bioihbjkbjnl/mcl2 huggingface dataset:
Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer
Condition: Breast - Female
Study type: Observational

Summary: 
      The primary objective is to determine how accurately one can estimate the size of the index
      tumor on preoperative imaging in patients with known breast cancer, using pathology as a
      reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the
      maximum diameter (mm) of the index tumor.
    

Detailed description: 
      The primary objective is to determine how accurately one can estimate the size of the index
      tumor on preoperative imaging in patients with known breast cancer, using pathology as a
      reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the
      maximum diameter (mm) of the index tumor.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult women, ages18-70 years old, of any race and ethnicity, with a recent diagnosis of
        breast cancer (histologically confirmed invasive and/or in situ carcinoma of the breast)who
        have not undergone surgery, are not planned to undergo neoadjuvant chemotherapy; and have a
        CE-MRI within 1 month(31 days) of enrollment.
The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
Condition: Edentulism; Alveolar Bone Atrophy; Sinus Pneumatization
MeSH terms: Alveolar Bone Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis of this study is that there is a significant difference in bone maturation
      after sinus grafting determined by the distance from the buccal to the palatal wall of this
      cavity.
    

Detailed description: 
      Inadequate alveolar bone height as a consequence of tooth loss is a common limitation for
      properly placing endosseous dental implants in the posterior maxilla. Grafting of the
      maxillary sinus has been regarded as one of the most reliable surgical alternatives to
      correct this problem. Several sinus grafting techniques, using different materials, have been
      reported showing high survival rates. However, there are many factors that may alter the
      outcomes of this procedure.

      The maturation and consolidation of the grafted area relies on the proper formation of a
      functional graft-vital bone complex. This maturation process requires an adequate migration
      of osteogenic cells from native bone, that could be limited in situations where the
      dimensions of the maxillary sinus are excessive. Hence, the purpose of this research project
      is to determine the influence of the distance from the lateral to the medial wall of the
      maxillary sinus on the outcomes of a sinus augmentation procedures performed using the
      lateral approach using clinical, radiographic and histomorphometric analysis.
    

Intervention name(s): Sinus grafting using allogenic bone
Intervention type(s): Procedure
Intervention description(s): Surgical bone grafting procedure oriented to provide enough bone volume in atrophic posterior maxillary segments, when placement of endosteal implants is planned in order to restore missing teeth.
Other intervention name(s): Mineross - Human allograft
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Implant site development; Bone grafting; Dental implants
Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway
Condition: Mental Disorders
MeSH terms: Cognitive Dysfunction; Mental Disorders
Study type: Observational

Summary: 
      Patients referred to pediatric rehabilitation services have often cognitive
      deficits/intellectual disabilities.Neurocognitive assessment is, hence, important when
      designing treatment plans.

      Children and adolescents with cognitive deficits and intellectual disabilities (ID) have a
      high risk of developing mental health problems. There is lack of knowledge about such
      comorbid mental disorders in the health service. There are also few validated instruments for
      assessing mental disorders among children and adolescents with cognitive deficits and ID both
      in Norway and abroad.

      The main aims of the current multicentre study are to:

      Investigate psychometric properties of different psychiatric instruments for children and
      adolescents. Investigate change and stability of symptoms over time. Investigate user
      satisfaction. The study will include Pediatric Rehabilitation Services at hospitals in
      Tromsø, Hammerfest and Bodø and will include in total 320 patients aged 4 to 18. We will use
      information from parents, teachers and patients, in addition to clinician-rated measures.
      Patients will be assessed at intake and after six months. We have conducted a pilot study in
      the period from 2012 to 2013.
    

Detailed description: 
      1. Investigate psychometric properties of a structured psychiatric interview

           (DAWBA) and a symptom measure (SDQ) in clinical samples of children and

           adolescents with cognitive deficits and intellectual disabilities. We will

           investigate the instruments' reliability and convergent validity with the

           Aberrant Behavior checklist (ABC), the DBC and the Social Responsiveness

           Scale (SRS), in addition to the clinician-rated severity of children's mental

           health problems measured with the CGAS and HoNOSCA.

        2. The psychiatric instruments will be administrated at intake and after six

           months. We will investigate prevalence rates and indicators of disorder

           severity (comorbidity and persistence), including risk factors (socioeconomic

           status, parenting styles).

        3. Investigate user satisfaction with the health service, i.e., the Pediatric

      Rehabilitation Services.
    

Intervention name(s): mental disorders; screening for mental disorders
Intervention type(s): Other; Behavioral
Intervention description(s): mental disorders; screening for mental disorders
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to pediatric rehabilitation outpatient clinic
Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The primary purpose of this study was to compare the relative effectiveness of cervical
      manipulation, mobilisation and the Activator instrument in the treatment of subacute
      non-specific neck pain. The secondary purpose was to describe any adverse effects of these
      treatments.
    

Detailed description: 
      Neck pain is a common disorder. About 70% of adults will experience neck pain during their
      lifetime. After low back pain, neck pain is the most common reason patients give for seeking
      chiropractic care, and the second most common reason for the use of spinal manipulation.
      Usually, the underlying cause of neck pain is non-specific and cannot be related to a
      particular pathology as a cause of the presenting symptoms. Due to the uncertainty of the
      results obtained in the limited number of studies of manipulation and mobilisation for neck
      pain, further studies are needed to compare the different therapies available for neck pain.
      Participants in the study were treated as they would normally be with the exception of the
      type of spinal manipulation. There were three groups: a manipulation group, a mobilisation
      group, and an Activator instrument group.
    

Intervention name(s): manipulation; Mobilisation; Activator instrument
Intervention type(s): Procedure; Procedure; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chiropractic; osteopathic physicians; manipulation; neck pain; adverse effects; randomized clinical trial; Subacute non-specific neck pain
The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation,
      occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH),
      this frequently performed procedure is currently done without anesthetic, making it a painful
      and uncomfortable experience for the child and their caregiver(s). Liposomal Lidocaine is a
      relatively new effective and "needle-free" topical anesthetic. The investigators were
      interested in examining its effectiveness in pain reduction in children undergoing Perc Pin
      removal. Objective: To determine if Liposomal Lidocaine is effective in reducing pain in a
      pediatric population undergoing Perc Pin removal compared to a placebo. Hypothesis: The
      investigators hypothesize that Liposomal Lidocaine would significantly reduce pain during
      Perc Pin removal compared to a placebo. Research Design: This was a triple-blinded,
      randomized placebo-controlled clinical trial with 281 patients (140 patients each in the
      Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher Scale (children)
      and a 10-cm Visual Analog Scale (parents and caregivers) were collected prior to
      randomization and immediately after Perc Pin removal. Data was analyzed using a Student's
      t-test and the Wilcoxon signed ranks test.
    


Intervention name(s): Liposomal Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4% Liposomal Lidocaine; Tubes were visually identical to the Liposomal Lidocaine tubes.
Other intervention name(s): Maxilene
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patients aged 3 to 16 years presenting for; removal of smooth percutaneous interosseus pins; after orthopeadic surgery
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational vaccine GSK2340272A in children aged between 3 and 17 years.
    

Detailed description: 
      This Protocol Posting has been updated following Protocol amendment 1, October 2009. The
      impacted section are the study design section, the outcomes measures section and the
      intervention section.
    

Intervention name(s): GSK investigational vaccine GSK2340272A
Intervention type(s): Biological
Intervention description(s): Three intramuscular injections
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GSK Bio's influenza vaccine GSK2340272A; influenza infection
Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics,
      preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an
      anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.
    

Detailed description: 
      This first-in-human study with a dose-escalation design is meant to evaluate the
      tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of
      single-dose JYB1904 in healthy Chinese subjects.

      The sequential dose levels (sample size) of JYB1904 are set at five different dose, with
      additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab
      (Xolair).

      Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the
      upper arm.
    

Intervention name(s): JYB1904; Omalizumab; JYB1904 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm.; Dosage form: injection, powder, lyophilized, for solution； Usage and dosage matching:dose 1; single-dose; subcutaneous injection in the deltoid region of the upper arm.; Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring.
      Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg
      (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing
      elective cesarean section; secondary, to compare the duration and quality of analgesia and
      anesthesia
    

Detailed description: 
      On arrival in the recovery room the ICG non-invasive blood pressure cuff will be placed on
      the left arm, two sensors will be placed above the clavicle on each side of the neck, and two
      sensors will bw placed on either side of the thorax at midaxillary line corresponding to the
      level of the xiphoid process. Using a computer- generated sequence of numbers, patients will
      be randomly allocated in one of the two groups: 6 mg (1.6 mL) levobupivacaine + 20 µg
      fentanyl (GL6 group) or 8 mg (2 mL) levobupivacaine + 20 µg fentanyl (GL8 group). Continuous
      spinal epidural anesthesia (CSE) will be performed with patient in sitting position: a
      18-gauge Tuohy needle will be inserted into the L2-L3 interspace using the loss of resistance
      of saline technique to identify the epidural space; a 27-gauge Withacre spinal needle will be
      then placed through the Tuohy needle until the dura mater wwill be punctured and isobaric
      undiluted levobupivacaine plus 20 µg fentanyl was administered. Afterwards, an epidural
      catheter (Espocan, B.Braun, Melsungen, Germany) wwill be inserted 4 cm into the epidural
      space.
    

Intervention name(s): Impedance cardiography; Sensory levels; Motor block; Sensory level
Intervention type(s): Device; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): hemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine; Sensory levels are checked using ice test cold; motor block is measured by modified Bromage scale; Sensory levels are checked using touch with alcohol puffs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425
      (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
    


Intervention name(s): CSL's 2009 H1N1 Influenza Vaccine (CSL425); CSL's 2009 H1N1 Influenza Vaccine (CSL425); Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL intramuscular injection on Day 0 and Day 21; 0.25 mL intramuscular injection on Day 0 and Day 21; Placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Dietary Advanced Glycation End-products and Insulin Resistance in Overweight and Obese Humans
Condition: Type 2 Diabetes; Insulin Resistance; Obesity
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      We hypothesize that reduction in dietary advance glycation endproducts (AGE) intake will
      increase insulin sensitivity and normalise insulin secretion in overweight and obese
      individuals through reduction of chronic low grade inflammation.

      We propose to test this hypothesis by performing euglycemic hypeinsulinemic glucose clamp and
      intravenous glucose tolerance test before and after low AGE diet and normal Australian diet
      in a cross-over design. This study will provide information relevant to the development and
      prevention of type 2 diabetes.
    


Intervention name(s): dietary intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Prevention
Keywords: insulin resistance; insulin secretion; advanced glycation end-products
Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia.
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life,
      Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan
    

Detailed description: 
      Title： Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in patients
      with primary insomnia. A multi-center, double blind, placebo controlled clinical trial.

      (First year of two-years' project)

      Design:

      Randomized, placebo-controlled trial comprising 3 arms: SZRT, placebo, TWBXD.

      Setting:

      The Chung Shan Medical University Affiliated Hospital and the Taipei City Hospital.

      Methods:

      A total of 128 subjects 20-80 years of age with a history of insomnia at least 1 month were
      recruited randomly assigned to SZRT (n = 48), placebo (n =32), TWBXD (n =48) and were
      instructed to take 6 gm 2 times per day of SZRT, TWBXD or placebo for a period of 4 weeks.
      The primary outcome measures were the mean component scores of the Pittsburgh Sleep Quality
      Index (PSQI). Secondary outcome parameter were the global score on the World Health
      Organization Quality of Life questionnaire - Taiwan brief version, drugs consumption counts,
      sleep diary and safety profiles by structures questionnaires.
    

Intervention name(s): TIAN WANG BU XIN DAN; Suan Tzao Ren Tang; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): assigned to TWBXD (n =48) and were instructed to take 6 gm 2 times per day of TWBXD for a period of 4 weeks.; assigned to SZRT (n = 48) and were instructed to take 6 gm 2 times per day of SZRT for a period of 4 weeks.; 1/10 TIAN WANG BU XIN DAN assigned to placebo (n =32) and were instructed to take 6 gm 2 times per day of placebo for a period of 4 weeks.
Other intervention name(s): TWBXD; STRT; P
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Suan-Zao-Ren Tang; Tian-wang-bu-xin-dan; Traditional Chinese Medicine; Herbs; Quality of life
Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans
Condition: Stress Disorders, Posttraumatic; PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive
      therapy control group.
    


Intervention name(s): MBSR
Intervention type(s): Behavioral
Intervention description(s): Mindfulness Based Stress Reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to learn about the safety, effects, and tolerability of
      the study medicine (sisunatovir).

      This study is looking for healthy adult participants who meet the following criteria:

        1. Males age 18 to 55 years

        2. All fertile participants must agree to the use of highly effective contraception

        3. Body mass index (BMI) of 18 to 32.0 kg/m2; body weight of 55.0 to 100.0 kg.

        4. Participants who are overtly healthy as determined by medical evaluation. This includes
           medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG
           (electrocardiogram), and laboratory tests.

      This study will enroll up to 10 participants. All study participants will receive 1 dose of
      sisunatovir by mouth. The study duration is expected to be about 9 weeks. This includes a
      28-day screening period, 16-day inpatient stay, and 2 overnight follow-up visits, if needed.
    


Intervention name(s): 200 mg RV521/78 µCi [ 14C]-RV521.
Intervention type(s): Drug
Intervention description(s): 200 mg RV521/78 µCi [ 14C]-RV521
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment