bioihbjkbjnl/mcl2 huggingface dataset:
The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars
Condition: Indirect Pulp Treatment
Study type: Interventional

Summary: 
      The aim of this study was to compare the clinical and radiographic success rates of indirect
      pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide
      aggregate (MTA) versus IPT performed with MTA in children's vital primary molars. A
      randomized, split-mouth design including 40 children aged 4-8 years was implemented. The
      study sample composed of 80 primary molars with deep carious lesions. Each child had 1 pair,
      one tooth from each pair was allocated randomly either to the 2% chlorhexidine gluconate/MTA
      group or the MTA group. All teeth were restored with stainless steel crowns. Follow-up is
      carried out to evaluate the teeth clinically and radiographically.
    

Detailed description: 
      A double blinded, randomized, controlled clinical trial was performed in a split-mouth
      design. Eighty primary molars in forty subjects were randomly allocated that each subject had
      one tooth treated with 2% chlorhexidine gluconate and MTA (experimental group), and the other
      tooth treated with only MTA (control group).

      The study was held at King Abdulaziz University Dental Hospital (KAUDH), Jeddah. Forty
      healthy children with the age range 4- to 8-year-old were included. Each patient had at least
      two first primary molars or two second primary molars with deep occlusal or proximal caries
      not approaching the pulp indicated for IPT.

      Preoperative periapical radiographs of the teeth considered for treatment in the study were
      made using extension cone paralleling technique in the x ray machine.

      The procedure was performed in two visits by one operator to allow for the setting of MTA.
      Stainless steel crowns were used as final restorations.
    

Intervention name(s): 2% chlorhexidine gluconate with mineral trioxide aggregate.; Mineral trioxide aggregate.
Intervention type(s): Other; Other
Intervention description(s): 2% chlorhexidine gluconate with mineral trioxide aggregate.; Mineral trioxide aggregate.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Indirect pulp treatment; Deep caries; Primary molars; Mineral trioxide aggregate; 2% chlorhexidine gluconate
Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment
Condition: Lipoprotein Lipase Deficiency
MeSH terms: Hyperlipoproteinemia Type I
Study type: Observational

Summary: 
      This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans.
      LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein
      lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no
      longer functional. This can cause conditions known as high triglycerides in the blood and
      inflammation of the pancreas.

      Investigational medications to treat LPLD are currently being developed. In order to see if
      these medications are effective, it is necessary to be able to accurately measure LPL
      activity in humans.

      LPL activity has been successfully measured in animal models after giving heparin. Heparin is
      a blood thinner which is approved by the FDA. It is originally used to prevent blood clots.
      This study will administer heparin to healthy adults through intravenous infusion (IV). Blood
      samples will be collected before and after the infusion to test LDL levels.

      The purpose of this study is to develop a cheap, more reliable standard for assessment of
      LPLD in patients
    


Intervention name(s): Heparin
Intervention type(s): Drug
Intervention description(s): Participants will be given IV heparin in order to release lipoprotein lipase from capillary endothelial cells. Blood will be drawn 10-15 minutes post-heparin administration and run through assay to determine lipoprotein lipase levels.
Intervention MeSH terms: Heparin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Male and female individuals
Hemodialysis Vascular Access Imaging Study
Condition: Chronic Kidney Disease; Fistula; Hemodialysis Fistula Thrombosis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Thrombosis; Arteriovenous Fistula; Fistula
Study type: Observational

Summary: 
      The goal of this study is to find the best techniques to take non-invasive images of the
      arteriovenous fistula (AVF) in hemodialysis patients.
    

Detailed description: 
      The vascular access is at the same time both the 'lifeline' and the 'Achilles' heel' of
      hemodialysis patients. Despite improved understanding of the pathophysiology of stenosis and
      thrombosis of the vascular access, unfortunately translating these advances into either
      improved therapies or a superior process of care has not been very successful. As a result,
      there continues to be an epidemic of arteriovenous fistula (AVF) maturation failure, a
      proliferation of relatively ineffective interventions such as angioplasty and stent
      placement, an extremely high incidence of catheter use (1).

      A major problem is the timely diagnosis of AVF access dysfunction, which - undiagnosed and
      untreated - will eventually result in its loss. Current methods of diagnosing impending AVF
      deterioration utilize measurement of access flow, access flow recirculation, ultrasound
      imaging and angiography. None of these methods are applicable on a per-treatment basis and
      require some sort of intervention.

      Recent advances in video-imaging open the opportunity to non-invasively track AVF movements,
      possibly on a routine basis. These AVF movements are created by the arterial pulse and
      routinely checked manually prior to each AVF cannulation. In this research the investigators
      plan to film the actual AVF movements with the goal to explore the technical feasibility of
      video-imaging based access surveillance.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators would like to study patients with chronic kidney disease, currently
        undergoing hemodialysis via AVF at Renal Research Institute dialysis clinics.
      
Keywords: Arteriovenous Fistula; Hemodialysis; Vascular Access
Mechanisms Mediating Cardiovascular Disease in Children With Obstructive Sleep Apnea
Condition: Cardiovascular Diseases; Heart Diseases; Sleep Apnea Syndromes; Lung Diseases; Hypertension
MeSH terms: Sleep Apnea Syndromes; Lung Diseases; Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To identify the early effects of obstructive sleep apnea on the cardiovascular system of
      children.
    

Detailed description: 
      BACKGROUND:

      Obstructive sleep apnea (OSA) is an important clinical disorder occurring in men, women, and
      children with a prevalence of 4 percent, 2 percent and 1-3 percent, respectively. OSA is
      under active study in adults and is definitely linked with increased cardiovascular
      morbidity, even in its mild to moderate clinical forms. In contrast, OSA has not been well
      studied in children and the potential deleterious consequences on cardiovascular function
      have received little or no attention.

      DESIGN NARRATIVE:

      The study will examine in children 1) The interaction between OSA and baroreflex dysfunction,
      2) The relation of OSA severity and baroreflex dysfunction to abnormalities in blood pressure
      control during wakefulness and sleep, 3) The association of the diminished baroreflex gain
      and impaired blood pressure control with an index of end organ damage, the left ventricular
      mass index, and 4) Whether effective treatment of OSA results in significant improvement in
      baroreceptor function, blood pressure control and a decrease in left ventricular mass index.
      A cross-sectional study will be conducted in 8-12 year old children with OSA and a matched
      group of normal children. Studies include baroreceptor function, 24-hour ambulatory blood
      pressure and left ventricular mass index. Baroreceptor function will be measured by
      non-invasive techniques based on combined computer analysis of heart rate and blood pressure
      measured by portapres. 24-hour ambulatory blood pressure will be measured by a Spacelab
      monitor and left ventricular mass index will be measured by direct M-mode echocardiogram. A
      longitudinal study will be conducted on the effect of adequate treatment of OSA on
      baroreceptor function, daytime and nocturnal blood pressure and left ventricular mass index.
      A cohort of children with OSA and a matched group of normal controls will be followed for a
      period of 12 months after treatment of the disorder. Results are expected to show that
      children with OSA have decreased baroreceptor sensitivity, elevated nocturnal blood pressure
      and increased left ventricular mass index and that effective therapy for OSA, as determined
      by polysomnography, will improve or normalize baroreceptor sensitivity as well as nocturnal
      blood pressures and will lead to a decrease in left ventricular mass index.
Functional Movement Analysis of Handball Players
Condition: Injuries; Sports Physical Therapy
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      RELATIONSHIP OF FUNCTIONAL MOVEMENT ANALYSIS WITH INJURY HISTORY AND ATHLETIC PARAMETERS IN
      HANDBALL ATHLETES

      Abstract Objectives: Handball is a popular sport in many countries. There is lack of
      knowledge about handball athlete's functional movement capacity. The aim of this study is to
      investigate the Functional Movement Screen (FMS™) scores, to evaluate the injury risks of
      handball athletes and to determine its relationship with athletic performance.

      Design: Observational study. Methods: A total of 51 professional handball players in Turkey
      were included in this study. The sport-specific features and demographic data were recorded.
      The functional movement analysis was performed and agility and balance and force were
      evaluated.
    

Detailed description: 
      In august 2018, same evaluations will be done for same individuals.
    

Intervention name(s): Functional Movement Screen
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Athletic Performance; Functional Movement Screen; Handball Athletes; Injury Prevention; Injury History
Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
Condition: In Vitro Fertilization
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of
      luteal support (S.C.) to an approved comparator (vaginal gel).
    


Intervention name(s): Progesterone; Progesterone
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg, s.c., once à day; 90 mg, vaginally, once à day
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Luteal Phase Support in IVF patients
Steroids for Pediatric Apnea Research in Kids
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids
      for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy,
      duration of action and side-effects will be determined.
    

Detailed description: 
      Several studies have suggested that Nasal corticosteroids (NCS) or leukotriene antagonists
      may be effective in the treatment of childhood OSAS. However, these studies have been limited
      by factors such as small size, lack of randomization and blinding, short-term follow-up,
      involvement of children with only very mild OSAS, and/or lack of stratifying for the presence
      of atopy. Therefore, investigators will plan a randomized controlled trial evaluating the
      efficacy and safety of NCS vs placebo in children with mild to moderate OSAS. The overall
      hypothesis is that NCS will be safe and efficacious in the treatment of mild to moderate
      childhood OSAS, particularly in children with asthma/atopy, but will require ongoing
      maintenance therapy.
    

Intervention name(s): Nasal Fluticasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One spray per nostril, per day.; One spray per nostril, per day.
Other intervention name(s): NCS; Nasal steroids; Nasal corticosteroids; Saline
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea syndrome; OSA; sleep apnea; nasal steroids; corticosteroids
Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 trial will assess the dose-related safety and PK profile of different doses of
      NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with
      chronic hepatitis B (part II). Additionally, in Part II, changes in patients' serum HBV DNA
      levels and other virologic efficacy parameters will be assessed.
    

Detailed description: 
      The Part I (Phase 1a) assessments of the dose-related safety and PK of NVR 3-778 in
      volunteers will be conducted an established Phase 1 unit, which will facilitate the overnight
      confinements and frequent safety assessments and blood sampling required for the Part I
      evaluations. The Part II (Phase 1b) assessments of the dose-related safety, PK, and initial
      antiviral efficacy of NVR 3-778 in hepatitis B patients will also be conducted at
      approximately 14 different sites to meet enrollment goals of 54-84 chronic hepatitis B
      patients.

      To promote objective safety and tolerance assessments during this trial, study subjects, and
      site personnel administering the study drug and performing the clinical assessments on the
      subjects, will be blinded to individual subjects' treatments assignments (active NVR 3-778 or
      placebo doses), for all treatment cohorts in the study. Study advancement to subsequent
      volunteer cohorts in Part I and subsequent patient cohorts in Part II will require
      satisfactory interim reviews of available cumulative safety data by the Part I and Part II
      Safety Review Committees (SRCs), using the safety criteria and review procedures described in
      the protocol. Also, there will be two interim reviews of safety data by an independent Safety
      Monitoring Board (SMB), as described in the protocol.
    

Intervention name(s): NVR 3-778; Placebo for NVR 3-778; Pegasys
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sugar pill manufactured to mimic the NVR 3-778 capsule
Other intervention name(s): peginterferon alfa-2a
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis B
Effect of Archwire Gauge on the Rate of Canine Retraction
Condition: Canine Retraction
Study type: Interventional

Summary: 
      trial will be done to evaluate the effect of archwire gauge on the rate of canine retraction,
      canine tip and torque, root resorption and loss of anchorage in maxillary dental protrusion
      cases requiring first premolars extraction.
    

Detailed description: 
      Three working archwires of different gauges will be used during canine retraction; st.st
      0.019×0.025" as a comparator, st.st 0.016×0.022" and st.st 0.017×0.025" wires as
      interventions. after levelling and alignment till reaching the working archwire, it will be
      left in place for a month then maxillary first premolars will be extracted and base line
      records will be taken(digital models, digital periapical radiographs and panorama). digital
      models will be taken monthly to measure rate of canine retraction for 6 months. after 6 month
      evaluation of anchorage loss, change in canine tip and torque will be done on last obtained
      digital model , panorama will be taken to evaluate the change in canine tip and digital
      periapical radiograph will be taken and compared with the preretraction radiograph to
      evaluate amount of root resorption.
    

Intervention name(s): st.st 0.019×0.025" wire; st.st 0.016×0.022" wire; st.st 0.017×0.025" wire
Intervention type(s): Other; Other; Other
Intervention description(s): rectangular stainless steel wire that will be used during canine retraction after first premolars extraction; rectangular stainless steel wire that will be used during canine retraction after first premolars extraction; rectangular stainless steel wire that will be used during canine retraction after first premolars extraction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups of patients each receives different wire gauge during canine retraction phase during space closure.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: canine retraction; archwire gauge
The Pharmacodynamic/Pharmacokinetic Interaction of Tipranavir and Ritonavir With Loperamide in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to determine if the co-administration of loperamide (LOP) with
      tipranavir (TPV), ritonavir (RTV), or TPV plus RTV (TPV/r) caused a clinically significant
      change in the respiratory response to carbon dioxide (CO2), defined as a 10% decrease in the
      area under the pharmacodynamic effect/time curve or at least a 25% decrease in at least one
      pharmacodynamic time point.
    


Intervention name(s): Tipranavir; Ritonavir; Loperamide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir; Loperamide; Antidiarrheals
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of RinASol project is to assess in patients with seasonal Allergic
      Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard
      saline solution on nasal inflammation by means of nasal cytology.

      The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom
      Score 5)
    


Intervention name(s): hypertonic saline solution (NACL 3%+NAHCO3); Saline Solution (NACL 0,9%)
Intervention type(s): Drug; Other
Intervention description(s): Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3); Treatment with nebulized Saline Solution (NACL 0,9%)
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children
A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, randomized, parallel-group, single-dose study. Approximately
      56 participants will be enrolled and randomized into 1 of the 2 treatment groups, with 28
      participants in each treatment group as follows:

        -  Treatment Group A (reference): Current ozanimod capsule formulation

        -  Treatment Group B (test): Ozanimod granule formulation participants will be screened
           within 28 days prior to dosing.

      Eligible participants will be admitted to the clinical research unit one day before dosing
      (Day -1) and will be domiciled until Day 15. On Day 1, a single oral dose of 0.92 mg of
      ozanimod will be administered using either the current capsule formulation (Group A) or the
      granule formulation (Group B).

      Participants will be contacted by telephone 30 ± 5 days after dosing for a follow up safety
      assessment.
    


Intervention name(s): Ozanimod; Ozanimod
Intervention type(s): Drug; Drug
Intervention description(s): Ozanimod capsule formulation of 0.92mg; Ozanimod, granule formulation of 0.92mg
Other intervention name(s): RPC1063
Intervention MeSH terms: Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ozanimod; RPC-1063; Pediatric Granule Formulation; Healthy Volunteer; Pharmacokinetics (PK)