bioihbjkbjnl/mcl2 huggingface dataset:
Age and Number of Previous Anesthesia on the Development of Mild Cognitive Decline (MCI)
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      Mild Cognitive Impairment (MCI), diagnosed with Montreal Cognitive assessment test (MoCA)
      define a condition that is insufficient to meet the threshold for a diagnosis of dementia,
      and it is an increasing health problem.

      It has been related to age and comorbilities, but the linkage between MCI and number of
      previous anesthesia is still unclear.
    

Detailed description: 
      Mild Cognitive Impairment (MCI) is a common neuropsychiatric term encompassing a
      greater-than-expected cognitive decline for patient's age and schooling and no more than mild
      functional impairment that is insufficient to meet the threshold for a diagnosis of dementia
      (DSM-V: "mild neurocognitive disorder") thus forming part of a declining cognitive
      trajectory.

      For the diagnosis of MCI, the core clinical criteria are: concern about a change in
      cognition, impairment in one or more cognitive domains, preservation of independence in
      functional abilities and no presence of dementia.

      The Montreal Cognitive Assessment (MoCA), a test that was developed specifically for
      detection of MCI, has a sensitivity of 80 to 100% and specificity of 50 to 76% using a
      cut-off point of 25 to make diagnosis, and it has been suggested that it is better than Mini
      Mental Status Evaluation (MMSE) in accurately differentiating individuals with MCI from those
      with normal cognition.

      Various risk factors have been proposed for MCI, in particular the role of multiple
      biological, behavioural, social and environmental factors have been investigated.

      Of them, increasing in age, lower educational level, sleep-disordered breathing and vascular
      risk factors (e.g. diabetes and hypertension) seem to be the most important.

      It has been estimated that MCI is itself a risk factor both for dementia (it converts to
      dementia at a rate of 10% per year, for delirium and Post-Operative Cognitive Decline (POCD).

      Hence, this study aims to investigate the incidence of MCI in cardiac-surgery adult patients,
      enlisted for Coronary Artery By-Pass Grafting (CABG) or Valve Surgery, and to investigate the
      role of previous general anaesthesia in anamnesis as a risk factor for MCI evenience.
    

Intervention name(s): Montreal Cognitive Assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Neuro-cognitive test evaluating general mental status and performance
Other intervention name(s): MoCA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective Observational Case-Control
Observational Study to Evaluate Bipolar Disorder Symptoms in Patients Presented With Schizophrenia or Depression
Condition: Schizophrenia; Schizoaffective Disorder; Recurrent Depression
MeSH terms: Recurrence; Depression; Depressive Disorder; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Observational

Summary: 
      This study is aimed to evaluate the bipolar disorder symptoms in patients presented with
      schizophrenia, schizoaffective disorder or recurrent depression.

      Bipolar disorder is a group of mood disorders characterised by elevated or irritable mood
      episodes in patient's lifetime history accompanied by some additional symptoms. In this study
      modern bipolar disorders screening/assessment instruments will be used to explore the
      prevalence of bipolarity symptoms in patients who never been diagnosed with bipolar
      disorders. The results of this study could be useful for more accurate assessment of bipolar
      disorders prevalence in psychiatric patient population, could help to improve the diagnostics
      of bipolar disorders and management of bipolar patients.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients having current diagnosis of schizophrenia/ schizoaffective disorder (in-patients)
        and patients having current diagnosis of recurrent depression (both in-patients and
        out-patients) will be included into this study.
      
Keywords: schizophrenia; schizoaffective disorder; recurrent depression; Bipolar disorders
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS
      113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a
      5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for
      dermatologic effects. The Isis Project Physician(s) will observe the injection sites on Study
      Day 2 and may also observe on Study Day 8.

      Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Day 1
      and Day 8. Subjects will be contacted by telephone on Study Day 30 to monitor for the
      occurrence of new serious adverse events (SAEs). Thereafter, the subjects will be discharged
      from the study.
    

Detailed description: 
      Following a two-week period for subject screening, 10 eligible subjects will be dosed
      subcutaneously with ISIS 113715 on a single calendar date (Study Day 1). Each subject will
      receive two subcutaneous injections given within a 5-minute period. The first injection will
      be 200 mg ISIS 113715 given in 1.0 mL and will be injected about 7.5 cm to the left of the
      umbilicus. The second injection will be 200 mg ISIS 113715 given in 2.0 mL and will be
      injected about 7.5 cm to the right of the umbilicus. Both injections will be delivered using
      3.0-mL syringes outfitted with 30-gauge, 0.5-inch needles. To further minimize variability,
      all injections will be performed by a single individual, the Investigator or his designee,
      employing uniform technique for all of the injections.

      Dermatologic responses at injection sites will be assessed at 1 and 7 days after the
      injections (Study Days 2 and 8, respectively). Effects will be evaluated through completion
      of the Injection Site Assessment Questionnaires by the Investigator and the recording of
      adverse events reported by the subject or observed by the Investigator. The Isis Project
      Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study
      Day 8.

      Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Days
      1 (prior to administration of ISIS 113715) and 8.

      Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new
      serious adverse events. Thereafter, the subjects will be discharged from the study.
    

Intervention name(s): ISIS 113715
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Injection Site Reaction; Subcutaneous administration; Dermatological effects; Antisense
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bioequivalence of the metformin component of the
      Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet
      coadministered with canagliflozin in healthy fed and fasted participants.
    


Intervention name(s): Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]; Canagliflozin; Metformin Extended Release (XR)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 500 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.; Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.; Participants will receive 1 metformin XR tablet of 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and the United States of America (USA). The aim of this
      clinical trial is to investigate the safety, tolerability, pharmacokinetics (the
      determination of the concentration of the administered medication in blood over time) and
      pharmacodynamics (the determination of the effect over time and the duration of action) of
      multiple doses of liraglutide in the pediatric population (children).
    


Intervention name(s): liraglutide; placebo; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg); Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg); Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).; Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Protocol to Streamline Dental Care in Autistic Children
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The investigators aim at creating a dedicated pathway to allow accessibility to dental care
      for ASD children within a hospital Dentistry Department, in order to diminish the need for
      general anesthesia. Visual pedagogy, parent training, a strict schedule for appointments
      (every two months) spanning over three years and longer duration of dedicated examination are
      set up for a group of ASD children, whose behavior is compared to that of children seen one
      or twice a year.
    

Detailed description: 
      Treated group:

      Enrollment: caregivers receive instructions and a visual pedagogy aid with instructions for
      toothbrushing. They complete also enrollment and informed consent forms.

      At the first visit: caregivers receive a dental mirror to be used at home. Children are free
      to explore the office and dental room.

      Subsequent visits, every two months for three years: trials are made to establish contact
      with children, make them seat at the dentist's chair, execute dental visits and treatments as
      needed.

      Control group: subjects (similar inclusion and exclusion criteria) that access the Department
      for clinical reasons or control visits, but cannot comply with the strict two-months
      schedule.
    

Intervention name(s): Behavioral support
Intervention type(s): Behavioral
Intervention description(s): Behavioral support as described under 'Arm description'.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Both treated and control groups will receive the same clinical intervention (dental care) when needed. Treated group will have visits every two months, visual pedagogy and caregiver instructions for oral hygiene maintenance at home. Control group will receive dentist visits twice a year (or more often if clinically required) according to Italian Ministry of Health guidelines for pediatric dentistry.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Dentistry
Diet, Obesity and Cardiovascular Risk Study
Condition: Cardiovascular Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Obesity
Study type: Interventional

Summary: 
      Controversy exists about the role of dietary glycemic index (GI) and fat content and
      cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI,
      carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein
      (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index
      values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks,
      then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with
      calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight
      conditions, and in the free-living state for 48 weeks.
    


Intervention name(s): Diet
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision
Condition: Pain, Postoperative; Gallstone
MeSH terms: Gallstones; Pain, Postoperative
Study type: Interventional

Summary: 
      This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between
      infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy
    

Detailed description: 
      Infra-umbilical wound have been used for a while with aim at improving cosmoses of the
      incision. Formerly, standard incision for laparoscopic cholecystectomy was infra-umbilical
      wound. However, no study directly compare these types of incisions in term of postoperative
      pain, wound infection, and patient satisfaction.
    

Intervention name(s): transumbilical incision; Infra umbilical incision
Intervention type(s): Procedure; Procedure
Intervention description(s): incision within umbilicus; incision about 1 cm below umbilicus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Beta-blocker Therapy on QTc Response in Exercise and Recovery in Normal Subjects
Condition: Long QT Syndrome; Cardiac Repolarization
MeSH terms: Long QT Syndrome
Study type: Interventional

Summary: 
      Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia
      are usually triggered by exercise and can be prevented in most patients by beta-blocker
      therapy. In addition, LQT1 associated with a normal resting QT interval can be unmasked by
      the abnormal QT response to exercise testing (failure of the QT interval to shorten
      normally). Preliminary data from our laboratory show that the exercise QT intervals of
      patients with LQT1 are partially normalized by beta-blocker therapy. It is still currently
      not known if beta-blockers modify the QT/heart rate relationship (a primary effect on
      repolarization) or if the "normalizing" effect is due to the inability of subjects on
      beta-blockers to attain sufficiently high workloads (due to reduced heart rate) for
      prolongation to occur. Moreover, the physiologic response of the exercise QT interval to
      beta-blockers in healthy control subjects is not known.

      Objective. The objective of this study is to define the impact of beta-blocker therapy on the
      QT response to exercise and recovery in normal subjects.

      Methods. Approximately 36 healthy adult subjects age-matched to previously studied LQT1
      subjects will undergo 1) screening history, 2) two weeks of beta-blocker therapy ending in an
      exercise test, and 3) two weeks of placebo therapy ending in an exercise test. Beta blocker
      and placebo will be given in random order in a double-blind fashion. The QT response to
      exercise and recovery will be compared between drug-free and beta-blocker-treated states.
      These data will be compared to those previously collected for LQT1 subjects.

      Implications. These results will provide new information about the effect of beta-blocker
      therapy on repolarization parameters in normal subjects, and will provide a context in which
      to interpret the previous findings that beta-blocker administration modifies the QT response
      to exercise in LQT1 subjects.
    


Intervention name(s): Placebo; Propranolol LA
Intervention type(s): Drug; Drug
Intervention description(s): Placebo will be given 1 pill daily for a week, then 2 pills daily, followed by the exercise test.; Subjects will receive propranolol LA 80 mg one pill daily for 1 week then 2 pills daily for 1 week followed by exercise test.
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: QT interval; beta-blocker; exercise; electrocardiogram; repolarizaton
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to address an Food Drug and Administration (FDA) request to
      provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following
      administration of fluticasone propionate HFA.
    

Detailed description: 
      A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and
      pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered
      twice-daily for 28 days delivered via an MDI and valved holding chamber with infant facemask
      to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in
      the preceding 6 months
    

Intervention name(s): FLOVENT (fluticasone propionate) HFA; Placebo HFA
Intervention type(s): Drug; Drug
Intervention description(s): FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask.; Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma infants FLOVENT spacer
Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form
      on Clinician Decision: observational study
    

Detailed description: 
      A main factor for planning any preventive program is to accurately assess a person's risk of
      developing a caries. Dental caries is a multifactorial disease and is affected by several
      factors, such as the patient's general health and diet, the amount and type of bacteria
      present in the oral cavity, salivary factors and exposure to fluoride.

      Thus, caries risk assessment approaches should take into account risk implications from
      various factors that influence carious activity Many caries risk assessment models had been
      developed to assess the caries for certain individual, this study will be carried out to
      measure the reproducibility between CAMBRA and cariogram model to evaluate if one of them is
      enough to be used as they give the same result or not
    

Intervention name(s): reproducability of caries risk assessment
Intervention type(s): Diagnostic Test
Intervention description(s): reproducability of caries risk assessment CAMBRA verses cariogram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients of both sex ,age from 18-40 with different oral hygiene and different dental
        condition but with good periodontal condition and no multiple extraction
      
Biospecimen description: 
      bacteria isolated from saliva
Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Human immunodeficiency virus (HIV) infection frequently involves combination drug therapy for
      its treatment; hence, it is important to understand their interactions and resulting changes
      in exposure which are associated with medications. This is a Phase-1, open-label,
      fixed-sequence 2-period, one-way drug interaction study to assess the pharmacokinetic (PK),
      safety, and tolerability of GSK3640254 and Tenofovir alafenamide/emtricitabine (TAF/FTC) when
      administered alone and in combination in healthy subjects. The study will consist of a
      screening period of 28 days before the first dose of study intervention followed by 2
      sequential treatment periods. Subjects will be administered TAF/FTC 25/200 milligram (mg)
      once daily (QD) on Days 1 to 14 of Period 1 followed by co-administration of TAF/FTC 25/200
      mg QD with GSK3640254 200 mg QD on Days 1 to 7 of Period 2.
    


Intervention name(s): Tenofovir alafenamide/emtricitabine; GSK3640254
Intervention type(s): Drug; Drug
Intervention description(s): TAF/FTC will be available as 25/200 milligrams (mg) tablet. Subjects will be administered TAF/FTC 25/200 mg QD via the oral route.; GSK3640254 will be available as 100 mg capsule. Subjects will be administered GSK3640254 200 mg capsule QD via the oral route.
Intervention MeSH terms: Tenofovir; Emtricitabine
Intervention model: Sequential Assignment
Intervention model description: This is a fixed-sequence 2-period, one-way drug interaction study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human immunodeficiency virus; Sequential; Tenofovir alafenamide; Emtricitabine; GSK3640254