bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)
      tablets of canagliflozin and metformin immediate release (IR) in comparison with the
      individual components of the FDC tablets (canagliflozin and metformin IR).
    

Detailed description: 
      This is an open-label (identity of study drug will be known to volunteer and study staff),
      single-center study to evaluate the bioequivalence (to see if blood levels of one drug are
      equivalent to blood levels of another drug) of canagliflozin and metformin IR when
      administered orally (by mouth) as individual components (ie, separate tablets of
      canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie,
      canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy
      volunteers participating in the study will be randomly (by chance) assigned to receive a
      single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed
      by Treatment A with a washout period of approximately 15 days between treatments. The total
      duration of the study will be approximately 51 days.
    

Intervention name(s): Canagliflozin tablets; Metformin IR tablets; Canagliflozin/metformin IR FDC tablets; Canagliflozin/metformin IR FDC tablets; Canagliflozin tablets; Metformin IR tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.; Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.; Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.; Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.; Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.; Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Other intervention name(s): Treatment A (Reference); Treatment A (Reference); Treatment B (Test); Treatment B (Test); Treatment A (Reference); Treatment A (Reference)
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Bioequivalence; Canagliflozin (JNJ-28431754); Metformin IR
Hyaluronidase Effect on Infusion Set Life
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study examines the effect of hyaluronidase on the length of time of insulin
      infusion set wear. The aim of the study is to improve the length of time that an infusion set
      can be worn by infusing hyaluronidase directly into the insulin infusion site.
    

Detailed description: 
      The investigators would like to see if the use of hyaluronidase will improve insulin infusion
      set survival and improve the onset of insulin action. The investigators will also assess the
      accuracy of the Dexcom G4P sensors with extended site use beyond the 7 day FDA approved time
      frame.

      The use of sensor information combined with the knowledge of infused insulin from pump
      therapy could potentially help us detect when an infusion set is beginning to fail.
      Information from the sensor function to the point of failure, and sensor function in response
      to Tylenol may allow us to develop special formulas to determine when a sensor is not working
      well. This will be very important for creating an artificial pancreas.

      Thirty subjects will be enrolled. Fifteen patients from each of the two sites: Stanford
      University and University of Colorado.
    

Intervention name(s): Hyaluronidase; Control
Intervention type(s): Drug; Other
Intervention description(s): 150 units/ml - subjects injected 1 milliliter (ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.; No hyaluronidase administered into insulin infusion set.
Other intervention name(s): Hylenex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyaluronidase; infusion sets; insulin pump; Continuous glucose monitor
Multiomics After Headache Provocation of People Who Are Unable to Have Headache
Condition: Headache; Healthy
MeSH terms: Headache
Study type: Interventional

Summary: 
      Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in
      Europe. Despite this high prevalence, there are persons who have never, in their whole life,
      encountered a headache.

      The aim of the study is to identify factors that protect against headache by studying
      multiomics in people who never have had a headache (headache resistant) versus non-resistant
      controls.

      The investigators will measure multiomic changes (transcriptomics and metabolomics) after
      headache provocation with isosorbide mononitrate. 3 blood samples, two for RNA and one for
      metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after
      administration of isosorbide mononitrate and again 5 hours after administration of isosorbide
      mononitrate.

      The investigators hope to contribute with novelty to the current understanding of headache
      pathophysiology and development of more efficient treatment of headache.
    


Intervention name(s): Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]; Blood sample
Intervention type(s): Drug; Other
Intervention description(s): 1 tablet Isosorbide Mononitrate 60 mg administrated orally.; 3 blood samples from a periferal vein, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Intervention model: Single Group Assignment
Intervention model description: Case-control study.
Masking: None (Open Label)
Primary purpose: Other
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
Condition: Postoperative Supraventricular Tachyarrythmia
MeSH terms: Tachycardia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy
      and safety in patients with postoperative supraventricular tachyarrhythmias.
    


Intervention name(s): ONO-1101
Intervention type(s): Drug
Intervention MeSH terms: Landiolol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia
Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on
      shortness of breath, exercise capacity, symptom control, mental health, cognitive function,
      and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary
      rehabilitation has already been shown to benefit patients with other chronic respiratory
      diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary
      rehabilitation will benefit patients with IPF as well.
    

Detailed description: 
      The goals of this project are to assess the effect of PR on a number of important outcomes in
      patients with IPF. Once enrolled in the study, subjects will complete a battery of
      questionnaires and tests that assess symptoms, quality of life, cognition, and mental health,
      and then subjects will complete a six week outpatient PR program (at National Jewish Medical
      and Research Center or other PR programs). Subjects will complete the same battery of
      questionnaires and tests immediately after completion of the PR program and again six months
      later.
    

Intervention name(s): Pulmonary rehabilitation
Intervention type(s): Other
Intervention description(s): Pulmonary rehabilitation is a multi-disciplinary program that includes exercise training, disease education, psychosocial education (e.g., stress management, coping with chronic illness) and nutrition education.
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Pulmonary fibrosis; Pulmonary rehabilitation; Dyspnea; Quality of life
Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Observational

Summary: 
      Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine
      (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular,
      uNGAL has been used for early detection of AKI in the emergency department, after
      cardiopulmonary bypass or following CM administration.

      This study will be conducted to assess the possible value of urinary Neutrophil
      Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy
      (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP)
      and whether or not uNGAL correlates with the volume of contrast medium (CM) used.
    

Detailed description: 
      Methods. We will enroll all consecutive patients undergoing PCP with iomeprolum during a
      3-month period at our institution. CIN will be defined as a ≥25% increase in SCr from
      baseline when measured 2-4 days after PCP. uNGAL will be measured at its peak with the Abbott
      ARCHITECT assay.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all consecutive patients
      
Biospecimen description: 
      urinary samples
    
Keywords: renal failure; cardiology; contrast-induced nephropathy
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image
      (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet
      and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg)
      as individual tablets. Subject will only participate in one part, receiving treatment A and B
      (Part I) or Treatment C and D (Part II).
    


Intervention name(s): sitagliptin phosphate (+) metformin hydrochloride; Comparator: metformin 500 mg; Comparator: sitagliptin; Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet; Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet; Comparator: metformin 1000 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): place holder - do not post; A single dose of metformin 500 mg tablets; A single 50 mg tablet of sitagliptin; A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet; A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet; A single dose of metformin 1000 mg tablets
Other intervention name(s): Apotex; Apotex
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Danish Carvedilol Study in Portal Hypertension
Condition: Cirrhosis; Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with large esophageal varices who have not yet experienced bleeding, are normally
      treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby
      diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or
      have to discontinue the treatment because of side effects. The aim of this study is to
      evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than
      propranolol in lowering the portal pressure in patients with cirrhosis.
    


Intervention name(s): carvedilol; propranolol
Intervention type(s): Drug; Drug
Intervention description(s): 6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 25 mg carvedilol daily.; 80 mg of propranolol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubles weekly up to a maximum of 360 mg propranolol daily
Intervention MeSH terms: Propranolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy
Condition: Common Bile Duct Stones
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether routine imaging of the biliary system during
      routine gallbladder surgery alters clinical outcome
    


Intervention name(s): on table cholangiography
Intervention type(s): Procedure
Intervention description(s): x-ray imaging of common bile duct
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: gallstones; cholangiography
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
Condition: Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal
      dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).
    


Intervention name(s): Chloral Hydrate; Dexmedetomidine; Oral placebo; Intranasal placebo
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Oral chloral hydrate 50 mg/kg; Intranasal dexmedetomidine 3 mcg/kg; Oral saline administered; Intranasal saline administered
Intervention MeSH terms: Dexmedetomidine; Chloral Hydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Family Planning Knowledge, Attitudes, and Practices of Postpartum Malawian Women
Condition: Contraception
Study type: Observational

Summary: 
      The purpose of this study is to understand the family planning needs and practices of
      postpartum Malawian women, with a focus on long-acting reversible contraception (LARC).

      Hypotheses:

        1. Postpartum women who are older, who have a history of unintended pregnancy, who do not
           desire another child within 2 years, and who were counseled about LARC during their
           pregnancy are more likely to have interest in using LARC.

        2. Postpartum women who are older are more likely to be aware of LARC methods.

        3. HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum
           Malawian women who are HIV-.
    

Detailed description: 
      This study is a prospective cohort study of 630 postpartum Malawian women. Since our focus is
      on HIV+ women, HIV+ participants will be recruited in a 1:2 ratio, with a total of 210 HIV+
      women and 420 HIV- women. We will recruit in the postpartum ward of Bwaila Maternity Hospital
      in Lilongwe, Malawi. Participants will complete a baseline survey about demographics,
      reproductive health history, and family planning knowledge, attitudes, and practices. At 3,
      6, and 12 months postpartum, we will complete follow-up phone calls to determine what family
      planning methods they are using and if they encountered any barriers to receiving LARC if
      they had been interested in using them.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Our study population will be a sample of 210 HIV+ and 420 HIV- postpartum Malawian women.
Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients
Condition: Pleural Effusion
MeSH terms: Pleural Effusion
Study type: Observational

Summary: 
      Collections of fluid around the lung (pleural effusions) are common in patients on mechanical
      ventilation. Long stays on mechanical ventilation can lead to serious complications such as
      pneumonia and are associated with significant morbidity and mortality. The drainage of
      pleural effusions may lead to improvements in oxygenation making it easier to discontinue
      mechanical ventilation.

      The purpose of this study was to examine the effects of thoracocentesis (pleural fluid
      drainage) on blood oxygenation over a 48 hour period to see whether the effects are sustained
      and therefore helpful in this discontinuation.
    

Detailed description: 
      This will be a collection of data in patients in whom it has been decided by the attending
      clinician that pleural drainage would be beneficial. Ultrasound will be used to confirm the
      presence of pleural effusion and to estimate the size of the pleural effusions and to confirm
      the position of the pleural drain. Data will be collected before drainage, 30 minutes after
      drainage and then at 4,8,12 and 24 hours after the insertion of the drain (please see also
      attached summary of investigations). Measurements will include arterial blood gas analysis
      drawn from an indwelling arterial catheter, blood pressure, pulse, respiratory rate, mixed,
      expired CO2 and ventilator settings. The measurements will stop either at the end of the 48
      hour period or when the team caring for the patient chose to remove the drain (whichever is
      the first).

      All measurements including the arterial blood gas analysis form part of the standard care of
      an ICU patient. The arterial blood gas measurements are withdrawn from an indwelling arterial
      catheter which is routinely in place on all ICU patients. Only the use of thoracic ultrasound
      by a trained ultrasonographer both before and after the procedure will be additional to the
      standard care of the patient. The use of Chest X-rays is at the discretion of the treating
      clinician and does not form part of the study protocol. Standard biochemical, microbiological
      and cytological tests will be performed on the pleural fluid and blood in keeping with the
      standard practice for pleural effusions.

      The primary outcome measure is the effects of drainage on the P:F ratio. measures of dead
      space ventilation, A-a gradiants, ventilator settings and dynamic compliance will also be
      assessed
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients on Mechanical ventilation with evidence of pleural effusion on CXR confirmed with
        bedside ultrasound
      
Keywords: ventilation; oxygenation
rTMS in Treatment of Obsessive Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in
      addition to the standard treatment regimen for OCD, will lead to significant improvement in
      patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores
      will be statistically significant in active treatment group compared to sham (placebo)
      treatment group.
    


Intervention name(s): repetitive transcranial magnetic stimulation; sham (placebo)
Intervention type(s): Device; Device
Intervention description(s): 6 weeks of stimulation with RMT frequency 1Hz, intensity 110% of RMT for 20 minutes, 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.; Sham treatment will mimic active treatment mentioned above.
Other intervention name(s): rTMS machine (MagPro, Medtronic); rTMS machine (MagPro, Medtronic).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Florbetaben PET Imaging in PPA
Condition: Primary Progressive Aphasia; Alzheimer Disease
MeSH terms: Alzheimer Disease; Aphasia; Aphasia, Primary Progressive; Pick Disease of the Brain; Frontotemporal Dementia
Study type: Observational

Summary: 
      The purpose of this research is to better understand how dementia affects activity in
      different parts of the brain.
    

Detailed description: 
      This study will examine Positron Emission Tomography (PET) imaging with Florbetaben F18.
      Florbetaben F18 is a radioactive tracer that binds to particles in your brain. This process
      displays activity in the brain. Florbetaben F18 is a PET amyloid imaging agent approved by
      the United States Food and Drug Administration (FDA) to estimate the amount of beta-amyloid
      plaque in adult patients who are being evaluated for Alzheimer's disease and other causes of
      cognitive decline. The purpose of this research is to better understand how dementia affects
      activity in different parts of the brain. Currently, the scientific community is limited by
      how well it can see inside the brain. The use of a PET scan better helps us understand what
      the brain looks like in a diseased state. Participation in the study will help to understand
      what brain activity looks like, especially around language regions.
    

Intervention name(s): Florbetaben F18; PET
Intervention type(s): Drug; Device
Intervention description(s): A single injection of 8.1mCi of florbetaben F18 will be administered by intravenous bolus injection; PET Scan for brain imaging
Other intervention name(s): trade name NeuraCeq
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from other research projects at Northwestern's Mesulam
        Center. Some of these projects recruit participants from the local Chicagoland area and
        others recruit participants from across the United States. As Primary Progressive Aphasia
        is an uncommon syndrome, participant recruitment is not focused on a specific demographic
        area.
      
Keywords: Alzheimer's Disease; Dementia; Primary Progressive Aphasia; Neurocognitive Disorders; Speech Disorders