bioihbjkbjnl/mcl2 huggingface dataset:
Neuroimaging of Diet in ADHD: Phase I
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be
      placed on a restriction diet for a 5 week period. Children will be randomized to either
      receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a
      double blind fashion. It is hypothesized that children who are consistently on the restricted
      diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.
    

Detailed description: 
      The ADHD rating scale (RS) will be the principal behavioral outcome measure. We hypothesize
      that children on restriction diet will have significantly lower ADHD RS scores after 5 weeks
      relative to the Ruse diet group. In addition children will undergo functional magnetic
      resonance imaging (fMRI) at baseline and again at 5 weeks. Children will perform a flanker
      task known to engage the dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate
      cortex (ACC) during attention tasks. The children will also perform will look at pictures of
      appealing and unappealing food and rate whether they would like to eat it or not. This task
      is known to activate the ventral striatum (VS) (reward processing). A secondary hypothesis is
      whether children on the restricted diet will show changes in activity and connectivity of
      areas (DLPFC, ACC, VS) relative to those on the Ruse diet.
    

Intervention name(s): Restricted Diet; Ruse Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.; Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Diet; Functional Magnetic Resonance Imaging
Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate two treatment regimens for prostate cancer,
      prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0
      Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate
      cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external
      beam radiation therapy as their intended treatment will be eligible and will be offered
      participation.
    

Detailed description: 
      Approximately 250,000 men are currently diagnosed with prostatic cancer in the United States
      each year. Of those, 70% have stage T1 or T2 disease (apparently limited to the prostate
      gland). Clinically localized prostate cancer is a spectrum of disease, ranging from good
      prognosis to poor prognosis. Patients with a PSA above 10 ng/ml or Gleason score of 7 to 10
      are referred to as intermediate risk, with approximately an 80% chance of cure.

      Implantation of radioactive sources directly into the prostate (brachytherapy) delivers a
      high, localized radiation dose while sparing most the of the bladder and rectum.
      Brachytherapy is well established for other tumor sites, and has become a standard treatment
      for prostate cancer.

      Establishing that a good quality implant alone is as effective as implant plus beam radiation
      will allow us to routinely drop the use of beam radiation, a change in policy that will
      decrease the risk of some complications, will be more convenient for patients, and will lower
      treatment costs.
    

Intervention name(s): External beam radiation; Pd-103
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostatic Cancer; Brachytherapy; Prostatic neoplasm; Radiation therapy
Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study
Condition: Celiac Disease; Celiac; Diabetes Mellitus, Type 1
MeSH terms: Celiac Disease; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      To the investigators' knowledge, no single long-term prospective observational study has
      assessed dietary factors, diabetes clinical variables (metabolic control and associated
      complications), and self -perceived health and wellness in T1D patients (both pediatric and
      adult) with CD identified by screening (positive/weakly positive serology). The aim of the
      current study is to observe the short- and long-term outcomes for Type 1 diabetic patients
      with new serology positive asymptomatic CD.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with an established diagnosis of T1D and positive/weakly positive serologic CD
        after entering the screening portion of the CD-DIET study will be recruited to participate
        in this study.
      
Keywords: pediatric; dietary treatment; celiac disease; T1D
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors
Condition: Sleep; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The proposed study aims to determine whether an intervention to increase sleep in school-age
      children is associated with positive changes in eating, activity behaviors and zBMI. One
      hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly
      assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce
      a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in
      sleep). Families of children in the optimize sleep group will be taught effective behavioral
      strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month
      follow-up, the following will be gathered: sleep duration (measured by actigraphy), food
      intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry),
      the relative reinforcing value (RRV) of food (measured using a validated experimental
      paradigm), and measured child height and weight.
    


Intervention name(s): Optimize Sleep
Intervention type(s): Behavioral
Intervention description(s): Children are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep; Obesity; Children; Eating behaviors; Activity
Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy
Condition: Cerebral Amyloid Angiopathy
MeSH terms: Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called
      amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood
      vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more
      hemorrhages in the brain cortex in individuals 55 years of age or older. This study will
      examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the
      maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30
      and 60. Subjects will be followed for 6 months after receiving the last dose of study
      medication.
    


Intervention name(s): Ponezumab; placebo
Intervention type(s): Biological; Other
Intervention description(s): Infusion of Ponezumab (Day 1=10mg/kg; Day 30 and Day 60 dose = 7.5mg/kg) or placebo (saline); administered via infusion for a total infusion time of 20 minutes.; placebo (saline)- given via infusion total infusion time of 20 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral amyloid angiopathy (CAA); cerebrovascular reactivity; functional MRI; randomized; double blind; safety; efficacy
Phase 3 Safety and Imaging Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing Coronary Angiography
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate the ability of AI-700-enhanced rest-stress
      echocardiography to detect coronary artery disease (CAD) in patients with suspected ischemic
      heart disease who are indicated for coronary angiography.
    

Detailed description: 
      Assessment of myocardial perfusion has been demonstrated to provide both diagnostic and
      prognostic value to patients with ischemic heart disease by allowing the clinician to assess
      the hemodynamic significance of coronary artery disease (CAD). The primary objective of the
      clinical development program for AI-700 is to demonstrate the safety and efficacy of AI-700
      as an intravenous ultrasound contrast agent in patients with suspected myocardial perfusion
      defects.

      The patient population is comprised of patients being evaluated for inducible ischemia and
      indicated for coronary angiography. The primary study objective was to determine the
      accuracy, sensitivity, and specificity of AI-700-enhanced echocardiographic imaging for
      detecting CAD, using coronary angiography/left ventriculography (ANGIO/LVG) as the reference
      standard.
    

Intervention name(s): AI-700 contrast-enhanced echocardiography
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery disease; ischemia; echocardiography; cardiac imaging; heart disease; myocardial contrast enhancement; myocardial perfusion; wall motion; ultrasound contrast agent
Quercetin's Effect on Bone Health and Inflammatory Markers
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      Quercetin is a plant-based flavonoid that is naturally found in many fruits and vegetables,
      and is considered to be a potent antioxidant with several expected health benefits such as
      anti-inflammatory effects and bone-conserving properties. Participants will supplement with
      either Quercetin, or placebo, for 90-days with pre- and post-testing visits.
    

Detailed description: 
      Quercetin is a plant-based flavonoid that is naturally found in many fruits and vegetables
      such as onions, apples, berries, green tea, and red wine and is currently an FDA approved
      supplement. Quercetin is considered to be a potent antioxidant with several expected health
      benefits. Both in vivo and in vitro studies have demonstrated that quercetin acts as a potent
      natural osteogenic agent with benefits that include anti-inflammatory effects and
      bone-conserving properties. Quercetin is suggested to protect against bone loss by inhibiting
      bone resorption and stimulating bone formation which is indicated by an increase in bone
      mineral density and bone formation markers such as osteocalcin.

      The purpose of this study is to investigate the effects of quercetin supplementation on bone,
      specifically on bone turnover markers, in postmenopausal women. The interplay between
      cytokines (i.e., IL-6, CRP, and TNF-alpha) and bone turnover markers was also considered.

      In a double-blind, placebo-controlled fashion, we aimed to recruit 50, healthy,
      postmenopausal women between the ages of 45-75 years to participate in a 90-day supplement
      trial. Participants will be randomly assigned to one of two supplement groups: 1) quercetin
      500 mg, once per day, or 2) placebo (methyl cellulose E4M) 500 mg, once per day for 90-days.

      Participants will be asked to visit the laboratory (KSU Human Performance Laboratory) on 2
      separate occasions for pre- and post-testing visits consisting of body composition
      measurements and blood draws by a CITI approved/IRB approved research team member trained in
      phlebotomy under the supervision of Dr. VanDusseldorp.
    

Intervention name(s): Quercetin (500 mg); Placebo (500 mg)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Once-daily 500 mg Quercetin; Once-daily 500 mg methylcellulose 9E4M)
Intervention MeSH terms: Quercetin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind placebo controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bone turnover markers; Quercetin
Bioavailability and Pharmacokinetic Parameters of Watermelon (Rind, Flesh and Seeds) Polyphenols
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The primary objectives of the study are outlined below:

        1. To investigate the relative bioavailability and absorption/kinetic profile of
           polyphenols after consumption of watermelon rind, flesh and seeds, respectively in an
           acute pilot study.

        2. To study the effects of watermelon intake on endothelial function using the FMD
           technique and to understand the relationship between plasma metabolites, including
           L-citrulline and arginine, and FMD responses.
    

Detailed description: 
      The proposed trial will be a randomized, 4 arm, placebo controlled, within-subject crossover,
      study design. It is a pilot trial to establish methods and collect the preliminary data
      (N=6). Subjects meeting eligibility criteria (see eligibility criteria) will participate in 4
      study visits where they will receive one serving (equivalent to 100 kcal) of 1 of 4
      treatments: watermelon rind, watermelon flesh, watermelon seeds or placebo.

      Qualified subjects from the screening visit will be randomized into the study and provided
      with a standard breakfast consisting of a high carbohydrate and moderate fat western-type
      meal 3 hours after the treatment. Each subject will be asked to come for one screening visit,
      a pre-study visit, and four dinner pick-ups on the day before each of the four test visits.
      The study day visit will last for approximately 9 h with a follow up visit the next day (24
      h) for blood collection to allow for the characterization of target watermelon polyphenols
      and metabolites in plasma. Subjects will be instructed not to alter their usual diet or fluid
      intake during the study periods. Seven days prior to each study day visit, subjects will be
      advised not to consume fruits and vegetables rich in polyphenols and carotenoids or other
      high phytochemical foods (watermelon and products, arugula, spinach, tea, berries, grapes,
      carrots, tomatoes, sweet potatoes etc.).

      Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5,
      1, 2, 3, 4, 5, 6, 7, 8 h and 24 hour (h). An assigned test treatment will be provided
      immediately after the 0 h blood collection, a breakfast meal will be provided immediately
      after the 2 h blood collection, and lunch after 6 h blood collection. FMD will be measured at
      0 (fasting), 1, 3, 5, and 7h.
    

Intervention name(s): Watermelon Rind; Watermelon Flesh; Watermelon Seeds; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): watermelon rind; watermelon flesh; watermelon seeds; Control Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Watermelon; Watermelon phytochemicals bioavailability; Flow Mediated Vasodilation; Pharmacokinetics
The Efficacy of Gliatiline® on Post-stroke Patients With Vascular Cognitive Impairment no Dementia
Condition: Cognitive Impairment; Stroke
MeSH terms: Stroke; Dementia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      To date, there are no approved treatments for vascular cognitive impairment (VCI) and the
      main therapeutic efforts are aimed at controlling vascular risk factors for countering VCI
      development or progression. Several studies have reported cholinergic deficits in brain and
      cerebrospinal fluid of patients with VCI. The effect of choline alphoscerate in clinical
      studies of Alzheimer's disease and VCI improved memory and attention impairments. The purpose
      of our study is to determine effectiveness of choline alphoscerate vs placebo in improving
      cognition in post-stroke patients with VCI-non dementia (VCI-ND).
    

Detailed description: 
      Impaired brain cholinergic neurotransmission has a key role in the deterioration of cognitive
      functions in Alzheimer's disease and vascular cognitive impairment (VCI). These deficits,
      although are of different degree than those found in Alzheimer's disease, were suggested to
      be associated with VCI.To date, there are no approved treatments for vascular
      dementia(VaD)and the main therapeutic efforts in this field are aimed at controlling vascular
      risk factors for countering VaD development or progression.

      There have also been several trials of cholinesterase inhibitors for treatment of VCI.
      Available data suggest some evidence of benefit of cholinesterase inhibitors in subcortical
      vascular dementia and vascular cognitive impairment.

      Treated patients had modest benefits in cognition, attention, executive functioning and
      ability to perform instrumental activities of daily living, but the effect is too limited due
      to the small numbers of subjects examined and it is complex to establish the clinical
      relevance of these effects. The majority of clinical studies available on the effect of
      choline alphoscerate in neurodegenerative and cerebrovascular disorders were reviewed. A
      comparison of Alzheimer's disease assessment scale-cognitive subscale(ADAS-Cog)analysis with
      the results obtained on the same item in 4 trials with the cholinesterase inhibitor revealed
      a more positive trend with the cholinergic precursor choline alphoscerate than with this
      cholinesterase inhibitor.
    

Intervention name(s): choline alfoscerate; placebo (for choline alphoscerate)
Intervention type(s): Drug; Drug
Intervention description(s): Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®); Pill manufactured to mimic choline alfoscerate 400mg tablet
Other intervention name(s): Gliatilin®; placebo
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: VCI-HS; stroke; choline alphoscerate
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning
Condition: Retinal Artery Occlusion; Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion; Retinal Artery Occlusion
Study type: Interventional

Summary: 
      Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue
      against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown
      whether this can be used in retinal vascular occlusive diseases. The purpose of the present
      study is to examine whether the autoregulation of retinal vessel diameters in normal persons
      change after remote ischemic conditioning.
    


Intervention name(s): Remote ischemic conditioning
Intervention type(s): Procedure
Intervention description(s): Briefly reversible restricting of blood flow to upper limb in four cycles of 5 minutes of inflation at 200mm Hg followed by 5 minutes of deflation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Aripiprazole on Cocaine Craving and Self-Administration
Condition: Cocaine Abuse
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether aripiprazole will decrease cocaine
      self-administration, subjective effects and cravings compared to placebo.
    

Detailed description: 
      Despite the recent increase in data about cocaine's basic neurochemical mechanisms of action,
      progress towards the development of an effective pharmacological treatment for cocaine abuse
      has been disappointing. We are proposing to use our laboratory model of repeated dose cocaine
      self-administration to assess the potential efficacy of the novel antipsychotic,
      aripiprazole. Aripiprazole is a partial agonist at both the dopamine D2 receptor and at the
      serotonin 5HT1a receptor, while antagonizing the 5HT2a receptor. By functioning as a partial
      D2 agonist, aripiprazole is hypothesized to function as a D2 antagonist during
      hypodopaminergic states, such as during cocaine use, while functioning as a D2 agonist during
      hypodopaminergic states, such as during cocaine withdrawal. This 42-day,
      outpatient/inpatient/outpatient/inpatient protocol will evaluate the effects of aripiprazole
      maintenance (0, 15 mg/day) on cocaine craving, subjective effects, and self-administration
      using a within-subjects design. Non-treatment seeking cocaine abusers will be maintained
      outpatient for 16 days of dose maintenance prior to inpatient cocaine self-administration
      sessions. During the inpatient phases, volunteers will live on a hospital clinical research
      unit and will participate in laboratory sessions in which they will have the opportunity to
      choose between repeated doses of smoked cocaine and $5. In addition to measuring their
      cocaine self-administration, we will measure the cardiovascular and subjective effects of
      cocaine under each aripiprazole maintenance condition.
    

Intervention name(s): Aripiprazole + Cocaine; Placebo + Cocaine
Intervention type(s): Drug; Drug
Intervention description(s): Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).; Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Other intervention name(s): Active; Placebo
Intervention MeSH terms: Cocaine; Aripiprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In order to achieve steady-state concentrations, participants (n=8 men) were administered placebo and aripiprazole (15 mg/day) capsules in counter-balanced order for 21 days. A smoked cocaine dose-response curve (0, 12, 25, 50 mg) was determined twice under placebo and aripiprazole maintenance.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aripiprazole; Cocaine abuse