bioihbjkbjnl/mcl2 huggingface dataset:
Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis
Condition: Cardiovascular Mortality
MeSH terms: Calcinosis
Study type: Interventional

Summary: 
      Research proposal to evaluate the impact of different phosphate binders on the progression of
      cardiovascular calcification and QT dispersion in new haemodialysis patients.
    

Detailed description: 
      The risk of developing cardiovascular diseases in patients on hemodialysis is higher than in
      general population. Higher levels of serum phosphate are associated with adverse
      cardiovascular outcomes, especially in the setting of overt hyperphosphatemia. Given the
      biological importance of serum phosphorus, it is conceivable that also within the normal
      range values the higher serum phosphate levels may be associated with the worst outcome.
      Several paper have shown that vascular calcifications in dialysis patients are associated
      with increased relative risk of death; it has also been demonstrated in uremic patients that
      vascular calcifications decrease arterial elasticity. We previously observed that vascular
      calcification directly correlate with QT interval (QTc) as well as QT dispersion (QTd) in
      dialysis. Also, QT correction (obtained by the correction of phosphoremia and dyslipidemia)
      can ameliorate the development of arrhythmia and sudden death. Aim of this study is to
      evaluate the relationship between vascular calcifications and both QTd increase and mortality
      in incident hemodialysis patients, and to investigate the efficacy of sevelamer to reduce
      vascular calcifications and QTd.
    

Intervention name(s): sevelamer phosphate-binders; Calcium Carbonate
Intervention type(s): Drug; Drug
Intervention description(s): 1600 mg/day for 2 years; Calcium carbonate 1 g/day for 2 years
Other intervention name(s): Renagel
Intervention MeSH terms: Calcium Carbonate; Calcium; Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: QT interval; QT dispersion; arrhythmias; death; TC score
Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized, prospective trial is to determine wether (a) a once weekly
      glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated
      haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic
      patients on conventional insulin treatment.
    

Detailed description: 
      The design is an open, prospective, randomised, multicentre parallel group study. The total
      duration will be 5 years with patient recruitment over 4 years and an individual observation
      period of 1 year. 300 participants from 43 study centres, hospitals and private practices
      were recruited. The study will run for one year and aims to determine, whether there is an
      advantage with regard to HbA1c levels when (a) a regular three-monthly HbA1c or (b) a weekly
      4-point glucose profile is taken and reported.

      After screening, patients will be assigned at random to one of the following study arms:

        1. no regular blood-glucose self-monitoring, no regular HbA1c

        2. regular blood glucose self monitoring, no regular HbA1c

        3. no regular blood glucose self monitoring, regular HbA1c

        4. regular blood glucose self monitoring, regular HbA1c

      The control for all participants is that urinary glucose should be monitored at least once a
      day, preferably in the late morning, as the highest increase in plasma glucose level occurs
      after breakfast.
    

Intervention name(s): weekly blood glucose profile; three-monthly haemoglobin A1c; no blood-glucose self-control
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): once daily self-control of urinary-glucose; once daily self-control of urinary-glucose; once daily self-control of urinary-glucose
Intervention MeSH terms: Chrysarobin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diabetes control; glycated haemoglobin; blood-glucose-self-monitoring; type 2-diabetes; conventional insulin therapy
Revival Active Program for Adolescents With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Active play and sports has shown to be effective intervention in managing depression.
      Extending the support with Mind body therapy, Revival Active Program was designed as an early
      intervention for adolescents.

      To measure the efficacy and feasibility of the community based revival active play
      intervention for adolescent depression, present pilot study was undertaken.
    


Intervention name(s): Revival Active Program
Intervention type(s): Other
Intervention description(s): Program comprised of physical activities, group play, mind games, reasoning and discussion on sleeted topics, breath work and relaxation techniques, 60 minutes all together.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Adolescent; Revival Active Program
Atopy Patch Test in Children With Atopic Dermatitis
Condition: Atopic Dermatitis; Food Allergy
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Food Hypersensitivity
Study type: Observational

Summary: 
      Positive reactions in atopy patch test in children with atopic dermatitis.
    

Detailed description: 
      The prevalence of food allergy seems to be increasing, which might explain the increased
      demand for reliable evaluation of patients with suspected food-related gastrointestinal
      symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the
      clinical practice. APT seems to have a better specificity than the IgE methods and seems to
      reflect late-phase clinical reactions.The aims of this study were to evaluate:

      (i) The prevalence of positive reaction of APTs for atopic dermatitis (ii)Positive reaction
      of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs
      commercially available food extracts. (iv)Side effect or adverse
    

Intervention name(s): atopic patch test
Intervention type(s): Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children with atopic dermatitis
      
Keywords: atopic dermatitis; atopic patch test
Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      Children are admitted in intermediate units when the severity requires continuous monitoring.
      In France, Resources allocated to intermediate units are determined from lists of diagnoses
      and associated acts to additional budget. A score to assess the severity of illness may be
      associated with acts to develop an activity indicator easy to use. The investigators have
      chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning
      Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not
      been validated. The correlation between the severity of children and the associated diagnoses
      and acts has not been studied. The main objective of this study is to validate these 2
      scores. The secondary objective is to determine a simplified activity indicator.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children admitted to the paediatric inpatient unit in 7 regional hospitals French
      
Keywords: critical illness; disease progression; child; severity of illness index; monitoring
Efficacy of Bifidus DR10 and Oligo Saccharides / Micronutrient Fortification of Milk
Condition: Diarrhea; Pneumonia; Febrile Illness; Growth; Child Development
MeSH terms: Pneumonia; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or
      with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and
      improvement in growth and development.
    

Detailed description: 
      The 1993 World Bank World Development Report (1) delivered a strong but sad reminder of the
      dramatic scale of suffering and death among preschool children attributable to pneumonia
      (2.7million in 1990) and diarrhea (another 2.5million deaths). In terms of "disability
      adjusted life years" (DALYS) lost, in 0-4 years old children, respiratory infections account
      for 18.5% and 17.6% (in boys & girls respectively) and diarrhea accounts of another 16.2% and
      15.7% respectively. The development of effective interventions to reduce morbidity from these
      illnesses has become a humanitarian, economic and political imperative and essential in
      achieving the morbidity and mortality reduction goals that the "World Summit for Children"
      set a decade ago. Therapy with Oral Rehydration Solution (ORS) for diarrhea, a cornerstone of
      the universal strategy for child survival, has low compliance due to having no effect on
      duration of diarrhea and has mixed impact on child mortality (2-5). Present strategies for
      containing morbidity and mortality due to respiratory infection focuses primarily on
      antibiotic treatment. Increasing prevalence of antibiotic resistant strains, poses a problem
      with the current strategy. Lack of any truly effective and affordable preventive vaccine, for
      both diarrhea and pneumonia has aroused considerable interest in food based preventive
      interventions. In the recent years increasing recognition and evidence regarding the role of
      Probiotics, and micronutrients like Zinc, as both preventive and therapeutic agents against
      infections has made them a potential and promising candidate. This study is in fact two trial
      run concurrently with two milk preparation one fortified with pre and Probiotics and second
      fortified with micronutrients and each having same milk unfortified as control.
    

Intervention name(s): Micronutrient (Zinc and Iron) fortification; Pre and Probiotic fortification
Intervention type(s): Drug; Drug
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Zinc; Iron; Probiotics; Prebiotics; Child health; Milk fortification; Randomized controlled trial
Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
Condition: Mouth Neoplasms
MeSH terms: Mouth Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The poor survival of Veterans with oral cancer underscores the significance of identifying
      new treatment approaches. The proposed studies will test a new 2 pronged immunotherapeutic
      approach for oral cancer patients which lessen the immune inhibitory environment while
      maturing cells that can stimulate T cell reactivity against oral cancer cells.
    

Detailed description: 
      The hypothesis of this study is beneficial T cell reactivity in oral squamous cell carcinoma
      (OSCC) tumors can be synergistically stimulated by blocking suppressor endothelial cells and
      their induction of other inhibitory cell populations while also maturing immune inhibitory
      CD34+ cells into antigen-presenting dendritic cells.

      To test this hypothesis, newly diagnosed OSCC patients will be administered the
      cyclooxigenase 2 inhibitor celecoxib and/or Calcitriol for the 3 week duration between cancer
      diagnosis and surgical treatment. The following aims will test the immunological and clinical
      effectiveness of the combination treatment:

        -  1. To block the suppressive activity of endothelial cells and increase the levels of
           dendritic that are stimulatory to T cell reactivity, thereby synergistically increasing
           intratumoral T cell reactivity. These functional immune analyses will use OSCC tissues
           removed from untreated patients or patients treated with celecoxib and/or Calcitriol.

        -  2. To reduce development of OSCC recurrences by synergistically stimulating intratumoral
           T cell reactivity with celecoxib to block suppressor endothelial cell activity and
           Calcitriol to mature CD34+ suppressor cells into T cell stimulatory dendritic cells.
    

Intervention name(s): Celecoxib; Calcitriol; Celecoxib plus Calcitriol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Celecoxib (400 mg twice daily); 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment); 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
Other intervention name(s): Celebrex; 1,25-dihydroxyvitamin D3; 1,25-dihydroxyvitamin D3
Intervention MeSH terms: Calcitriol; Dihydroxycholecalciferols; Vitamin D; Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Calcitriol; Celecoxib; Immunotherapy
Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effectiveness of autologous fat as a grafting
      material for soft tissue volume augmentation of localized horizontal ridge defects in humans.
    

Detailed description: 
      A total of 20 patients having 26 localized horizontal ridge defects were recruited for the
      study from the patient pool at the dental clinics of the faculty of dentistry, Alexandria
      University. Ridge defects were divided into two parallel groups:

      Test group: localized ridge defects were augmented using autologous fat grafting Control
      group: localized ridge defects were augmented using conventional subepithelial connective
      tissue graft.
    

Intervention name(s): Autologous fat grafting; Sub-epithelial connective tissue graft
Intervention type(s): Other; Other
Intervention description(s): A fat graft will be aspirated from the abdomen under local anaesthesia and processed using the Microfat grafting technique. Afterwards the fat graft will be injected in the previously created pouch at the recipient site. Then the pouch will be closed using interrupted sutures 5-0 vicryl.; A subepithelial connective tissue graft of a size that corresponds to that of the defect will be harvested from the palate using the trap door technique. The donor site will be closed using cross horizontal sling sutures and interrupted sutures 4-0 vicryl. Subsequently, the graft will be inserted in the previously created pouch at the recipient site and secured to the flap using vicryl sutures 5-0. Then the pouch will be closed using interrupted sutures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This non-inferiority study was designed as a randomized controlled clinical trial including 26 localized horizontal ridge defects that were equally allocated (1:1) into one of two parallel groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Naltrexone as Adjunct in Alcoholic Cocaine Dependent Patients - 4
Condition: Alcohol-Related Disorders; Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders; Alcohol-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate naltrexone as an adjunct in alcoholic cocaine
      dependent patients; concurrent relapse prevention theory.
    


Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Primary purpose: Treatment
Keywords: alcohol dependence
Use of Fissure Sealants on Primary Molars
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      Sealants have been shown to be the most effective caries preventive measure in permanent
      dentition. Sealants of the primary molars soon after they erupt would reduce the total caries
      experience of the primary teeth of the children and could possibly also postpone the caries
      process in the permanent dentition.

      The aim of this study is to measure the caries preventive effect of sealants in primary
      molars. The specific objectives are: 1) to compare the number of new caries experience teeth
      and surfaces among the intervention group of 4-years old pre-school children during the 1
      year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish
      on the caries experience on the occlusal surfaces of the primary molars and on the total
      caries experience of all the primary and permanent teeth, 3) to test the feasibility of the
      sealant program in one kindergarten in Kuwait city.
    


Intervention name(s): Fissure sealant; Fissure sealants and fluoride varnish
Intervention type(s): Other; Other
Intervention description(s): Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.; Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars
Other intervention name(s): Brand name: Clinpro™ Sealant; Produced by: 3M ESPE; www.3MESPE.com/PrventiveCare; Brand name: DuraShield® 5% Sodium Fluoride Varnish; Produced by: Sultan Dental Products; www.sultandental.com; ClinproTM (3M ESPE); DuraShield® (Sultan Healthcare)
Intervention MeSH terms: Fluorides; Sodium Fluoride; Fluorides, Topical
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dental caries; Fissure sealant; Fluoride varnish; Primary molar
Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)
Condition: Asthma, Bronchial; Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the protective effect of an approved medication on
      asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure
      to cats.
    

Detailed description: 
      The duration of treatment is 2 weeks.
    

Intervention name(s): MK0476, montelukast sodium; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Rhinitis, Allergic
Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)
Condition: Appendicitis; Children
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a patient activation tool (PAT) can improve
      decision making and patient centered outcomes in pediatric patients with appendicitis and
      their caregivers choosing between antibiotics alone and appendectomy.
    

Detailed description: 
      The objective of this study is to to determine if a patient activation tool (PAT) can improve
      decision making and patient centered outcomes in pediatric patients with appendicitis and
      their caregivers.

      Hypothesis: A PAT that activates patient-caregiver dyads will improve decision making and
      patient centered outcomes without compromising medical outcomes in children with
      appendicitis. Specifically,the investigators expect the PAT to improve decision self-efficacy
      and healthcare satisfaction without increasing disability days.

      Methods/Outcomes: The investigators will perform a randomized controlled trial comparing a
      PAT to standard surgical consultation in patient-caregiver dyads choosing between either
      antibiotics alone or appendectomy for early appendicitis. The investigators will identify
      differences in various components of decision making and patient centered outcomes including
      caregiver decision self-efficacy, preparedness for decision making, decisional conflict,
      decision regret, caregiver activation, caregiver and child satisfaction with care and health
      related quality of life (HRQOL), and caregiver and child knowledge. The investigators will
      also characterize the effects of a PAT on medical outcomes from appendicitis in patients
      receiving the PAT compared to those receiving standard surgical consultation alone. The
      investigators will determine differences in disability days, length of stay, readmission
      rates, and medical complications related to treatment choice (e.g. infection, recurrence).
    

Intervention name(s): Patient Activation Tool
Intervention type(s): Other
Intervention description(s): An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Appendicitis; Pediatric; Children; Non-operative; Antibiotics alone