bioihbjkbjnl/mcl2 huggingface dataset:
Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
Condition: Metastatic Cancer
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor
      and cause less damage to normal tissue.

      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic
      radiation therapy in treating patients with liver metastases.
    

Detailed description: 
      OBJECTIVES:

        -  To identify the maximum tolerated dose of stereotactic radiation therapy in patients
           with hepatic metastases.

        -  To determine the toxicity and adverse events profile of this patient population.

        -  To examine patient response, treatment effect on blood chemistry, and hematology values
           and patient quality-of-life in this patient population.

      OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3)
      and the number of liver lesions present (1-2 vs 3-5 vs > 5).

      Patients undergo percutaneous placement of metallic fiducial markers within the liver for
      stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic
      radiotherapy within 1 week of the marker placement.

      Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess
      quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study
      treatment.

      After completion of study treatment, patients are followed for at least 8 weeks.
    

Intervention name(s): quality-of-life assessment; stereotactic body radiation therapy
Intervention type(s): Procedure; Radiation
Primary purpose: Treatment
Keywords: liver metastases
The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and
      mood, however, the data in older adults and those most prone to cognitive dysfunction, is
      limited and conflicting. One explanation is that the GL of a meal may interact with a
      person's pre-existing glucose tolerance (GT).

      As older adults have a higher incidence of glucose tolerance and are more likely to
      experience memory problems the present study considers the interaction between the GL of meal
      in those with better or poorer GT.

      The population studied will not have a history of diabetes or dementia. A battery of
      cognitive tests will be administered after meals sweetened with one of three sugars known to
      vary in the rate that they release glucose into the blood stream.
    

Detailed description: 
      On day one subjects will take an oral glucose tolerance test and will then be divided into
      four groups depending on their glucose tolerance (how long values remain raised) and the
      tendency for values to subsequently fall to low values.

      On a second occasion 155 healthy older adults, aged 45-80 years, will be randomly assigned to
      receive either a glucose, sucrose or isomaltulose based meal. All meals are matched on
      macronutrient composition and differ only in glycemic load. Cognitive performance and mood
      will be assessed 30, 105 and 180 minutes after breakfast. Measures of memory, attention,
      reaction times and mood will be taken.

      The response to the three meals will be contrasted in those with different glucose profiles
      on day one
    

Intervention name(s): Isomaltulose; Sucrose; Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance; Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance; Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glycemic load; memory; mood
Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects
Condition: Pseudomonas Infection
MeSH terms: Pseudomonas Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single
      doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug,
      Monurol® (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to
      dosing on Day 1 of Period 1 prior to study screening.
    

Detailed description: 
      This is a Phase 1 single-dose, randomized, 3-Period, crossover study conducted at a single
      center. A total of 30 healthy subjects, aged 18-45years, will be randomized to receive one of
      3 treatment sequences. The duration of study will be approximately 18-26 days and subject
      participation will be the duration of study. Each treatment sequence will be enrolled in
      parallel and each subject will receive all 3 treatments in crossover fashion. Each subject
      will complete Screening, Baseline, and Treatment Phases. The Screening Phase will be
      conducted on an outpatient basis within 35 days of admission (Day -1 of Period 1). All
      subjects admitted to the study center the day before dosing in each treatment period (Day -1;
      check-in) for pre-dosing assessments and will remain in the study center through 48 hours
      post-dose for each Period. Final baseline qualification will only be evaluated prior to
      randomization for Treatment Period 1. Each one of the periods will be separated by a 3
      (minimum) to 7 days (maximum) washout period. The Treatment Phase will be comprised of 3
      crossover periods (duration Day-1 to 48 hours post dose). Each crossover period will include
      a single dose of study drug under fasting conditions followed by post-dose safety assessments
      and blood and urine collection for PK measures through 48 hours post-dose; each period will
      be separated by a 3 to 7 days washout. Subjects will remain in the study center for all 3-
      study treatment periods (Day -1 to 48 hours post dosing) and will be discharged after the
      48-hour sampling timepoint (if safety parameters are acceptable to the Investigator on Day
      3).
    

Intervention name(s): Fosfomycin tromethamine; Fosfomycin disodium
Intervention type(s): Drug; Drug
Intervention description(s): A phosphonic acid derivative is the mono-acid salt of Fosfomycin with Tromethamine. Sequence 1-3 receive 3 grams oral sachet; ZTI-01 is a phosphonic acid derivative formulated as a disodium salt intravenous formulation. ZTI-01 acts by inhibiting peptidoglycan assembly, thereby disrupting cell wall synthesis. Sequence 1-3 receive 1 gram and 8 grams of Intravenous ZTI-01 for 1-hour infusion
Intervention MeSH terms: Fosfomycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pseudomonas aeruginosa, ZTI-101, phosphonic acid derivative, Monurol, fosfomycin tromethamine
Variance of Video Games Playing Patterns Among Adolescents With Psychiatric Disorders
Condition: ADHD; Conduct; Depression; Anxiety; PDD
MeSH terms: Depression; Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      As the use of video games (VG) is rapidly increasing, many studies have tries to understand
      the effects of VG on the children and adolescents playing them.

      Most of the research was directed towards negative effects (especially violence, attention
      and school performance), producing mixed results.

      Recently, more studies had focused their attention on the opposite angle: The influence of
      the player's mental and behavioral parameters, influencing his VG playing patterns. The focus
      of most of these researches was time of playing, addictive patterns and exposure to violence.

      The current study will try to characterize the variance of VG playing pattern among
      adolescents diagnosed with psychiatric disorders, in order to better under the rich
      interaction between a player and his VG, and to understand whether VG playing patterns holds
      diagnostical clues for the child's diagnosis and his inner world.
    

Detailed description: 
      The participants will be asked to attend 2 session, 2 hours each, at 3-14 days interval.

      At the first session, after signing consent form, will asked to fill out questionaires
      regarding demographic data, personality, empathy trait, aggression state and trait and
      computer games usage.

      also, they will be asked to complete HTP and TAT psycho-diagnostic tests. Then, using heart
      rate variability (HRV) and Galvanic skin response (GSR), monitor of sympathetic tonus will be
      measured while playing a shooting and race game.

      At the end of the first session, they will be asked to fill additional aggression state
      questionaire.

      On the second session, monitored by HRV and GSR, they will be asked to play a role playing
      game (RPG) and real-time strategy game (RTS). At the end of session, they will be asked to
      fill additional aggression state questionaire.

      Parameters of playing patterns collected from the VG will be recorded and analyzed.
    

Intervention name(s): Video Game
Intervention type(s): Behavioral
Intervention description(s): Playing various video games: RPG, Race, FPS, Strategy
Other intervention name(s): Video Games; Computer Games; RPG; Role Playing Games; FPS; First Person Shooter; Strategy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ADHD; Attention Deficit/Hyperactivity Disorder; Conduct; Depression; Anxiety; PDD; Pervasive Developmental Disorders
Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy
Condition: Patellar Tendinitis; Jumper's Knee
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance
      program vs Heavy slow resistance in patients with chronic patellar tendinopathy.

      The investigators hypothesize that Inertial Flywheel Resistance program will yield a more
      positive clinical outcome and function in patients with patellar tendinopathy compared to
      heavy slow resistance group.
    

Detailed description: 
      Randomized controlled intervention study
    

Intervention name(s): Exercises program for patellar tendinopathy
Intervention type(s): Behavioral
Intervention description(s): To compare the effectiveness of the inertial flywheel resistance program versus slow heavy resistance in patients with chronic patellar tendinopathy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Perioperative pain control is necessary in children as inadequate treatment may lead to
      progression of perception of pain and development of chronic pain in the future.

      Anesthetists tend to adopt approach to perioperative control of pain by non-opioid drugs that
      mediate pain modulation. Its use as opioid sparing analgesia in different surgeries leading
      to mixed results.
    

Detailed description: 
      Site of study:

      This study will be carried out in neurosurgical operating rooms of Zagazig University
      Hospitals.

      b. Sample size: A pilot study was done to estimate percent of children need intraoperative
      fentanyl was (10%) for dexmedetomidine group, and ( 40%) for lidocaine group, at 0.05 α error
      and 0.2 β error . Sample size was calculated using Open Epi software, is 32 children in each
      group.
    

Intervention name(s): Dexmedetomidine injection; Lidocaine Iv
Intervention type(s): Drug; Drug
Intervention description(s): receive IV bolus dose of 0.5 ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5 ug/kg/h; IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
Other intervention name(s): precedex; xylocaine 1%
Intervention MeSH terms: Lidocaine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to characterize the pharmacokinetics, safety and tolerability of KD025 and
      KD025 metabolites in subjects with mild, moderate or severe hepatic impairment compared to
      healthy subjects with normal hepatic function.
    

Detailed description: 
      The primary objective of the study is:

      • To assess the pharmacokinetics (PK) of KD025 following a single oral dose of KD025 in
      subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with
      normal hepatic function.

      The secondary objectives of the study are:

        -  To evaluate the safety and tolerability of a single oral dose of KD025 in subjects with
           mild, moderate, or severe hepatic impairment, and in healthy subjects with normal
           hepatic function.

        -  To assess the PK of the KD025 metabolites following a single oral dose of KD025 in
           subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects
           with normal hepatic function.
    

Intervention name(s): KD025
Intervention type(s): Drug
Intervention description(s): Single dose of 200 mg KD025 orally
Other intervention name(s): belumosudil
Intervention MeSH terms: Belumosudil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, non-randomized, parallel-group study with the following subject treatment arms:
Group 1: normal hepatic function; Group 2: mild hepatic impairment; Group 3: moderate hepatic impairment; Group 4: severe hepatic impairment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
Condition: Primary Hypercholesterolemia; Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of
      laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in
      combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3
      will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and
      laropiprant components of Tredaptive.
    


Intervention name(s): niacin (+) laropiprant; Comparator: aspirin; Comparator: clopidogrel; Comparator: laropiprant; Comparator: placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets; 81 mg oral tablet once daily for 7 days; 75 mg oral tablet once daily for 7 days; 40 mg oral tablet once daily for 7 days; placebo oral tablet once daily for 7 days
Other intervention name(s): Tredaptive
Intervention MeSH terms: Aspirin; Niacin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose
      study of PRT064445 or its matching placebo, in healthy subjects.
    


Intervention name(s): PRT064445; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Intravenous; Intravenous to mimic PRT064445
Other intervention name(s): Placebo (for PRT064445)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Healthy Volunteers
SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a
      single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86
      years.
    


Intervention name(s): Staphylococcus aureus 4-antigen vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm; a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm
Other intervention name(s): SA4Ag
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Healthy Eating and Lifestyle for Total Health
Condition: Eating Behavior
Study type: Observational

Summary: 
      The Dietary Guidelines for Americans provide recommendations for making better food and
      physical activity choices that promote health and help prevent disease. Yet, few Americans
      meet the Dietary Guidelines for Americans (DGA) and a large percentage are overweight.
    

Detailed description: 
      The goal of the research was to examine the association between weight and the barriers and
      facilitators to meeting the DGA in a multi-site study using a cross-sectional survey. 836
      caregiver-child dyads enrolled and completed the HEALTH study questionnaire across six sites
      among three race/ethnic groups participating in the HEALTH Study. Barriers and facilitators
      to meeting the DGA were assessed using a validated questionnaire which was developed
      specifically for the HEALTH Study. Heights and weights were measured. A series of bivariate
      regression analyses were conducted to examine the association between the caregivers BMI or
      the children BMI z-score and the barriers and facilitators to meeting the DGA, adjusting for
      appropriate covariates in the models. Path analysis was used to examine the relationship of
      caregivers and children barriers and facilitators to their relative BMI.
    

Intervention name(s): survey
Intervention type(s): Other
Intervention description(s): Cross-sectional survey
Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Fifth-grade children and their caregivers, or a caregiver of a 5th grade child attending a
        public school.
      
Keywords: HEALTH; barriers; facilitators; DGA; BMI; Public Schools
Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity
Condition: Diabetes; Pre-diabetes
MeSH terms: Diabetes Mellitus; Insulin Resistance; Prediabetic State; Weight Loss
Study type: Interventional

Summary: 
      The investigators will use exercise training and weight loss to discover localized lipid
      species related to diabetes risk in people.
    


Intervention name(s): Weight loss and exercise training intervention; Weight loss Only Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Combined weight loss and exercise training intervention; Weight loss Only Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)
Condition: Fibroids, Uterine; Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study evaluates the safety and tolerability of a single injection of collagenase
      enzyme directly into a uterine fibroid in subjects already selected for hysterectomy or
      myomectomy.

      Fibroids contain excessive amounts of collagen and it is possible that digestion of collagen
      may be beneficial in reducing pain and bleeding associated with fibroids.

      Three subjects will be injected with saline only to evaluate the safety and effectiveness of
      the injection method. Additional subjects will then be injected with increasing doses of
      study drug.
    

Detailed description: 
      Collagenase enzyme breaks down collagen and has shown efficacy in clinical trials for a
      number of diseases for which there is an accumulation of collagen.

      It is possible that lysis of collagen may reduce the collagen content of fibroids thus
      decreasing the size of fibroids, and possibly reducing the stiffness of fibroids. This may
      result in reducing the symptoms of pain and bleeding associated with fibroids.

      In this study three subjects will be injected with saline only followed immediately by
      hysterectomy in order to evaluate the safety and effectiveness of the injection method.

      Twelve subjects will receive a single injection of study drug as follows: three subjects will
      receive a set dose of collagenase enzyme followed by hysterectomy or myomectomy 24-96 hours
      later (Group 1) to evaluate safety of the injection of study drug. Nine subjects will then
      receive increasing doses of collagenase enzyme followed by hysterectomy or myomectomy 60-90
      days later (Group 2).
    

Intervention name(s): Saline; EN3835
Intervention type(s): Other; Drug
Intervention description(s): Saline injection; Comparison of maximum marketed dose and multiple doses EN3835
Other intervention name(s): Collagenase clostridium histolyticum
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment