bioihbjkbjnl/mcl2 huggingface dataset:
In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with
      supportive home oral care for the treatment of periodontal disease.

      Patients with bilateral periodontal pathological sites will undergo professional dental
      hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual
      instrumentation with Gracey curettes and application of erythritol Airflow powders. Then,
      patients will be randomly divided into two groups according to a split-mouth design: the
      Control Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants
      1/3 (or 2/4), while for the Trial Group Ozoral Pro for quadrants 2/4 (or 1/3) will be used.
      Patients will use the products at home with one daily application for the following 14 days
      after the visits. The Trial Group will use Ozoral Gel for home applications.

      The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6
      months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels
      will be performed.
    

Detailed description: 
      The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with
      supportive home oral care for the treatment of periodontal disease comparing chlorhexidine
      and ozone gels.

      Patients with bilateral periodontal pathological sites will undergo professional dental
      hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual
      instrumentation with Gracey curettes and application of erythritol Airflow powders. Then,
      patients will be randomly divided into two groups according to a split-mouth design:

        -  Control Group: application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4)

        -  Trial Group: administration of Ozoral Pro for quadrants 2/4 (or 1/3).

      Patients will use the products at home with one daily application for the following 14 days
      after the visits. The Trial Group will use Ozoral Gel for home applications.

      The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6
      months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels
      will be performed.
    

Intervention name(s): Chlorhexidine; Ozoral gels
Intervention type(s): Other; Other
Intervention description(s): In-office and domiciliary use of chlorhexidine for 14 days.; In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ozone; chlorhexidine; split-mouth
Drug-Drug Interaction Study in Health Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of K-877 on the pharmacokinetics of
      digoxin in healthy adult volunteers.
    


Intervention name(s): Digoxin; K-877
Intervention type(s): Drug; Drug
Intervention MeSH terms: Digoxin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Adult Volunteers
Primary Molars Restoration Using CAD/CAM Crowns.
Condition: Restoration of Primary Molars With CAD/CAM Crowns
Study type: Interventional

Summary: 
      study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia crowns restoring
      primary molars through In-vivo evaluation of the clinical outcomes in terms of; treatment
      failure, amount of tooth wear in the opposing tooth and gingival health
    


Intervention name(s): CAD/CAM crowns
Intervention type(s): Other
Intervention description(s): CAD/CAM crowns
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Crowns; Zirconium; Computer-Aided Design
A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
Condition: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Healthy
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety, local tolerability and pharmacokinetic profile (the determination of the
      concentration of the administered medication in blood over time) of long acting activated
      recombinant human factor VII when injected subcutaneously (under the skin).
    


Intervention name(s): activated recombinant human factor VII, long acting; placebo; activated recombinant human factor VII, long acting
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.; Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.; Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Quality of Life After Permanent Interstitial Iodine Seed Prostate Brachytherapy
Condition: Neoplasms, Prostate
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for
      localized prostate cancer
    

Detailed description: 
      Retrospective Evaluation of Quality of life data collected on men who underwent iodine seed
      brachytherapy at the University Hospital Zurich
    

Intervention name(s): No intervention in this retrospective study
Intervention type(s): Other
Intervention description(s): No Intervention in this retrospective Analysis.
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients having had idodine seed brachytherapy for localized prostate cancer between 2009
        and 2014
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This
      clinical study is designed to test the hypothesis that lurasidone is more efficacious than
      placebo. The study will also evaluate the safety and tolerability of lurasidone as compared
      to placebo.
    


Intervention name(s): Lurasidone HCl
Intervention type(s): Drug
Intervention description(s): Once daily
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; SM-13496; Latuda; Lurasidone
Muscular Biomarkers in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to
      diagnosis. The second objective is to better understand the pathogenesis of this disease by
      the exploration of muscle, blood and satellite cells metabolomes and transcriptomes.
    

Detailed description: 
      Amyotrophic Lateral Sclerosis (ALS), the most common MND, is a fatal adult-onset
      neuromuscular disease. Due to clinical heterogeneity and absence of biological tools to
      diagnose ALS, the delay between the first symptoms and diagnosis averages 9-13 months. A
      group of pathophysiological processes, including oxidative stress and glutamate-mediated
      excitotoxicity contribute to cell death, but the triggering factor, the timing and the
      interaction of different cellular events await elucidation [2]. Unknown pathogenesis for most
      patients means few available treatments. The search for biomarkers that can aid diagnosis,
      characterize phenotype, define pathophysiology, identify endpoints in trials and measure
      disease progression is of utmost importance for the field. Some studies have advocated that
      muscle per se may be impaired by pathogenesis of the diseases. Muscle has been poorly studied
      and its central role in energetic metabolism suggests that this tissue, quite easily
      available, should be more analyzed to find biomarkers and to compare muscular metabolism with
      those of brain and overall body. Specific aims of our subjects are:

      Specific aims are focused on:

        1. the acquisition of metabolites profiles of the muscle, blood and satellite cells using
           an analytical platform enable a deep exploration. For that, the use of three analytical
           modalities (NMR, mass spectrometry coupled to GC or UPLC) ensures the best coverage of
           the metabolite population with a high range of concentration variability and molecular
           diversity.

        2. the building of metabolites profiles models that discriminate pathological and control
           situations.

        3. the identification of metabolites implicated in the discriminant model.

        4. the generation of metabolism pathways hypothesis related to the discriminant model.

        5. the acquisition of transcriptomics data to confirm and add complementary results to
           metabolomics data
    

Intervention name(s): Samples
Intervention type(s): Other
Intervention description(s): Blood samples, muscle biopsy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Amyotrophic Lateral Sclerosis; Muscle metabolism; Metabolomics; Transcriptomics
Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients
Condition: Hemolysis; Exercise; Sleep Disorder; Fatigue; Adipocytes
MeSH terms: Sleep Wake Disorders; Parasomnias; Fatigue; Hemolysis
Study type: Interventional

Summary: 
      To determine the effect of intradialytic cycling exercise on fatigability, sleep disorders,
      arterial stiffness and endothelial function in dialysis patients
    

Detailed description: 
      The endothelium is a key regulator of vascular homeostasis and chronic exposure to vascular
      risk factors alters the regulatory properties of the endothelium, which progresses toward a
      pro-inflammatory pattern, senescence, and apoptosis. Endothelial cell integrity and function
      are critical to the prevention of atherosclerosis, and therefore endothelial cell injury and
      dysfunction are major steps in the development and progression of cardiovascular disease.
      Endothelial dysfunction may be the landmark of active disease process through the course of
      atherosclerotic cardiovascular disease, and a significant risk factor for future
      cardiovascular events.

      Several studies had reported that not only medical treatment but also exercise could improve
      physical and vascular functions, dialytic efficiency, quality of sleep, fatigue and
      depression et al. Exercise could be classified to aerobic, Anaerobic exercise and resistance
      et. Several studies have shown that regular cycling exercise in hemodialysis patients could
      improve physical activity, sleep quality, and reduce fatigability. Therefore, exercise plays
      an important role in hemodialysis patients. According to these benefits, the investigator's
      study was designed to explore the effects of intradialytic cycling exercise on sleep quality
      and fatigability, adipokines and myokinins levels in hemodialysis patients.
    

Intervention name(s): Cycling exercise
Intervention type(s): Other
Intervention description(s): Intradialytic cycling exercise for 30 minutes a time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of different dietary fats (saturated or
      unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. The
      investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase
      postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial
      endotoxemia.Participants were recruited via email and randomized to treatment meal in this
      single-blind, cross-over study. Each test session participants reported to the laboratory
      right away in the morning. An indwelling catheter was inserted into the participant
      non-dominant arm by a qualified nurse and a baseline blood draw was taken. The participant
      was then provided with one of four test meals (a porridge-type meal containing a different
      dietary fat), which they ate in entirety within 15 minutes. The participants remained in the
      laboratory for the next five and a half hours and were not allowed to consume any food or
      drink except water. During this time, further blood draws were taken at intervals of one hour
      for a total of five hours after the consumption of the test meal. Collected blood was
      processed on-site and the serum fraction collected and tested for endotoxin, inflammatory
      biomarkers, and metabolites.
    


Intervention name(s): Low-fat Treatment Meal; Saturated-fat Treatment Meal; N-3 fat Treatment Meal; N-6 fat Treatment Meal
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Isocaloric test meal that provided 20% fat.; Isocaloric test meal that provided 35% fat with saturated fat (16 g).; Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg); Isocaloric test meal that provided 35% fat with n-6 (7.4 g).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Inflammation; Endotoxemia; Lipopolysaccharide; Diet; Fat; Postprandial
Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This pilot study will investigate the enrichment type, in pancakes, most effective at
      improving markers of metabolic syndrome. Ready-made pancakes enriched with either
      docosahexaenoic acid (DHA), beta-glucan (BG) or anthocyanins (AC), alone or in combination of
      DHA+BG or DHA+AC, will be consumed for 4 weeks.
    

Detailed description: 
      There is scientific evidence to support health claims that docosahexaenoic acid (DHA), an
      omega-3 fatty acid, and beta-glucan (BG), a soluble plant fibre, can help to maintain healthy
      cholesterol and triglyceride levels. It is also reported that anthocyanins (AC), colour
      pigments found in many dietary plants, can lower concentrations of low-density lipoprotein
      (LDL) cholesterol and increase high-density lipoprotein (HDL) cholesterol in dyslipidemic
      adults. Research studies often focus on bioactives administered as supplements, this study
      will also investigate the effectiveness of the food matrix. The project addresses the
      exploitation of bioactive compounds extracted from natural food sources that when added as
      ingredients to foods and consumed within the common diet, could significantly benefit human
      health and wellbeing.
    

Intervention name(s): Ready-made pancakes enriched with docosahexaenoic acid (DHA); Ready-made pancakes enriched with beta-glucan (BG); Ready-made pancakes enriched with anthocyanins (AC); Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG); Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.; One portion of BG-enriched pancakes will be eaten each day for 4 weeks.; One portion of AC-enriched pancakes will be eaten each day for 4 weeks.; One portion of DHA+BG-enriched pancakes will be eaten each day for 4 weeks.; One portion of DHA+AC-enriched pancakes will be eaten each day for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Five treatment groups, no placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Assessment of the New Lateral Sinus Floor Elevation Technique Using Piezosurgery: A Clinical and Radiographic Retrospective Study
Condition: Lateral Sinus Lift; Per-operation Complications
Study type: Observational

Summary: 
      All patients who received lateral sinus floor elevation using this new piezosurgery
      technique, were selected. The personal file of each patient was retrieved and the following
      data were taken: age, sex, smoking habits, occurrence of per-operative complications (mucosal
      perforation, hemorrhage) and post-operative infectious complications. Pre-operative CBCT of
      included patients were all performed using the same Newtom VGI radiographic machine and
      collected from the radiology unit at the Faculty of Dental Medicine at Saint Joseph
      University of Beirut. The measurement of the studied factors was performed on Newtom VGI
      viewer software, by two evaluators J.B. and A.M.
    


Intervention name(s): Complication
Intervention type(s): Other
Intervention description(s): whether or not complications occur
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All the patient needing lateral sinus lift procedure prior to implant placement.
Dry Eye Evaluation After Transepithelial PRK
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser
      vision correction using no-touch all-laser photorefractive keratectomy in comparison to
      conventional lasik
    

Detailed description: 
      Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients
      undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using
      mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate
      severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6
      months
    

Intervention name(s): transepithelial PRK; LASIK
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Transepithelial PRK; Dry eye; Schirmer test; Tear break up time; Dry eye after advanced surface ablation technique
Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?
Condition: Pain After Shoulder Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      Peripheral nerve blocks provide many advantages for patients (excellent pain control and
      reduction in nausea) undergoing upper and lower limb surgery however several commonly
      occurring complications can produce annoying but sometimes serious adverse effects. The
      interscalene brachial plexus block (ISBPB) is one such technique, commonly performed for
      shoulder surgery, but also produces paralysis of the diaphragm, Horner's syndrome and
      sometimes vocal cord paralysis with standard volumes of local anesthetic. This threat of
      these side effects limits the use of ISBPB in many patients who would particularly benefit
      e.g. patients with lung disease. Recently the use of ultrasound guidance is allowing
      practitioners to place smaller volumes of local anesthetic with much greater accuracy. This
      can potentially avoid anesthetizing important adjacent nerves to the target structure. If
      ultrasound-guided techniques with smaller volumes of local anesthetic could be demonstrated
      to reduce the incidence of complications without reducing effectiveness this would be very
      beneficial for patients.This will be the first randomized, double blind study to evaluate if
      an ultrasound-guided ISBPB with low volumes of local anesthetic can reduce complications for
      patients whilst maintaining quality of anesthesia and pain relief in the intra-operative and
      postoperative period.
    


Intervention name(s): Variation in volume of local anesthetic; Ultrasound-guided interscalene brachial plexus block
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ultrasound, Complications, Regional Anesthesia