bioihbjkbjnl/mcl2 huggingface dataset:
Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia
Condition: Children Under General Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine a effect-site concentration of propofol in children
      3 to 11 years effective to make a induction of general anesthesia.
    


Intervention name(s): endotracheal intubation
Intervention type(s): Procedure
Intervention description(s): to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients
Condition: Neoplasms, Liver
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors
      into immunosuppressed mice, preventing an assessment on the immunologic interactions and
      effects of CSCs. In this study, the investigators examined the vaccination effects produced
      by CSC-enriched populations from histologically distinct murine tumors after their
      inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic
      and more effective as an antigen source than unselected tumor cells in inducing protective
      antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which
      bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from
      peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were
      capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed
      antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor
      immunity.
    

Detailed description: 
      To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the
      investigators will harvest peripheral blood and tumor specimen from patients with
      hepatocellular cancer. The investigators will purify T, B cells and generate DCs from the
      PBMCs of the hepatocellular cancer patient.On the other hand, investigators will isolate
      ALDHhigh and ALDHlow tumor cells from the tumor specimen of the hepatocellular cancer patient
      using a similar protocol as investigators reported .

      Aim 1: To demonstrate, in vitro, the relative cellular anti-hepatocellular cancer CSC
      immunity induced by hepatocellular cancer CSC-DC primed cytotoxic T cells.

      Aim 2: To determine, in vitro, specific binding and lysis of hepatocellular cancer CSCs by
      antibodies produced by purified B cells from PBMCs stimulated with hepatocellular cancer
      CSC-DC.
    

Intervention name(s): cancer stem cell vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effectiveness of Motivational Interview in Patients With Dyslipidemia
Condition: Patients With Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      Evaluate the effectiveness of motivational interviewing to improve lipid control and
      cardiovascular risk in patients with dyslipidemia.
    


Intervention name(s): Motivational interview
Intervention type(s): Behavioral
Intervention description(s): Motivational interview
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dyslipidemia, motivational interview, prevention
The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.
Condition: Umbilical Hernia; Inguinal Hernia
MeSH terms: Hernia, Umbilical; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      The purpose of our study to quantitatively examine the stress levels prior to surgery and the
      use of analgesics post surgery in both children and their parents following a preoperative
      intervention with a medical clown compared to children that were not exposed to this
      intervention.
    


Intervention name(s): Medical Clown
Intervention type(s): Behavioral
Intervention description(s): Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Medical clown
Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Condition: Disruptive Behavior Disorders
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      This study aims to the test the efficacy and cost effectiveness of new service delivery
      methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent
      Training (BPT), for early onset disruptive behavior disorders.
    

Detailed description: 
      Families will be randomized to one of two active treatment conditions, the standard BPT
      program or the standard BPT program plus some new service delivery methods.
    

Intervention name(s): Behavioral Parent Training
Intervention type(s): Behavioral
Intervention description(s): Weekly clinic session, mid-week call, home practice
Other intervention name(s): Parent Management Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Disruptive behavior disorders; Early Onset; Young Children; Parenting; Behavioral Parent Training
The Effects of the Swiss Ball on Cerebral Vascular Accident
Condition: Hemiplegia; Cerebrovascular Accident
MeSH terms: Stroke; Hemiplegia
Study type: Interventional

Summary: 
      The objective of this study was to investigate the effects of the Swiss ball on patients with
      hemiplegia due to CVA.
    

Detailed description: 
      The Cerebral Vascular Accident (CVA) is a neurological deficit, which may be transitory or
      definite, leading to motor, psychological and social alterations. It's the third cause of
      death in the industrialized world, of which 90% of the survivors have some residual deficit
      and 30% become disabled. The objective of this study was to investigate the effects of the
      Swiss ball on patients with hemiplegia due to CVA. An intervening and controlled study was
      conducted on 12 patients of both genders and over 50 years old with chronic hemiplegia, all
      undergoing treatment at the Beneficent Rehabilitation Association of Ceará. The patients in
      the experimental group (EG) underwent treatment with the Swiss ball added to conventional
      physical therapy and the control group (CG) went through conventional physiotherapy sessions.
      The treatment was done twice a week, consisting of 14 sessions altogether. The data were
      collected in an evaluation form at the beginning and at the end of the treatment. Most
      patients were found to be males; they had typical walking ability, tonus, and posture of
      chronic hemiplegia patients. The patients in the experimental group showed significantly
      greater muscular strength on the lower limbs than the control group (p < 0,05, Student t
      test), however, the same did not happen in the case of the other parameters, such as strength
      on the upper limbs, coordination, and balance. We can conclude that the treatment with the
      Swiss ball can promote increased strength, which will allow for a more efficient recovery in
      the studied population.
    

Intervention name(s): Physiotherapy with Swiss Ball
Intervention type(s): Other
Primary purpose: Treatment
Keywords: Physical therapy; Physical therapy modalities; Cerebral Vascular Accident (CVA)
The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
Condition: Atrial Fibrillation; Arrhythmia; Inflammation; Endothelial Dysfunction
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be
      effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial
      ablation procedure. We further hypothesize this reduction will result from diminished
      peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP)
      values in the blood.
    

Detailed description: 
      Although pharmacologic therapy is the traditional mainstay of therapy for AF, curative
      therapy has recently become possible.

      There is growing evidence that inflammation may be involved in the pathogenesis of AF. CRP, a
      sensitive marker of systemic inflammation, is increased in patients with AF compared with
      patients in sinus rhythm. Elevated CRP levels are associated with increased likelihood of new
      onset AF and with recurrence of AF after successful cardioversion. Clinical and basic
      laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins
      may also have anti-inflammatory properties and protective effect against AF.

      125 eligible patients with AF, undergoing left atrial ablation, will be randomly assigned in
      a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3
      months after their ablation procedure.

      Patients will have baseline lipids, CRP, endothelial function tests and Quality of Life (QoL)
      surveys compared with testing at 3 months post ablation.
    

Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg tablet taken by mouth daily for 90 days; Placebo tablet taken by mouth once daily for 90 days
Other intervention name(s): Lipitor; Placebo (dummy) tablet to match appearance of atorvastatin
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Arrhythmia; Pulmonary Vein Isolation; Left atrial catheter ablation; Inflammation; Endothelial dysfunction
Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on the fact that the fundamental pathogenic mechanism of the Multiple Sclerosis (MS)
      disease is neuroinflammation, related in turn to cellular oxidation and mitochondrial
      alterations, this project aims to assess the impact of a nutritional intervention on the
      evolution of MS patients in their different slopes. To this end, the administration of
      medium-chain triglycerides, whose metabolism produces the increase of ketone bodies in the
      blood, will be carried out; and another of the antioxidant polyphenol epigallocatechin
      gallate. This procedure will be applied over 6 months, based on a isocaloric Mediterranean
      diet, with a population for the study of 80 patients with different variants of the disease.
      The assessment of the intervention will be carried out every two months, at motor-functional,
      anthropometric, cognitive and emotional, inflammatory, and oxidation levels.
    


Intervention name(s): Coconut oil and epigallocatechin gallate; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 600 mg of epigallocatechin gallate (EGCG) and 60 ml of coconut oil (3600 mg of TGCM) per day, divided into two doses (one in the morning and one at noon); Lactose
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Prepivotal Omnipod Horizon™ Automated Glucose Control System
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and
      insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase
      conducted in both a hotel/rental house setting and outpatient setting.
    

Detailed description: 
      The study schedule will consist of a standard therapy data collection phase followed by a
      hybrid closed-loop phase.

      Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and
      insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at
      home per their usual routine using the study continuous glucose monitoring system (CGM) and
      remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a
      14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an
      outpatient setting.

      The hybrid closed-loop phase will begin on Study Day 1.

      During the hybrid closed-loop phase, subjects will be divided into two groups. The first
      group of subjects will commence the hybrid closed-loop phase in the hotel/rental house
      setting. On Study Day 3, subjects will transition to an outpatient setting for the remaining
      12 days. After all subjects from the first group have completed the 2-day hotel/rental house
      phase, the second group of subjects may commence the hybrid closed-loop phase in an
      outpatient setting for 14-days.

      During the hybrid closed-loop phase, all subjects will participate in specific target blood
      glucose (BG) challenges.

      After each subject in the prepivotal study has successfully completed 14-days of
      hybrid-closed-loop, they may immediately transition to and enroll in the pivotal study.
    

Intervention name(s): Omnipod Horizon™ Automated Glucose Control System
Intervention type(s): Device
Intervention description(s): The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Intervention model: Single Group Assignment
Intervention model description: This is a single-arm, multi-center, prospective clinical study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T1D; Omnipod
Functional Inspiratory Muscle Training in Chronic Kidney Disease
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Effects of functional inspiratory muscle training by telerehabilitation on respiratory and
      peripheral functions, functional capacity, diaphragm thickness and mobility, posture, quality
      of life, cognitive function, fatigue, physical activity, endothelial function and aortic
      stiffness in patients with chronic kidney disease will be investigated.
    


Intervention name(s): Functional Inspiratory Muscle Training; Inspiratory Muscle Training; Breathing exercises
Intervention type(s): Other; Other; Other
Intervention description(s): The inspiratory muscle training program will be consist of 4 weeks of foundation inspiratory muscle training and 6 weeks of functional inspiratory muscle training; The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training; The program will be consist of 10 weeks of breathing exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory muscle
A Multiple Ascending Dose Study of KBP-7072 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-blind, placebo-controlled, sequential parallel-group and
      multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics
      of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before
      progressing to the next higher dose.
    


Intervention name(s): KBP-7072; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Drug Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension
Condition: Sleep Disorders
MeSH terms: Pulmonary Arterial Hypertension; Sleep Wake Disorders; Hypertension
Study type: Observational

Summary: 
      In the investigators study, and regarding results of small cohorts in the literature, the
      investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators
      will explore these patients with a one night polysomnography and transcutaneous capnography,
      searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.
    

Detailed description: 
      Pulmonary hypertension (PH) is a rare and severe disease of young adults, characterized by a
      progressive increase in pulmonary vascular resistances leading to cardiac failure and death.
      Patients with PH are categorized in two major groups: primary PH (PPH) wich is idiopathic,
      and secondary PH associated with many conditions such as chronic pulmonary embolic diseases
      (CPED).Increase in vascular resistance in PH is secondary to vasoconstriction and to a
      proliferative remodeling process of the arterial wall leading to obliteration of the small
      arterioles. On the other hand, hypoxemia is known to cause similar changes in vascular
      architecture. Also, some small cohorts study in the literature mentioned an increase of sleep
      hypoxemia prevalence accounting for almost 70% of cases. The mechanisms of this hypoxemia are
      completely unknown.Our study is observational, prospective and transversal, searching for
      hypoxemic respiratory sleep disorders (HRSD) in PPH and in CPEPH. Included patients will have
      one night polysomnography (CIDELEC) with a continuous measurement of transcutaneous PCO2.The
      major objectives are to determine the prevalence of HRSD, their physiopathologic mechanisms
      and their possible causal factors according to PH history, clinical findings and hemodynamic
      severity.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with IPAH or CPEPH hospitalized in our pulmonary department for a standard
        follow-up. They have to be in a stable condition, as defined by the New York Heart
        Association classes for dyspnea and the six minutes walking test. Furthermore, no changes
        in medical therapy could have been made during the last three months.
      
Keywords: Pulmonary arterial hypertension; Chronic post embolic disease; Sleep hypoxemia; polysomnography; sleep apnea; periodic respiration
Sonographic Detection of Prophylactic Pancreatic Stents
Condition: Pancreatitis; Stent Dislodgement
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      The Retention of pancreatic stents for prophylaxis of post-ERCP pancreatitis (PEP) is
      assessed by abdominal x-ray according to international Guidelines. The current study aimed to
      analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to
      save the x-ray examination.
    

Detailed description: 
      Pancreatitis is the most common complication of endoscopic retrograde
      cholangiopancreatography (ERCP). Several pharmacologic and procedure-related measurements
      have been established for post-ERCP pancreatitis (PEP) prophylaxis one being the placement of
      pancreatic duct stents in patients with high risk for PEP. The beneficial role of pancreatic
      stenting in the prophylaxis of PEP was demonstrated in large meta-analyses. The used stents
      have a high potential of self dislodgment, retained stents have to be removed endoscopically
      after 5-10 days. For evaluation of spontaneous stent passage abdominal x-ray ist used and
      accordingly retained stents removed. The current study aimed to analyze whether prophylactic
      pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.
    

Intervention name(s): Abdominal ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Abdominal ultrasound for detection of the pancreatic stent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Acute Effects of Mango Leaf Extract on Cognitive Function in Healthy Adults: A Double-Blind, Placebo-Controlled Crossover Study
Condition: Attention; Cognition; Mood
Study type: Interventional

Summary: 
      The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to
      assess the short-term cognitive effects of a single dose (300 mg) of Mango Leaf Extract
      compared to a placebo on cognitive function, including during cognitively demanding task
      performance. The trial will utilise the COMPASS cognitive assessment system and cognitive
      demand battery (CDB), and Profile of Mood States (POMS), visual analogue mood scales (VAMS),
      and Stress Visual Analogue Scales (S-VAS) with assessments taking place at baseline, 30
      minutes, 180 minutes and 300 minutes post treatment, on two separate testing days separated
      by 7 days (minimum).
    


Intervention name(s): Mango leaf extract capsule; Placebo capsule
Intervention type(s): Other; Other
Intervention description(s): Single dose; Single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: mood; cognitive function; mango leaf; mango
US-CT Fusion for Post Implant Dosimetry
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Post implant dosimetry is an essential part of quality assurance after permanent seed
      prostate brachytherapy. CT imaging is the standard of assessment but due to contouring
      uncertainties, MR-CT fusion is preferred. This is not always available due to financial
      restrictions. This study explores the possibility of post implant US-CT fusion to improve
      contouring accuracy and potentially replace the use of MR-CT fusion.
    

Detailed description: 
      25 participants undergoing permanent seed prostate brachytherapy will be approached to
      undergo collection of prostate US images at the completion of their procedure. This will add
      approximately 5 minutes to the duration of their brachytherapy procedure. The US study will
      not entail any discomfort or risk to participants as they are still under anesthesia for the
      implant procedure. The institution standard of care for quality assurance will be complied
      with, obtaining a CT and MRI of the prostate at 30 days after the procedure. These will be
      co-registered and analyzed in the normal fashion. In addition, the post implant US images
      will also be co-registered with the CT and the resulting dosimetric parameters compared.
    

Intervention name(s): transrectal ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Use of US for post implant quality assessment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients undergoing prostate brachytherapy for localized prostate cancer.
      
Keywords: prostate cancer; brachytherapy; Quality assurance