bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Different Strategies for Titrating a High MAP on Microcirculation
Condition: Septic Shock; Hypertension
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      Assess the effect of fluids and norepinephrine for mean arterial pressure titration to
      patients' usual level on the microcirculation of initial resuscitated hypertensive septic
      shock patients.
    

Detailed description: 
      Microcirculatory dysfunction plays an important role in the development of organ failure in
      patients with septic shock. Numerous studies focus on the effect of mean arterial pressure
      (MAP) titration on microcirculation, however, by what strategy is better for microcirculation
      in septic shock patients with previous hypertension is still a matter of debate. The goal of
      this study was to assess the effect of different strategies for MAP titration to
      individualized level on microcirculation in hypertensive septic shock patients.
    

Intervention name(s): Norepinephrine; Crystalloid
Intervention type(s): Drug; Drug
Intervention description(s): Norepinephrine infusion to titrate MAP to usual level; Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one.
Other intervention name(s): NE group; Fluid group
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: septic shock; microcirculation; norepinephrine
Enhancing Family Based Treatment of Childhood Obesity Through Social Networks
Condition: Child Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that
      will be integrated into a standard treatment program for childhood overweight. The
      investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its
      effectiveness compared with historical controls who received standard treatment. The
      historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use
      of Strategies; NCT00746629).
    


Intervention name(s): Social Network Engagement+Std Treatment; Standard Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)
Other intervention name(s): SNE; FOCUS Intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; child; weight management; behavioral; social networks; social support
Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation
Condition: HMG COA Reductase Inhibitor Adverse Reaction
Study type: Interventional

Summary: 
      This proposal will explore muscle function (strength and endurance) in men and women
      suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle
      symptoms will be explored. Also, the investigators will assess the potential usefulness of
      vitamin D supplementation in a randomized control trial.
    

Detailed description: 
      Statins are a class of drugs that are widely prescribed to lower blood cholesterol levels.
      Although they have few side effects, many patients report muscle pain, cramps, and weakness
      when using these drugs. We know very little on the real impact of these muscle symptoms on
      patient quality of life, especially in relation to muscle strength and endurance.

      Patients under statin therapy will stop medication for 2 months. Results from blood sample,
      muscle function and muscle biopsy (in some participants) will be compared with baseline.
      Participants will then take vitamin D supplementation or placebo for one month. Thereafter,
      statin will be reintroduced for two months while continuing vitamin D or placebo
      supplementation. At the end of that time, measures from blood sample, muscle function and
      muscle biopsy will be compared with other visits.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.; Participants will receive placebo (lactose 100 mg) for 3 months.
Other intervention name(s): Cholecalciferol, D-tabs
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: statins; side effects; muscle; vitamin D; biopsy; strength; fatigue
Digital Storytelling in Pediatric Safe Drug
Condition: Education; Nursing; Innovativeness
Study type: Interventional

Summary: 
      Summary Aim: This research was conducted to determine the effectiveness of education given to
      students using digital storytelling in safe pediatric intravenous drug administration.

      Method: It is a randomized controlled experimental study. The sample of the study consisted
      of 84 nursing students. The students included in the study were divided into two equal
      groups: the experimental and control groups. Digital education material of the experimental
      group and theoretical education was applied to the control group. Before and after the
      training, a post-knowledge test was made and evaluated.
    


Intervention name(s): Digital Education Group
Intervention type(s): Other
Intervention description(s): Providing training on safe pediatric intravenous drug administration with digital storytelling method
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The research was a randomized controlled, experimental study.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Nursing students; Education; Digital stroytelling; pediatrics; safe drug application
The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
Condition: Aneuploid Oocytes
MeSH terms: Aneuploidy
Study type: Interventional

Summary: 
      A pragmatic, multicentre, randomized double-blind controlled trial with an intention-to-treat
      analysis, of the use of preimplantation genetic screening (PGS) for aneuploidy by means of
      microarray comparative genomic hybridization (CGH) for the chromosomal analysis of the polar
      bodies (PB) of oocytes collected after ovarian stimulation for in vitro fertilization (IVF),
      and with the intention to assess the genetic competence of oocytes of advanced biological
      age, and the effect of this technique on reproductive outcome.
    


Intervention name(s): Polar Body Biopsy
Intervention type(s): Other
Intervention description(s): PB biopsy (PBB) will be performed between 9 and 12 hours after ICSI using laser or the mechanical procedure. PB1 and PB2 will be removed simultaneously (both at the same time) and transferred to different tubes for the chromosomal analysis.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Screening
Keywords: aneuploid oocytes; ICSI; IVF; Polar Body Biopsy
Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
Condition: Allodynic Symptoms; Localized Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on
      allodynic symptoms of localized neuropathic pain after knee surgery.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial
      comparing 5% lidocaine medicated plaster (5LP) and placebo whether neuropathic pain symptoms
      (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological
      improvement with 5LP compared to placebo. Pain intensity and pain relief, sleep and quality
      of life and osteoarthritis severity are also assessed.
    

Intervention name(s): Lidocaine; placebo plaster
Intervention type(s): Drug; Other
Intervention description(s): The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery; This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing 5% lidocaine medicated plaster (5LP) and placebo whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo. Pain intensity and pain relief, sleep and quality of life and osteoarthritis severity are also assessed.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Localized Neuropathic pain; 5% lidocaine medicated plaster; Knee surgery
Attention, Teleconferencing and Social Anxiety
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      This study involves completing some online assessments and an intervention for social anxiety
      that all involve interactions with other people on a teleconferencing call.
    


Intervention name(s): Experimental: Attention Guidance + Exposure; Active Comparator: Exposure Alone; Experimental: Attention Control + Exposure
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive a brief standardized psychoeducation module, presented via a video recording.
Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.
Between speeches participants will have a 1-minute break.
Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.
The experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.; Participants will receive a brief standardized psychoeducation module, presented via a video recording.
Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.
Between speeches participants will have a 1-minute break.
Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.; Participants will receive a brief standardized psychoeducation module, presented via a video recording.
F
Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.
Between speeches participants will have a 1-minute break.
Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.
The experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lifestyle Intervention of Obese Teenagers (LITE) Program
Condition: Adolescent Obesity; Lifestyle Intervention
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Background: Family-based lifestyle intervention programmes have been known to reduce
      overweight and improve cardiovascular risk in adolescent obesity [1]. This study was designed
      to address the gap in service provision of a family based weight management program for
      overweight and obese adolescents. The LITE (Lifestyle Intervention for obese teenagers) group
      program is a 6-month, family-based behavioural lifestyle intervention, specifically designed
      to treat obesity in adolescents 10-16 years referred to the Weight Management Clinic. The
      main principles underpinning LITE program are that parents are identified as the agents of
      change responsible for implementing lifestyle change in the family .

      Methods: The study design is a two-arm randomized controlled trial that recruited 60
      overweight and obese adolescents 10-16 year olds that attended Kandang Kerbau Women and
      Children's Hospital(KKH) weight management clinic. Adolescents with secondary cause for
      obesity are excluded. Participants are randomized to LITE program with usual care or usual
      care.

      Briefly, the LITE program involves four x 180 min weekly sessions, followed by three x 90 min
      monthly sessions, for adolescents and parents. The key aspects covered in the LITE program
      are in keeping with Health Promotion Board guidelines for the management of overweight and
      obesity and include healthy food choices and eating patterns, increasing physical activity
      and reducing sedentary behavior. The parenting aspects aim to support and increase parental
      capacity to implement and maintain the lifestyle changes. The program takes a solution
      focused approach with families identifying small changes that they would like to try each
      week instead of a child-centric approach.

      Outcome measurement are assessed at 3 and 6 months post baseline and include anthropometric
      measurements, physical activity, dietary intake, metabolic profile, improvement in positive
      parenting behaviour and measurement of family support.

      Primary outcome is change in body mass index (BMI) z-score at 6 months. Secondary aim is to
      evaluate the changes in waist-height ratio and fat percentage change and improvement in
      positive parenting behaviour.
    


Intervention name(s): LITE Program and Usual Care; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Family based lifestyle Intervention; Usual care consisting of 3 visits to weight management clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One arm will be randomised to usual care The experimental arm group will be randomised to usual care and LITE program
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)
Condition: Atherosclerotic Vascular Disease
MeSH terms: Vascular Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose
      Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.
    


Intervention name(s): atorvastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.; Participants will be asked to self-administer one tablet of placebo to atorvastatin 10 mg or 80 mg at approximately the same time each day.
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness of an Investigational use of an
      allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a
      nasal spray that contains no medicine). In addition, the study will also compare the safety
      and effectiveness of an investigational use of another allergy medication (MP03-36) used to
      treat perennial allergic rhinitis to placebo.
    

Detailed description: 
      in Children Ages >6 to <12 with Perennial Allergic Rhinitis (PAR)
    

Intervention name(s): Azelastine hydrochloride nasal spray 0.15%; Azelastine hydrochloride nasal spray 0.10%; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks; 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks; 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Other intervention name(s): Astepro 0.15%; Astepro 0.10%
Intervention MeSH terms: Azelastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and distribution and
      elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition
      its effects on some inflammatory parameters will be measured in presence or absence of
      lipopolysaccharide stimulation.
    


Intervention name(s): Monoclonal antibody
Intervention type(s): Biological
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Serum Biomarkers Associated With Postpartum T2DM in Women With GDM
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      Gestational diabetes mellitus (GDM) is commonly linked to the development of type 2 diabetes
      mellitus (T2DM). There is a need to characterize metabolic changes associated with GDM in
      order to find novel biomarkers for T2DM.
    

Detailed description: 
      GDM, a common complication of pregnancy, affects 17.8% of pregnancies worldwide per year.
      Women with a history of GDM have an approximately 7-fold higher risk for developing T2DM in
      the future than women without GDM. However, data on the factors associated with the
      development of T2DM in women with GDM are not widely available.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        GDM Women.
      
Keywords: GDM; T2DM; NGT; lipids
To Investigate the Safety and Efficacy of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the intraocular pressure (IOP)-lowering effect and safety of DE-104 ophthalmic
      solution in patients with Primary Open-Angle Glaucoma or Ocular Hypertension
    


Intervention name(s): DE-104 ophthalmic solution; DE-104 vehicle
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ophthalmic Solutions
Changes in Physical, Cognitive and Emotional Function 5 and 10 Years After Aneurysmal Subarachnoid Hemorrhage (aSAH)
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      The current study is a continuation of the study "Effect of early rehabilitation in patients
      with acute aSAH" which was approved by the Regional Committee for Medical Research Ethics,
      South-East Norway, archive number 2011/2189, Clinical Trials number 0925-0586 (Clinical
      Trials gov. identifier NCT01656317). The original study was a prospective, controlled,
      interventional study comprising patients managed at the neuro-intermediate ward following
      repair of a ruptured intracranial aneurysm in 2011-2012. 157 patients signed the informed
      consent form and were included in the study. Patients were assessed in the acute phase, as
      well as a 3 and 12 months post ictus. The main research goal of the present study will be to
      assess physical, cognitive and emotional function 5 and 10 years after aSAH in the 2011-2012
      population. In addition we will also describe quality of life and work-status along with the
      time-course of recovery from the acute sage after aSAH to the chronic phase.
    


Intervention name(s): Clinical follow-up
Intervention type(s): Behavioral
Intervention description(s): All included patients will have a clinical follow-up consisting of:
A medical examination
Quality of life questionnaires
Neuropsychological test
All instruments have been translated into Norwegian and validated and tested in clinical practice.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated for aSAH at Oslo University Hospital in 2011-2012
      
Keywords: Cognitive function; Quality of Life
Regulation of Sterol Homeostasis
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Observational

Summary: 
      The purpose of this study is to determine how people with high triglycerides metabolize and
      absorb bile acids, compounds made in the body from cholesterol.

      This project has two objectives: A) To define the mechanism of impaired bile acid absorption
      in hypertriglyceridemia (specifically we will determine if the active or passive component of
      absorption is abnormal) and B) to determine the contribution of an alternative pathway of
      bile acid synthesis which begins with 27-hydroxylation of cholesterol. Because 27-hydroxylase
      is present in endothelial cells as well as liver, this pathway may play a role in removal of
      cholesterol from incipient atherosclerotic plaque.
    


Time perspective: Prospective
Keywords: triglyceride; bile acids; cholelithias
Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
Condition: Mild to Moderate Skin Laxity Under the Chin; Mild to Moderate Skin Laxity on Neck
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in
      Chinese patients
    


Intervention name(s): Microfocused ultrasound with visualization
Intervention type(s): Device
Intervention description(s): All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.
Other intervention name(s): Ultherapy®
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment