bioihbjkbjnl/mcl2 huggingface dataset:
Montmorency Cherry Juice and Uric Acid Metabolism
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Cherries have been show to possess the ability to reduce uric acid concentrations and
      inflammation. Tart Montmorency cherries possess a higher concentration of the plant compounds
      than other cherries and hence makes the expectation possible that Montmorency cherries will
      lower uric acid and inflammation.
    

Detailed description: 
      Plasma and urinary uric acid concentration, plasma phytochemical content and inflammatory
      biomarkers will be measured in order to elucidate the effects of an acute dose of tart cherry
      juice on indices related to the condition of gout.

      Participants will be required to attend the laboratory at a range of time points over two
      periods of 96 hours, separated by a 7 day washout period, to provide blood samples. In order
      to provide a baseline sample, participants will attend the laboratory in the morning
      following an overnight fast and voiding of any urine. Following this participants will be
      given 30mls (30 mls provides 323 mg/380 µmol of anthocyanins) of tart cherry juice or
      placebo, diluted with 60 mls of water to consume within 10 minutes. Participants will be
      required to consume identical dosages of the supplement immediately prior to evening meals
      and breakfasts (or same time each morning following blood sampling if non-breakfast eater)
      over the next 96 hours. Further blood and urine samples will be collected at 1, 2, 3, 5, 8,
      24, 26, 48, 50, 72, 74 and 96 hours and will require participants to return to the laboratory
      at each of these time points. Following the first period of supplementation participants will
      complete a 7 day washout period in which they will not be required to attend the laboratory.
      Following the washout period they will repeat the supplementation period consuming the
      supplement they did not receive during the first period.
    

Intervention name(s): Montmorency cherry concentrate
Intervention type(s): Dietary Supplement
Intervention description(s): Tart Montmorency cherry juice concentrate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: Montmorency tart cherries; Inflammation; Uric acid
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of a parent training program in the
      treatment of social and communication deficits in children with autism. Specifically, this
      study will evaluate a developmentally based parent delivered intervention in the community
      developed by Pacific Autism Center for Education (PACE).
    

Detailed description: 
      There are many treatments that claim to be effective for children with autism; however many
      of these treatments have not been investigated using scientifically rigorous methodology. A
      variety of developmentally based parent delivered interventions are gaining popularity as a
      type of treatment parents utilize to improve symptoms related to their child's diagnosis of
      autism. Pacific Autism Center for Education (PACE)is a agency that provides a developmentally
      based parent delivered intervention in the community. Currently, this parent training program
      has not been evaluated using scientific methodology. Investigation into this community
      delivered treatment and its effectiveness to improve social and communication deficits will
      aid clinicians in providing better care for children with autism.
    

Intervention name(s): Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Intervention type(s): Behavioral
Intervention description(s): Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PACE
Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess
      the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy
      Filipino participants aged 6 months to 45 years.
    


Intervention name(s): EuTCV (Vi-CRM Typhoid conjugate vaccine); Typbar-TCV
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, Intramuscular administration; Single dose, Intramuscular administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of Early Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      Establishing that mucosal healing (MH) has occurred after therapy is an important treatment
      goal, and the gold standard is endoscopic evaluation. In UC it is unclear if clinical
      parameters are adequate. The pediatric ulcerative colitis activity index (PUCAI) has
      demonstrated good correlations for clinical remission and disease severity, but its role for
      establishing mucosal healing after therapy has not been validated . The ability to predict
      mucosal healing may be different for patients in long term remission compared to assessment
      after obtaining clinical remission. No previous study has prospectively validated the use of
      PUCAI as a proxy for MH specifically during clinical remission after therapy.
    

Detailed description: 
      All pediatric patients ≤ 19 years old and at the Wolfson Medical Center pediatric IBD center
      who enter clinical remission are routinely assessed by colposcopy or sigmoidoscopy assess.
      This is an analysis of prospectively collected data regarding PUCAI and endoscopic Mayo score
      at the time of assessment of mucosal healing by endoscopy. Patients could be included if they
      have establish ulcerative colitis, while they are on remission for at least 3 months after
      treatment of flare. For this study, complete clinical remission was absence of abdominal
      pain, and no diarrhea or bleeding (PUCAI<10). sigmoidoscopy will be performed between 12-24
      weeks after remission was documented.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients could be included if they have establish ulcerative colitis, while they are on
        clinical remission
Apply the (MyTransition) App In Transition
Condition: Chronic Health Condition
MeSH terms: Disease
Study type: Interventional

Summary: 
      Moving from child care to adult care is a hard time for patients and their families. Parents
      of children with chronic conditions say they need more support around the time of changing
      care. Care providers say they do not have the tools to provide smooth transitions or help
      their patients manage their own health. This study is to see if a smart-phone-based app
      (named MyTransition) can improve healthcare transition experiences and health outcomes for
      youth, compared to usual care.
    

Detailed description: 
      Transition to adult care is an unavoidable and challenging period for patients and their
      families, and comes with adverse outcomes in experience of care, population health, and
      costs. Parents of children with chronic conditions report a greater need for support around
      the time of healthcare transition. Providers report neither having the tools nor appropriate
      resources to foster smooth transitions for patients and their families. We hypothesize that
      an app-based transition toolkit (named MyTransition) designed to support youth moving from
      child to adult care can improve their experiences and lead to better health. The main
      objective of this study is to collect information to design a large multi-centre randomized
      control trial to assess implementation of the MyTransition app including recruitment,
      completion of follow-up, and scale-ability of the intervention. The secondary objective is to
      assess the feasibility and potential effect of the MyTransition app-based transition toolkit
      for improving health of youth (quality of life), healthcare transition experience, and
      achievement of health and life goals.
    

Intervention name(s): MyTransition app
Intervention type(s): Other
Intervention description(s): MyTransition app is designed to support youth moving from pediatric to adult healthcare.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After completing the baseline assessment, participants will be randomized into one of two groups: intervention or control. Those in the control group will be thanked for their time and informed that the research coordinator will be in touch to set up the follow-up visits (3- and 6-months following baseline). Those in the intervention group will be provided access to the MyTransition app (intervention). The research coordinator will help them navigate through the app and will instruct them on how to use it. These participants will also receive monthly reminder messages from the research coordinator to promote the use of the app.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Transition; Improved patient outcomes; RCT; Child health; Empower youth
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an
      extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to
      placebo when administered to healthy adult participants.
    

Detailed description: 
      This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to
      evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when
      administered to healthy adult participants. There were 136 participants randomized to receive
      MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to
      3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational
      product were evaluated across the 5 cohorts. Participants were followed for approximately 1
      year.
    

Intervention name(s): MEDI8897 Intravenous; Placebo; MEDI8897 Intravenous; MEDI8897 Intravenous; MEDI8897 Intramuscular; MEDI8897 Intramuscular
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.; Participants received placebo on Day 1.; Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.; Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.; Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.; Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus, RSV
A Study to Assess the Absorption, Metabolism and Excretion of Migalastat Hydrochloride (AT1001-014)
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to describe the metabolism of AT1001 (migalastat HCl) and the
      contribution of metabolism and urinary excretion to its overall elimination as part of the
      continuing assessment of the safety and effectiveness of the drug.

      This is a Phase 1, single-site, open-label, single dose study of the absorption, metabolism
      and excretion of radiolabeled AT1001 in healthy male subjects between 30 and 55 years of age,
      inclusive. Six subjects will be dosed, with the goal of having at least 4 subjects complete
      the study through follow-up. All subjects will be screened within 28 days before admission to
      the Clinical Unit. Subjects will be confined to the clinical unit for 10 days after dosing
      and will return to the clinic for a follow-up visit 28 days after dosing.

      Each subject will receive a single oral dose of AT1001 as an aqueous solution containing 150
      mg [14C] AT1001 (1 μCi). Blood, duodenal bile, expired air, urine, and feces samples will be
      collected at specified time points after dosing throughout the period of confinement at the
      study site. Safety will be assessed throughout the study by monitoring clinical laboratory
      tests, ECGs, physical examinations, vital signs, and adverse events. The total duration of
      the study for each subject is approximately 8 weeks.
    


Intervention name(s): [14C] AT1001
Intervention type(s): Drug
Intervention description(s): 150 mg of [14C] labelled AT1001 will be administered as a solution (prepared by weighing 150 mg of AT1001 powder and dissolving in 100 mL of water). The entire solution will be swallowed orally. After ingestion of study medication, the dosing bottle will be rinsed with 50 mL of water and this will be ingested by the subject. This rinse procedure should be performed twice. Following the second rinse ingestion, the subjects should be instructed to drink additional water to bring the total volume ingested to 240 mL.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: excretion; healthy volunteer; migalastat hydrochloride; AT1001; pharmacokinetics; Fabry disease
Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication
Condition: Cardiovascular Diseases; Hepatitis C; Hiv
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an interventional, non-randomized, controlled prospective study to treat HCV in
      mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV
      mono-infected controls. This pilot study will demonstrate whether functional cure of HCV
      reduces myocardial injury and risk of cardiovascular disease.
    


Intervention name(s): Elbasvir / Grazoprevir Oral Tablet [Zepatier]; Cardiac MRI
Intervention type(s): Drug; Procedure
Intervention description(s): All approved direct-acting antivirals for hepatitis C will be used as the intervention.; Cardiac MRI to assess for myocardial function and fibrosis
Other intervention name(s): Sofosbuvir/Ledipasvir; Sofosbuvir/Velpatasvir; Glecaprevir/Pibrentasvir; Sofosbuvir/Velpatasvir/Voxilaprevir
Intervention MeSH terms: Sofosbuvir; Grazoprevir; Ledipasvir; Velpatasvir; Elbasvir-grazoprevir drug combination; Sofosbuvir-velpatasvir drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cardiovascular Disease
Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Condition: Cerebral Palsy; Hemiplegia; Children; Pediatric
MeSH terms: Paralysis; Cerebral Palsy; Hemiplegia
Study type: Interventional

Summary: 
      A randomized control trial of bimanual training. The protocols have been developed at
      Columbia University to be child friendly and draws upon our experience since 1997 with
      constraint-induced movement therapy in children with cerebral palsy.
    

Detailed description: 
      A new treatment involving bimanual (Hand-Arm Bimanual Intensive Therapy (HABIT). The
      protocols have been developed at Columbia University to be child friendly and draws upon our
      experience since 1998 with constraint-induced movement therapy in children with cerebral
      palsy. The interventions are performed in a 15 day day-camp setting with several children and
      at least one therapist per child. We have conducted 24 day camps to date since 2002, and are
      now collaborating with clinicians worldwide to expand our treatment availability. The aim is
      to promote the use of and improve the coordination of movement of both hands together.
      PARTICIPATION IS FREE. Please check out our website for more information:
      http://www.tc.edu/centers/cit/.
    

Intervention name(s): Constraint-Induced Movement Therapy (CIMT); Hand-Arm Bimanual Intensive Therapy (HABIT)
Intervention type(s): Procedure; Procedure
Intervention description(s): 90 hours; 90 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; constraint-induced therapy; constraint-induced movement therapy; CP; hemiplegia; hand; forced use; motor control; children; HABIT; Hand-arm bimanual intensive therapy; Bilateral training; Bimanual training; functional therapy; physical therapy; occupational therapy; intensive; pediatric; development; upper extremity; hemiplegic
Metabolic Cost of Bodyweight Training
Condition: Body Composition; Physical Fitness; Energy Expenditure; Resting Metabolic Rate
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      In this study, the investigators will be able to estimate the metabolic cost of several
      foundational bodyweight training exercises.
    

Detailed description: 
      Bodyweight training has become a popular cardiovascular training choice in fitness centers
      and athletic performance enhancement facilities. Despite widespread use and growing
      popularity, little is known about the metabolic demands of such a training method. Therefore,
      the purpose of this study was to quantify the cardiovascular and metabolic cost from various
      foundational bodyweight exercises in order to contribute to a better planning of exercise
      programs in the real world.

      Ten healthy young adults were assigned to execute seven bodyweight exercises (acute bout) for
      30 and 45 seconds. Anthropometric, metabolic, and performance measurements were conducted at
      baseline. The metabolic cost was estimated from heart rate, blood lactate, resting oxygen
      uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements
      using a portable gas analyzer.
    

Intervention name(s): TR-30; TR-45
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Bodyweight training exercises will be performed for 30 seconds and the training volume will be consisted of 1 repetition.; Bodyweight training exercises will be performed for 45 seconds and the training volume will be consisted of 1 repetition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: functional fitness training; bodyweight training; energy expenditure; oxygen consumption; resistance training
ClearUP Longitudinal Pilot Study
Condition: Sinus Pain; Congestion
Study type: Interventional

Summary: 
      Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain
      Relief for four weeks.
    


Intervention name(s): ClearUP Sinus Pain Relief
Intervention type(s): Device
Intervention description(s): Microcurrent Device Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation Of TBI Detection System For Head Injured Patients
Condition: Brain Injuries
MeSH terms: Brain Injuries
Study type: Observational

Summary: 
      A prospective, non-randomized trial to validate the database of brain electrical activity
      recordings and clinical information collected from patients who present to the ED following
      closed head injury.
    

Detailed description: 
      The objective of this study is to validate the clinical utility of the BrainScope technology
      for the acute identification of structural brain injuries in a TBI population presenting to
      the ED with mild symptoms, following closed head injury.
    

Intervention name(s): BrainScope Ahead 200
Intervention type(s): Device
Intervention description(s): A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are suspected of a traumatic, closed head injury within 72 hours will be
        recruited from patients who enter the Emergency Department at hospitals that are
        participating as clinical sites for this study.
The Kilimanjaro Cervical Screening Project
Condition: Uterine Cervical Neoplasms; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      Although highly curable, cervical cancer kills thousands of women in developing countries
      annually. The investigators will pilot a project to improve detection of cervical cancer in
      Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise
      available in a large medical centre and remote use of a mobile phone camera application.
    


Intervention name(s): Cervical cancer screening
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening