bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes in Children With Cancer
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Many medical interventions, including the dressing of central venous catheters, a common
      procedure used for children with cancer, cause anxiety and pain in children. This can
      adversely affect their care and recovery. This study aims to determine the effect of using a
      kaleidoscope during central venous catheter dressing on anxiety and pain in children with
      cancer.
    

Detailed description: 
      This was a randomised controlled trial with 60 children aged 6-12 diagnosed with cancer who
      were placed either in a kaleidoscope group (n=30) or a control group (n=30). Each child's
      anxiety was evaluated by the child using the Child Fear Scale before, during and after a
      central venous catheter dressing procedure, and each child's pain during and after the
      procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale (WB-FACES).
      Each child's heart rate and oxygen saturation were measured with a pulse oximeter device
      before, during and after central venous catheter dressing.

      The children in kaleidoscope group looked into the kaleidoscope and slowly turned it. This
      distraction procedure began immediately before the central venous catheter dressing and
      continued until it was finished.

      No intervention was performed to reduce pain and anxiety for children in the control group.

      Parents accompanied their children during the procedure in both groups.
    

Intervention name(s): kaleidoscope application
Intervention type(s): Behavioral
Intervention description(s): The children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization was done using the closed-envelope method. A total of 60 cards, equally divided between the kaleidoscope and control groups (30 of each), were placed in sealed envelopes. The children were asked to choose one of these envelopes, which determined their placement in the kaleidoscope group or the control group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anxiety; Cancer; Central venous catheter; Child; Pain
Comparative Effects of Costophrenic Assisted Cough and Anterior Chest Compression Technique in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that
      causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus
      (sputum) production and wheezing. In Costophrenic assist, the therapist gives a quick stretch
      to the diaphragm and intercostals with repetitions. The patientt holds air in the lungs. As
      the patient gets ready to cough, the therapist performs a diaphragmatic assist. In Anterior
      chest compression: the therapist places one arm across the patient's pectorals and the other
      parallel to it. After the patient takes a maximal breath, the therapist pushes down to help
      the patient cough. The greatest force is applied through the lower chest during expulsion. A
      total 34 patients will be taken. 2 groups will be created to apply intervention. After
      signing consent form, 17 patients in group A will be given costophrenic assist technique and
      17 patients in group B will be given anterior chest compression technique. Baseline treatment
      given to both groups will include percussion and tapping. The data collected will then be
      analyzed using IBM SPSS version 25
    


Intervention name(s): Costophrenic assisted cough; Anterior chest compression
Intervention type(s): Other; Other
Intervention description(s): Therapist places the hands on the costophrenic angles of the patient's rib cage. During the patient's inspiration, the therapist applies a series of three repeated quick-stretch contractions down and in to encourage maximal inspiration. At the end of expiration, the therapist applies a quick stretch down and in on the patient's lower chest to facilitate a stronger diaphragmatic and intercostal muscle contraction. While instructing the patient to cough, the therapist applies strong pressure through the hands in toward the central tendon of the patient's diaphragm; The therapist puts one arm across the patient's pectoral region to stabilize or compress the upper chest while the other arm is placed either parallel on the lower chest or abdomen below the xiphoid process
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anterior chest compression; Chest Physio; Costophrenic assist; Sputum expectoration; Oxygen Saturation
BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the current study is to investigate the efficacy, safety and tolerability of
      BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to
      metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with
      insufficient glycaemic control.
    


Intervention name(s): linagliptin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): active; placebo to linagliptin 5 mg
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Objective Brain Function Assessment of mTBI/Concussion in College Athletes
Condition: Brain Injuries, Traumatic; Concussion, Mild; Concussion, Brain; Concussion, Intermediate; Concussion, Severe
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study (Part 1) is designed to build a database including EEG, neurocognitive
      performance, clinical symptoms, history and other relevant data, which will be used to derive
      a multimodal EEG based algorithm for the identification of concussion and tracking of
      recovery. In addition, neuroimaging will be conducted at time of injury and following Return
      to Play (RTP).
    

Detailed description: 
      Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points
      following injury. Matched controls will be tested following the same schedule as the injured
      athletes. In addition, the study will include an additional pool of contact and non-contact
      athletes who are not head injured and will be assessed prior to the season and then after the
      season has ended. This data will be used to populate a database for the purpose of deriving a
      multimodal concussion index.
    

Intervention name(s): BrainScope Ahead 200iD; Advanced MRI Neuroimaging
Intervention type(s): Device; Device
Intervention description(s): The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.; Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
Other intervention name(s): Magnetic Resonance Imaging; Diffusion Tension Imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 450 male and female student-athletes from participating universities or
        colleges will be invited to participate.
      
Keywords: Concussion; Mild Traumatic Brain Injury; Sport Related Concussion
Brow Enhancement Study
Condition: Brow Ptosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated
      by patient satisfaction
    


Intervention name(s): Juvederm XC; Botox
Intervention type(s): Device; Drug
Intervention description(s): Filler; 26 units dosed one time
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of a Novel Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a four arm, parallel study.

      Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC
      or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous
      administration of 100 μg/kg of Neulasta (an active comparator).
    

Detailed description: 
      Eligibility for participation of this study was determined from demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 3 weeks before study drug administration. Subjects suitable for this study were
      admitted to the Clinical Trials Center, Seoul National University Hospital on the day before
      dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug
      via subcutaneous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including
      clinical laboratory tests, electrocardiograms and pharmacokinetic and pharmacodynamic
      samplings. Subjects were discharged on Day 8, and visited Clinical Trials Center on Day 9,
      Day 11 and Day 14. Study participation was terminated on post-study visit (Day 20 - 22).
    

Intervention name(s): GCPGC, Neulasta, Placebo
Intervention type(s): Drug
Intervention description(s): A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg
Other intervention name(s): Neulasta® (Amgen, USA; active comparator)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GCPGC; Pharmacokinetics; Pharmacodynamics
Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The addition of heparin increases pregnancy outcome parameters in poor responders undergoing
      In Vitro Fertilisation (IVF)
    


Intervention name(s): Heparin, Low-Molecular-Weight; no heparin
Intervention type(s): Drug; Drug
Intervention description(s): Heparin from start till hcg test
Intervention MeSH terms: Heparin; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: In Vitro Fertilisation; poor responders
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Condition: Brain Tumors; Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one drug with radiation therapy may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation
      therapy in treating children who have newly diagnosed brain stem glioma.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the efficacy of vincristine plus etoposide with concurrent
      radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain
      stem glioma. II. Assess the toxicity of this regimen in this patient population.

      OUTLINE: Induction: Patients receive oral etoposide daily on days 1-21 and vincristine IV on
      days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive
      radiotherapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One
      week after induction therapy, patients receive vincristine IV on days 1 and 8 and oral
      etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence
      of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2
      years, every 6 months for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.
    

Intervention name(s): etoposide; vincristine sulfate; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Other intervention name(s): VP-16; VePesid; NSC # 141540; VCR; Oncovin; NSC # 067574
Intervention MeSH terms: Etoposide; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: untreated childhood brain stem glioma
2-HOBA: Multiple Dosing Study in Older Adults
Condition: Older Adults
Study type: Interventional

Summary: 
      The purpose of this study is to test how well people tolerate a new dietary ingredient called
      2-HOBA and how it is metabolized in the body. 2-HOBA is a compound that occurs naturally in
      buckwheat seeds. This dietary ingredient has been used in animal studies, and single doses
      have been tolerated well when given to a small group of healthy people. In this study we will
      test how well people tolerate taking 2-HOBA over 2 weeks and how it is metabolized by the
      body.
    

Detailed description: 
      Consenting volunteers between 55 and 79 years old with metabolic syndrome, including males,
      and post-menopausal females will be recruited for the study. Eighteen volunteers will be
      studied with a reasonable sampling of ethnicities from the Nashville area, and an effort will
      be made to recruit equal numbers of males and females. The study will be conducted by the
      Vanderbilt Clinical Research Center (CRC).

      Based upon single dose pharmacokinetics, two multiple dose regimens will be studied to
      determine the safety, accumulation kinetics, and pharmacodynamic effects of multiple daily
      doses administered over 2 weeks. A complete health history and physical examination will be
      conducted by a physician. An EKG, baseline blood and urine sample, and vital signs will be
      taken prior to supplement administration. A physician will oversee all clinical aspects of
      the study and will be responsible for all trial-related medical decisions. Additionally, DNA
      will be collected from the blood drawn and used to determine if there are any genetic
      differences in metabolism of 2-HOBA. Volunteers will be given 3 daily doses of either placebo
      or one of two levels of 2-HOBA to determine the safety, accumulation kinetics, and
      pharmacodynamic effects of the multiple dose administration over a 2 week period.
    

Intervention name(s): 2-HOBA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate; Placebo Comparator
Other intervention name(s): 2-Hydroxybenzylamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned in a blinded fashion to 2-HOBA or placebo. A computer-generated randomization sequence with a block of size 3 will be used to assign participants at the ratio of 1:2 (placebo:2-HOBA) at each dose level of the treatment. All participants receiving the lower dose regimen will be completed before enrolling participants in the higher dose group.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Multiple Dosage
Botulinum Toxin (BOTOX) for Cerebral Palsy
Condition: Cerebral Palsy; Muscle Spasticity
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and
      spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally
      occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.
    

Detailed description: 
      This trial will test the effectiveness of BTX injections versus placebo to reduce
      plantar-flexor spasticity and improve function and mobility in children with spastic
      diplegia, a common form of cerebral palsy. The study will evaluate the effects of the
      treatment across five domains that relate to disability: pathophysiology, impairment,
      functional limitation, disability, and societal limitation.

      Forty children, ages 4 to 12 years, will be recruited and randomized into one of two groups.
      Group A will receive BTX. Group B will receive a placebo injection. Participants will be
      assessed at the beginning of the trial and at Weeks 3, 8, 12, and 24. Assessments include
      quantitative electromyographic kinesiology measurements, electromechanical measurement of
      joint torque across the ankle joint using the Spasticity Measurement System, Gross Motor
      Function Measure, physical exam parameters, energy expenditure using the Energy Cost Index,
      kinematic gait analysis, and the Canadian Occupational Performance Measure.

      Participants are followed for a total of 6 months. Participants initially randomized to Group
      B will have the opportunity for BTX treatment after 24 weeks.
    

Intervention name(s): Botulinum toxin type A
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cerebral Palsy; Spasticity; Botulinum toxin; BOTOX
Evaluation of Soluble ST2 in Patients Receiving Primary PCI With ST-elevation Myocardial Infarction
Condition: Myocardial Infarction; Shock
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden
      myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary
      intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients
      are readmitted shortly after the primary PCI for several unfavorable clinical outcomes
      including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart
      failure. This study is intended to test the predictive ability of a new biomarker soluble ST2
      (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly
      associated with unfavorable clinical outcomes of patients with ischemia heart diseases and
      heart failure. This study will further investigate the ability of sST2 to predict unfavorable
      outcomes for STEMI patients after primary PCI.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Chinese han population in middle China
      
Biospecimen description: 
      peripheral blood
    
Keywords: STEMI; primary PCI; sST2; prognosis
Serial Therapeutic and Antifungal Monitoring Protocol
Condition: Candidemia
MeSH terms: Candidemia
Study type: Observational

Summary: 
      The objective of this study is to investigate T2Candida performance as a monitoring tool for
      post-therapy clearance of Candida compared to blood culture.

      This study will collect a T2clinical specimen and companion blood culture from patients who
      have exhibited a positive blood culture by gram stain for yeast, and who are receiving
      treatment with antifungal therapy.
    

Detailed description: 
      One blood culture and one set of T2clinical specimens will be collected at specified
      intervals to monitor the clearance of Candida infection from the bloodstream.

      Each T2 result will be compared to the companion blood culture result. The comparison will
      determine if the presence of antifungal therapy inhibits blood culture and leads to an
      incidence of blood culture false negative test results. The T2 result, which is not impacted
      by the presence of antifungal therapy, can show that the pathogen is still present for some
      additional period of time.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving treatment with antifungal therapy for 1 of 5 Candida species:

          -  Candida albicans

          -  Candida tropicalis

          -  Candida glabrata

          -  Candida parapsolosis

          -  Candida krusei
      
Biospecimen description: 
      At each time point, three 4 ml whole blood specimens will be collected. One sample will be
      tested, and the remaining samples will be available for use in investigating discrepant
      T2Candida assay and blood culture results, or may be used for research purposes
    
Keywords: Candida; Blood culture; Antifungal therapy; Sepsis
Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in
      adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved
      stimulant medication to explore a possible impact on sleep, quality of life and cognitive
      function.
    


Intervention name(s): OPDC-34712; Placebo; Stimulant Therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): OPDC-34712 tablets, daily, Orally.; Matching-placebo tablets, daily, Orally.; Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.
Other intervention name(s): Brexpiprazole
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inattention; Hyperactivity; Impulsivity; Distractibility; Procrastination; Disorganized; ADHD