bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to evaluate the pharmacokinetics, tolerability, and safety of
      exenatide once weekly suspension in both healthy subjects and in subjects with type 2
      diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development
      of this exenatide once weekly presentation would eliminate the need to reconstitute the
      product prior to use.
    


Intervention name(s): exenatide once weekly; exenatide once weekly; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): subcutaneous injection, 10.0 mg, single injection; subcutaneous injection, 2.0 mg, once a week for 12 weeks; subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetes; exenatide once weekly; Byetta; Amylin; Lilly
Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
Condition: Persistent Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the efficacy, safety and tolerability of omalizumab, compared to
      placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic
      asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4
      therapy.
    


Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.; The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: omalizumab; asthma; immunoglobulin E; IgE
The Prognostic Value of Lactate is Different Among Septic Patients
Condition: Sepsis; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host
      response to infection. Early diagnosis of sepsis and identification of more severe sepsis is
      important to improve the outcomes .Therefore, reliable markers are required to early identify
      the high-risk patients. Currently, lactate is widely applied as the marker for evaluating the
      severity of sepsis and for outcome predicting. DM affects lactate balance and raised baseline
      lactate. The objective of this study was to compare the different prognostic value of
      admission lactate for sepsis patients with or without DM.
    

Detailed description: 
      Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host
      response to infection. Early diagnosis of sepsis and identification of more severe sepsis is
      important to improve the outcomes .Therefore, reliable markers are required to early identify
      the high-risk patients.

      Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and
      for outcome predicting.Nevertheless, the value of lactate for predicting sepsis is still
      controversial.The reasons for the different cutoff value may be due to the fact that sepsis
      is a heterogeneous disease which has already been defined by a number of clinical, laboratory
      and radiologic criteria, rather than specific pathologic findings. Therefore, we hypothesized
      that the discrepancy clinical value of lactate may be resulted from the heterogeneous feature
      of sepsis.

      DM affects lactate balance and raised baseline lactate. The objective of this study was to
      compare the different prognostic value of admission lactate for sepsis patients with or
      without DM.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Septic patients were recruited with lactate level obtained, and admission to the intensive
        care unit (ICU) .
      
Keywords: hyperlactatemia
Effects of Acupuncture as Adjunctive Therapy in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Acupuncture
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study aims to determine the effect of acupuncture as an adjunctive therapy on
      homeostasis model assessment-insulin resistance (HOMA-IR) and health-related quality of life
      (HRQoL) in patients with type 2 diabetes mellitus.
    

Detailed description: 
      This is a randomised, double-blind, placebo controlled and parallel design trial.
      Participants will be randomized to either acupuncture (n=30) or placebo (n=30) using a 1:1
      ratio. The permuted blocks with a block size of 2 will be used. Both groups will continue
      with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of
      recruitment (baseline) and after completion of 10 sessions (week 7) of the treatment.
      Secondary outcome of HRQOL will be measured at the time of recruitment (baseline), after
      completion of 5 sessions (week 3/4) and 10 sessions (week 7) of the treatment while outcomes
      of body mass index and waist circumference are measured at the time of recruitment (baseline)
      and after completion of 10 sessions (week 7) of the treatment. Any adverse event will be
      recorded at every visit. The sequence generation and allocation will remain concealed from
      the patient and practitioner.
    

Intervention name(s): SEIRIN PYONEX Acupuncture Needles; PYONEX Placebo
Intervention type(s): Device; Other
Intervention description(s): 10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks.; Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Acupuncture; Randomized controlled trial
Gaining Real-Life Skills Over the Web
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Gaining Real-life Skills Over the Web (GROW) is an online parenting-skills intervention for
      caregivers of children aged 0-4 who sustained traumatic brain injuries. GROW is designed to
      promote family and child coping and adjustment for caregivers.
    

Detailed description: 
      This project develops and evaluates an online learning environment of web-based intervention
      modules designed to promote family and child coping and adjustment (GROW: Gaining Real-life
      Skills Over the Web) based on a comprehensive needs assessment of children aged 0 to 14 years
      old, who experienced a traumatic brain injury (TBI) between the ages of 0 to 4 years, and
      their families. The incidence of TBI peaks between the ages 0 to 4 years, yet there are no
      evidenced-based interventions to facilitate neurocognitive development and socio-emotional
      functioning of children injured during this critical development period. To address the unmet
      need of caregivers of infants and toddlers with TBI, the project uses a three-phase
      development process to generate proof of concept and initial proof of product. Phase 1
      involves a comprehensive needs assessment that includes quantitative assessment of family and
      child needs, qualitative assessment through focus groups and interviews of families, feedback
      from family and professional advisory boards, and consultation with professionals
      implementing interventions with similar populations (e.g., families of children with very low
      birth weight). During Phase 2, the project develops the content and manual for the
      intervention modules, designs the online learning environment, and conducts intensive,
      iterative usability testing. Phase 3 involves a pilot of the GROW program with 20 families to
      evaluate its usability, acceptability, and qualitative and quantitative impact on stakeholder
      identified outcomes.
    

Intervention name(s): Positive Parenting Intervention
Intervention type(s): Behavioral
Intervention description(s): The highly interactive GROW Program consists of 5 core modules and 1 optional, supplemental session. Each session is expected to take 15-20 minutes to complete, and at the end of each module, parents record a 5 minute "special play time" video interacting with their child to demonstrate the skills they learned in the session. Each online module is followed by a meeting with a trained therapist who will discuss their "special play time" video and the skills they are learning. Parents make their way through the 5 core modules sequentially before accessing the supplemental session that may be relevant to them.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Parent-Child Relations; Parenting
Platelet Dysfunction in Blood Donors
Condition: Platelet Dysfunction in Blood Donors
MeSH terms: Blood Platelet Disorders
Study type: Interventional

Summary: 
      Platelets are circulating blood cells. They bind to each other and to the damaged vessel wall
      to prevent excessive bllod loss. Unlike quantitative platelet defects, there is no automated,
      simple test to diagnose qualitative platelets defects. However, these defects expose to
      bleeding in a surgical situation and could explain the transfusion inefficiency of some
      platelet concentrates.

      In recent decades, considerable progress has been made in understanding qualitative platelet
      disorders.

      In this project, we propose to submit blood donors to a standardized hemorrhagic diathesis
      questionnaire and to compare the prevalence of platelet function abnormalities in blood
      donors with and without hemorrhagic diathesis.
    

Detailed description: 
      Primary objective specify the prevalence of qualitative platelet disorders in blood donors
      with i) a clinical history of bleeding diathesis collected through a standardized and
      validated questionnaire ii) and / or a hematoma (more than 4 cm) that occurred during blood
      donation.

      Secondary objectives to obtain the prevalence of other defects of hemostasis
    

Intervention name(s): sample
Intervention type(s): Biological
Intervention description(s): confirmation of platelet dysfunction
Other intervention name(s): questionnary to obtain an hemorrhagic score
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective case control
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: platelets; bleeding
Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life
Condition: Trans Epidermal Water Loss
Study type: Interventional

Summary: 
      The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits
      even more vulnerability to the environment due to poor self regulatory heat mechanisms,
      paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight
      as water loss from their skin during the first week of life. Many strategies have been
      utilized by neonatologists to decrease this water loss. Edible coconut oil application on the
      skin acts as a non permeable barrier and can help in achieving this. Hence the investigators
      decided to undertake this study to objectively assess the reduction in water loss from skin
      after oil application.
    


Intervention name(s): Coconut Oil Application
Intervention type(s): Procedure
Intervention description(s): Coconut oil - 4 ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preterms; Coconut Oil application; Trans epidermal water loss; Weight gain
Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation.
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      Recently, 4 mm long implants with a standard diameter have been used for the restoration of
      the posterior edentulous mandible with favorable results. However, randomized clinical trials
      reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants
      placed in the posterior regions of the maxilla have not been published yet. The aim of the
      present study will be to compare the survival and success rates of 4 mm implants used as
      distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm)
      implants placed in association with a bilateral sinus floor augmentation procedure
    

Detailed description: 
      Two groups will be randomly prepared, the Short group and the Standard group. In the Short
      group, one 4 mm long and 4.1 mm in diameter implant (extra-short implant) will be installed
      in each side of the posterior region of the maxilla. In the Standard group, bilateral sinus
      floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in
      diameter implant (standard implant) will be installed into each augmented sinus. In the
      frontal region, four 10 mm long implants will be installed in both groups. Clinical
      assessments and x-rays will be taken at prosthesis delivering (6-8 weeks after implant
      installation), and after 6, 12, 18 and 24 months.
    

Intervention name(s): Placement of extra short implants; maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation; placement of standard implant
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): placement of an extra short implant in the posterior edentulous ridge; placement of standard implant in the posterior edentulous ridge after maxillary sinus augmentation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups will be randomly prepared. The Short group, one 4 mm long and 4.1 mm in diameter implant (Short implant) will be installed in each side of the posterior region of the maxilla. The standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (Standard implant) will be installed into each augmented sinus.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.
Condition: Elective Off-pump Coronary Artery Bypass Grafting
Study type: Observational

Summary: 
      In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with
      relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that
      previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might
      be related to time delay issues and to the measurement technology.

      42 consenting patients undergoing elective off-pump coronary artery bypass grafting were
      included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead
      for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed
      just above the eyebrows, and the sensors of the other monitor were placed just above the
      former sensors. The sensors placement was determined at random by a computerized
      randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All
      variables were recorded continuously. The study ended at the end of the operation.
    


Intervention name(s): Relative and absolute cerebral oxygen saturation (rScO2) measurements.
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective off-pump coronary artery bypass grafting.
      
Keywords: bypass grafting
Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy
Condition: Tonsillectomy
Study type: Interventional

Summary: 
      This study will evaluate whether lowering the default number of doses for opioid
      prescriptions written in an electronic health record system can decrease opioid prescribing
      without causing unintended consequences such as worsened pain control.
    


Intervention name(s): Default setting intervention
Intervention type(s): Behavioral
Intervention description(s): The new default settings will be implemented only for patients in the experimental arm.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Default settings; Opioid prescribing; Electronic Health Record; Opioid; Opioid Use; Behavioral intervention
Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma
Condition: Recurrent Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence
Study type: Observational

Summary: 
      This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of
      recurrent hepatocellular carcinoma (HCC).
    

Detailed description: 
      The investigators conducted a prospective study of 64 patients who were diagnosed with
      recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center
      from June 2014 to November 2014; 31 patients were enrolled in the laparoscopic group and
      underwent complete laparoscopic resection of HCC, and 33 patients were enrolled in the
      control group and underwent open surgical resection. The operation time, intraoperative blood
      loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain
      scores, postoperative time until the patient could walk, postoperative time until the patient
      could pass gas, hospital stay, and inpatient costs were compared between the two groups. The
      patients were followed up for one year after surgery, and the relapse-free survival was
      compared between the two groups.
    

Intervention name(s): laparoscopic resection
Intervention type(s): Procedure
Intervention description(s): The surgical instruments used for the laparoscopic group included conventional laparoscopic instruments (three 5 mm trocars, two 10 mm trocars, and two damage-free laparoscopic clamps), the STORZ high-resolution laparoscopic operating system (Germany), the GEN300 ultrasonic scalpel system (Johnson & Johnson, USA), a laparoscopic linear cutter stapler (Johnson & Johnson, USA), a laparoscopic ultrasound device, LigaSure, bipolar coagulation, titanium laparoscopic clips, and absorbable hemostatic gauze.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun
        Yat-sen University Cancer Center from June 2014 to November 2014
      
Keywords: laparoscopic; hepatocellular carcinoma; recurrence
Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which surgical method is better for anterior
      cruciate ligament teas in outcomes.
    

Detailed description: 
      The anterior cruciate ligament (ACL) is one of the most commonly injured ligaments of the
      knee. This study was conducted to determine whether the outcome of treatment is superior in
      early surgical reconstruction compared with optional delay reconstruction.
    

Intervention name(s): early reconstruction; delay reconstruction
Intervention type(s): Procedure; Procedure
Intervention description(s): patients underwent < 8 weeks reconstruction after injury; patients underwent > 8 weeks reconstruction after injury
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anterior Cruciate Ligament,Early,Delay,Reconstruction
Effect of a Fermented Dairy Food With Probiotics on Mental Performance
Condition: Cognitive Change
Study type: Interventional

Summary: 
      Single-center, randomized, double-blind, placebo-controlled clinical study with two study
      groups.

      One group will consume a product with functional ingredients and the other group will consume
      a placebo product. will consume a placebo product.
    

Detailed description: 
      When individuals are included in the study they will be randomized in equal proportion to one
      of the 2 groups of the study. The randomization will be stratified by age taking into account
      2 strata (1:1). The first stratum corresponds to an age range of 18 to 40 years and the
      second stratum to an age range of 41 to 60 years.

      The subject must consume the product for 8 weeks and will have a visit 4 weeks later as a
      follow-up of the study.

      At the visits the subject will perform a series of cognitive tests and the intestinal
      microbiota will be evaluated.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fermented milk product containing a probiotic; Product with identical characteristics to the experimental product.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Probiotic; Fermented milk