bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects With Normal, Mild, Moderate and Severe Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down
      and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to
      healthy subjects of a similar age, sex and weight. As for all clinical trials, safety and
      tolerability of the drug will be evaluated as well to develop dosing recommendations for
      dosing of ZD4054 (Zibotentan) in subjects with varying stages of hepatic impairment.
    


Intervention name(s): ZD4054
Intervention type(s): Drug
Intervention description(s): 10mg, Oral tablet, single dose
Other intervention name(s): Zibotentan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment
A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
Condition: Liver Diseases; Hepatic Insufficiency
MeSH terms: Liver Diseases; Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure how much of the study drug called baricitinib
      gets into the blood stream and how long it takes the body to get rid of it. Healthy
      participants and those with liver disease may enroll. The study will last about 7 days for
      each participant, not including screening.
    


Intervention name(s): Baricitinib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY3009104
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2 study in two parts (A & B) designed to evaluate the effect of MEDI0382 on Hepatic
      Glycogen Metabolism in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately 20
      subjects will be enrolled in Part A and approximately 30 subjects in Part B.
    

Detailed description: 
      This is a 2-part exploratory Phase 2 study.

      Part A is a randomised, double-blind, placebo-controlled study to evaluate the effect of
      MEDI0382 (also known as Cotadutide) administered once daily subcutaneously (SC) for 28 days
      on hepatic glycogen metabolism in overweight and obese subjects with T2DM. Part A is planned
      to randomise up to 20 subjects. Subjects from Part A will not be re-enrolled in Part B.

      Part B is an exploratory Phase 2 randomised, double-blind, placebo-controlled and open-label
      active comparator study to evaluate the effect of MEDI0382 on hepatic glycogen metabolism in
      overweight and obese subjects with T2DM. Part B is planned to randomise approximately 30
      subjects (not to exceed a maximum of 35 subjects). Subjects in Part B will be randomised to
      receive double-blind MEDI0382 or placebo, or open-label liraglutide once daily for 35 days.
    

Intervention name(s): MEDI0382; Placebo; Liraglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MEDI0382 administered subcutaneously; Placebo administered subcutaneously; Liraglutide administered subcutaneously
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: 0382, T2DM, Cotadutide, Overweight, Obese, MEDI0382
The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy
Condition: Ischemic Cardiomyopathy
MeSH terms: Cardiomyopathies; Ischemia
Study type: Interventional

Summary: 
      Patients with ischemic cardiomyopathy (left ventricular ejection fraction <35%) and heart
      failure who already have an implantable device with an atrial lead (dual chamber
      defibrillator or biventricular defibrillator) will undergo sequentially 1. Sham low level
      tragus stimulation (LLTS) (5min), 2. Active LLTS at 5Hz (15min) and 20Hz (15min) and 3.
      Active LLTS group with atrial pacing at 100bpm at 5Hz (15min) and 20Hz (15min). The latter is
      required to examine the effect of LLTS on RA independent of heart rate. Repolarization
      alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software.
    


Intervention name(s): Low level tragus stimulation
Intervention type(s): Device
Intervention description(s): All patients will undergo sequentially: sham stimulation; LLTS (5Hz), LLTS (20Hz). The sequence will be repeated during atrial pacing at 100bpm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ischemic cardiomyopathy; neuromodulation; repolarization alternans
Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac
      and metabolic risk. The aim of this study the effects of exercise in cardiac fat content,
      cardiac function, physical fitness, and metabolic activity in obesity.
    

Detailed description: 
      Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac
      and metabolic risk. More effective treatments are needed to induce changes in cardiac fat
      content, body composition, and cardiac fat metabolic activity that result in a reduction in
      cardiovascular risk in overweight and obese population. Despite this need, little is known
      about which mode, frequency, and duration of exercise will allow for greater reductions in
      cardiac fat, improvements in body composition, restoration of a healthy cardiac fat metabolic
      activity, and improvement on cardiovascular risk markers. The aim of this study the effects
      of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic
      activity in obesity.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Other
Intervention description(s): The intervention will consist of 3 weeks of whole body circuit training (resistance training) where participants in the intervention group will perform 7 different exercises. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. Intensity will be 6-7 of RPE at the first set, and 9-10 at the third set.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence of Telmisartan / HCTZ Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs.
      its monocomponents
    


Intervention name(s): Telmisartan; Hydrochlorthiazide (HCTZ); Telmisartan/HCTZ fixed combination
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Telmisartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation Of The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And Food Effect In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the bioavailability of PF-04457845 tablets relative
      to solution and evaluate the effect of food (fasted vs. high fat meal) on the
      pharmacokinetics of an oral tablet formulation of PF-04457845
    


Intervention name(s): PF-04457845
Intervention type(s): Drug
Intervention description(s): Single dose, 8 mg as oral tablet and solution formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study consists of three parts: single oral dose escalation in healthy volunteers (Part
      A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants
      with chronic plaque psoriasis (Part C)
    


Intervention name(s): PRCL-02; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet(s) administered with water; Administered with water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking
      and on patient management, and its reproducibility (Test-Retest), for the diagnosis of
      hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose
      intolerance.
    


Intervention name(s): gaxilose; lactose
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): After gaxilose administration, urine collection, cuantification (firstly from 0 to 4 hours, and total urine from 0 to 5 hours), and xilose cuantification afterwards.; After lactose administration, expired hydrogen measurement at pre-specified intervals.
Other intervention name(s): LacTEST; Hydrogen Breath Test (HBT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
DePuy Attune Total Knee Arthroplasty RSA Study
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The DePuy Attune knee system incorporates several key features aimed at improving kinematics
      of the knee joint, range of motion, and smoothness of use compared to existing total knee
      replacement technologies. As this is a newly approved medical device, clinical testing in
      patients using high precision diagnostics is important to evaluate the stability of implant
      fixation and in vivo function. We propose a multi-centre consecutive series study examining
      the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total
      knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be
      utilized to identify the micromotion of the tibial tray with respect to the surrounding bone.
      Health status and functional outcome measures will be recorded to quantify functional status
      of subjects before surgery and at follow-up intervals.
    


Intervention name(s): DePuy Attune posterior stabilized fixed bearing total knee replacement
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Repeat Topical Application of BOS-356 in Subjects With Moderate to Severe Acne Vulgaris
Condition: Moderate to Severe Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to characterize the safety and tolerability of BOS-356 in adult
      participants with moderate to severe acne vulgaris following 14 days or 28 days of repeated
      topical application
    

Detailed description: 
      In Cohorts 1-3, participants will be randomized to receive twice daily (BID) topical
      applications of BOS-356 gel or vehicle gel to the face during a 14-day treatment period.
      Doses will be escalated in successive cohorts with BOS-356 gel 0.1%, 0.4%, and 0.7%.

      In Cohort 4, participants will be randomized to receive BID topical applications of BOS-356
      gel or vehicle gel to the face, upper chest, upper back, shoulders, and posterior neck during
      a 28-day treatment period. The dose of BOS-356 to be used in this cohort will be determined
      based on safety and tolerability data from Cohorts 1-3.

      In Cohort 5, participants will complete a 7-day run-in period to receive BID topical
      applications of vehicle gel to the face. Participants will be randomized to receive BID
      topical applications of BOS-356 gel or vehicle gel to the face during a 28-day treatment
      period. The dose of BOS-356 to be used in this cohort will be the same as the dose used in
      Cohort 4. Cohorts 4 and 5 may proceed in parallel.
    

Intervention name(s): BOS-356; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): topical gel; topical gel
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BOS-356; acne
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of a specially-constructed crib mattress
      that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary,
      non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids
      in utero.
    

Detailed description: 
      This study will test the therapeutic efficacy of stochastic vibrotactile stimulation (SVS)
      for reducing withdrawal symptoms, pharmacological treatment and hospitalization, and for
      improving neurobehavioral developmental outcomes in opioid-exposed newborns.

      Candidates at-risk for NAS due opioid exposure in utero will be identified to investigators
      by medical caregiver and/or prescreened using HIPAA Waiver for recruitment
      (maternal-prenatal; infant-postnatal). Infants will be randomized into either SVS
      (complementary to standard of care) or Treatment as Usual (TAU), restricted by equipment
      (mattress) availability. Infants will be enrolled and assigned to a condition within 48 hours
      post birth and participate throughout hospitalization. Infants assigned SVS will receive
      daily intervention of continuous intervals of SVS throughout hospitalization using a
      specially constructed crib mattress that delivers gentle vibrations at preset intervals.

      Specific Aim 1. Determine the efficacy of SVS as a non-pharmacological therapy complementary
      to standard of care for reducing severity and duration of opioid withdrawal in newborns
      compared to TAU alone. Quantify clinical variables: NAS severity, treatment days, days in
      hospital, velocity of weight gain, cumulative morphine dose.

      Specific Aim 2. Compare neurobehavioral outcomes in fetal drug-exposed infants between
      infants who received SVS and those who received TAU. Longitudinal outcomes assessment at
      6-months and 1 year to test whether early intervention with SVS compared to standard care
      improves physical, social, emotional and cognitive development.
    

Intervention name(s): Stochastic Vibrotactile Stimulation (SVS)
Intervention type(s): Device
Intervention description(s): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle vibrations and sounds during mattress stimulations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stochastic Resonance; Fetus/Newborn Infant; Drug Withdrawal; Substance Abuse
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of the study drug relative to
      an active comparator losartan which is in the same class of drug and is approved for use in
      the pediatric population aged 6 years and older. Approximately 260 subjects will participate
      in a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind,
      randomized, placebo-controlled withdrawal phase. A 44-week, open-label extension in which all
      subjects will receive azilsartan and other antihypertensive medications (if needed). Blood
      pressure will be assessed throughout the study.
    

Detailed description: 
      The purpose of the study is to evaluate the efficacy and safety of the study drug relative to
      an active comparator losartan which the same class of drug and is approved for use in the
      pediatric population aged 6 years and older. Approximately 260 subjects will participate in a
      6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind,
      randomized, placebo-controlled withdrawal phase. This study also includes a 44-week,
      open-label extension Phase in which all subjects will receive azilsartan and other
      antihypertensive medications (if needed) in order to reach an optimal blood pressure. Blood
      pressure will be assessed in the clinic throughout the study, and subjects may also
      participate in a 24-hour ambulatory blood pressure monitoring procedure at baseline, at the
      end of the double-blind Phase and at the end of the open-label Phase.
    

Intervention name(s): Azilsartan Medoxomil Low-dose; Losartan; Placebo for Azilsartan Medoxomil; Placebo for Losartan; antihypertension medication - Add-on Therapy; Azilsartan Medoxomil Medium-dose; Azilsartan Medoxomil High-dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): add-on therapy (e.g., a calcium channel blocker, such as amlodipine, a diuretic, such as hydrochlorothiazide, or a beta-blocker such as metoprolol) per PI's clinical judgment.
Other intervention name(s): AZM; AR14; AZM-L; Cozaar; sugar pill; sugar pill; AZM; AR14; AZM-M; AZM; AR14; AZM-H
Intervention MeSH terms: Losartan; Azilsartan medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 3 phases in this study. Double-blind, withdrawal phase, and open-label phase.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pediatric Hypertension; High Blood Pressure; Hypertension; Pediatric; Primary Hypertension; Secondary Hypertension
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate safety,
      tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single
      doses of NNC0113-0987 in healthy male subjects.
    


Intervention name(s): NNC0113-0987; placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.; A single dose of oral placebo administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram
      (mg) administered as PFS vs investigational device.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab SC. The study will assess the PK,
      and variability of a vedolizumab SC in a PFS versus an investigational device.

      This study will include 2 different device delivery presentations in 2 treatment groups.
      Participants in each treatment group will be randomized to one of the three administration
      sites: Abdomen, thigh, or arm. The study will enroll approximately 102 participants,
      including 17 participants allocated to each administration site within each treatment group.
      Participants will be randomly assigned (per randomization schedule) to one of the two
      treatment groups:

        -  Group A: Vedolizumab SC PFS

        -  Group B: Vedolizumab SC Investigational Device

      All participants will receive a single dose of study drug on Day 1.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 196 days. Participants will be contacted by
      telephone on Day 168 after their last dose of study drug for a follow-up assessment which
      will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.
    

Intervention name(s): Vedolizumab SC
Intervention type(s): Drug
Intervention description(s): Vedolizumab SC liquid.
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy