bioihbjkbjnl/mcl2 huggingface dataset:
Diet and Well-being of Young Danish Children
Condition: Growth Acceleration; Overweight or Obesity; Biomarkers of Metabolic Syndrome; Programming and Tracking
MeSH terms: Overweight; Metabolic Syndrome
Study type: Observational

Summary: 
      The overall objective with the study was to contribute to the scientific basis for dietary
      and life strategies, policies and dietary guidelines to infants and young children in Denmark
      and with special focus on prevention of obesity and diet related chronic diseases such as
      type 2 diabetes, ischemic heart disease and osteoporosis.
    

Detailed description: 
      The SKOT I study is a prospective cohort study monitoring healthy young children from 9 to 36
      months of age. In 2007, 2211 families from Copenhagen were randomly selected through the
      National Civil Registry and invited to participate in the study by letter. The participants
      were invited to three examinations at 9 months ±2 weeks, 18 months ±4 weeks and 36 months ±3
      months. A total of 330 children are included in the study, where 312 have completed the 9
      months examination, 291 completed the 18 months examination and 263 completed the 3-year
      examination. All examinations took place at Department of Nutrition, Exercise and Sports,
      Frederiksberg Denmark. The examinations involved collecting a broad spectrum of data.
      Following data were collected: anthropometry (weight, height, age- and sex-specific Z-scores
      for body composition, triceps and subscapularis skinfolds), background interview (concerning
      e.g. infant feeding, household income, the parent's educational level, allergy and chronic
      diseases), blood pressure (systolic, diastolic and mean arterial pressure), faeces- and urine
      sample, blood samples (9 and 36 months), Bio impedance analysis (36 months), 7 day diet
      registration, general questionaire (concerning e.g. sleep, daycare, attendance and use of
      screen devices), psychomotor questionnaire (motoric development), 7 day physical activity
      monitoring and dual energy x-ray absorptiometry scan (36 months).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy young Danish Children selected through the National Civil Registry and invited to
        participate by letter.
      
Biospecimen description: 
      Urine, faeces, white cells, plama/serum
    
Keywords: growth,; infancy,; children,; diet,; breastfeeding; complementary feeding; early life programming; tracking; physical activity
HCC Staging Modified by Tumor Micronecrosis
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Tumor micronecrosis is a pathological feature that reflects malignant biological behavior in
      hepatocellular carcinoma (HCC). This study aimed to evaluate the prognostic significance of
      tumor micronecrosis based on the current BCLC and TNM staging systems, and futher improve the
      performance of the staging models by establishing modified new staging models including tumor
      micronecrosis.
    


Intervention name(s): tumor micronecrosis
Intervention type(s): Behavioral
Intervention description(s): whether HCC patients have tumor micronecrosis or not
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective study enrolled patients who underwent liver resection from four
        institutions in China: the First Affiliated Hospital, Zhejiang University School of
        Medicine (FAHZU) (n = 896), Mengchao Hepatobiliary Hospital of Fujian Medical University (n
        = 94), the Second Affiliated Hospital of Nanchang University (n = 84), and Huzhou Central
        Hospital (n = 36).
      
Keywords: Hepatocellular carcinoma; Tumor micronecrosis; BCLC; TNM; Disease staging
Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
Condition: Rotavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK
      Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when
      administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose
      one, with no previous history of rotavirus illness or vaccination.

      While the lyophilized formulation of the HRV vaccine was licensed in India in February 2008,
      this study is conducted to generate additional clinical data for the liquid formulation of
      the HRV vaccine in India, as recommended by New Drug Advisory Committee on Vaccines
      (NDAC-Vaccines) of Drug Controller General of India (DCGI).
    


Intervention name(s): HRV Liquid; HRV Lyophilized
Intervention type(s): Biological; Biological
Intervention description(s): Two doses administered orally according to a 0, 1-month schedule.; Two doses administered orally according to a 0, 1-month schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rotarix; HRV; Healthy infants; Liquid formulation; Lyophilized formulation; Human rotavirus vaccine
Vitamin D Status in Pediatric Asthma
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      The purpose of this study is to evaluate level of vitamin D in pediatric asthma and
      relationship between vitamin D and level control of asthma.
    

Detailed description: 
      cross-sectional study
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        allergy clinic in tertiary hospital
      
Biospecimen description: 
      whole blood, serum
    
Keywords: vitamin D; asthma
Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal
Condition: Infant Nutrition Sciences
Study type: Interventional

Summary: 
      This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic
      effect in infants.
    

Detailed description: 
      This is a controlled, randomized, prospective, crossover, triple-blind study to evaluate of a
      new infant cereal with a portion of whole grain flour on sensorial acceptability,
      gastrointestinal tolerance, satiety and prebiotic effect in healthy infants fron 5 to 8
      months of age at the beginning of complementary feeding.
    

Intervention name(s): New Infant Cereal; Multicereals Infant Cereal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations.; The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer for Normal Adults in South Korea
Condition: Healthy
Study type: Observational

Summary: 
      The human cornea is affected by the magnitude and velocity of both internal and external
      forces because the cornea has both static and dynamic resistance components. Considering
      these natures of the human cornea, many investigators have tried to demonstrate corneal
      biomechanical properties to understand these characteristics of the cornea. Corneal
      biomechanical properties are known to influence the accuracy of measurements in intraocular
      pressure (IOP) and are recognized as important factor to explain the susceptibility of
      development of glaucomatous damage. Until recently, the only instrument which enabled the in
      vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA,
      Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the
      biomechanical properties of the cornea according to the dynamic bidirectional applanation
      process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis
      ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful
      instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer
      captures the dynamic process of corneal deformation caused by an air puff using an
      ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now,
      well-organized analysis on the normative data of the corneal biomechanical profiles measured
      with the dynamic Scheimpflug analyzer has not been reported yet. Hence, in the present study,
      we aim to conduct normative data analysis for the corneal biomechanical properties with the
      dynamic Scheimpflug analyzer in South Korea.
    


Intervention name(s): dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis ST], OCULUS, Wetzlar, Germany)
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal healthy population
      
Keywords: Adults
Corneal Topography Asymmetry Indices Changes After Corneal Refractive Surgery
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      To evaluate the changes that occur in the corneal indices after corneal refractive surgery
      either PRK or LASIK.
    

Detailed description: 
      Retrospectively review the medical records of all patients who underwent refractive surgery
      referred from the out-patient clinic of Tanta University hospital between September 2015 and
      September 2020 .

      Data collection will include:

      Preoperative and postoperative Evaluation: Age, sex, uncorrected distance visual acuity
      (UDVA), corrected distance visual acuity (CDVA), manifest and cycloplegic refraction, Slit
      lamp biomicroscopy, fundus examination.

      Data of Corneal Tomography keratometric using Scheimpflug camera (Pentacam Oculus- Germany)
      :that includes the following indices

        1. Average keratometric value (K mean) in diopters

        2. Maximum simulated keratometry (Kmax) in diopters

        3. Index of Surface Variance (ISV) in microns

        4. Index of Vertical Asymmetey (IVA) in microns

        5. Radii Minimum (R min) in microns

        6. Index of height asymmetry (IHA) in microns

        7. Index of height decantation (IHD) in microns

        8. Aberration coefficient (ABR)

      The data of the pentacam will be collected pre-operative and analyzed at 1 month, 3 months
      and 6 months with recording of the complications.
    

Intervention name(s): Refractive surgery
Intervention type(s): Other
Intervention description(s): Refractive surgery for correction of error of refraction
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We will retrospectively review the medical records of all patients who underwent refractive
        surgery referred from the out-patient clinic of Tanta University hospital between September
        2015 and September 2020
EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The objective of this study is to evaluate at 3 months in a prospective study, the
      effectiveness of arterial embolization of neo-vessels in patients with a painful total knee
      prosthesis despite a well-conducted medical treatment
    

Detailed description: 
      To date, no study has attempted to measure the effects of arterial embolization on pain in
      patients with total knee prosthesis. It would be interesting to evaluate, in a therapeutic
      trial with a good level of evidence, this alternative to drug treatments that are often
      poorly tolerated, contraindicated or failing in this population of elderly subjects often
      presenting co-morbidities. This pilot study will be used to calculate the number of patients
      to be included in a comparative, placebo-controlled, double-blind study. In addition to the
      evaluation of the undesirable effects of arterial embolization, the objective of this study
      is to evaluate the effectiveness at 3 and 6 months of embolization of the neovessels on pain,
      stiffness, physical activity, quality of life and consumption of analgesics and
      anti-inflammatories.

      Evaluation criteria: modification of the pain item in the EVA (Analog Visual Scale), EQ-5D
      (quality of life scale), and Knee injury and Osteoarthritis Outcome Score (KOOS)
      self-questionnaire collected in the 15 days preceding the procedure and then at 3 and 6
      months ; the use of analgesics and anti-inflammatories; adverse events.

      Study population: Patients aged 40 to 80 years with a painful total knee joint. The visual
      analogue scale (VAS) score must be greater than or equal to 50 mm for at least 3 months
      optimal medical treatment, and for whom, no surgical retreatment is indicated.

      The expected benefits are the improvement of the treatment of patients in therapeutic
      impasse, wearing a total knee prosthesis whose pain is rebellious and disabling. More
      generally, the investigators expect an improvement in the quality of life of these patients
      currently without satisfactory alternative care.
    

Intervention name(s): Arteriography knee arteriography
Intervention type(s): Procedure
Intervention description(s): arteriography and an injection of inert microparticles of 75 μm in neovessels
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Trial of a Gum Health Formulation
Condition: Periodontal Diseases; Gingivitis; Periodontitis; Halitosis
MeSH terms: Gingivitis; Periodontitis; Periodontal Diseases; Halitosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a newly formulated
      foaming gel product on gingivitis and/or moderate periodontitis when used with or without the
      GLO Science accelerating device (GLO Device), compared to standard tooth brushing with
      antioxidant whitening toothpaste with or without flossing (split mouth design for control
      group).

      This is a 60-day randomized single blinded parallel group study. After 42 days, all use of
      interventional products were discontinued, and the participants returned to the clinical
      center at day 60 for final measurements. The primary outcomes assessed in this study were the
      differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 & 60
      days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque
      amount.

      It is hypothesized that participants using the gingival health product with the GLO Device
      will experience greater reductions in GI & BOP measurements than the control group, as well
      as participants using the gingival health product on a toothbrush alone.
    


Intervention name(s): Gingival health formulation in an accelerating device; Gingival health formulation on a toothbrush; OTC fluoride toothpaste
Intervention type(s): Other; Other; Other
Intervention description(s): The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used with the GLO Science Device; The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used on a toothbrush together with toothpaste.; OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.
Other intervention name(s): ECO Balance; GLO Science accelerating device; ECO Balance; GLO Science Antioxidant Toothpaste
Intervention MeSH terms: Fluorides; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Gingivitis; Periodontal disease; Inflammation; Teeth whitening; Breath freshening; Periodontal pathogens; Bleeding on probing
Medibio DDA Confirmatory Performance Study
Condition: Major Depressive Episode
Study type: Observational

Summary: 
      This study will determine whether the Medibio Depression Diagnostic Aid exceeds minimally
      acceptable thresholds for sensitivity and sensitivity in cases with a current depression
      episode and non-depressed controls.
    

Detailed description: 
      Subjects meeting study criteria will be enrolled into one of two study cohorts: a) outpatient
      individuals with current, moderate-to-severe major depressive episode (experimental group)
      and b) individuals without current major depressive episode that have been matched at the
      group level for age and gender (control group).

      All subjects will undergo two separate psychiatric interviews to confirm current depression
      episode presence or absence. Thereafter subjects will wear a heart rate monitor on the chest
      to capture data over the course of 72 hours. Subjects will return approximately 1 week after
      initial placement of the monitor for equipment return and a safety check. Subjects will wear
      a heart-rate monitor over the course of 72 hours. Subjects will return within a week from the
      last visit for equipment return.
    

Intervention name(s): Medibio Depression Diagnostic Aid; Mini International Neuropsychiatric Interview; Hamilton Rating Scale for Depression - 17 Item
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): The Medibio DDA processes the heart rate and actigraphy data from the third-party devices, characterizes these data in comparison to the benchmark patterns of persons currently experiencing a depressive episode.; The Mini International Neuropsychiatric Interview (M.I.N.I.) is a structured diagnostic interview that was developed as a simple tool to assist clinicians to conduct psychiatric diagnoses according to the DSM-IV and International Statistical Classification of Diseases and Related Health Problems tenth revision (ICD-10) criteria.; The clinician-administered Hamilton Depression Rating Scale (also known as the HAM-D) is the most widely used depression assessment scale . The original version contains 17 items (HDRS17) pertaining to symptoms of depression experienced over the past week. There are numerous versions with varying lengths that include the HDRS21, HDRS24, and HDRS29. This study will utilize the HDRS17 (HAMD-17) version.
Other intervention name(s): M.I.N.I.; HAMD-17
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects who may be currently experiencing an episode of depression that are being
        diagnosed or treated in a mental health setting.
The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children
Condition: Pain, Acute; Child Behavior; Anxiety and Fear; Venipuncture Site Reaction; Quantum
MeSH terms: Acute Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      This research is a randomized controlled experimental study designed to determine the effect
      of the Quantum-Touch method applied during the vascular access procedure in children aged
      7-12 years, on the level of pain, fear and anxiety in children.
    

Detailed description: 
      Quantum-Touch was first described by Richard Gordon and Bob Rasmusson in 1978; it activates
      life force energy by combining various hand positions, various breathing techniques and body
      awareness exercises. It is applied by directing the formed high energy field to an area of
      pain, stress or illness through therapeutic touch. Tully found that Quantum Touch in reducing
      acute and chronic pain; Walton reported that Quantum-Touch application is effective in
      chronic musculoskeletal pain. It is important to conduct studies with a high level of
      evidence investigating the effect of Quantum Touch, which is a non-pharmacological method, on
      pain, fear and anxiety for children of different age groups, which is easily applied during
      invasive procedures. Based on this information, in this study, which was planned in a
      randomized controlled and experimental design, it was aimed to determine the effect of the
      Quantum-Touch method applied during the vascular access procedure in children between the
      ages of 7-12 on the level of pain, fear and anxiety in children.
    

Intervention name(s): Quantum touch
Intervention type(s): Behavioral
Intervention description(s): this group by the nurse who is included in the study and who has a practice certificate before vascular access is established. In this process, the treatment process of the patient will continue and will not create an obstacle. While the child is in a comfortable position (lying or sitting position) during the application, the child's back/shoulder/head will be touched by the practitioner and guantum touch energy will be applied. Then, vascular access will be performed by the nurse included in the study. The child will be asked to rate the level of pain during the procedure with 'FPS-R', the level of fear with 'CDS', and the level of anxiety with 'ÇAS-D'.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: this study is an experimental, parallel-group (intervention-control), randomized controlled design
Masking: None (Open Label)
Primary purpose: Supportive Care
Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the pharmacokinetics in subjects with severe renal insufficiency and
      healthy subjects.
    


Intervention name(s): Certoparin 3,000 IU Once Daily; Certoparin 3,000 IU Twice a Day; Certoparin 8,000 IU Once Daily; Certoparin 8,000 IU Twice a Day
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Certoparin 3,000 IU subcutaneous injection once daily; Certoparin 3,000 IU subcutaneous injection twice a day; Certoparin 8,000 IU subcutaneous injection once daily; Certoparin 8,000 IU subcutaneous injection twice a day
Other intervention name(s): Mono-Embolex; Mono-Embolex; Mono-Embolex; Mono-Embolex
Intervention MeSH terms: Heparin, Low-Molecular-Weight; Dihydroergotamine; Certoparin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Severe renal insufficiency certoparin; Severe renal insufficiency
Biomarker Development for Future PAC1 Antagonists With Maxadilan
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This will be a single center, open-label study in healthy male subjects between 18 and 45
      years old to determine the dose response profiles of dermal blood flow in response to
      intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time
      finding and Part II: reproducibility over time.
    


Intervention name(s): Maxadilan; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Maxadilan protein, insect
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment