bioihbjkbjnl/mcl2 huggingface dataset:
Tissue Sealant Use in LASIK Enhancement Surgery
Condition: Epithelial Ingrowth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent
      epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery
    

Detailed description: 
      Participants will have a comprehensive eye examination once they express an interest in the
      study. This includes a slit lamp examination of the front of the eye and a dilated
      fundoscopic examination of the back of the eye. If there is any pathology noted that would
      exclude the participant from the study, then the participant will be informed and given an
      appropriate referral. If the participant is deemed appropriate for the study after a
      comprehensive examination included computerized videokeratography, then they can be enrolled.
      The participant will undergo LASIK flap lift eye surgery.

      Tissue sealant will be applied at to the edge of the LASIK flap at the conclusion of the
      surgery. A bandage contact lens will also be placed. The bandage contact lens is used in the
      usual and customary fashion as in non-study LASIK flap lift surgery.

      The participants will be seen on the day of surgery, post op day one, one month, and three
      months. The participant will receive topical antibiotics in each eye for one week following
      the procedure. The participant will receive pred forte 1% ophthalmic drops for one week after
      treatment. The participant will also receive vigamox ophthalmic drops for seven days after
      treatment. All of this is within the usual and customary standard of care for the treatment
      of participants undergoing LASIK surgery.
    

Intervention name(s): Tissue sealant
Intervention type(s): Drug
Intervention description(s): Application of tissue sealant on eyes undergoing LASIK enhancement
Other intervention name(s): ReSure sealant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: LASIK, Ingrowth, Tissue sealant
Early Versus Late Enteral Iron in Infants Less Than 1301 Grams
Condition: Iron Deficiency; Anemia of Prematurity
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at
      birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.

      Hypothesis: Preterm infants with a birth weight of less than 1301g require iron
      supplementation earlier than previously recommended.

      Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron
      supplementation may reduce the incidence of iron deficiency and the need for late blood
      transfusions.
    

Detailed description: 
      Objectives. To examine whether early enteral iron supplementation (EI) would improve serum
      ferritin as a measure of nutritional iron status at 2 months of age and would prevent
      definite iron deficiency (ID) in infants with a birth weight of <1301 g. Methods. Infants
      were randomly assigned to receive enteral iron supplementation of 2 to 6 mg/kg/day as soon as
      enteral feedings of >100 mL/kg/day were tolerated (EI) or at 61 days of life (late enteral
      iron supplementation [LI]). Nutritional iron status was assessed: 1) at birth, 2) at 61 days
      of life, 3) when the infants reached a weight of 1.6 times birth weight, and 4) before blood
      was transfused at a hematocrit of <.25. ID was defined by any one of the following criteria:
      ferritin, <12 mg/L; transferrin saturation, <17%; or increase of absolute reticulocyte counts
      by >50% one week after the onset of enteral iron supplementation. Restrictive red cell
      transfusion guidelines were followed and all transfusions were documented. Erythropoietin was
      not administered. The primary outcome variables were: 1) ferritin at 61 days and 2) the
      number of infants with ID. Results. Ferritin at 61 days was not different between the groups.
      Infants in the LI group were more often iron-deficient (26/65 vs 10/68) and received more
      blood transfusions after day 14 of life. No adverse effects of EI were noted. Conclusions. EI
      is feasible and probably safe in infants with birth weight <1301 g. EI may reduce the
      incidence of ID and the number of late blood transfusions. ID may occur in very low birth
      weight infants despite early supplementation with iron and should be considered in the case
      of progressive anemia. Pediatrics 2000; 106:700 -706; preterm infant, iron supplementation,
      iron deficiency, blood transfusion.
    

Intervention name(s): Oral administration of ferrous sulphate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Prevention
Keywords: preterm infant; iron supplementation; iron deficiency; blood transfusion
Role of Carbohydrate Modification in Weight Management Among Obese Children
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that a low-carbohydrate diet and a
      low-glycemic load diet will improve body mass index and result in more body fat loss than a
      control diet among overweight children ages 7 to 12. In addition this study is also designed
      to test the safety of diets with modified carbohydrate content as compared to a conventional
      weight management diet among younger overweight children.
    

Detailed description: 
      The treatment of pediatric obesity supported by the medical community is a moderate
      restriction in calories by modifying intake of fat and simple sugars, along with an increase
      in energy expenditure through more physical activity. However, this approach is associated
      with only limited success. As a result, overweight children and adolescents are seeking
      alternative approaches to weight management, such as diets that modify the type and amount of
      carbohydrates. However, at this time there is limited data on the safety and efficacy of
      these diets, particularly with younger children. This study is a controlled clinical trial
      that compares the safety and efficacy of a low carbohydrate and reduced glycemic load diets
      to a more standard dietary intervention for the management of pediatric obesity (i.e.
      portion-controlled, moderate fat, high carbohydrate diet). This study will involve 150
      overweight children (ages 7 to 12) who will be randomly assigned to one of the three diet
      groups for 12 months. The effects of each diet will be determined by measuring changes in
      anthropometric measures (body weight, height, body mass index, waist circumference, body
      composition), other cardiovascular risk factors (blood pressure, fasting lipid profile,
      fasting glucose and insulin, and inflammatory markers of cardiovascular disease), and
      measures of psychological well-being and mental status. The results of this study will
      provide needed information to the public in their quest for safe, effective, and
      health-promoting weight management strategies for obese children. Such information is vital
      if we are to address the obesity epidemic in the United States.
    

Intervention name(s): Low carbohydrate, reduced glycemic load, and a control diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood obesity; weight management; dietary interventions; cardiovascular disease risk factors
Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This study evaluates the feasibility of three-dimensional printed template in transthoracic
      pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy
      schedule to receive template-guided transthoracic needle aspiration.
    

Detailed description: 
      In previous study,a navigational template has been created to simplify the procedure of
      preoperative lung nodule localization. It was reported that localizer deviation was
      10(0-20)mm.In this trial,Investigator explores the utility of this navigational template in
      transthoracic lung nodule biopsy.
    

Intervention name(s): navigational template
Intervention type(s): Device
Intervention description(s): The navigational template was created based on computed tomography data using three-dimensional technology.
Intervention model: Single Group Assignment
Intervention model description: single-armed feasibility trial
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Biopsy, Needle; Printing, Three-Dimensional; Image-Guided Biopsy
EMG Activation of Gluteal Musculature During Exercises With and Without Resistance
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the
      treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises
      which activate the Gmed and Gmax, but limited research remains on exercises involving
      resistance and the role of the TFL. The purpose of this study is to evaluate Gmed, Gmax, and
      TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in healthy
      and low back pain patients while performing exercises with and without resistance. Methods: A
      convenience sample of healthy subjects and patients diagnosed with non-radicular low back
      pain will be recruited. Exclusionary criteria will include: current low back or lower
      extremity injury (healthy group), pregnancy, history of hip surgery, and radicular symptoms.
      Surface electromyography will be used to quantify the activity level of the gluteal muscles
      and TFL while performing a series of 8 exercises with and without Thera-Band® Resistance
      Tubing and Stability Trainer. The maximal voluntary isometric contraction (MVIC) will be
      established for each muscle group and the order of exercises performed will be randomized to
      minimize the effect of fatigue. Following the completion of each exercise, the patient will
      rate their perceived exertion level on the Thera-Band® Resistance Intensity Scale for
      Exercise (RISE). The EMG signals will be smoothed and rectified and analyzed using a
      root-mean-square algorithm. Clinical Relevance: The results of this study will allow
      clinicians to better prescribe exercises, proven to activate the gluteal muscles and limit
      the TFL involvement, in the treatment of low back pain.
    


Intervention name(s): Lower Body Exercises with and without resistance
Intervention type(s): Device
Intervention description(s): lower body exercises with and without resistance designed to activate the gluteal/hip musculature
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gluteus Maximus; Gluteus Medius; TFL; EMG; Perceived Exertion; Thera-Band
Quantification, Analysis and Simulation of Facial Mimics Movements
Condition: Mimic Facial Muscles
MeSH terms: Facies
Study type: Interventional

Summary: 
      The SIMOVI project is a collaboration between our Department of Maxillofacial Surgery (CHU
      Amiens) and the Biomechanical bioengineer Research Department and Roberval Labs
      (Technological University of Compiègne). The question raised is the extent to which a facial
      mimic can be evaluated objectively. In today's clinical practice, the investigators use
      grading systems based on muscular scale or testing, in order to evaluate a facial muscular
      disorder. This assessment remains subjective because the investigators are deducing from
      surfacing cutaneous deformations the movement quality of the solicited muscle.

      This qualitative approach is therefore an approximate approach and deserves to be better
      thought to plan a surgical treatment which involves mimic facial muscle (as rehabilitation of
      facial palsy, cleft palate for example), to monitor the results, and to follow the recovery
      and progress in physiotherapy care.

      The aim of this study is to correlate external soft tissue movement (essentially cutaneous)
      during facial mimic with internal movement (essentially facial mimic muscle) using
      qualitative and QUANTITATIVE indicators, and to perform a biomechanical model of selected
      mimic face's movement using the precedent data.
    


Intervention name(s): Magnetic Resonance Imaging (MRI), Surface scan, Motion capture, Digital Image Correlation
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Facial Mimic Muscle; MRI; Segmentation; Three dimensional assessment; Motion capture; Movement analysis; Digital Image Correlation
Olfactory Odour Stimulation for Metabolism Control
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In this preliminary short-term study it is investigated, whether a short olfactory
      stimulation with D-Limonene leads to an acute improvement of glucose metabolism in patients
      with obesity.
    


Intervention name(s): D-Limonene; SLVO
Intervention type(s): Other; Other
Intervention description(s): Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% D-Limonene in the nose for 15 minutes; Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% SLVO in the nose for 15 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: D-limonene; lavender oil (SLVO); Olfactory stimulation; Obesity; glucose metabolism
Comparison of Osteoporosis Disease Management Strategies (0000-039)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of disease management interventions on bone
      mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at
      high risk for osteoporosis.
    


Intervention name(s): Disease Management Assessment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The reason for this study is to see if the study drug mirikizumab is safe and effective in
      participants with moderately to severely active Crohn's disease.
    


Intervention name(s): Mirikizumab; Mirikizumab; Ustekinumab; Ustekinumab; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered IV; Administered SC; Administered IV; Administered SC; Administered IV; Administered SC
Other intervention name(s): LY3074828; LY3074828
Intervention MeSH terms: Mirikizumab; Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring
Condition: Hemodynamic (MAP) Stability
Study type: Interventional

Summary: 
      Intraoperative hypotension and blood pressure variability are associated with postoperative
      complications in surgical patients.

      The investigators have developed a closed-loop vasopressor (CLV) controller that titrates
      norepinephrine to correct hypotension.

      After having tested the system in a small cohort series of patients undergoing major
      surgeries, the investigators aimed to test the feasibility of the CLV controller guided
      noninvasively and continuously with the ClearSight system (Edwards Lifesciences, USA) in
      three high risk patients undergoing renal transplant surgery
    

Detailed description: 
      Intraoperative hypotension is frequent in patients undergoing surgery and can negatively
      impact organ perfusion.

      The investigators have developed a closed-loop vasopressor (CLV) controller to more
      efficiently correct hypotension.

      The investigators tested it extensively in preclinical studies and recently demonstrated its
      feasibility and excellent performance metrics in a short series of high-risk patients
      undergoing major surgical procedures.

      In these studies, the controller was linked to a minimally-invasive advanced hemodynamic
      monitoring device utilizing an arterial line which then controlled a vasopressor infusion.
      However, the vast majority of patients who undergo surgery do not require an arterial line
      but should still benefit from rapid corrections of hypotensive episodes that are less rapidly
      detected via an intermittent non-invasive blood pressure cuff. Fortunately, completely
      noninvasive technology now allows us to continuously monitor blood pressure and therefore
      extend the use of our closed-loop vasopressor system to patients in whom an arterial catheter
      would not typically be placed. Patients undergoing renal transplant surgeries are the ideal
      patient population.

      The investigators aimed to test the feasibility of guiding our CLV controller with a
      continuous noninvasive blood pressure monitoring device (ClearSight system, Edwards
      Lifesciences, Irvine, CA, USA) in three patients (case series)
    

Intervention name(s): Closed-loop system
Intervention type(s): Device
Intervention description(s): the CLV system will correct hypotension by automated adjustment of norepinephrine.
Intervention model: Single Group Assignment
Intervention model description: Single prospective pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation
Condition: Generalized Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the rise
      of quality of life when using methods of relaxation combined with virtual reality with
      patients suffering from generalized anxiety disorder in comparison of the effect of
      traditional relaxation therapy. Observe and evaluate the effect of perceived presence in
      synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic
      efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment of
      generalized anxiety disorder.

      It is a comparative, randomized, two groups study (29 in each group):

        -  Relaxation optimized virtual reality

        -  Classical relaxation (without Virtual Reality). The protocol comprised for each groups 7
           relaxing sessions (with or without virtual reality epending on the group). Each session
           lasted for approximately 30 to 35 minutes, including a 5-minute pause between immersive
           trials, in order to avoid cyber sickness in the virtual reality group.

      Expected results: a measurable therapeutic improvement produced by the combination of
      relaxation and virtual and its additional effect when compared to the traditional treatment.

      Measurements of variables and therapeutic effects will be carried out with psychometric
      measures.

      The creation process of the relaxing virtual environments has already been completed. The
      virtual environments are ready for use.

      The apparatus needed and in our possession include:

        -  A laptop for generating virtual environments

        -  A stereoscopic display

        -  Apparatus for physiological measurements
    


Intervention name(s): Relaxation optimized virtual reality; Classical relaxation (without Virtual Reality)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Patient with Generalized Anxiety Disorders
Study of the Effects of Ethnicity on the Pharmacokinetics, Pharmacodynamics and Safety of DS-1040b
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is not hypothesis testing but is intended to explore the effects of
      different ethnic groups (Caucasian, Japanese, Chinese, and Korean) on the PK
      (pharmacokinetic), PD (pharmacodynamic), and safety of an IV infusion of DS 1040b.

      Subjects entering the study will receive a single 12 hour infusion of DS-1040b and be
      followed up to assess the effects on ethnicity on blood levels of DS-1040b as well as safety
      & tolerability.
    


Intervention name(s): DS-1040b
Intervention type(s): Drug
Intervention description(s): Single 12-hour intravenous infusion of DS-1040b (20 mg)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With
      Active Rheumatoid Arthritis
    

Detailed description: 
      CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal
      antibody that is being developed as a similar biological medicinal product to Humira. The
      purpose of this study is to evaluate usability of subcutaneous auto-injector of CT-P17 in
      patients with moderate to severe rheumatoid arthritis.
    

Intervention name(s): CT-P17 SC AI (adalimumab)
Intervention type(s): Biological
Intervention description(s): Subcutaneous Injection of Adalimumab 40mg once every two weeks
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      A prospective, open-label, multi-center study designed to validate the agreement of CometTM
      Pressure Guidewire and Pressure Wire Certus® in FFR measurements
    

Detailed description: 
      The COMET China study is a prospective, open-label, multi-center study designed to validate
      the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements.
      Patient with stable angina or any form of non-ST elevation acute coronary syndrome, who are
      scheduled for diagnostic angiography and pressure wire assessment, and signed the informed
      consent, will be screened for enrollment in this study.
    

Intervention name(s): Pressure Guidewire
Intervention type(s): Device
Intervention description(s): Fractional Flow Reserve measurement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic