bioihbjkbjnl/mcl2 huggingface dataset:
Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome (OSAS) After Tonsillectomy
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side
      effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.
    

Detailed description: 
      Eligible pediatric patients that are undergoing tonsillectomy for sleep-disordered breathing
      or obstructive sleep apnea AND are to be admitted into a monitored setting will be recruited
      for this study. They will be randomized into two groups:1) Control group receiving continuous
      infusion of saline (placebo) and 2) Study group receiving continuous infusion of low-dose
      ketamine at 0.1 mg/kg/hr. Both patients will receive scheduled oral acetaminophen and rescue
      intravenous morphine as required. The infusions will be stopped at 0600 the next morning.
      Morphine requirements, pain scores at selected times, central nervous system side effects,
      and adverse cardiorespiratory events will be recorded.
    

Intervention name(s): Ketamine; Saline infusion
Intervention type(s): Drug; Other
Intervention description(s): Post-operative continuous infusion until 0600 the next day; Post-operative continuous infusion until 0600 the next day
Other intervention name(s): Ketalar; Placebo comparator
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; obstructive sleep apnea; tonsillectomy; analgesia
Safety and Efficacy of "Immuncell-LC" in TACE Therapy
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the
      patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular
      carcinoma
    

Detailed description: 
      ILC-IIT-05 is randomized, open-label, multi-center phase 2 clinical trial. To confirm
      clinical efficacy and safety between 'Immuncell-LC group' and 'non-treatment group', primary
      outcome, recurrence free survival(RFS) will be evaluated.

      For secondary outcome, overall survival(OS), changes of Alpha Feto Protein(AFP), correlation
      of between myeloid-derived suppressor cell change and prognosis, adverse event, ECOG-PS and
      hematological examination will be evaluated.
    

Intervention name(s): Immuncell-LC
Intervention type(s): Biological
Intervention description(s): Activated T lymphocyte : intravenous dripping of 200ml (1 x 10^9 ~ 2 x 10^10 lymphocytes / 60kg adult) for 1 hour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immuncell-LC; Transarterial Chemoembolization
Non-alcoholic Fatty Liver Disease and Its Treatment
Condition: NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Dipeptidyl peptidase-4 inhibitors (DPP-4I), key regulators of the actions of incretin
      hormones, exert anti-hyperglycemic effects in type 2 diabetes mellitus (T2DM) patients. A
      major unanswered question concerns the potential ability of DPP-4I to improve intrahepatic
      lipid (IHL) content in nonalcoholic fatty liver disease (NAFLD) patients. The aim of this
      study was to evaluate the effects of sitagliptin on IHL in NAFLD patients.
    

Detailed description: 
      A prospective, 24-week, single-center, open-label, comparative study enrolled 68 Chinese
      NAFLD patients with T2DM. Subjects were randomly divided into 4 groups: control group who did
      not take medicine (14 patients); sitagliptin group who received sitagliptin treatment (100mg
      per day) (17 patients); metformin group who received metformin (500mg three times per day)
      (17 patients); and sitagliptin plus metformin group who received sitagliptin (100mg per day)
      and metformin (500 mg three times per day) (20 patients). IHL, physical examination (waist
      circumstances, WC; body mass index, BMI), glucose-lipid metabolism (fasting plasma glucose,
      FPG; hemoglobin A1c, Hb1A1c; triglycerides; cholesterol; alanine aminotransferase, ALT;
      aspartate aminotransferase, AST) were measured at baseline and at 24 weeks.
    

Intervention name(s): sitagliptin and metformin; Sitagliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sitagliptin plus metformin group who received sitagliptin (100mg per day) and metformin (500 mg three times per day) (20 patients); sitagliptin treatment (100mg per day); metformin group who received metformin (500mg three times per day)
Other intervention name(s): DPP
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome
Condition: High-Frequency Microsatellite Instability; Mismatch Repair Gene Mutation; Mutation-Negative Lynch Syndrome; Mutation-Positive Lynch Syndrome
MeSH terms: Colorectal Neoplasms, Hereditary Nonpolyposis; Syndrome; Microsatellite Instability
Study type: Interventional

Summary: 
      This trial studies how well cycling works in preventing colorectal cancer in participants
      with Lynch syndrome. Exercise such as cycling may reduce colorectal cancer risk in
      participants with Lynch syndrome.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the feasibility of a 12-month exercise cycling intervention among Lynch syndrome
      (LS) patients.

      SECONDARY OBJECTIVES:

      I. To assess the effect size of exercise on circulating biomarkers as well as regulation of
      genomic, transcriptomic, and immunologic biomarkers in normal intestinal mucosa of LS
      patients.

      OUTLINE: Participants are assigned to 1 of 2 groups.

      GROUP I: Starting on day 15, participants wear FITBIT and complete cycling classes over 45
      minutes 3 times a week for a total of 12 classes a month for up to 1 year.

      GROUP II: Starting on day 15, participants receive information about exercise guidelines and
      wear FITBIT to track heart rate and activities for up to 1 year.

      After completion of study interventions, participants are followed up at 30 days.
    

Intervention name(s): Exercise Intervention; Informational Intervention; Monitoring Device; Questionnaire Administration
Intervention type(s): Behavioral; Other; Device; Other
Intervention description(s): Complete cycling classes; Receive information about exercise guidelines; Wear Fitbit; Complete questionnaire
Other intervention name(s): Monitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Reliability of Methods for Determining the Vibration Threshold
Condition: Reflex, Abnormal
MeSH terms: Reflex, Abnormal
Study type: Interventional

Summary: 
      It is known that whole-body vibration (TVV) has beneficial neuromuscular effects such as
      muscle strength increase. These beneficial effects are explained by the muscular reflex
      response induced by TVV. Reflex latency measurement is frequently used in clinical and
      neurophysiological research. The latency of the reflex response induced by TVV is defined as
      the period between the onset of the vibration stimulus and the onset point of the spike in
      the EMG signal. The current research aimed to determine whether the cumulative average method
      is reliable for estimating the EST.
    

Detailed description: 
      This is an experimental study for method development; a self-controlled (single group) study.
      Ten healthy male or female subjects between the ages of 18-45 will be included in the study.
      After obtaining informed consent from the subjects, 30 Hz low amplitude (2 mm) vibration for
      30 seconds will be applied on the PowerPlate Pro5 device to meet TVV. After three minutes of
      rest, two sets of TVV will be applied for test purposes. For the test TVV, vibration will be
      applied at 25, 30, 35, 40, 45, 50 Hz frequencies, each lasting 30 seconds, with low
      amplitude.

      Vibration stimuli detected by using an accelerometer fixed on the TVV platform will be
      recorded the Data acquisition (PowerLab data acquisition system (ADInstruments, Oxford,
      United Kingdom). Soleus EMG responses will be recorded using the superficial electrodes
      (Kendall Covidien). The sample rate for recordings will be 40KHz.

      Latency calculation with Cumulative Average Method: It will be done. An 80-500 Hz band-pass
      filter and full-wave rectification will be applied to EMG recordings. The peak of reflex
      responses (spike) will be marked with the help of LabChart7 (ver 7.3.7, ADInstruments,
      Oxford, United Kingdom). According to this marked point, the averaging process covered 75 ms
      of the vibration data preceding the trigger and 15 ms after for each vibration frequency
      separately. Then, the average of the five vibration frequencies will be calculated for the
      accelerometer recordings and EMG recordings. The point where the standard error is lowest in
      the accelerometer recordings will be determined as the "effective stimulation point".
    

Intervention name(s): whole body vibration
Intervention type(s): Device
Intervention description(s): whole body vibration is a modality of physical therapy
Intervention model: Single Group Assignment
Intervention model description: self-controlled study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sensor; vibration; reflex
Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
Condition: Sleep Disordered Breathing; Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Respiratory Aspiration; Pulmonary Heart Disease
Study type: Interventional

Summary: 
      Overall objective: To understand the feasibility of performing a randomized trial using a
      simple, minimally-invasive postural therapy approach to improve sleep disordered breathing
      (SDB).
    

Detailed description: 
      Specific Aims:

        -  To examine the relative efficacy of postural therapy (a 15-degree wedge mattress) on
           measures of chronic cardiometabolic stress in high altitude residents.

        -  To determine the tolerability of postural therapy.

      Primary outcomes, at 4 and 8 weeks:

        -  Mean nocturnal oxyhemoglobin saturation (SPO2)

        -  Apnea-hypopnea index (AHI).

      Secondary outcomes

        -  Markers of hypoxemia exposure: the investigators will evaluate for differences in
           average hemoglobin and erythropoietin concentrations between intervention groups using
           t-tests or Wilcoxon rank sum tests, as considered appropriate. If transformations are
           necessary, the investigators will use Box-Cox power transform to identify the best
           transformation for the investigators' data.

        -  Markers of metabolic dysfunction: the investigators will evaluate for differences in
           average Glycated hemoglobin test (HbA1c), homeostatic model assessment of insulin
           resistance (HOMA-IR), total cholesterol, low-density lipoprotein cholesterol (LDL),
           High-density lipoprotein cholesterol (HDL), triglycerides, SVEGF-R1 , and soluble
           Vascular Endothelial Growth Factor (SVEGF-1) concentrations between intervention groups
           using t-tests or Wilcoxon rank sum tests, as appropriate. If transformations are
           necessary, the investigators will use Box-Cox power transform to identify the best
           transformation for the investigators' data.

        -  Markers of cardiometabolic stress: the investigators will evaluate for differences in
           average systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse, and %
           change in endothelial function (reactive hyperemia index) as assessed by brachial artery
           reactivity testing (BART) between intervention groups using t-tests or Wilcoxon rank sum
           tests, as considered appropriate.

        -  Adherence (the average number of nights during the 8-week period that participants slept
           on the wedge mattress),
    

Intervention name(s): Inclined Sleep
Intervention type(s): Device
Intervention description(s): Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress.
Other intervention name(s): wedge mattress; postural therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Mental Practice in Gait of Individuals With Parkinson Disease: Randomized Clinical Trial
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of mental practice, associated with
      physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic
      Parkinson's disease. It is believed that familiarity with the normal gait pattern, associated
      with mental practice and physical practice can trigger significant changes in spatiotemporal
      and angular parameters that are not observed in the group not submitted to mental practice.
    


Intervention name(s): Physical practice; Mental and physical practice
Intervention type(s): Other; Other
Intervention description(s): The control group underwent familiarization of gait phases using cards with gait phases and physical gait training.
Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a physical gait training. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility.; The experimental group underwent familiarization of gait phases using cards with gait phases, mental practice of gait and physical gait training.
Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases.
Then, they were submitted to a mental training of gait. They imagined the gait steps per 400 repetitions. While imagining, they verbalized the gait phases.
Finally, they were submitted to a physical gait training. They executed 400 steps.
They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Primary Parkinsonism.; Rehabilitation.; Biomechanics.; Neurological gait disorders.
Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma
Condition: Cancer of Liver
MeSH terms: Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Observational

Summary: 
      This is a large-scale study in China to provide evidence and insights in the role of gender
      in LT for HCC by analyzing the data of 3769 recipients with HCC registered in the China Liver
      Transplant Registry.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 3769 HCC patients underwent liver transplant with the age between 18-65 years
        old were studied.
Effect of the EnkFiberoptic Atomizer Set on Usage of Anaesthetics During the Bronchoscopy
Condition: Administration of Local Anaesthetics With a Special Atomizing Set Durching Fexible Bronchoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this prospective study is to examine the benefits und risks of administration of
      local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)
      during flexible bronchoscopy.
    


Intervention name(s): Enk Fiberoptic Atomizer; bronchoscope
Intervention type(s): Device; Device
Intervention description(s): Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the felxible bronchoscopy; Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the felxible bronchoscopy
Other intervention name(s): Enk Fiberoptic Atomizer Set, Cook Medical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: felxible bronchoscopy; anaesthetics; transcutaneous pCO2; capillary pCO2
Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1
Condition: Hepatocellular Carcinoma; TACE; Notch1; Rg3
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a
      randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE
      on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high
      expression of Notch1.
    


Intervention name(s): TACE; Rg3; TACE + Rg3; protective therapy
Intervention type(s): Procedure; Drug; Other; Procedure
Intervention description(s): iodized oil (5ml) + Pirarubicin (20mg); 20mg, BID, maintained though Month 12.; standard liver protective therapy
Other intervention name(s): Transcatheter Arterial Chemoembolization
Intervention MeSH terms: Chlorotrianisene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carcinoma; Hepatocellular; Notch1
Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
Condition: Nasolabial Folds
Study type: Interventional

Summary: 
      This clinical investigation is a randomized, evaluator-blind, active controlled,
      noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine
      when compared with YVOIRE® Volume Plus.
    

Detailed description: 
      Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4
      points in the WSRS and who provided written informed consent are to be included in the
      investigation.
    

Intervention name(s): experimental; comparator
Intervention type(s): Device; Device
Intervention description(s): Neuramis® Deep Lidocaine; YVOIRE® Volume Plus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the
      pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in
      subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic
      fibrosis transmembrane conductance regulator (CFTR) gene.
    


Intervention name(s): Lumacaftor; Ivacaftor
Intervention type(s): Drug; Drug
Other intervention name(s): VX-809; VX-770
Intervention MeSH terms: Ivacaftor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Motor Imagery in Healthy Individuals
Condition: Health, Subjective
MeSH terms: Mental Fatigue
Study type: Interventional

Summary: 
      The research will be the first to examine the relationship between mental fatigue induced by
      motor imagery and upper extremity performance. This study, it is aimed to examine whether the
      effects of mental fatigue created by motor imagery on upper extremity performance can be
      reduced by diaphragmatic breathing exercises.
    


Intervention name(s): İntervention group
Intervention type(s): Other
Intervention description(s): Diaphragmatic Breathing Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: motor imagery; mental fatigue; diaphragmatic breathing exercises
Acupuncture in Cardiovascular Disease
Condition: Congestive Heart Failure
MeSH terms: Heart Failure; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if acupuncture decreases adrenaline levels in heart
      failure, thereby potentially improving survival and quality of life.
    

Detailed description: 
      Acupuncture is used to lower blood pressure in patients with hypertension, and to relieve
      angina in patients with coronary artery disease. While the biological mechanisms of
      acupuncture analgesia have been studied intensely in animals and humans, the biological
      mechanisms for modulation of the cardiovascular system in humans remain largely unexplored.
      Acupuncture at traditional acupoints, and at nonacupoints, decreases the blood pressure
      response during mental stress in normal humans. This depressor effect cannot be fully
      explained by a decline in muscle sympathetic nerve activity (MSNA). Further, in humans with
      heart failure (HF) in whom MSNA is elevated, we have preliminary data that acupuncture
      significantly decreases the MSNA response during mental stress. The following hypotheses will
      be tested: 1) acupuncture, performed at traditional acupoints and non-acupoints in normal
      humans, stimulates skeletal muscle afferent neurons causing a release of endogenous opioids,
      which oppose sympathetic excitation and vasoconstriction in visceral vascular beds, such as
      the kidney; 2) in humans with HF in whom MSNA is elevated and renal vasoconstriction is the
      rule, acupuncture utilizes similar mechanisms as in normal humans to produce exaggerated
      inhibition of MSNA and reflex renal vasoconstriction. Positron emission tomography and
      microneurography will be utilized to answer the following questions in normal humans and
      patients with heart failure: 1. Is acupuncture attenuation of BP during mental stress
      mediated by a decrease in renal vasoconstriction? 2. Is acupuncture sympathoinhibitory? 3. Is
      acupuncture modulation of the autonomic nervous system mediated by muscle afferents? 4. Is
      acupuncture modulation of the autonomic nervous system mediated by activation of endogenous
      opioids? Understanding the mechanisms of acupuncture modulation of the autonomic nervous
      system in humans may help clarify its role as a therapeutic modality in cardiovascular
      diseases, such as heart failure.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Acupuncture; Heart Failure; Autonomic nervous system