bioihbjkbjnl/mcl2 huggingface dataset:
An Innovative Model of Pediatric Acute Mental Health and Addictions Care
Condition: Mental Health; Mental Disorders; Pediatrics; Emergency Psychiatric
MeSH terms: Emergencies; Mental Disorders
Study type: Observational

Summary: 
      The investigators will implement and evaluate an integrated, evidence-based bundle of
      family-centred, pediatric emergency mental health and addictions care.
    

Detailed description: 
      The investigators will implement and evaluate an integrated, evidence-based bundle of
      family-centred, emergency mental health and addictions care. This care bundle will provide
      high value to families, matching resources and services to need while eliminating healthcare
      inefficiencies and closing care gaps. The bundle will introduce two well-established tools
      for healthcare providers to use in EDs, walk-in clinics, and urgent mental health care
      appointments. These tools are the Ask Suicide-Screening Questions (ASQ) and HEADS-ED, an
      assessment mnemonic (Home; Education & Employment; Activities & Peers; Drugs & Alcohol;
      Suicidality; Emotions & Behaviours; Discharge or Current Resources).

      The bundle will also introduce new processes to improve healthcare system efficiencies,
      navigation and transitions between healthcare sectors. For families who receive care in the
      ED, the investigators will remove the physician gatekeeper role so that children/youth who
      are screened as low-risk will be offered a follow-up appointment in an urgent mental health
      care clinic within 24-48 hours. Those who screen as high-risk will see a mental health
      specialist and undergo a HEADS-ED assessment. Families who follow up in the clinic will
      receive care that applies a Choice And Partnership Approach (CAPA). CAPA is a collaborative
      approach to healthcare, where healthcare providers work in partnership with children/youth
      and their parents to identify choices for care that best match individual needs and
      preferences.

      Study Goal: The investigators' goal is the right care, with the right people, at the right
      place and time.

      Study Design: To measure the bundle's impact, the investigators will use an interrupted time
      series (ITS) design.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients less than 18 years of age that present to the emergency department with a mental
        health complaint, and do not require medical clearance by an emergency department
        physician.
      
Keywords: Emergency Psychiatric Services; Healthcare Delivery
Effects of Smoking Environment on Craving and Smoking
Condition: Smoking
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the effects of exposure to standard smoking
      environments on ability to resist smoking as measured with a Delay to Smoking Task. The
      results of this study will inform whether the Delay to Smoking Task is a sensitive measure
      for evaluating environment-provoked craving and smoking behavior.
    

Detailed description: 
      Adult smokers (n=25) will complete 4 visits and a 6 month follow-up phone call. Participants
      will complete a Delay to Smoking Task following 6 hours smoking abstinence. The task involves
      viewing pictures of smoking and non-smoking locations and participants will have the choice
      to smoke a cigarette at any time during the session. A monetary reinforcer will be provided
      for each 6-minute period that a participant resists smoking. Once participants stop the task
      they can choose to smoke as much or a little as they want for the next 30 minutes.
      Participants will be provided with a smoking tab. Each cigarette they light will cost them
      from their tab. Measurements of tobacco craving, emotion ratings, and nicotine withdrawal
      will be assessed.
    

Intervention name(s): 6 hour smoking abstinence; Delay to Smoking Task (smoking cues); Delay to Smoking Task (nonsmoking cues)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be presented with an unlit cigarette of their brand and an opportunity to initiate ad lib smoking at any time during the 60-minute task. During this period, participants will be allowed to read books or magazines, but will hear a tone alerting them to view cues (standard smoking environments) for the final minute of each 6-minute period. A monetary reinforcer will be provided for each 6-minute period that a participant resists smoking. Once participants stop the task they can choose to smoke as much or a little as they want for the next 30 minutes. Participants will be provided with a smoking tab. Each cigarette they light will cost them from their tab.; Participants will be presented with an unlit cigarette of their brand and an opportunity to initiate ad lib smoking at any time during the 60-minute task. During this period, participants will be allowed to read books or magazines, but will hear a tone alerting them to view cues (standard nonsmoking environments) for the final minute of each 6-minute period. A monetary reinforcer will be provided for each 6-minute period that a participant resists smoking. Once participants stop the task they can choose to smoke as much or a little as they want for the next 30 minutes. Participants will be provided with a smoking tab. Each cigarette they light will cost them from their tab.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Examination of the Pancreas in New-onset Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to create a prospective cohort of subjects with increased
      probability of being diagnosed with pancreatic cancer and then screen this cohort for
      pancreatic cancer
    

Detailed description: 
      Compared to the general population, subjects >50 years of age with new-onset diabetes (DM)
      are 8-times more likely to have pancreatic cancer (PaC). The likelihood of PaC in new-onset
      DM is further increased in those who have weight loss or elevated CA19-9. In this study
      patients with newly diagnosed diabetes will be prospectively identified. Those with weight
      loss and/or elevated pancreatic cancer marker (CA 19-9) will undergo pancreatic imaging. All
      subjects will be followed up to 24 months. If successful in identifying surgically removable
      PaC, this study will fundamentally change our practice and will be a major breakthrough in
      PaC treatment and research.
    

Intervention name(s): medical chart review; survey administration; Specimen collection
Intervention type(s): Other; Other; Other
Intervention description(s): baseline, quarterly follow-up for 24 months; baseline; baseline
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Suspected or definite new-onset diabetes
      
Biospecimen description: 
      60ml of whole blood. 5ml urine sample for pregancy testing (if necessary). Stool and saliva
      samples may be collected.
    
Keywords: pancreatic cancer; new-onset diabetic; diabetes
Macular Detachment Associated With Intrachoroidal Cavitation
Condition: Macular Detachment; Macular Retinoschisis; Intrachoroidal Cavitation
MeSH terms: Retinoschisis; Dissociative Disorders
Study type: Interventional

Summary: 
      Evaluation of clinical characteristics and surgical outcome for macular detachment associated
      with peripapillary intrachoroidal cavitation with or without pathologic myopia.
    


Intervention name(s): Vitrectomy
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular detachment; Macular retinoschisis; Vitrectomy
Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)
Condition: Pneumonia Due to Staphylococcus Aureus
MeSH terms: Pneumonia; Pneumonia, Staphylococcal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this study are to assess the safety, tolerability, pharmacokinetics,
      pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by
      Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in
      addition of standard of care antibiotic treatment.
    

Detailed description: 
      S. aureus is a leading cause of bloodstream, skin, soft tissue, and lower respiratory tract
      infections worldwide. The frequencies of both nosocomial and community-acquired S. aureus
      infections have increased steadily over the years and the treatment of these infections has
      become more challenging due to the emergence of multi-drug resistant strains (e.g.
      methicillin-resistant Staphylococcus aureus).

      S. aureus has several virulence factors that contribute to the pathogenesis of the infection.
      Amongst them, alpha-toxin that is involved in the pathogenesis of pneumonia, as it leads to
      apoptosis and cell lysis, in particular lymphocytes, macrophages, alveolar epithelial cells,
      pulmonary endothelium, and thrombocytes.

      In spite of preventive measures for S. aureus infections and current medical treatment
      (mostly antibiotic therapy, alone or in combination), there is a clear unmet medical need in
      the clinic for additional treatment options. Passive immunotherapy with monoclonal antibodies
      may improve treatment options for severe and life-threatening infections like those caused by
      S. aureus.
    

Intervention name(s): KBSA301; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.; Placebo administered as a single intravenous infusion
Other intervention name(s): AR301; Placebo KBSA301
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pneumonia; Monoclonal antibody; Staphylococcus aureus
The Frequency Forward Head Posture in Subjects With Temporomandibular Disorder
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      The aim of this study was to verify the frequency of the forward head posture in subjects
      with temporomandibular disorder and to compare them with control group
    

Detailed description: 
      Postural habit is defined as "the attitude of the body" being characterized as good when the
      parts of the body muscles and bones are lined up and work together in a harmonious form
      protecting the body of injury or gradual deformity and independently the attitude. The bad
      posture is a bad habit, but it can be which results in the disagreement of some parts of the
      body. These are at risk of injury or pain due to and increased tension that the disagreement
      imposes to the support structures. Several study confirm this occurrence relating that this
      the attitude can alter itself principally if a discomfort occurs. When it occurs there will
      be the installation of alterations, limitation of movements or even deformity, leading it to
      the development of an abnormal of posture of the body which will be able to reduce the
      functional capacity of various structures and organs of the human body.

      The forward head posture is a common abnormality in cervical spine that can contribute to
      perpetuation the trigger points in muscles of the head as well as some kinds of
      temporomandibular disorder. It was suggested its influence in the treatment of patients with
      orofacial pain and TMD the FHP may occur a result of an acute trauma or if develop itself
      gradually because of an inadequate position.
    

Intervention name(s): The measure of the cervical posture
Intervention type(s): Other
Intervention description(s): The investigation of the cervical position consisted of locating the individual in side view with the parallel feet in erect position and tracing an imprisoned plumb wire to the ceiling and tangent to the kyphosis curve of the thoracic column. With a ruler it was verified at a distance of this line until the point deepest of the cervical lordosis curve.
Other intervention name(s): there are not brand or serial numbers.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study was randomized with one hundred subjects that were divided fifty for study group
        and fifty of the control group with age between 18 and 65 years old, of both sexes. The
        volunteers were selected among the individuals who went to the clinic of orofacial pain and
        TMD of São Paulo Hospital and the dental offices of the researchers
      
Keywords: temporomandibular disorder; orofacial pain; posture of the head
Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis
Condition: Ankylosing Spondylitis; Treatment
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective randomized controlled study to evaluated the efficacy and safety of
      kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major
      outcome index is proportion of patients achieving ASAS20 response at week12, and minor
      outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events
      at any time were recorded to evaluate the safety.
    


Intervention name(s): kunxian capsule
Intervention type(s): Drug
Intervention description(s): The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; treatment; Sulfasalazine; kunxian capsule
The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study is

        -  To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood
           lipids and lipoprotein parameters from baseline after 12 weeks of treatment.

        -  To evaluate the safety of PRC-4016 as assessed by adverse events and other safety
           parameters
    

Detailed description: 
      6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification
    

Intervention name(s): PRC-4016; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessing Continuous Glucose Monitors in Healthy Children
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes
      mellitus. The purpose of this study was to determine whether two FDA-approved continuous
      glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM
      Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose
      levels in children.
    

Detailed description: 
      The characterization of glucose levels in healthy children during day and nighttime is
      critical to the interpretation of glucose levels in diseases such as diabetes. This study was
      conducted by the DirecNet Study Group to determine whether two FDA-approved continuous
      glucose monitors are sufficiently accurate.

      The study was conducted at five clinical centers and enrolled approximately 20 healthy
      children (ages 7 to 17 years old) who did not have Type 1 or Type 2 diabetes nor a history of
      the disease in their immediate families. Each participant was hospitalized for approximately
      26 hours to assess the accuracy of the continuous glucose monitors compared with serum
      glucose determinations.
    

Intervention name(s): Continuous Glucose Monitoring System (CGMS); GlucoWatch G2TM Biographer (GW2B)
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Glucose Monitoring Devices; Blood glucose profiles in normal children; Blood glucose profiles in non-diabetic children
Cold Plasma for Dental Restoration and Caries Prevention
Condition: Dental Restoration; Caries
Study type: Interventional

Summary: 
      The main objective of this entire research project is to develop a miniature atmospheric cold
      plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical trial
      portion of the study is to compare the longevity and durability of dental composite
      restorations created using the plasma brush, to that of the standard care in dentistry for
      treating dental cavities, and effects on caries prevention.
    

Detailed description: 
      The study will be a randomized controlled trial (RCT) and be approved by the institute review
      board of the University of Tennessee Health Science Center. The study subjects will be
      composed of young adults 18-35 years old in order to control effects of age on caries. Also
      the subjects must be Caucasian or Africa American. Young adult patients will be recruited
      from the UTHSC dental clinics.The baseline visit include a dental exam by one of the
      investigators, standard preventive dental care (e.g cleaning, application of fluoride
      varnish), anthropometric measurements, oral health interview survey. 100 patients who meet
      all inclusion and exclusion criteria will be recruited after they sign an informed consent
      form. These patients will be randomly assigned to 1 of 2 study groups. Randomization
      assignment will be stratified by age and number of teeth with caries. Two study groups will
      be: 1.) plasma treatment group and 2) standard treatment group. For patients in standard
      treatment group, they will receive composite resin restoration for all decayed teeth and
      standard preventive treatment (cleaning and fluoride varnish application) at baseline. For
      patients in plasma treatment group, they will receive plasma treatment after cavity
      preparation, composite resin restoration, standard preventive treatment followed by plasma
      treatment for non-carious teeth. Standard preventive treatment and plasma treatment will be
      repeated on semi-annual (6-month) recall visits. All composite restorations will be placed
      according to the manufacturer's instruction. Only one composite commercially available will
      be used during the study.
    

Intervention name(s): Composite restoration and tooth cleaning; Plasma treatment
Intervention type(s): Other; Procedure
Intervention description(s): Standard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction.; plasma treatment after preparation and for caries prevention
Other intervention name(s): Standard composite filling and preventive treatment; Plasma treatment and standard preventive treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dental restoration; dental caries; tooth cavity
The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis
Condition: Pulmonary Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult
      after the surgery. Lung Ultrasound Scoring (LUS) can provide an objective measuring system to
      understand the condition of the lungs in the perioperative period. In this randomized
      controlled study, it is aimed to investigate the effects of one single recruitment maneuver
      (RM) just before emergence and extubation (at the end of surgery) on LUS scores and
      postoperative recovery room oxygenation in laparoscopic nephrectomy surgeries. Accordingly,
      the intervention group will be applied single RM before extubation, while the control group
      will be awaken without RM.

      There will be LUS evaluation at 4 different time for intervention group (Group RM) points
      that are:

      T1: 5 min after the intubation T2: At the end of surgery (After skin closure, before
      recruitment maneuver) T3(RM): After recruitment maneuver, before extubation T4: 30 minutes
      after extubation in the recovery room

      LUS evaluation will be made at 3 different time points in control group (Group NoRM):

      T1: 5 min after the intubation T3(NoRM): Before extubation (no recruitment maneuvers will be
      made) T4: 30 minutes after extubation in the recovery room.

      The primary outcome is the comparison of the T3 LUS scores. Assuming a 40% difference in the
      T3 LUS score, total number of 30 patients were calculated to be included in the study with an
      alpha value of 0.05 and 95% power. A possible drop-out of 5 patients per group, 20 patients
      were planned to be enrolled in each group.

      Secondary outcomes will include; difference in T4 LUS scores, the effect of RM on
      postoperative recovery room oxygenation, and the effect of deltaLUS (T3-T2) on postoperative
      recovery room oxygenation.
    


Intervention name(s): Recruitment maneuver
Intervention type(s): Other
Intervention description(s): In Group RM (intervention group) after skin closure, mechanical ventilation settings will be set to FiO2:100%, I:E=1:1, respiratory rate: 6, and then tidal volume will be increased gradually by 150 ml until reaching a plato pressure of 30 mmHg. After 3 breaths in this state, RM will be considered accomplished. LUS evaluation will be made just before and after the RM.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic