bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is determine that Dapagliflozin has no effect on the
      pharmacokinetics (PK) or pharmacodynamics (PD) of warfarin when dapagliflozin is
      coadministered with warfarin. Also, that Dapagliflozin has no effect on the PK of digoxin
      when dapagliflozin is coadministered with digoxin.
    


Intervention name(s): Dapagliflozin; Warfarin; Digoxin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 20 mg, followed by 10 mg, Single Dose; Tablets, Oral, 25 mg, Single Dose; Tablets, Oral, 0.25, Single Dose
Other intervention name(s): Coumadin; Lanoxin
Intervention MeSH terms: Dapagliflozin; Digoxin; Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect and Safety of Marealis RPC (Refined Peptide Concentrate) in Mild or Moderate Hypertensive Subjects
Condition: Prehypertension
MeSH terms: Prehypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases.
      Epidemiological studies show that there is a direct relationship between blood pressure and
      CVD, and cardiovascular mortality increases progressively throughout the range of blood
      pressure, including the prehypertensive range. There is also evidence from cell and animal
      studies that shrimp tissue hydrolysates may have higher ACE inhibitory activity than other
      marine protein hydrolysates. It is hypothesized that Marealis RPC (refined peptide
      concentrate)will lower systolic blood pressure in subjects with elevated blood pressure.
    


Intervention name(s): Marealis refined peptide concentrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 tablets, once per day before noon; 2 tablets, once per day before noon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Prehypertension; Hypertension; Shrimp protein hydrolysate; Marine protein hydrolysate; Ambulatory blood pressure; Blood pressure
Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease
      of the central nervous system, characterized by demyelination due to inflammation and
      degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter,
      brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic
      fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems.
      Strength training has been shown to improve strength and mobility in persons with MS.
    

Detailed description: 
      Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease
      of the central nervous system, characterized by demyelination due to inflammation and
      degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter,
      brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic
      fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems.
      Resistance training has been shown to improve strength, sleep quality and mobility in persons
      with MS.
    

Intervention name(s): Physical exercise; Testing sessions
Intervention type(s): Other; Other
Intervention description(s): Physical exercise intervention; Testing sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: neurological disorders; resistance training; strength training; sleep quality; neuromuscular performance; functional capacity
Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The specific aim of this Phase I/II study is to assess the safety of intravenous administered
      Morpholino oligomer directed against exon 51 (AVI-4658 PMO).
    

Detailed description: 
      Primary outcome is safety, tolerability and dose selection for future studies.
    

Intervention name(s): AVI-4658 for Injection
Intervention type(s): Drug
Intervention description(s): AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline in 6 dose cohorts.
Other intervention name(s): Eteplirsen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3
Condition: Infant,Premature
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      To determine if servo-controlled oxygen environment is associated with reduction in (a)
      bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
    

Detailed description: 
      This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1;
      401-1000g at birth and/or 22w 0d-28w 6d; enrolled at <1 week postnatal age; eligible for full
      care and surviving beyond 24 hours, with informed consent; and with no major malformations)
      who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not
      judged too unstable by the Attending neonatologist.

      For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96
      hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen
      supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic
      monitoring at 36w PMA as well as data from the sleep study.

      The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the
      investigators will evaluate 3 interventions in a cross-over manner with the initial
      intervention (cannula or oxygen environment) randomly assigned: Intervention 1 (24-48h of
      data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).
    

Intervention name(s): Cardiorespiratory monitoring
Intervention type(s): Diagnostic Test
Intervention description(s): The investigators will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: (b) The first 24h of the data collection will be the baseline data. Over the next 72h, we will evaluate 3 interventions in a cross-over manner: Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h; same as intervention 1). Initial intervention will be by random assignment (computer-generated). The intervention will be to provide oxygen either by nasal cannula or by servo-controlled oxygen environment, followed by cross-over to other intervention for 24h, and then back to original intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: apnea of prematurity; bradycardia; hypoxemic episode; oxygen delivery
Effect of CEAG on Inflammation and Endothelial Function
Condition: Inflammation; Endothelial Dysfunction
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of the study is to look at the effect a dietary supplement called CEAG
      [Curcuminoids, EPA (Omega-3), Astaxanthin and Gamma Linolenic Acid (GLA)] has on inflammation
      and endothelial (inner layer of the blood vessels) function and whether it causes a lowering
      of blood pressure.The endothelium plays in an important role in blood pressure.
    

Detailed description: 
      This clinical trial is to assess the efficacy of Curcuminoids, EPA (Omega-3), Astaxanthin and
      GLA for improving inflammation and endothelial reactivity over a four week intervention
      period in individuals with metabolic syndrome. The study also examines the effect of
      Curcuminoids, EPA (Omega-3), Astaxanthin and GLA administration on other markers of
      cardiovascular function and cardiovascular disease risk including Total, LDL and
      HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
    

Intervention name(s): CEAG; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Endothelium
Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
Condition: Cocaine Abuse
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine if there are significant interactions
      between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine
      infusions by measuring adverse events (AEs) and cardiovascular responses including heart rate
      (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).
    


Intervention name(s): Lorcaserin; Placebo; Cocaine Infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg 2 times per day from Day 3 to 9 and one time on Day 10; 10 mg 2 times per day from Day 3 to 9 and one time on Day 10; Screening / Session 1, Study Day -2: 20 mg cocaine, followed by a saline infusion, followed by 40 mg cocaine Baseline/ Session 2, Study Day 1: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Baseline / Session 3, Study Day 2: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline Treatment / Session 4, Study Day 9: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Treatment / Session 5, Study Day10: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline
Intervention MeSH terms: Cocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of CYP3A4/5 inhibitor or inducer on
      the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to
      healthy Japanese men for 7 days.
    


Intervention name(s): KW-6356; Clarithromycin; Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral dose will be administered at Day 1 and 15; 400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28; 600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21
Intervention MeSH terms: Clarithromycin; Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral and IV Baclofen in Adult Volunteers
Condition: Baclofen Withdrawal Syndrome
MeSH terms: Syndrome; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterize baclofen pharmacokinetics following
      oral and intravenous administration in patients who are on chronic oral baclofen therapy. The
      secondary objective is to determine the safety profile of an IV baclofen formulation.

      This study is a randomized crossover study with two treatment arms. All subjects will receive
      a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or
      intravenous form is given on the first study day will be randomized in a 1:1 manner.

      The pharmacokinetic and tolerability information gained from this study will support the
      development of further studies to assess the use of IV baclofen to prevent or treat baclofen
      withdrawal syndrome.
    


Intervention name(s): Oral baclofen; Intervenous baclofen
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive one dose of oral baclofen and one dose of intravenous baclofen on different study days.
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: baclofen, withdrawal, interuption, spasticity, pharmacokinetics, tolerability, intravenous, oral
Response Evolution Chart
Condition: Obesity; Overweight; Motivation; Adherence, Patient
MeSH terms: Obesity; Overweight
Study type: Observational [Patient Registry]

Summary: 
      This study evaluates patient response to a motivation evolution chart for a medical-nutrition
      intervention as a continuation of a previous study: adherence to an overweight and obesity
      treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227
    


Intervention name(s): Lifestyle-medicine intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Overweight and obese participants who consulted a medical nutrition clinic
      
Keywords: motivation; Treatment adherence; Waist circumference; obesity; overweight
Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
Condition: Locally Advanced Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and
      preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end
      point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of
      combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor
      response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free
      survival and overall survival.
    

Detailed description: 
      The primary objective is to determine the pathological complete response (pCR) of combining
      preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal
      cancer.

      The secondary objectives of this study are to determine:

        1. Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative
           radiation for locally advanced rectal cancer.

        2. Negative resection margins (circumferential resection margin) rate.

        3. Downstaging rate.

        4. Sphincter preservation rate

        5. Locoregional and distant failure rate.

        6. Overall survival
    

Intervention name(s): Celecoxib
Intervention type(s): Drug
Intervention description(s): Celecoxib (400 mg/d) will be continued from day 1 to 65
Intervention MeSH terms: Celecoxib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Follow Fever to Decide
Condition: Body Temperature Changes
MeSH terms: Body Temperature Changes
Study type: Interventional

Summary: 
      Body temperature is one of the markers of biological rhythms. The precise determination of
      the functioning of the biological clock for an individual is essential to understanding his
      physiological state at a given time. This condition is dependent on the "timing" of its
      central clock on the time scale (chronotype). The provision of a simple-to-use (F2D cuff),
      non-invasive and time-dependable temperature tool and the creation of appropriate algorithms
      would allow access to the operation of the central clock and open up many therapeutic
      applications.
    

Detailed description: 
      While the measurement of body temperature is one of the first self-diagnosis gestures at
      home, it is unanimously agreed by healthcare professionals that the measurement of
      non-invasive body temperature performed both in a hospital setting, in the office, that at
      home is very imprecise, or even false. As a result, temperature is only an indicator and is
      of little interest. Only the rectal thermometer and the telemetric capsule (e-CELSIUS®
      capsule to be ingested that allows a reliable and continuous measurement of gastrointestinal
      temperature without the intervention of the caregiver) are reliable tools, but they remain
      invasive and do not always allow for fully reliable follow-up over time. We propose to
      develop an algorithm integrated in an external, non-invasive cuff, allowing the continuous
      recording of body temperature.

      In addition, body temperature is one of the markers of biological rhythms. The precise
      determination of the functioning of the biological clock for an individual is essential to
      understanding his physiological state at a given time. This condition is dependent on the
      "timing" of its central clock on the time scale (chronotype). The provision of a
      simple-to-use (F2D cuff), non-invasive and time-dependable temperature tool and the creation
      of appropriate algorithms would allow access to the operation of the central clock and open
      up many therapeutic applications.

      This work proposes to validate the tool on the one hand and on the other to use this tool to
      produce the elements necessary for monitoring the functioning of the central biological
      clock.
    

Intervention name(s): F2D armband
Intervention type(s): Device
Intervention description(s): Comparison of the core temperature obtained during 24-48 h with eCelsius and with F2D armband in different life situations.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Body Temperature; Circadian Rhythm
Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Opioid medications are commonly used for pain relief. When given over time, physical
      dependence can occur. This results in unpleasant side effects--such as agitation and
      nausea--if opioid medications are suddenly stopped. However, we do not know how withdrawal
      affects the brain. We know that a medication named Ondansetron can help ease or prevent
      symptoms associated with opioid withdrawal. Through imaging of the brain by fMRI, we hope to
      see how opioid withdrawal, with and without the administration of ondansetron, affects brain
      activity.
    

Detailed description: 
      During the study, each participant attended three separate lab-based acute opioid withdrawal
      sessions. The first session was undertaken in a mock MRI scanner and was designed to
      determine if participants could tolerate withdrawal in the scanning environment. Participants
      who were able to successfully and safely tolerate opioid withdrawal while in the scanner were
      approved to continue with the following study sessions. Participants were then pretreated
      intravenously (IV) with either 0.9% normal saline placebo or 8mg ondansetron. Later,
      participants in all sessions received IV naloxone (10mg/70kg) to precipitate opioid
      withdrawal. Participants were assigned to ondansetron or placebo pretreatment conditions in a
      randomized, double-blinded, and counter-balanced order. Objective Opioid Withdrawal Scale
      (OOWS) and Subjective Opioid Withdrawal Scale (SOWS) were assessed throughout the study to
      quantify withdrawal. Study timeline progressed as follows: T=-165, 8mg ondansetron or placebo
      infusion, T=-135, Morphine infusion (10mg/70kg), T=-41 preparation for MRI, T=-21, start MRI,
      T=-13, baseline OOWS/SOWS, T=-9, start of fMRI, T=0 Naloxone induced withdrawal, T=5, OOWS,
      T=15, OOWS, T=20, Retrospective OOWS.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): In this cross-over study, the blinded patient will receive saline placebo in one session and ondansetron in the other. The order is decided with a randomization table. If ondansetron is randomly chosen, an 8mg IV Bolus will be given at the start of the study for 30 minutes by the unblinded investigator.
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability
      and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.
    


Intervention name(s): PF-05231023; PF-05231023; PF-05231023; PF-05231023; PF-05231023; PF-05231023; PF-05231023; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): 0.5 mg QD IV x 1 day; 1.5 mg QD IV x 1 day; 5 mg QD IV x 1 day; 15 mg QD IV x 1 day; 50 mg QD IV x 1 day; 100 mg QD IV x 1 day; 200 mg QD IV x 1 day; 0.9% w/v sodium chloride injection, USP QD IVx 1 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; intravenous; single dose