bioihbjkbjnl/mcl2 huggingface dataset:
Study on Correlated Factors of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)
Condition: Stress Related Mucosal Disease
Study type: Interventional

Summary: 
      To study the changes of barrier and immune function in Stress Related Mucosal Disease (SRMD).
    

Detailed description: 
      38 patients admitted to ICU and 15 healthy volunteers were successively enrolled in this
      study.The healthy volunteers were treated with endoscopy and biopsy .The 38 patients were
      treated with bedside gastroscopy and diagnosed with SRMD due to illness. The acute physiology
      and chronic health evaluation（APACHE）II score were evaluated, malondialdehyde (MDA) as an
      index of oxygen radical-lipid peroxidation was assessed in the serum. Transforming growth
      factor(TGF)β1,claudin3, interleukin (IL) 1 and interleukin（IL）10 levels in the gastric mucosa
      and plasma level of superoxide dismutase(SOD)，Ischemic modified albumin(IMA)and C-reactive
      protein（CRP）were evaluated.
    

Intervention name(s): Endoscopy biopsy and blood
Intervention type(s): Other
Intervention description(s): Medical operation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Stress related mucosal disease (SRMD); APACHEII score; C-reactive protein; Malondialdehyde (MDA); transforming growth factor (TGF); interleukin (IL)
A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function
Condition: Diabetes; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the
      NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent
      that the dose should be adjusted in subjects with impaired renal function compared to the
      dose for subjects with normal renal function.
    


Intervention name(s): insulin degludec; insulin degludec; insulin degludec; insulin degludec; insulin degludec
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease; Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment; Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment; Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers; Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Therapy in Children With Refractory Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to
      ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure
      reduction from baseline seizure frequency at 6 months
    

Detailed description: 
      Primary objective:

      To compare the efficacy of Modified Atkins diet compared to Ketogenic diet * in children aged
      1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of
      diet intake in terms of percentage of seizure reduction from base line.

      Secondary objective:

      Proportion of patients who achieve > 50% seizure reduction from baseline after 6 months in
      both groups To evaluate the nature of adverse events in both the groups
    

Intervention name(s): Ketogenic diet (2.5 to 4:1); Modified Atkin's diet
Intervention type(s): Other; Other
Intervention description(s): Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given; 1:1 fixed ketogenic ratio Modified atkins diet will be given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to assess the relative bioavailability of
      risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy
      1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A
      liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).
    


Intervention name(s): Risankizumab; Risankizumab; Risankizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous Injection via prefilled syringe (PFS); Intravenous Infusion; Subcutaneous Injection via on-body delivery system (OBDS)
Other intervention name(s): SKYRIZI; SKYRIZI; SKYRIZI
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Risankizumab; SKYRIZI
Diabetes Distress, Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With T1D
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Parents have an important role in child's diabetes management. Many studies show that
      parental psychological stress and family dynamics are associated with parental
      diabetes-related distress and treatment outcomes among children and adolescents with type 1
      diabetes.

      The aim of this study is to analyze diabetes distress (diabetes-related parenting burden and
      fear of hypoglycemia), parental psychological well-being (anxiety, satisfaction with life,
      positive and negative affect and adult attachment relationship pattern), family hardiness and
      characteristics of children with type 1 diabetes in a sample of mothers and fathers of
      children and adolescents with type 1 diabetes of ages up to 18 years.

      In this study it is hypothesized that:

        1. greater parental fear of hypoglycemia and diabetes-related burden are associated with
           lower family hardiness and worse psychological well-being parents and higher HbA1c
           levels in children and adolescents with type 1 diabetes;

        2. mothers will report greater fear of hypoglycemia, diabetes-related burden and lower
           psychological well-being comparing to fathers.

        3. parents of children and adolescents with type 1diabetes will report greater anxiety,
           lower psychological well-being and family hardiness comparing to parents of children
           without diabetes.

      Standardized and validated questionnaires will be used to determine: parental fear of
      hypoglycemia, diabetes-related burden, parent level of anxiety, psychological well-being,
      adult attachment relationship pattern and family hardiness.

      The investigators will also measure parent daily involvement in child's diabetes management,
      frequency of blood glucose monitoring and parent general satisfaction with glycemic control.
      Objective measures such as child's HbA1c level and experience of severe hypoglycemia episode
      will also be obtained. These measures will be correlated with other research variables.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All children that have diabetes in Slovenia are controlled at the Dept. of Pediatric
        Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL and the
        population will be taken from here
      
Keywords: Diabetes related distress, children, T1D, family hardiness, psychological well-being
Non Cardiac Chest Pain and Benign Palpitations
Condition: Anxiety/Depression in Cardiological Unit
MeSH terms: Chest Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or
      palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have
      symptoms of chest pain or palpitation. If they still have some of the symptoms they are
      invited to participate in a coping course to learn a better way to deal with their symptoms.

      The coping course consist of three sessions of cognitive behaviour therapy.
    


Intervention name(s): Cognitive behaviour therapy
Intervention type(s): Behavioral
Intervention description(s): Three hours with cognitive therapy focusing on the chest pain and palpitations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anxiety; panic disorder; chest pain; palpitations
Comparing Harmonic Ultrasonic Scalpel to Small Jaw Bipolar Device in Thyroid Surgery
Condition: Thyroid Diseases
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      Energy devices are used routinely during thyroid surgery to aid surgical dissection and to
      stop bleeding. The newer generation energy devices have several advantages over older
      machines. The two most commonly used newer generation energy devices are the Harmonic scalpel
      and the Small Jaw bipolar device. Currently there has been no randomized controlled trial
      that compares both devices side to side. We aim to compare the effectiveness of these two
      newer generation energy devices in thyroid surgery.
    

Detailed description: 
      Energy devices are used routinely during thyroid surgery to aid surgical dissection and
      haemostasis. The newer generation energy devices have several advantages over older machines.
      First, the newer devices deliver more focussed thermal application and thus are less likely
      to cause collateral injury to surrounding healthy tissue. This is particularly relevant in
      thyroid surgery because the thyroid gland is in close proximity to vital nerves that control
      our airway and glands that regulate calcium metabolism. Secondly, the newer energy devices
      have multifunctional properties and are capable of sealing, blunt dissection, grasping and
      dividing tissue. This is advantageous in thyroid surgery as the operating field has many
      narrow areas within and the potential reduction in the exchange of instruments facilitates
      surgery.

      Currently, two of these newer generation energy devices are available for use in Singapore
      General Hospital and National Cancer Centre Singapore. Both devices are similarly priced; one
      is based on an ultrasonic vibrating blade (UCSD) to cut and coagulate tissue while the other
      uses bipolar electrical energy and pressure to form a seal and a micro blade to divide the
      sealed tissue (EBVS). To date, clinical studies comparing both devices have only been done on
      animal models and focus on sealing times in animal blood vessels.

      We aim to compare the effectiveness of these two newer generation energy devices in thyroid
      surgery by looking at the incidence of post surgical complications, post operative drainage
      as well as the ease of use as reflected in the operating time.
    

Intervention name(s): Harmonic Scalpel (Ethicon Endo-Surgery, USA); Ligasure Small Jaw (Covidien, USA)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether giving women feedback concerning their bone
      mineral density, combined with either an information leaflet or group education concerning
      osteoporosis changes women's behavior and/or bone density.
    

Detailed description: 
      Fractures due to osteoporosis are a major public health problem. Bone density is one of the
      major predictors of these osteoporotic fractures and is the result of the amount of bone
      gained in early life (i.e peak bone mass) and subsequent bone loss. Cigarette smoking,
      physical inactivity and inadequate calcium intake are widely regarded as risk factors for
      osteoporosis (as well as for other common diseases for the former two). Despite this
      information being widely available and actively promoted, the prevalence of these risk
      factors in the population remains unacceptably high. In women (mean age 33) taking part in a
      study of the determinants of bone mass in children, we recently reported substantial change
      in these behaviours at 12 months follow-up when women received an information leaflet and
      individualised bone density feedback. These women were highly selected and it is unclear if
      this response is representative of all women. With this study, we aim to test whether
      individualised bone density feedback, combined with either an information leaflet or small
      group education will change women's osteporosis preventive behaviors and/or bone density.

      Specifically, we aimed to test the following hypotheses:

        1. Women are more likely to change calcium intake and physical activity if their BMD is
           low.

        2. Group education (in the form of the Osteoporosis Prevention and Self Management course)
           will be more efficacious at changing these lifestyle behaviours than an information
           leaflet alone.

        3. Bone density feedback and educational intervention have independent effects on behavior
           and BMD change.

        4. Women who improve their physical activity or dietary calcium intake will have a change
           in bone mass over 2 years that is 0.34-0.54% per annum better (depending on site and
           lifestyle factor) than those who do not alter their behaviour.
    

Intervention name(s): individualised bone density feedback and education
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Efficacy of Xuebijing Injection on Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The Efficacy of Xuebijing Injection in Adult Patients with Sepsis
    

Detailed description: 
      The purpose of this placebo-controlled study is to determine if Xuebijing Injection treatment
      provides significant mortality reduction improvement in patients with sepsis compared with
      placebo treatment in patients receiving the current standard of care for sepsis. This study
      will also assess the effectiveness of Xuebijing Injection in reducing 28-day mortality in
      patients with sepsis.
    

Intervention name(s): Xuebijing Injection; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 100ml Xuebijing Injection every 12 hours for 5 days; 200ml normal saline every 12 hours for 5 days
Other intervention name(s): NS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Xuebijing Injection, morality, sepsis
the Regulation of Phosphorus Homeostasis by Dietary Phosphorus Intake in Normal Men
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators have conducted the study about the effects of normal diet and
      low-phosphorus diet on phosphorus homeostasis in healthy subjects, now this study is designed
      to explore further about the effect of high-phosphorus diet on phosphorus homeostasis.
    

Detailed description: 
      Serum phosphate concentrations are not only associated with cardiovascular and all-cause
      mortality in chronic kidney disease (CKD) patients, but also associated with the mortality in
      community population. Thus, maintaining normal serum phosphate and reducing postprandial
      fluctuation of serum phosphate are essential for healthy people.

      The investigators have conducted a study about the effects of normal diet (phosphorus 1500mg)
      and low-phosphorus diet (phosphorus 500mg) on phosphorus homeostasis in healthy men. The
      results showed low-phosphorus diet could significantly reduce serum phosphorus and urine
      phosphorus level compared to normal diet. However, the levels of serum FGF23 and a-klotho
      were not different between these two groups.Thus, the investigators want to further explore
      the effects of high-phosphorus diet (phosphorus 2300mg)on phosphorus homeostasis in healthy
      men.

      Therefore, the investigators plan to conduct a crossover clinical study to evaluate the
      phosphorus homeostasis modulated by native normal diet, restricted phosphorus diet, high
      phosphorus diet and then to explore the underlying mechanisms.
    

Intervention name(s): normal diet; low-phosphorus diet; high-phosphorus diet
Intervention type(s): Other; Other; Other
Intervention description(s): Diet containing 1500mg of phosphorus; Diet containing 500mg of phosphorus; Diet containing 2300mg of phosphorus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: phosphorus,diet; phosphorus; healthy subject
Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to assess the stomach emptying effect of a maximum dose of 3 mg
      Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a
      medication approved by the Food and Drug Administration (FDA) for routine clinical use.
    


Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.; Placebo administration will match the study drug.
Other intervention name(s): Saxenda; Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Functional Communicative Profile of Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of this study was to verify the use of communicative functions by children with DS in
      two interaction conditions: interaction with therapist and interaction with parent.
    

Detailed description: 
      Parents and caregivers' engagement on therapeutic process of children with Down syndrome (DS)
      is important for language and communication development. The identification of the
      communicative skills presented by these children as well as the context influence in their
      performance as interlocutors, will contribute to the design of therapeutic interventions.

      Pragmatics theories are helpful to language use studies, since it takes into account social
      and environmental aspects and considers adult-child interaction as a determinant factor for
      its occurrence.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        15 children with Down syndrome aged from 5 to 8 years.
      
Keywords: Down syndrome; Pragmatics; Language Development
A Multicenter, Randomized, Double-blind Non-inferiority Trial to Evaluate the Efficacy and Safety of Entelon®
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a multicentre, randomised, double-blind controlled study that compared the efficacy
      and safety of V. vinifera extract, calcium dobesilate (CD), and placebo in subjects with DME.
      Patients made 6 clinic visits, namely the screening visit; baseline visit (T0); and follow-up
      visits at 3 (T3), 6 (T6), 9 (T9), and 12 (T12) months.
    

Detailed description: 
      Eligible patients were randomised to one of the three study groups in a 1:2:2 ratio
      (placebo:GSPE:CD group). The randomization schedule was generated and prepared using
      cubeIWRS® solution (CRScube Inc., Seoul, South Korea, HQ). Randomization was performed using
      a complete randomization algorithm according to the order of the baseline visit. Subjects
      took three tablets of a masked study medication three times daily for 12 months; the first
      dose was taken in the morning of the baseline visit (T0) after baseline assessments were
      performed, and the last dose was taken in the evening before the month 12 visit (T12). Three
      daily oral doses of 50mg tablets of GSPE (Entelon®, Hanlim Pharm, Seoul, South Korea) were
      administered to patients in the GSPE group. Placebo tablets lacked GSPE, but their appearance
      was identical to that of the study group tablets. Commercially available 250mg CD tablets
      (Doxium®, Ilsung Pharm, Seoul, South Korea) were used in this study. The identity of the
      masked study medications was concealed by storing the medications in individually sealed
      envelopes at the study sites.
    

Intervention name(s): Vitis vinifera extract; Calcium Dobesilate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Three daily oral doses of 50mg tablets of Vitis vinifera extract(Entelon®, Hanlim Pharm, Seoul, South Korea) were administered to patients in this group; Three daily oral doses of 50mg tablets of Calcium Dobesilate(Doxium®, Ilsung Pharm, Seoul, South Korea) were administered to patients in this group; Placebo tablets lacked Vitis vinifera extract or calcium dobesilate, but their appearance was identical to those of the study group tablets.
Other intervention name(s): Experimental: Entelon; Active comparator:Doxium; Placebo comparator:Placebo
Intervention MeSH terms: Calcium Dobesilate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetic retinopathy, hard exudates