleeding defects

          -  Plasma FVIII level >= 1%, as assayed at the central laboratory

             o Those patients originally diagnosed locally as severe but subsequently found to have
             FVIII levels ranging from 1% to 2% on testing at the central laboratory will be
             separately recorded in the screening list.

          -  Concomitant congenital or acquired immunodeficiency

          -  Concomitant treatment with systemic immunosuppressive drugs

          -  Concomitant treatment with any investigational drug
Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Eszopiclone; Placebo
Intervention description: Eszopiclone has been approved by the US Food and Drug Administration (FDA) for the treatment of insomnia (inability to sleep). Eszopiclone has not been specifically approved by the FDA for people who have PTSD-related sleep disturbance.; The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Post-traumatic stress disorder; sleep disturbance; insomnia; cytokines; anxiety; traumatic event; memory

Summary:

      The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is
      effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep
      disturbance. The investigators will also examine the impact of treatment on sleep patterns,
      memory recall bias, and level of inflammatory markers (cytokines). The investigators predict
      eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms,
      memory recall bias, and level of inflammatory markers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients age 18-65 with a primary diagnosis of PTSD and associated
             sleep disturbance

          -  Good physical health

          -  Willingness and ability to comply with the requirements of the study protocol

        Exclusion Criteria:

          -  Women pregnant, lactating, or of childbearing potential not using medically accepted
             contraception

          -  Concurrent use of other psychotropic medications at least two weeks prior to baseline

          -  Concurrent use of other anti-inflammatory medications or anti-cytokine medications. If
             used on an as-needed (PRN) basis, subjects may enter the study, but will be excluded
             from cytokine analyses

          -  Concurrent use of beta-blockers less than one month prior to baseline

          -  Serious medical illness or instability for which hospitalization may be likely within
             the next year

          -  Seizure disorders with the exception of a history of febrile seizures if they occurred
             during childhood

          -  Sleep apnea or restless leg syndrome

          -  Concurrent psychotherapy initiated within 3 months of randomization or ongoing
             psychotherapy of any duration directed specifically toward treatment of PTSD and/or
             sleep disturbance

          -  Patients with significant suicidal ideation

          -  Current legal actions related to trauma or an ongoing relationship with assailant
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
Condition: Breast Cancer; Mastectomy
MeSH terms: Breast Neoplasms
Intervention: AlloDerm RTU; SurgiMend PRS
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We are looking at 2 products called Acellular Dermal Matrix (ADM) implant to evaluate the outcomes of 2 specific ADM products: SurgiMend PRS and AlloDerm RTU.
Masking: Single (Participant)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Mastectomy; Immediate reconstruction

Summary:

      The purpose of this study is to assess the relative performance and complication rates
      between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of
      these two treatment options.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject's with ability to provide informed consent.

          2. Subjects greater than 18 years old

          3. Subjects to undergo an immediate tissue expander reconstruction following mastectomy;
             and

          4. Subjects who are, in the opinion of the Investigator, able to understand the study,
             comply with the study design and are willing to return to the clinic for all the
             research required follow-up visits.

        Exclusion Criteria:

          1. Subjects less than 18 years of age

          2. Subjects that based on surgeon's discretion cannot be effectively reconstructed with
             the use of ADM product

          3. Pregnancy

          4. Bovine allergy
Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin; Placebo
Intervention description: One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.; One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Hypertension; Canagliflozin; JNJ 28431754; Sodium-Glucose Transporter 2; Blood Glucose; Type 2 Diabetes Mellitus

Summary:

      The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood
      pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes
      mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents.
      Overall safety and tolerability of canagliflozin will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with a diagnosis of type 2 diabetes mellitus

          -  patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated
             office DBP of >= 70 mmHg at screening and at Week -2

          -  patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks
             before screening

          -  patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include
             metformin, for at least 8 weeks before screening

        Exclusion Criteria:

          -  a history of diabetic ketoacidosis

          -  type 1 diabetes mellitus (T1DM)

          -  pancreas or beta-cell transplantation

          -  fasting C-peptide <0.70 ng/mL (0.23 nmol/L)

          -  body mass index <30 kg/m2

          -  has ongoing, inadequately controlled thyroid disorder

          -  has a history of cardio-renal disease that required treatment with immunosuppressive
             therapy.
Prophylactic Phenobarbital After Neonatal Seizures
Condition: Neonatal Seizures
MeSH terms: Seizures
Intervention: phenobarbital; placebo
Intervention description: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months; Matched placebo, same volume as active drug, by mouth daily for 4 months
Intervention MeSH terms: Phenobarbital
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 2 Days
Maximum age: 2 Weeks
Healthy volunteers: No
Keywords: phenobarbital; neonate; antiepileptic drugs; neurodevelopmental outcome; seizure

Summary:

      The treatment of infants with medications after their seizures have stopped is very variable.
      No one knows if continuing treatment with phenobarbital for up to several months is helpful
      or harmful. This clinical trial is designed to help answer that question and provide data
      that will help determine standard of care for these children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Birth at > 34 weeks' gestation

          -  Neonatal seizures (clinical, electrographic or both), with onset in the first 120
             hours after birth and resolution within 7 days of onset

          -  Parental informed consent

        Exclusion Criteria:

          -  Birth at < 34 weeks' gestation

          -  If the attending neonatologist attributes the seizures solely to a transient
             abnormality, easily correctable and unlikely to recur (eg, transient electrolyte
             abnormalities). If the attending neonatologist cannot be contacted, the site PI will
             be asked to review the available information and judge whether the infant is eligible.

          -  If the infant has been diagnosed with or there is a strong suspicion of an inborn
             error of metabolism, significant brain malformation, microcephaly (< 3 %ile), or a
             chromosomal abnormality which, in the absence of seizures, is known to be
             independently associated with an increased likelihood of cognitive impairment

          -  If the infant has been diagnosed with an intrauterine viral infection

          -  If the infant is not expected to survive to discharge
Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
Condition: Hemorrhoid
MeSH terms: Hemorrhoids
Intervention: Exparel; Bupivacaine HCl with Epinephrine; Normal Saline
Intervention description: 266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL); 75mg/30mL 0.25% Bupivacaine HCl with epinephrine; 30mL Normal Saline
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Liposomal Bupivacaine; Exparel

Summary:

      The purpose of this study is to compare the quality and duration of pain relief after a
      hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine
      hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more
      effective postoperative pain relief than both bupivacaine hcl and the control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are
             English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30

        Exclusion Criteria:

          -  contraindications to administration of local anesthesia (e.g., local anesthetic
             allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders,
             pregnancy , and history of substance abuse or chronic opioid use
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered subcutaneously (SC); Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 159.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of combination therapy
      with dulaglutide and insulin in Japanese participants with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have had a diagnosis of type 2 diabetes mellitus

          -  Participants who have been treated with insulin therapy (basal insulin, premixed
             insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics
             (OADs) at stable dose for at least 3 months before screening

          -  Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant
             is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or
             glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs

          -  Participants who have stable weight (±5%) ≥3 months prior to screening

          -  Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter
             squared (kg/m^2)

        Exclusion Criteria:

          -  Participants who have a diagnosis of type 1 diabetes

          -  Participants who have previously received therapy with a glucagon-like peptide-1
             receptor agonist within 3 months prior to screening

          -  Participants who have been previously treated with dulaglutide prior to screening

          -  Participants who have been treated with 2 of the following at screening: DPP-4
             inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and
             glinide)

          -  Participants who have been treated with continuous subcutaneous insulin infusion
             (CSII) at screening

          -  Participants who have clinically significant gastric emptying abnormality, hepatitis,
             pancreatitis, renal dysfunction, or thyroid abnormalities

          -  Participants who have a history of clinically significant cardiovascular disease,
             transplanted organ, or active or untreated malignancy