bioihbjkbjnl/mcl2 huggingface dataset:
Osteoporosis Prevention: Changes to Exercise and Diet in Children
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether educating parents about health and behavior
      management techniques will increase physical activity, calcium intake, fitness, and bone
      density in their children.
    

Detailed description: 
      In recent years, osteoporosis has become a major public health problem in the United States.
      Osteoporosis can best be prevented by optimizing bone mineral gain and reducing bone loss.
      Because the rate of bone development reaches its peak during adolescence, fostering bone
      health in childhood is of critical importance. Although there have been many studies of
      exercise and nutritional factors that influence bone mass in adults, few randomized,
      prospective studies have been conducted in children. This study will determine whether parent
      training is effective in increasing children's calcium intake, strength, and frequency of
      aerobic exercise.

      Families will be randomly assigned to either the physical activity and nutrition intervention
      group or to the injury prevention control group. Families in both groups will undergo
      training during 9 weekly classes. The intervention training will emphasize health topics,
      principles of behavior, and contingency management techniques. Post-training coaching
      procedures will be provided periodically for 9 months. Coaching procedures will assist
      parents with problem solving and help them refine and maintain parenting skills. All families
      will be assessed prior to training and at Months 3, 9, and 12. Outcome measures will include
      24-hour recall estimates of change in diet and change in physical activity. Total bone
      calcium, bone density, body composition, and skeletal age will also be assessed.
    

Intervention name(s): Physical activity and nutrition intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bone density; Children; Adolescents; Behavior; Health education; Health promotion; Physical fitness; Diet; Parent training; Injury control
Serotonin, Anxiety and Visceral Sensation
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this crossover study was to learn about the potential regulatory role of
      serotonin in interoceptive processing and its relationship to levels of state anxiety. This
      experiment directly compared the impact of a selective serotonin reuptake inhibitor (SSRI)
      (20mg CITALOPRAM) to that of a PLACEBO on the neural processing of ordinary interoceptive
      sensations and the relationship of these influences to anxious states.

      Healthy young volunteers completed the visceral interoceptive attention task with each
      treatment condition (citalopram and placebo). The task involves focusing attention on heart,
      stomach, or visual sensation control while scanned with functional magnetic resonance imaging
      (fMRI). The difference in haemodynamic response between interoceptive sensation(s) and visual
      sensation (i.e. the relative interoceptive response) is compared between treatment
      conditions. State anxiety is measured at each test period. It is used to test for a
      moderating effect of state anxiety on the influence of serotonin in interoceptive processing
      and used post-hoc to explore associations between changes in state anxiety and changes of
      interoceptive relative interoceptive response due to the SSRI.
    


Intervention name(s): Citalopram 20mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doses were delivered in gelatine capsules filled with microcrystalline cellulose.; Doses were gelatine capsules filled with microcrystalline cellulose
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: serotonin; interoception; ssri; anxiety
Clinical Evaluation of Two Daily Disposable Contact Lenses
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      This study seeks to evaluate the clinical performance of two daily disposable contact lenses.
    


Intervention name(s): etafilcon A; ocufilcon D
Intervention type(s): Device; Device
Intervention description(s): daily disposable contact lens; daily disposable contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Metabolic Response to the Acute Consumption of Fiber-enriched Pasta
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years,
      therefore, there have been considerable efforts to identify strategies for prevention and
      management of risk factors. The diet, with its pleiotropic effects, is one of the most
      effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers
      have been extensively studied and the available evidence supports the beneficial effects of
      its consumption. However, worldwide the average fiber consumption is still less than the
      recommended daily dose. For this reason, the availability of functional foods, such as
      additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.
    


Intervention name(s): Test meal
Intervention type(s): Other
Intervention description(s): The two test meals are designed to have the same energy and macronutrient composition. They differ only in the carbohydrate source: fiber-enriched pasta or control pasta. Blood samples are taken at fasting and every 30 minutes over 4 hours. Fasting and postprandial intestinal fermentation is evaluated by breath test.
Other intervention name(s): Acute test meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two
      pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking
      speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk
      Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not
      been investigated in patients responding to the drug measured by the abovementioned test.

      The question is if this will be the case and also if another walking test, termed the Six
      Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.

      Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not
      less sensitive to the effect of Fampridine-SR than T25FW.
    


Intervention name(s): Fampridine-SR
Intervention type(s): Drug
Intervention description(s): Subjects will all receive Fampridine-SR in an open label enrichment phase lasting four weeks. Those 40% improvin the most measured by SSST will go onto the intervention. Here randomization in a 1:1 key between Fampridine-SR and placebo will be undertaken. Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks. Arms will be double blind.
Other intervention name(s): Fampyra (Ampyra in the US).
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Walking disablility; Mobility; Six Spot Step Test; Outcome measures; Fampridine-SR; Fampyra
The Evaluation of the Safety and Effectiveness of a Novel Gel-type Sodium Hyaluronate for the Correction of Aging Mid-face
Condition: Dermal Filler; Hyaluronic Acid; Lidocaine; Aging Mid-Face
Study type: Interventional

Summary: 
      This study is to evaluate the safety and effectiveness for the correction of aging mid-face
      of treatment group compared with the negative control group.
    


Intervention name(s): 2% HA
Intervention type(s): Device
Intervention description(s): 2% HA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Clinicopathological and Prognostic Factors of Hepatocellular Carcinoma; 10 Years' Tertiary Center Experience in Egypt
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      This study aimed at study the clinical and pathological criteria of Hepatocellular carcinoma
      to keep with new challenging in diagnosis and morpho-molecular classifications
    


Intervention name(s): Morphological classifications of HCC
Intervention type(s): Other
Intervention description(s): Morphological classifications of Hepatocellular carcinoma
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HCC cases from a single tertiary center eligible for pathological analysis as a primary
        tool
Rotavirus Vaccine in Premature Babies
Condition: Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Observational

Summary: 
      This study will establish the duration of excretion of rotavirus vaccine in stool following
      vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.
    

Detailed description: 
      Rotavirus is the commonest cause of severe gastroenteritis in young children, and premature
      babies are at high risk of serious disease. The RV1 rotavirus vaccine is an altered form of
      the virus and is given to all children at 8 weeks and 12 weeks of age in the UK. It is given
      by mouth and excreted in the stool following vaccination - the vaccine virus can therefore be
      transmitted between people in the same way as the normal virus. Premature babies often
      receive their initial vaccines while they are still hospitalised in neonatal units. There are
      no data regarding stool excretion of the RV1 rotavirus vaccine in premature babies - there is
      a theoretical risk of transmission of the vaccine virus to other babies in the unit (if there
      was inadequate staff hand washing). Some countries have therefore advised against
      immunisation of babies while in the neonatal unit. In the UK, however, the vaccine is being
      given in neonatal units, enabling evaluation of the vaccine in hospitalised premature babies.

      This is an observational study of babies admitted to the neonatal unit at the John Radcliffe
      Hospital, Oxford University Hospitals NHS Trust who receive their first dose of rotavirus
      vaccine during their hospital stay.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature babies receiving their first dose of rotavirus vaccine while an inpatient on the
        neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust
      
Biospecimen description: 
      Stool, serum
    
Keywords: Rotavirus; Vaccine
Individualized Maternal Milk Fortification for Feeding the Preterm Infants
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a
      high percentage of amino acids from the first day of life in order to achieve normal
      neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased
      visceral fat) that this type feeding, in conjunction with complexity of prematurity, is
      likely to cause. Current study aims to investigate is whether individualized fortification of
      breast milk protein, based on the mother's milk protein content and targeting the recommended
      daily protein requirements, is associated with better nutrition, growth, biochemical and
      endocrine markers associated with the nutrition of preterm low birth weight neonates,
      compared to the standard fortification of human milk.
    

Detailed description: 
      Proteins are of the most important macromolecules in living organisms participating in almost
      all biological processes. Premature infants are forced to adapt to a new (extrauterine)
      environment where supply of nutrients, including amino acids, from mother ceases abruptly.
      Consequently, the aim of neonatologist is the appropriate, quantitatively and qualitatively
      nutritional support, to promote brain development, achieve normal endocrine and metabolic
      function, maintain a growth rate similar to the intrauterine one avoiding extrauterine growth
      restriction during postnatal period and at the same time encouraging the analogue modulation
      of body composition (increased muscle mass, decrease body fat, hydration).

      Malnutrition or inadequate nutrition of preterm infant which remains undiagnosed and without
      proper treatment could have serious consequences on psychomotor development and metabolic
      activity. Indeed, 75% of low birth weight premature infants exhibit extrauterine growth
      restriction at discharge, even when they have achieved growth equal to the considered
      satisfactory, ie 15g/kg/day.

      Beyond anthropometrics differences between preterm and full-term newborns, body composition
      varies as well. Preterms have higher percentage of body fat and decreased muscle mass at term
      time compared with full term neonates. However, it has not been clarified whether this
      differentiation is harmful predisposing to chronic diseases later in childhood or adult life
      (eg. obesity, metabolic syndrome).
    

Intervention name(s): Tailored protein fortification
Intervention type(s): Dietary Supplement
Intervention description(s): 4-4.5g of protein/kg/d
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preterm neonate; tailored fortification; nutrition; maternal breast milk composition
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)
Condition: Frown Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of
      moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of
      the glabellar complex.
    


Intervention name(s): DaxibotulinumtoxinA for injection
Intervention type(s): Biological
Intervention description(s): Intramuscular injection
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Forehead Lines; Glabellar Lines; Frown Lines
Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir
Condition: Hepatitis C Genotype 4
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open, uncontrolled pilot study of thirty chronic HCV infected patients carried out
      at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study
      is to investigate the safety & efficacy of combined therapy sofosbuvir (SOF) and daclatasvir
      (DCV) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results
      in other clinical studies of this drug it is expected that the drug will have high safety and
      high efficacy. Safety will be measured by checking for adverse effects, while efficacy will
      be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral
      nucleic acids in blood samples.
    


Intervention name(s): Combined Therapy SOF and DCV
Intervention type(s): Drug
Intervention description(s): 1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day
SOF dosage: 400 mg/day for greater than 45 kg weight patients; 200 mg/day for 17 kg to 45 kg patients
DCV dosage: 60 mg/day for greater than 45 kg weight patients; 30 mg for 17 kg to 45 kg patients
Other intervention name(s): sofosbuvir; daclatasvir
Intervention MeSH terms: Sofosbuvir
Intervention model: Single Group Assignment
Intervention model description: All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
Condition: Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/
      Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and
      one dose on every other week (EOW) regime administered for a period of 24 weeks initial
      study.
    

Detailed description: 
      -  To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III
           study on the basis of the safety and PK/PD profile after 24 weeks of treatment

        -  To assess the long term safety of HM10560A when administered in optimal dose range and
           dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)
    

Intervention name(s): HM10560A; Genotropin
Intervention type(s): Drug; Drug
Intervention description(s): Once weekly HM10560A; Once daily Genotropin
Other intervention name(s): LAPS-rhGH; Genotropin 5.3mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AGHD
Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain
Condition: Visceral Pain; Pancreatitis; Pelvic Pain
MeSH terms: Pancreatitis; Pelvic Pain; Visceral Pain
Study type: Interventional

Summary: 
      This study investigates comparing the effects of transcranial Pulsed Current Stimulation and
      transcranial Direct Current Stimulation (tDCS) (Soterix ©) and their combination on
      neurophysiological outcomes on healthy subjects as well as on the clinical population for
      chronic visceral pain. The study also aims to evaluate the effects of these techniques on
      pain thresholds in healthy subjects as well as for chronic visceral pain patients.
    


Intervention name(s): Active tPCS; Active tDCS; Sham tPCS; Sham tDCS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): A current intensity of 2mA and a stimulation frequency range of 6-10 Hz will be used with a peri-aurical ear-clip electrode montage for 20 minutes.; A current intensity of 2.0 mA will be used for 20 minutes. The electrodes that will be used will be standard sponge electrodes. The anode will be placed over left motor cortex. The cathode electrode will be placed over the contralateral supraorbitofrontal area.; Sham tPCS stimulation will consist of applying the same parameters as for active, but the corresponding device will be turned off after 30 seconds, as to simulate the initial sensation of the active current. A current intensity of 2mA and a stimulation frequency range of 6-10 Hz will still be used (only this will be turned off after 30 seconds using ramping) with a peri-aurical ear-clip electrode montage.; Sham tDCS stimulation will consist of applying the same parameters as for active, but the corresponding device will be turned off after 30 seconds, as to simulate the initial sensation of the active current. A current intensity of 2.0 mA will still be used (but turned off after 30 seconds using ramping). The electrodes that will be used will be same, standard sponge electrodes. The anode will be placed over the left motor cortex The cathode electrode will be placed over the contralateral supraorbitofrontal area.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TPCS; tDCS; visceral pain; pancreatitis; healthy subjects; pelvic pain; neuromodulation; non-invasive brain stimulation
Levo Phencynonate Hydrochloride for the Prevention of Seasickness
Condition: Motion Sickness
MeSH terms: Motion Sickness
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical
      superiority study.
    

Detailed description: 
      The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety
      tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the
      impact of voyage experience. 3) On-boat drug testing period. The subjects will be
      administered the drug before voyage. The seasickness symptoms will be evaluated during
      voyage. The safety test will be conducted before and after one day of on-boat testing.
    

Intervention name(s): placebo; levo phencynonate hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): placebo of levo phencynonate hydrochloride; levo phencynonate hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: motion sickness
The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types
Condition: Intestinal Polyps
MeSH terms: Polyps; Intestinal Polyps
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to confirm the TCM syndrome types and TCM constitution
      classifications of the patients with intestinal polyps via on-site epidemiological survey, to
      analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers, and to
      study the metabolomics differences of the two populations and the metabolomics variations of
      the patients with intestinal polyps of pre-polypectomy and post-polypectomy. Finally, this
      study is to investigate the serum metabolomics variations of patients with intestinal polyps
      of pre-polypectomy and post-polypectomy and the relationship with their TCM syndrome types
      and TCM constitution classifications, to determine the correlation among pathology, TCM
      constitution, TCM syndrome types and the metabonomics variations of patients with intestinal
      polyps.
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Intestinal polyps patients
      
Biospecimen description: 
      serum
    
Keywords: Metabolomics; Intestinal Polyps; TCM Syndromes; TCM Constitution Types