bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain (PP)
Condition: Post-operative Pain; Apical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis; Pain, Postoperative
Study type: Interventional

Summary: 
      Aim: The aim of this study was to examine post-operative pain (PP) severity after
      conventional irrigation and sonic activation methods, with and without laser disinfection in
      mandibular molar teeth diagnosed with symptomatic apical periodontitis.

      Methods: In total, 80 patients with symptomatic apical periodontitis were included in this
      randomized clinical study. There were four different irrigation and disinfection groups. In
      group 1, conventional irrigation only was applied. In group 2, EDDY (VDW, Munich, Germany), a
      sonic irrigation activation system, was applied. In groups 3 and 4, irradiation with a 980-nm
      diode laser was performed, following irrigation with the conventional method (needle
      irrigation) and EDDY (VDW) irrigation system, respectively. PP was assessed using a visual
      analogue scale (VAS). The patients were instructed to record their PP using this scale 8, 24,
      48 hours and 7 days post-procedure, in addition to their analgesic intake. A chi-square test,
      Fisher's exact chi-square test and Fisher-Freeman-Halton exact test were used to assess
      qualitative data. Inter-group and intra-group parameters were assessed using the
      Kruskal-Wallis test and Wilcoxon's test at a significance level of p < 0.05 (for both).
    


Intervention name(s): EDDY; Diode Laser device; Conventional irrigation
Intervention type(s): Device; Device; Device
Intervention description(s): EDDY (VDW) sonic irrigation activation system; 980-nm diode laser device; Conventional root canal irrigation with 31-guage side port needle
Other intervention name(s): EDDY (VDW, Munich, Germany); Medency Primo 10 W Diode Laser, Vicenza, Italy; 31-guage side port needle (NaviTip; Ultradent, South Jordan, UT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: diode laser; EDDY; post-operative pain; sypmtomatic apical periodontitis
MMR at 6 Months Trial
Condition: Meales-mumps-rubella Vaccine
MeSH terms: Rubella
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and
      potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of
      age
    


Intervention name(s): MMRvaxpro; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): MMRvaxpro vaccine; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: measles-mumps-rubella vaccine
A Study of RO4995819 in Healthy Elderly Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in
      healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of
      RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.
    


Intervention name(s): Placebo; RO4995819
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to RO4995819 once daily for 14 days; RO4995819 doses once daily for 14 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment
Condition: Autoimmune Diseases; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Autoimmune Diseases
Study type: Interventional

Summary: 
      This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical
      coherence tomography and safety and efficacy of new generation fully bioresorbable vascular
      scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective
      tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary
      disease patients.
    

Detailed description: 
      The aim of this study is to assess in vivo intracoronary anatomy using intravascular
      ultrasound and optical coherence tomography and assess the efficacy and safety of new
      generation fully bioresorbable vascular scaffolds in a systemic autoimmune and coronary heart
      disease patient population.

      The following four well defined systemic autoimmune entities are linked to increased
      cardiovascular risk: rheumatoid arthritis, mixed connective tissue disease, systemic
      sclerosis and systemic lupus erythematosus. One of the main causes of death in systemic
      autoimmune subjects is cardiovascular disease. In-vivo intracoronary anatomy and pathology
      regarding systemic autoimmune diseases is unknown. Furthermore, all forms of
      revascularization in such patients yield sub-optimal results, with poor outcomes using even
      the most modern drug eluting metallic stents. This may be linked to a long term exaggerated
      chronic inflammation response to the metallic components. Thus, fully bioresorbable vascular
      scaffolds may prove more efficacious in systemic autoimmune subjects.
    

Intervention name(s): Percutaneous coronary intervention with new generation fully resorbable scaffold
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics.
Condition: Tooth Loss, Teeth Replaced Using All Ceramic FPDs
MeSH terms: Tooth Loss
Study type: Interventional

Summary: 
      Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some
      time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial
      dentures is unknown.

      The hypothesis was that long FDPs fabricated of zirkon-oxide withstand masticatory forces in
      the posterior and anterior regio of the jaw.
    

Detailed description: 
      30 patients with at least 2 missing posterior or anterior teeth will be included in the
      study. All patients will receive all-ceramic fixed partial dentures.
    

Intervention name(s): All ceramic FPDs
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FPD, all-ceramic
A Study of the Efficacy and Safety of VX-150 in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The Primary objective of this study is to evaluate the efficacy of VX-150 in the treatment of
      osteoarthritis pain
    


Intervention name(s): VX-150; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious
      than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee
      and hip.
    


Intervention name(s): Celecoxib; Celecoxib
Intervention type(s): Drug; Drug
Intervention description(s): 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily.
Placebo used as flare medication when directed.; 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily.
Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects
Condition: Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC73077 in Healthy
      Subjects
    


Intervention name(s): HEC73077 tablets; HEC73077 placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.; Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension
Condition: COPD; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of
      pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric
      oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries
      of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary
      disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary
      hemodynamics and increase exercise tolerance in this condition.
    

Detailed description: 
      It is a prospective, randomized, double-blind, placebo controlled trial to assess the effect
      of 3 months treatment with sildenafil (20 mg/8 h), added to a pulmonary rehabilitation
      program, on exercise tolerance. Subjects: 60 patients (30 by treatment group). Main end-point
      variable: endurance time in constant work exercise test (CWET). Other measurements: 6 min
      walk distance, performance in incremental exercise test, physiological and metabolic response
      at iso-time and iso-load in CWET, dyspnea, and health-related quality of life.
    

Intervention name(s): Sildenafil; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Sildenafil 20mg TID orally; Placebo TID orally
Other intervention name(s): Revatio
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Exercise tolerance; COPD; Pulmonary hypertension; Sildenafil
Intravenous Access Using Infrared Laser
Condition: Obesity, Morbid; Obstetric Anesthesia Problems
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      Peripheral venous access is a prerequisite for anesthesiological for surgical patients.It is
      often difficult to establish and potentially painful in obese patients (Body mass Index >
      35). AV300 uses near infrared laser light to improve visibility of peripheral veins and could
      help cannulating them. The aim of this study was to examine if use of Accuvein(®) AV300 vein
      viewer could facilitate venous cannulation in obese patients (surgical and obstetric).
    


Intervention name(s): infrared transluminescent device
Intervention type(s): Device
Intervention description(s): use of infra red for venous access for second intravenous access
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients that need second intravenous access for surgery or obstetric
Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity
Condition: OAG - Open-Angle Glaucoma; OHT - Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional

Summary: 
      The purpose of this research study is to compare the effect of Latanoprostene Bunod and
      Timolol on eye pressure and blood vessels of the back of the eye.
    

Detailed description: 
      The primary objective of this clinical investigation is to compare the difference in change
      in retinal blood vessel density (peripapillary and macular) between latanoprostene bunod
      (LBN) ophthalmic solution 0.024% dosed once daily (QD) and timolol maleate 0.5% dosed twice
      daily (BID) in subjects with OAG or OHT and in normal subjects.

      Primary Efficacy Endpoint The primary efficacy endpoint for this study is the change in
      retinal blood vessel density (peripapillary and macular) between treatment groups after 4
      weeks of treatment (Visit 4 [Week 5] and Visit 6 [Week 11]).

      Secondary Efficacy Endpoints The secondary efficacy endpoint for this study is change in
      best-corrected visual acuity (BCVA).

      Safety Endpoints The safety endpoint for this study is the incidence of ocular and systemic
      adverse events (AEs).
    

Intervention name(s): Latanoprostene bunod 0.024% QD; Timolol maleate 0.5% BID
Intervention type(s): Drug; Drug
Intervention description(s): This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: latanoprostene bunod 0.024% QD and timolol maleate 0.5% BID.; This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: latanoprostene bunod 0.024% QD and timolol maleate 0.5% BID.
Other intervention name(s): Vyzulta; Timoptic
Intervention MeSH terms: Timolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and
      PK of vantictumab when combined with paclitaxel.
    

Detailed description: 
      Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined,
      up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the
      safety, tolerability and PK of vantictumab combined with paclitaxel. Up to approximately 34
      patients may be enrolled into the study.
    

Intervention name(s): Vantictumab combined with paclitaxel
Intervention type(s): Drug
Intervention description(s): Vantictumab combined with paclitaxel will be administered IV.
Other intervention name(s): (OMP-18R5)
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locally Recurrent; Metastatic Breast Cancer
Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Women with low ovarian reserve typically respond less well to the drugs used to stimulate the
      ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall
      pregnant either naturally or after fertility treatment. The ideal stimulation regimen for
      poor responders is currently unknown.

      Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor
      responders, and is now utilized by approximately one third of all IVF centers world-wide.
      However, the current clinical evidence for DHEA on improvement of ovarian response and IVF
      outcome is insufficient. The validity of the results of the former studies, especially the
      varied inclusion criteria used to specify poor responders, is a subject of debate. Recently a
      uniform definition on poor ovarian response, the Bologna criteria, has been proposed by the
      European Society for Human Reproduction and Embryology(ESHRE). However, no studies have been
      performed study to evaluate the potential effects of DHEA supplementation according to these
      standards.

      The purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of
      poor ovarian responders that fulfill the Bologna criteria.
    


Intervention name(s): DHEA
Intervention type(s): Drug
Other intervention name(s): dehydroepiandrosterone
Intervention MeSH terms: Dehydroepiandrosterone
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients were stratified according to the Bologna criteria for poor ovarian response.
        Poor responders were classified with at least two of the three following criteria: (I)
        advanced maternal age (≥40 years) or any other risk factor for POR; (II) a previous POR(≤3
        oocytes with a conventional ovarian stimulation protocol); and (III) an abnormal ovarian
        reserve test (ORT): antral follicle count (AFC) < 5-7 or serum anti-Mullerian hormone (AMH)
        <0.5-1.1 ng/mL, as described by the Bologna criteria
Peripheral Immunologic Response of Solid Organ Transplant Recipients to Depletion Versus Non-depletion Protocols
Condition: Liver Disease; Liver Transplantation
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Rejection and infection are primary causes of morbidity and mortality in solid organ
      transplant recipients. Current clinical practice relies on immunosuppressive drug levels
      measured in plasma to reflect the peripheral immune response in solid organ transplant
      recipients. Direct measurement of the number and functions of the immune cells themselves
      using multi-parameter flow cytometry may enable individualized immunosuppression management
      for organ transplant recipients. Multi-parameter flow cytometry will be used to compare
      levels and functional capabilities of multiple lymphocyte subsets between cohorts of patients
      receiving depletion induction and those receiving a non-depletion regimen. The activation
      state, cytotoxic potential and the functional capabilities of these cells will be examined
      within patients over the first six months post transplant.
    


Intervention name(s): blood sampling
Intervention type(s): Procedure
Intervention description(s): peripheral blood draw
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        liver transplant recipients
      
Biospecimen description: 
      blood
    
Keywords: liver disease; liver transplantation; depletion immunosuppression; non-depletion immunosuppression
Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity
Condition: Malaria; Malnutrition
MeSH terms: Malaria; Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine whether young children receiving Vitamin A and
      Zinc supplements will have a lower incidence of symptomatic malaria than similar children
      receiving vitamin A supplements alone.
    

Detailed description: 
      The aim of our study was to determine the impact of the combination of vitamin A and zinc
      supplements on malaria morbidity in young children. The primary objective was to determine
      the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical
      malaria. The specific objectives were to determine the effect of vitamin A alone vs. vitamin
      A and zinc supplements on changes in anthropometric measurements specifically weight and
      length/height and to assess the effect of the study interventions on the incidence of anemia,
      diarrhea and pneumonia. It also assessed the tolerability of the supplements and determined
      the change in zinc status by measuring plasma zinc concentration using atomic absorption
      spectrometry before and at the end of the intervention. The study also determined the change
      in vitamin A status as assessed by the modified relative dose response (MRDR) test during and
      at the end of the intervention.
    

Intervention name(s): vitamin A; vitamin A and zinc
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): vitamin A with placebo; combination of vitamin A and zinc supplements
Intervention MeSH terms: Vitamins; Vitamin A; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Vitamin A; Zinc; Malaria; Morbidity; MRDR
Topiramate for the Treatment of Methamphetamine Dependence - 1
Condition: Methamphetamine
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of topiramate as compared to
      placebo in reducing methamphetamine use in subjects with methamphetamine dependence.
    


Intervention name(s): Topiramate; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Other intervention name(s): Topamax
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: methamphetamine addiction
MAGZEN® Effect on Recent Anxiety Reaction
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Observational [Patient Registry]

Summary: 
      Multicentres, observational study, prospective, to evaluate the effect of MAGZEN® in the
      treatment of recent anxiety reaction.
    

Detailed description: 
      107 patients suffering from recent anxiety reaction will be included in the study. They will
      be treated by MAGZEN® during 4 weeks and we will study the effect of this treatment on the
      evolution of their anxiety after the cure.
    

Intervention name(s): Hamilton-anxiety scale (HAM-A)
Intervention type(s): Other
Intervention description(s): Evolution of anxiety disorders is evaluated by the Hamilton-anxiety scale (HAM-A)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients suffuring from a recent anxiety reaction not already treated.