bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects
      to evaluate the Absorption, Metabolism, and Excretion of Poziotinib following a single oral
      dose of [14C]-poziotinib to healthy male subjects.
    

Detailed description: 
      Potential subjects will be screened to assess their eligibility to enter the study within 28
      days prior to the dose administration. Subjects will be admitted into the Clinical Research
      Unit (CRU) on Day -1. On the morning of Day 1, all subjects will receive a single oral dose
      of 8 mg (as the hydrochloride salt) containing approximately 100 μCi of [14C]-poziotinib in
      the fasted state.

      Subjects will be confined to the CRU until at least Day 8.

      Subjects will be discharged from the CRU on Day 8 if the following criteria are met:

        -  ≥90% mass balance recovery in combined urine and feces, and

        -  ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in
           2 consecutive 24-hour periods in which fecal and urine samples are obtained.

      If these criteria are not met by Day 8, subjects will remain in the CRU until all discharge
      criteria are met up to a maximum of Day 15 in order to continue 24-hour blood, urine, and
      feces collections, unless otherwise agreed upon by the Sponsor and Investigator.
    

Intervention name(s): [14C]-Poziotinib
Intervention type(s): Drug
Intervention description(s): Single oral administration of 8 mg (as the hydrocholoride salt) of [14C]-poziotinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers
Behavior Management Using Audiovisual Tools
Condition: Disruptive Global Behavior During Previous Treatment Visits
Study type: Interventional

Summary: 
      The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric
      patients during dental treatment improves when a cartoon film is viewed or a videogame is
      played as methods of distraction.
    

Detailed description: 
      Each patient required a minimum of 2 visits for restorative treatment in a mandibular
      quadrant and had undergone a previous restorative dental experience. All parents or guardians
      of the children who participated in the study were informed about the study before enrolment,
      and gave their voluntary consent. Each visit lasted approximately 35 minutes and involved
      restorative treatment in a mandibular quadrant with an alveolar nerve block. The parents were
      not present in the operating room during the treatment. The maximum time between the 2
      treatment sessions was 2 weeks. Before the start of each treatment session, as a part of the
      standard process of a paediatric dental visit, the child was given an explanation as to what
      the visit would comprise, with the aim of interrupting the treatment as little as possible.
      The children knew at the beginning of the first appointment (control) that they would be able
      to watch a movie or play a videogame during their next visit.
    

Intervention name(s): No distraction method; Distraction method; Distraction method
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Patients with conventional treatment. No distraction method during the treatment visits.; Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.; Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Audiovisual distraction; Pediatric dentistry
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of
      Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of
      treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient
      glycaemic control.
    


Intervention name(s): Linagliptin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): once a day; once a day
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Exercise for Depressed Smokers
Condition: Tobacco Smoking; Smoking Cessation
Study type: Interventional

Summary: 
      The purpose of this study is to test the effect of a moderate-intensity aerobic exercise
      intervention for helping individuals with elevated depressive symptoms to quit smoking. The
      investigators expect that this project will contribute much needed knowledge about the role
      that aerobic exercise can play in smoking cessation. The long-term goal of this program of
      research is to disseminate an effective, aerobic exercise (AE) intervention for smoking
      cessation that can be readily adopted by smokers with elevated depressive symptoms, including
      those with current major depressive disorder (MDD).
    


Intervention name(s): Aerobic Exercise; Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals. Two month course of the nicotine patch initiated during week 5.; 12-week health education control. Weekly sessions about 12 different topics related to the health effects of smoking, led by an expert in smoking cessation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quit smoking; Exercise; Tobacco; Smoking
Preventing Post-Stroke Depression
Condition: Depression; Cerebrovascular Accident
MeSH terms: Stroke; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of both drug and non-drug treatments in preventing
      depression after a stroke.
    

Detailed description: 
      The development of depression after a stroke is a serious condition that can have negative
      effects on thought, emotions, and overall daily functioning, particularly in the first year
      following the stroke. Evidence suggests that antidepressants may be used to prevent
      post-stroke depression. This study will treat nondepressed stroke patients with
      antidepressants or problem solving therapy (PST) to determine the most effective treatments
      for preventing depression.

      Participants in this study will be randomly assigned to receive PST, escitalopram, or placebo
      (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or
      more will be removed from the study. After 12 months, treatment will be discontinued and
      participants will be monitored for an additional 6 months.
    

Intervention name(s): Problem Solving Therapy; Escitalopram; Placebo
Intervention type(s): Behavioral; Drug; Other
Intervention description(s): Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.; Participants will receive escitalopram, a selective serotonin reuptake inhibitor.; Participants will receive a placebo pill.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Stroke
A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia
Condition: Complex-dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus
      Pitavastatin/Fenofibrate in complex-dyslipidemia patients.
    

Detailed description: 
      The purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in
      complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with
      Pitavastatin.
    

Intervention name(s): HL-PIF cap.160/2mg + Placebo; Livalo tab. 2mg + Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg; Pitavastatin ca 2mg
Other intervention name(s): Fenofibrate 160mg/Pitavastatin Ca 2mg; Pitavastatin Ca 2mg
Intervention MeSH terms: Fenofibrate; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum
      abnormalities, lung function, and overall feeling of well-being in people with cystic
      fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory
      infections in people who do not have CF, and is sometimes used in CF patients as well.
      Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some
      preliminary studies that have been done in CF patients suggest that Biaxin might have a
      beneficial effect on CF sputum in ways unrelated to its antibiotic activity.
    


Intervention name(s): Biaxin ( clarithromycin)
Intervention type(s): Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cystic Fibrosis (CF); Macrolide antiobiotics; airway inflammation
The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patient
Condition: Liver Transplantation
Study type: Observational

Summary: 
      Background. Acute renal failure after liver transplantation (LT) requiring continuous renal
      replacement therapy (CRRT) adversely affects patient survival. However, there are few reports
      to assess the predictors for postoperative CRRT in liver transplant patients. The
      investigators undertook this study to identify perioperative factors that would predict
      patients at risk of CRRT.

      Patients and Methods. The investigators retrospectively reviewed the data of 148 liver
      transplant patients from January 2007 to November 2010 at Severance Hospital, Yonsei
      University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18
      patients from living and 26 from deceased donors) and those without CRRT was 104. Univariate
      and stepwise logistic multivariate analyses were performed.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the data of 148 liver transplant patients from January 2008 to December 2011 at Severance
        Hospital, Yonsei University HealthSystem, in Seoul, Korea. The number of patients treated
        with CRRT was 44 (18 patients from living and 26 from deceased donors) and those without
        CRRT was 104.
Evaluation of COVID-19 Fear, Anxiety and Their Effects in Physiotherapy Technician Students
Condition: Covid19; Anxiety and Fear
MeSH terms: COVID-19; Anxiety Disorders
Study type: Observational

Summary: 
      80 participants studying in the physiotherapy technician department were included in this
      cross-sectional study. Participants' age, gender, year of being a student, the people they
      live with, the precautions they take regarding COVID-19, whether there is a history of
      COVID-19 in them or their immediate surroundings, and whether they have COVID-19 transmission
      and / or contagion fears during their vocational training, whether there are fears of
      achieving professional goals and competence because of COVID-19 and / or its consequences
      were recorded. Afterwards, the participants were asked to answer the questions on the
      coronavirus anxiety scale, the fear of COVID-19 scale and the cognitive and behavioral
      avoidance subscales of the Avoidance Attitudes from COVID-19 scale.
    


Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Survey
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        80 volunteers between the ages of 18-65, who are physiotherapy technician students, were
        included in the study.
Cardiovascular Fitness and Venous Function in Trained and Untrained Subjects
Condition: Healthy Subjects
Study type: Observational

Summary: 
      The primary aim is to study the relationship between vascular function, cardiovascular
      fitness and age in healthy subjects. Individuals with the highest cardiovascular fitness will
      have the greatest arterial inflow independent of age.
    


Intervention name(s): Aerobic Interval Training
Intervention type(s): Behavioral
Intervention description(s): One interval training session
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy men and women, aged 18-75 yrs
      
Biospecimen description: 
      Blood samples
    
Keywords: Veins; Exercise tests; maximal oxygen uptake; VO2max
Wii-Fit For Balance And Gait In Elderly Veterans
Condition: Gait, Unsteady; Postural Balance
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      Falls are a major public health problem. They are the leading cause of injuries and
      injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major
      reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly.
      Despite the many proven benefits of exercise, many older adults in the US remain sedentary.
      This study targets at improving balance and gait with use of Wii-Fit as an exercise program.
    

Detailed description: 
      Objectives/Rationale Falls are a major public health problem. They are the leading cause of
      injuries and injury-related deaths in those aged over 65 years. Balance and gait
      abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and
      balance in the elderly. Despite the many proven benefits of exercise, many older adults in
      the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit
      as an exercise program.

      Specific aims

        1. To establish the safety, feasibility, and efficacy of an 8-week Wii-Fit program to
           improve measures of balance, and gait in older adults, compared to a cognitive
           remediation program, Brain fitness.

        2. To compare the effect of an 8-week Wii-Fit program to Brain fitness program, on measures
           of biomechanical assessment, adherence, safety, physical activity, fear of fall,
           enjoyment, functional status, cognition and quality of life.

      Design 8-week, randomized, parallel group, active intervention study Methods Patients will be
      recruited via IRB approved flyers posted in various locations of the Little Rock and North
      Little Rock CAVHS campuses and via referrals from the CAVHS providers. Thirty elderly
      Veterans will be randomly assigned to Wii-Fit arm or Brain fitness arm. Both groups will
      participate in the intervention for approximately 45 minutes 3 days a week for 8 weeks.
      Outcome measures will be assessed at baseline, and approximately week 4 and after completion
      of week 8. Balance and gait will be assessed by Berg Balance Scale. Secondary outcome
      measures include biomechanical testing for gait and balance, Safety, Adherence, measures of
      functional status, cognition, quality of life, fear of falling, physical activity and
      physical activity enjoyment.
    

Intervention name(s): Wii-Fit exercises; Cognitive remediation exercises
Intervention type(s): Other; Other
Intervention description(s): Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks; Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balance; gait; Wii-Fit
TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
Condition: Genetic Predisposition to Disease; Hyperglycemia; Intensive Care Unit Syndrome; Multiple Organ Failure
MeSH terms: Hyperglycemia; Genetic Predisposition to Disease; Multiple Organ Failure
Study type: Observational

Summary: 
      This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2
      gene and the risk of developing hyperglycemia during Intensive care unit stay
    


Intervention name(s): genetic analysis; blood and stools samples
Intervention type(s): Genetic; Biological
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients admitted in ICU > 48h with at least one organ dysfunction
      
Biospecimen description: 
      blood, plasma, mononuclear cells, DNA
    
Keywords: hyperglycemia; Multiple Organ Failure; biobank; diabetes
In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
Condition: Interface Acceptance During Delivery of Aerosol Medicine to an Infant or Child
Study type: Interventional

Summary: 
      We hypothesize that infant and children will show different levels of acceptance of different
      interfaces while they receive inhaled therapy.

      We also hypothesize that children will exhibit different amounts of time with the aerosol
      well aligned with the nostrils during transnasal aerosol delivery.
    

Detailed description: 
      Aerosol medicine is widely used in treating pulmonary diseases in children. Delivering drugs
      via aerosol faces several challenges; some are related to the drug and the delivery methods
      and others to the patient behavior. The latter are crucial and can significantly affect the
      lung deposition of the drug. Infants are known to be obligate nose breathers making the
      transnasal route the natural approach for drug delivery in this age group. Different
      interfaces are already available in the market and are specifically designed to be used in
      children to improve the child acceptability of the interface and by the result to improve
      drug deposition. Due to limitations in the use of radiolabeled aerosols and
      pharmacokinetics/pharmacodynamics studies in infants and children, in-vitro models were
      developed. These models still lack biological variability which leads to overestimating lung
      deposition. So, real life correction factors are needed to improve current in-vitro modeling.
      Previous unpublished data from our laboratory showed that alignment of the aerosol stream
      with the nostrils is very important for pulmonary deposition.

      Our objectives are to provide real life data of acceptance of different interfaces by infants
      and children and to provide a real life correction factor to improve current in-vitro
      modeling.
    

Intervention name(s): inhaled normal saline using different interfaces.
Intervention type(s): Behavioral
Intervention description(s): A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The infants will be videotape while they receive inhaled aerosol, and sound will be captured. The camera will be positioned so the face of the parent holding the child will not be visible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Interface, aerosol, child, acceptance
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effectiveness of the co-administration of
      canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and
      metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite
      treatment with diet and exercise. The safety and tolerability of canagliflozin will also be
      assessed.
    

Detailed description: 
      This study will be a randomized (the study medication is assigned by chance), double-blind
      (neither physician nor participant knows the identity of the assigned treatment),
      active-controlled (one of the treatments is an established effective treatment for type 2
      diabetes mellitus), parallel-group (each group of participants will be treated at the same
      time), 5-arm (groups), multicenter study. Approximately 1,200 participants will be randomly
      assigned to the 5 treatment arms in a 1:1:1:1:1 ratio for 26 weeks.
    

Intervention name(s): Canagliflozin 100 mg; Canagliflozin 300 mg; Metformin XR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One 100 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 100 mg arm) or with the evening meal (for the Canagliflozin 100 mg + Metformin XR arm).; One 300 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 300 mg arm) or with the evening meal (for the Canagliflozin 300 mg + Metformin XR arm).; One 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Canagliflozin (JNJ-28431754); Metformin