bioihbjkbjnl/mcl2 huggingface dataset:
Snack Food Reinforcement in Obese and Non-obese Women
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Food reinforcement, motivation to obtain food, is associated with energy intake and obesity.
      Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to
      diets and weight loss. Our previous study in non-obese adults showed that daily consumption
      of the same snack food (food typically consumed outside of meals) for 14 days significantly
      decreased its reinforcing value. The purpose of this study was to replicate and extend these
      findings to obese individuals as well as to examine effects of different portion sizes of
      snack foods on food reinforcement. Thirty-one obese (body mass index > 30 kg/m2) and 27
      non-obese (BMI < 30 kg/m2) women had food reinforcement and liking tested at baseline and
      after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the
      same snack food.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women ages 18 - 50 years who were obese (body mass index >/= 30) or non-obese (BMI < 30)
      
Keywords: BMI; obesity; sensitization; food reinforcement; snack food; Portion size of daily snacks; Weight status
Neurocognition and Work Productivity in Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study will investigate the relationships between subjective cognitive complaints,
      neurocognitive deficits, and work productivity in participants with Major Depressive Disorder
      (MDD), before and after 8 weeks of treatment with an antidepressant medication. Our
      hypothesis is that, in working participants with MDD of at least moderate severity,
      neurocognitive deficits will predict poorer work functioning and productivity.
    


Intervention name(s): desvenlafaxine
Intervention type(s): Drug
Intervention description(s): 50-100 mg daily for 8 weeks
Other intervention name(s): Pristiq
Intervention MeSH terms: Desvenlafaxine Succinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; cognition; occupational functioning; productivity; neuropsychology; desvenlafaxine; antidepressants
Autologous Culture Expanded Mesenchymal Stromal Cells for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The study seeks to determine the safety and feasibility of using adipose-derived mesenchymal
      stromal cells to treat symptoms of mild to severe knee osteoarthritis.
    

Detailed description: 
      Interventions to alter the natural course of osteoarthritis (OA) in the knee are elusive and
      joint replacement remains the definitive management for refractory, end-stage disease. The
      Mayo Clinic has a large, ongoing experience using autologous adipose derived mesenchymal
      stromal cells (AMSCs) for the treatment of a variety of other diseases under INDs. Thus far,
      the treatments have been well tolerated. These data along with the investigators'
      pre-clinical animal studies and published experiences using related approaches lead the
      investigators to believe that this approach provides a reasonable safety profile to treat
      patients with refractory painful knee OA. The purpose of the current study is to investigate
      the safety and feasibility of single and multiple injections of autologous, culture expanded
      AMSCs in subjects with painful, refractory knee OA. Subjects with unilaterally symptomatic
      mild to severe knee OA will be enrolled based on satisfaction of inclusion and exclusion
      criteria.
    

Intervention name(s): Autologous Adipose-Derived Mesenchymal Stromal Cells
Intervention type(s): Drug
Intervention description(s): Human, autologous, culture expanded, adipose derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Human Cellular Therapy Laboratory using current good manufacturing practices (cGMPs).
Other intervention name(s): AMSCs
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra
      standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI)
      measuring the effects on the acute rise and fall of the plasma C reactive protein levels
      during the first 14 days.
    

Detailed description: 
      VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra
      standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI)
      measuring the effects on the acute rise and fall of the plasma C reactive protein levels
      during the first 14 days
    

Intervention name(s): Anakinra 100 mg; Anakinra 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Anakinra 100 mg starting immediately and then every 24 hours; Anakinra 100 mg starting 12 hours after first dose and then every 24 hours (so that Anakinra is given every 12 hours); Placebo 0.67 ml injections twice daily
Other intervention name(s): Kineret; Kineret; Placebo injections twice daily
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      This purpose of this study is to determine if bosutinib reduces the rate of kidney
      enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering
      the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or
      equal to 60 mL/min/1.73m2.
    


Intervention name(s): Bosutinib; Bosutinib; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily oral dose of 200 mg of bosutinib; Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day; Once daily oral dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bosutinib; Autosomal Dominant Polycystic Kidney Disease
Analyzing Stump-socket Interface Pressure to Improve Gait in Above-knee Amputee
Condition: Lower Limb Amputation Above Knee (Injury)
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims at evaluating the relation between quality of the interface between the stump
      and the prosthesis, and the quality of gait in above-knee amputees.

      The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee
      amputees corresponds to an homogeneous pressure distribution pattern onto the stump.
    

Detailed description: 
      Forty amputee patients will be evaluated for satisfaction with the prosthesis, pressure
      repartition pattern and functional capabilities.

      Pressure at the stump-socket interface will be recorded using a set of 14 single cells
      sensors placed in predefined positions onto the stump. Pattern of pressure will be measured
      in four tasks: sitting posture, standing posture, gait initiation, and gait at preferred
      velocity.

      Reproducibility of the pressure repartition pattern will be analyzed by repeating gait and
      standing posture task in the first 15 patients included.

      In patients whom prosthesis has been modified on the basis on the first pressure measurement
      (pressure peak and bad functional capacities), a new pressure measurement will be repeated
      2-8 weeks apart.

      Postural and gait abilities will be also assessed in 40 age/gender matched non-amputated
      subjects to serve as control data.
    

Intervention name(s): Clinical and instrumented measurements
Intervention type(s): Device
Intervention description(s): Clinical examination will include stump pain, wound, scar and unusual shape.
Questionnaire will include satisfaction scale (SatPro), comfort scale (SCE), and functional scale (PPA-LCI)
After installing the sensors on the stump, the patient will put his prosthesis on and will perform the following tasks: gait, sitting and standing posture and gait initiation.
Pressure repartition at the stump-socket interface will be assessed with the 14 flat sensors.
Gait parameters will be assessed with the OptoGait device. Standing posture and gait initiation parameters will be assessed with a force-plate.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amputation; prosthesis; stump; socket; pressure; gait; posture
Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
Condition: Multiple Sclerosis, Relapsing-remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      This is a pilot study of oral vitamin D supplementation to determine if patients with
      Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum
      25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or
      relevant gene expression response to oral vitamin D supplementation differs in patients with
      MS and healthy controls.
    


Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Multiple sclerosis; Healthy controls; Pharmacokinetics; Vitamin D
Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Condition: Pediatric Obesity; Nutrition Disorders; Overnutrition, Child; Obesity
MeSH terms: Obesity; Pediatric Obesity; Nutrition Disorders; Overnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      The goals of this study are to 1) pilot the feasibility of a novel meal kit delivery
      intervention in families and children with food insecurity and obesity and 2) evaluate the
      implementation of the pilot intervention.
    

Detailed description: 
      Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood,
      increasing the risks of chronic diseases such as type 2 diabetes. Households of children with
      obesity also face unmet social needs, such as food insecurity. Food insecurity is associated
      with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however,
      data are inconsistent and less known regarding longitudinal health effects in children.
      Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and
      lower-income households, there is an urgent need to examine and intervene in the social
      determinants associated with rising childhood obesity prevalence.
    

Intervention name(s): Meal Kit Delivery
Intervention type(s): Behavioral
Intervention description(s): Families receive 6 weeks of healthy meal kit delivery. Meal kits come with embedded nutrition education and access to online cooking demonstrations.
Other intervention name(s): EatWell Meal Kits
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Families will be randomized to one of two intervention sequences:
Meal kit intervention without delay followed by newsletter + pantry referral
Newsletter + pantry referral followed by meal kit intervention after a delay of 8 weeks
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food Insecurity; Nutrition Security
Cholecalciferol on Hemodialysis Patients
Condition: Hemodialysis Complication; Vitamin D Deficiency; Vascular Calcification
MeSH terms: Vitamin D Deficiency; Vascular Calcification
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      -  Screening the prevalence of vitamin D deficiency among Egyptian hemodialysis patients on
           a single center (Ain Shams University hospital).

        -  Assessing the effect of the native type of vitamin D (Cholecalciferol) on replenishing
           its deficiency via extra-renal vitamin D receptors (VDR), among Egyptian hemodialysis
           patients.

        -  Assessing the effect of cholecalciferol on vascular calcification among Egyptian
           hemodialysis patients.

        -  Assessing the effect of cholecalciferol on Blood pressure, parathyroid hormone.
    


Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Native vitamin D dose of 200IU to be given once per month to hemodialysis patients; A Placebo ampule will be given to hemodialysis patients once per month with their standard treatment for 3 months period. Same color, odor and size, only without the active constituent.
Other intervention name(s): Native vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Brain Oxygenation Marker for Cognitive Function in Healthy Adults
Condition: Mental Fatigue
MeSH terms: Mental Fatigue
Study type: Observational [Patient Registry]

Summary: 
      This study aims to identify a cortical oxygenation marker for cognitive function using
      functional Near Infrared Spectroscopy in healthy adults.
    

Detailed description: 
      This study will aim to establish a model between the cortical oxygenation and cognitive
      performances given modulations by experimental conditions including the cognitive workload
      and the time-on-task, and individual variabilities such as the age or the gender.
    

Intervention name(s): Cognitive intervention
Intervention type(s): Behavioral
Intervention description(s): This is a cognitive intervention consisting in the repetition according to three blocks, of cognitive tasks (Stroop and N-back tasks) at variating workload levels (low, middle and high levels). Each cognitive task will be presented for each workload level during three minutes.
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        The study population will comprise of 36 healthy adults from 25 to 45 years old.
      
Keywords: Cortical tissue oxygenation; Cognition; Time-on-task; Functional Near Infrared Spectroscopy
Low-dose Digital Radiographs in the Idiopathic Scoliosis
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The aim of the study is to evaluate the intraobserver repeatability and the interobserver
      reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients
      with idiopathic scoliosis.
    

Detailed description: 
      The 80% of scoliosis is idiopathic and begins mostly in adolescence (10-20 years).

      The young patients need to undergo several radiographic controls for a correct therapeutic
      balance. However, the repeated radiation exposures is associated with a greater risk of
      carcinogenesis even if reduced with a digital imaging technique.

      The aim of this study is to evaluate the intraobserver repeatability and the interobserver
      reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients
      with idiopathic scoliosis.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with suspected or known idiopathic scoliosis selected at the Rizzoli Orthopaedic
        Institute
      
Keywords: idiopathic scoliosis; radiographs; low dose
A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral
      or better than placebo in lowering ambient glucose levels during a graded glucose infusion
      (GGI) and that a single dose of OXM will lead to a statistically significant increase in the
      sum of the plasma βOHB + AcAc levels compared to placebo.
    


Intervention name(s): Oxyntomodulin (OXM); Comparator: Oxyntomodulin (OXM); Comparator: Placebo [ hemaccel-containing saline]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single infusion of OXM 3.0 pmol/kg/min by IV; Single infusion of OXM 0.6 pmol/kg/min by IV; Single Placebo infusion of hemaccel-containing saline by IV
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ketogenesis; Glucose-Dependent Insulin Secretion; Graded Glucose Infusion; Oxyntomodulin
Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three
      modified release formulations of PF-04937319 compared with the immediate release
      material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.
    


Intervention name(s): PF-04937319 IR MST; PF-04937319 MR 1; PF-04937319 MR 2; PF-04937319 MR 3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch; Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST; Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST; Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; bioavailability; type 2 diabetes mellitus; PF-04937319
Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
Condition: PCOS; Obesity
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether combined treatment with liraglutide and
      metformin is more effective than liraglutide or metformin as monotherapy in the treatment of
      obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders
      regarding weight reduction on metformin monotherapy. We anticipated greater changes in body
      weight in patients on combined treatment than in those on monotherapy with liraglutide or
      metformin.
    


Intervention name(s): metformin; liraglutide; metformin and liraglutide
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Glucophage tablets; Victoza 6 mg/ml solution for injection in pre-filled pen; Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen
Intervention MeSH terms: Metformin; Liraglutide; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; obesity; GLP-1 receptor agonist; liraglutide; metformin
Relationships and Health in the OEF/OIF Veteran Population
Condition: Stress Disorder; Marriage; Suicidal Ideation
MeSH terms: Suicidal Ideation
Study type: Observational

Summary: 
      The current study will explore relationships and health in the OEF/OIF Veteran population.
      Specifically, this study will examine PTSD symptom severity, traumatic brain injury,
      relationship satisfaction, leisure, general health ratings, feelings of burdensomeness and
      belongingness, and suicidal ideation.
    

Detailed description: 
      United States military troops returning home from Operation Enduring Freedom and Operation
      Iraqi Freedom deployments are presenting with "invisible wounds". These "invisible wounds"
      include mental health conditions such as posttraumatic stress disorder and traumatic brain
      injury. Recent literature has begun to explore how PTSD affects the service member, as well
      as their significant others. Several studies have shown that Veteran endorsement of PTSD
      symptoms is associated with decreased relationship satisfaction. Prior literature has shown
      that spending time together and engaging in pleasurable activities as a couple are important
      strategies for enduring relationship quality and satisfaction. Literature has demonstrated
      moderate relationships between PTSD and suicidal ideation. A previous study conducted by two
      of the investigators in this population showed that perceived feelings of burdensomeness and
      belongingness and identification of suicide as a potential strategy for dealing with these
      feelings. Joiner has hypothesized that acquired capacity of painful experiences, perceived
      burdensomeness and thwarted belongingness are the three components of increased suicide risk.
      Yet few studies exist that examine these constructs in the military population, though
      research indicates the clinical utility for exploring these constructs and related
      consequences.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        OEF/OIF Veterans receiving or eligible to receive care at the VA
      
Keywords: OEF/OIF Veterans; Relationships
Acute Effects of Continuous Verses Interval Aerobic Training in Spinal Cord Injury Patient
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      To determine the Acute effects of continuous verses interval aerobic training on autonomic
      dysreflexia in Spinal Cord injury Patient. To Determine the Acute effects of these training
      on, Exercise Self efficacy and pain.
    


Intervention name(s): Interval Aerobic Exercise training Group; Continuous Aerobic Exercise training Group
Intervention type(s): Other; Other
Intervention description(s): Interval Aerobic exercise will be on upper limb Bicycle with a pause of 3 mins interval Interval Aerobic Exercises: Frequency= 3 times per week Intensity= 50% of heart rate reserve for 2 mins 80% of heart rate reserve for 1 min Type= interval aerobic exercise Time= 40 minutes
There will be 5 minutes for warm up and 5 minutes for cool down.; Continuous Aerobic exercise will be on upper limb Bicycle Continuous Aerobic Exercise: Frequency= 3 times per week Intensity= 50% of heart rate reserve Type= continuous aerobic exercise Time= 40 minutes
There will be 5 minutes for warm up and 5 minutes for cool down.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Continuous Aerobic Exercise; Interval Aerobic Exercise