bioihbjkbjnl/mcl2 huggingface dataset:
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
Condition: Pharmacokinetics
MeSH terms: Renal Insufficiency
Intervention: Colchicine
Intervention description: Colchicine tablets
Intervention MeSH terms: Colchicine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to compare the pharmacokinetic profiles of colchicine
      and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of
      colchicine in healthy adults with normal renal function, in patients with mild, moderate or
      severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An
      additional objective of this study is to study the clearance of colchicine and its
      metabolites by hemodialysis. Secondary objectives include evaluation of the safety and
      tolerability of colchicine in the study population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males and females 18-70 years old with a body mass index of <39 kg/m^2.

          -  Patients with normal renal function or mild renal impairment should be generally
             healthy on the basis of medical history and physical exam.

          -  Patients with moderate to end stage renal impairment should be generally medically
             healthy other than with respect to the morbidities associated with impaired renal
             function.

          -  Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive
             measures).

        Exclusion Criteria:

          -  Known hypersensitivity to colchicine or any component of the formulation of the study
             drug.

          -  Patients with a history or presence of a significant medical condition that would
             interfere with interpretation of the study results.

          -  Patients who have used any drugs or substances known to inhibit or induce cytochrome
             P450 (CYP) enzymes and/or P-glycoprotein within 28 days prior to the first dose and
             throughout the study.

          -  Patients with recent (2 year) history or evidence of alcoholism or drug abuse or
             significant psychiatric disease.

          -  Patients with chronic hepatic dysfunction.
Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)
Condition: Pseudobulbar Affect (Involuntary Laughing and/or Crying)
Intervention: NUEDEXTA®
Intervention description: NUEDEXTA® only
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: PBA; involuntary crying; involuntary laughing

Summary:

      6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the
      treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a neurological disorder affecting the brain (e.g. Alzheimer's and other
             dementias, stroke, Trauma Brain Injury, Multiple Sclerosis, Amyotrophic Lateral
             Sclerosis, Huntington's disease, Parkinson's disease) of at least 3 months duration
             prior to baseline and which is not rapidly progressing

          -  Diagnosis of Pseudobulbar Affect (PBA)

          -  A Center for Neurologic Study-Lability Scale (CNS-LS) score of 13 or greater at
             Baseline

          -  Minimum Data Set (MDS) information for patient available within 60 days prior to
             Baseline

          -  Informant who is willing to comply with study procedures

        Exclusion Criteria:

          -  Patients who have received NUEDEXTA® in the past 1 year

          -  Patients with the diagnosis of Severe Depressive Disorder that would interfere with
             the conduct of the study

          -  Patients who have a history of schizophrenia spectrum and other psychotic disorders

          -  Patients with co-existent clinically significant or unstable systemic diseased that
             could confound the interpretation of the safety results of the study (e.g.,malignancy,
             poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal
             or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or
             unstable valvular heart disease)

          -  Patients with myasthenia gravis
Osimertinib Study in Indian Patients
Condition: Non Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Osimertinib
Intervention description: Osimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.
Intervention MeSH terms: Osimertinib
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
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Non small cell lung cancer (NSCLC)

Summary:

      This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of
      osimertinib in Indian adult patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient of either gender and ≥18 years of age

          2. Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an
             appropriate test, who have progressed on or after EGFR TKI therapy by an independent
             clinical judgment of treating physician based on locally approved prescribing
             information

          3. Each patient must sign an informed consent form (ICF)

        Exclusion Criteria:

          1. Patient with either the history of hypersensitivity to excipients of the study drug or
             to drugs with a similar chemical structure or class to the study drug.

          2. Pregnant and/or lactating women

          3. Patients participating in any current or future interventional trial will not be
             enrolled in the current study
Catheter Ablation of Arrhythmias to Improve CRT Response
Condition: Arrhythmia, Cardiac
MeSH terms: Arrhythmias, Cardiac
Intervention: Catheter Ablation; Anti-Arrhythmics
Intervention description: Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.; Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.
Intervention MeSH terms: Anti-Arrhythmia Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test if catheter ablation is better than medication therapy
      at treating arrhythmias originating from the upper and/or lower chambers of the heart in
      order to allow the heart to beat properly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart failure patients with CRT-D or CRT-P greater than 3 months

          -  Bi-ventricular pacing less than 94% of the time

          -  3 months after CRT-D or CRT-P implantation an EF improvement less than 5%

          -  Presence of one of the following arrhythmias and eligible for catheter ablation:

          -  Atrial fibrillation

          -  Atrial flutter

          -  Supraventricular tachycardia

          -  Premature ventricular contraction burden greater than 30% in a 24-hour period

          -  Ventricular tachycardia

        Exclusion Criteria:

          -  Estimated survival less than one year

          -  Patient unable to make scheduled follow up visits at treating center

          -  Participating in another investigational study
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Condition: Diabetes Mellitus, Type 2; Heart Failure, Diastolic
MeSH terms: Heart Failure; Heart Failure, Diastolic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide
Intervention description: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Diabetes; Diastolic Heart Failure; Aortic Stiffness; Exenatide

Summary:

      People with type 2 diabetes experience heart failure more often than do people without
      diabetes. This may be due to increased stiffness in the heart as a result of diabetes. This
      study will examine whether exenatide, a medication used to treat diabetes, may have
      beneficial effects on the heart in people with type 2 diabetes and heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable New York Heart Association (NYHA) Class II-IV heart failure symptoms for at
             least 4 weeks before study entry

          -  Diagnosis of diastolic heart failure with a normal ejection fraction

          -  Admitted to the hospital with a diagnosis of heart failure in the 12 months before
             study entry

          -  Type 2 diabetes

        Exclusion Criteria:

          -  Unstable angina, heart attack, coronary artery bypass surgery, or angioplasty in the 3
             months before study entry

          -  Angina with exertion

          -  Technically inadequate echocardiogram

          -  Atrial fibrillation or atrial flutter

          -  Severe valvular heart disease

          -  Significant kidney insufficiency (serum creatinine greater than 2.0 mg/dL or require
             hemodialysis)

          -  Conditions that may be associated with changes in markers of fibrosis or collagen
             turnover (e.g., ongoing or active rheumatological disease, requiring significant
             anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)

          -  Significant history of active substance abuse

          -  Type 1 diabetes

          -  Type 2 diabetes requiring chronic insulin use before study entry

          -  Active thiazolidinedione (TZD) use, because TZDs have been shown to worsen volume
             retention and may exacerbate signs and/or symptoms of heart failure

          -  Pregnant or breastfeeding

          -  Hypertrophic cardiomyopathy
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Pitavastatin; Pravastatin
Intervention description: Pitavastatin 4 mg QD; Pravastatin 40 mg QD
Intervention MeSH terms: Pravastatin; Pitavastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive,
             at time of consent.

          -  Both men and women of child bearing potential (i.e., not surgically sterile or
             post-menopausal defined as age >40 years without menses for ≥2 years) must agree to
             use at least 2 reliable forms of contraception

          -  Documented HIV infection.

        Exclusion Criteria:

          -  Homozygous familial hypercholesterolemia

          -  Any conditions that may cause secondary dyslipidemia

          -  History of coronary artery disease (CAD) or CAD equivalent
A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Intervention: LUM/IVA; activated smart device; de-activated smart device
Intervention description: LUM 400 mg q12h/IVA 250 mg q12h through Week 48.
Intervention MeSH terms: Ivacaftor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The study will evaluate the impact of smart adherence technology for monitoring on
      lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with
      Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane
      Conductance Regulator (CFTR) mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject (or his or her legally appointed and authorized representative) will sign and
             date an informed consent form (ICF).

          -  Willing and able to comply with scheduled visits, treatment plan, study restrictions,
             laboratory tests, contraceptive guidelines, and other study procedures.

          -  Confirmed diagnosis of CF and homozygous for the F508del-CFTR mutation

          -  Forced Expiratory Volume in one second/forced vital capacity (FEV1) ≥40% of predicted
             normal for age, sex, and height

        Exclusion Criteria:

          -  Presence of moderate or severe hepatic impairment (Child-Pugh Class B or C)

          -  Subjects currently receiving invasive mechanical ventilation

          -  Known history of alcohol or drug abuse in the past year

          -  Clinically significant abnormal laboratory values during screening

          -  Pregnant or nursing females

          -  Female subjects and female partners of male subjects who plan to become pregnant
             during Treatment Period or within 90 days following the last dose of study drug

          -  History of solid organ or hematological transplantation

          -  Ongoing or prior participation in an investigational drug study within 30 days of
             screening

          -  Current use of commercial LUM/IVA combination therapy
Xyrem and Brain Dopamine in Narcolepsy
Condition: Narcolepsy With Cataplexy; Healthy Controls
MeSH terms: Narcolepsy; Cataplexy
Intervention: Xyrem
Intervention description: single 3.0 gram dose
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be recruited to fill 2 separate study groups: 1) participants with a diagnosis of narcolepsy with cataplexy; 2) healthy controls.
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Xyrem; narcolepsy with cataplexy; positron emission tomography; dopamine

Summary:

      The overall aim of this investigation is to establish whether an action of Xyrem® on the
      brain dopamine system in patients with narcolepsy, and in a comparison control group, might
      explain part of the anti-narcoleptic effect of the drug.

      Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve
      narcolepsy with cataplexy patients, and in matched controls, whether a single dose of Xyrem®
      causes changes in striatal binding of 11C-raclopride and 11C-DTBZ that would suggest altered
      activity of brain dopamine neurones.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current diagnosis of narcolepsy with cataplexy OR healthy control

        Exclusion Criteria:

          -  use of any sedative hypnotics, tranquilizers, anticonvulsants, antihistamines (except
             non-sedating), benzodiazepines, clonidine or any medication known to affect dopamine
             at start of baseline period

          -  significant unstable or uncontrolled medical/psychiatric disease

          -  significant history of head trauma/surgery or seizure disorder

          -  radiation exposure exceeding 20mSv in last 12 months

          -  pregnancy

          -  substance abuse/dependence (including alcohol)

          -  have sleep apnea, or are shift workers

          -  on a sodium-restricted diet

          -  has ever taken Xyrem / sodium oxybate / GHB at any time

          -  claustrophobia

          -  metal implants / objects in the body that may interfere with MRI

          -  succinic semialdehyde dehydrogenase deficiency
Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Inhaled treprostinil
Intervention MeSH terms: Treprostinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: pulmonary arterial hypertension; PAH; treprostinil sodium; inhalation; ventavis; iloprost

Summary:

      This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects
      following transition from a stable dose of inhaled iloprost (Ventavis).

      Subjects are to be evaluated for safety throughout the course of the study while secondary
      assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24
      following initiation of treprostinil sodium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 18 and 75 years of age

          -  PAH diagnosis defined by following WHO Group I categories: idiopathic/familial,
             associated with unrepaired or repaired congenital systemic-to-pulmonary shunts
             (repaired >/= 5 years), associated with collagen vascular disease, associated with
             HIV, associated with appetite suppressant/toxin use

          -  Baseline six-minute walk distance (6MWD) >/= 250 meters

          -  Currently receiving Ventavis and be stable at current dose for 30 days prior to
             Baseline

          -  If currently receiving other approved background therapy (i.e. endothelin receptor
             antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30
             days prior to Baseline

          -  Previous testing (e.g. right heart catheterization, echocardiography) consistent with
             diagnosis of PAH

        Exclusion Criteria:

          -  Nursing or pregnant

          -  Has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic
             disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of
             the inclusion criteria or has had atrial septostomy

          -  History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung
             disease

          -  Use of investigational drug within 30 days of Baseline
SUBLOCADE Rapid Initiation Extension Study
Condition: Opioid Use Disorder, Severe; Opioid Use Disorder, Moderate
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Sublocade
Intervention description: SUBLOCADE to be administered approximately every 4 weeks per local standard of care
Intervention MeSH terms: Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: After an initial injection of 300mg SUBLOCADE, all subjects will receive SUBLOCADE doses of 100mg or 300mg based on the medical judgement of the Investigator
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A single center, open-label SUBLOCADE treatment extension study in which up to 25
      participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed the informed consent form (ICF) and have the ability to comply with the
             requirements and restrictions listed therein.

          -  Completed the EOT Visit for the INDV-6000-403 Study.

          -  Is an appropriate candidate in the opinion of the Investigator or medically qualified
             sub-Investigator.

        Exclusion Criteria:

          -  Subject compliance issues during participation in the INDV-6000-403 study which, in
             the opinion of the Investigator, could potentially compromise subject safety.

          -  Subjects who are unable, in the opinion of the Investigator or Indivior, to comply
             fully with the study requirements including those who are currently incarcerated or
             pending incarceration legal action.
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma
Condition: Hilar Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma; Klatskin Tumor
Intervention: biliary stent (self expandable metallic stent); PS
Intervention description: metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP; plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: biliary stent; plastic stent; metallic stent; Complex hilar cholangiocarcinoma (Bismuth type II,III,IV)

Summary:

      The purpose of this study is to compare the adequacy of unilateral endoscopic biliary
      drainage using metallic stent with plastic stent in unresectable, complex, hilar,
      cholangiocarcinoma and cost analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on
             computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)

        Exclusion Criteria:

          -  Patients with ASA 4 or 5

          -  Patients with liver failure.

          -  Patients unable to comply with follow-up