bioihbjkbjnl/mcl2 huggingface dataset:
Assessing Risk of Food Insecurity Within Households of Children With Food Allergy
Condition: Food Allergy; Asthma; Allergic Rhinitis; Atopic Dermatitis; Eosinophilic Esophagitis
MeSH terms: Rhinitis; Esophagitis; Eosinophilic Esophagitis; Rhinitis, Allergic; Dermatitis; Hypersensitivity; Food Hypersensitivity
Study type: Observational

Summary: 
      Our central hypothesis is that dietary limitations introduced by food allergy will contribute
      to increased food insecurity in households with food allergic children when compared to food
      insecure households without food allergic children.
    

Detailed description: 
      Specific Aim 1 To describe food insecurity in families of the pediatric allergy population,
      specifically comparing the prevalence of food insecurity rates between households of food
      allergic patients and households of allergic patients without food allergy.

      Specific Aim 2 To examine health literacy in parents of patients in the pediatric allergy
      population, comparing food insecure patients with and without food allergy to food secure
      patients with food allergy.

      Specific Aim 3 To examine quality of life in food allergic patients' households using the
      food allergy impact scale, comparing food allergic patients' households with food insecurity
      to food allergic patients' households without food insecurity.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Families with children who have allergy appointments at Arkansas Children's Hospital
        between 1-17 years of age. We will recruit 325 families with patients in the food allergy
        group and 325 families with patients in the without food allergy group.
      
Keywords: Food insecurity; Health literacy; Quality of life
Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
Condition: Obesity; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance; Metabolic Diseases
Study type: Interventional

Summary: 
      Studies of the human gut microbiome have suggested that treatment or prevention aimed at the
      obese microbiome could influence the development of obesity-associated metabolic
      disturbances.

      The objective of this project is to explore if a dietary intervention in 60 obese women with
      the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the gut
      microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to
      explore the interaction between the human genome and the gut microbiome.

      The study is based on the following hypotheses:

        -  Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed
           fibres will lower the metabolic risk profile in the intervention groups compared with
           placebo.

        -  The effect on the metabolic risk markers can be correlated with changes in the gut
           microbiota (measured in faeces).

      After completion of the dietary intervention, the participants are offered a 10-week weight
      reduction program. Those who participate in the weight-loss program are invited to an
      optional follow-up visit in connection with the last visit at the clinical dietician, for the
      purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated
      metabolic disturbances.
    


Intervention name(s): Lactobacillus paracasei ssp paracasei F19; Flax seed fibres; Maltodextrin (Placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day); 10 grams of flax seed fibres per day (baked into two breakfast buns); Maltodextrin is dissolved in a glas of water once per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Obesity; Insulin resistance; Microbiota; Probiotic; Prebiotic
Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis
Condition: Palmar Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Observational

Summary: 
      T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for
      primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional
      thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. The
      team from thoracic department of Peking University People's Hospital discovered that the
      sympathetic ganglions can be visualized with fluorescent thoracoscopy. Thus, investigators
      want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct
      a more precise operation and compare the efficiency of the novel and traditional methods.
    


Intervention name(s): Near-Infrared Imaging Thoracoscopy
Intervention type(s): Procedure
Intervention description(s): Sympathicotomy performed by near-infrared imaging thoracoscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients suffering from primary palmar hyperhidrosis
An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71
      Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy
      infants volunteers aged from 6 to 35months old.
    

Detailed description: 
      The phase II study of inactivated vaccine (vero cell) against EV71 has completed on Dec 2011
      in China. The data from the phase I and II study suggested that the inactivated EV71 vaccine
      had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. In
      order to evaluate the efficacy of the vaccine against Hand, Foot and Mouth disease caused by
      EV71, and to further explore the safety profile of this vaccine in expending infant
      population, a phase III clinical trial is planed to conduct.
    

Intervention name(s): 400U /0.5ml EV71 vaccine; 0/0.5ml placebo
Intervention type(s): Biological; Biological
Intervention description(s): inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval; 0/0.5ml placebo, two doses, 28 days interval
Other intervention name(s): EV71 vaccine; placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: EV71 vaccine; HFMD; efficacy; EV71 associated disease
Effect of Exercise on Genes That Control Muscle Function
Condition: Healthy
Study type: Interventional

Summary: 
      The proposed project will examine how exercise counteracts metabolic disorders and type 2
      diabetes through regulating gene expression. The project is highly relevant to public health
      because of the global pandemic of diabetes, obesity, and associated metabolic syndromes as
      well as the well-known metabolic benefit of physical exercise in correcting these disorders.
    

Detailed description: 
      Exercise is a first-line treatment for type 2 diabetes, and exerts its beneficial effects not
      only by burning off energy but also by causing prolonged metabolic changes through changing
      gene expression. Genes are our genetic materials and the expression of genes determines our
      biology. In our previous study in animals, we identified some factors that drive
      exercise-induced gene expression changes. Here we would like to address whether the result is
      also true in human. This work will provide molecular insights into how exercise remodels our
      metabolism and will potentially find a way to maximize the benefit we get from physical
      exercise.

      The purpose of this study is to determine whether acute exercise activate certain molecular
      factors in human skeletal muscle. Participants will be asked to undergo an acute bout of
      aerobic exercise at ~ moderate intensity for about 2 hours. Before and after the exercise,
      the participants will undergo a muscle biopsy. The muscle tissues will be used for total RNA
      extraction and RT-qPCR analysis of genes that include but are not limited to de facto
      JunD/AP-1 target genes and will also be analyzed by Jun D Chip-qPCT to assess binding of Jun
      D on its de facto target genes.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Acute bout of aerobic exercise at moderate intensity for 2 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
Condition: Healthy
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1

Summary: 
      Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot
      of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for
      all S. sonnei vaccine candidates. An adaptable dosing plan was used to determine the dose of
      Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.
    

Detailed description: 
      Primary objectives:

        1. Establish a human challenge model of S. sonnei 53G infection using a lyophilized
           formulation of the challenge strain.

        2. Identify a dose of lyophilized S. sonnei 53G that induces the primary outcome in
           approximately 60% of subjects with no adverse safety concerns.

      Secondary objectives:

        1. Estimate quantitative shedding and basic immunogenicity of the challenge strain.

        2. Collect and archive blood and fecal samples for systems biology, microbiome, and other
           omics-based work to be conducted under a separate research protocol in future studies.
    

Intervention name(s): Shigella sonnei 53G
Intervention type(s): Biological
Intervention description(s): Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: shigella
Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Study Objective:

      Primary

      1. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel,
      Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with
      intensity-modulated radiotherapy (IMRT).

      Secondary

        1. To determine the overall response rate.

        2. To determine the locoregional and distant control rate

        3. To determine the progression-free survival (PFS)

        4. To determine the overall survival (OS)

        5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus
           Cetuximab.
    


Intervention name(s): Docetaxel, Cisplatin, 5-FU and Cetuximab
Intervention type(s): Drug
Intervention description(s): Induction phase (Weeks 1-9):
Drug Docetaxel Docetaxel 75 mg/m2 IV, D1 every 3 weeks for 3 cycles
Drug Cisplatin Cisplatin 75 mg/m2 IV, D1 every 3 weeks for 3 cycles
Drug Fluorouracil Fluorouracil 750 mg/m2 IV, D1-4 every 3 weeks for 3 cycles
Concurrent phase (weeks 10-16):
Drug Docetaxel Docetaxel 15 mg/m2 IV, D1 weekly for 7 weeks (Weeks 10-16)
Drug Cetuximab Cetuximab 400 mg m2 IV, D1 initial dose, then 250 mg/m2 weekly for 7 week (Weeks 10-16)
IMRT (60 Gy to GTV or biological dose equivalent): 2 Gy/fraction/day, D1-5 per week, for 6 weeks (Weeks 11-16)
Intervention MeSH terms: Docetaxel; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: induction chemotherapy; docetaxel; cisplatin; fluorouracil; cetuximab; intensity-modulated radiotherapy
A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions
Condition: Anxiety Disorders; Separation Anxiety Disorder; Phobic Disorders
MeSH terms: Anxiety Disorders; Anxiety, Separation; Phobic Disorders
Study type: Observational

Summary: 
      The purpose of this trial is to study how teens with and without an anxiety disorder make
      decisions.

      This is a brain imaging study using functional magnetic resonance imaging (fMRI) in
      adolescents between the ages of 13 and 17.
    

Detailed description: 
      Preliminary analyses of behavioral data showed no group differences in response times during
      the decision-making games. However, behavioral ratings of certainty during the task showed
      differences between groups. Anxiety-disordered participants indicated lower levels of
      certainty during the most uncertain conditions of the task (p < .05). This difference was
      consistent with the study hypothesis. Within-subjects analyses of the decision-making tasks
      showed that subjects responded as expected. Reaction times (RT) during uncertain conditions
      of the HiLo-Game were significantly longer than during more certain conditions (p = .001).
      Diary Task RTs for rating ambiguous situations were significantly longer than ratings of
      unambiguous situations (p = .019). Preliminary Analyses showed a significant correlation
      between Intolerance of Uncertainty (IU) and RT during the Marble Task (r = -0.54, p < .05).
      Preliminary analysis also showed significant correlation between ratings of level of anxiety
      during the diary task and IU, IS, MASC and the child version of the SCARED. These preliminary
      results were not submitted for publication.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Anxious and healthy adolescents
      
Keywords: Anxiety; Adolescence; Generalized Anxiety Disorder
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Condition: Deep Vein Thrombosis; Venous Thromboembolism
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a
      single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy
      to see what the body does to the drug (pharmacokinetics) and what the drug does to the body
      (pharmacodynamics), and to compare if these effects are similar to those observed in adults.
    

Detailed description: 
      Phase 1, open-label, multiple-center study in pediatric patients from 0 to < 18 years of age.
      Patients will receive a single dose of edoxaban to match either the 30 mg (low dose) or the
      60 mg (high dose) exposure in adults. Exact doses will be selected during the study on the
      basis of PK modeling of emerging data. If unanticipated exposures are observed, the target
      doses may be modified to best match expected exposure response relationships observed in
      adults.

      Enrollment in the study will start with the low dose, highest age group (adolescents) and
      will continue from low to high dose in each age group and from higher to lower age groups.
      Enrollment in the next dose/age cohort will begin after 50% of the subjects have completed
      the previous dose/age cohort.

      Age cohorts and dose groups: (6 participants each in low and high dose groups, for a total of
      12 participants per age cohort)

        -  12 to < 18 years of age

        -  6 to <12 years of age

        -  2 to <6 years of age

        -  6 months to <2 years of age

        -  0 to <6 months of age
    

Intervention name(s): Edoxaban low dose; Edoxaban high dose
Intervention type(s): Drug; Drug
Intervention description(s): Edoxaban low dose; Edoxaban high dose
Intervention MeSH terms: Edoxaban
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pediatric; Pharmacokinetics (PK); Pharmacodynamics (PDy); Anticoagulant; Safety
Intravenous Fluid for Pediatric Migraine in the Emergency Department
Condition: Migraine; Headache
MeSH terms: Migraine Disorders; Emergencies; Headache
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of intravenous fluid (0.9% sodium
      chloride and water) alone on headache pain in children with migraine visiting the Emergency
      Department.
    

Detailed description: 
      Migraine is a common and disabling disorder for children. The pain may be severe and
      relatively few effective medications are approved for use in children. The Emergency
      Department (ED) remains an important resource for children suffering from migraine whom have
      not responded to their usual therapy. While a number of effective intravenous therapies have
      been studied in adults, there has been only one such study in children. As such, emergency
      physicians have little or no information about the safety and efficacy of these medications
      in children. However, the conduct of clinical trials where pain is the outcome measure is
      often limited by a high placebo-response rate. The expectation of treatment can significantly
      alter the response to medications especially when pain severity is the outcome measure.
      Moreover, the investigators have found that intravenous fluid alone may help to treat
      migraine headache in children. The investigators propose a study to examine the response to
      intravenous fluid hydration as initial therapy comparing a group with expectation of
      medication and another group without the initial expectation of medication. The results of
      the study will help to estimate the rate of response to intravenous fluid and to evaluate the
      placebo-effect (i.e. expectation of treatment) in studies of migraine treatment in the ED.
      Exposure to additional and possibly unnecessary medications will thus be minimized and the
      results of future trials more definitive on the effect of the study medication.
    

Intervention name(s): Normal saline
Intervention type(s): Drug
Intervention description(s): 10 ml/kg of normal saline will be administered over 30 minutes
Other intervention name(s): 0.9% sodium chloride and water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: migraine; headache; pediatric; children; Emergency Department
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin®
      (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the
      pharmacokinetics, safety, tolerability and immunogenicity.
    


Intervention name(s): ALT02; EU-licensed Herceptin; US-licensed Herceptin
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HER2 Positive Breast Cancer; Trastuzumab; Biosimilar
A Phase 1B Dose-escalation and Phase 2a Study of Carotuximab (TRC105) in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma
Condition: Advanced Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a
      recommended phase 2 dose for TRC105 when added to standard dose pazopanib in patients with
      advanced soft tissue sarcoma. Up to 30 patients will be treated.

      The purpose of the phase 2 portion is to estimate the PFS of patients with advanced soft
      tissue sarcoma by RECIST 1.1 and estimate ORR in a separate cohort of patients with
      angiosarcoma by RECIST 1.1. Up to 89 patients will be treated in phase 2, including two
      cohorts of up to 13 patients with angiosarcoma.
    

Detailed description: 
      Pazopanib is an oral inhibitor of multiple receptor tyrosine kinases, including vascular
      endothelial growth factor receptor VEGFR-1, VEGFR-2, and VEGFR-3 at therapeutic plasma
      concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and
      cancer progression. Pazopanib is approved for the treatment of advanced soft tissue sarcoma,
      following progression on one prior systemic therapy, based on improved progression free
      survival. TRC105 is an antibody to CD105, an important angiogenic target on vascular
      endothelial cells that is distinct from VEGFR. TRC105 inhibits angiogenesis, tumor growth and
      metastases in preclinical models and complements the activity of bevacizumab and multi-kinase
      inhibitors that target the VEGFR. In a phase 1 study of advanced solid tumors, TRC105 therapy
      caused a global reduction in angiogenic biomarkers and reduced tumor burden at doses that
      were well-tolerated. In a phase 1b study, the combination of TRC105 and bevacizumab produced
      radiographic reductions in tumor volume in bevacizumab-refractory patients, and was well
      tolerated. TRC105 potentiates bevacizumab and VEGFR tyrosine kinases (VEGFR TKI) in
      preclinical models. By targeting a non-VEGF pathway that is upregulated following VEGF
      inhibition, TRC105 has the potential to complement VEGFR TKIs and could represent a major
      advance in cancer therapy. Together, the use of TRC105 with pazopanib may result in more
      effective angiogenesis inhibition and improved clinical efficacy over that seen with
      pazopanib alone.
    

Intervention name(s): TRC105 and Pazopanib
Intervention type(s): Drug
Intervention description(s): Weekly TRC105 in combination with standard dose Pazopanib.
Other intervention name(s): Chimeric Antibody (TRC105) to CD105; Votrient
Intervention MeSH terms: Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TRC105; CD105; Endoglin; Angiogenesis Inhibitor; STS; Soft Tissue Sarcoma; TKI; Tyrosine Kinase Inhibitor; Pazopanib; Votrient; Advanced Soft Tissue Sarcoma; Angiosarcoma