bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Hemodialysis on Serum Sclerostin Levels
Condition: Diabetes Mellitus; Renal Failure; Hemodialysis Access Failure
MeSH terms: Renal Insufficiency; Diabetes Mellitus
Study type: Observational

Summary: 
      Background: Parathyroid hormone (PTH) and 1,25-dihydroxy vitamin D (1,25-OHD) as well as
      mineral bone metabolism modulators like sclerostin are thought to play an important role in
      in diabetic patients with chronic renal failure. The present study aimed to analyse the
      levels of serum sclerostin before and after hemodialysis which is a primary element of
      treatment in such combined disease states.

      Methods: Serum sclerostin concentrations were measured using a commercially available
      enzyme-linked immunosorbent assay kit with 56 individuals who 14 chronic hemodialysis
      patients with diabetes, 14 chronic hemodialysis patients with non-diabetes and 28 healthy
      volunteers as a control group.
    

Detailed description: 
      Sclerostin results in a phenotype characterized by high bone mass (sclerosteosis) in humans,
      it is produced by osteocytes and chondrocytes, it suppresses osteoblast activity by
      inhibiting canonicular Wnt / β-catenin signal, it is described as an anti-anabolic protein of
      22-kDa size.In diabetes mellitus patients osteoporosis and obesity always create problems,
      increased levels of sclerostin inhibit canonicular Wnt / β-catenin signal and is potentially
      held responsible from bone fragility. Bone problems are important both for chronic kidney
      disease patients and diabetes mellitus patients and in instances where these two diseases
      coexist, the importance of sclerostin as a new marker of bone turnover increases. The
      objective of this study is to evaluate how serum sclerostin levels are affected in diabetes
      mellitus patients undergoing hemodialysis treatment. To this end, the investigators analyzed
      the levels of serum sclerostin before and after hemodialysis as it is a main element of
      treatment in such combined disease states.
    

Intervention name(s): serum sclerostin
Intervention type(s): Diagnostic Test
Intervention description(s): blood samples obtained
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study was designed with 56 individuals; 28 chronic hemodialysis patients (17 men, 11
        women) receiving treatment at our hospital and 28 healthy volunteers as a control group. Of
        the 28 hemodialysis patients, 14 had Type 2 diabetes mellitus while the other 14 were not
        diabetic.
      
Keywords: Diabetes Mellitus; Renal Failure; Hemodialysis Access Failure; Sclerostin
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This single and multiple ascending dose study is a first in human assessment of PF-06480605.
      The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.
    


Intervention name(s): PF-06480605; Placebo; PF-06480605; Placebo; PF-06480605; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format.; Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.; Subjects will receive three subcutaneous doses of 30, 100, or 300 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).; Subjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).; Subjects will receive three intravenous doses of 500 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).; Subjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Randomized; Double-blind; Placebo-controlled; Dose escalating; Single and Multiple doses; Safety; Tolerability; PK/PD; PF-06480605
Postural Assessment in Plagiocephaly
Condition: Plagiocephaly
MeSH terms: Plagiocephaly
Study type: Observational

Summary: 
      The positional plagiocephaly is a condition involving craniofacial asymmetry. The purpose of
      this study is to evaluate the spine, the posture and the psychomotor state in children who
      were diagnosed with infant plagiocephaly.
    

Detailed description: 
      Positional infant plagiocephaly is a clinical entity in which the shape of an infant's head
      becomes altered as the result of external forces applied to the malleable bones of the
      cranium and can occur pre- or postnatally. It is characterized by asymmetric occipital
      flattening (one side or the central part of the occiput is flattened)with ipsilateral frontal
      bossing.Viewed from above, this results in a parallelogram deformity of the head. We
      hypothesize that children who had plagiocephaly when they were infants, they have postural
      and spine implications at 3-5 years old.
    

Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): The posture, motor development and balance are going to be assessed.
Other intervention name(s): Evaluation; Posture assessment; Psychomotor development
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who were diagnosed by plagiocephaly and a control group.
      
Keywords: Plagiocephaly; Posture; Spine
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in
      pregnant women with short cervical length at 18-22 weeks scan.
    

Detailed description: 
      This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6
      weeks of gestation.
    

Intervention name(s): Silicon ring (Arabin Pessary)
Intervention type(s): Device
Intervention description(s): Placement of a silicon pessary in the vagina, around the cervix.
Other intervention name(s): Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Short cervix; preterm birth; arabin pessary
Child Care Wellness Study on Nutrition and Physical Activity
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The study is an evaluation of a nutrition and physical activity intervention in child care
      centers in NC, CA, and CT.
    

Detailed description: 
      The broad, long term goal is to develop a reproducible nutrition and physical activity
      intervention which utilizes child care consultant nutrition specialists to reduce the risk of
      overweight among children in regulated out-of-home child care. The objectives are:

        1. To train Child Care Health consultants (CCHCs) to become specialists in nutrition
           consultation in child care such that they will increase their daily consultation
           activities on nutrition, physical activity, and childhood overweight,

        2. To increase child care staff and parental knowledge of and positive attitudes toward
           providing healthy foods, appropriate portions of foods, and appropriate levels of
           physical activity for young children in out-of-home child care centers.,

        3. To strengthen child care center policies, procedures, practices and behaviors, regarding
           providing healthy foods, appropriate portions of foods, and appropriate levels of
           physical activity for young children in out-of-home child care centers, and

        4. To improve dietary intake and levels of physical activity, and to prevent increases in
           overweight and the risk of overweight as determined by body mass indexes among children
           in out-of-home child care centers.
    

Intervention name(s): NAP-SACC Child Care Wellness Program
Intervention type(s): Behavioral
Intervention description(s): Nutrition And Physical activity Self-Assessment for Child Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Preloading to Prevent Hypotension During Cesarean Section
Condition: Obstetric Anesthesia Problems
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in
      caesarean section can effectively reduce the incidence of hypotension and fetal
      complications.
    

Detailed description: 
      Spinal anesthesia in the cesarean section often causes significant peripheral vascular
      dilatation, decreases blood pressure and cardiac output reduction which leads to maternal
      nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of
      vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can
      not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In
      the present study, perioperative goal directed fluid therapy is used. The non-invasive
      continuous hemodynamic monitor is used in this study, and the parameters (blood pressure
      (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to
      determine the parameters of the blood transfusion in cesarean section as infusion guidelines.
      The application of Clearsight system to the pre-infusion of target-guided crystalloid
      solution is compared with the infusion of quantitative crystalline solution in the hope of
      reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving
      uteroplacental perfusion and reducing the incidence of fetal acidosis.
    

Intervention name(s): Fluid therapy; Spinal anaesthesia
Intervention type(s): Drug; Procedure
Intervention description(s): Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until ΔSV<5%; Inject marcaine and fentanyl to CSF for anaesthesia
Other intervention name(s): "Ringer's Injection"
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Anesthesia, Obstetric; fluid therapy; cesarean section; spinal anesthesia
Culturally Modified Family Based Therapy for Haitian Youth in South Florida
Condition: Problem Behavior
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The Culturally Modified Family Based Therapy for Haitian Youth and Their Families in South
      Florida study is a unique intervention that will develop and implement a culturally-specific,
      integrated family and individual-based, drug use, sexual risk and delinquency risk reduction
      program for Haitian youth ages 13-17 in Miami-Dade County, Florida.
    

Detailed description: 
      Haitian youth in Miami-Dade County who become part of the juvenile justice system have not
      received culturally appropriate remediating or rehabilitative attention by that system. This
      study will modify a specific variety of intervention, the Culturally Informed and Flexible
      Family-Based Treatment for Adolescents (CIFFTA) for appropriateness in Miami's Haitian
      cultural contexts. This study will develop and implement a culturally specific, integrated
      family and individual-based, drug use, sexual risk and delinquency risk reduction program for
      Haitian adolescents aged 13-17 in Miami-Dade County, Florida.
    

Intervention name(s): Haitian youth and family intervention study: family functioning; Haitian youth intervention study: youth psychoeducational; Haitian family intervention study: family psychoeducational; Diversion Programs
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): A weekly group therapy with the youth, the parents and other members of the family.; Weekly one and one psychoeducational module will be delivered to the youth.; Weekly psychoeducational module will be delivered to the family.; Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of the Healthy Apple Program in San Francisco
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      This randomized controlled trial uses administrative public health screening data to test
      whether the Healthy Apple program (HAP), designed to support local implementation of national
      Let's Move! Child Care guidelines in San Francisco (SF), improves child care center nutrition
      and physical activity practices and child weight change.
    

Detailed description: 
      In the USA, First Lady Michelle Obama started a nationwide child care initiative called
      'Let's Move! Child Care' which aims to improve nutrition and physical activity practices in
      child care centers to promote healthy weight for children ages 0-5y.

      The San Francisco Child Care Wellness Collaborative, including the San Francisco Department
      of Public Health (SFDPH) and SF Children's Council, developed a citywide Healthy Apple
      Program (HAP) to support local implementation of the Let's Move! initiative.

      The San Francisco Department of Public Health (SFDH) has an existing Child Care Health
      Program (CCHP) which provides nurse consultation and health education materials for child
      care centers and annual health screenings for children.

      The aim of this analysis is to see whether child care centers offered the HAP in addition to
      usual CCHP services can improve child care center nutrition and physical activity practices
      and child weight change better than usual CCHP services alone.
    

Intervention name(s): Usual services + HAP; Usual services
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The HAP process includes child care center providers completing a self-assessment(s), setting improvement goals, receiving technical assistance materials, attending topic-specific workshops, improving best practices, re-self-assessment and qualification for a HAP award.; Control condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Water; Physical activity; Child care; Weight change
Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000
      births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery,
      intensive care, and cardiac catheterization have reduced morbidity and early mortality in
      this population. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus
      been significantly increasing. Nowadays, quality of life (QoL) assessment of this population
      is in the foreground. Our team is a reference center in the management of patient with CHD,
      from the fetal period to adulthood. The investigators have been conducting a clinical
      research program on health related QoL in pediatric and congenital heart disease. The
      investigators thus demonstrated the link between cardiopulmonary fitness and QoL in children
      with CHD aged 8 to 18 years, the correlation between functional class and QoL in adults with
      CHD, and the impact of therapeutic education on QoL in children under anticoagulants.
      Currently, no controlled cross-sectional quality of life study assessment has been leaded in
      the youngest children with CHD. This present study therefore extends our work in younger
      children aged 5 to 7 years.
    

Detailed description: 
      248 patients will be enrolled in this study.

      Patient from groups 1 is included during his annual medical check-up. Quality of life
      questionnaire and other examinations are performed during this site visit. Its is a part of
      his usual care. No supplementary visit, directly related to the research, are necessary. 2
      sites will participate to the enrollment, belonging to the French national network for
      complex congenital heart diseases (M3C) .

      Participants (healthy children) from groups 2 are included from schools.The prior agreement
      of the Ministry of National Education was obtained before any procedure related to this
      study. 3 schools will participate to the enrolment
    

Intervention name(s): Quality of life questionnaire
Intervention type(s): Other
Intervention description(s): Self and proxy PedsQL 4.0 questionnaires.
Other intervention name(s): Quality of life questionnaire: Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Groups 1 : Children with congenital heart disease aged 5 to 7 years Groups 2 : Healthy
        children aged 5 to 7 years
      
Keywords: health related quality of life; congenital heart disease; pediatrics; cardiology; PedsQL 4.0; psychometric properties
A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult
      population with a diagnosis of PD. PD is generally treated with benzodiazepines which are
      very effective but have a high risk for addiction, fall, and cognitive impairment. There is
      still a need for better treatment for PD for longer term use. There are other drugs within
      the SSRI/SNRI class which have proven to be effective in treating patients with this
      diagnosis.
    

Detailed description: 
      The primary objective of the study is to evaluate the efficacy of Vortioxetine (5, 10, or
      20mg) over a period of 10 weeks in subjects with PD, with or without Agoraphobia. The
      efficacy of Vortioxetine will be evaluated using the Mean Change from Baseline in the Panic
      Disorder Severity Scale (PDSS) score and the reduction in occurrence of panic attacks as
      measured by item 1 in the PDSS Scale after 10 weeks of treatment with Vortioxetine. This
      study is an open-label, adaptive study with flexible dose strategies lasting 10 weeks.
      Approximately 20 male and female subjects over the age of 18aged 18-60 years who currently
      meet DSM-IV criteria for PD with or without Agoraphobia or who have a PDSS score > 8 at
      Baseline will be enrolled in this study.
    

Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Vortioxetine 5-20mg
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Neuroimaging of Pain Using EEG and fMRI
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      The purpose of this research is to use non-invasive imaging technologies to study how the
      human brain processes pain. The investigators will use contact heat to induce pain and record
      data scalp EEG and functional magnetic resonance imaging (fMRI). What the investigators learn
      from this study will help us gain insights in pain management with broad socioeconomic
      impacts
    

Detailed description: 
      Functional imaging of brain networks associated with pain processing is of vital importance
      to aid developing new pain-relief therapy and to better understand the mechanisms of brain
      function. The pain response in the brain is a complex process, which involves multiple
      cortical brain regions, such as primary and secondary somatosensory cortices, anterior
      cingulate cortex, and insular cortex . Recent advancement in neuroimaging techniques suggests
      the possibility to map the brain structure and networks that involve pain processing.
      Electroencephalography (EEG) is a noninvasive monitoring technique, which is widely used to
      probe neurological disorders with high temporal resolution. Few attempts have been made to
      use EEG to map the active brain regions in pain patients. Functional MRI (fMRI) measures the
      hemodynamic brain response and could image the active brain regions with high spatial
      resolution. Studies have shown that fMRI is a useful tool to delineate the brain regions
      associated with pain processing. Recent studies from simultaneous EEG and fMRI recording have
      suggested that the EEG response to the pain may be correlated with the fMRI response, and
      both EEG and fMRI could be used to image the brain pain processing regions, such as the
      primary somatosensory cortex and anterior cingulate cortex.

      The aim of this research is to develop and evaluate a functional neuroimaging approach using
      EEG, fMRI and EEG-fMRI, in pain study. EEG, fMRI, or simultaneous EEG-fMRI will be collected
      in healthy subjects who receive external thermal stimulation inducing pain. The painful
      stimuli will be delivered at different intensity levels and the subject pain rating will be
      collected. The imaging technique combines the EEG signal with high temporal resolution and
      the fMRI signal with high spatial resolution to obtain a spatiotemporal imaging of the brain
      electrophysiological and hemodynamic activity in response to different levels of pain. Cross
      validation between this method and subject pain score will be used to quantitatively and
      qualitatively evaluate the technique. The successful completion of the current protocol will
      help establish an important imaging technology accessing pain level in an objective way.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects Sickle cell patients
      
Keywords: Sickle Cell