bioihbjkbjnl/mcl2 huggingface dataset:
Success of Zirconia and Composite Strip Crowns for Primary Incisors
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the clinical and radiographic
      performance of zirconia and composite strip crowns bonded on primary incisors
    

Detailed description: 
      Zirconia and composite strip crowns will be placed on at least two primary incisor teeth, in
      a split mouth design. A caries-free primary incisor tooth will be used as control. 100
      patients will be included in the study. The teeth will be randomized into two groups
      according to the crown type.

      Group 1: Zirconia crown 2: Composite Strip Crown 3: Control tooth. Plaque index, gingival
      index, crown retention, presence of restoration failure, gingival margin extension, color
      match of the crowns and pulpal health of the teeth will be clinically evaluated at baseline
      and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6.,
      12. and 18. months. Intra-oral photos will be taken directly after treatment and at control
      appointments.

      The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square
      test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.
    

Intervention name(s): Zirconia crown; composite strip crown
Intervention type(s): Device; Device
Intervention description(s): Esthetic crowns for capping primary incisor with caries; Esthetic resin restoration for primary incisor with caries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: zirconia crowns, composite strip crowns, dental caries
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is open to adults with depression (major depressive disorder) for whom standard
      treatment with antidepressants alone does not work sufficiently. The purpose of the trial is
      to find out whether a medicine called BI 1358894 helps to improve symptoms of depression.
      Four different doses of BI 1358894 are tested in the study. Participants continue their
      standard antidepressant therapy throughout the study. Participants are put into 6 groups by
      chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo.
      Participants in the fifth group take quetiapine, a medicine already used to treat depression,
      and placebo. Participants in the sixth group take placebo only.

      Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI
      1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets
      twice a day. Participants are in the study for about 3 months. During this time, they visit
      the study site about 8 times and get about 2 phone calls. At the visits, doctors ask
      participants about their symptoms.

      The results between the BI 1358894 groups, the quetiapine group, and the placebo group are
      then compared. The doctors also regularly check the general health of the participants.
    


Intervention name(s): BI 1358894; Placebo; Quetiapine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 1358894; Placebo; quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Applicability of Uroflowmetry in Children With Cerebral Palsy
Condition: Cerebral Palsy; Lower Urinary Tract Symptoms
MeSH terms: Paralysis; Cerebral Palsy; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      Until now, the use of invasive urodynamics with use of catheters is still the gold standard
      for lower urinary tract evaluation in subjects with CP. This suggests a psychological and
      physical impact of invasive urodynamics in subjects with CP and further demonstrates the need
      to avoid standard use of invasive urodynamics in children and adults with CP.

      The current study will evaluate usefulness of uroflowmetry, correlation between uroflowmetry
      parameters and different lower urinary tract symptoms will be investigated. Secondly, results
      of uroflowmetry indicating possible vulnerability of the upper urinary tract will be defined.
    

Detailed description: 
      A cross-sectional case-control study comparing children with CP and LUTS and children with CP
      without LUTS will be conducted with the primary objective to investigate correlation between
      uroflowmetry parameters and different LUTS.

      Children will be evaluated with uroflowmetry and subsequent post void residual measurement
      and the validated vancouver symptom score for dysfunctional elimination syndrome.
    

Intervention name(s): uroflow measurement; Bladder ultrasound
Intervention type(s): Device; Device
Intervention description(s): Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie; Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700
Other intervention name(s): uroflowmetry; US
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children will be randomised in two groups, with evaluation with a standard toilet seat or a toilet seat with decreased hip angle.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: cerebral palsy; lower urinary tract symptoms; incontinence; uroflow measurement
Cataract Surgery In Patients With Advanced Age
Condition: Cataract Senile
MeSH terms: Cataract
Study type: Observational

Summary: 
      This study evaluates and compares clinical outcomes of < 85 and ≥ 85 year old patients who
      underwent cataract surgeries.
    

Detailed description: 
      The medical records of patients who were underwent cataract surgery between January 2014 and
      October 2017 were investigated retrospectively and patients 65 years and older were
      recruited. Two groups were made according to age: group1 composed of patients age range
      between 65 and 85 years and group 2 composed of patients 85 years and older. Gender, presence
      of diabetes mellitus (DM), hypertension (HT), drug use were noted.

      The results of best corrected visual acuity (BCVA) converted to LogMar, intraocular pressure
      (IOP) before and 3 months after operation, biomicroscopic and fundus examinations were
      investigated.

      Additional ocular diseases such as glaucoma, age related macular degeneration (AMD),
      pseudoexfoliation syndrome, retinopathies and maculopathies related to systemic diseases were
      noted. Pupil dilation properties were also noted as poor, mid or full pupil dilation.

      Cataract surgery techniques such as phacoemulsification, extra- and intracapsular lens
      extractions, peroperative complications, intracameral drug use were investigated.

      these aforementioned outcomes evaluated and compared between groups.
    

Intervention name(s): Cataract Surgery
Intervention type(s): Procedure
Intervention description(s): Cataract surgery was performed by using phacoemulsification technique, routinely. But other techniques for instance extra or intracapsular cataract extraction (ECCE, ICCE) techniques were performed when needed. Phacoemulsification technique was performed by 2 experienced surgeon (G.A. and E.C.) under topical anesthesia, thorough limbal incision. Foldable single piece hydrophobic acrylic intraocular lens (IOL) was inserted in the bag. In the presence of complications related to anterior or posterior capsules, 3 pieces IOL was preferred. When ECCE technique was chosen, single piece polymethyl methacrylate IOL was inserted.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients aged 65 years and older who underwent cataract surgery
      
Keywords: geriatry; cataract surgery; advanced age
Health Professions Students and Faculty Perceptions of Poisoning Severity
Condition: Poisoning
MeSH terms: Poisoning
Study type: Observational

Summary: 
      Inaccurate perceptions of the severity of an exposure may result in unnecessary visits to the
      Emergency Department or Health Care Facility which can result in crowding of Emergency
      Departments, unnecessary utilization of valuable health care resources, unnecessary
      treatments, and or mistakes / errors resulting in harm to the patient.

      Inaccurate perceptions about the severity of an exposure can result in delays in proper
      evaluation and treatment resulting in harm or in some cases death of the patient.
    

Detailed description: 
      Consumers and health professionals are often surprised about the toxicity (or lack of
      toxicity) after exposure to a number of pharmaceutical or non-pharmaceutical agents. Past
      experience with the survey used in this study has indicated that consumers and health
      professional perform about the same. Most individuals answer less than 50% of questions
      incorrectly.

      Pharmacy students will be asked to participate in a short (5-7 minutes) survey (see below)
      that contains 21-short cases involving an exposure to a pharmaceutical or non-pharmaceutical
      agent. All cases involve children less than 19 years of age. Participants will be asked to
      indicate their year in pharmacy school (1st or 2nd) and their gender (f/m). The survey will
      be given after a scheduled examination or other classroom activity and will not involve class
      time. Students will be provided a link to an online version of the survey.

      Conclusions will be derived through the analysis of the data. At a later date, all students
      in the class (whether they participated in the survey or not)students will be provided a link
      to video that describes the correct answers to each of the cases and an explanation.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Pharmacy students will be asked to participate in a short (5-7 minutes) survey (see below) that contains 21-short cases involving an exposure to a pharmaceutical or non-pharmaceutical agent. All cases involve children less than 19 years of age. Participants will be asked to indicate their year in pharmacy school (1st or 2nd) and their gender (female/male).
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pharmacy students in their 1st or 2nd year of pharmacy school.
Treatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      -  All participants will be divided into 2 groups : Group A & Group B.

        -  Group A will be subjected to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser
           to one side of the face & fractional co2 laser to the other side of the face with one
           month interval between sessions.

        -  Group B will be subjected also to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG
           laser to one side of the face & an additional fractional co2 laser to the other side of
           the face using the above mentioned parameters with one month interval between sessions.

        -  Response to treatment will be assessed using the Melanin Index (MI) score, Melasma Area
           and Severity Index (MASI) score, spectrophotometer ( Derma catch, colorix, Neuchatel,
           Switzerland ) and a subjective self-assessment method.
    


Intervention name(s): Q switched Nd YAG laser; Fractional CO2 laser
Intervention type(s): Device; Device
Intervention description(s): Laser device emitting Q switched Nd YAG aiming for skin toning; Laser device emitting fractionated ablative laser aiming for skin resurfacing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
      activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
      to normal participants. Until recently, the search for medicines to activate pharyngeal
      muscles in sleeping humans has been discouraging. However, exciting new animal research has
      shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle
      activity to waking levels. In this protocol the investigators will test the effect of
      desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects)
      on upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA
      patients.
    

Detailed description: 
      Two overnight sleep studies, a placebo night and a drug night, will be performed
      approximately one week apart in random order. The placebo or drug will be administered 2
      hours before lights out. At least 15 minutes of quiet wakefulness will be recorded to
      quantify the participant's EMG GG activity while awake and at sleep onset (alpha-theta
      transition at the electroencephalogram).

      During the second part of the night, the participants will be connected to a modified
      continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide
      a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure
      and measure pharyngeal critical collapsing pressure (Pcrit), ventilation at 0 cmH2O when UA
      muscle are passive and active as well as change in EMG GG as a function of epiglottic
      pressure (muscle responsiveness).

      Apnea-hypopnea index (AHI) will be calculated in each night from the part of the study off
      CPAP.
    

Intervention name(s): Desipramine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg administered 2 hours before normal sleep time; Placebo-matching desipramine administered 2 hours before normal sleep time
Other intervention name(s): Norpramine
Intervention MeSH terms: Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Controlled Human Pneumococcal Infection Model (PIM) Study
Condition: Streptococcus Pneumoniae Infection
MeSH terms: Infections; Communicable Diseases; Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Interventional

Summary: 
      Infection with Streptococcus pneumoniae (the pneumococcus) is the leading cause of pneumonia,
      bacterial meningitis and bacteraemia worldwide in the very young and the elderly. Although
      pneumococcal vaccines exist, they do not provide complete protection and new strategies to
      combat this pathogen are urgently needed. Asymptomatic infection of S. pneumoniae in the
      human nasopharynx precedes the development of pneumococcal disease. Previously, an
      Experimental Human Pneumococcal Carriage (EHPC) model has been developed at the Liverpool
      School of Tropical Medicine (LSTM). The current study entails to establish this model in
      healthy adults living in the Netherlands using the inoculation dose currently used at LSTM.

      Healthy adult participants (M/F) will be inoculated intranasally with strain BHN418, a
      penicillin sensitive serotype 6B strain of S. pneumoniae that was previously isolated from a
      healthy carrier. Following inoculation, participants will be monitored and blood and nasal
      samples will be collected over a period of 28 ± 3 days. Participants will receive a course of
      amoxicillin to eradicate infection on or shortly after the last visit at day 28 ± 3, unless
      S. pneumoniae is not detected on both day 14 and 28 ± 3 post-inoculation.
    


Intervention name(s): Sp_6B; Amoxicillin 500 mg
Intervention type(s): Biological; Drug
Intervention description(s): Intranasal inoculation of Streptococcus pneumoniae serotype 6B, 160,000 colony forming units (CFU); Amoxicillin, 7 days, 2x 500 mg
Intervention MeSH terms: Amoxicillin
Intervention model: Single Group Assignment
Intervention model description: Single dose open label intervention study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Controlled human infection model; Streptococcus pneumoniae; Asymptomatic infection; Colonization; Healthy adults
Short- and Long Term Growth in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess if treatment with budesonide 200 microgram per day
      affects short- or long term growth in children with asthma
    

Detailed description: 
      When children with asthma are treated with inhaled corticosteroids there is a risk of
      systemic adverse events such as growth suppression. It has been reported that treatment with
      budesonide 200 microgram per day does not affect short term growth in children with asthma.
      The aim of the present study is to assess if an unaffected short term growth means that also
      long term growth will be unaffected.

      Short and long term growth in asthmatic children treated with budesonide will be compared
      with the growth in asthmatic children treated with montelukast.
    

Intervention name(s): Budesonide; Montelukast
Intervention type(s): Drug; Drug
Intervention description(s): 200µg daily; 5 mg daily
Other intervention name(s): Singulair
Intervention MeSH terms: Budesonide; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pharmacokinetics of BAF312 in Patients With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate
      and severe hepatic impairment compared to healthy control subjects.
    


Intervention name(s): BAF312
Intervention type(s): Drug
Intervention description(s): Treatment with a single oral dose of 0.25 mg BAF312
Intervention MeSH terms: Siponimod
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: BAF312; Pharmacokinetics; Hepatic impairment
Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
Condition: Diabetes; Insulin Resistance; Inflammation; Cardiovascular Disease; Periodontal Disease
MeSH terms: Periodontal Diseases; Cardiovascular Diseases; Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      We hypothesize that Asian Americans compared to Caucasians, will be at higher risk of
      developing a pro-inflammatory state that may contribute to the development of heart disease
      and diabetes when they change from a traditional Asian diet to a typical Western diet. These
      inflammatory responses will be reflected by the activation of monocytes as measured by
      protein kinase C (PKC), a known activator of monocytes.

      We also hypothesize that the changes of these inflammatory responses in the gingival
      crevicular fluid (GCF) will reflect similar changes of these markers in the plasma and
      monocytes.

      Specific aims:

        1. To compare the inflammatory responses (primarily PKC activation in monocytes), between
           Far-East Asian Americans and Caucasian Americans, when they change from a traditional
           Asian diet to a typical American diet.

        2. To correlate the biochemical changes of inflammatory responses in the plasma and
           monocytes with those in the gingival crevicular fluid (GCF).
    


Intervention name(s): 2 groups of population responding to 2 types of diets
Intervention type(s): Behavioral
Intervention description(s): Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Surgical Evacuation of Abortion Under Ultrasonographic Guide
Condition: Abortion
Study type: Interventional
Phase: Phase 2

Summary: 
      The abortion considers the most common cause of fetal demise all over the world. The majority
      of cases occur in the first trimester.The termination of abortion may be by medical or
      surgical methods, however; the surgical methods represents the greater part of termination.
      Therefore, the safety of this procedure is a worldwide public health concern . Many clinical
      studies have been reported the safety of surgical evacuation in the first trimester.

      The suction-aspiration or vacuum aspiration are the most common surgical methods of induced
      abortion. This consists of removing the fetus, embryo, placenta, and membranes by suction
      using a manual syringe or electric pump. However; these technique always need cervical
      dilation before aspiration. The menstrual extraction does not require cervical dilation and
      can be used in very early pregnancy.

      The surgical evacuation is generally considered safe, however; short-term complications are
      reported due to need of dilatation of the cervix and incomplete evacuation because the
      surgeon is the only one who can decide the end of the operation depending on his subjective
      sense.

      However; with continuous ultrasound guidance, the process could be almost complete because
      the ultrasound can accurately identify the direction and size of the uterus, position of the
      gestational sac, observe the insertion of surgical instruments and the advancement of the
      operation especially when the configuration of the uterus is distorted.

      At present; ultrasonography is not considered to be an essential pre-requisite for abortion
      in all cases so our study aims to detect if complete evacuation can be achieved by
      ultrasonographic assistance or not. We also tried in this study to compare the operative
      time, amount of blood loss and the occurrence of accidental uterine perforation during the
      procedure with and without use of ultrasound.
    


Intervention name(s): Blinded evacuation; Evacuation under ultrasound guidance
Intervention type(s): Procedure; Procedure
Intervention description(s): Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation.; Ring evacuation was performed under ultrasound guidance followed by sharp gentle curettage until complete evacuation. The surgery was considered complete when the endometrial cavity appeared as a regular echogenic line.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention