bioihbjkbjnl/mcl2 huggingface dataset:
Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS)
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      To assess zinc-related biochemical and functional responses among young Burkinabe children
      with a presumed high risk of zinc deficiency who receive micronutrient products containing
      different amounts of zinc, provided with or between meals.
    

Detailed description: 
      Young healthy children will be identified by periodic consensus in the study area. 3200
      infants meeting a set of eligibility criteria will be randomly assigned to receive
      lipid-based nutrient supplements (LNS) with different amounts of zinc and a placebo or zinc
      supplement from 9 to 18 months of age. The families will receive the respective supplement at
      weekly intervals and the participants undergo a morbidity evaluation weekly, anthropometric
      evaluation at 9, 12, 15 and 18 months and laboratory analyses at enrollment and at 18 months
      of age. Growth outcomes will be analyzed during the two-year follow up at 24, 30, 36 and 42
      months of age.
    

Intervention name(s): LNS-Zn5; LNS-Zn10; LNS-Zn0; Suppl-Zn5
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement; Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement; 20 g of LNS containing 0 mg of zinc and a daily placebo supplement; Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc
Other intervention name(s): Nutriset; Nutriset; Nutriset; Nutriset
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: point-of-use fortification; zinc supplement; lipid-based nutrient supplement; zinc deficiency; micronutrient deficiency; anemia
An Integrative Approach to Improve Child Outcomes Through Research-based Parent and Teacher Interventions
Condition: Growth & Development
Study type: Interventional

Summary: 
      The purpose of this study is to learn whether a combination of two research-proven programs,
      a responsive caregiving parenting program and a teacher training program, will have an effect
      on infants' and toddlers' language, cognitive, social-emotional, and self-regulation skills.
      The interventions are designed to specifically target parent use of a responsive, stimulating
      caregiving style in the home in combination with teacher instructional practices and the use
      of a responsive interactive style in the classroom.
    


Intervention name(s): PALS and; BEECH; Control condition
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Play and Learning Strategies (PALS) include web-based parent training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input.
Parents will begin their 11 week (infant) or 14 week (toddler) parenting program in October and complete it by April. There will be monthly Parent Meetings related to the content they are learning online. Post-assessments will occur in late April and May. Each weekly online parent session will take approximately 30 minutes to complete with a 40 - 60 minute weekly remote coach call.; Beginning Education: Early Childcare at Home (BEECH) includes web-based teacher training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input.
Teachers will complete the 20 online sessions weekly, except for planned center closings due to holidays or agency-related events. The three in-person trainings will occur before Session 1 and after Sessions 8 and 14. Each weekly online teacher session will take approximately one-hour for a teacher to complete with a 30 minute weekly remote coach call. Each in-person teacher training will be 6-hours in duration.; Parents and teachers conduct business as usual in regards to care-giving in the school and at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Oxytocin Effects on Self and Other Processing
Condition: Social Behavior
Study type: Interventional

Summary: 
      To determine whether the neuropeptide oxytocin (OXT) influences self-processing by
      investigating whether it increases the endowment effect in relation to both self and others.
    

Detailed description: 
      In a double-blind, between- subject placebo (PLC) controlled design, investigator aimed to
      measure the effect of intranasal OXT on the endowment effect. All subjects completed a range
      of questionnaires measuring personality and affective traits and levels of anxiety before
      self-administration: Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety
      Inventory (STAI) , Beck Depression Inventory (BDI), self-esteem scale (SES). Subjects were
      asked to decide whether to buy or sell their own or others' (their mothers'/ fathers'/
      classmate'/ strangers') possessions at various prices. Indifference point and brain
      activation were inluded into analysis as dependent variables.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: self-processing; endowment effect; neuroimage
Interactionality of Music Preference and Individual Variables in Pain Perception and Management
Condition: Cancer
Study type: Observational

Summary: 
      The purposes of this study were 1) to delineate any differences in general musical taste
      (trait) and context-specific music preference (state), as well as preferred music
      characteristics in cancer patients, 2) to investigate the contributions of individual
      variabilities, personality, behavioral coping styles, and pain levels in predicting changes
      from trait to state preferences and preferred music characteristics under various pain
      conditions.

      Cancer patients were recruited to fill in questionnaires pertaining to their demographic
      information (age, gender, religious preference, ethnicity, music background and experience),
      personality traits, music preferences, preferences for music characteristics, coping styles,
      and pain experiences.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): Questionnaires
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cancer patients
Impaired Vigilance, and Its Effects on Cognition and Behavior
Condition: Sleep Deprivation; Feeding Behavior
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions
      that were at least five days apart. The first session was a baseline. The sleep intervention
      took place on the night prior to Session 2, where the amount of time in bed was manipulated
      to be 60-130% of the individual's habitual sleep time. Within both sessions, subjective
      (Stanford Sleepiness Scale, SSS) and objective (Psychomotor Vigilance Test, PVT) alertness
      were measured. During the middle of each session, a 40-minute ad libitum meal opportunity
      allowed participants to eat from eight different food items. Food healthfulness, caloric
      density, distribution and number of calories were measured and compared to alertness levels.
    


Intervention name(s): Time in bed
Intervention type(s): Behavioral
Intervention description(s): Habitual time spent in bed for the purpose of sleep was determined at baseline. This was used to calculated the experimental time in bed the subject was to spent on the one night prior to the second lab visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular
      health among obese schoolchildren. The intervention methods include dietary instruction and
      exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids
      and glucose.
    

Detailed description: 
      Two public primary schools of a similar size were selected. They were allocated either to the
      intervention or control group. Children in Grade 4th and 5th in each school were invited to
      participate in the physical examination (height and weight measures).Obese children based on
      Chinese BMI cut-off points were included in this study.Children in the intervention group
      were encouraged to take healthy diet habits and increased their physical activity.After eight
      months healthy behavior intervention, Children's height, weight, waist, hip, blood pressure,
      cardiorespiratory fitness will be measured. Fasting blood will be taken to measure lipids and
      glucose levels.
    

Intervention name(s): Intervention group
Intervention type(s): Behavioral
Intervention description(s): Diet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; children; cardiovascular health; intervention study
Effect of D-amphetamine on Reward Functioning
Condition: Anhedonia
MeSH terms: Anhedonia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the dose-response curve for therapeutic doses of
      d-amphetamine on tasks of motivation and reward learning in the same participants and to use
      d-amphetamine as a dopaminergic probe to test newer theories about the role of dopamine in
      reward-related decision-making.
    


Intervention name(s): 10 mg d-amphetamine; 20mg d-amphetamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.; 20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.; Placebo dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Reward Learning; Decision Making
A Study of Single Dose of ABT-333 in Healthy Male Adults
Condition: HCV Infections
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of
      blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male
      adult in Japan.
    


Intervention name(s): ABT-333; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, see arms for interventional description; Tablet, see arms for interventional description.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Penicillin Allergy De-Labelling in Elective Surgical Patients (PADLES)
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than
      killing a broad range. Unfortunately, around 10% of the population are labelled as
      'penicillin allergic'. This is often based on side effects such as rash and diarrhoea, and
      90-95% of people with the label are not actually allergic to the drug.

      The label leads to the use of alternative antibiotics, which tend to more toxic, and less
      specific about which bacteria they kill; this increases the risk of infections with so-called
      'super-bugs', compared to patients without the label. People with the label also have an
      increased length of hospital stay and rates of readmission. These are significant problems
      for individuals, as well as wider society. Where the diagnosis is in doubt, the gold standard
      test for allergy is an oral challenge. Patients undergo skin +/- blood tests prior to a
      challenge, as these can help make the diagnosis. This combined pathway is expensive and time
      consuming, so testing cannot be offered routinely to all patients. However in patients with
      'historic' reactions (many years previously), skin and blood tests become much less useful;
      in one study, 100% of patients who skin tested positive for amoxycillin allergy, tested
      negative 5 years later. Patients with historic reactions can therefore proceed directly to an
      oral challenge without prior skin or blood testing, since these offer little help in making
      the diagnosis. This streamlines the pathway, making it quick, non-invasive and cheap. Already
      established practice in several centres in Europe and beyond, this abbreviated pathway is
      offered on an ad-hoc basis in some centres in the UK.

      The aim is to demonstrate that this pathway offers a safe and effective way to perform
      large-scale delabelling of elective surgical patients, who might not otherwise meet NICE
      criteria for testing.
    


Intervention name(s): Amoxicillin
Intervention type(s): Drug
Intervention description(s): A graded oral challenge test, using amoxicillin in syrup form, will be administered as follows:
50mg amoxicillin (10% total dose)
250mg amoxicillin (50% total dose)
200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available.
Intervention MeSH terms: Amoxicillin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Magnetic Resonance Imaging (MRI) Analysis of Coronary Artery Plaque Components
Condition: Coronary Artery Plaque Components
Study type: Observational

Summary: 
      The purpose of this study is to analyze atherosclerotic vessel wall components with
      multidetector computed tomography (MDCT) and compare with MRI. The hypothesis is that MRI is
      comparable to computed tomography (CT) in showing plaque components of coronary plaques.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and Females 18 - 65 scheduled to undergo a clinically-indicated coronary artery CT
        scan.
The Molecular Mechanism of RAS Wild-type mCRC Resistance to Anti-EGFR-antibody
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Establishing the genetic map of primary and secondary resistance of Chinese wild RAS
      colorectal cancer received anti-EGFR treatment through tissues and peripheral blood NGS
      testing. Combination genetic data with clinical characteristics, prognosis and treatment data
      to explore the molecular mechanism of resistance of anti-EGFR-antibody.
    

Detailed description: 
      Cetuximab is a chimeric (mouse/human) monoclonal antibody, an epidermal growth factor
      receptor (EGFR) inhibitor. Many large clinical trials demonstrated that for RAS wild-type
      metastatic colorectal cancer (mCRC), especially left-sided RAS wild-type mCRC, cetuximab can
      prolong OS. But some of patients have primary resistance to cetuximab and for all patients
      received cetuximab will develop secondary resistance. Cell-free or circulating tumour DNA
      (ctDNA) including primary site and metastatic site genetic information, which can avoid tumor
      heterogeneity. The results of paired test detection of tissue and ctDNA showed there is 93%
      consistency in RAS testing. Therefore, dynamic monitoring ctDNA during anti-EGFR targeted
      treatment of RAS wild-type mCRC patients can implement prognosis of efficacy and response
      evaluation in real-time. Besides, it can monitor the variation features of resistance gene
      and find resistance gene in real-time. According the situation of gene change to find
      potential drug resistance mechanism and formulate individualization treatment plan.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        RAS wild-type metastatic colorectal cancer patients treatment with FOLFOX/FORFIRI +
        cetuximab
      
Biospecimen description: 
      Tissues and peripheral blood
Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The purpose of the study is to better understand how the use of antibiotics changes
      micro-organisms in the intestines. The change to micro-organisms in the intestines may change
      the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu)
      vaccine.

      In particular, the investigators will be looking at certain markers in blood after
      vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before
      vaccination.

      There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days
      prior to vaccination and continue taking antibiotics the day of vaccination and one day after
      vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine)
      and will not take any antibiotics.

      The investigators hope to enroll 50 subjects at Emory.
    

Detailed description: 
      We will study using a system biology approach the immune responses to IIV alone vs. IIV with
      antibiotic administration
    

Intervention name(s): IIV Flu Vaccine; Metronidazole; Neomycin; Vancomycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): This is an FDA approved and tested Inactivated Flu Vaccine.; This is a standard antibiotic; This is a standard antibiotic.; This is a standard antibiotic.
Other intervention name(s): Fluzone; Flagyl; Vancocin
Intervention MeSH terms: Metronidazole; Vancomycin; Neomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Flu Vaccine, Intestinal Microbiome, Antibiotics
The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this randomized cross-over study is to investigate how consumption of protein and
      fat affects the FGF21 response triggered by sucrose. The hypothesis is that the consumption
      of protein, but not fat, will attenuate the FGF21 response triggered by sucrose.

      Exploratory, and in order to investigate mechanisms behind the potential attenuation in the
      sucrose-induced FGF21 response after protein consumption, glucose, insulin, glucagon,
      triglycerides, amino acids, glicentin and cholecystokinin (CCK) will be assessed before and
      after consumption of sucrose, sucrose+protein and sucrose+fat. Furthermore, the association
      between the FGF21 response after consumption of sucrose, sucrose + protein and sucrose + fat
      and subjective rating of appetite for sweet will also be investigated.
    


Intervention name(s): Sucrose; Sucrose + protein; Sucrose + fat
Intervention type(s): Other; Other; Other
Intervention description(s): The participants consume A) water with 75 g sucrose; The participants consume B) water with 75 g sucrose + approx. 100 kcal protein; The participants C) water with 75 g sucrose + approx. 100 kcal fat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
Condition: Carcinoid Syndrome
MeSH terms: Malignant Carcinoid Syndrome; Serotonin Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and
      its primary metabolite LX1033.
    


Intervention name(s): 500 mg [14C]-LX1606
Intervention type(s): Drug
Intervention description(s): 500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Absorption; Metabolism; Excretion
Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Tetanus, Diphtheria, Pertussis and Poliomyelitis) in Children Who Received Different Pertussis Primary Vaccine Regimens in Republic of South Africa
Condition: Pertussis Immunisation; Diphtheria Immunisation; Tetanus Immunisation; Poliomyelitis Vaccine
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objectives :

        -  To describe the long-term humoral immune responses to pertussis, diphtheria, and tetanus
           after homologous and heterologous pertussis vaccine priming regimens

        -  To determine the effects of the priming regimen on humoral responses to booster
           vaccination with Tdap-IPV vaccine

        -  To describe the long-term cell-mediated immune responses to pertussis after homologous
           and heterologous pertussis vaccine priming regimens

        -  To determine the effects of the priming regimen on cell-mediated immune response to
           booster vaccination with Tdap-IPV vaccine

      Secondary Objective:

      To describe the safety profile of Tdap-IPV vaccine in each group
    

Detailed description: 
      Study duration per participant will be approximately 30 days including: 1 day of screening
      and vaccination, a phone call and a safety follow-up/end of study visit, at Day 8 and Day 30
      after vaccine administration, respectively.
    

Intervention name(s): Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Intervention type(s): Biological
Intervention description(s): Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Other intervention name(s): Adacel®-Polio, Adacel Quadra®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention