bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Helmet Use in Preschool Children
Condition: Head Injuries; Facial Injuries
MeSH terms: Craniocerebral Trauma; Facial Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      -  To test the hypothesis if provision of helmet education and free helmet distribution
           will significantly increase helmet use in preschool children of low-income families
           compared to those children receiving helmet education without free helmet distribution;

        -  To test the hypothesis if helmet users in preschool children will significantly reduce
           head and facial injuries compared to those non-helmet users
    

Detailed description: 
      Current literature review shows that there were no definite prospective research studies that
      indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction
      particularly to head and facial injuries among preschool children of low-income families.

      The magnitude and seriousness of the injury problem in these children in the community could
      be high. Many injuries may occur that are not treated in emergency departments. Even the
      occurrence of a minor injury in the face is undesirable. These ages are learning periods to
      ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also
      tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).
    

Intervention name(s): Bicycle helmet from Bell Sports Inc.; Bicycle helmet education only
Intervention type(s): Other; Other
Intervention description(s): As described under the respective arm; As described under the respective arm
Other intervention name(s): Bell bicycle helmets; Bicycle helmet education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bicycle helmet
Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine
Condition: Rubella; Varicella; Mumps; Measles
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      Follow-up to evaluate the immunogenicity and safety of three production lots of GSK
      Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second
      year of life, as compared to separate administration of GSK Biologicals'
      measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany &
      Austria. Blood samples were collected at three time points during the follow-up period (Year
      1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.
    


Intervention name(s): MMRV; MMR (Priorix®); Varicella (Varilrix®)
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rubella; Varicella; Measles; Mumps; Germany; Austria
Urban Walking Circuits
Condition: Severe Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study was to assess the effectiveness of the implementation of walking urban
      circuits in increasing the level of physical activity and exercise capacity in severe chronic
      obstructive pulmonary disease (COPD) patients after being enrolled in a pulmonary
      rehabilitation program.
    


Intervention name(s): rehabilitation more the urban circuit; rehabilitation program but not given urbane circuits
Intervention type(s): Other; Other
Intervention description(s): included in a standard rehabilitation program + the urban circuit. A total of 32 urban walking circuits were developed jointly with the town hall of Mataró(124,000 in habitants)and were included in a triptych called "A PEU, FEM SALUT! Itineraris urbans per Mataró" http://www.mataro.cat/web/portal/ca/salut/salut_publica/itineraris/index; Only rehabilitation program and general recommendations on physical activity and lifestyle . No urbans circuits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Exercise, Physical activity, Rehabilitation, COPD.
Hypoxia and Exercise in the Elderly
Condition: Elderly Persons
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Ageing is the primary risk factor for most chronic diseases including type 2 diabetes
      mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms
      leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic
      disease and frailty, which limits physical mobility as well as quality of life, share common
      cellular mechanisms.

      The investigators will test the hypothesis that a combination of normobaric hypoxia and
      exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle
      dysfunction and the investigators will address the molecular mechanisms. In a randomized
      clinical study, the investigators will compare normoxic and hypoxic training conditions in
      elderly subjects. Outcome measures will focus on whole body insulin sensitivity and
      mitochondrial responses in skeletal muscle before and after the 8-week training intervention.
    


Intervention name(s): Hypoxic exercise; Normoxic Exercise
Intervention type(s): Other; Other
Intervention description(s): Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions; Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair
Condition: Hernia
MeSH terms: Hernia
Study type: Interventional

Summary: 
      The investigators will perform a randomized controlled trial with a stratified-block design
      to compare the effect of the part versus whole task simulation training for TEP repairs.
    


Intervention name(s): Online Video Curriculum; Whole Task Mastery Training; Part Task Mastery Training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A video curriculum has been designed for the purpose of educating general surgery residents in laparoscopic hernia repairs. The curriculum covers topics from basic anatomy, selection of patients, management, and operative technique.; Trainees will undergo whole task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of whole task tep repairs was established with performance measures of multiple staff surgeons previously.; Trainees will undergo part task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of part task tep repairs was established with performance measures of multiple staff surgeons previously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mastery Learning; Surgical Education; Laparoscopic Hernia Repair; Part vs Whole Task; Contextual Interference; laparoscopy; training; curriculum
Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany
Condition: Overweight, Childhood; Obesity, Childhood; Child Development; Overweight and Obesity; Underweight
MeSH terms: Obesity; Overweight; Pediatric Obesity; Thinness
Study type: Observational

Summary: 
      The study will determine the weight status in primary school children in the Rhein-Neckar
      Region in Germany and will analyse the development of height and weight in these children
      during the time of COVID-19 related restrictions by asking parents to provide data from
      childhood examinations. Additionally, interactions between cognitive abilities and
      weight-status will be studied.
    

Detailed description: 
      The prevalence of obesity and overweight is increasing among both adults and children. School
      and kindergarten closings during the COVID-19 epidemic may have had an additional negative
      impact on the weight development of the affected children. This study aims to examine the
      post-lockdown prevalence of overweight and obesity in school children in the second grade in
      the Rhein-Neckar Region in Germany and look at possible lockdown effects. Additionally,
      interactions between cognitive abilities and weight-status will be studied.

      Anthropometric measurements, interviews as well as cognitive testing will be performed in
      schools in the summer of 2021 in children in the first grade (class 2020/2021). Parents will
      be asked to provide measurements from U-childhood-examinations and complete a 3-day food
      record. The local health authority (Gesundheitsamt) will assist in making a representative
      selection of schools from different socioeconomic areas and provide data from the pre-school
      examinations. Collected data will be analyzed and compared to national and international
      surveys, evaluating the trends of the children's height and weight development. Weight status
      will be assessed by calculating z-BMI standardized for age and compared with national and
      international growth charts using both national and WHO classification. Potential
      interrelation between weight-status, weight development with cognitive performance will be
      explored.

      The study will be able to deliver valuable insights in regards to the health of school
      children in the Rhein-Neckar Region as well as evaluate the effect of COVID-19 related
      lockdowns on their health.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children in the second grade
      
Keywords: overweight; obesity; children; cognitive function; cognitive function and weight status
A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms
      beyond 6 months and will measure the impact of withdrawal of laropiprant in patients
      following 20 weeks of stable maintenance therapy.
    


Intervention name(s): ER niacin (+) laropiprant (ERN/LRPT); ER niacin (+) laropiprant (ERN/LRPT); Extended-release niacin (ERN); Placebo to ERN/LRPT
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks; One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks.; Two 1g tablets ERN (2g total) once daily for 12 weeks.; One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Normal Values of Parameters of Thrombin Generation in Function of Different Tissue Factor Concentrations
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.TGA
      using Calibrated Automated Thrombography method, enables the quantification of thrombin
      concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP).According to
      the clinical context, different TF(Tissue Factor) concentrations (1, 5 and 10 pM) can be used
      to trigger the coagulation cascade.The aim of the study is to determine the normal values of
      TG (Thrombin Generation) in fresh PRP and in PPP with different TF concentrations.
    

Detailed description: 
      The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.
      TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin
      concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP). The thrombin
      generation (TG) profile varies from patient to patient and depends on the activity of the pro
      and anti-coagulant factors. The TGA values depend on the analytical conditions such as Tissue
      Factor (TF) concentration and the plasma analyzed (PRP or PPP). According to the clinical
      context, different TF concentrations (1, 5 and 10 pM) can be used to trigger the coagulation
      cascade.

      As a consequence, the reference values vary with the analytical conditions but also with the
      studied population (men or women). The reference values are not provided by the manufacturer
      and each laboratory has to establish the normal values according to the analytical conditions
      chosen for the pathology explored (hemorrhagic or thrombotic). Moreover, in PPP, the TG
      results can be different according to batch reagents. That is the reason why plasma will be
      frozen for a new determination in case of deviation of the result of the control plasma.

      The aim of the study is to determine the normal values of TG in fresh PRP and in PPP with
      different TF concentrations.
    

Intervention name(s): Blood samples
Intervention type(s): Biological
Intervention description(s): sampling of 10 S-Monovette tubes (Sarstedt) 4.3 ml of blood specifically for the study representing a total blood volume of 43 ml
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers both sex aged between 18 and 50 without personal or family history of
        hemorrhage, thrombosis before 45 years old,
      
Biospecimen description: 
      plasma
    
Keywords: blood; plasma; blood platelets
Chest Physiotherapy in Pediatrics Patients With Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia
      however there was no evidence to support a beneficial effect in pediatric patients.
    


Intervention name(s): Physiotherapy; Positioning and cough
Intervention type(s): Other; Other
Intervention description(s): Physiotherapy: three times per day, for 10 to 12 minutes, during hospital admission; Non-mandatory request to maintain lateral positioning to improve air exchange and cough
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: physiotherapy; children; clinical trial
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Liver Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to evaluate and compare the safety and tolerability of tenofovir
      disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of
      hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating
      adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating
      reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores,
      reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes,
      development of drug-resistant mutations, and generation of antibody to virus.

      A maximum randomized treatment duration of 168 weeks was planned. Since subjects with
      decompensated liver disease were enrolled into this study, it was necessary to provide early
      intervention strategies if profound viral suppression was not expeditiously achieved. For
      this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL
      and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who
      entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start
      open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who
      had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of
      treatment could have been unblinded at the investigator's discretion for selection of
      alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was
      permanently discontinued, immediate initiation of another anti-HBV regimen was strongly
      recommended.
    


Intervention name(s): Tenofovir disoproxil fumarate (tenofovir DF; TDF); Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF); Entecavir (ETV); TDF placebo; FTC/TDF placebo; ETV placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300-mg tablet QD; FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD; 0.5-mg or 1-mg tablet QD; Placebo to match TDF QD; Placebo to match FTC/TDF QD; Placebo to match ETV QD
Other intervention name(s): Viread; Truvada; Baraclude
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis; Hepatitis B virus; Tenofovir
A Study to Investigate the Effect of Inhaling Single Doses of Different Formulations of GW642444M in Asthmatic Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will involve the use of a new medicine called GW642444 being developed for the
      treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the
      study is to see how safe and how well tolerated the study drug is when inhaled in two
      different formulations as a fine powder by asthmatic patients. In addition, the study is
      designed to examine the effect of the study drug on the lungs, how the study drug affects
      parts of the body other than the lungs and to see how the body affects the study drug when it
      is given in single doses.
    


Intervention name(s): Placebo; GW642444; Magnesium Stearate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): comparator; investigational drug or placebo; Magnesium Stearate
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma patients; Magnesium stearate; Tolerability; Safety; Lactose; GW642444M; Pharmacodynamics; Efficacy; Pharmacokinetics
Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess clemastine as a remyelinating agent in patients
      with relapsing forms of multiple sclerosis. The study will also evaluate the tolerability of
      clemastine, originally approved as first-generation antihistamine, in patients with multiple
      sclerosis. Study procedures will include assessments for evidence of remyelination in the
      anterior visual pathway and in the brain using electrophysiologic techniques and magnetic
      resonance imaging. The study will also assess the robustness and stability of this clinical
      effect in patients taking clemastine for up to 3 months. Patients in this study can remain on
      their standard disease modifying treatment during the course of the study. However, patients
      cannot participate in any other investigational new drug research study concurrently.
    


Intervention name(s): Clemastine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4mg tablet twice daily; Placebo tablet twice daily
Other intervention name(s): Clemastine Fumarate,; Tavist -1
Intervention MeSH terms: Clemastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
Condition: Healthy Subjects; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently
      discovered protein, called hCAP18, likely plays an important role in the immune system and
      may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are
      needed to allow the body to make this protein. Nor is it known if giving vitamin D to people
      who are found to be deficient will help boost levels of hCAP18. This study aims to clarify
      the relationship between vitamin D levels and hCAP18.
    


Intervention name(s): ergocalciferol
Intervention type(s): Drug
Intervention description(s): Ergocalciferol 50,000 IU given every other day for 5 total doses
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment