bioihbjkbjnl/mcl2 huggingface dataset:
Adult Accuracy Study of the Enlite 3 Glucose Sensor
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168
      hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G
      Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.
    

Detailed description: 
      This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the
      performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and
      used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or
      type 2 diabetes for at least one year.

      Subjects are randomized into either Group A or Group B. The groups assigned will determine
      when the subject will be participating in the in-clinic YSI frequent sample testing (FST).
      For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B
      begins FST 14 hours after Enlite 3 Sensor Insertion.
    

Intervention name(s): Enlite 3; Guardian Mobile App; 640G Insulin Pump
Intervention type(s): Device; Device; Device
Intervention description(s): Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Type 1 Diabetes; Type 2 Diabetes; Enlite 3
RAAS Optimization for Acute CHF Patients
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Holding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure
      may help preserve renal function with a lesser decline in GFR. This treatment modification
      will also allow the option of aggressive diuresis in volume overloaded CHF patients which
      should result in a lesser decline of AKI, length of stay, readmission rates, and cost
      associated with CHF treatment.
    

Detailed description: 
      The investigators hypothesize that worsening renal function can be mitigated by withholding
      ACEI/ARB during the initial phase of in-patient treatment with aggressive diuresis. This
      hypothesis will be tested by randomly allocating 360 admitted patients with ADHF on two
      treatment paths: 1) no ACEI/ARB administered for initial 72 hours of treatment during
      aggressive diuresis versus 2) full dose ACEI/ARB administered concurrently with aggressive
      diuresis in naïve patients/home dose, who are already on such therapy. The study team hopes
      to find that holding ACEI/ARBs during the initial 72 hours of admission with acute
      decompensated systolic heart failure will help preserve renal function, as demonstrated by a
      lesser decline in GFR. In addition, this treatment would allow the option of aggressive
      diuresis in volume overloaded CHF patients, resulting in a lesser decline of AKI, length of
      stay, readmission rates, and costs associated with CHF treatment. By understanding the
      complex interaction between holding ACEIs/ARBs and continued aggressive diuresis, the
      investigators intend to develop optimal dosing strategies for acute, decompensated CHF
      patients, further minimizing adverse events such as electrolyte issues and declining GFR/AKI.
    

Intervention name(s): Change of treatment plan
Intervention type(s): Other
Intervention description(s): Withholding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure may help preserve renal function with a lesser decline in GFR. This treatment modification will also allow the option of aggressive diuresis in volume overloaded CHF patients which should result in a lesser decline of AKI, length of stay, readmission rates, and cost associated with CHF treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The subjects will be randomized into a control group or variable group with an approximate 50/50 randomization. The control group will consist of subjects receiving ACEIs/ARBs. The variable group will consist of subjects that will not receive ACEI/ARBs during the first 72 hours of admission.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACEI (Angiotensin-Converting-Enzyme Inhibitor); ARB (Angiotensin II Receptor Blocker); CHF (Congestive Heart Failure); RAAS (Renin Angiotensin Aldosterone System)
Impact of Personality on Satisfaction Following Presbyopic Correction
Condition: Personality; Patient Satisfaction; Presbyopia
MeSH terms: Presbyopia; Personality Disorders
Study type: Observational [Patient Registry]

Summary: 
      Primary objective of this study is the exploration of the impact of personality type, social
      roles and working mandates οn the visual capacity and satisfaction of patients that underwent
      pseudophakic presbyopic correction.
    

Detailed description: 
      Personality type, social types and working mandates will be evaluated as a routine procedure
      to patients that visit the Presbyopia Service of the University Hospital of Alexandroupolis,
      by means of structured questionnaires. Six months following pseudophakic presbyopic
      correction surgery, each study participant will be evaluated for his/her visual capacity and
      vision-specific quality of life. Regression modeling will be attempted in order to identify
      the exact demographics, social roles and personality type of the patient that is most
      compatible to receive pseudophakic presbyopic correction.
    

Intervention name(s): TPQue Greek version, NEI-VFQ-25 Greek version
Intervention type(s): Diagnostic Test
Intervention description(s): Study participants with non surgical presbyopic correction will be evaluated with TPQue regarding their personality traits. Visual acuity will also be assessed. Study participants with pseudophakic presbyopic correction will be evaluated with the TPQue before surgery. They will also be visual acuity evaluation and NEI-VFQ-25 assessment six months after surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        participants with presbyopia, either surgically or non surgically corrected, aged 40 to 85
        years
      
Keywords: multifocal presbyopic correction; personality traits; vision oriented quality of life
Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination
Condition: Virus Diseases; Hepatitis B
MeSH terms: Hepatitis B; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the ability of the Protector Cap Jet
      Injector to prevent cross-contamination in the next injection sample. The hypothesis is that
      the Protector Cap Jet Injector will prevent contamination in the next injection sample, even
      following injection of volunteers with high levels of hepatitis B virus.
    

Detailed description: 
      The jet injector is a needle-free injection device that uses a high-pressure stream to
      penetrate the skin and deliver medication into intradermal, subcutaneous, or intramuscular
      tissues. Multi-dose jet injectors are a type of jet injector with a reusable fluid path that
      consists of the vial adapter, dose chamber, fluid pathway, and nozzle. Although credited with
      decades of use and the delivery of millions of doses of vaccine in the field, multi-dose jet
      injectors are no longer used due to evidence of cross-contamination between injections. The
      HSI-500 Jet Injector with Protector Cap has been designed with a disposable plastic cap that
      acts as a shield between the nozzle and the skin to eliminate cross-contamination between
      injections while maintaining a high rate of vaccine delivery to multiple patients.

      The objective of this pilot safety study is to provide a preliminary indication of the
      ability of the jet injector to prevent cross-contamination from hepatitis B virus between
      volunteer injections. A secondary objective of the study is to test study procedures prior to
      a larger-scale safety study.
    

Intervention name(s): Jet Injector with Protector Cap (HSI-500)
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pilot Projects; Injections, Jet; Injections, Jet/instrumentation; Equipment Contamination/prevention and control; Blood-Borne Pathogens; Disease Transmission, Horizontal
Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
Condition: Delayed Gastric Emptying
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      One big problem in mechanically ventilated ICU patients is delayed gastric emptying. Delayed
      gastric emptying in these patients, causes intolerance and high gastric residual volume (GRV)
      that can lead to abdominal distention, vomiting, increased aspiration risk and consequently
      increased the length of hospital stay.

      In this study, investigators will evaluate Neostigmine's effect in reducing GRV in
      mechanically ventilated patients and compare its effect with metoclopramide and Ondansetron

      .
    

Detailed description: 
      It has been shown that delayed gastric emptying and high GRV in critically ill patients are
      associated with increased mortality in these patients. Different kinds of drugs including
      metoclopramide, erythromycin and cisapride are used, but none of them had conclusive evidence
      of better eﬀects on each other. Moreover, complications such as dysrhythmia and
      extrapyramidal side eﬀects limit the use of these drugs.

      Another drug that can be used to increase gastric emptying in critically ill patients is
      neostigmine. Although several studies have evaluated the efficacy of neostigmine on
      postoperative ileus, very few studies have evaluated the effect of this drug on GRV in ICU
      patients.

      The aim of the current study will be to compare the effects of Neostigmine on gastric
      residual volume in mechanically ventilated patients in the intensive care unit. A comparative
      controlled study by Ondansetron.
    

Intervention name(s): Neostigmine; Ondansetron 8mg; Metoclopramide Injection; Enteral feeding nutrition; Sequential Organ Failure Assessment (SOFA) score
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs; will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs; will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs; The type and rate of enteral feeding nutrition will be the same for all patients (180ml/3h). All patients have a 30-degree head-up position; SOFA score will be performed on all patients before the beginning of the study
Other intervention name(s): Neostigmine injection; Dansetron injection; primperan injection; Enteral feeding; SOFA score
Intervention MeSH terms: Ondansetron; Metoclopramide; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: gastric residual volume; neostigmine; ondansetron; mechanically ventilated patients
A Study to Compare the Amount of Drug in the Blood After a Single Tablet EC905 Containing Solifenacin and Tamsulosin is Taken by Healthy Males Compared to Separate Tablets of Solifenacin and Tamsulosin
Condition: EC905; Pharmacokinetics; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the amount of drug in the blood of young to middle aged, healthy, male
      subjects after they received the final formulation of EC905 compared to solifenacin
      (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).

      Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS®
      in 3 separate periods.
    

Detailed description: 
      The subjects are randomized to one of 6 treatment sequence groups.

      Subjects are admitted to the clinical unit on Day -1 for pre-dose assessments. They remain in
      the clinic for two periods of 11 days and one period of 14 days.

      After randomization the subjects receive a single dose treatment on Day 1 followed by blood
      sampling for pharmacokinetic (PK) assessment. For both EC905 and Vesicare®, blood sampling
      continues for 10 days after dosing; for Omnic OCAS®, it continues for 3 days after dosing.

      Each period is separated by a wash-out period of at least 4 day, and subjects are checked for
      eligibility again one day prior to the start of a new dosing day.

      Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and
      concomitant medications are monitored throughout the investigational period.

      A blood sample is drawn for CYP2D6 genotyping, in order to evaluate the effect of the CYP2D6
      genotype on the PK of tamsulosin.

      Subjects return for an End of Study Visit (ESV) 7 days after the last on-site period, or
      after withdrawal.
    

Intervention name(s): EC905; solifenacin; tamsulosin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; oral; oral
Other intervention name(s): Vesicare®; Omnic OCAS®
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Final formulation EC905; Solifenacin succinate; Tamsulosin HCl; Marketed drugs
A Food-Effect Study of BPI-16350 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.

      Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose
      of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting
      conditions(Treatment A) or with a high-fat meal(Treatment B).
    


Intervention name(s): BPI-16350
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability
      and preliminary efficacy of a guided imagery intervention to reduce RT-related symptoms of
      anxiety and depression in patients with HNC relative to treatment as usual.
    

Detailed description: 
      The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability
      and preliminary efficacy of a guided imagery intervention to reduce RT-related symptoms of
      anxiety and depression in patients with HNC relative to treatment as usual. Treatment as
      usual contains no psychological interventions to aid in distress, however participants will
      have access to the psychosocial supports at the cancer center available to all patients.
      Patients will be randomized to either condition, and surveys of their well-being will be
      conducted throughout the study.
    

Intervention name(s): Guided Imagery; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): GI is a relaxation technique involving the visualization of images and is considered an adjuvant cancer therapy.The GI intervention will include two hour-long meetings between the participant and a trained interventionist. The sessions will include direct, written, and audio delivery of one of three GI vignettes. The patient will be able to choose one of the three vignettes. The approximately twelve minute long vignettes included in the study will be: Taking a Walk, Healthy Cell Alliance for Treatment, and Daily Intention (32). Patients will also be given access to psychosocial support resources (i.e., clinical psychologists and social workers) at UCCC.; This will include a tour of the treatment room and education about RT. Patients will also receive educational materials about RT including the process of RT and CT simulation, treatment side effects, pain management, and swallowing exercises. Participants in this condition will also have access to psychosocial support resources (i.e., clinical psychologists and social workers) at UCCC.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to the guided imagery intervention or to treatment as usual.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Radiotherapy; Guided Imagery; Therapy; Distress; Anxiety; Depression
Early Enteral Nutrition for Severe Acute Pancreatitis
Condition: Acute Necrotizing Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Acute Necrotizing
Study type: Interventional
Phase: Phase 4

Summary: 
      There is increasing evidence that indicates early enteral nutrition may be associated with
      improved outcome in acute pancreatitis patients. However, most of the clinical trials
      regarding this targeted mild to moderated pancreatitis patients. In regard to severe acute
      pancreatitis (SAP) patients, current results from randomized control trials (RCTs) are
      inconclusive. The researchers of this study aim to investigate the impact of early enteral
      nutrition on the clinical outcomes of SAP patients.
    


Intervention name(s): early enteral nutrition; Parenteral nutrition
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Enteral nutrition will be administered within 24 hours of admission through naso-jejunal tube and continue for 7 days after admission. Naso-jejunal tube will be set up by endoscopy. X-ray will be used to place the distal end of the feeding tube and EN would not start until the distal end of the feeding tube has been placed at the remote end of Treitz ligament. Standard enteral nutrition liquid regimen (Nutrison Fibre) will be used. Patients are targeted to receive calories for 25 kcal/kg/day and nitrogen for 0.2g/kg/day.; PN administration will start within 12 hours of admission and continue for 7 days after admission. Patients will receive calories for 25 kcal/kg and nitrogen for 0.2g/kg. Twenty percent of the calories will be provided by fat emulsion (LCT/MCT) and the remaining will be provided by dextrose. Nitrogen will be provided by balanced amino acids injection (Novamin). All PN components will be compounded into 3-liters bags under sterile conditions. Nutrition regimen will be administered through subclavian central venous catheter.
Other intervention name(s): Nutrison Fibre; Lipovenoes(LCT/MCT fat emulsion, 20%); Novamin (11.4%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute severe pancreatitis; nutritional support; enteral nutrition; parenteral nutrition
Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals
Condition: Glucose Metabolism Disorders; Overweight or Obesity
MeSH terms: Overweight; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Numerous evidences suggest an important role of short-chain fatty acids, produced by the
      intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of
      various biological functions relevant to human health. In particular, butyrate, in addition
      to its trophic action on enterocytes, could improve insulin sensitivity and increase GLP-1
      secretion, suggesting a possible role in the modulation of glucose metabolism. However, to
      date, very few randomized controlled trials (RCTs) have observed a significant increase in
      plasma butyrate concentrations in humans after nutritional interventions with high-fiber
      diets or foods. Butyrate occurs naturally in some foods, such as milk and dairy products,
      where it is often associated with sodium, becoming sodium butyrate. Therefore, recent studies
      suggest the use of oral sodium butyrate supplements in order to obtain a significant increase
      in butyrate plasma concentrations able to exert the potential beneficial effects related to
      them. To date, few studies have investigated the effect of oral sodium butyrate
      supplementation on glucose metabolism in healthy or overweight individuals, individuals at
      high cardiometabolic risk, and individuals with type 2 diabetes. Therefore, the purpose of
      this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus
      placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese
      individuals and the mechanisms underlying these effects.
    


Intervention name(s): Supplementation with sodium- butyrrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral supplementation with sodium butyrrate capsules; Oral supplementation with placebo capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: butyrate; sodium butyrate; short chain fatty acids; glucose; insulin
Prediction of Thyroid Cancer From Ultrasonographic Characteristics of Thyroid Nodules
Condition: Thyroid Nodule
MeSH terms: Thyroid Neoplasms; Thyroid Nodule; Thyroid Diseases
Study type: Observational

Summary: 
      The aim of this study is to identify which ultrasonographic feature or a combination of
      features is the best predictor of thyroid cancer in thyroid nodules.
    


Intervention name(s): Thyroid ultrasonography
Intervention type(s): Procedure
Intervention description(s): Ultrasound-guided thyroid fine-needle aspiration biopsy
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Endocrinology Clinic
      
Keywords: Thyroid nodule; Biopsy, Fine-Needle