bioihbjkbjnl/mcl2 huggingface dataset:
Probiotic Yoghurt Effect on Experimental Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study was to evaluate the effects of probiotic yoghurt on the development of
      gingival inflammation.

      Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and
      randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt
      containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural
      yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted
      for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data
      (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected
      at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
    

Detailed description: 
      Probiotics are viable bacteria with scientifically confirmed health benefits for
      gastrointestinal system. However, there is paucity of information on its impact in
      periodontal disease. The aim of this study was to evaluate the effects of probiotic yoghurt
      on the development of gingival inflammation.

      Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and
      randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt
      containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural
      yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted
      for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data
      (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected
      at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
    

Intervention name(s): Probiotic Yoghurt; Natural Yoghurt
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic yoghurt consumption; Natural yoghurt consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Bifidobacterium; Gingivitis; Gingival crevicular fluid; Interleukin-1beta; Probiotics
Effect of Energy Density on Liking and on Caloric Adjustment Conditioning
Condition: Conditioning of Caloric Adjustment and Liking in Children
Study type: Interventional

Summary: 
      The main objective is to study, in 8-11 year old children, the influence of energy density
      conditioning on liking for new flavored beverages and on caloric adjustment after the
      beverage consumption. The stability of the energy conditioning was evaluated after a period
      without exposure and after an extinction period during which the energy density of the
      beverages was changed.
    


Intervention name(s): 2 exposures arm; 7 exposures arm
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal).
During a 4-wk conditioning period, children were exposed either 2 times to each beverage.
After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period).; During this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal).
During a 4-wk conditioning period, children were exposed either 7 times to each beverage.
After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: caloric adjustment,liking, flavour nutrient learning, children
Physical Activity Measured Through Accelerometers and Its Association With Endothelial Function in Young Patients With Fontan Physiology
Condition: Heart Defects
Study type: Interventional

Summary: 
      This study will be a cross sectional assessment of physical activity as measured through
      accelerometers and its association with endothelial function of children with Fontan
      circulation and healthy age and gender matched controls who are followed at the University of
      Alberta - Stollery Children's hospital.
    


Intervention name(s): Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days
Intervention type(s): Other
Other intervention name(s): Endothelial function measurements: Digital Thermal Monitoring (DTM) via Vendys (VENDYS-6000, Endothelix Inc., Houston, TX); Endothelial function measurements: Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: congenital
Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in
      comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or
      non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite
      receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70
      mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L)
      for those patients without clinical ASCVD.
    


Intervention name(s): Evinacumab; Matching placebo; Background Lipid Modifying Therapy (LMT)
Intervention type(s): Drug; Drug; Other
Intervention description(s): SC or IV administration; SC or IV administration; All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.
Other intervention name(s): REGN1500
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD
Condition: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of
      ODD in children with ADHD and ODD.
    


Intervention name(s): atomoxetine hydrochloride; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Hemodialysis Catheters
Condition: Kidney Failure, Chronic; Vascular Access Devices
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Observational

Summary: 
      Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading to
      inadequate dialysis dose, need to catheter replacement with as consequence progressive
      exclusion of vascular sites. Thrombolytic agent can be used as therapeutic locking solution
      to dissolve the clotting formed in of around the catheter lumen. There are few studies on the
      optimal approach of TCC-related thrombosis with thrombolytic containing locking solution
      (dose, number of administrations, timing of administration - intra or interdialytic use). The
      primary objective of this retrospective study was to compare the efficacy of inter versus
      intradialytic Urokinase containing locking solution on restoration of the TCC blood flow. The
      investigators also assess the question of multiple administrations of Urokinase are more
      efficient than one single administration
    


Intervention name(s): Urokinase locking solution
Intervention type(s): Device
Intervention description(s): On basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions)
Other intervention name(s): Actosolv
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Incident and prevalent patients on hemodialysis, more than 18y old, receiving dialysis via
        a tunneled cuffed catheter between 1st May 2010 and 31st October 2014.
Smoking Research Study
Condition: Smoking; Non-smoking
Study type: Interventional

Summary: 
      The purpose of this study is to develop a fit-for-purpose biochemical verification tool that
      can be used to detect concomitant use of a few (less than 5) conventional cigarettes.
    

Detailed description: 
      This study will be performed in two parts. The first part, Part A, is a dose titration study
      in healthy smokers with incremental cigarette consumption performed in confinement. The
      second part, Part B, is an observational study on healthy non-smokers in an ambulatory
      setting

      PART A (smokers only)

      A screening visit will be conducted within 4 weeks prior to admission to the investigational
      site. The 8-day confinement period consists of the admission day (Day1), 1 day ad-libitum
      smoking (Day0), 3 days of smoking abstinence (Day1-3), 2-day exposure period smoking 2 and 4
      cigarettes (Day4-5), and the day of discharge (Day6) followed by a 7-day safety follow-up
      period. Urine collection will be performed for each subject from Day0 to Day5 in 4 intervals.

      PART B (non-smokers)

      Screening visit will be conducted within 4 weeks prior to the ambulatory Visit 1 (collection
      of 24-hour urine and spot urine) to the investigational site. The minimum interval between
      the screening and Visit 1 is of 7 days.
    

Intervention name(s): Part A
Intervention type(s): Other
Intervention description(s): Smoking abstinence, smoking 2 and 4 cigarettes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Smoking research study
Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Condition: Preeclampsia; Hypertension; Proteinuria; Thrombocytopenia; Renal Insufficiency; Impaired Liver Function; Pulmonary Edema
MeSH terms: Pulmonary Edema; Pre-Eclampsia; Renal Insufficiency; Proteinuria; Hypertension; Thrombocytopenia
Study type: Observational

Summary: 
      Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement
      that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S.
      pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the
      current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method
      has emerged that more accurately identifies women at risk for preeclampsia, warranting
      improvements in diagnosing Pre-E.

      This sample collection study will obtain serum and urine samples from pregnant women who
      present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E.
      Samples will be used to evaluate and validate the performance of an assay intended to aid in
      assessing the risk of Pre-E.
    

Detailed description: 
      Eligible subjects will provide written informed consent after which demographic and baseline
      clinical data will be recorded.

      Collection of whole blood and urine samples will be performed at one or more clinic visits
      from pregnant women carrying a single fetus with no known fetal abnormalities.

      Interim study visits will continue every 14 days [+/- 3 days] until the subject either: 1)
      reaches 37 0/7 weeks' gestation, 2) develops Pre-E, 3) delivers, or 4) is lost to follow-up.

      In addition, a group of pregnant women diagnosed with Pre-E will be enrolled as positive
      control cases.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women 18 to 45 years of age and 28 0/7 to 36 6/7 weeks gestational age with a
        singleton fetus presenting to clinic/triage/Labor & Delivery for evaluation of, but not
        limited to, one or more of the following:

          -  new onset elevated blood pressure

          -  pre-existing hypertension

          -  new onset proteinuria or worsening of pre-existing proteinuria

          -  other organ system findings including thrombocytopenia, renal insufficiency, impaired
             liver function, pulmonary edema, and cerebral or visual symptoms
      
Biospecimen description: 
      This research study will collect 20 mL of whole blood and a 5 mL urine sample at one or more
      clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities.
    
Keywords: Hypertension; Proteinuria; Thrombocytopenia; Renal Insufficiency; Impaired Liver Function; Pulmonary Edema
Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester
Condition: Gestational Diabetes; DUCTUS VENOSUS VOLUME; PLACENTA VOLUME; 3D SONOGRAPHY; FETAL LİVER VOLUME
MeSH terms: Diabetes, Gestational
Study type: Interventional

Summary: 
      Investigators measured the placenta, fetal liver and ductus venosus volumes of pregnant women
      with GDM diagnosis and normal glycemic indices in the second trimester.Investigators aimed to
      correlate measurements with maternal/fetal outcomes and evaluate their success in predicting
      poor obstetric outcomes
    

Detailed description: 
      GDM screening may not always be possible with OGTT performed in limited weeks of gestation.
      In addition, mid-trimester ultrasound scanning is done in all pregnancies. Therefore,
      measurement of placental volume and fetal liver volume may be an alternative method for the
      diagnosis of GDM. In order to predict GDM in the second trimester, the use of 3D sonography
      and VOCAL (Virtual Organ Computer Aided Analysis) technology in high-risk pregnant women and
      their cost-effectiveness rates should be investigated further. Multicenter randomized
      controlled studies with more patients are needed to be able to say more clearly.
    

Intervention name(s): 3D sonography
Intervention type(s): Other
Intervention description(s): Fetal liver, placenta, and ductus venosus were defined in 3 orthogonal multi-plane images in the voluson 4D view vocal program.
Other intervention name(s): 3D volume description
Intervention model: Single Group Assignment
Intervention model description: 46 pregnant women diagnosed with gestational diabetes mellitus, 93 pregnant women with normal glycemic index
Masking: None (Open Label)
Primary purpose: Other
Keywords: GESTATİONAL DİABETES MELLİTUS; PLACENTA VOLUME; FETAL LİVER VOLUME; DUCTUS VENOSUS VOLUME; 3D SONUGRAPHY
The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity
Condition: Other Preterm Infants; Vitamin D Deficiency; Bronchiolitis; Asthma; Pneumonia
MeSH terms: Bronchiolitis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      This trial objective is to assess whether doubling the daily intake of vitamin D improves
      serum vitamin D levels and serves as primary prevention of respiratory infections and asthma
      in premature infants.

      This is a prospective randomized (1:1) double-blinded trial.

      The study population will be randomized into two groups (1:1):

        -  Intervention Group - 800 IU of Vitamin D once daily

        -  Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year
           after randomization for serum Vitamin D levels and respiratory morbidity.
    

Detailed description: 
      The rational of this trial is that a daily supplementation of a double dose of Vitamin D (800
      IU instead of 400 IU) to late premature infants during the first year of life will result in
      elevated Vitamin D serum levels and in an improvement in respiratory morbidity.

      This randomized trial of vitamin D supplementation is planned to determine the optimal dose
      of daily vitamin D supplementation required to achieve sufficient vitamin D levels in preterm
      infants and to assess whether doubling the daily intake of vitamin D may serve as primary
      prevention of respiratory infections and asthma in premature infants.
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): also known as Cholecalciferol, is one of the two most important compounds within the group of Vitamin D. It can be ingested from the diet and from supplements. In this study it is pharmacologically acquired and referred to as Vitamin D
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Respiratory Morbidity; prematurity
Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer
Condition: Breast Cancer; Transcriptomes; Molecular Diagnostic; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      This is a case-control study of molecular diagnostics.

      This study requires two steps:

        -  The first part of the study will be conducted on a population of 20 women without breast
           cancer and, or ovarian family (Healthy Volunteers controls)

        -  The second part of the study will be conducted on a population of 50 patients
           predisposed to familial breast and, or ovarian cancer compared to 20 controls .

      For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL
      study, ID-RCB 2009-A00833-54) will be used.
    

Detailed description: 
      This study requires two steps:

      - The first part of the study will be conducted on a population of 20 women free of breast
      cancer and, or ovarian Family (healthy volunteers controls) and without a known family
      history of breast and or ovarian cancer.

      Mapping the level of blood (leukocytes) and the breast tissue will be drawn for the same
      individual on the physiological profiles splicing of the messenger RNA of genes involved in
      this predisposition, targeted by high-throughput sequencing of RNA (RNASeq).

      A direct comparison of RNA splicing patterns between blood and breast tissue from the same
      witness will detect any differences between these two tissues.

      -The second part of the study will be conducted on a population of 50 patients predisposed to
      familial breast and, or ovarian cancer compared to 20 controls with no known family history
      of breast and, or ovarian cancer.

      Analysis of the results will highlight potential splicing abnormalities.
    

Intervention name(s): collection of a blood sample and breast and ovarian tissue; use of a previous blood collection for patients
Intervention type(s): Other; Other
Intervention description(s): a blood sample and a breast and ovarian tissue sample will be collected in healthy women during their surgery (breast or ovarian surgery according to selection group :A, B or C)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: splice profiles of messenger RNA
Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
Condition: Pain After Stapled Haemorrhoidopexy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the
      postoperative pain related to anorectal spasm (anismus) while performing a stapled
      haemorrhoidopexy.
    


Intervention name(s): 0.4% nitroglycerin ointment; lidocaine cloridrato 2.5% ointment
Intervention type(s): Drug; Drug
Intervention description(s): Local endoanal application 2 times a day; Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day
Other intervention name(s): Rectogesic; Luan
Intervention MeSH terms: Lidocaine; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
SMART Program for Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation; Stress
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is a pilot study to test the effects of the SMART-3RP (Stress Management and Resiliency
      Training Relaxation Response Resiliency Program) on quality of life, mental health,
      arrhythmia burden, and heart rate variability (HRV) in patients with paroxysmal atrial
      fibrillation (PAF).
    

Detailed description: 
      Mind-body practices that elicit the relaxation response (RR) have been used worldwide to
      prevent and treat disease. The Stress Management and Resiliency Training - Relaxation
      Response Resiliency Program (SMART-3RP) is an 8-week manualized psycho-educational program
      that incorporates RR methods such as meditation or seated yoga along with cognitive skills
      building and lifestyle approaches to increase resiliency to stress. This study will use a
      randomized, wait-list controlled trial design to test the effects of the SMART-3RP on quality
      of life (QoL), mental health, arrhythmia burden, and HRV in patients with PAF. The program
      will be delivered virtually (via computer video conferencing), questionnaires will be
      completed, and physiological data as well as blood will be collected.
    

Intervention name(s): SMART Program
Intervention type(s): Other
Intervention description(s): This is an 8-week, multimodal resiliency program that targets stress with 4 main components: mind-body skills (participants learn a variety of meditation techniques, mini relaxations, walking meditation, and yoga), traditional stress management techniques, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive reappraisal and adaptive coping skills (borrowed from cognitive behavioral therapy, acceptance and commitment therapy, and positive psychology)
Other intervention name(s): Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) or Stress Management and Resiliency Training Program (SMART Program)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Mind-Body