bioihbjkbjnl/mcl2 huggingface dataset:
Test-Retest Variability of Quick Contrast Sensitivity Function Testing
Condition: Healthy
Study type: Observational

Summary: 
      The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial
      vision and predicts functional vision better than visual acuity, but long testing times
      prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al. (2010)
      developed the qCSF method to obtain precise CSF measurements in only 30-50 trials using a
      computerized software program that presents letters on a large monitor that are identified by
      a patient similar to typical visual acuity testing with an eye chart. The quick CSF method is
      a Bayesian adaptive method that estimates the full shape of the CSF, and the test duration is
      only about 3-6 minutes. Some preliminary testing has been performed at other sites with this
      test in patients with vision loss due to amblyopia and glaucoma, but data from individuals
      without eye disease who have normal visual acuity has not been systematically collected with
      the latest version of this test procedure across a wide range of ages. In addition, we aim to
      gain a better understanding of the typical test-retest variability that is obtained
      between-sessions that are about a week apart from individuals with good ocular health and
      visual acuity.
    


Intervention name(s): quick Contrast Sensitivity Function test
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals between the ages of 20-89 without ocular disease will be recruited from among
        patients seen in the Primary Eye Care Clinic at the Nova Southeastern University's The Eye
        Care Institute in Davie-Ft. Lauderdale, FL, as well as faculty, students and staff at this
        institution.
      
Keywords: Normal, healthy individuals without ocular disease; Ages 20-89; English speaking; Visual acuity better than 20/25
Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry
Condition: Blindness
MeSH terms: Blindness
Study type: Observational

Summary: 
      This is a study to focus on the feasibility of using a monitor which may signal loss of
      visual function intraoperatively.
    

Detailed description: 
      The degree of a relative afferent pupillary defect (RAPD) has been correlated with the
      severity of an eye injury and has been shown to have prognostic significance as an indicator
      of retinal ischemia. Therefore light flashed evoked pupillometry (LFEP) may serve as a useful
      indicator of visual function. LFEP's are not known to be sensitive to anesthetics. We will
      measure LFEP's using different anesthetic techniques to see if there are measurable
      differences in the latency, amplitude and constriction velocity of the pupillary reflex.
      Prior to induction of anesthesia, pupillometer readings will be taken in the supine position
      in both eyes. The patient will be anesthetised using a standard induction technique. For
      maintenance of anesthesia a remifentanil infusion will be administered and supplemented by
      either propofol infusion (at 120 and 160 mcg/kg/min)or sevoflurane (at 1.5 and 2.5% end-tidal
      in random sequence. The patients will receive muscle relaxants as needed. Pupillometry
      readings will be taken in both eyes after induction, after steady maintenance has been
      achieved and every 10 minutes for 30 minutes at each drug dose.
    

Intervention name(s): propofol; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Propofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure; sevoflurane 1.5% and 2.5% end tidal in random sequence
Other intervention name(s): deprivan; Sevoflurane at 1.5 and 2.5% end tidal
Intervention MeSH terms: Propofol; Sevoflurane
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects undergoing orthopedic surgery in the supine position
      
Keywords: blindness; ischemic optic neuropathy
Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine
      Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous
      (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector
      (PharmaJet Stratis™).
    

Detailed description: 
      The vaccine tested in this study was TDV. TDV was tested to assess safety and immunogenicity
      of various dosing schedules, routes of administration, and delivery methods in healthy
      flavivirus-seronegative adults living in a dengue non-endemic country.

      The study enrolled 80 participants. Participants were randomly assigned to one of the five
      treatment groups:

        -  Group 1: TDV SC injection on Day 0 in each arm using needle/syringe

        -  Group 2: TDV IM injection on Day 0 in each arm using needle/syringe

        -  Group3: TDV IM injection on Days 0 and 90 using needle/syringe

        -  Group 4: TDV SC on Day 0 in each arm using the PharmaJet Stratis™ device

        -  Group 5: TDV IM on Day 0 in each arm using the PharmaJet Stratis™ device

      This single-center trial was conducted in the United States. The overall time to participate
      in this study was up to 5 months. Participants made multiple visits to the clinic including a
      final visit at Day 120 for a safety follow-up assessment.

      This work was supported by the US Army Medical Research and Materiel Command under Contract
      No. W81XWH-12-C-0278.

      The views, opinions and/or findings contained in this report are those of the author(s) and
      should not be construed as an official Department of the Army position, policy or decision
      unless so designated by other documentation.
    

Intervention name(s): TDV
Intervention type(s): Biological
Intervention description(s): TDV IM or SC injection
Other intervention name(s): DENVax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylactic vaccination
Swallowing Pressure Profiles in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to determine the impact of a pharyngeal High Resolution Manometry
      catheter on swallowing biomechanics
    

Detailed description: 
      During pharyngeal High Resolution Manometry (pHRM) a small bore flexible catheter is
      introduced into the pharynx to detect intrabolus pressure and contact of pharyngeal
      structures during swallowing. The presence of the catheter through the upper esophageal
      sphincter (UES) leads to a violation of its natural closed state. It is not clear how this
      intrusion influences the swallowing biomechanics . Hence, this project's goal is to identify
      how hyoid movement is altered during swallowing with the presence of a pHRM catheter in
      place.
    

Intervention name(s): Videofluoroscopic swallow study; pharyngeal High Resolution Manometry
Intervention type(s): Procedure; Procedure
Intervention description(s): The Swallowing Systems Core laboratory is fully equipped to perform VFSS with a C-arm (OEC 9900) that is dedicated solely for research purposes. VFSS recordings will be kept to a minimum and only turned on during the execution of each swallow in all sequences. Video recording and images captured during the VFSS will be synced and saved to a secure server for data analysis. VFSS allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks. The physiological swallowing measures (temporal and kinematic movement of the hyolaryngeal complex during swallowing) cannot be visualized with any other technique. Patients will swallow only water. Aspiration (bolus into trachea) is not expected to occur during this study given that the individuals recruited will have no prior history of disease or disorder, and aspiration is uncommon in healthy individuals.; This procedure will only take place once during sequence 2 of the randomization B session. If desired, a small amount (< 0.5 mL) of topical 2% viscous lidocaine hydrochloride will be applied to the participant's nostril of choice prior to catheter insertion. The catheter will be placed through the nasal passage, oropharynx, and hypopharynx to the esophagus. Correct catheter placement will be verified with VFSS. With the catheter in place, the subject will perform 10 swallows of 10ml and is expected to take approximately 2.5 minutes. The catheter will then be removed and the subject will move on to sequence 3. Individuals have the option to decline this procedure if it is uncomfortable or difficult to tolerate.
Other intervention name(s): VFSS, x-ray of swallowing; pHRM, HRM
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Participants will include healthy adults, between the ages of 18 and 45 years with no major medical history.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Swallowing
Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is an open-label, phase I clinical trial designed to evaluate the safety and
      tolerability of intrathecal administration of autologous mesenchymal stem cell-derived neural
      progenitor cells (MSC-NP) in patients with progressive multiple sclerosis. Study participants
      will receive three intrathecal injections of culture-expanded autologous MSC-NPs at three
      month intervals.
    


Intervention name(s): intrathecal administration of autologous MSC-NP
Intervention type(s): Biological
Intervention description(s): Autologous MSC-NPs administered intrathecally at a dose between 2 and 10 million cells, depending on ex vivo expansion characteristics. Three doses will be administered at 3 month intervals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mesenchymal stem cells; neural progenitors; autologous; bone marrow; multiple sclerosis
The Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis
Condition: Liver Cirrhosis; Esophageal and Gastric Varices
MeSH terms: Liver Cirrhosis; Esophageal and Gastric Varices; Varicose Veins; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study was to evaluate the safety of early enteral nutrition on endoscopic
      therapy of esophagogastric varices in Liver Cirrhosis ,and to assess the impact of different
      eating times on patients, so as to determine the best time for patients to obtain nutrition
      after surgery.
    

Detailed description: 
      For patients with gastroesophageal varices in Liver Cirrhosis,, there is no clear guideline
      and consensus on when to start eating after endoscopic treatment. In 2015, a randomized
      controlled study in Taiwan of China confirmed that compared with liquid diet given 48 h after
      endoscopic treatment, liquid diet given 4 h and started enteral nutrition would not increase
      the risk of rebleeding, and could improve the nutritional status of patients. However, some
      patients after endoscopic treatment would suffer from post-sternal pain, abdominal pain,
      nausea, vomiting and other discomforts, affecting appetite and delay the diet time. Based on
      the above research background, we observed and evaluated the safety and effectiveness of
      early enteral nutrition in patients with cirrhotic esophageal and gastric varices after
      endoscopic treatment, and analyzed the influencing factors of enteral nutrition in patients
      with cirrhotic esophageal and gastric varices after endoscopic treatment, so as to further
      clarify the optimal time for patients to eat after endoscopic treatment.
    

Intervention name(s): nutrient solution
Intervention type(s): Dietary Supplement
Intervention description(s): For the patients with esophageal and gastric varices after endoscopic treatment，start taking the nutrient solution at the fourth hour.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cirrhosis of gastroesophageal varices undergoing endoscopic
      
Keywords: Early enteral nutrition; Esophageal and Gastric Varices; Rebleeding
The Effects of Renal Denervation on Insulin Sensitivity
Condition: Treatment Resistant Essential Hypertension; Insulin Resistance
MeSH terms: Hypertension; Essential Hypertension; Insulin Resistance
Study type: Interventional

Summary: 
      Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity
      also induces insulin resistance and it could therefore be assumed that a renal denervation
      might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in
      patients with treatment resistant essential hypertension both 1 and 3 months after renal
      denervation compared to a control group with treatment resistant essential hypertension.
      Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance
      assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation on
      insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to
      investigate the degree of insulin resistance in muscle, liver and adipose tissue.
    


Intervention name(s): Renal denervation
Intervention type(s): Procedure
Intervention description(s): The patients are examined prior to and 6 months after renal denervation. On the day of examination the patients will have blood samples taken and the hyperinsulinemic euglycemic clamp and muscle and adipose tissue biopsies will be performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
Condition: Respiratory Distress Syndrome, Newborn; Respiratory Failure; Premature Birth
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Premature Birth; Syndrome
Study type: Interventional

Summary: 
      The aim of the study was to assess the effect of volume targeted vs. pressure-controlled
      mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the
      extremely preterm infants.
    

Detailed description: 
      Prospective, cross-over trial enrolling neonates <28 weeks' gestation requiring MV. Patients
      were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by
      3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was
      carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR),
      near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry
      (circulatory parameters).
    

Intervention name(s): volume guarantee; pressure-controlled
Intervention type(s): Other; Other
Intervention description(s): volume guarantee assist-control mechanical ventilation; pressure-controlled assist-control mechanical ventilation
Intervention model: Single Group Assignment
Intervention model description: prospective crossover study
Masking: None (Open Label)
Primary purpose: Treatment
Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is set up to determine the consumption safety and the effect of a food supplement
      containing dietary fiber from cassava on the alterations of physiological parameters
      including fasting blood sugar, HbA1c, insulin resistance, lipid profiles, atherogenic index,
      blood pressure and gut microbes in overweight female volunteers.
    

Detailed description: 
      Cassava is one of the important industrial crops in Thailand. The leftover fiber of cassava
      is still valuable and can be used as a dietary fiber. The previous study demonstrated that
      dietary fiber containing cassava fiber was safe for consumption without any contamination of
      the cyanide and heavy metals. Moreover, the microbial contaminations were within the safety
      range. The toxicity study revealed that the LD50 of the cassava dietary fiber was more than 5
      g/kg body weight (BW) and NOAEL was 3 g/kg BW. The NOAEL was used to calculate the human
      equivalent dose for determining the effect of cassava dietary fiber in a clinical study.

      Cassava dietary fiber consists of water-insoluble fiber such as cellulose more than 50%. The
      previous study showed that insoluble fiber decreased the risk of type 2 diabetes and
      increased insulin release. Moreover, a high fiber diet also decreased the fasting glucose and
      HbA1C in type 2 diabetes volunteer. In addition, the effect of dietary fiber on the reduction
      of cholesterol was also reported. The previous study reported that the cassava dietary fiber
      could decrease the total cholesterol, triglyceride but increase high-density lipoprotein in a
      dyslipidemia rat model. Therefore, the cassava fiber might be the potential food supplement
      for the control of blood sugar and lipid profiles in human. However, less scientific data
      support the effect of cassava dietary fiber in human.
    

Intervention name(s): Cassava dietary fiber capsule
Intervention type(s): Dietary Supplement
Intervention description(s): Cassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: physiological parameters; consumption safety; cassava; food supplement; overweight female
Efficacy and Safety Curcumin in Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Antidepressants generally do not lead to an immediate relief of symptoms. Most people will
      not see a significant improvement for at least 4 weeks. Studies have generally shown that the
      full benefits of antidepressant therapy may take as long as 8 to 12 weeks. However, this
      timeline is variable among individuals.Curcumin is one of the main curcuminoids isolated from
      this perennial herb. It possesses a variety of pharmacological activities, including
      anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects. Curcumin has
      been found to possess antidepressant action in various animal models of depression. Chronic
      administration of curcumin has been reported to exert antidepressant-like action in olfactory
      bulbectomy model of depression in rats. Although the mechanism of the antidepressant effect
      of curcumin is not fully understood, it is hypothesized that it acts through inhibiting the
      monoamine oxidase enzyme and modulating the release of serotonin and dopamine.In randomized,
      double-blind, placebo-controlled study 40 patients will be randomized to receive either 500
      mg/day of curcumin or placebo together with antidepressants for 6 weeks.
    


Intervention name(s): curcumin
Intervention type(s): Drug
Intervention description(s): 500 mg/day for 6 week
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: antioxidants; curcumin; depression
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind,
      placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine
      whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and
      to determine the maximum dose tolerated (MTD).
    


Intervention name(s): TJ003234; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline; Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline
Intervention MeSH terms: Plonmarlimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Anti-GM-CSF agents; GM-CSF/GM-CSFR (GM-CSF receptor) antibody; colony-stimulating factor 2; monoclonal antibody