bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Intravenous Fentanyl on the Occurrence of Postoperative Nausea and Vomiting According to Time of Administration Around the End of Tonsillectomy With or Without Adenoidectomy
Condition: Follicular Tonsillitis (Chronic)
MeSH terms: Tonsillitis; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Fentanyl is a commonly used drug for the prevention of emergence agitation and reduction in
      postoperative pain in children receiving tonsillectomy. However, fentanyl can cause
      postoperative nausea and vomiting (PONV), which is a main target side effect that medical
      staff strives to prevent. However, recent meta-analysis showed that the incidence of PONV may
      be different depending on the time of administration of fentanyl. However, the research
      design of patients enrolled in each study, such as the age, the name of the operation, and
      the method of anesthesia, is not identical. The aim of this study was to evaluate the
      efficacy and safety of fentanyl in patients undergoing tonsillectomy with a prospective
      randomized controlled trial. Secondary outcomes include incidence and severity of emergence
      agitation and anesthesia recovery time, postanesthesia care unit (PACU) time, side effects.
    


Intervention name(s): fentanyl at 10-15 min before end of surgery; fentanyl at end of surgery
Intervention type(s): Drug; Drug
Intervention description(s): Label 2 syringe is filled with 1mcg/kg of fentanyl, label 1 syringe is filled with same amount of saline solution. If the surgeon notifies the anesthesiologist 10-15 minutes before the end of the operation, the syringe drug labeled 1 will be administered intravenously(that is, normal saline ). At the end of the surgery, the syringe drug labeled 2 is administered intravenously((that is, 1mcg/kg of fentanyl); Label 2 syringe is filled with 1mcg/kg of fentanyl, label 1 syringe is filled with same amount of saline solution. If the surgeon notifies the anesthesiologist 10-15 minutes before the end of the operation, the syringe drug labeled 1 will be administered intravenously(that is, normal saline ). At the end of the surgery, the syringe drug labeled 2 is administered intravenously((that is, 1mcg/kg of fentanyl)
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients
    

Detailed description: 
      To Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of multiple-dose Kukoamine B
      Mesilate in Sepsis Patients
    

Intervention name(s): 0.06mg/kg,KB; 0.12mg/kg,KB; 0.24mg/,KB; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.06mg/kg,Q8h,Day1-Day7; 0.12mg/kg,Q8h,Day1-Day7; 0.24mg/kg,Q8h,Day1-Day7; Placebos,Q8h,Day1-Day7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect on Music Therapy on Quality of Recovery After Gynecological Laparoscopy
Condition: Quality of Recovery After General Anesthesia; Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In the present study, we intended to evaluate the effect of music intervention on
      postoperative pain, nausea, and comprehensive recovery quality in patients undergoing
      gynecological laparoscopic surgery.
    


Intervention name(s): music; control
Intervention type(s): Other; Other
Intervention description(s): Classical music pre-selected was started to the patients with individual comfortable volume.; music player was not started.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
Condition: Fetal Alcohol Spectrum Disorder; Attachment Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional

Summary: 
      Study Summary: This study is being conducted in order to rigorously evaluate the real-world
      effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of
      Security (COS) Family Intervention Model (Marvin) in improving caregiving and child outcomes
      in families who have children with Fetal Alcohol Spectrum Disorder (FASD) or who are at-risk
      for FASD, as delivered under routine practice conditions.

      Hypothesis: At post-test (after 36 sessions and 3-month follow-up), compared to a wait-list
      control group receiving standard services, the treatment group receiving COS will show
      greater improvement in caregiver behaviour, as well as child emotional and behavioural
      outcomes.
    

Detailed description: 
      See Arms and Intervention
    

Intervention name(s): Circle of Security (COS)
Intervention type(s): Behavioral
Intervention description(s): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment theory of John Bowlby and Mary Ainsworth and integrates neuroscientific principles of emotional regulation and attachment. The protocol contains both educational and therapeutic components. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour.
Other intervention name(s): Attachment Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fetal Alcohol Spectrum Disorder; FASD
CLBS201 in Patients With Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD
      and T2DM.
    


Intervention name(s): CLBS201
Intervention type(s): Drug
Intervention description(s): 1 x 10^6 to 300 x 10^6 autologous CD34+ cells
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Kidney disease; Type 2 Diabetes Mellitus; Diabetic Kidney disease
Safety and Efficacy Study of Sintilimab Combined With IBI305 in Patients With Advanced Hepatocellular Carcinoma
Condition: Advanced Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ib study to evaluate the safety, tolerability and efficacy of Sintilimab
      combined with IBI305 in patients with advanced hepatocellular carcinoma in China.
    

Detailed description: 
      This study is to evaluate the safety, tolerability and efficacy of Sintilimab combined with
      IBI305 in patients with advanced hepatocellular carcinoma in China.

      Approximately 26-38 subjects with locally advanced or metastatic hepatocellular carcinoma
      will be enrolled in the study. It includes dose escalation and dose expansion stage. 12-18
      subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation.
      Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 20 patients for the
      further safety and efficacy study.

      The study treatment lasts up to 24 months, or until disease progresses, intolerable toxicity,
      withdrawal of informed consent, loss of follow-up, death, or other circumstances that require
      termination of treatment, whichever occurs first.
    

Intervention name(s): Sintilimab+IBI305
Intervention type(s): Drug
Intervention description(s): It includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 36-39 patients for the further safety and efficacy study.The study treatment lasts up to 24 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Hepatocellular Carcinoma; Sintilimab; IBI305
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,
      and an open-label extension phase. The open-label extension phase only will be described in
      this record. All participants will receive GWP42003-P.
    


Intervention name(s): GWP42003-P
Intervention type(s): Drug
Intervention description(s): Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other intervention name(s): CBD; Cannabidiol
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GWP42003-P; Cannabidiol
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Injury; Osteoarthritis
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in
      subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction
    

Detailed description: 
      This is a prospective, single center, randomized, double blind, controlled Phase 1b/2a study
      designed to evaluate the safety and tolerability of a single injection into the knee joint of
      two different doses of MPCs combined with Hyaluronan compared to Hyaluronan alone in patients
      who have recently undergone an Anterior Cruciate Ligament Reconstruction.

      All subjects in this study have undergone unilateral ACL reconstruction surgery within six
      months of injury. MSB-CAR001 plus Hyaluronan at one of two doses or Hyaluronan alone will be
      injected into the knee joint.

      After the screening and injection visits, each subject will be evaluated clinically within 3
      days and 28 days after surgery, and at 2, 3, 6, 9, 12, 18, and 24 months after surgery. The
      radiographical exams will be performed at 6, 12, 18, and 24 months after surgery.

      Subjects will be evaluated at 24 months after surgery for safety.
    

Intervention name(s): MSB-CAR001 Combined With Hyaluronan; Hyaluronan
Intervention type(s): Biological; Drug
Intervention description(s): Knee Injection of Biological: MSB-CAR001 Combined With Hyaluronan
Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan; Hyaluronan alone
Other intervention name(s): Anterior Cruciate Ligament Reconstruction; Adult Stem Cells; Knee Injection; Active Control
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Reconstruction; Adult Stem Cells; Mesenchymal precursor cells
Bypass PACU in Knee and Hip Arthroplasty
Condition: Surgery; Knee Osteoarthritis; Postoperative Complications; Hip Osteoarthritis; Arthroplasty Complications
MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Postoperative Complications
Study type: Observational [Patient Registry]

Summary: 
      A Quality Study in the use of Post-Anaesthesia Care Unit(PACU) in Hip and Knee Arthroplasty,
      and the ability to bypass this unit.

      The investigators wish to investigate the amount of patients who is required to be secondary
      admitted to the PACU, after primary discharge from the operating room to the surgical ward,
      thereby bypassing the PACU.
    

Detailed description: 
      The investigators wish to investigate the use of our standardized regimen for discharging
      patients directly to the surgical ward, thereby bypassing the PACU. The anaesthesiology dept.
      have a local standard operating procedure for doing this, and the patients will be treated
      according to this.

      This means that Patients will be discharged directly to the surgical ward if the following
      criteria are met:

        -  American Society of Anaesthesiologist-score (ASA-score) < 3

        -  Anaesthesia and surgery without any complications, vital signs normal during the whole
           procedure and not demanding oxygen supplement on the end of the procedure.

        -  Bloodloss < 500 ml.

        -  Postoperative evaluation, Early Warning Score, and postoperative score documented in
           Electronic Patient journal(EPJ).

      The patients will upon arrival at the surgery start a registration containing preoperative
      data(baseline morbidity, sex, height, weight, type of anaesthesia and surgery), perioperative
      data containing surgery and anaesthesia data, and postoperative discharge-score(local
      operating procedure).

      After discharge to either the surgical ward or the PACU, the patient will be observed closely
      the first 2 hours while recording every intervention made by the nurse staff.

      After the initial 2 hours the recording goes on the next 24 hours recording every event and
      intervention which lead to a doctor consult, by telephone or physically examining the
      patient.

      Also, the investigators wish to evaluate the use of the discharge Score(Danish Society of
      Anaesthesia and Intensive care Medicine(DASAIM)-SCORE), which is used as the discharge score
      after surgery in other hospitals in Denmark, and the investigators therefore record this
      after surgery, and every 30 minutes after the surgery for the first 2 hours.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Every patient planned for unilateral Primary Total Hip and Knee Arthroplasty and unilateral
        unicompartmental knee arthroplasty within a year, or until 600 patients is included.
      
Keywords: Knee Arthroplasty; Hip Arthroplasty; Postoperative Anaesthesia Care Unit
Compassionate Treatment : An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the safety and possible effectiveness of Autologous
      Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.
    

Detailed description: 
      This pilot clinical trial is design to see the safety and possible efficiency of ADSCs
      treatment in a ALS patient. one subjects will be treated (n=1). The patient will receive
      brain transplantation of ADSCs and combines intravenous infusion ADSCs 4 times. Subjects will
      be assessed by adverse effects and functional outcomes of clinical: PI max , PE max,and
      Haloscale respiration, ALS functional rating scale (ALS-FRS) are analyzed at 1 month, 3
      months, 6 months 9 months and 12 months.

      Brain MRI scans will be obtained before and after the treatment. Long term follow-up will be
      performed at 1, 6 , and 12months for safety reasons. Brain CT for check operation safety
      before and after brain implantation.

      Timing of Study: 12months recruitment period after approvals
    

Intervention name(s): Autologous Adipose-Tissue Derived Stem Cells
Intervention type(s): Procedure
Intervention description(s): Intravenous and Intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells
Patient will receive brain implantation of approximately 100 -400million Autologous Adipose-Tissue Derived Stem Cells.
Patient will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice , before brain implantation, and will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice, after brain implantation .
Other intervention name(s): ADSCs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic
      malnutrition caused by chronic diseases.

      We aimed to evaluate the use of the Screening Tool for the Assessment of Malnutrition in
      Pediatrics (STAMP) among children admitted in a pediatric hospital, and assess its effect on
      medical staff's awareness to nutritional status and health outcomes at discharge.
    

Detailed description: 
      Malnutrition prevalence upon admission to paediatric hospitals remains considerably high,
      ranging from 7.3 to 17.9% in the developed world with higher prevalence rates in infants and
      toddlers and particularly high rates for specific medical conditions. Several studies have
      reported deterioration of nutritional status during hospitalization. Screening children for
      malnutrition risk is recommended by a number of international organizations such as the
      American Society for Parenteral and Enteral Nutrition (ASPEN), the European Society for
      Parenteral and Enteral Nutrition (ESPEN) and the European Society for Paediatric
      Gastroenterology, Hepatology and Nutrition (ESPGHAN).

      Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) was chosen for this
      study because it is highly applicable, frequently used by nurses and has shown high
      reproducibility, as well as concurrent and predictive validity. The tool was developed by
      McCarthy et al11 in England. It collects the following information to assess nutritional risk
      for a patient: discrepancy between the weight and height percentile weight for the age
      expected nutritional risk caused by clinical diagnosis, recent changes in the appetite. The
      assessment results are used to define if there is a need for a referral to a full nutritional
      assessment.

      We aimed to evaluate the use of the Screening Tool for the Assessment of Malnutrition in
      Pediatrics among children admitted in a pediatric hospital, and assess its effect on medical
      staff's awareness to nutritional status and health outcomes at discharge.
    

Intervention name(s): questionnaire STAMP and dietary; No intervention
Intervention type(s): Other; Other
Intervention description(s): Children will undergo a complete evaluation by an investigating dietician and assessment by the STAMP tool in order to determine the extent of the nutritional risk on a numerical scale. According to findings children will get the dietary recommendations.; The Placebo Comparator arm children got the classic care that practiced in hospitalization
Other intervention name(s): STAMP using; No STAMP using
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: tool for nutritional evaluation; children; malnutrition
Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke
Condition: Stroke; Activities of Daily Living
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study was to conduct a randomized clinical trial. Implement instrumental
      daily activities of daily living (A-IADL) in home rehabilitation. To explore the effect of
      A-IADL on stroke patients' movement, cognition, social participation, daily life function and
      quality of life.
    

Detailed description: 
      Subjects were randomized to intervention group and control group. The experiment was designed
      as randomized cross-over control trial. The primary outcome included 11 measures, Fugl-Meyer
      Assessment, Balance computerized adaptive testing, Mini Mental State Examination,
      Participation Measure-3 Domains ,4 Dimensions, Canadian Occupational Performance Measure,
      Barthel Index-based Supplementary Scales, Frenchay Activities Index, Lawnton Instrumental
      Activities of Daily Living, stroke impact scale, Stroke Self-Efficacy Questionnaire, and
      Kingston Caregiver Stress Scale.
    

Intervention name(s): Approach-Instrumental Activities of Daily Living; Home health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individualized instrumental activities of daily living training; Individualized home health education
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Activities of Daily Living; Home Care Services
Radiation Therapy in Treating Women With Localized Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
      therapy in different ways and giving it after surgery may kill any tumor cells that remain
      after surgery.

      PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it
      works in treating women with localized breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare late normal tissue effects of standard vs 2 different dose levels of
           hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic
           breast appearance, in women with localized breast cancer who are at average or low risk
           of recurrence.

        -  Compare tumor control in patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center. Patients are randomized to 1 of 3 treatment arms.

        -  Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks.

        -  Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks.

        -  Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once
           a week for 5 weeks.

      After completion of study treatment, patients are followed annually for 5-10 years.

      PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this
      study within 12 months.
    

Intervention name(s): Radiation therapy
Intervention type(s): Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer