bioihbjkbjnl/mcl2 huggingface dataset:
PT005 MDI Dose Ranging Versus Foradil Aerolizer Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI
      compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic
      obstructive pulmonary disease (COPD).
    


Intervention name(s): PT005 MDI; Formoterol Fumarate 12 μg (Foradil® Aerolizer®); Formoterol Fumarate 24 μg (Foradil® Aerolizer®); Placebo MDI
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): PT005 MDI taken as two inhalations; Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece; Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece; Matching placebo to PT005 MDI taken as two inhalations
Other intervention name(s): Foradil® Aerolizer®; Foradil® Aerolizer®
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and
      cardiorespiratory fitness after a diet and physical activity intervention in breast cancer
      survivors and to asses possible relation between these changes.
    

Detailed description: 
      Aim:

      The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory
      fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC)
      survivors and investigated the possible relation between these changes.

      Methods:

      The intervention of this 12-week single-arm pre-post pilot study involved group-based
      sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA
      sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to
      promote weight loss, targeted overweight/obese women who had completed treatment less than
      six months before recruitment. CRF and QoL were assessed before and after the intervention
      and compared using paired t-tests. Linear regression models, including CRF variables, weight
      change and participants' characteristics, were used to assess the independent association
      between change in CRF and change in QoL.
    

Intervention name(s): Weight loss intervention
Intervention type(s): Behavioral
Intervention description(s): This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (PA) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, Quality of Life (QoL) and cardiorespiratory fitness (CRF) were collected.
Other intervention name(s): Dietary and Physical Activity Intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast cancer; Survivors; Weight loss; Diet; Physical activity
Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children
Condition: Emergence Delirium
MeSH terms: Delirium; Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 3

Summary: 
      Study where children will receive one premedication, either intranasal dexmedetomidine or
      oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that
      dexmedetomidine is superior but previous studies lack quality.
    

Detailed description: 
      Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine
      (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.
    

Intervention name(s): Dexmedetomidine; Midazolam oral solution; Oral saline; Nasal saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution); Oral midazolam, 0.5mg/kg (its a 2mg/ml solution); Oral saline, 0.25ml/kg; Nasal saline 0.01ml/kg
Other intervention name(s): Precedex; 0.9% Saline solution; 0.9% Saline solution
Intervention MeSH terms: Midazolam; Dexmedetomidine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants will receive an intranasal and an oral drug. One group will receive oral midazolam and intranasal saline, the other will receive oral saline and intranasal dexmededomedine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Emergence Delirium; Emergence Agitation; premedication; dexmedetomidine; midazolam
Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-related Volume Deficit
Condition: Aesthetics; Intradermal Injections
Study type: Interventional

Summary: 
      Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement
      of facial volume, effect on the restoration and/or augmentation in subjects with mid-face
      age-related volume deficit after injection of a filler with lidocaine.
    

Detailed description: 
      Prospective, non comparative, single center study, on healthy female subjects. The scope is
      to evaluate the performance and safety of a dermal filler (definisse core filler plus
      lidocaine) to evaluate the aesthetic improvement of facial volume, effect on the restoration
      and/or augmentation in subjects with mid-face age-related volume deficit after injection of a
      filler with lidocaine.
    

Intervention name(s): DEFINISSE CORE FILLER
Intervention type(s): Device
Intervention description(s): DEFINISSE CORE FILLER volume will be injected between 4.0 of 5.0 ml on the whole face (at the discretion of the treating physician to achieve an optimal aesthetic result).
A touch-up will be possible at the first follow-up visit (after one month) with a amount of product between 4.0 and 5.0 ml on the whole face
Intervention model: Single Group Assignment
Intervention model description: prospective,
non comparative
single centre,
on healthy subjects.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DERMAL FILLER; sodium hyaluronate; RELIFE
Adolescent MenACWY Booster Study
Condition: Meningococcal Disease, Invasive
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to confirm non-inferiority of the three MenACWY vaccines (Menveo, Menactra or
      Nimenrix) in adolescents, and to identify whether the number of previous doses of MenC
      influences the response to the MenACWY vaccine.
    

Detailed description: 
      Participants will be randomized to receive one of the three doses of licensed MenACWY as a
      booster dose in adolescents. Serology will be collect at 3 time points; prior to the booster
      dose and 1 month and 1 year post-vaccination to measure antibody levels. The participants are
      healthy students in grades 7-9 who have not received their MenACWY vaccine yet and received
      their routine infant MenC vaccines per previous Canadian schedules.
    

Intervention name(s): MenACWY-CRM; MenACWY-DT; MenACWY-TT
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Booster vaccination with MenACWY-CRM; Booster vaccination with MenACWY-DT; Booster vaccination with MenACWY-TT
Other intervention name(s): Menveo; Menactra; Nimenrix
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 = 3 prior doses of MenC vaccine (Alberta), Group 2 = 2 prior doses of MenC vaccine (British Columbia), Group 3 = 1 prior dose of MenC vaccine (Nova Scotia). Group A = Menveo (MenACWY-CRM), Group B = Menactra (MenACWY-DT), Group C = Nimenrix (MenACWY-TT)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: MenACWY; Neisseria meningitidis; adolescents
Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the
      uterus or womb). This infection may go away by itself, but if it does not go away (this is
      called persistent infection), it can lead in women over a long period of time to cancer of
      the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals
      HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start.
      Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly
      according to a 0-1-6 month schedule. The study will be extended to assess long-term safety
      and immunogenicity of the HPV-16/18 vaccine.
    


Intervention name(s): Cervarix
Intervention type(s): Biological
Intervention description(s): Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV Vaccine Safety
Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men
Condition: Obesity; Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      Obesity is associated with low testosterone in men and with dyslipidemia. Adropin hormone is
      negatively correlated with body mass index and is associated with dyslipidemia.

      correlation between adropin and testosterone will be evaluated.
    

Detailed description: 
      Obesity, a worldwide epidemic is associated with multiple adverse health outcome as diabetes
      mellitus, hypertension and cardiovascular diseases caused mainly by dyslipidemia linked to
      obesity. Low testosterone levels in obese men were found associated with dyslipidemia.

      Adropin is a new metabolic hormone that was first isolated in liver and brain tissues, It was
      observed that mice fed on a high-fat diet (HFD) had a rapid increase in adropin expression
      compared to control values. In human also, adropin levels were negatively correlated with
      body mass index (BMI) and were associated with dyslipidemia.

      Adiponectin is a protein that is mainly produced by white adipose tissue and has an important
      role in lipid metabolism. Serum adiponectin concentrations were decreased in obese compared
      to normal weight men and significantly correlated with testosterone level.
    

Intervention name(s): lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL)); Total testosterone; Adropin; Adiponectin
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): blood samples will be collected after 10 hours fasting; blood samples will be collected after 10 hours fasting; blood samples will be collected after 10 hours fasting; blood samples will be collected after 10 hours fasting
Intervention MeSH terms: Testosterone
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        obese and normal weight men from 18 years to 50 years
      
Keywords: Adropin; adiponectin; testosterone; obese men
Ghrelin Levels in Children With Poor Growth
Condition: Idiopathic Short Stature; Failure to Thrive
MeSH terms: Dwarfism; Failure to Thrive
Study type: Observational

Summary: 
      The investigators hypothesize that low serum ghrelin levels may characterize a group of
      patients with poor weight gain and/or linear growth who do not have any other identified
      cause for growth failure. These patients may present with a variety of complaints and are
      often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. The
      investigators hypothesize that ghrelin has a physiologically important role in linear growth
      and that chronic diseases of the gastrointestinal system, such as H. Pylori infection or
      celiac disease, may alter serum ghrelin levels in children. Low ghrelin levels may be a
      factor leading to poor growth, potentially by altering growth hormone secretion and/or by
      decreasing appetite. By measuring ghrelin levels in children with short stature and in
      children with gastrointestinal disease, the investigators will further elucidate the possible
      physiologic role of ghrelin in childhood growth and how it may be altered in conditions
      causing short stature and in certain gastrointestinal diseases.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty-five (25) patients seen for evaluation of short stature in the pediatric
        endocrinology clinic will have serum ghrelin levels measured in addition to their usual
        routine bloods tests.

        Twenty-five (25) patients will be selected from patients who present with chronic
        gastrointestinal symptoms (symptoms of gastrointestinal disease for greater than 6 weeks or
        recurrent symptoms) and who have poor growth.

        The remaining 25 will be selected from patients with chronic gastrointestinal symptoms
        (symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms) who
        have normal growth.
      
Keywords: Ghrelin; short stature; failure to thrive
Exposure, Relaxation, & Rescripting Therapy-Child
Condition: Nightmares Associated With Trauma and Stress
Study type: Interventional

Summary: 
      Untreated trauma-related nightmares and sleep-related disorders are associated with chronic
      health problems, burdening both the suffering individual and the health-care system. The
      study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed
      children. It is the first randomized clinical trial with children, adapting an efficacious
      adult therapy to a 5-session nightmare treatment for 5-17 year-olds. Trauma nightmares are a
      mechanism in development and maintenance of secondary post-trauma psychopathology, medical
      problems and family dysfunction. Therefore, this treatment may prevent long-term secondary
      health and behavioral problems. It provides a viable healthcare option to Oklahomans,
      lessening long-term financial medical and behavioral health expenses. Scientific models
      currently view PTSD treatment as primary, often leaving nightmares untreated. That approach
      does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold
      PTSD or whose nightmares are a primary condition. The theoretical innovation of this therapy
      can advance the field's understanding of the development of trauma sequelae.
    


Intervention name(s): Exposure, Relaxation, & Rescripting Therapy-Child
Intervention type(s): Behavioral
Intervention description(s): Exposure, Relaxation, & Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, psycho-education, Progressive Muscle Relaxation, diaphragmatic breathing,child-friendly exposure to the trauma-nightmare, and rescription.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: nightmare; PTSD; trauma; children; cognitive behavior therapy; stress; sleep
A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to assess the effect of different dose levels of pneumococcal
      polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and
      infants.
    


Intervention name(s): V114 Medium Dose; V114 High Dose; V114 Medium Dose with Alternative Carrier Protein; V114 High Dose with Alternative Carrier Protein; Prevnar 13™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitis
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Observational

Summary: 
      125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62
      healthy siblings also enrolled in the study.

      Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive
      control skills at entry to the study (Test 1) and after two years of close monitoring for
      blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before
      and after cognitive testing to ensure their blood sugar is within range during the testing.
      The 2-year follow-up period involves parents/child reporting any severe diabetic episode and
      periodically providing the results of the diabetic child's usual blood tests from their
      glucose monitoring device.

      Children 7 and older also underwent high resolution MRI scans.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        125 children with Type 1 Diabetes Mellitus (T1DM) between 4 and 16 were recruited from the
        Diabetes Clinic at St. Louis Children's Hospital. 62 healthy siblings between 4 and 16 also
        enrolled in the study.
      
Keywords: Type 1 Diabetes Mellitis; MRI
Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.
Condition: Postoperative Residual Curarization
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional

Summary: 
      Objective neuromuscular monitoring is the gold standard to detect postoperative residual
      curarization (PORC). Many anesthesiologist just use qualitative neuromuscular monitoring or
      unreliable, clinical tests. Goal of this study is to develop an algorithm of muscle function
      tests to identify PORC
    

Detailed description: 
      Background: Quantitative neuromuscular monitoring is the gold standard to detect
      postoperative residual curarization (PORC). Many anesthesiologists, however, use insensitive,
      qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this multicentre,
      prospective, double-blinded, assessor controlled study is to develop an algorithm of muscle
      function tests to identify PORC.

      Methods: After extubation a blinded anesthetist performs eight clinical tests in 165
      patients. Test results are correlated to calibrated electromyography train-of-four (TOF)
      ratio and to a postoperatively applied uncalibrated acceleromyography. A classification and
      regression tree (CART) is calculated developing the algorithm to identify PORC. This is
      validated against uncalibrated acceleromyography and tactile judgement of TOF fading in
      separate 100 patients.
    

Intervention name(s): Acceleromyography
Intervention type(s): Device
Intervention description(s): Use of an uncalibrated acceleromyography
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: During anaesthesia calibrated neuromuscular function is monitored using evoked EMG of the adductor pollicis muscle (immobilised forearm) with a NMT module by a non-blinded investigator. During surgery, the (blinded) attending anaesthesiologist administers maintenance doses of atracurium according to clinical needs, i.e. without knowing the TOFR.
After surgery patients' trachea is extubated according to clinical judgement. Immediately after extubation blinded anaesthesiologist tests the patient. The postoperative evaluation of neuromuscular function consists of eight clinical tests applied in a random order.
Thereafter, an uncalibrated acceleromyography (50 mA, 2 Hz) is started on the contralateral arm and TOF ratio is measured.
During the validation part of the developed algorithm the anaesthesiologist additionally had to judge tactile fading of the adductor pollicis.
If a patient had any clinical signs of neuromuscular dysfunction, reversal with neostigmine is administered.
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Keywords: muscle function tests