bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Denture Base Adaptation and Per-iimplant Tissue Health Between CAD and CAM Implant Overdenture
Condition: Periimplantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      Background: Complete overdenture manufacturing has been greatly developed using
      computer-aided designing and computer-aided manufacturing (CAD-CAM) technology.

      Material and method: 15 completely edentulous patients, divided into two groups, received two
      implants in the mandibular canine area with ball attachment. The first group received a
      CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture,
      while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic
      complete denture. Peri-implant soft tissue and denture adaptation were evaluated using
      clinical parameters
    

Detailed description: 
      Background: In recent years, complete overdenture manufacturing has been greatly developed
      using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology. This
      clinical study compared the soft tissue health between CAD/CAM-milled and 3D-printed implants
      that retained complete overdentures.

      Material and method: 15 completely edentulous patients, divided into two groups, received two
      implants in the mandibular canine area with ball attachment. The first group received a
      CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture,
      while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic
      complete denture. Peri-implant soft tissue was evaluated using clinical parameters including
      the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular
      complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.
    

Intervention name(s): subtractive technique; additive technique
Intervention type(s): Device; Device
Intervention description(s): The milled denture teeth are then bonded into the milled recesses using a special PMMA bonding system.; The denture teeth were printed as one unit using the same method with tooth resin (DENTCA Denture Tooth, Shade A2).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.
Masking: Single (Investigator)
Primary purpose: Other
Post-prandial Glucose in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The study is designed to determine the extent to which foods containing different levels of
      plant-based ingredients affect blood glucose responses in healthy subjects.
    


Intervention name(s): no added plant-based ingredients to starchy meal; Low level plant-based ingredients added to starchy meal; Medium level plant-based ingredients added to starchy meal; High level plant-based ingredients added to starchy meal
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): no added plant-based ingredients to starchy meal; Low level plant-based ingredients added to starchy meal; Medium level plant-based ingredients added to starchy meal; High level plant-based ingredients added to starchy meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Blood glucose
Collection of Information-Rich Type 1 Diabetes Data
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The aim of this clinical study was to obtain type 1 diabetes data to identify models for
      glucose prediction and control and to construct a physiological
      pharmaco-kinetic/pharmaco-dynamic computer model of a type 1 diabetic person.
    


Intervention name(s): Insulin Aspart; Exercise; Carbohydrate
Intervention type(s): Drug; Other; Dietary Supplement
Intervention description(s): Insulin bolus with and without carbohydrate intake.; Exercise on tread mill; Carbohydrate intake
Intervention MeSH terms: Insulin Aspart
Intervention model: Single Group Assignment
Primary purpose: Prevention
Keywords: Artificial pancreas; Model predictive control; Virtual patient
A Study in Healthy Men to Test the Effects of Different Doses of BI 1467335 on MAO-B Activity in the Brain.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect of multiple oral dosing of high
      dose BI 1467335 over 28 days and multiple oral dosing of low dose BI 1467335 over 42 days on
      MAO-B occupancy in the brain compared to baseline using [11C]-L-deprenyl-D2 PET tracer in
      healthy male subjects.
    


Intervention name(s): BI 1467335
Intervention type(s): Drug
Intervention description(s): tablet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3502970 in Healthy Overweight and Obese Participants
Condition: Healthy; Obese
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in
      healthy overweight and obese participants. The blood tests will be conducted to measure how
      much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in
      these participants. The study will last up to 42 days excluding the screening period.
    


Intervention name(s): LY3502970
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Safety and Tolerability; LY3502970
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of
      AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation.
      The safety and efficacy of 12 weeks of administration will also be evaluated.
    


Intervention name(s): AJG555
Intervention type(s): Drug
Intervention description(s): Participants will receive 1 to 6 sachets daily per participants' age and conditions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AJG555; Constipation; Phase 3; Pediatric participants
Comparison of Cardiotoxicity Induced by Selective Estrogen REceptor Modulators and aNti-Aromatase
Condition: Cardiac Affections
MeSH terms: Cardiotoxicity
Study type: Observational

Summary: 
      Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast
      cancer seems to have an impact on the cardio-vascular system. This study investigates reports
      of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC)
      classification: L02 in the European pharmacovigilance database, Eudravigilance.
    

Detailed description: 
      Hormone replacement therapies and contraceptive pills are responsible of a wide range of
      cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart
      disease. The difference of incidence and type of cardio-vascular events between men and women
      are strongly related to sex hormones. This study investigates the main characteristics of
      patients affected by cardiovascular side effects (of which ventricular arrhythmia's, QT
      prolongation and Torsade de Pointe) imputed to drugs classified as L02 according to ATC.
    

Intervention name(s): Hormonal therapies L02 in the ATC classification
Intervention type(s): Drug
Intervention description(s): Hormonal therapies L02 in the ATC classification
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The population is selected in the Eurodravigilance database from 01/2002 to 08/2017 and
        included patients treated with hormonal therapies L02 in the ATC classification.
      
Keywords: Cardiotoxicity; selective estrogen receptor modulators; aromatase inhibitors; hormone replacement therapy; estrogen
A Study of Two Different Formulations of LY3074828 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at the amount of the study drug, LY3074828, that gets
      into the blood stream and how long it takes the body to get rid of LY3074828 when given as
      different formulations. The tolerability of LY3074828 will also be evaluated and information
      about any side effects experienced will be collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be approximately 13 weeks, not including
      screening.
    


Intervention name(s): LY3074828
Intervention type(s): Biological
Intervention description(s): Administered SC
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Economic Outcomes of EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) in T2D Patients Who Are New to Injectable Therapy
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Primary objective of this study is to compare diabetes-related healthcare utilization and
      costs in patients initiating exenatide once weekly vs insulin glargine.
    

Detailed description: 
      This retrospective, observational cohort analysis will assess medical and pharmacy claims for
      adult patients with type 2 diabetes from the Truven Health MarketScan® Commercial and
      Medicare Supplemental claims databases between 2011 and 2015. Diabetes-related healthcare
      utilization and costs will be measured as a primary outcome. Secondary outcomes include
      all-cause healthcare utilization and costs, major adverse cardiovascular event (MACE)-related
      utilization and costs, and medically attended hypoglycemia events.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Commercial Insurance
      
Keywords: Diabetes Mellitus Type 2
A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of Flavoxate
      Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas®
      tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions.
    


Intervention name(s): Flavoxate Hydrochloride Tablets, 100mg; Urispas® Tablets, 100mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Flavoxate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laryngeal Disorders and GERD in Assiut University
Condition: Laryngeal Disease
MeSH terms: Laryngeal Diseases
Study type: Observational

Summary: 
      Study laryngeal disorders by laryngoscopic examination by two physicians on GERD patients
      diagnosed by gastroenterology department by endoscopy and effect of GERD treatment for 3
      months on these laryngeal disorders without any treatment to laryngeal disorders
    


Intervention name(s): Laryngoscopy
Intervention type(s): Device
Intervention description(s): Laryngoscopic examination of patients with GERD by two physicians
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who diagnosed GERD by gastroenterology department before start of treatment of
        GERD Will examine by laryngoscopy for laryngeal lesions then they Will take treatment to
        GERD by gastroenterology department without any treatment to laryngeal disorders and study
        effect of GERD treatment on these laryngeal disorders
13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a follow-on, multi-centre, open-label, clinical trial. The purpose of this trial is
      to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in
      children who have received either the PCV7 or PCV13 primary immunisation at 2, 4 and 12
      months of age. We intend to recruit all interested participants who completed the
      Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e. those
      that recruited the majority of the children in the original study). The study will start in
      March 2010, at which time the eldest participants in the 6096A1-007 study will be
      approximately 42 months of age. There will be two visits per participant, 1 month apart from
      each other. At visit one, all participants will have a blood test and receive a dose of
      PCV13. At visit 2, all participants will have a blood test and will be offered the remaining
      pre-school booster vaccinations unless they have already received them.
    


Intervention name(s): PCV13
Intervention type(s): Biological
Intervention description(s): Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.
Other intervention name(s): 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: 7 valent Pneumococcal conjugate vaccine; 13 valent Pneumococcal conjugate vaccine; PCV13; PCV7
Multiple Dose Study of DS-1971a
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, placebo-controlled multiple dose study designed to
      explore the safety, tolerability and PK of DS-1971a following oral administration over 14
      days to healthy male subjects.
    


Intervention name(s): DS-1971a; placebo
Intervention type(s): Drug; Drug
Intervention description(s): suspension; placebo matching DS-1971a
Intervention MeSH terms: DS-1971a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; pharmacokinetics; DS-1971a
Sleep Disordered Breathing and Chronic Pain
Condition: Sleep Apnea Syndromes
MeSH terms: Sleep Apnea Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate positive pressure in patients with chronic pain
      taking opioid medications who have sleep disordered breathing.
    

Detailed description: 
      Purpose: Opioid treatment of non-malignant chronic pain can result in hypoxemia, hypercarbia,
      and central sleep apnea. The aim of this study was to determine the initial efficacy of auto
      servo-ventilation (ASV) and after 3 months of home use.

      Methods: This prospective multicenter interventional study recruited chronic pain patients
      prescribed ≥100 morphine equivalents for at least 4 months.

      Participants: Following full-night polysomnography (PSG) to confirm the presence of
      sleep-disordered breathing, patients were randomized to three additional full-night-attended
      PSGs with continuous positive airway pressure (CPAP), ASV, and servo-ventilation with an
      initial mandatory pressure support of 6 cm water (H2O) ASV manual Minimum Pressure Support
      (PSmin). Following the PSGs, patients were sent home with EncoreAnywhere and ASV with or
      without mandatory pressure support.
    

Intervention name(s): servo ventilation auto; Continuous positive airway pressure; servo ventilation manual
Intervention type(s): Device; Device; Device
Intervention description(s): Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.; continuous positive airway pressure; servo ventilation titrated in manual mode
Other intervention name(s): CPAP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: chronic pain; sleep disordered breathing; Opioids
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective to assess the long-term safety and tolerability of LOU064 in patients with
      chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)
    

Detailed description: 
      This was an open-label, single-arm, multicenter, long-term safety and tolerability extension
      study for CSU patients rolling over from study CLOU064A2201 (NCT03926611).

      Subjects rolling over from CLOU064A2201 with a weekly Urticaria Activity Score (UAS7)<16
      after the follow-up period at Week 16 were further followed up without receiving LOU064 for
      up to 12 weeks (observational period). If there was a relapse (UAS7≥16 at least once), the
      12-week observational period was terminated, and subjects entered the treatment period.
      Subjects who never relapsed within 12 weeks completed the study after the observational
      period without treatment.

      Subjects who rolled over from CLOU064A2201 with a UAS7≥16 at Week 12 or Week 16, as well as
      those subjects who relapsed during the 12-week observational period, were treated with 100 mg
      LOU064 twice a day (b.i.d.) open-label for 52 weeks. No background medication with a
      second-generation H1-antihistamine was permitted up to Week 4 of the treatment period.
      Subjects who completed the treatment period or who discontinued treatment early were
      followed-up for a minimum duration of 4 weeks. Subjects who had a UAS7≤6 at Week 52 of the
      treatment period had their follow-up period extended until relapse (UAS7≥16) for up to a
      total of 16 weeks.
    

Intervention name(s): LOU064
Intervention type(s): Drug
Intervention description(s): Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered LOU064 50mg capsules b.i.d. (i.e. two capsules of LOU064 50mg in the morning and two capsules of LOU064 50mg in the evening) from Day 1 up to Week 52 of the Treatment period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic spontaneous urticaria; BTK Inhibitor; Long term safety; Urticaria activity score
Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA
Condition: Post Operative Pain; Total Knee Replacement
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparative efficacy of 24 and 48 hours post operative pain control in single total knee
      replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or
      0.5 % bupivacaine for single femoral nerve block
    


Intervention name(s): morphine and bupivacaine; spinal morphine and marcaine; morphine and bupivacaine; morphine and bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block; 0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block; 0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block; 0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block
Other intervention name(s): marcaine; marcaine; marcaine; marcaine
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of ascending single oral doses greater
      than 500 mg of AEB071 in healthy subjects
    


Intervention name(s): AEB071
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Safety, tolerability, pharmacokinetics, pharmacodynamics, AEB071, healthy subjects, transplantation