bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Bullying in Children
Condition: Problematic Behavior in Children
MeSH terms: Bullying
Study type: Observational

Summary: 
      The specific aims of this study are:

        -  To determine the prevalence of bullying in children who present to the ED with
           behavioral symptoms

        -  To assess mental health diagnoses and their relationship to type, severity and frequency
           of bullying behaviors, as well as demographic and psychosocial correlates (socioeconomic
           status, stress and support) and their relationship to type, severity and frequency of
           bullying (bullies versus victims).

        -  To explore the attitudes, values, triggering events and potential solutions using
           qualitative methods

        -  To gain greater insight into the patient experience and perceptions of the bullying
           events
    

Detailed description: 
      This is a mix method study which has both qualitative and quantitative components.

        -  Data Collection sheet

        -  Qualitative Measurement

        -  Quantitative Measurement

        -  Data Collection sheet

             1. Demographic information (Date of birth, gender, race/ethnicity)

             2. Assessment of socioeconomic status (Type of Insurance, Zip Code, Parent education
                level, Parent type of work)

             3. Child physical attributes (Appearance, Weight, Height, Percentiles & BMI, Assisted
                Devices, Disabilities)

             4. Academic performance (Whether grades are age appropriate, previous grade results

             5. Extra-curricular activities (Questions include do you participate in sports? Are
                you member of any sport team? Are you member of any club?)

      Qualitative Measurement

      In order to understand bullying and victimization, a brief qualitative interview will be
      conducted by the principal investigator and his team. These questions may provide insights
      into the dynamics of bullying.

      Quantitative Measurement

      Following measurement scales will be used in the assessment of children with bullying
      Bullying → Olweus Bullying Questionnaire Child behavior → Achenbach Child Behavior Checklist
      Stress, life events and adversities → Adolescent Perceived Events Scale (APES) Social support
      → Child and Adolescent Social Support Scale (Malecki 2000) Social status → MacArthur Scale of
      Subjective Social Status Family Structure → A documentation of family structure and dynamics
      Mental health status → Psychiatric evaluation
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children 8-18 years of age referred from school to the Emergency Department due to Behavior
        Problems
      
Keywords: Bullies; Bully victims; Psychiatric symptoms
Telerehabilitation on Hand-Affected Scleroderma
Condition: Scleroderma; Scleroderma, Systemic; Scleroderma Associated Digital Ulcer; Hand Rheumatism; Physiotherapy; Rehabilitation
MeSH terms: Rheumatic Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional

Summary: 
      Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma
    

Detailed description: 
      The effects of exercises performed by telerehabilitation on individuals with hand-affected
      scleroderma on range of motion, grip strength, function, sensation, daily life activities and
      general health will be compared with the effects of home-exercises.

      Firstly, the evaluation results will be published; and after all data are collected, the
      results will be published.
    

Intervention name(s): Hand Therapy via Telerehabilitation; Hand Therapy via home-exercises
Intervention type(s): Other; Other
Intervention description(s): Hand Therapy via Telerehabilitation; Hand Therapy via home-exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scleroderma; Systemic sclerosis; Telerehabilitation; Hand therapy
Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.
Condition: Snake Bite
MeSH terms: Snake Bites
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae
      envenomation. Confirm its effectiveness in preventing the occurrence of delayed
      coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients
      with Crotalinae envenomation.
    

Detailed description: 
      Fewer than 200,000 crotaline envenomations occur annually in the US.Crotaline venoms contain
      a broad variety of toxins, venom variability and injection quantity among individual snakes
      and across species result in broadly variable patient presentations. Clinical consequences of
      crotaline envenomation include local and systemic effects, both of which may progress for
      hours to days.The best studied systemic consequence is coagulopathy, which may in its
      complexity mimic disseminated intravascular coagulation. Platelet and clotting disorders
      respond rapidly to administration of polyvalent antivenom.

      Crotaline viper envenomation in the United States is treated with one of two licensed
      products: Wyeth Antivenin (Crotalidae) Polyvalent (Polyvalent), or CroFab® (antivenin
      Crotalidae polyvalent immune Fab, ovine). In recent years, both of these products have been
      in critically short supply. Use of Wyeth Polyvalent has been associated with a greater than
      75% incidence of adverse reactions, including acute type 1 and delayed type 2 immune
      reactions.These phenomena are an inherent risk in the use of whole immunoglobulin. CroFab´s
      low molecular weight creates a pharmacokinetic mismatch with crotaline venom which leds to a
      recurrent venom effects.

      Anavip is pharmacologically and pharmacokinetically different.Because of the elimination of
      the Fc portion of the immunoglobulin molecule, Anavip is expected to produce far fewer
      adverse reactions than seen with whole immunoglobulin antivenoms and unlike Fab molecules,
      F(ab)2 molecules exceed the size threshold for renal clearance and thus are expected to
      remain in circulation for a significantly longer time and substantially reduce the incidence
      of recurrent coagulopathy.
    

Intervention name(s): Crotalinae (pit viper) equine immune F(ab)2; Crotalinae (pit viper) equine immune F(ab)2; Crotalidae Polyvalent Immune Fab, ovine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Anavip with Anavip Maintenance Therapy; Anavip with Placebo Maintenance Therapy; CroFab with CroFab Maintenance Therapy
Other intervention name(s): Anavip; Anavip; CroFab
Intervention MeSH terms: Antivenins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: snake bite; antivenin treatment
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Condition: Low Cardiac Output
MeSH terms: Cardiac Output, Low
Study type: Interventional
Phase: Phase 3

Summary: 
      Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG
      subjects have shown an increase in several cardiac performance parameters, with lesser volume
      of resuscitation fluid required to reach circulation volume, as compared to Sodium
      Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock
      patients.

      The primary objectives of this prospective, randomized, open-label trial are to evaluate the
      clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain
      hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and
      body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence
      of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of
      the two fluids in relation to reduction in concomitant drug utilization, duration of
      ventilator usage, length of stay in ICU as well as total duration of hospitalization and
      neurocognitive status upto a period of 1 year post-CABG.
    

Detailed description: 
      Details provided in summary.
    

Intervention name(s): Hypertonic lactate; Ringer's lactate
Intervention type(s): Drug; Drug
Intervention description(s): Solution given parenterally as follows:
Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.; Solution given parenterally as follows:
Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours.
Other intervention name(s): Totilac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary; artery; bypass; grafting; IV; cardiac output
Effects of Drospirenone-containing or -Not Containing Combined Oral Contraceptives on General and Sexual Well-being
Condition: Contraception
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the symptoms and satisfaction for women taking
      drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking
      other kind of combined oral contraceptives.
    


Intervention name(s): EE30-DRSP (Yasmin, BAY86-5131); Other combined oral contraceptives
Intervention type(s): Drug; Drug
Intervention description(s): DRSP-containing combined oral contraceptives according to the normal routine praxis; Other combined oral contraceptives according to the normal routine praxis
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women using Combined Oral Contraceptive (COC)
      
Keywords: Combined Oral Contraceptives; COC
Study to Evaluate the Efficacy and Safety of Camrelizumab and Famitinib in Patients With Advanced Solid Tumor
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multi-center study to evaluate the anti-tumor activity and safety of
      camrelizumab combined famitinib in subjects with selected advanced solid tumor.
    


Intervention name(s): Camrelizumab; Famitinib
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) camrelizumab on Day 1 of each cycle; famitinib po qd
Other intervention name(s): SHR-1210
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety and PK study in adults weighing more than 120 kg
    

Detailed description: 
      The primary objective of this study is to determine the pharmacokinetic (PK) profile of 600
      mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult
      subjects weighing more than 120 kg to determine if a change in dosing regimen would be needed
      in these patients.

      Secondary:

      The secondary objective of this study is to evaluate the safety and tolerability of 600 mg
      oral TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg.
    

Intervention name(s): Tpoxx
Intervention type(s): Drug
Intervention description(s): oral antiviral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Multiple-Dose Study of LY3493269 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to conduct blood tests to measure how much LY3493269 is in
      the bloodstream and how the body handles and eliminates LY3493269 when administered orally as
      test compared to reference formulations in healthy participants in fed and/or fasted states.
      The study will also evaluate the safety and tolerability of LY3493269 in these participants.
      The study will last up to 43 days excluding the screening period.
    


Intervention name(s): LY3493269
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois
Condition: Chronic Kidney Disease
MeSH terms: Dyssomnias; Parasomnias; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      This study will help determine the relationship between impaired sleep and chronic kidney
      disease, specifically to determine if sleep disturbances are a risk factor for worsening
      kidney function.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Renal Clinic patients at The University of Illinois at Chicago Hospital
      
Keywords: Sleep; CKD; kidney; PSG; polysomnography; Decreased sleep time; Decreased sleep quality
Changes in Acid Base Status During High Salt Intake
Condition: Low Grade Metabolic Acidosis
MeSH terms: Acidosis
Study type: Interventional

Summary: 
      The study aimed to examine the effects of an alkalinisation of a NaCl (sodium chloride,
      salt)-rich diet on acid base status, bone metabolism, protein turnover and other influenced
      physiological systems. Due to increased urinary calcium excretion and bone resorption a high
      NaCl-intake is considered as a risk factor for osteoporosis. On the contrary an alkaline diet
      is known to have a beneficial influence on bone metabolism. Therefore the investigators
      hypothesized that an alkaline diet can reduce NaCl-induced bone resorption.

      8 healthy male volunteers took part in a stationary study carried out in the metabolic ward
      of the German Aerospace Center. The study consisted of 2 campaigns, each lasting 16 days.
      Both campaigns were divided into 5 days of adaptation, 10 days of intervention and 1.5 days
      of stationary recovery. During the intervention period the volunteers diet was NaCl-rich (7.7
      mmol Na/kg body weight/day) and supplemented in one campaign by 90 mmol potassium bicarbonate
      (KHCO3) in a randomized cross-over design. The other campaign served as control.

      Bone metabolism was studied by bone formation markers in the fasting morning blood and
      24h-urinary bone resorption markers. Acid base status was assessed by blood gas analyses in
      the fasted and the postprandial state as well as urinary markers. Protein turnover was
      studied with stable isotopes. Further physiological systems like energy metabolism and the
      cardiovascular system are also under investigation.
    


Intervention name(s): High NaCl + KHCO3; Control: high NaCl
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 7.7 mmol Na/kgBW/d + 90 mmol KHCO3; 7.7 mmol Na/kgBW/d
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to
      biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive
      subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.
    


Intervention name(s): biphasic insulin aspart 30; biphasic human insulin 30; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner; The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner; Metformin dose must remain the same as that used prior to the trial.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
Condition: Acute Pain; Soft Tissue Injury
MeSH terms: Acute Pain; Wounds and Injuries; Soft Tissue Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to assess the effectiveness of once daily application of
      a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when
      applied to the painful area.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, parallel group study will be conducted in
      patients with mild to moderate soft tissue injuries.

      Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with
      either the diclofenac topical patch or a matching placebo patch to be applied once daily for
      14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a
      follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary
      in which assessments including pain intensity and pain relief will be recorded twice daily.
      Functional disability and global impression of change will be recorded in the diary at study
      visits, ratings of the quality of sleep will be recorded in the diary each morning, and the
      use of study treatment and rescue medication will be recorded in the diary each day.
    

Intervention name(s): Diclofenac Sodium; Matching Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): Topical diclofenac patch applied once daily to area of pain; Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diclofenac; acute pain; topical; patch; Acute Pain due to Mild to Moderate Soft Tissue Injury
[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      AIM: Investigate wether there are differences in the parasympathetic nervous system in
      Parkinsons patients compared to controls.

      MATERIALS AND METHODS: We use the tracer [11C]donepezil to image the parasympathetic nervous
      system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged
      40-80 in our study. The participants will receive a careful medical examination, including a
      neurological examination, as part of the inclusion process. The subjects also have an MRI
      scan of the brain. Then PET/CT scans with [11C]donepezil are conducted - once for the upper
      abdominal region and once for the head region. For evaluating the function of the
      parasympathetic nervous system gastric emptying time, heart rate variability and salivary
      flow will be measured. These measureless will be correlated to the PET findings.

      PERSPECTIVES: The study will potentially result in the development of a PET ligand for
      imaging the parasympathetic nervous system. This will have applications for research in
      Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic
      nervous system is involved
    


Intervention name(s): [11C]donepezil PET
Intervention type(s): Other
Intervention description(s): Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil
Intervention MeSH terms: Donepezil
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's patients with moderate symptoms (diagnosis > 4 years earlier, bilateral
        disease). Will be recruited through department of neurology Aarhus University Hospital,
        Denmark.

        Healthy controls recruited through local media.
A Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Sitravatinib
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe
      Hepatic Impairment on the Single-Dose Pharmacokinetics of Sitravatinib
    


Intervention name(s): sitravatinib
Intervention type(s): Drug
Intervention description(s): sitravatinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment