bioihbjkbjnl/mcl2 huggingface dataset:
Soft Drink, Milk and Obesity in Chilean Children
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The primary aim of this randomized controlled trial is to evaluate the effects of replacing
      habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.
    

Detailed description: 
      The prevalence of obesity has risen dramatically among children in the U.S. and throughout
      the world since the 1960s. Many factors are thought to have contributed to the epidemic of
      pediatric obesity. One factor that has received increasing attention is consumption of
      sugar-sweetened beverages. Feeding studies suggest physiological mechanisms by which sugar in
      liquid form may be less satiating than other foods. An observational study found total energy
      consumption to be greater among children who consume sugar-sweetened beverages compared to
      non-consumes. Short-term interventional studies report increasing energy intake and body
      weight in subjects given sugar-sweetened beverages compared to non-caloric beverages. Our
      preliminary data found that the risk for becoming obese increased by about 60% in middle
      school children for every additional serving per day of sugar-sweetened beverage consumed.
      The purpose of the present study is to conduct a 16-week clinical trial involving 96 children
      ages 8 to 10 years in Chile, a developing nation characterized as undergoing a "nutrition
      transition." The subjects, selected for current sugar-sweetened soft drink consumption, will
      be randomly assigned to intervention or control groups. The intervention group will be
      encouraged to substitute milk products for soft-drinks; to facilitate this dietary change, a
      variety of milk products will be delivered to subjects' homes on a weekly basis. Clinical
      endpoints include changes in dietary quality, body weight, adiposity by DEXA-scan and
      measures of calcium homeostasis.
    

Intervention name(s): Weekly home delivery of milk products
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Obesity, beverages, weight loss, body mass index, diet
Effectiveness of Neck Stabilization Training Program With Conventional Therapy in Management of Text Neck Syndrome
Condition: Neck Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      1. To compare the effectiveness of neck stabilization training program with conventional
           physical therapy in management of neck pain and disability in individuals with text neck
           syndrome.

        2. To compare the effectiveness of neck stabilization training program with conventional
           physical therapy in improving muscle strength and range of motion of cervical spine in
           individuals with text neck syndrome.
    

Detailed description: 
      The text neck syndrome was described as a compilation of signs and symptoms due to the
      repetitive load, stress and pain in the body regions including; neck, shoulder joints,
      shoulder muscles, and thoracic region initiated by the excessive usage of smartphones for the
      prolonged time. The text neck syndrome is also called as 'Turtle neck neck syndrome' or
      'anterior head syndrome.

      Neck flexion in forward direction for using any smart phone could directly affects the
      cervical and upper thoracic spine. It is stated that increased tilt of the head forward to
      fifteen degrees exaggerate about 13 Kgs of mechanical force on the cervical spine.

      Likewise it progresses to 18 Kgs at 30 degrees, 23 Kgs at 45 degrees and 28 Kgs at 60 degrees
      of forward neck flexion. The pathological consequences caused by incase of not managing the
      text neck could be alike to occupational overuse disease or repetitive stress and strain
      pathology.
    

Intervention name(s): Neck Stabilization Training Program; Conventional physical therapy
Intervention type(s): Other; Other
Intervention description(s): 3 times a week stretching exercises approximately 10 mins dumb bell exercises - 2 sets of 15 reps with weights varying from 1 to 2 kg cranio-cervical isometrics for 10 sec with 15 sec breaks between holds with 10-15 reps Tens 5-10 mins Hotpack 5-10 mins neck stretches home plan - 5 reps/set, 3 sets/ day; Tens 5-10 mins Hotpack 5-10 mins neck stretches home plan - 5 reps/set, 3 sets/ day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia
Condition: Invasive Candidiasis
MeSH terms: Candidiasis; Candidiasis, Invasive
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study is to 1) define the operating characteristics of fungal biomarker
      assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine
      the change in fungal biomarker assay results in children who develop invasive candidiasis,
      and 3) create a biobank of blood samples from pediatric patients at high-risk for invasive
      candidiasis and those with invasive candidiasis for future testing of fungal biomarker assays
      and development of new fungal biomarker assays. The study will assemble a prospective cohort
      of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for
      biomarker testing will be obtained at the time a patient has a clinical indication for blood
      culture attainment. Additional blood sampling will be performed on the sub-set of patients
      that are found to have invasive candidiasis. The sensitivity, specificity, PPV, and NPV of
      biomarker assays will be determined for each biomarker assay. No PHI will be stored in the
      database and limits on blood draws (3 ml/kg in an 8 week period) will be adhered to.
    

Detailed description: 
      This study will create an international multi-center cohort of children with new clinical
      concern for infection while in the hospital. Sites used are part of the International
      Pediatric Fungal Network (ipfn.org). The study plans to prospectively enroll pediatric
      patients at high-risk of developing invasive candidiasis over a four year period. The study
      duration per subject will be up to 14 days for blood collection and 30 days for data
      collection from the medical record.

      For the first aim, this study will assemble a prospective cohort of pediatric patients at
      high-risk for developing invasive candidiasis. Blood samples for biomarker testing will be
      obtained within 24-hours of a patient having a clinical indication for blood culture
      attainment. To accomplish the second aim, additional blood sampling will be performed in the
      sub-set of patients that are found to have invasive candidiasis. For the third aim, remnant
      blood samples following biomarker testing from all consenting participants will be stored in
      a biobank. This biobank will be used to examine future, currently undeveloped, biomarker
      assays in an effort to further reduce the time to diagnosis of invasive candidiasis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will create an international multi-center cohort of children with new clinical
        concern for infection while in the hospital.
      
Biospecimen description: 
      Blood samples
    
Keywords: IPFN; Pediatric; Fungal; Biomarker Assays; Candida; Pediatric ICU patient
Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults
Condition: Cigarette Smoking; Current Smoker
Study type: Interventional

Summary: 
      This trial studies how well Quit4Health intervention works in supporting smoking cessation
      and preventing smoking initiation in young adults. Quit4Health intervention may help young
      adults learn more about the risks of tobacco use and may help them to quit smoking.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To evaluate whether smokers randomized to Quit4Health are more likely to quit smoking and
      remain tobacco-free at 6 months than subjects randomized to the education only control group.

      II. To evaluate whether non-smokers who are randomized to Quit4Health are less likely to
      initiate tobacco usage and remain tobacco-free at 6 months than non-smokers randomized to the
      education only control group.

      SECONDARY OBJECTIVES:

      I. To evaluate whether well-established predictors of susceptibility and barriers to
      cessation (e.g. self-efficacy, knowledge about associated risks, normative beliefs,
      attitudes, resistance skills, peer pressure) and recently identified predictors of tobacco
      use (e.g., depression, nicotine dependence, alcohol use, risk-taking propensity) will mediate
      the effect of the intervention on both onset (for non-smokers) and cessation (for smokers) of
      tobacco use.

      II. To evaluate whether, at the end-of-treatment (EOT) assessment, participants (both smokers
      and non-smokers) in Quit4Health will report a significantly better perception of Quit4Health
      (message relevance, tailoring to specific needs based on tobacco use status, motivation to
      quit, etc.) compared with their counterparts in the education only control arm.

      OUTLINE: Participants are randomized to 1 of 2 groups.

      GROUP I: Participants utilize Quit4Health intervention that includes interactive features,
      coping strategies and games related to cigarettes and other tobacco products for 1 month.

      GROUP II: Participants read an educational booklet about cigarettes and other tobacco
      products for 1 month.

      After completion of study, participants are followed at 3 and 6 months.
    

Intervention name(s): Educational Intervention; Questionnaire Administration; Smoking Cessation Intervention
Intervention type(s): Other; Other; Behavioral
Intervention description(s): Read educational booklet; Ancillary studies; Utilize Quit4Health
Other intervention name(s): Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Smoking and Tobacco Use Cessation Interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
Condition: Fibrocystic Disease of Breast; Breast Cancer
MeSH terms: Cystic Fibrosis; Fibrocystic Breast Disease; Breast Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2
      dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the
      appearance of non-calcified breast masses. It is thought that non-calcified breast masses
      will be better visualized with the new 3D technology.
    


Intervention name(s): Digital Breast Tomosynthesis
Intervention type(s): Device
Intervention description(s): Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Breast Cancer; Mammography; Benign masses; Breast Lump; Breast Biopsy; Breast Mass
Stearoyl-CoA Desaturase and Energy Metabolism in Humans
Condition: Healthy; Obesity
Study type: Interventional

Summary: 
      The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1)
      activity through dietary interventions can increase energy metabolism in humans.
    

Detailed description: 
      In rodents as well as humans, high stearoyl-coenzyme A desaturase-1 (SCD1) activity is
      considered to be involved in development of obesity. In animal models, polyunsaturated fatty
      acids (PUFA) inhibit Scd1 gene expression and at the population level, dietary PUFA and
      plasma PUFA show strong inverse associations with plasma SCD indices. Emerging evidence also
      suggests a role for the sulphur amino acid cysteine in regulating SCD1 activity and obesity.

      The overall aim of the project is to examine if interventions that lowers SCD1 activity lead
      to increased energy metabolism. In this project, the investigators will conduct dietary
      intervention trials to evaluate the effects of short-term consumption of a diet rich in
      polyunsaturated fatty acids (PUFA) and low in cysteine and its precursor methionine
      (PUFA-Cys/Met) vs. a diet rich in saturated fatty acids (SFA) and cysteine/methionine
      (SFA+Cys/Met) on SCD1 activity, lipids, amino acids, glucose and other biomarkers related to
      energy metabolism, in healthy normal-weight subjects. Healthy volunteers will be randomized
      to the PUFA-Cys/Met or SFA+Cys/Met diets receiving supplements/meals in a single dose or for
      7 days.

      This study is a pilot study, with main focus on feasibility, tolerance and side effects. If
      the pilot shows positive results in terms of side effects, safety and tolerance, the
      investigators will follow-up by including obese subjects in a longer dietary intervention.
    

Intervention name(s): PUFA-Cys/Met diet; SFA+Cys/Met diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Provision of food and supplements that are rich in polyunsaturated fatty acids (PUFA, n-3 and n-6) and low in the amino acids cysteine (Cys) and methionine (Met).; Provision of food and supplements that are rich in saturated fatty acids (SFA) and the amino acids cysteine (Cys) and methionine (Met).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Energy metabolism
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a proof of concept study designed to assess the effects of a single intravenous dose
      of etokimab compared to placebo in adult participants with severe eosinophilic asthma. This
      study will also assess the safety and tolerability of etokimab in adult participants with
      severe eosinophilic asthma.
    


Intervention name(s): Etokimab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered on Day 1 over 1 hour by IV infusion; Administered on Day 1 over 1 hour by IV infusion
Other intervention name(s): ANB020
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement
Condition: Aseptic Loosening; Arthroplasty Complications
Study type: Observational

Summary: 
      Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular
      injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved
      effective in preventing dislocation in THA revision for instability, but their behavior when
      cemented in a metal reinforcement has been little studied.

      The present study assessed results for a dual-mobility cup cemented in a metal reinforcement,
      in terms of aseptic loosening and postoperative instability.

      A single-center continuous series of 62 patients receiving such an assembly in THA revision
      was assessed retrospectively at a minimum 5 years' follow-up.
    

Detailed description: 
      Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular
      injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved
      effective in preventing dislocation in THA revision for instability, but their behavior when
      cemented in a metal reinforcement has been little studied.

      The present study assessed results for a dual-mobility cup cemented in a metal reinforcement,
      in terms of aseptic loosening and postoperative instability.

      A single-center continuous series of 62 patients receiving such an assembly in THA revision
      was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic
      loosening or instability and implant survival at last follow-up were analyzed.
    

Intervention name(s): assembly in THA revision
Intervention type(s): Other
Intervention description(s): A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        62 patients receiving such an assembly in THA revision was assessed retrospectively at a
        minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant
        survival at last follow-up were analyzed.
      
Keywords: revision; reinforcement
Relationship Between Functional Health Status and Ventricular Performance After Fontan--Pediatric Heart Network
Condition: Defect, Congenital Heart; Arrhythmia
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Observational

Summary: 
      The purpose of this cross-sectional study was to determine the interrelationships between
      health status and measures of cardiac performance in children 6 to 18 years of age with
      congenital heart disease who have undergone a Fontan procedure as surgical treatment for
      functional single ventricle. The goal was to develop a data set that will permit
      identification of a clinically relevant endpoint for subsequent trials of medical management
      of the Fontan patient.
    

Detailed description: 
      BACKGROUND:

      Children born with one functional ventricle and who undergo a Fontan procedure, have a higher
      incidence of late complications than other congenital heart patients. While the Fontan
      procedure results in restoring near-normal systemic oxygen saturation, there are recognized
      problems and little information about the overall health status, functional status and
      ventricular performance in these children.

      DESIGN NARRATIVE:

      This cross-sectional observational study included children 6-18 years of age who had
      undergone a Fontan procedure for a congenital cardiac defect. Prospective data collection for
      each patient occured within a 3 month time period and included cardiac MRI, echocardiography,
      serology and exercise testing. Historical clinical and surgical data, as well as parent and
      child self reports of health status, was collected.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects must have had Fontan surgery of any type at least 6 months prior to the time of
        testing
The Hordaland Health Study
Condition: Chronic Disease
MeSH terms: Chronic Disease
Study type: Observational

Summary: 
      The Hordaland Health Studies (HHS) were conducted in 1992-93 (The Homocysteine study) and in
      1997-99 (HUSK). Both surveys were conducted as a joint project between the University of
      Bergen, the Norwegian Health Screening Service (SHUS) (now part of the National Institute of
      Public Health) and the Municipal Health Service in Hordaland.

      The main focus of the studies is on chronic diseases including cardiovascular disease,
      cancer, osteoporosis, anxiety and depression. Some projects focus on psychosocial factors,
      occupational research, musculoskeletal diseases, urinary incontinence and mapping of drug
      use. The main purpose of the surveys is to gather information so that disease ultimately can
      be prevented.

      Approximately 36,000 residents of Hordaland county participated in the studies, ca. 18,000 in
      1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who participated in the 1992-93
      survey also participated in 1997-99.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Approximately 36,000 residents of Hordaland county participated in the studies (both men
        and women), ca. 18,000 in 1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who
        participated in the 1992-93 survey also participated in 1997-99.
      
Biospecimen description: 
      Blood samples are stored at two biobanks located in Bergen and Levanger. The blood was
      divided in full blood, plasma and serum.
Comparing Efficacy and Safety of Inhaled SNG001 to Placebo
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      When people with asthma get respiratory virus such as a cold or flu it often increases asthma
      symptoms. The investigators will test the study medication to find out if it can prevent the
      virus spreading from the nose to the lungs.

      SNG001 contains Interferon-beta that occurs naturally in the body. In this study, SNG001 will
      be given by a nebuliser.
    

Detailed description: 
      The study will consist of a Pre-Treatment Phase into which subjects potentially eligible for
      the Treatment Phase will be recruited. Subjects will remain in the Pre-Treatment Phase until
      they experience respiratory virus symptoms at which time they will be further screened for
      eligibility for entry into the Treatment Phase. If eligible, subjects will be randomised 1:1
      to receive SNG001 or placebo once daily for 14 days. Doses will be delivered by a CE marked
      breath actuated nebuliser (I-neb Philips Respironics). Subjects will be assessed for changes
      in changes in respiratory virus symptoms and asthma symptoms at home using a text message
      system, and via telephone questionnaire. Lung function will be measured both at home by the
      subjects (PEFR only) and in the clinic. Efficacy and safety will be monitored until at least
      30 days post treatment.
    

Intervention name(s): Interferon beta 1a; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SNG001, IFN-β1a solution for inhalation; Placebo (excipients of the SNG001 solution only)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma