bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study is to propose a new method for evaluating coronary artery calcium
      scores (CACS) in individuals with coronary artery disease.
    

Detailed description: 
      The proposed research, if successfully implemented, will result in a new method for
      evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.
      Using the Cardiac Gated Stationary Chest Tomosynthesis (CG-SDCT) system the imaging dose for
      a a full tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The
      targeted imaging time of 25-30 seconds is 1/2 of that from a current commercial DCT system at
      the same imaging dose. As with current commercial DCT systems, our s-DCT system will expose
      patients to less radiation and deliver comparable data for CACS. CG-SDCT will likely result
      in accurate CAC scoring and allow for a more complete patient risk assessment as compared to
      Framingham risk scoring alone.
    

Intervention name(s): Gated Stationary Chest Tomosynthesis
Intervention type(s): Device
Intervention description(s): The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of siltuximab on immune cell functions
      in patients with Type 1 diabetes (T1D).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single center,
      non-randomized (patients are not assigned by chance to treatment groups), Mechanistic Study
      (a study that focuses on the biologic activity of the drug, rather than on disease
      treatment). Up to 10 patients with Type 1 diabetes (T1D) will be enrolled in the study.
      Participants will receive a single dose of siltuximab and blood samples will be obtained a
      total of 6 times until 12 weeks after dosing. Cells will be isolated from the blood samples
      and used to measure specific activities of cells in the immune system. Safety evaluations for
      adverse events, clinical laboratory tests, vital signs, and physical examination will be
      performed throughout the study. The end of study is the date of the last assessment for the
      last patient.
    

Intervention name(s): Siltuximab
Intervention type(s): Drug
Intervention description(s): Single infusion of siltuximab (11 mg/kg)
Other intervention name(s): Sylvant
Intervention MeSH terms: Siltuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: T1D; Type 1 diabetes
The Value of Botox-A for Management of Low Anterior Resection Syndrome
Condition: Low Anterior Resection Syndrome; Rectal Cancer
MeSH terms: Rectal Neoplasms; Low Anterior Resection Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer.
      Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious
      impacts on quality of life in a third of the cases.

      One possible physiopathology hypothesis suggests an ongoing spastic process; different
      mechanisms have been postulated. These include alteration of normal anorectal sensation with
      loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced
      rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy
      or during surgery.

      Current available treatments are often ineffective, highlighting the need for more successful
      management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine release at the
      neuromuscular junction. It is currently used for the treatment of various smooth muscle
      spastic diseases.

      The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical
      treatment alternative for LARS. The goal of this study is to document the effects of
      intra-rectal BTX-A injections on sphincter function and quality of life of patients with
      LARS.
    

Detailed description: 
      No more information desired
    

Intervention name(s): intra-rectal Botulinum toxin A injection
Intervention type(s): Drug
Intervention description(s): intra-colic injection of 100 U of Botulinum toxin A as a single injection distributed amongst the four quadrants, 5 cm above anastomosis
Other intervention name(s): Botox (Allergan)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low anterior resection syndrome; Botulinum toxin A; Quality of life; Incontinence; Rectal cancer; Anorectal manometry
Physical Training and Diet for Childhood Obesity
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      It is observed that children affected with COVID-19 who are physically inactive or in a
      sedentary lifestyle may induce and develop childhood obesity (CO). the management of this
      clinical condition has received very little attention, there is no well-defined exercise
      protocols or dietary prescription for this special population; therefore, it needs an
      elaborative trial in this field, so the aim of his study was to find the clinical and
      biochemical effects of high-intensity aerobic training with a high protein diet in childhood
      obesity following COVID-19 infection
    


Intervention name(s): High-intensity aerobic training with high protein diet
Intervention type(s): Other
Intervention description(s): High-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Children in Action Feasibility Study
Condition: Obesity; Motor Activity
Study type: Interventional

Summary: 
      The Children in Action (CIA) program was a five month physical activity intervention. This
      intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start
      centers. After baseline assessment, centers were matched by ethnicity and for number of
      participants and randomly assigned to either the intervention or the control condition. A
      total of 224 preschool children were randomly selected across the four centers. To evaluate
      the efficacy of the CIA intervention, the change in physical activity, gross motor skills and
      weight during the awake time and used mixed effect time-series regression models was
      compared. Observations did not show a statistical difference between intervention and control
      groups in physical activity level during the awake time, gross motor development or weight
      status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among
      preschool children attending Head Start Centers but that an increased dose and/or longer
      intervention duration will be required to impact gross motor skills, weight status and
      physical activity levels during this critical early childhood development stage.
    


Intervention name(s): SPARK-EC
Intervention type(s): Behavioral
Intervention description(s): The CIA study was a 5 month physical activity change intervention that utilized the SPARK-EC curriculum as the intervention. The SPARK-EC curriculum was designed to be a quality, comprehensive physical activity program for the preschool setting. Pre-and Post-intervention assessments were conducted
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical activity; children; Head Start; SPARK-EC
Pars Plana Surgical Capsulotomy for Posterior Capsular Opacification
Condition: Blindness
MeSH terms: Blindness; Capsule Opacification
Study type: Observational

Summary: 
      Cataract is a leading cause of Global blindness. After cataract surgery nearly half of the
      people become blind due to posterior capsular opacification. The only solution for this
      problem is LASER capsulotomy. Laser machine is not available in remote areas especially in
      underdeveloped countries. The solution of this problem is surgical capsulotomy which can be
      performed any where.
    

Detailed description: 
      posterior capsular opacification is treated by YAG laser capsulotomy. this require
      sophisticated technology ans specific environment which is not possible in underdeveloped
      countries. we describe a method in which posterior capsular opacification could be managed by
      using only a 27 Gauge needle through pars plana. opacified posterior capsule is under tension
      that is why a small puncture results in a large central opening
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients having posterior capsular opacification
      
Keywords: Pars Plana; Surgical Capsulotomy; Posterior capsule opacification; visual outcome; Complications
Using Bite Counter for Weight Loss: A One-month Usability Trial to Test the Effectiveness of Using the Bite Counter
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This is a 1-month study that will examine the use of podcasting and a wearable wrist-worn
      device to track calorie intake and promote weight loss. A podcast is a digital audio file
      that can be listened to on portable media players, like iPods, and personal computers. This
      study will run from July 14, 2015 to August 11, 2015. In this study, you will receive weight
      loss information delivered via twice weekly podcasts. You will also track each meal you eat
      by wearing a provided watch-like device.
    

Detailed description: 
      This study will last approximately 1 month (about 4 weeks). Participants will need to attend
      one 1.5-hour orientation meeting, baseline assessment, and training meeting, and then weekly
      1-hour meetings for four weeks (5 meetings total). Participants will listen to 2 podcasts per
      week and will be encouraged to monitor exercise and body weight and track each meal using the
      provided wearable, wrist worn device. Each of the podcasts will take about 15 - 20 minutes to
      listen to and so participants should expect to spend 30 - 40 minutes each week listening to
      podcasts and up to 3 hours completing other study-related activities each week-including
      attending the weekly meetings-for a total of about 4 hours per week.
    

Intervention name(s): Bite Counter tracking
Intervention type(s): Behavioral
Intervention description(s): Participants will be asked to use the bite counter to track all meals and provide feedback on using the bite counter for dietary self-monitoring.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and efficacy of an investigational
      treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
    


Intervention name(s): MK0249; Concerta (methylphenidate); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.; Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.; For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
Other intervention name(s): CONCERTA®
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and immunogenicity in
      healthy adult subjects of an investigational vaccine being developed for the prevention of
      pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the recombinant
      four-antigen Mycobacterium tuberculosis recombinant protein ID93 together with the adjuvant
      GLA-SE.
    


Intervention name(s): ID93 + GLA-SE; ID93 alone
Intervention type(s): Biological; Biological
Intervention description(s): ID93 antigen and GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.; ID93 antigen alone. 3 injections and Days 0, 28, and 56.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tuberculosis; TB; Pulmonary; Vaccine
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB
      vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.
    


Intervention name(s): GSK's candidate Mycobacterium tuberculosis vaccine 692342; Control vaccine with the adjuvant system.; Control vaccine with physiological saline
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 2 doses at 0, 1 month; Intramuscular injection, 2 doses at 0, 1 month; Intramuscular injection, 2 doses at 0, 1 month
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tuberculosis vaccine
Dressing Wear Time After Reduction Mammaplasty
Condition: Surgical Site Infection; Skin Colonization
MeSH terms: Surgical Wound Infection
Study type: Interventional

Summary: 
      This study was designed to determine whether the duration of dressing wear following
      reduction mammaplasty influence skin colonization and surgical site infections rates.
    

Detailed description: 
      Surgical site infections (SSI) are wound infections that occur after invasive
      procedures.Particularly in plastic surgery procedures, to minimize the risk of SSI is
      imperative, since even minor infections are able to complicate the healing process and harm
      the cosmetic result.

      Reduction mammaplasty is an effective and well established procedure performed for the relief
      of physical pain and discomfort associated with macromastia, which significantly decreases
      patients' quality of life.Breast reduction has provided long-term relief for most patients,
      with high patient satisfaction.

      The demand for this kind of plastic surgery is high.Reduction mammaplasty was the fifth most
      commonly surgical procedure performed by plastic surgeons in women of United States.Since
      reduction mammaplasty is associated with a high incidence of wound problems,all effort to
      minimize the risk of SSI is valid.
    

Intervention name(s): reduction mammaplasty; reduction mammaplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Dressing following reduction mammaplasty is removed on the first postoperative day; Dressing following reduction mammaplasty is removed on the sixth postoperative day
Other intervention name(s): Breast reduction surgery; Breast reduction surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: breast hypertrophy; mammaplasty; bandages; surgical site infection; skin colonization
Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the
      efficacy and safety of Prochymal® versus placebo in combination with corticosteroids as
      initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients
      with previously untreated acute GVHD and the historical published data define an expected 35%
      complete response (CR) at Day +28 using this therapy.
    

Detailed description: 
      Participants will be treated with a total of 6 infusions of investigational agent during the
      first 4 weeks of the study. The first infusion of the investigational product (IP) will be
      administered within 72 hours of the start of systemic corticosteroid therapy. Four infusions
      will be administered during the first two weeks (twice weekly), then two infusions
      administered during the next two weeks (once weekly). Participants assigned to the active
      treatment group will receive Prochymal®. Participants assigned to the non active treatment
      group will receive placebo (excipient, less cells). It is recommended that all participants
      receive all six infusions. The discontinuation of investigational agent is allowed for GVHD
      worsening with subsequent need for salvage therapy. All infusions must be given at least 3
      days apart.

      Participants will be evaluated for efficacy and safety until death, withdrawal or 90 study
      days after randomization, whichever occurs first. Study will be unblinded and data analyzed
      at Day 90 post 1st infusion (Day 0) following final participant enrollment. Participants will
      be followed for safety for 12 months post 1st infusion (Day 0).
    

Intervention name(s): Prochymal®; Placebo; Corticosteroid
Intervention type(s): Drug; Other; Other
Intervention description(s): Prochymal® intravenous infusion.; Placebo-matching Prochymal® intravenous infusion.; Administration will be intravenously as prescribed by the caregiver.
Other intervention name(s): Remestemcel-L; Methylprednisolone; Prednisone
Intervention MeSH terms: Remestemcel-l; Prednisone; Methylprednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute GVHD; Acute Graft Versus Host Disease
End Tidal Control of Sevoflurane
Condition: Anesthesia of Living Donor Hepatectomy
Study type: Interventional

Summary: 
      the study compares the use of end tidal (Et) control of sevoflurane during anesthesia for
      living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as
      effective as FGF control with less cost and more operator satisfaction.
    


Intervention name(s): End tidal control module in Aisys anesthesia workstation
Intervention type(s): Device
Intervention description(s): THE USE OF AUTOMATED CONTROL OF END TIDAL SEVOFLURANE CONCENTRATION TO MAINTAIN ANESTHESIA DURING DONOR HEPATECTOMY
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
External Nasal Dilator and Oxygen Therapy in Respiratory Failure
Condition: Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome
Study type: Interventional

Summary: 
      Acute respiratory failure secondary to bronchiolitis and asthma is one of the most common
      diagnoses in children admitted to pediatric intensive care unit.

      Objectives: The primary outcome of the study is to compare the respiratory parameters between
      patients on HFNC and HFNC with ENDs.

      Methods: This is a prospective randomized controlled trial. All children admitted to Loma
      Linda University Children's Hospital due to acute respiratory failure secondary to
      bronchiolitis and asthma are eligible for inclusion in the study. Multiple respiratory
      parameters will be collected as part of the study. The investigators anticipate that use of
      END will have a positive impact on the respiratory status of children with acute respiratory
      failure. Appropriate statistical analysis of the data will occur after the data has been
      de-identified.
    

Detailed description: 
      Acute respiratory failure secondary to bronchiolitis is one of the most common diagnoses in
      children admitted to pediatric intensive care unit.

      Objectives: The primary outcome of the study is to compare the respiratory parameters between
      patients on high flow nasal cannula (HFNC) and HFNC with an external nasal dilator (END).

      Methods: This is a prospective randomized controlled trial. All children admitted to Loma
      Linda University Children's Hospital between July 2015 and May 2017 for approximately 22
      months due to acute respiratory failure secondary to bronchiolitis are eligible for inclusion
      in the study. Two arms will be studied, one with HFNC and the other with HFNC and ENDS.
      Modified Bronchiolitis Severity Score will be used to assess respiratory parameters as part
      of the study. The investigators anticipate that use of END will have a positive impact on the
      respiratory status of children with acute respiratory failure. Appropriate statistical
      analysis of the data will occur after the data has been de-identified.
    

Intervention name(s): External nasal dilator (END); High flow nasal cannula (HFNC)
Intervention type(s): Device; Other
Intervention description(s): Applying External nasal dilator as adjuvant to high flow oxygen; Non-invasive positive pressure ventilation
Other intervention name(s): nasal strip
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment